US20120109279A1 - Apparatus and method of placement of a graft or graft system - Google Patents
Apparatus and method of placement of a graft or graft system Download PDFInfo
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- US20120109279A1 US20120109279A1 US13/287,907 US201113287907A US2012109279A1 US 20120109279 A1 US20120109279 A1 US 20120109279A1 US 201113287907 A US201113287907 A US 201113287907A US 2012109279 A1 US2012109279 A1 US 2012109279A1
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- prosthesis
- fenestration
- graft
- opening
- branch
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/954—Instruments specially adapted for placement or removal of stents or stent-grafts for placing stents or stent-grafts in a bifurcation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
- A61F2/97—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve the outer sleeve being splittable
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/89—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2002/061—Blood vessels provided with means for allowing access to secondary lumens
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2002/065—Y-shaped blood vessels
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
- A61F2002/075—Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2002/821—Ostial stents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0004—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable
- A61F2250/0008—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable for adjusting a position by translation along an axis or two perpendicular axes
Definitions
- 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.
- An abdominal aortic aneurysm is a sac caused by an abnormal dilation of the wall of the aorta, a major artery of the body, as it passes through the abdomen.
- the 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.
- SMA superior mesenteric artery
- the hypogastric arteries supply blood to the reproductive organs
- the subclavian arteries supply blood to the arms.
- 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.
- 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.
- 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.
- SMA superior mesenteric artery
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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 in FIG. 1 .
- FIG. 3 is a cross-sectional view of the endoluminal prosthesis deployed in the patient's anatomy, taken at 3 - 3 in FIG. 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 at 3 - 3 in FIG. 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 in FIG. 5A , showing the outer sheath in a partially retracted position.
- FIG. 6 is an oblique view of introducer catheter shown in FIGS. 5A and 5B .
- FIG. 7 is an exploded view the introducer catheter shown in FIGS. 5A and 5B .
- FIG. 8 is a close up view the delivery catheter shown in FIGS. 5A and 5B .
- FIG. 9 is an exploded view the delivery catheter shown in FIG. 5A .
- FIG. 10 is a sectional view of a portion 10 - 10 of delivery catheter shown in FIG. 5A .
- FIG. 11A is a sectional view of the delivery catheter shown in FIGS. 5A and 5B , taken at 11 A- 11 A in FIG. 10 .
- FIG. 11B is a sectional view the delivery catheter shown in FIGS. 5A and 5B , taken at 11 B- 11 B in FIG. 10 .
- FIG. 12 is a side view the catheter system shown in FIG. 5B , showing the outer sheath in a partially retracted position.
- FIG. 13 is an close up side view of the portion 13 - 13 of the catheter system shown in FIG. 12 , showing the outer sheath in a partially retracted position.
- FIG. 14 is an close up side view of the portion 14 - 14 of the catheter system shown in FIG. 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 in FIGS. 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 of FIG. 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 of FIG. 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 in FIG. 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 in FIG. 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 in FIG. 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 in FIG. 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 of FIG. 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 in FIG. 24B for clarity.
- FIG. 25 is a top view of the prosthesis of FIG. 24 .
- FIG. 26 is an enlarged view of a portion of the prosthesis of FIG. 24 , defined by curve 26 - 26 of FIG. 24B .
- FIG. 27 is a side view of the stent shown in FIG. 24 , perpendicular to an axis projecting through the fenestration.
- FIG. 28 is a side view of the stent shown in FIG. 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 in FIG. 29 .
- FIG. 31A is an end view of the fenestration alignment component illustrated in FIG. 29 .
- FIG. 31B is a sectional view through a portion of the fenestration alignment component, taken at 31 B- 31 B of FIG. 31A .
- FIG. 32 is an oblique view of a delivery catheter having the fenestration alignment component of FIG. 29 .
- FIG. 33 is an exploded view of the delivery catheter shown in FIG. 32 .
- FIG. 34 is a sectional view of a portion of a patient's vasculature, showing the fenestration alignment component illustrated in FIG. 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 in FIG. 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.
- 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.
- 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.
- the systems, methods, and apparatuses may have application to the treatment of blood vessels in animals.
- 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 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.
- 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.
- this can result in both freedom of circumferential and axial movement of the fenestrations, thereby improving the positional adjustability of the fenestrations.
- 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.
- 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.
- 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.
- 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.
- FIG. 1 shows an endoluminal prosthesis deployed in a patient's aorta 10 .
- An aneurysmal sac 10 A is also shown.
- FIG. 2 is a side view of the endoluminal prosthesis 20 illustrated in FIG. 1 .
- the endoluminal prosthesis 20 illustrated in FIGS. 1 and 2 has a main graft body 22 , a first fenestration 24 , and a second fenestration 26 .
- the main graft is a bifurcated graft having a first bifurcated branch 28 and a second bifurcated branch 30 for placement in the ipsilateral and contralateral iliac arteries.
- the main graft body 22 has a generally cylindrical, tubular shape.
- the endoluminal prosthesis 20 can be formed from any suitable material, such as, but not limited to, ePTFE.
- the endoluminal prosthesis 20 is formed from an expandable material.
- the endoluminal prosthesis 20 is formed such that the main graft body 22 can be sized to be larger than the target vessel into which the main graft body 22 is to be deployed. As illustrated in FIG. 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.
- the diameter of the graft body (such as without limitation the main graft body 22 ) 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 body 22 ) 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.
- 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.
- 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.
- the fenestrations can be adjusted to align with the ostium of the patient's branch vessels.
- the diameter of the main graft body 22 configured for placement in an approximately 26 mm vessel can be approximately 34 mm in diameter. Therefore, the diameter of the main graft body 22 can be approximately 8 mm larger than the diameter of the target vessel.
- the diameter of the main graft body 22 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 the main graft body 22 can provide excess or slack graft material in the main graft body 22 such that the fenestrations 24 , 26 can each be moved in an axial, rotational, or angular direction, or a combination thereof to align the fenestrations 24 , 26 with the branch vessels arteries, as will be described in greater detail below.
- two or more fenestrations can be formed in the main graft body 22 at any desired location.
- the two fenestrations 24 , 26 can be formed at generally diametrically opposed locations.
- any number of fenestrations can be formed in the main graft body 22 at any desired locations.
- scallops or cutouts can be formed in the distal end portion or at any suitable location in the main graft body 22 , the scallops or cutouts being configured to prevent obstruction of other arteries branching off of the main vessel into which the main graft body 22 is to be deployed.
- an additional fenestration 32 can be formed in a distal portion of the main graft body 22 .
- the fenestration 32 can be formed so as to align with a patient's SMA
- FIG. 3 is a cross-sectional view of the endoluminal prosthesis 20 deployed in the patient's anatomy, taken at 3 - 3 in FIG. 1 , as it might appear before the fenestrations 24 , 26 have become aligned with the respective branch vessels, for example renal arteries 12 , 14 .
- the main graft body 22 (which can be oversized) has been deployed in the target vessel.
- the main graft body 22 can have a larger diameter than the vessel diameter, folds, wrinkles, or other undulations (collectively referred to as folds) 34 can form in the main graft body 22 about the circumference of the main graft body 22 .
- the folds 34 can form in the main graft body 22 as a result of the fact that there can be excess or slack material in the main graft body 22 after the main graft body 22 has been deployed in the target vessel.
- At least a portion of the main graft body 22 can have undulations, folds, bends, corrugations, or other similar features in the axial direction therein when the main graft body 22 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 the endoluminal prosthesis 20 deployed in the patient's anatomy, taken at 3 - 3 in FIG. 1 , after the fenestrations 24 , 26 have become aligned with the respective branch vessels.
- the oversized main graft body 22 is aligned with the patient's anatomy by the fenestration 24 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.
- the fenestration 24 as it moves closer to the fenestration 26 , causes a gathering of slack material or folds 34 in a first portion 22 a of the main graft body 22 and partially or fully removing the slack material or folds from a second portion 22 b of the main graft body 22 .
- 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 the main graft body 22 can compress the folds 34 that are formed in the main graft body 22 , if any, against the wall of the vessel and secure the main graft body 22 and the fenestrations 24 , 26 in the desired locations.
- 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.
- 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.
- 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 a catheter system 1000 comprising an introducer catheter 1002 (also referred to as an introducer) and a delivery catheter 1004 .
- the delivery catheter 1004 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 a catheter system 1000 illustrated in FIG. 5A , showing an outer sheath 1006 of the delivery catheter 1004 in a partially retracted position.
- the outer sheath 1006 can be used to constrain at least a portion of a prosthesis 1010 .
- the prosthesis 1010 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 the prosthesis 1200 described below.
- the prosthesis 1010 can have any number of stents or other support members, connectors, grafts, cuts, fenestrations, or other suitable components or features.
- distal refers to the end of the prosthesis that is further from the patient's heart
- proximal refers to the end of the prosthesis that is closer to the patient's heart.
- distal refers to the end of the catheter system that is further from the surgeon or medical practitioner using the catheter system
- proximal refers to the end of the catheter system that is closer to the surgeon or medical practitioner.
- a distal sheath 1012 (also referred to herein as a first restraint or first restraining means) can be used to constrain a proximal portion of the stent graft 1010 .
- the distal sheath 1012 can be supported by (connected to) a distal tip 1014 of the catheter system 1000 .
- the distal tip 1014 can comprise an atraumatic material and design.
- the distal tip 1014 and, hence, the distal sheath 1012 can be attached to an inner tube 1016 to control the position of the distal tip 1014 and the distal sheath 1012 relative to an inner core 1020 of the delivery catheter 1004 .
- the inner core 1020 can be rotatable relative to the outer sheath 1006 so that a prosthesis supported by the delivery catheter 1004 can be rotated during deployment.
- the inner tube 1016 can be slidably positioned coaxially within a lumen in an outer tube 1018 that can connect a support member 1022 to the inner core 1020 .
- the outer tube 1018 can be connected to an opening or partial lumen 1019 in the inner core 1020 so as to be axially and rotationally fixed to the inner core 1020 .
- the catheter system 1000 can be configured such that advancing the inner tube 1016 relative to an inner core 1020 of the delivery catheter 1004 causes the distal sheath 1012 to advance relative to the prosthesis 1010 , causing the proximal portion of the prosthesis 1010 to be deployed.
- the prosthesis 1010 (or any other prosthesis disclosed herein) can be at least partially self-expanding such that, as the tubular distal sheath 1012 is advanced relative to the prosthesis 1010 , a proximal portion of the prosthesis 1010 expands against a vessel wall.
- only some segments or portions of the prosthesis 1010 such as, portions of the prosthesis axially adjacent to enlarged graft portions of the prosthesis, can be configured to be self-expanding.
- the inner core 1020 can be slidably received within the outer sheath 1006 of the delivery catheter 1004 .
- the outer sheath 1006 of the delivery catheter 1004 can be longer than an introducer sheath 1008 of the introducer catheter 1002 .
- a clip 1007 can be supported by the outer sheath 1006 to limit the range of axial movement of the outer sheath 1006 relative to the introducer catheter 1002 .
- a core assembly 1021 can be connected to a proximal end portion of the inner core 1020 , the core assembly 1021 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 the delivery catheter 1004 and be advanced into one or more lumen within the inner core 1020 .
- the inner core 1020 can be configured to accommodate the insertion of such sheath members, fenestration alignment components, or other tubular components into the lumen of the inner core 1020 .
- a proximal end portion of the core assembly 1021 can comprise a handle member 1023 that is positioned outside a proximal end portion of the delivery catheter 1004 so as to be accessible by a user.
- the handle member 1023 can be configured to permit a user to axially or rotationally adjust the position of the inner core 1020 relative to the outer sheath 1006 .
- the inner core 1020 can extend proximally past the proximal end portion 1004 a of the delivery catheter system 1004 so that a user can adjust and/or change the axial and/or radial position of the inner core 1020 and, hence, the prosthesis 1010 , relative to the outer sheath 1006 .
- the inner tube 1016 can extend proximally past the proximal end portion 1004 a of the delivery catheter 1004 and a proximal end portion 1021 a of the core assembly 1021 so that a user can adjust and change the position of the inner tube 1016 relative to the inner core 1020 .
- the prosthesis 1010 supported by the catheter system 1000 can be exposed and, potentially, deployed.
- a distal portion of the prosthesis 1010 can be exposed and deployed by retracting the outer sheath 1006 relative to the inner core 1020 or distally advancing the inner core 1020 relative to the outer sheath 1006 , causing at least a portion of the distal portion of the prosthesis 1010 to self-expand.
- the prosthesis 1010 can be configured to have radially self-expanding support members therein along only a portion or portions of the prosthesis 1010 .
- a graft of the prosthesis 1010 can be radially unsupported at or adjacent to fenestrations formed in the graft.
- at least the distal portion of the prosthesis 1010 can be constrained within a sheath, such as a peelable sheath. Embodiments of the sheath will be described in greater detail below.
- the delivery catheter 1004 can also have one or more branch or guide sheaths 1024 supported thereby.
- the delivery catheter 1004 can have three or more branch sheaths 1024 .
- Such a configuration can be used for deploying branch stents into one or more branch vessels in the thoracic aorta.
- Each of the one or more branch sheaths 1024 can be configured to be slidably supported within one or more lumen 1025 formed in the inner core 1020 so that each of the one or more branch sheaths 1024 can be axially advanced or retracted relative to the inner core 1020 .
- the delivery catheter 1004 can be configured such that the branch sheaths 1024 can be rotationally adjusted or twisted relative to the inner core 1020 .
- each branch sheath 1024 can be positioned within the delivery catheter 1004 such that, in the loaded configuration wherein a prosthesis 1010 is supported (compressed) within the delivery catheter 1004 , each branch sheath 1024 is pre-positioned so as to be advanced through a fenestration or branch graft of the prosthesis 1010 .
