US20050070992A1 - Prosthesis systems and methods sized and configured for the receipt and retention of fasteners - Google Patents
Prosthesis systems and methods sized and configured for the receipt and retention of fasteners Download PDFInfo
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- US20050070992A1 US20050070992A1 US10/752,435 US75243504A US2005070992A1 US 20050070992 A1 US20050070992 A1 US 20050070992A1 US 75243504 A US75243504 A US 75243504A US 2005070992 A1 US2005070992 A1 US 2005070992A1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/064—Surgical staples, i.e. penetrating the tissue
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
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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
- A61F2/02—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
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
- A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
- A61B2017/003—Steerable
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/064—Surgical staples, i.e. penetrating the tissue
- A61B2017/0646—Surgical staples, i.e. penetrating the tissue for insertion into cartillege, e.g. meniscus
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- A—HUMAN NECESSITIES
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/064—Surgical staples, i.e. penetrating the tissue
- A61B2017/0649—Coils or spirals
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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
- A61F2/02—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
- A61F2/064—Blood vessels with special features to facilitate anastomotic coupling
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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
- A61F2/82—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
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- 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
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
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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
- A61F2/02—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
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- 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
- A61F2002/067—Y-shaped blood vessels modular
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- A—HUMAN NECESSITIES
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- 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
- 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
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/0015—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in density or specific weight
- A61F2250/0017—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in density or specific weight differing in yarn density
-
- 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
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/0023—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in porosity
-
- 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
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter
Definitions
- the invention relates generally to prostheses, and in particular, to prostheses used in the repair of diseased and/or damaged sections of a hollow body organ and/or a blood vessel.
- the weakening of a vessel wall from damage or disease can lead to vessel dilatation and the formation of an aneurysm. Left untreated, an aneurysm can grow in size and may eventually rupture.
- aneurysms of the aorta primarily occur in abdominal region, usually in the infrarenal area between the renal arteries and the aortic bifurcation. Aneurysms can also occur in the thoracic region between the aortic arch and renal arteries. The rupture of an aortic aneurysm results in massive hemorrhaging and has a high rate of mortality.
- Open surgical replacement of a diseased or damaged section of vessel can eliminate the risk of vessel rupture.
- a prosthetic graft made either in a straight of bifurcated configuration, is installed and then permanently attached and sealed to the ends of the native vessel by suture.
- the prosthetic grafts for these procedures are usually unsupported woven tubes and are typically made from polyester, ePTFE or other suitable materials.
- the grafts are longitudinally unsupported so they can accommodate changes in the morphology of the aneurysm and native vessel.
- these procedures require a large surgical incision and have a high rate of morbidity and mortality.
- many patients are unsuitable for this type of major surgery due to other co-morbidities.
- Endovascular aneurysm repair has been introduced to overcome the problems associated with open surgical repair.
- the aneurysm is bridged with a vascular prosthesis, which is placed intraluminally.
- vascular prosthesis which is placed intraluminally.
- these prosthetic grafts for aortic aneurysms are delivered collapsed on a catheter through the femoral artery.
- These grafts are usually designed with a fabric material attached to a metallic scaffolding (stent) structure, which expands or is expanded to contact the internal diameter of the vessel.
- intraluminally deployed grafts are not sutured to the native vessel, but rely on either barbs extending from the stent, which penetrate into the native vessel during deployment, or the radial expansion force of the stent itself is utilized to hold the graft in position.
- These graft attachment means do not provide the same level of attachment when compared to suture and can damage the native vessel upon deployment.
- the invention provides apparatus and methods for repairing diseased and/or damaged sections of a hollow body organ and/or a blood vessel.
- the prosthesis comprises a trunk that includes a prosthetic material and a scaffold.
- the scaffold supports the prosthetic material to define a lumen within the trunk.
- the trunk includes a main body region and a fastening region.
- the fastening region is configured differently than the main body region for the receipt and retention in the second region of at least one fastener implanted into tissue by an external fastener attachment assembly.
- the different configuration of the fastening region can comprise, e.g., a prosthetic material in the fastening region that is different than a prosthetic material in the main body region; and/or a prosthetic material in the fastening region that includes more layers than the prosthetic material in the main body region; and/or a prescribed weave pattern in the fastening region that is not present in the main body region; and/or a prescribed weave pattern in the fastening region that is denser that a weave pattern in the main body region; and/or a scaffold configuration in the fastening region that is different than a scaffold configuration in the main body region.
- FIG. 1 is a perspective view of a tissue reinforcement prosthesis having a fastening region that accommodates the introduction of one or more fasteners.
- FIG. 2 is a perspective view of a prosthesis system that includes the tissue reinforcement prosthesis shown in FIG. 1 and an auxiliary prosthesis that, in use, is telescopically anchored and supported by the tissue reinforcement prosthesis.
- FIG. 3 is a perspective view of the tissue reinforcement prosthesis shown in FIG. 1 , showing the attachment of fasteners in the fastening region.
- FIG. 4 is a perspective view of the tissue reinforcement prosthesis shown in FIG. 1 positioned within a hollow body organ by use of fasteners.
- FIG. 5A is a perspective view of the tissue reinforcement prosthesis shown in FIG. 1 positioned within the proximal neck of an abdominal aortic aneurysm.
- FIG. 5B is a perspective view of the tissue reinforcement prosthesis shown in FIG. 5A , with the inclusion of an optional supra-renal stent.
- FIG. 6A is a perspective view of a prosthesis system that includes the tissue reinforcement prosthesis shown in FIG. 5A positioned within a proximal neck of the abdominal aortic aneurysm and an auxiliary prosthesis that is telescopically anchored and supported by the tissue reinforcement prosthesis and that bridges the aneurysm.
- FIG. 6B is an enlarged view of the system shown in FIG. 6A , showing the telescopic fitment of the auxiliary prosthesis in the tissue reinforcement prosthesis.
- FIG. 6C is an enlarged view of the system shown in FIG. 6A , showing a telescopic, interlocking fitment of the auxiliary prosthesis in the tissue reinforcement prosthesis.
- FIGS. 7, 8 , and 9 are perspective views of the deployment of the system shown in FIG. 6A by the sequential use of various intra-vascular catheters, one to deploy the tissue reinforcement prosthesis ( FIG. 7 ), another to apply fasteners to the tissue reinforcement prosthesis ( FIG. 8 ), and another to deploy the auxiliary prosthesis ( FIG. 9 ).
- FIG. 10 is a perspective view of prosthesis positioned within an abdominal aortic aneurysm, the prosthesis having a fastening region that accommodates the introduction of one or more fasteners.
- FIG. 11 is a perspective view of prosthesis positioned within an abdominal aortic aneurysm, the prosthesis having a tapered trunk located, at its proximal end, within the aorta and, at its distal end, in an iliac, the prosthesis also having a fastening region that accommodates the introduction of one or more fasteners.
- FIG. 1 shows a tissue reinforcement prosthesis 10 that embodies features of the invention.
- the prosthesis 10 serves to reinforce a region of a vessel wall or hollow body organ which has been weakened by disease or damage.
- the prosthesis 10 desirable provides a platform on which to deploy a second prosthesis 36 (see FIG. 2 ) in the vessel or hollow body organ.
- the reinforcement prosthesis 10 comprises a component part of an overall prosthesis system 52 .
- the prosthesis 10 comprises a tubular trunk 12 .
- the trunk 12 is sized and configured to fit within a targeted region of a hollow body organ and/or a blood vessel.
- the targeted region is selected on the basis of certain anatomic characteristics. These characteristics include a weakened conditioned caused, e.g., by disease or damage.
- the trunk 12 forms a generally cylindrical structure with an open interior lumen 18 .
- the trunk 12 fortifies the body organ or blood vessel in the targeted region, to keep it from collapsing.
- the trunk 12 includes a prosthetic material 14 supported by a scaffold 16 .
- the prosthetic material 14 is selected on the basis of its biocompatibility, durability, and flexible mechanical properties.
- the material 14 can comprise, e.g., woven polyester. Alternatively, a material comprising ePTFE can be used.
- the scaffold 16 is desirable sized and configured to permit non-invasive deployment of the prosthesis 10 by an intra-vascular catheter.
- the scaffold 16 is sized and configured to assume a compressed or collapsed, low profile condition, to permit its intra-vascular introduction into the hollow body organ and/or blood vessel by a catheter, as will be described in greater detail later.
- the scaffold 16 is sized and configured for expansion in situ from its collapsed condition into an expanded condition in contact with tissue in the targeted region, as will also be described in greater detail later.
- the scaffold 16 can comprise, e.g., a malleable plastic or metal material that expands in the presence of an applied force.
- the deployment catheter can include, e.g., an expandable body, such as a balloon, to apply the expansion force to the scaffold 16 in situ.
- the scaffold 16 can comprise a self-expanding plastic or metal material that can be compressed in the presence of a force, but self-expands upon removal of the compressive force.
- the deployment catheter can include, e.g., a sleeve that can be manipulated to enclosed the scaffold 16 in a collapsed condition, thereby applying the compressive force, and to release the scaffold 16 when desired to allow the scaffold 16 to self-expand in situ.
- the scaffold 16 can include individual self-expanding, zigzag type main stent rings 22 .
- the main stent rings 22 can be made, e.g., from Nitinol® wire. Still, other materials, manufacturing methods and designs can be used.
- the main stent rings 22 need not be attached to one another throughout the prosthesis material 14 .