- Each branch sheath 1024 can be positioned within the delivery catheter 1004 such that a distal end portion of each branch sheath 1024 projects past an end portion of the inner core 1020 and is constrained within the outer sheath 1006 . As illustrated in FIGS. 5A-5B , in this configuration, the distal end portion of each branch sheath 1024 can be exposed by retracting the outer sheath 1006 relative to the inner core 1020 and/or the branch sheaths 1024 .
- the delivery catheter 1004 can have one or more fenestration alignment components 1026 supported thereby.
- the one or more fenestration alignment components 1026 can be slidably received within one or more lumen 1027 formed in the inner core 1020 .
- the one or more fenestration alignment components 1026 can each have an end portion 1026 a that can be sized and configured to surround an outer surface of each of the branch sheaths 1024 .
- each fenestration alignment component 1026 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 the prosthesis 1010 .
- a user can independently or collectively axially advance the fenestration alignment component 1026 over the branch sheaths 1024 such that the end portion 1026 a of each fenestration alignment component 1026 contacts the edge or surface adjacent to and surrounding the fenestration or branch graft of the prosthesis 1010 and pushes the fenestration or branch graft toward an ostium of the target branch vessel of the patient's vasculature.
- each of the one or more fenestration alignment components 1026 is configured to be slidably supported within a lumen formed in the inner core 1020 so that each of the one or more fenestration alignment components 1026 can be axially advanced relative to the inner core 1020 .
- the delivery catheter 1004 can be configured such that the fenestration alignment components 1026 can be axially or rotationally adjusted or twisted relative to the inner core 1020 , for increased maneuverability of the fenestration alignment components 1026 .
- each fenestration alignment component 1026 can be positioned within the delivery catheter 1004 such that, in the loaded configuration wherein a prosthesis 1010 is supported (compressed) within the delivery catheter 1004 , each fenestration alignment component 1026 is pre-positioned so that the end portion 1026 a of each fenestration alignment component 1026 is positioned distal to the end portion of the inner core 1020 . In the loaded configuration, each fenestration alignment component 1026 can be positioned such that the end portion 1026 a of each fenestration alignment component 1026 is located within the main lumen of the main body of the prosthesis 1010 .
- the branch sheaths 1024 and fenestration alignment components 1026 can have any suitable size and can be made from any suitable material.
- the branch sheaths 1024 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.
- the fenestration alignment components 1026 can be formed from stainless steel, Nitinol, or any other suitable metallic or non-metallic material, and can have a thickness suitable to prevent the fenestration alignment components 1026 from buckling when axially advanced against a portion of the prosthesis 1010 .
- the fenestration alignment components 1026 can have an approximately 1 Fr diameter, or between approximately a 1 Fr and approximately a 4 Fr diameter.
- the fenestration alignment component or catheters can be formed from a 0.035 in guidewire or otherwise have a 0.035 in diameter.
- the catheter system 1000 can be configured such that the distal sheath 1012 can be advanced relative to the inner core 1020 and the prosthesis 1010 , to expose a proximal portion of the prosthesis 1010 .
- advancing the distal sheath 1012 can be accomplished by advancing the inner tube 1016 connected to the distal tip 1014 and the distal sheath 1012 , so that the distal sheath 1012 releases the proximal portion of the prosthesis 1010 .
- Other details regarding the distal sheath 1012 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 the introducer catheter 1002 shown in FIG. 5A .
- the introducer catheter 1002 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.
- the introducer 1002 can have a main body 1030 , a threadably engageable hub portion 1032 , a threaded cap 1034 configured to threadably engage with a threaded distal end portion 1030 a of the main body 1030 so as to secure the outer sheath 1006 to the main body 1030 .
- the outer sheath 1006 can have a flanged end portion 1036 secured thereto or integrally formed therewith.
- the main body 1030 can support a seal assembly 1040 therein to seal around the inner core 1020 of the delivery catheter 1004 and/or other components of the catheter system 1000 .
- a threaded end member 1042 having a threaded proximal end portion 1042 a can be supported by the main body 1030 .
- An annular seal member 1046 can be supported by the main body 1030 of the introducer catheter 1002 .
- the introducer catheter 1002 can be configured such that the seal member 1046 can be adjusted to provide an additional seal around the inner core 1020 of the delivery catheter 1004 by threadably engaging the hub portion 1032 .
- seal assembly 1040 and seal member 1046 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.
- a tube assembly 1048 can be supported by the main body 1030 of the introducer catheter 1002 so as to provide an orifice or access port into the main body 1030 .
- the tube assembly 1048 can be used to flush the introducer catheter 1002 with saline or other suitable substances at any stage, such as but not limited to prior to the advancement of an endoluminal prosthesis through the introducer catheter 1002 and/or delivery catheter 1004 , or prior to other procedures for which another type of delivery catheter may be used.
- the tube assembly 1048 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 the delivery catheter 1004 shown in FIG. 5A .
- FIG. 10 is a sectional view of a portion 10 - 10 of the delivery catheter 1004 shown in FIG. 5A .
- FIG. 11A is a sectional view of the delivery catheter 1004 shown in FIG. 5A , taken at 11 A- 11 A shown in FIG. 10 .
- FIG. 11B is a sectional view of the delivery catheter 1004 shown in FIG. 5A , taken at 11 B- 11 B shown in FIG. 10 .
- the delivery catheter 1004 can have a main body 1050 that can support the inner core 1020 and/or core assembly 1021 , one or more access ports 1052 for the one or more branch sheaths 1024 , and one or more access ports 1054 for the one or more fenestration alignment components 1026 .
- the access ports 1052 , 1054 can be configured to sealingly tighten around the branch sheaths 1024 or the fenestration alignment components 1026 , and to constrict around the branch sheaths 1024 or the fenestration alignment components 1026 so as to substantially axially secure the branch sheaths 1024 or the fenestration alignment components 1026 .
- a sealable cap assembly 1051 can be threadably engaged with the main body 1050 of the delivery catheter 1004 .
- the cap assembly 1051 can be configured such that, when a user tightens the cap assembly 1051 relative to the main body 1050 of the delivery catheter 1004 , the core assembly 1021 and/or inner core 1020 will be axially and/or rotational secured to the main body 1050 of the delivery catheter 1004 .
- a tube assembly 1059 can be supported by the main body 1050 of the delivery catheter 1004 so as to provide an orifice or access port into the main body 1050 .
- the tube assembly 1059 can be used to flush the delivery catheter 1004 with saline or other suitable substances.
- the tube assembly 1059 can support any suitable medical connector and/or valve on the distal end thereof.
- the support member 1022 can be connected to a distal end portion of the outer tube 1018 so as to be axially engaged by the outer tube 1018 .
- the support member 1022 can have a substantially cylindrical shape and can be sized to fit within the inner lumen of a main body of the prosthesis 1010 when the prosthesis 1010 is in a constrained configuration.
- the prosthesis 1010 in the loaded configuration, can be positioned over the support member 1022 so that a proximal portion of a main body of the prosthesis 1010 is positioned distally of the support member 1022 and so that a distal portion of a main body of the prosthesis 1010 is positioned proximally of the support member 1022 .
- a proximal end portion 1012 a of the distal sheath 1012 can be positioned over a distal portion 1022 a of the support member 1022 , and a distal end portion 1006 a of the outer sheath 1006 over a proximal portion 1022 b of the support member 1022 .
- one or more tab members 1074 can be supported by the outer tube 1018 .
- the one or more tab members 1074 can be configured to increase the rotational engagement of the constrained prosthesis 1010 relative to the outer tube 1018 so that the constrained prosthesis 1010 can be rotated with greater accuracy during deployment.
- the one or more tab members 1074 can have a generally flat, plate-like shape, such as is illustrated in FIG. 8 .
- the one or more tab members 1074 can be formed from a suitable polymeric or metallic material.
- the one or more tab members 1074 can comprise one or more radiopaque features or be formed from a radiopaque material to improve the visibility and alignability of the delivery catheter 1004 under fluoroscopy during deployment of the prosthesis 1010 .
- the one or more tab members 1074 can be similar to any of the embodiments of the torsion tab (such as the torsion tab 196 ) 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 or more tab members 1074 can be integrally formed with the outer tube 1018 , or secured thereto such as by thermal bonding, adhesive bonding, and/or any of a variety of other securing techniques known in the art.
- the main body portion of the prosthesis 1010 can be constrained by a peelable sheath or by the outer sheath 1006 such that the prosthesis 1010 is engaged with the one or more tab members 1074 .
- the one or more tabs 1074 can engage a stent or other portion of an endoskeleton of the prosthesis 1010 , or, can engage the material of the graft 1204 surrounding the tab member 1074 so that the prosthesis 1010 can substantially rotate with the inner core 1020 of the deployment catheter 1004 .
- FIG. 12 is a side view of the catheter system 1000 showing the outer sheath 1006 in a partially retracted position, similar to the configuration shown in FIG. 5B .
- FIG. 13 is an enlarged side view of the portion 13 - 13 of the catheter system shown in FIG. 12 .
- the mid portion of the prosthesis 1010 adjacent to the one or more fenestrations 1011 and/or the distal portion 1010 a of the prosthesis can be constrained within a peelable sheath 1060 .
- the peelable sheath 1060 can have a release wire 1062 threadably advanced through a plurality of openings 1064 formed along at least a portion of the sheath 1060 .
- the peelable sheath 1060 , release wire 1062 , and openings 1064 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.
- the release wire 1062 can be slidably received within a lumen in the inner core 1020 so that a user can retract the release wire 1062 by grasping and retracting a proximal portion of the release wire 1062 positioned outside the patient's body.
- the mid portion of the prosthesis 1010 adjacent to the one or more fenestrations 1011 and/or the distal portion 1010 a of the prosthesis can be constrained within one or more tubular sheaths, such as the outer sheath 1006 (also referred to herein as a second restraint or second restraining means) and/or distal sheath 1012 such that additional restraining means such as the sheath 1060 are not required (not illustrated). Therefore, any of the embodiments disclosed herein having the optional sheath 1060 should be understood to be configurable to not use the sheath 1060 to restrain one or more portions of the prosthesis 1010 .
- the prosthesis 1010 can be configured such that the mid portion of the prosthesis 1010 adjacent to the one or more fenestrations 1011 is not radially supported by a stent, connectors, struts, or any other similar structure such that, when the outer sheath 1006 is partially retracted, the mid portion of the prosthesis does not self-expand.
- the prosthesis 1010 can have one or more openings 1011 formed therein.
- the fenestrations or openings 1011 can be formed in the prosthesis 1010 at diametrically opposing positions.
- one or more of the openings 1011 can be formed in the prosthesis 1010 at a position that is angularly offset from the diametrically opposing position.
- the sheath 1060 can have one or more openings 1061 formed therein, the openings 1061 being positioned adjacent to the similar number of openings 1011 formed in the prosthesis.
- the catheter system 1000 can be configured such that the sheaths 1024 are advanced through the openings 1011 formed in the prosthesis 1010 and the openings 1061 formed in the sheath 1060 , when the prosthesis 1010 is loaded within the catheter system 1000 .
- the prosthesis 1010 can be efficiently packed within the outer sheath 1006 so as to surround the sheaths 1024 and efficiently fill the space within the outer sheath 1006 .
- the prosthesis 1010 can be loaded within the outer sheath 1006 so that the sheaths 1024 are advanced between many of the struts, bends, loops, and other features that the stent can comprise, thereby permitting the sheaths 1024 sufficient space to be loaded within the outer sheath 1006 so that the lumen of the sheaths 1024 are not compressed or collapsed in the loaded state.
- the graft can be formed from a bidirectionally expanded, layered PTFE material have thin walls to further increase the space efficiency of the prosthesis 1010 .
- the peelable sheath 1060 can have one or more release wires 1062 (two being shown) advanced through openings or perforations 1064 formed in the sheath 1060 along two sides of the sheath 1060 .
- the release wires 1062 can be configured to tear the sheath 1060 along two lines of perforations 1064 and/or scores formed along two sides of the sheath 1060 , so that the sheath 1060 can be removed from the prosthesis 1010 while the sheaths 1024 are advanced through the fenestrations 1011 , 1061 , respectively, in the prosthesis 1010 and sheath 1060 .
- each of the two release wires 1062 can be secured to a proximal end portion 1060 a of the sheath 1060 , so that both halves of the sheath 1060 can be retracted through the outer sheath 1006 .
- FIG. 14 is an enlarged side view of the catheter system 1000 shown in FIG. 5A , defined by curve 14 - 14 shown in FIG. 12 , showing the outer sheath 1006 in a partially retracted position and the distal sheath 1012 in a partially advanced position.
- the perforations 1064 formed in the sheath 1060 can be arranged along an axial line along the length of the portion of the sheath 1060 from the fenestrations 1061 to the distal end of the sheath 1060 , and also arranged to split the sheath 1060 between the two fenestrations 1061 formed in the sheath 1060 . As illustrated in FIG.
- the perforations 1064 formed in the sheath 1060 arranged along the length of the sheath 1060 can be positioned to tear the sheath 1060 from one of the fenestrations 1061 to the distal end 1060 b of the sheath 1060 , and also to circumferentially tear the sheath 1060 between the fenestrations 1061 .
- the catheter system 1000 can be configured such that a proximal portion 1010 b of the prosthesis 1010 can be deployed by axially advancing the inner tube 1016 relative to the inner core 1020 of the delivery catheter 1004 and, hence, the prosthesis 1010 .
- the prosthesis 1010 can be self-expanding such that removing the radial constraint provided by the distal sheath 1012 can cause the portion of the prosthesis 1010 constrained by the inner tube 1016 to expand toward the vessel wall.
- the proximal portion 1010 b of the prosthesis 1010 can be deployed in this manner before the distal portion 1010 a of the prosthesis 1010 is deployed, or simultaneously with the deployment of the distal portion 1010 a of the prosthesis 1010 .
- the proximal portion 1010 b of the prosthesis 1010 can be deployed in this manner after the distal portion 1010 a of the prosthesis 1010 is deployed.
- FIG. 15 is a side view of the catheter system 1000 shown in FIG. 5A , showing the outer sheath 1006 in a partially retracted position and one branch sheath 1024 ′ and one fenestration alignment component 1026 ′ in a partially advanced position.
- the branch sheath 1024 ′ can be advanced relative to the inner core 1020 , the prosthesis, and the second branch sheath 1024 ′′ by advancing a proximal portion of the branch sheath 1024 ′ in the direction of arrow A 1 in FIG. 15 through the access port 1052 ′ at the proximal end of the delivery catheter 1004 .
- the second branch sheath 1024 ′′ can be advanced relative to the inner core 1020 , the prosthesis, and the first branch sheath 1024 ′ by advancing a proximal portion of the branch sheath 1024 ′′ through the access port 1052 ′′ at the proximal end of the delivery catheter 1004 .
- either of the fenestration alignment components 1026 ′, 1026 ′′ can be advanced relative to the branch sheaths 1024 ′, 1024 ′′ by advancing the respective fenestration alignment component 1026 through the respective access port 1054 .
- the fenestration alignment component 1026 ′ can be advanced by advancing the proximal portion of the fenestration alignment component 1026 ′ in the direction of arrow A 2 in FIG. 15 .
- FIG. 16 is a sectional view of a portion of a patient's vasculature, showing the delivery catheter 1000 being advanced through a patient's abdominal aorta over a guidewire 1070 positioned within a patient's vasculature.
- the delivery catheter 1000 can be advanced through a prosthesis 1080 (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 the delivery catheter 1000 and an angiographic catheter 1065 being advanced through a branch sheath 1024 of the delivery catheter toward a target branch vessel.
- an outer sheath 1006 of the catheter system 1000 has been retracted relative to the inner core (not shown) and the prosthesis 1010 , exposing a middle portion of the prosthesis 1010 (i.e., a portion of the prosthesis 1010 radially adjacent to the one or more fenestrations 1011 ) and the branch sheaths 1024 a , 1024 b .
- a suitable angiographic catheter 1065 can be advanced through the lumen of either or both of the branch sheaths 1024 a , 1024 b and directed into the target branch vessel or vessels.
- a user can rotate the inner core 1020 to approximately rotationally align the fenestrations 1011 of the prosthesis 1010 or the branch sheaths 1024 with the branch vessels.
- the optional sheath 1060 can constrain the mid and distal portions of the prosthesis 1010 such that, when the outer sheath 1006 is retracted, the mid and distal portions of the prosthesis 1010 do not self-expand.
- the mid portion of the prosthesis 1010 radially adjacent to the one or more fenestrations 1011 can be unsupported by any stents 1254 .
- the prosthesis 1010 can be configured such that there is no radial force or support provided to the mid portion of the prosthesis 1010 , or such that the mid portion of the prosthesis 1010 will not be biased to self-expand when the outer sheath 1006 is retracted.
- some embodiments can be configured such that no additional restraint in addition to, for example, the outer sheath 1006 , is required. Therefore, only the outer sheath 1006 and the distal sheath 1012 can be used to restrain the prosthesis 1010 .
- the outer sheath 1006 can be partially retracted to release the sheaths 1024 so that one or more angiographic catheters 1065 can be advanced through the sheaths 1024 and into the target branch vessels before the proximal and distal portions of the prosthesis 1010 are released from the deployment catheter 1004 .
- the angiographic catheter 1065 can be configured such that an end portion thereof is biased to have a curved disposition (shape), as is well known in the art.
- an angiographic catheter 1065 is being advanced relative to the branch sheath 1024 a and into the target branch vessel, in this case a renal artery.
- the delivery catheter 1000 can be configured such that an angiographic catheter can be advanced through the desired branch sheath 1024 and into the target vessel without retracting the outer sheath 1006 .
- the branch sheaths 1024 can be independently or simultaneously advanced over the angiographic catheters 1065 into the target branch vessels, as is illustrated in FIG. 18 .
- the branch sheaths 1024 , the fenestrations 1011 , 1061 formed in either the prosthesis 1010 or the sheath 1060 , respectively, and/or any other components or features of the delivery catheter 1000 can have radiopaque markers or other indicators to assist a medical practitioner in the deployment procedures described herein or other suitable deployment procedures.
- a proximal portion 1010 b of the prosthesis 1010 can be deployed by axially advancing the distal sheath 1012 relative to the inner core 1020 and the prosthesis 1010 .
- the prosthesis 1010 can be axially and rotationally secured to the outer tube 1018 , which can be axially and rotationally secured to the inner core 1020 , such that advancing the distal sheath 1012 relative to the inner core 1020 will advance the distal sheath 1012 relative to the prosthesis 1010 .
- the distal sheath 1012 can be advanced relative to the inner core 1020 and the prosthesis 1010 by advancing the inner tube 1016 relative to the inner core 1020 , the inner tube 1016 being axially engaged with the distal tip 1014 which can support the distal sheath 1012 .
- FIG. 20 is a sectional view of a portion of a patient's vasculature, showing a peelable sheath 1060 being removed from the distal portion 1010 a of the prosthesis 1010 so as to deploy a distal portion 1010 a of the prosthesis 1010 .
- the sheath 1060 can be removed by axially retracting a release wire 1062 , which can be looped or other otherwise threaded through openings or perforations 1064 formed in the sheath material.
- the release wire 1062 can be configured to tear through the sheath material between the perforations 1064 , thereby permitting the self-expanding prosthesis 1010 to expand toward the vessel walls.
- the prosthesis 1010 can be configured to be restrained within the outer sheath 1006 and the distal sheath 1012 such that an additional restraint, such as the peelable sheath 1060 , is not required.
- a distal portion 1060 a of the sheath 1060 can be torn by the release wire 1062 before a proximal portion 1060 b of the sheath 1060 is torn by the release wire so that a proximal portion 1010 b of the prosthesis (i.e., adjacent to the proximal portion 1060 a of the sheath 1060 ) can be deployed before a distal portion 1010 a of the sheath 1010 .
- a proximal portion 1060 b or a middle portion of the sheath 1060 can be torn by the release wire 1062 before a distal portion 1060 a of the sheath 1060 is torn by the release wire (not illustrated).
- the release wire 1062 can be secured to the proximal portion 1060 b or other suitable portion of the sheath 1060 such that, after the sheath 1060 has been torn, the sheath 1060 can be removed through the delivery catheter 1000 by continuing to axially retract the release wire 1062 relative to the prosthesis 1010 .
- a distal portion 1010 a of the prosthesis 1010 (i.e., the downstream portion of the prosthesis 1010 ) can be deployed within an opening of an adjacent prosthesis, such as without limitation the bifurcated prosthesis 1080 illustrated in FIG. 20 .
- the delivery catheter 1000 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.
- the prosthesis 1010 can be a bifurcated prosthesis.
- FIG. 21 is a sectional view of a portion of a patient's vasculature, showing a fenestration alignment component 1026 contacting and pushing an inner wall of the prosthesis 1010 adjacent to a fenestration 1011 toward an ostium of the target branch vessel.
- the fenestration alignment component 1026 can be advanced through a lumen in the inner core 1020 to push the fenestration 1011 of the prosthesis 1010 over the branch sheath 1024 and into approximate alignment with the ostium of the branch vessel.
- the catheter system 1000 can be configured to not have a fenestration alignment component 1026 , and can accordingly be configured to deploy a fenestrated graft without the use of such a component
- a covered or uncovered branch stent 1084 can be deployed in the branch vessel by advancing the branch stent 1084 through the branch sheath 1024 using a suitable catheter, such as a renal stent catheter, into the target vessel, after the angiographic catheter has been removed from the branch sheath 1024 .
- the stent 1084 can be supported on an inflation balloon 1086 , which can be supported by a guidewire 1088 .
- the guidewire 1088 can be configured to have an inflation lumen therein, to inflate the balloon 1086 and expand the branch stent 1084 in the target location after the branch sheath 1024 has been at least partially retracted so as to not interfere with the expansion of the branch stent 1084 , as illustrated in FIG. 23 .
- the inflation balloon 1086 can be configured to expand and flare a portion of the stent 1084 within or to the inside of the fenestration 1011 formed in the prosthesis.
- the fenestration alignment component 1026 described above can be configured to be supported within a renal or branch stent delivery catheter.
- the fenestration alignment component 1026 can be configured to be supported within a modified renal stent catheter, such as the renal stent catheter illustrated in FIG. 22 .
- the fenestration alignment component 1026 can be configured to only partially surround the branch sheath 1024 or the branch stent delivery catheter. In this configuration, the fenestration alignment component 1026 can be configured to be entirely positioned within and advanceable through a lumen of the branch sheath 1024 or the branch stent delivery catheter.
- the fenestration alignment component 1026 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.
- 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.
- 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 the branch sheath 1024 .
- 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.
- the fenestration 1011 in the prosthesis 1010 can expand as the branch stent 1084 is being expanded, to improve the seal between the fenestration 1011 and the branch stent 1084 .
- a second expansion balloon can be positioned in the portion of the stent 1084 within or to the inside of the fenestration 1011 to flare that portion of the stent 1084 , either with or without removing the first balloon used to expand the main portion of the branch stent 1084 .
- Some arrangements are directed to methods of deploying an endoluminal prosthesis, such as without limitation the prosthesis 1010 described above, comprising inserting a delivery catheter such as catheter system 1000 into an artery, exposing one or more branch sheaths 1024 , advancing one or more angiographic catheters having one or more guidewires into the one or more branch sheaths 1024 and cannulating the target branch vessels, advancing the one or more branch sheaths 1024 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.
- the target branch vessels are the renal arteries.
- 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 a prosthesis 1200 comprising one or more fenestrations 1202 formed in the graft 1204 , and a stent or support member 1206 .
- the graft 1204 is shown in dashed lines in FIG. 24B for clarity.
- the prosthesis 1200 can have any of the features, components, or other details of any other prosthesis embodiments disclosed herein such as, prosthesis 1010 described above. Further, any of the features of the prosthesis 1200 can be used in combination with any of the other prosthesis embodiments disclosed herein.
- the graft 1204 can be supported by the stent 1206 along at least a portion of the graft 1204 . Further, the graft 1204 can be overlapped and can have stitching or sutures 1208 along one or more edges of the graft 1204 , which can improve the tear resistance of the graft 1204 and can improve the connection between the graft 1204 and the stent 1206 .
- the graft 1204 can be configured to have excess or slack graft material in at least a portion thereof relative to the stent which supports the graft.
- the excess graft material can form a bulge or other enlargement in the graft 1204 in the approximate location of one or more fenestrations 1202 formed through the graft material.
- the excess or slack material along the circumference of the graft 1204 can allow for circumferential and/or axial movement of the graft material and, hence, the one or more fenestrations 1202 , relative to the stent 1206 and the ostium of the patient's branch vessels. Therefore, the diameter of the graft 1204 at and/or adjacent to the location of one or more fenestrations 1202 can be larger than the local diameter of the target vessel. Similarly, the diameter of the graft 1204 at and/or adjacent to the location of one or more fenestrations 1202 can be larger than the diameter of the non-enlarged portion of the graft material.
- the outside surface of the graft 1204 in the enlarged portion 1204 a or otherwise can be free from any corrugations or other preformed folds, overlaps, or other similar pre-formed features.
- the graft 1204 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 the graft 1204 can increase the circumferential and/or axial adjustability or movement of the graft material adjacent to the one or more fenestrations 1202 formed in the graft 1204 .
- the length of the graft material between the proximal and distal attachment points to the stent 1206 can be longer than that of the stent 1206 between the proximal and distal attachment points.
- the graft material in a mid-portion of the graft 1204 including on either side of the enlarged portion 1204 a , can have an increased length relative to the stent radially adjacent to such graft portion.
- the enlarged portion and/or excess length of the graft 1204 or any other graft embodiment disclosed herein can be free from any attachment points to the stent or support member which supports the graft 1204 .
- 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 the graft 1204 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 the graft 1204 .
- the attachment points can be sufficiently away from the fenestration or opening so as to not substantially affect the adjustability of the fenestration.
- the prosthesis 1010 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 connector 1254 ) away from the fenestrations 1202 so that the adjustability of the enlarged or slack portion is not significantly affected.
- 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.
- the graft 1204 can have one or more enlarged portions 1204 a having an enlarged diameter relative to the target vessel or relative to one or more non-enlarged portions of the graft 1204 , such as portions 1204 b , 1204 c that can improve the radial and/or axial adjustability of the fenestrations 1202 formed in the enlarged portions 1204 a to better accommodate asymmetrically positioned branch vessel ostium.
- portions 1204 b , 1204 c can improve the radial and/or axial adjustability of the fenestrations 1202 formed in the enlarged portions 1204 a to better accommodate asymmetrically positioned branch vessel ostium.
- the graft 1204 can have an enlarged middle portion 1204 a having one or more fenestrations 1202 formed therein, a non-enlarged proximal portion 1204 b , and a non-enlarged distal portion 1204 c.
- the enlarged portion 1204 a of the graft 1204 can have a diameter that is approximately 30% larger than a diameter of the target vessel or the diameter of the non-enlarged portions 1204 b , 1204 c of the graft 1204 .
- the diameter of the enlarged portion 1204 a of the graft 1204 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 the non-enlarged portions 1204 b , 1204 c of the graft 1204 , or to or from any values within these ranges.