- the individual main stent rings 22 allow for longitudinal compliance while maintaining radial support of the open interior lumen 18 . This technical feature allows the prosthesis 10 to more readily accommodate changes in morphology in the targeted region. Still, it may be desirable in certain locations within the prosthesis structure to have attachments between the individual main stent rings 22 to provide enhanced stability and/or additional radial support.
- Each of the main stent rings 22 can be, e.g., sewn onto prosthetic material 14 .
- the attachment of the main stent rings 22 can be made, e.g., with polyester suture.
- attachment means could be utilized to secure the main stent rings 22 to the prosthetic material 14 .
- These means include bonding; capturing the main stent rings 22 between two layers of prosthetic material 14 ; and incorporating the main stent rings 22 directly into the prosthetic material 14 .
- main stent rings 22 In certain locations it is desired to have the main stent rings 22 attached to the outer diameter of the prosthetic material 14 . Still, it is also contemplated that the main stent rings 22 could be attached to the inner diameter of the prosthetic material 22 .
- At least one end of the trunk 12 desirably also includes one or more end stent rings 24 .
- the principal purpose of an end stent ring 24 is to provide a seal between the trunk 12 and adjoining tissue. This sealing function is particularly desirable when the prosthesis 10 is deployed in a blood vessel or other body organ, where body fluids are intended to reside or pass through the prosthesis 10 .
- the end sent rings 24 can also serve, with the main stent rings 22 , to help maintain the position of the prosthesis 10 in the targeted region.
- the end stent rings 24 desirably serve more of a sealing function than a retention function, the end stent rings 24 are desirably more compliant than the main stent rings 22 .
- the end stent rings 24 also desirably occupy a minimum of area on the trunk 12 .
- the trunk 12 (material 14 and/or scaffold 16 ) can carry radiopaque markers 46 to help fluoroscopically position the prosthesis 10 .
- the markers 46 can take the form, e.g. of marker bands, tight wound coils, or wire made from radiopaque materials such as platinum, platinum/iridium, or gold.
- the trunk 12 also desirably includes at least one fastening region 26 that accommodates the introduction of one or more fasteners 28 to anchor the prosthesis 10 in place (see FIG. 3 ). It is desirable that this region 26 of the trunk 12 be specially sized and configured for the receipt and retention of fasteners 28 .
- the size and spacing of ring stent patterns can be configured in the region 26 to specially accommodate the placement of fasteners; and/or woven fibers with an “X-pattern” or a “sinusoidal pattern” can be used in the region 26 to specially accommodate placement of fasteners; and/or the prosthetic material 14 can be folded-over to form multiple layers, to reinforce the prosthesis in the region 26 where fasteners are placed; and/or denser weave patterns or stronger fibers can be used, selected from, e.g., KevlarTM material or VectranTM material or metallic wire woven alone or interwoven with typical polyester fibers in the region 26 were fasteners are placed. It may also be desirable to fluoroscopically indicate this region 26 with auxiliary radiopaque markers 30 on the prosthetic material 14 , and/or auxiliary stent rings 32 to aid in positioning the fasteners.
- the fasteners 28 can be variously constructed. They can, e.g., comprise helical fasteners or staples.
- the fasteners 28 are introduced by an intra-vascular fastener attachment assembly. Details of a fastener attachment assembly that deploys helical fasteners can be found in U.S. patent application Ser. No. 10/307,226, filed Nov. 29, 2002, which is incorporated herein by reference.
- the targeted region for deployment of the tissue reinforcement prosthesis 10 as just described can vary.
- the targeted region can comprise a damaged or weakened area within a given body organ, as FIG. 4 shows.
- the presence of prosthesis 10 provides reinforcement to the body organ where damage or weakness exists.
- the targeted region can comprise an aorta with an aneurysm.
- a tissue reinforcement prosthesis 10 in this targeted region could be indicated, e.g., when the neck proximal to the aneurysm (i.e., closest to the head) is either too short or otherwise has a native anatomic feature that interferes with the secure placement of a conventional endovascular prosthesis to bridge the aneurysm.
- the presence of prosthesis 10 provides reinforcement to the proximal neck of the aneurysmal aorta adjacent the renal arteries.
- the reinforcement prosthesis 10 can also serve to anchor and support an auxiliary prosthesis structure 36 that, in the absence of the reinforcement prosthesis 10 , could not be deployed, due to native anatomic features of the vessel.
- the auxiliary prosthesis structure 36 comprises an endovascular graft that, when deployed, bridges the aneurysm. Together, the reinforcement prosthesis 10 and the graft 36 form a prosthesis system 52 , as shown in FIG. 6A .
- the graft 36 includes a proximal end 38 that is sized and configured to be telescopically fitted within the lumen 18 of the trunk 12 .