- the enlarged portion 1204 a or portion of the graft 1204 adjacent to the enlarged portion 1204 a of the graft 1204 can be sized and configured to be substantially longer (i.e., in the axial direction) than the stent 1206 , which can improve the radial and/or axial adjustability of the fenestrations 1202 formed in the enlarged portions 1204 a to better accommodate the asymmetric and/or non-uniform positioning of branch vessel ostium.
- the graft 1204 can be longer than the stent 1206 in both the enlarged portion 1204 a of the graft 1204 and/or in the portion of the non-enlarged distal portion 1204 c of the graft adjacent to the enlarged portion 1204 a of the graft 1204 .
- the enlarged portion 1204 a or portion of the graft 1204 adjacent to the enlarged portion 1204 a of the graft 1204 can be sized and configured to be approximately 20% longer in the axial direction than the stent 1206 .
- the enlarged portion 1204 a or portion of the graft 1204 adjacent to the enlarged portion 1204 a of the graft 1204 can be sized and configured to be from approximately 10% to approximately 40% or more longer in the axial direction than the stent 1206 .
- FIG. 25 is a top view of the prosthesis 1200 of FIG. 24 .
- the prosthesis 1200 can have fenestrations 1202 formed in an enlarged portion 1204 a of the graft 1204 .
- the fenestrations 1202 can be formed at non-diametrically opposed positions. This can improve the alignment of the fenestrations 1202 with the ostium of the target branch vessels, which in general can be located at non-diametrically opposed positions.
- the fenestrations 1202 formed in either the enlarged portion or portions 1204 a or non-enlarged portions 1204 b , 1204 c of the graft 1204 can be angled away from the diametrically opposed position (represented by angle X in FIG. 25 ) such that the fenestrations 1202 are separated by an angle (represented by angle Y in FIG. 25 ) that is less than 180 degrees.
- the graft 1204 can have two fenestrations 1202 formed at an angle away from the diametrically opposed position (represented by angle X in FIG. 25 ) of approximately 15 degrees such that the fenestrations 1202 are separated by an angle (represented by angle Y in FIG. 25 ) that is approximately 150 degrees.
- the graft 1204 can have two fenestrations 1202 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 the fenestrations 1202 are separated by an angle (represented by angle Y in FIG. 25 ) that is between approximately 160 degrees and approximately 140 degrees.
- the graft 1204 can have two fenestrations 1202 formed in an enlarged portion 1204 a of the graft and wherein the fenestrations 1202 are separated by an angle that is less than 180 degrees, for example approximately 150 degrees.
- positioning the fenestrations 1202 to be separated by an angle that is less than 180 degrees can improve the alignment of the fenestrations 1202 with the ostium of the target branch vessels such that the enlarged portion 1204 a of the graft 1204 can be from approximately 20% to approximately 60% greater than the non-enlarged portion 1204 b , 1204 c of the graft 1204 .
- the enlarged portion 1204 a of the graft 1204 can be from approximately 20% to approximately 40% greater than the non-enlarged portion 1204 b , 1204 c of the graft 1204 .
- the graft 1204 which can be a bifurcated or other suitably configured graft, can have two fenestrations 1202 formed in an enlarged portion 1204 a of the graft, wherein the fenestrations 1202 can be separated by an angle that is less than 180 degrees, and wherein the length of at least a portion of the graft 1204 can be substantially greater than the length of the stent 1206 , for example approximately 10% greater than the length of the stent 1206 .
- positioning the fenestrations 1202 to be separated by an angle that is less than 180 degrees (such as, for example, approximately 150 degrees) and increasing the length of the graft 1204 to be approximately 10% greater than the length of the stent 1206 can improve the alignment/alignability of the fenestrations 1202 with the ostium of the target branch vessels such that the enlarged portion 1204 a of the graft 1204 can be from approximately 10% or less to approximately 20% greater than the non-enlarged portion 1204 b , 1204 c of the graft 1204 .
- the prosthesis 1200 can have reinforced fenestrations 1202 comprising a tubular member 1210 inserted through the fenestration 1202 and stitched to the graft 1204 with one or more sutures 1212 .
- the tubular member 1210 can improve the tear resistance of the fenestration 1202 and also improve the sealability between the fenestrations 1202 and the branch grafts and stents deployed within the fenestrations 1202 as well as the pull-out resistance of the branch grafts and stents within the fenestrations 1202 .
- This configuration can reduce leakage between the fenestrations 1202 and the branch grafts and stents deployed within the fenestrations 1202 .
- this configuration can also increase the force required to pull the branch grafts and stents deployed within the fenestrations 1202 out of the fenestrations 1202 , thereby reducing the inadvertent axial movement of the branch grafts and stents deployed within the fenestrations 1202 .
- the graft 1204 can have a scallop or cut-away 1230 at a proximal end portion 1204 b of the graft 1204 .
- the cut-away 1230 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-away 1230 can be based on the anatomy of a patient, or can be sized to accommodate a wide range of vessel anatomies.
- the cut-away 1230 can have a length approximately equal to the length of two stent struts, such as stent strut 1246 described below.
- the graft 1204 can be overlapped and have stitching 1208 along an edge of the cut-away 1230 .
- the prosthesis 1200 can have a flared proximal end portion to increase the sealability of such end portion of the prosthesis 1200 .
- the prosthesis 1200 can have one or more radiopaque markers, such as but not limited to the annular radiopaque marker 1222 surrounding at least a portion of the fenestration 1202 , 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 the stent 1206 shown in FIG. 24 , viewed along a line that is perpendicular to an axis projecting through a fenestration formed in the graft 1204 (not shown). For clarity, the location of a fenestration 1202 is shown dashed lines.
- FIG. 28 is a side view of the stent 1206 , viewed along an axis projecting through a fenestration. Again, for clarity, the location of a fenestration 1202 is shown dashed lines.
- the stent 1206 can be formed from one or more wires forming a plurality of loops 1240 , which can be closed loops or eyelets, bends 1242 , and struts 1246 . Some of the bends 1242 can be configured to slide along a portion of the length of a respective strut 1246 , to improve the flexibility and bendability of the stent 1206 .
- the positioning of the plurality of loops 1240 and bends 1242 can be longitudinally offset or staggered to decrease the collapsed diameter of the prosthesis 1200 .
- the stent 1206 can comprise a first stent segment 1250 formed from one or more lengths of wire, a second stent segment 1252 formed from one or more lengths of wire, and one or more connecting members 1254 formed from one or more lengths of wire.
- the first and second stent segments 1250 , 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 the stent 1206 .
- the length of the first stent segment 1250 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.
- two connecting members 1254 can be positioned between the first and second stent segments 1250 , 1252 , and can be sized and offset from one another to provide a significant gap around the position of the fenestrations 1202 to increase the accessibility and adjustability of the fenestrations 1202 during deployment of the prosthesis 1200 .
- the connecting members 1254 can have four struts.
- the connecting members 1254 can have three or less struts, or can have five or more struts.
- the connecting members 1254 can have a first connecting member 1254 having fewer struts than a second connecting member 1254 .
- FIGS. 29-31 are oblique, side, and end views, respectively, of a fenestration alignment component 2026 (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 a delivery catheter 2004 having the fenestration alignment component 2026 of FIG. 29 .
- FIG. 33 is an exploded view of the delivery catheter 2004 shown in FIG. 32 .
- one or more fenestration alignment components 2026 can be used in place of or in conjunction with one or more fenestration alignment components 1026 described above in any of the delivery catheter embodiments disclosed herein.
- the fenestration alignment component 2026 can serve the same or similar function or be used for the same or similar procedural step or steps as with the embodiments of the fenestration alignment component 1026 described above. Therefore, the fenestration alignment component 2026 can be used in any of the procedures, steps, or methods as described above for the fenestration alignment component 1026 .
- a user can independently or collectively axially advance the fenestration alignment component 2026 relative to the guide sheath 2024 (which can be the same as the guide sheath 1024 described above) supporting the fenestration alignment component 2026 such that a portion of the fenestration alignment component 2026 engages the fenestration or branch graft of the prosthesis 1010 and pushes the fenestration or branch graft toward an ostium of the target branch vessel of the patient's vasculature.
- the guide sheath 2024 which can be the same as the guide sheath 1024 described above
- a body portion 2027 of the fenestration alignment component 2026 can be slidably positioned around or over an outside surface of the guide sheath 2024 .
- the body portion 2027 can be cylindrical or tubular.
- the body portion 2027 can have an inside diameter or size that is greater than an outside diameter or size of the guide sheath 1024 so that the fenestration alignment component 2026 can axially translate relative to the guide sheath 1024 .
- the body portion 2027 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.
- the body portion 2027 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.
- the body portion 2027 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.
- the body portion 2027 can be formed from a PEBAX covered alloy coil.
- the body portion 2027 can have a stainless steel coil with a PEBAX tube surrounding the coil.
- the PEBAX can have varying hardness.
- the body portion 2027 can have a PTFE liner surrounding all or a portion of the body portion 2027 .
- the body portion 2027 can have a radiopaque marker or band supported thereon, or have portions or components thereof that are made from a radiopaque material.
- a radiopaque band having a length of approximately 0.020 in to approximately 0.060 in can be supported by the body portion 2037 .
- the fenestration alignment component 2026 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.
- the fenestration alignment component 2026 can have a tab or protruding portion 2028 (also referred to as a protrusion or projection) projecting from the body portion 2027 .
- the protruding portion 2028 can project away from the outside surface of the body portion 2027 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 protruding portion 2028 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 the body portion 2027 and/or the fenestration, or between any values within this range.
- the protruding portion or other component or element supported at an end of the body portion 2027 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 the body portion 2027 more than in the first position.
- 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.
- the positioning wire 2030 could be made hollow to allow for inflation of the inflatable component or element.
- the protruding portion 2028 can be integrally formed with the body portion 2027 , or can be formed separately and adhered to, supported by, or otherwise coupled with the body portion 2027 .
- the protruding portion 2028 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 protruding portion 2028 can be made from PEBAX.
- the protruding portion 2028 can be made from a PEBAX material having a higher hardness value than the PEBAX material used to form the body portion 2027 .
- the fenestration alignment component 2026 can be configured to engage a fenestration of a prosthesis deployable by the delivery catheter 2004 .
- the enlarged or protruding portion 2028 can have a size or profile that is greater than a size or profile of the guide sheath 2024 or of the body portion 2027 of the fenestration alignment component 2026 so that, while the guide sheath 2024 can be advanced through the fenestration, the protruding portion 2028 can be sized and configured to be larger than the size or diameter of the fenestration so that the protruding portion 2028 does not pass through the fenestration.
- the enlarged portion 2028 of the fenestration alignment component 2026 can have a circular cross-sectional shape or, as illustrated in FIGS. 29-31A , a non-circular cross-sectional shape.
- the enlarged portion 2028 can have an approximately triangular or pointed shape with a rounded upper surface or portion 2028 a .
- the enlarged portion 2028 can have a circular cross-sectional shape or a pointed shape with more than one pointed or protruding portion, or any other suitable shape.
- the enlarged portion 2028 can have a tapered surface 2028 b at the trailing end of the enlarged portion 2028 .
- the tapered surface 2028 b can facilitate the removability of the fenestration alignment component 2026 if the enlarged portion 2028 of the fenestration alignment component 2026 is inadvertently advanced through a fenestration.
- the fenestration alignment components 2026 can each be attached to positioning wires 2030 such that axially advancing or retracting the positioning wires 2030 will advance or retract the fenestration alignment components 2026 .
- the positioning wires 2030 can each define a tapering cross-sectional size that decreases toward a distal end of the positioning wire 2030 such that a cross-sectional size of the positioning wire 2030 near the body portion 2027 is smaller than a cross-sectional size of the positioning wire 2030 near the catheter handle.
- the positioning wire 2030 can made from a PTFE coated stainless steel, such as 304, or from any other suitable material or combination of materials.
- the positioning wire 2030 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.
- the positioning wire 2030 can have a uniform diameter or cross-sectional size along the length thereof.
- an end portion 2030 a of the positioning wire 2030 can overlap and be affixed to the body portion 2037 of the fenestration alignment component 2026 .
- the end portion 2030 a can be bonded to the body portion 2037 using any suitable technique or process.
- the end portion 2030 a can be thermally bonded to the body portion 2037 using one or more PET sleeves.
- a portion of the end portion 2030 a can be coined or flattened.
- the end portion can have a greater surface area than a remainder of the end portion 2030 a .
- approximately half of the end portion 2030 a can be coined or flattened.
- FIG. 32 is an oblique view of a delivery catheter 2004 having the fenestration alignment component 2026 of FIG. 29 .
- FIG. 33 is an exploded view of the delivery catheter 2004 shown in FIG. 32 .
- FIG. 32 illustrates a handle portion 2050 of the delivery catheter 2004 , which can provide an entry point for the guide sheaths 2024 and the positioning wires 2030 so as to provide an orifice or access port for these components into the main body of the delivery catheter 2004 .
- a surgeon or user can manipulate the guide sheaths 2024 and fenestration alignment components 2026 by manipulating the end portions of the guide sheaths 2024 and positioning wires 2030 that extend proximally from the end of the handle portion 2050 of the delivery catheter.
- the catheter 2004 can have two or more guide sheaths 2024 and two or more fenestration alignment components 2026 , or the same number of guide sheaths 2024 and fenestration alignment components 2026 as the number of fenestrations in the prosthesis.
- the catheter 2004 having guide sheaths 2024 with fenestration alignment components 2026 as described herein can be configured such that the guide sheaths 2024 , fenestration alignment components 2026 , and/or positioning wires 2030 are advanceable within standard lumen formed in the delivery catheter 2004 .
- the lumen of the delivery catheter 2004 may be enlarged or sized and configured to accommodate such guide sheaths 2024 with fenestration alignment components 2026 .
- FIG. 34 is a sectional view of a portion of a patient's vasculature, showing the fenestration alignment component 2026 illustrated in FIG. 29 advancing an inner wall of the prosthesis adjacent to a fenestration toward an ostium of the target branch vessel.
- the fenestration alignment component 2026 of the catheter 2004 can be axially advanced relative to the guide sheath 2024 (which can be the same as any other guide sheath embodiments disclosed herein, including without limitation guide sheath 1024 ) by advancing the positioning wire 2030 distally to push the fenestration 1011 of the prosthesis 1010 over the branch sheath 2024 and into approximate alignment with the ostium of the branch vessel.
- the catheter system 2004 can be configured to not have a fenestration alignment component 2026 , and can accordingly be configured to deploy a fenestrated graft without the use of such a component.
- a fenestration alignment component 2026 can be configured to deploy a fenestrated graft without the use of such a component.
- snares, protrusions, tabs, or other features can be formed on the sheaths 1024 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 the fenestration alignment component 2026 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.
- the fenestration alignment components 2026 have been advanced to a second position, the second position being defined as the position where the fenestrations 1011 are approximately aligned with the ostium of the target branch vessels.
- 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 2026 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.
- the fenestration alignment components 2026 have been advanced
- a covered or uncovered branch stent 1084 can be deployed in the branch vessel by advancing the branch stent 1084 through the branch sheath 2024 using a suitable catheter, such as a renal stent catheter, into the target vessel, after the angiographic catheter has been removed from the branch sheath 2024 .
- the stent 1084 can be supported on an inflation balloon 1086 , which can be supported by a guidewire 1088 .
- the guidewire 1088 can be configured to have an inflation lumen therein, to inflate the balloon 1086 and expand the branch stent 1084 in the target location after the branch sheath 2024 has been at least partially retracted so as to not interfere with the expansion of the branch stent 1084 .
- the fenestration alignment components 2026 may need to be at least partially withdrawn before deploying the stents 1084 , to enable the inflation balloon to expand the stents 1084 .
- the inflation balloon 1086 can be configured to expand and flare a portion of the stent 1084 within or to the inside of the fenestration 1011 formed in the prosthesis. Thereafter, the components comprising the delivery catheter 2004 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.
- any embodiments of the delivery catheter 2004 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 the delivery catheter 1004 described above.
- Like numbered features shown in the illustrations of the delivery catheter 2004 can be the same or similar to the same numbered features of the delivery catheter 1004 embodiments described herein.
- 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.
- 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.
Abstract
Description
- 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.
- 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.
- 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.
-
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 at 3-3 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 at 3-3 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 portion 10-10 of delivery catheter shown inFIG. 5A . -
FIG. 11A is a sectional view of the delivery catheter shown inFIGS. 5A and 5B , taken at 11A-11A inFIG. 10 . -
FIG. 11B is a sectional view the delivery catheter shown inFIGS. 5A and 5B , taken at 11B-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 portion 13-13 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 portion 14-14 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 curve 26-26 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 at 31B-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. - 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.
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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'saorta 10. Ananeurysmal sac 10A is also shown. For reference, also illustrated are a patient's first and secondrenal arteries iliac arteries FIG. 2 is a side view of theendoluminal prosthesis 20 illustrated inFIG. 1 . theendoluminal prosthesis 20 illustrated inFIGS. 1 and 2 has amain graft body 22, afirst fenestration 24, and asecond fenestration 26. The main graft is a bifurcated graft having a firstbifurcated branch 28 and a secondbifurcated branch 30 for placement in the ipsilateral and contralateral iliac arteries. - The
main graft body 22 has a generally cylindrical, tubular shape. Theendoluminal prosthesis 20 can be formed from any suitable material, such as, but not limited to, ePTFE. Theendoluminal prosthesis 20 is formed from an expandable material. Theendoluminal prosthesis 20 is formed such that themain graft body 22 can be sized to be larger than the target vessel into which themain graft body 22 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 body 22) 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 body 22) 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 the
main graft body 22 configured for placement in an approximately 26 mm vessel can be approximately 34 mm in diameter. Therefore, the diameter of themain graft body 22 can be approximately 8 mm larger than the diameter of the target vessel. The diameter of themain graft body 22 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 the
main graft body 22 can provide excess or slack graft material in themain graft body 22 such that thefenestrations fenestrations - As described above, two or more fenestrations can be formed in the
main graft body 22 at any desired location. With reference toFIG. 2 , the twofenestrations main graft body 22 at any desired locations. Additionally, scallops or cutouts can be formed in the distal end portion or at any suitable location in themain graft body 22, the scallops or cutouts being configured to prevent obstruction of other arteries branching off of the main vessel into which themain graft body 22 is to be deployed. For example, anadditional fenestration 32 can be formed in a distal portion of themain graft body 22. Thefenestration 32 can be formed so as to align with a patient's SMA -
FIG. 3 is a cross-sectional view of theendoluminal prosthesis 20 deployed in the patient's anatomy, taken at 3-3 inFIG. 1 , as it might appear before thefenestrations renal arteries FIG. 3 , the main graft body 22 (which can be oversized) has been deployed in the target vessel. After themain graft body 22 has been deployed in the target vessel, because themain graft body 22 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 body 22 about the circumference of themain graft body 22. Thefolds 34 can form in themain graft body 22 as a result of the fact that there can be excess or slack material in themain graft body 22 after themain graft body 22 has been deployed in the target vessel. - At least a portion of the
main graft body 22 can have undulations, folds, bends, corrugations, or other similar features in the axial direction therein when themain graft body 22 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 prosthesis 20 deployed in the patient's anatomy, taken at 3-3 inFIG. 1 , after thefenestrations FIG. 4 , the oversizedmain graft body 22 is aligned with the patient's anatomy by thefenestration 24 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, thefenestration 24 as it moves closer to thefenestration 26, causes a gathering of slack material or folds 34 in afirst portion 22 a of themain graft body 22 and partially or fully removing the slack material or folds from asecond portion 22 b of themain graft body 22. - After the
main graft body 22 has been positioned within the patient's anatomy such that thefenestrations main graft body 22 can compress thefolds 34 that are formed in themain graft body 22, if any, against the wall of the vessel and secure themain graft body 22 and thefenestrations - 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.
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FIG. 5A is a side view of acatheter system 1000 comprising an introducer catheter 1002 (also referred to as an introducer) and adelivery catheter 1004. Thedelivery catheter 1004 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 system 1000 illustrated inFIG. 5A , showing anouter sheath 1006 of thedelivery catheter 1004 in a partially retracted position. With reference toFIGS. 5A and 5B , theouter sheath 1006 can be used to constrain at least a portion of aprosthesis 1010. Theprosthesis 1010 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 theprosthesis 1200 described below. Theprosthesis 1010 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 theprosthesis 1010, 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 system 1000, 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 in
FIG. 5B , a distal sheath 1012 (also referred to herein as a first restraint or first restraining means) can be used to constrain a proximal portion of thestent graft 1010. Thedistal sheath 1012 can be supported by (connected to) adistal tip 1014 of thecatheter system 1000. Thedistal tip 1014 can comprise an atraumatic material and design. As will be described in greater detail below, thedistal tip 1014 and, hence, thedistal sheath 1012 can be attached to aninner tube 1016 to control the position of thedistal tip 1014 and thedistal sheath 1012 relative to aninner core 1020 of thedelivery catheter 1004. Theinner core 1020 can be rotatable relative to theouter sheath 1006 so that a prosthesis supported by thedelivery catheter 1004 can be rotated during deployment. Theinner tube 1016 can be slidably positioned coaxially within a lumen in anouter tube 1018 that can connect asupport member 1022 to theinner core 1020. Theouter tube 1018 can be connected to an opening orpartial lumen 1019 in theinner core 1020 so as to be axially and rotationally fixed to theinner core 1020. - In this configuration, the
catheter system 1000 can be configured such that advancing theinner tube 1016 relative to aninner core 1020 of thedelivery catheter 1004 causes thedistal sheath 1012 to advance relative to theprosthesis 1010, causing the proximal portion of theprosthesis 1010 to be deployed. The prosthesis 1010 (or any other prosthesis disclosed herein) can be at least partially self-expanding such that, as the tubulardistal sheath 1012 is advanced relative to theprosthesis 1010, a proximal portion of theprosthesis 1010 expands against a vessel wall. In some embodiments, only some segments or portions of theprosthesis 1010 such as, portions of the prosthesis axially adjacent to enlarged graft portions of the prosthesis, can be configured to be self-expanding. - The
inner core 1020 can be slidably received within theouter sheath 1006 of thedelivery catheter 1004. As in the illustrated embodiment, theouter sheath 1006 of thedelivery catheter 1004 can be longer than anintroducer sheath 1008 of theintroducer catheter 1002. Further, aclip 1007 can be supported by theouter sheath 1006 to limit the range of axial movement of theouter sheath 1006 relative to theintroducer catheter 1002. - Although not required, a
core assembly 1021 can be connected to a proximal end portion of theinner core 1020, thecore assembly 1021 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 catheter 1004 and be advanced into one or more lumen within theinner core 1020. Theinner core 1020 can be configured to accommodate the insertion of such sheath members, fenestration alignment components, or other tubular components into the lumen of theinner core 1020. - In the illustrated embodiment, a proximal end portion of the
core assembly 1021 can comprise ahandle member 1023 that is positioned outside a proximal end portion of thedelivery catheter 1004 so as to be accessible by a user. Thehandle member 1023 can be configured to permit a user to axially or rotationally adjust the position of theinner core 1020 relative to theouter sheath 1006. - As discussed above, the
inner core 1020, or components axially connected to theinner core 1020 such as thecore assembly 1021, can extend proximally past theproximal end portion 1004 a of thedelivery catheter system 1004 so that a user can adjust and/or change the axial and/or radial position of theinner core 1020 and, hence, theprosthesis 1010, relative to theouter sheath 1006. Similarly, theinner tube 1016 can extend proximally past theproximal end portion 1004 a of thedelivery catheter 1004 and aproximal end portion 1021 a of thecore assembly 1021 so that a user can adjust and change the position of theinner tube 1016 relative to theinner core 1020. - In the partially retracted position of the
outer sheath 1006 illustrated inFIG. 5B , at least a portion of theprosthesis 1010 supported by thecatheter system 1000 can be exposed and, potentially, deployed. A distal portion of theprosthesis 1010 can be exposed and deployed by retracting theouter sheath 1006 relative to theinner core 1020 or distally advancing theinner core 1020 relative to theouter sheath 1006, causing at least a portion of the distal portion of theprosthesis 1010 to self-expand. As will be described, theprosthesis 1010 can be configured to have radially self-expanding support members therein along only a portion or portions of theprosthesis 1010. For example, a graft of theprosthesis 1010 can be radially unsupported at or adjacent to fenestrations formed in the graft. Alternatively, at least the distal portion of theprosthesis 1010 can be constrained within a sheath, such as a peelable sheath. Embodiments of the sheath will be described in greater detail below. - The
delivery catheter 1004 can also have one or more branch or guidesheaths 1024 supported thereby. Thedelivery catheter 1004 can have three ormore branch sheaths 1024. 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 sheaths 1024 can be configured to be slidably supported within one ormore lumen 1025 formed in theinner core 1020 so that each of the one ormore branch sheaths 1024 can be axially advanced or retracted relative to theinner core 1020. Further, thedelivery catheter 1004 can be configured such that thebranch sheaths 1024 can be rotationally adjusted or twisted relative to theinner core 1020. In some embodiments, eachbranch sheath 1024 can be positioned within thedelivery catheter 1004 such that, in the loaded configuration wherein aprosthesis 1010 is supported (compressed) within thedelivery catheter 1004, eachbranch sheath 1024 is pre-positioned so as to be advanced through a fenestration or branch graft of theprosthesis 1010. Eachbranch sheath 1024 can be positioned within thedelivery catheter 1004 such that a distal end portion of eachbranch sheath 1024 projects past an end portion of theinner core 1020 and is constrained within theouter sheath 1006. As illustrated inFIGS. 5A-5B , in this configuration, the distal end portion of eachbranch sheath 1024 can be exposed by retracting theouter sheath 1006 relative to theinner core 1020 and/or thebranch sheaths 1024. - Additionally, with reference to
FIG. 5B , although not required, thedelivery catheter 1004 can have one or morefenestration alignment components 1026 supported thereby. The one or morefenestration alignment components 1026 can be slidably received within one ormore lumen 1027 formed in theinner core 1020. The one or morefenestration alignment components 1026 can each have anend portion 1026 a that can be sized and configured to surround an outer surface of each of thebranch sheaths 1024. Theend portion 1026 a of eachfenestration alignment component 1026 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 theprosthesis 1010. For example, as will be described in greater detail below, after the main body of theprosthesis 1010 has been released from theouter sheath 1006 and any other radial restraints, a user can independently or collectively axially advance thefenestration alignment component 1026 over thebranch sheaths 1024 such that theend portion 1026 a of eachfenestration alignment component 1026 contacts the edge or surface adjacent to and surrounding the fenestration or branch graft of theprosthesis 1010 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 more
fenestration alignment components 1026 is configured to be slidably supported within a lumen formed in theinner core 1020 so that each of the one or morefenestration alignment components 1026 can be axially advanced relative to theinner core 1020. Further, thedelivery catheter 1004 can be configured such that thefenestration alignment components 1026 can be axially or rotationally adjusted or twisted relative to theinner core 1020, for increased maneuverability of thefenestration alignment components 1026. - In some embodiments, each
fenestration alignment component 1026 can be positioned within thedelivery catheter 1004 such that, in the loaded configuration wherein aprosthesis 1010 is supported (compressed) within thedelivery catheter 1004, eachfenestration alignment component 1026 is pre-positioned so that theend portion 1026 a of eachfenestration alignment component 1026 is positioned distal to the end portion of theinner core 1020. In the loaded configuration, eachfenestration alignment component 1026 can be positioned such that theend portion 1026 a of eachfenestration alignment component 1026 is located within the main lumen of the main body of theprosthesis 1010. - The
branch sheaths 1024 andfenestration alignment components 1026 can have any suitable size and can be made from any suitable material. For example, thebranch sheaths 1024 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 components 1026 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 components 1026 from buckling when axially advanced against a portion of theprosthesis 1010. For example, thefenestration alignment components 1026 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, the
catheter system 1000 can be configured such that thedistal sheath 1012 can be advanced relative to theinner core 1020 and theprosthesis 1010, to expose a proximal portion of theprosthesis 1010. In particular, advancing thedistal sheath 1012 can be accomplished by advancing theinner tube 1016 connected to thedistal tip 1014 and thedistal sheath 1012, so that thedistal sheath 1012 releases the proximal portion of theprosthesis 1010. Other details regarding thedistal sheath 1012 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 catheter 1002 shown inFIG. 5A . Theintroducer catheter 1002 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 , theintroducer 1002 can have amain body 1030, a threadablyengageable hub portion 1032, a threadedcap 1034 configured to threadably engage with a threadeddistal end portion 1030 a of themain body 1030 so as to secure theouter sheath 1006 to themain body 1030. Theouter sheath 1006 can have aflanged end portion 1036 secured thereto or integrally formed therewith. Themain body 1030 can support aseal assembly 1040 therein to seal around theinner core 1020 of thedelivery catheter 1004 and/or other components of thecatheter system 1000. A threadedend member 1042 having a threadedproximal end portion 1042 a can be supported by themain body 1030. Anannular seal member 1046 can be supported by themain body 1030 of theintroducer catheter 1002. Theintroducer catheter 1002 can be configured such that theseal member 1046 can be adjusted to provide an additional seal around theinner core 1020 of thedelivery catheter 1004 by threadably engaging thehub portion 1032. Theseal assembly 1040 andseal member 1046 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. - A
tube assembly 1048 can be supported by themain body 1030 of theintroducer catheter 1002 so as to provide an orifice or access port into themain body 1030. Thetube assembly 1048 can be used to flush theintroducer catheter 1002 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 catheter 1002 and/ordelivery catheter 1004, or prior to other procedures for which another type of delivery catheter may be used. Thetube assembly 1048 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 catheter 1004 shown inFIG. 5A .FIG. 10 is a sectional view of a portion 10-10 of thedelivery catheter 1004 shown inFIG. 5A .FIG. 11A is a sectional view of thedelivery catheter 1004 shown inFIG. 5A , taken at 11A-11A shown inFIG. 10 .FIG. 11B is a sectional view of thedelivery catheter 1004 shown inFIG. 5A , taken at 11B-11B shown inFIG. 10 . - As shown therein, the
delivery catheter 1004 can have amain body 1050 that can support theinner core 1020 and/orcore assembly 1021, one ormore access ports 1052 for the one ormore branch sheaths 1024, and one ormore access ports 1054 for the one or morefenestration alignment components 1026. Theaccess ports branch sheaths 1024 or thefenestration alignment components 1026, and to constrict around thebranch sheaths 1024 or thefenestration alignment components 1026 so as to substantially axially secure thebranch sheaths 1024 or thefenestration alignment components 1026. Asealable cap assembly 1051 can be threadably engaged with themain body 1050 of thedelivery catheter 1004. Thecap assembly 1051 can be configured such that, when a user tightens thecap assembly 1051 relative to themain body 1050 of thedelivery catheter 1004, thecore assembly 1021 and/orinner core 1020 will be axially and/or rotational secured to themain body 1050 of thedelivery catheter 1004. - A
tube assembly 1059 can be supported by themain body 1050 of thedelivery catheter 1004 so as to provide an orifice or access port into themain body 1050. Thetube assembly 1059 can be used to flush thedelivery catheter 1004 with saline or other suitable substances. Thetube assembly 1059 can support any suitable medical connector and/or valve on the distal end thereof. - As mentioned above, the
support member 1022 can be connected to a distal end portion of theouter tube 1018 so as to be axially engaged by theouter tube 1018. Thesupport member 1022 can have a substantially cylindrical shape and can be sized to fit within the inner lumen of a main body of theprosthesis 1010 when theprosthesis 1010 is in a constrained configuration. As will be described, in the loaded configuration, theprosthesis 1010 can be positioned over thesupport member 1022 so that a proximal portion of a main body of theprosthesis 1010 is positioned distally of thesupport member 1022 and so that a distal portion of a main body of theprosthesis 1010 is positioned proximally of thesupport member 1022. In this configuration, aproximal end portion 1012 a of thedistal sheath 1012 can be positioned over adistal portion 1022 a of thesupport member 1022, and a distal end portion 1006 a of theouter sheath 1006 over aproximal portion 1022 b of thesupport member 1022. - In some embodiments, one or
more tab members 1074 can be supported by theouter tube 1018. The one ormore tab members 1074 can be configured to increase the rotational engagement of the constrainedprosthesis 1010 relative to theouter tube 1018 so that the constrainedprosthesis 1010 can be rotated with greater accuracy during deployment. The one ormore tab members 1074 can have a generally flat, plate-like shape, such as is illustrated inFIG. 8 . The one ormore tab members 1074 can be formed from a suitable polymeric or metallic material. The one ormore tab members 1074 can comprise one or more radiopaque features or be formed from a radiopaque material to improve the visibility and alignability of thedelivery catheter 1004 under fluoroscopy during deployment of theprosthesis 1010. - The one or
more tab members 1074 can be similar to any of the embodiments of the torsion tab (such as the torsion tab 196) 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 members 1074 can be integrally formed with theouter tube 1018, 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 the
prosthesis 1010 can be constrained by a peelable sheath or by theouter sheath 1006 such that theprosthesis 1010 is engaged with the one ormore tab members 1074. The one ormore tabs 1074 can engage a stent or other portion of an endoskeleton of theprosthesis 1010, or, can engage the material of thegraft 1204 surrounding thetab member 1074 so that theprosthesis 1010 can substantially rotate with theinner core 1020 of thedeployment catheter 1004. -
FIG. 12 is a side view of thecatheter system 1000 showing theouter sheath 1006 in a partially retracted position, similar to the configuration shown inFIG. 5B .FIG. 13 is an enlarged side view of the portion 13-13 of the catheter system shown inFIG. 12 . - With reference to
FIG. 13 , the mid portion of theprosthesis 1010 adjacent to the one or more fenestrations 1011 and/or thedistal portion 1010 a of the prosthesis can be constrained within apeelable sheath 1060. Thepeelable sheath 1060 can have arelease wire 1062 threadably advanced through a plurality ofopenings 1064 formed along at least a portion of thesheath 1060. Thepeelable sheath 1060,release wire 1062, andopenings 1064 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 wire 1062 can be slidably received within a lumen in theinner core 1020 so that a user can retract therelease wire 1062 by grasping and retracting a proximal portion of therelease wire 1062 positioned outside the patient's body. - However, the mid portion of the
prosthesis 1010 adjacent to the one or more fenestrations 1011 and/or thedistal portion 1010 a of the prosthesis can be constrained within one or more tubular sheaths, such as the outer sheath 1006 (also referred to herein as a second restraint or second restraining means) and/ordistal sheath 1012 such that additional restraining means such as thesheath 1060 are not required (not illustrated). Therefore, any of the embodiments disclosed herein having theoptional sheath 1060 should be understood to be configurable to not use thesheath 1060 to restrain one or more portions of theprosthesis 1010. Theprosthesis 1010 can be configured such that the mid portion of theprosthesis 1010 adjacent to the one or more fenestrations 1011 is not radially supported by a stent, connectors, struts, or any other similar structure such that, when theouter sheath 1006 is partially retracted, the mid portion of the prosthesis does not self-expand. - The
prosthesis 1010 can have one ormore openings 1011 formed therein. For example and the fenestrations oropenings 1011 can be formed in theprosthesis 1010 at diametrically opposing positions. As will be described in greater detail below, one or more of theopenings 1011 can be formed in theprosthesis 1010 at a position that is angularly offset from the diametrically opposing position. Similarly, when used, thesheath 1060 can have one ormore openings 1061 formed therein, theopenings 1061 being positioned adjacent to the similar number ofopenings 1011 formed in the prosthesis. Thecatheter system 1000 can be configured such that thesheaths 1024 are advanced through theopenings 1011 formed in theprosthesis 1010 and theopenings 1061 formed in thesheath 1060, when theprosthesis 1010 is loaded within thecatheter system 1000. - With reference to
FIG. 11B , due to the non-uniform design of the stent within the graft material, theprosthesis 1010 can be efficiently packed within theouter sheath 1006 so as to surround thesheaths 1024 and efficiently fill the space within theouter sheath 1006. In this configuration, for example, theprosthesis 1010 can be loaded within theouter sheath 1006 so that thesheaths 1024 are advanced between many of the struts, bends, loops, and other features that the stent can comprise, thereby permitting thesheaths 1024 sufficient space to be loaded within theouter sheath 1006 so that the lumen of thesheaths 1024 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 theprosthesis 1010. - As illustrated in
FIG. 13 , where used, thepeelable sheath 1060 can have one or more release wires 1062 (two being shown) advanced through openings orperforations 1064 formed in thesheath 1060 along two sides of thesheath 1060. Therelease wires 1062 can be configured to tear thesheath 1060 along two lines ofperforations 1064 and/or scores formed along two sides of thesheath 1060, so that thesheath 1060 can be removed from theprosthesis 1010 while thesheaths 1024 are advanced through thefenestrations prosthesis 1010 andsheath 1060. In this configuration, each of the tworelease wires 1062 can be secured to aproximal end portion 1060 a of thesheath 1060, so that both halves of thesheath 1060 can be retracted through theouter sheath 1006. - However, as illustrated in
FIG. 14 , thecatheter system 1000 can be configured to only have onerelease wire 1062 threadably advanced through thesheath 1060.FIG. 14 is an enlarged side view of thecatheter system 1000 shown inFIG. 5A , defined by curve 14-14 shown inFIG. 12 , showing theouter sheath 1006 in a partially retracted position and thedistal sheath 1012 in a partially advanced position. - The
perforations 1064 formed in thesheath 1060 can be arranged along an axial line along the length of the portion of thesheath 1060 from thefenestrations 1061 to the distal end of thesheath 1060, and also arranged to split thesheath 1060 between the twofenestrations 1061 formed in thesheath 1060. As illustrated inFIG. 14 , theperforations 1064 formed in thesheath 1060 arranged along the length of thesheath 1060 can be positioned to tear thesheath 1060 from one of thefenestrations 1061 to thedistal end 1060 b of thesheath 1060, and also to circumferentially tear thesheath 1060 between thefenestrations 1061. - As mentioned above, with reference to
FIG. 14 , thecatheter system 1000 can be configured such that aproximal portion 1010 b of theprosthesis 1010 can be deployed by axially advancing theinner tube 1016 relative to theinner core 1020 of thedelivery catheter 1004 and, hence, theprosthesis 1010. Theprosthesis 1010 can be self-expanding such that removing the radial constraint provided by thedistal sheath 1012 can cause the portion of theprosthesis 1010 constrained by theinner tube 1016 to expand toward the vessel wall. Theproximal portion 1010 b of theprosthesis 1010 can be deployed in this manner before thedistal portion 1010 a of theprosthesis 1010 is deployed, or simultaneously with the deployment of thedistal portion 1010 a of theprosthesis 1010. Theproximal portion 1010 b of theprosthesis 1010 can be deployed in this manner after thedistal portion 1010 a of theprosthesis 1010 is deployed. -
FIG. 15 is a side view of thecatheter system 1000 shown inFIG. 5A , showing theouter sheath 1006 in a partially retracted position and onebranch sheath 1024′ and onefenestration alignment component 1026′ in a partially advanced position. Thebranch sheath 1024′ can be advanced relative to theinner core 1020, the prosthesis, and thesecond branch sheath 1024″ by advancing a proximal portion of thebranch sheath 1024′ in the direction of arrow A1 inFIG. 15 through theaccess port 1052′ at the proximal end of thedelivery catheter 1004. Similarly (not shown), thesecond branch sheath 1024″ can be advanced relative to theinner core 1020, the prosthesis, and thefirst branch sheath 1024′ by advancing a proximal portion of thebranch sheath 1024″ through theaccess port 1052″ at the proximal end of thedelivery catheter 1004. Additionally, either of thefenestration alignment components 1026′, 1026″ can be advanced relative to thebranch sheaths 1024′, 1024″ by advancing the respectivefenestration alignment component 1026 through therespective access port 1054. For example, thefenestration alignment component 1026′ can be advanced by advancing the proximal portion of thefenestration alignment component 1026′ in the direction of arrow A2 inFIG. 15 . - With the embodiments of the
catheter system 1000 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 catheter 1000 being advanced through a patient's abdominal aorta over aguidewire 1070 positioned within a patient's vasculature. As in the illustrated embodiment, thedelivery catheter 1000 can be advanced through a prosthesis 1080 (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 catheter 1000 and anangiographic catheter 1065 being advanced through abranch sheath 1024 of the delivery catheter toward a target branch vessel. As illustrated, anouter sheath 1006 of thecatheter system 1000 has been retracted relative to the inner core (not shown) and theprosthesis 1010, exposing a middle portion of the prosthesis 1010 (i.e., a portion of theprosthesis 1010 radially adjacent to the one or more fenestrations 1011) and thebranch sheaths branch sheaths angiographic catheter 1065 can be advanced through the lumen of either or both of thebranch sheaths inner core 1020 to approximately rotationally align thefenestrations 1011 of theprosthesis 1010 or thebranch sheaths 1024 with the branch vessels. - As discussed above, the
optional sheath 1060 can constrain the mid and distal portions of theprosthesis 1010 such that, when theouter sheath 1006 is retracted, the mid and distal portions of theprosthesis 1010 do not self-expand. However, the mid portion of theprosthesis 1010 radially adjacent to the one or more fenestrations 1011 can be unsupported by anystents 1254. In this configuration, theprosthesis 1010 can be configured such that there is no radial force or support provided to the mid portion of theprosthesis 1010, or such that the mid portion of theprosthesis 1010 will not be biased to self-expand when theouter sheath 1006 is retracted. Accordingly, some embodiments can be configured such that no additional restraint in addition to, for example, theouter sheath 1006, is required. Therefore, only theouter sheath 1006 and thedistal sheath 1012 can be used to restrain theprosthesis 1010. In this configuration, theouter sheath 1006 can be partially retracted to release thesheaths 1024 so that one or moreangiographic catheters 1065 can be advanced through thesheaths 1024 and into the target branch vessels before the proximal and distal portions of theprosthesis 1010 are released from thedeployment catheter 1004. - The
angiographic catheter 1065 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, an
angiographic catheter 1065 is being advanced relative to thebranch sheath 1024 a and into the target branch vessel, in this case a renal artery. Thedelivery catheter 1000 can be configured such that an angiographic catheter can be advanced through the desiredbranch sheath 1024 and into the target vessel without retracting theouter sheath 1006. After theangiographic catheters 1065 have been directed into the target location, in this case the branch vessels, either or both of thebranch sheaths 1024 can be independently or simultaneously advanced over theangiographic catheters 1065 into the target branch vessels, as is illustrated inFIG. 18 . Thebranch sheaths 1024, thefenestrations prosthesis 1010 or thesheath 1060, respectively, and/or any other components or features of thedelivery catheter 1000 can have radiopaque markers or other indicators to assist a medical practitioner in the deployment procedures described herein or other suitable deployment procedures. - With the
branch sheaths 1024 in the target vessels and theouter sheath 1006 axially retracted, as shown inFIG. 19 , aproximal portion 1010 b of theprosthesis 1010 can be deployed by axially advancing thedistal sheath 1012 relative to theinner core 1020 and theprosthesis 1010. Theprosthesis 1010 can be axially and rotationally secured to theouter tube 1018, which can be axially and rotationally secured to theinner core 1020, such that advancing thedistal sheath 1012 relative to theinner core 1020 will advance thedistal sheath 1012 relative to theprosthesis 1010. As described above, thedistal sheath 1012 can be advanced relative to theinner core 1020 and theprosthesis 1010 by advancing theinner tube 1016 relative to theinner core 1020, theinner tube 1016 being axially engaged with thedistal tip 1014 which can support thedistal sheath 1012. -
FIG. 20 is a sectional view of a portion of a patient's vasculature, showing apeelable sheath 1060 being removed from thedistal portion 1010 a of theprosthesis 1010 so as to deploy adistal portion 1010 a of theprosthesis 1010. Thesheath 1060 can be removed by axially retracting arelease wire 1062, which can be looped or other otherwise threaded through openings orperforations 1064 formed in the sheath material. Therelease wire 1062 can be configured to tear through the sheath material between theperforations 1064, thereby permitting the self-expandingprosthesis 1010 to expand toward the vessel walls. As mentioned, theprosthesis 1010 can be configured to be restrained within theouter sheath 1006 and thedistal sheath 1012 such that an additional restraint, such as thepeelable sheath 1060, is not required. - As illustrated, a
distal portion 1060 a of thesheath 1060 can be torn by therelease wire 1062 before aproximal portion 1060 b of thesheath 1060 is torn by the release wire so that aproximal portion 1010 b of the prosthesis (i.e., adjacent to theproximal portion 1060 a of the sheath 1060) can be deployed before adistal portion 1010 a of thesheath 1010. Aproximal portion 1060 b or a middle portion of thesheath 1060 can be torn by therelease wire 1062 before adistal portion 1060 a of thesheath 1060 is torn by the release wire (not illustrated). Therelease wire 1062 can be secured to theproximal portion 1060 b or other suitable portion of thesheath 1060 such that, after thesheath 1060 has been torn, thesheath 1060 can be removed through thedelivery catheter 1000 by continuing to axially retract therelease wire 1062 relative to theprosthesis 1010. - As illustrated, a
distal portion 1010 a of the prosthesis 1010 (i.e., the downstream portion of the prosthesis 1010) can be deployed within an opening of an adjacent prosthesis, such as without limitation thebifurcated prosthesis 1080 illustrated inFIG. 20 . However, thedelivery catheter 1000 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, theprosthesis 1010 can be a bifurcated prosthesis. -
FIG. 21 is a sectional view of a portion of a patient's vasculature, showing afenestration alignment component 1026 contacting and pushing an inner wall of theprosthesis 1010 adjacent to afenestration 1011 toward an ostium of the target branch vessel. As illustrated, thefenestration alignment component 1026 can be advanced through a lumen in theinner core 1020 to push thefenestration 1011 of theprosthesis 1010 over thebranch sheath 1024 and into approximate alignment with the ostium of the branch vessel. Thecatheter system 1000 can be configured to not have afenestration alignment component 1026, and can accordingly be configured to deploy a fenestrated graft without the use of such a component - As illustrated in
FIG. 22 , a covered or uncoveredbranch stent 1084 can be deployed in the branch vessel by advancing thebranch stent 1084 through thebranch sheath 1024 using a suitable catheter, such as a renal stent catheter, into the target vessel, after the angiographic catheter has been removed from thebranch sheath 1024. Thestent 1084 can be supported on aninflation balloon 1086, which can be supported by aguidewire 1088. Theguidewire 1088 can be configured to have an inflation lumen therein, to inflate theballoon 1086 and expand thebranch stent 1084 in the target location after thebranch sheath 1024 has been at least partially retracted so as to not interfere with the expansion of thebranch stent 1084, as illustrated inFIG. 23 . Theinflation balloon 1086 can be configured to expand and flare a portion of thestent 1084 within or to the inside of thefenestration 1011 formed in the prosthesis. - The
fenestration alignment component 1026 described above can be configured to be supported within a renal or branch stent delivery catheter. For example, thefenestration alignment component 1026 can be configured to be supported within a modified renal stent catheter, such as the renal stent catheter illustrated inFIG. 22 . Thefenestration alignment component 1026 can be configured to only partially surround thebranch sheath 1024 or the branch stent delivery catheter. In this configuration, thefenestration alignment component 1026 can be configured to be entirely positioned within and advanceable through a lumen of thebranch sheath 1024 or the branch stent delivery catheter. For example, thefenestration alignment component 1026 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 the
branch sheath 1024. 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. - The
fenestration 1011 in theprosthesis 1010 can expand as thebranch stent 1084 is being expanded, to improve the seal between thefenestration 1011 and thebranch stent 1084. A second expansion balloon can be positioned in the portion of thestent 1084 within or to the inside of thefenestration 1011 to flare that portion of thestent 1084, either with or without removing the first balloon used to expand the main portion of thebranch stent 1084. - Some arrangements are directed to methods of deploying an endoluminal prosthesis, such as without limitation the
prosthesis 1010 described above, comprising inserting a delivery catheter such ascatheter system 1000 into an artery, exposing one ormore branch sheaths 1024, advancing one or more angiographic catheters having one or more guidewires into the one ormore branch sheaths 1024 and cannulating the target branch vessels, advancing the one ormore branch sheaths 1024 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 aprosthesis 1200 comprising one or more fenestrations 1202 formed in thegraft 1204, and a stent orsupport member 1206. thegraft 1204 is shown in dashed lines inFIG. 24B for clarity. Theprosthesis 1200 can have any of the features, components, or other details of any other prosthesis embodiments disclosed herein such as,prosthesis 1010 described above. Further, any of the features of theprosthesis 1200 can be used in combination with any of the other prosthesis embodiments disclosed herein. - The
graft 1204 can be supported by thestent 1206 along at least a portion of thegraft 1204. Further, thegraft 1204 can be overlapped and can have stitching orsutures 1208 along one or more edges of thegraft 1204, which can improve the tear resistance of thegraft 1204 and can improve the connection between thegraft 1204 and thestent 1206. - Similar to other graft embodiments described herein, the
graft 1204 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 thegraft 1204 in the approximate location of one or more fenestrations 1202 formed through the graft material. The excess or slack material along the circumference of the graft 1204 (for example, in theenlarged portion 1204 a of the graft 1204) can allow for circumferential and/or axial movement of the graft material and, hence, the one or more fenestrations 1202, relative to thestent 1206 and the ostium of the patient's branch vessels. Therefore, the diameter of thegraft 1204 at and/or adjacent to the location of one or more fenestrations 1202 can be larger than the local diameter of the target vessel. Similarly, the diameter of thegraft 1204 at and/or adjacent to the location of one or more fenestrations 1202 can be larger than the diameter of the non-enlarged portion of the graft material. In some embodiments, the outside surface of thegraft 1204 in theenlarged portion 1204 a or 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, the
graft 1204 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 thegraft 1204 can increase the circumferential and/or axial adjustability or movement of the graft material adjacent to the one or more fenestrations 1202 formed in thegraft 1204. Accordingly, the length of the graft material between the proximal and distal attachment points to thestent 1206 can be longer than that of thestent 1206 between the proximal and distal attachment points. Or, the graft material in a mid-portion of thegraft 1204, including on either side of theenlarged portion 1204 a, can have an increased length relative to the stent radially adjacent to such graft portion. - Further, the enlarged portion and/or excess length of the
graft 1204 or any other graft embodiment disclosed herein can be free from any attachment points to the stent or support member which supports thegraft 1204. 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 thegraft 1204 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 thegraft 1204. 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, theprosthesis 1010 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 connector 1254) away from thefenestrations 1202 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 to
FIGS. 24A-25 , thegraft 1204 can have one or moreenlarged portions 1204 a having an enlarged diameter relative to the target vessel or relative to one or more non-enlarged portions of thegraft 1204, such asportions fenestrations 1202 formed in theenlarged portions 1204 a to better accommodate asymmetrically positioned branch vessel ostium. In some embodiments, with reference toFIGS. 24A and 24B , thegraft 1204 can have anenlarged middle portion 1204 a having one or more fenestrations 1202 formed therein, a non-enlargedproximal portion 1204 b, and a non-enlargeddistal portion 1204 c. - As discussed above, in the
prosthesis 1200, theenlarged portion 1204 a of thegraft 1204 can have a diameter that is approximately 30% larger than a diameter of the target vessel or the diameter of thenon-enlarged portions graft 1204. The diameter of theenlarged portion 1204 a of thegraft 1204 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 portions graft 1204, or to or from any values within these ranges. - Additionally, the
enlarged portion 1204 a or portion of thegraft 1204 adjacent to theenlarged portion 1204 a of thegraft 1204 can be sized and configured to be substantially longer (i.e., in the axial direction) than thestent 1206, which can improve the radial and/or axial adjustability of thefenestrations 1202 formed in theenlarged portions 1204 a to better accommodate the asymmetric and/or non-uniform positioning of branch vessel ostium. Thegraft 1204 can be longer than thestent 1206 in both theenlarged portion 1204 a of thegraft 1204 and/or in the portion of the non-enlargeddistal portion 1204 c of the graft adjacent to theenlarged portion 1204 a of thegraft 1204. For example, theenlarged portion 1204 a or portion of thegraft 1204 adjacent to theenlarged portion 1204 a of thegraft 1204 can be sized and configured to be approximately 20% longer in the axial direction than thestent 1206. Theenlarged portion 1204 a or portion of thegraft 1204 adjacent to theenlarged portion 1204 a of thegraft 1204 can be sized and configured to be from approximately 10% to approximately 40% or more longer in the axial direction than thestent 1206. -
FIG. 25 is a top view of theprosthesis 1200 ofFIG. 24 . With reference toFIGS. 24-25 , theprosthesis 1200 can have fenestrations 1202 formed in anenlarged portion 1204 a of thegraft 1204. Thefenestrations 1202 can be formed at non-diametrically opposed positions. This can improve the alignment of thefenestrations 1202 with the ostium of the target branch vessels, which in general can be located at non-diametrically opposed positions. Thefenestrations 1202 formed in either the enlarged portion orportions 1204 a ornon-enlarged portions graft 1204, can be angled away from the diametrically opposed position (represented by angle X inFIG. 25 ) such that thefenestrations 1202 are separated by an angle (represented by angle Y inFIG. 25 ) that is less than 180 degrees. - For example, the
graft 1204 can have twofenestrations 1202 formed at an angle away from the diametrically opposed position (represented by angle X inFIG. 25 ) of approximately 15 degrees such that thefenestrations 1202 are separated by an angle (represented by angle Y inFIG. 25 ) that is approximately 150 degrees. Thegraft 1204 can have twofenestrations 1202 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 thefenestrations 1202 are separated by an angle (represented by angle Y inFIG. 25 ) that is between approximately 160 degrees and approximately 140 degrees. - The
graft 1204 can have twofenestrations 1202 formed in anenlarged portion 1204 a of the graft and wherein thefenestrations 1202 are separated by an angle that is less than 180 degrees, for example approximately 150 degrees. In this configuration, positioning thefenestrations 1202 to be separated by an angle that is less than 180 degrees (such as, for example, approximately 150 degrees) can improve the alignment of thefenestrations 1202 with the ostium of the target branch vessels such that theenlarged portion 1204 a of thegraft 1204 can be from approximately 20% to approximately 60% greater than thenon-enlarged portion graft 1204. In this configuration, theenlarged portion 1204 a of thegraft 1204 can be from approximately 20% to approximately 40% greater than thenon-enlarged portion graft 1204. - The
graft 1204, which can be a bifurcated or other suitably configured graft, can have twofenestrations 1202 formed in anenlarged portion 1204 a of the graft, wherein thefenestrations 1202 can be separated by an angle that is less than 180 degrees, and wherein the length of at least a portion of thegraft 1204 can be substantially greater than the length of thestent 1206, for example approximately 10% greater than the length of thestent 1206. In this configuration, positioning thefenestrations 1202 to be separated by an angle that is less than 180 degrees (such as, for example, approximately 150 degrees) and increasing the length of thegraft 1204 to be approximately 10% greater than the length of thestent 1206 can improve the alignment/alignability of thefenestrations 1202 with the ostium of the target branch vessels such that theenlarged portion 1204 a of thegraft 1204 can be from approximately 10% or less to approximately 20% greater than thenon-enlarged portion graft 1204. - With reference to
FIGS. 24-25 , though not required, theprosthesis 1200 can have reinforced fenestrations 1202 comprising atubular member 1210 inserted through thefenestration 1202 and stitched to thegraft 1204 with one ormore sutures 1212. In this configuration, which will be described in greater detail below, thetubular member 1210 can improve the tear resistance of thefenestration 1202 and also improve the sealability between thefenestrations 1202 and the branch grafts and stents deployed within thefenestrations 1202 as well as the pull-out resistance of the branch grafts and stents within thefenestrations 1202. This configuration can reduce leakage between thefenestrations 1202 and the branch grafts and stents deployed within thefenestrations 1202. In some embodiments, this configuration can also increase the force required to pull the branch grafts and stents deployed within thefenestrations 1202 out of thefenestrations 1202, thereby reducing the inadvertent axial movement of the branch grafts and stents deployed within thefenestrations 1202. - With reference to
FIGS. 24A and 24B , although not required, thegraft 1204 can have a scallop or cut-away 1230 at aproximal end portion 1204 b of thegraft 1204. The cut-away 1230 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-away 1230 can be based on the anatomy of a patient, or can be sized to accommodate a wide range of vessel anatomies. The cut-away 1230 can have a length approximately equal to the length of two stent struts, such asstent strut 1246 described below. Thegraft 1204 can be overlapped and havestitching 1208 along an edge of the cut-away 1230. Theprosthesis 1200 can have a flared proximal end portion to increase the sealability of such end portion of theprosthesis 1200. - As described above, the
prosthesis 1200 can have one or more radiopaque markers, such as but not limited to the annular radiopaque marker 1222 surrounding at least a portion of thefenestration 1202, 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 thestent 1206 shown inFIG. 24 , viewed along a line that is perpendicular to an axis projecting through a fenestration formed in the graft 1204 (not shown). For clarity, the location of afenestration 1202 is shown dashed lines.FIG. 28 is a side view of thestent 1206, viewed along an axis projecting through a fenestration. Again, for clarity, the location of afenestration 1202 is shown dashed lines. - With reference to FIGS. 26 and 27-28, the
stent 1206 can be formed from one or more wires forming a plurality ofloops 1240, which can be closed loops or eyelets, bends 1242, and struts 1246. Some of thebends 1242 can be configured to slide along a portion of the length of arespective strut 1246, to improve the flexibility and bendability of thestent 1206. The positioning of the plurality ofloops 1240 and bends 1242 can be longitudinally offset or staggered to decrease the collapsed diameter of theprosthesis 1200. - The
stent 1206 can comprise afirst stent segment 1250 formed from one or more lengths of wire, asecond stent segment 1252 formed from one or more lengths of wire, and one or more connectingmembers 1254 formed from one or more lengths of wire. The first andsecond stent segments stent 1206. The length of thefirst stent segment 1250 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 connecting
members 1254 can be positioned between the first andsecond stent segments fenestrations 1202 to increase the accessibility and adjustability of thefenestrations 1202 during deployment of theprosthesis 1200. As illustrated, the connectingmembers 1254 can have four struts. The connectingmembers 1254 can have three or less struts, or can have five or more struts. The connectingmembers 1254 can have a first connectingmember 1254 having fewer struts than a second connectingmember 1254. -
FIGS. 29-31 are oblique, side, and end views, respectively, of a fenestration alignment component 2026 (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 catheter 2004 having thefenestration alignment component 2026 ofFIG. 29 .FIG. 33 is an exploded view of thedelivery catheter 2004 shown inFIG. 32 . In some delivery catheter embodiments, one or morefenestration alignment components 2026 can be used in place of or in conjunction with one or morefenestration alignment components 1026 described above in any of the delivery catheter embodiments disclosed herein. - Therefore, the
fenestration alignment component 2026 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 component 1026 described above. Therefore, thefenestration alignment component 2026 can be used in any of the procedures, steps, or methods as described above for thefenestration alignment component 1026. For example, after the main body of a prosthesis (such as prosthesis 1010) has been released from theouter sheath 1006 and any other radial restraints, a user can independently or collectively axially advance thefenestration alignment component 2026 relative to the guide sheath 2024 (which can be the same as theguide sheath 1024 described above) supporting thefenestration alignment component 2026 such that a portion of thefenestration alignment component 2026 engages the fenestration or branch graft of theprosthesis 1010 and pushes the fenestration or branch graft toward an ostium of the target branch vessel of the patient's vasculature. - A
body portion 2027 of thefenestration alignment component 2026 can be slidably positioned around or over an outside surface of theguide sheath 2024. As illustrated inFIGS. 29 , 31, and 32, thebody portion 2027 can be cylindrical or tubular. Thebody portion 2027 can have an inside diameter or size that is greater than an outside diameter or size of theguide sheath 1024 so that thefenestration alignment component 2026 can axially translate relative to theguide sheath 1024. Thebody portion 2027 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 portion 2027 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. - The
body portion 2027 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 portion 2027 can be formed from a PEBAX covered alloy coil. For example, thebody portion 2027 can have a stainless steel coil with a PEBAX tube surrounding the coil. The PEBAX can have varying hardness. Thebody portion 2027 can have a PTFE liner surrounding all or a portion of thebody portion 2027. Additionally, thebody portion 2027 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 portion 2037. - As will be described in greater detail, the
fenestration alignment component 2026 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 component 2026 can have a tab or protruding portion 2028 (also referred to as a protrusion or projection) projecting from thebody portion 2027. The protrudingportion 2028 can project away from the outside surface of thebody portion 2027 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 protrudingportion 2028 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 portion 2027 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 the
body portion 2027 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 portion 2027 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 wire 2030 could be made hollow to allow for inflation of the inflatable component or element. - The protruding
portion 2028 can be integrally formed with thebody portion 2027, or can be formed separately and adhered to, supported by, or otherwise coupled with thebody portion 2027. The protrudingportion 2028 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 protrudingportion 2028 can be made from PEBAX. The protrudingportion 2028 can be made from a PEBAX material having a higher hardness value than the PEBAX material used to form thebody portion 2027. - As mentioned, the
fenestration alignment component 2026 can be configured to engage a fenestration of a prosthesis deployable by thedelivery catheter 2004. For example, the enlarged or protrudingportion 2028 can have a size or profile that is greater than a size or profile of theguide sheath 2024 or of thebody portion 2027 of thefenestration alignment component 2026 so that, while theguide sheath 2024 can be advanced through the fenestration, the protrudingportion 2028 can be sized and configured to be larger than the size or diameter of the fenestration so that the protrudingportion 2028 does not pass through the fenestration. - The
enlarged portion 2028 of thefenestration alignment component 2026 can have a circular cross-sectional shape or, as illustrated inFIGS. 29-31A , a non-circular cross-sectional shape. For example, theenlarged portion 2028 can have an approximately triangular or pointed shape with a rounded upper surface orportion 2028 a. Theenlarged portion 2028 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 to
FIGS. 29-30 , theenlarged portion 2028 can have a taperedsurface 2028 b at the trailing end of theenlarged portion 2028. The taperedsurface 2028 b can facilitate the removability of thefenestration alignment component 2026 if theenlarged portion 2028 of thefenestration alignment component 2026 is inadvertently advanced through a fenestration. - The
fenestration alignment components 2026 can each be attached topositioning wires 2030 such that axially advancing or retracting thepositioning wires 2030 will advance or retract thefenestration alignment components 2026. Thepositioning wires 2030 can each define a tapering cross-sectional size that decreases toward a distal end of thepositioning wire 2030 such that a cross-sectional size of thepositioning wire 2030 near thebody portion 2027 is smaller than a cross-sectional size of thepositioning wire 2030 near the catheter handle. Thepositioning wire 2030 can made from a PTFE coated stainless steel, such as 304, or from any other suitable material or combination of materials. Thepositioning wire 2030 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 wire 2030 can have a uniform diameter or cross-sectional size along the length thereof. - With reference to
FIG. 31B , anend portion 2030 a of thepositioning wire 2030 can overlap and be affixed to the body portion 2037 of thefenestration alignment component 2026. For example, between approximately 1.0 cm (0.394 in) or less and 1.5 cm (0.591 in) or more of thepositioning wire 2030 can overlap the body portion 2037. Theend portion 2030 a can be bonded to the body portion 2037 using any suitable technique or process. For example, theend portion 2030 a can be thermally bonded to the body portion 2037 using one or more PET sleeves. A portion of theend portion 2030 a can be coined or flattened. The end portion can have a greater surface area than a remainder of theend portion 2030 a. For example, approximately half of theend portion 2030 a can be coined or flattened. -
FIG. 32 is an oblique view of adelivery catheter 2004 having thefenestration alignment component 2026 ofFIG. 29 .FIG. 33 is an exploded view of thedelivery catheter 2004 shown inFIG. 32 .FIG. 32 illustrates ahandle portion 2050 of thedelivery catheter 2004, which can provide an entry point for theguide sheaths 2024 and thepositioning wires 2030 so as to provide an orifice or access port for these components into the main body of thedelivery catheter 2004. In this configuration, a surgeon or user can manipulate theguide sheaths 2024 andfenestration alignment components 2026 by manipulating the end portions of theguide sheaths 2024 andpositioning wires 2030 that extend proximally from the end of thehandle portion 2050 of the delivery catheter. - The
catheter 2004 can have two ormore guide sheaths 2024 and two or morefenestration alignment components 2026, or the same number ofguide sheaths 2024 andfenestration alignment components 2026 as the number of fenestrations in the prosthesis. Thecatheter 2004 havingguide sheaths 2024 withfenestration alignment components 2026 as described herein can be configured such that theguide sheaths 2024,fenestration alignment components 2026, and/orpositioning wires 2030 are advanceable within standard lumen formed in thedelivery catheter 2004. The lumen of thedelivery catheter 2004 may be enlarged or sized and configured to accommodatesuch guide sheaths 2024 withfenestration alignment components 2026. -
FIG. 34 is a sectional view of a portion of a patient's vasculature, showing thefenestration alignment component 2026 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 component 2026 of thecatheter 2004 can be axially advanced relative to the guide sheath 2024 (which can be the same as any other guide sheath embodiments disclosed herein, including without limitation guide sheath 1024) by advancing thepositioning wire 2030 distally to push thefenestration 1011 of theprosthesis 1010 over thebranch sheath 2024 and into approximate alignment with the ostium of the branch vessel. Thecatheter system 2004 can be configured to not have afenestration alignment component 2026, 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 thesheaths 1024 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 component 2026 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 components 2026 have been advanced to a second position, the second position being defined as the position where thefenestrations 1011 are approximately aligned with the ostium of the target branch vessels. As illustrated inFIG. 35 , a covered or uncoveredbranch stent 1084 can be deployed in the branch vessel by advancing thebranch stent 1084 through thebranch sheath 2024 using a suitable catheter, such as a renal stent catheter, into the target vessel, after the angiographic catheter has been removed from thebranch sheath 2024. - The
stent 1084 can be supported on aninflation balloon 1086, which can be supported by aguidewire 1088. Theguidewire 1088 can be configured to have an inflation lumen therein, to inflate theballoon 1086 and expand thebranch stent 1084 in the target location after thebranch sheath 2024 has been at least partially retracted so as to not interfere with the expansion of thebranch stent 1084. Thefenestration alignment components 2026 may need to be at least partially withdrawn before deploying thestents 1084, to enable the inflation balloon to expand thestents 1084. Theinflation balloon 1086 can be configured to expand and flare a portion of thestent 1084 within or to the inside of thefenestration 1011 formed in the prosthesis. Thereafter, the components comprising thedelivery catheter 2004 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 the
delivery catheter 2004 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 catheter 1004 described above. Like numbered features shown in the illustrations of thedelivery catheter 2004 can be the same or similar to the same numbered features of thedelivery catheter 1004 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)
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US17/882,378 US20230218416A1 (en) | 2010-11-02 | 2022-08-05 | Apparatus and method of placement of a graft or graft system |
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US11406518B2 (en) | 2022-08-09 |
JP6261339B2 (en) | 2018-01-17 |
WO2012061526A2 (en) | 2012-05-10 |
US20170128246A1 (en) | 2017-05-11 |
WO2012061526A3 (en) | 2012-08-23 |
EP2635241A2 (en) | 2013-09-11 |
JP2014500056A (en) | 2014-01-09 |
EP2635241B1 (en) | 2019-02-20 |
US20230218416A1 (en) | 2023-07-13 |
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