- the lumen 18 of the trunk 12 provides an interface region or socket 40 (see FIG. 6B ) that is fully enclosed within the body of the trunk 12 itself.
- the lumen 18 is therefore not prone to kinking or twisting or other kinds of movement independent of the trunk 12 .
- the socket region 40 of the trunk 12 be specially sized and configured for the receipt and retention of the auxiliary graft 36 , e.g., by the use of folded-over materials to form multiple layers, and/or the use of denser weave patters or stronger fibers from, e.g., KevlarTM material or VectranTM material or metallic wire woven alone or interwoven with typical polyester fibers in the socket region 40 , additional stent rings, and the like, to reinforce the prosthesis in the socket region 40 where hooks or barbs 60 of the graft 36 can obtain purchase; and/or by the use of radiopaque markers 42 to fluoroscopically identify the socket region 40 on the prosthetic material 14 ; and/or the use of auxiliary stent rings on the inside of the prosthetic material 14 in the socket region 40 that interfere with exterior stent rings on the graft 36 , to resist migration of graft 36 from the prosthesis 10 .
- the mechanical properties of the graft 36 are supplemented by the reinforcement, support, and integrity of the socket region 40 and trunk 12 themselves, and vice versa. Coupled together, the trunk 12 and the graft 36 provide enhanced resistance to migration and/or separation of the graft 36 from the trunk 12 . Seated within the enclosed socket region 40 , the graft 36 is peripherally sealed within the trunk 12 to resist leaks or seepage of fluids around the graft 36 .
- a mechanically interlocking relationship can be established.
- a supplemental main stent ring 22 A on the interior of the socket region 40 which would comprise the distal-most main stent ring of the trunk 12 —could be provided to mechanically engage or nest with a supplemental main stent ring 22 B on the exterior of the proximal end of the auxiliary prosthesis structure 36 .
- the mechanical interference between the supplemental stent rings 22 A and 22 B serves to capture the auxiliary prosthesis structure 36 within the trunk 12 , preventing both distal and proximal migration between the two prostheses 10 and 36 .
- auxiliary prosthesis structure 36 can be deployed first, and the prosthesis 10 deployed second to nest within an end of the auxiliary prosthesis structure 36 , thereby elongating and reinforcing the neck region.
- the trunk 12 may include a supra-renal stent 44 at its proximal end, which extends beyond the prosthetic material 14 .
- this stent 44 When deployed within the aorta, this stent 44 would extend above the level of the renal arteries.
- the supra-renal stent 44 orients the prosthesis 10 within the lumen and aids in maintaining the position of the prosthesis 10 in the aorta without obstructing the normal blood flow into the renal arteries.
- a first catheter 20 is navigated over a guide wire 48 through an iliac to the desired location within the aorta near the renal arteries.
- the catheter 20 carries the reinforcement prosthesis 10 in a radially reduced configuration.
- the catheter 20 releases the reinforcement prosthesis 10 , which expands radially into the position shown in FIG. 5A .
- the trunk 12 of the prosthesis 10 desirable extends distally from the proximal neck and partially into the aneurysm sac.
- a fastener assembly 34 is next deployed (see FIG. 8 ) to place fasteners 28 into the end region 28 of the trunk 12 .
- the prosthesis 10 is thereby secured in position.
- the auxiliary graft 36 is carried in a radially compressed condition by another over-the-wire catheter 50 (see FIG. 9 ).
- the catheter 50 deploys the graft 36 , such that the proximal end of the graft 36 is telescopically received within the socket region 40 of the trunk 12 .
- the prosthesis system 52 is thereby formed.
- any given tubular prosthesis 54 can include a trunk 56 having a region 26 that is specially sized and configured for the receipt and retention of fasteners 28 , in the ways previously described.
- the trunk 56 is sized and configured to extend, for purposes of illustration, in the aorta adjacent the renal arteries distally to a location proximal the natural bifurcation of the iliac arteries.
- the region 26 is located in the neck of the aorta adjacent to the renal arteries. The features of the region 26 , previously described, make possible the secure attachment of the prosthesis 54 , without migration.
- the prosthesis 54 desirable also includes other features of the prosthesis 10 already described, e.g., the main stent rings 22 , the end stent rings 24 , and the radiopaque markers 46 .
- the prosthesis 54 can also include a supra-renal stent 44 of the type shown in FIG. 5B .
- the trunk 58 of a given prosthesis 56 may be tapered, changing diameter from the proximal region to the distal region.
- the taper reduces the diameter of the trunk 58 in the proximal to distal direction. This taper direction is well suited for placement of the prosthesis 56 , at its proximal end, in the aorta adjacent the renal arteries and, at its distal end, in an iliac artery, as FIG. 11 shows.
- the trunk 58 of the prosthesis 56 desirable also includes a region 26 that is specially sized and configured for the receipt and retention of fasteners 28 , in the ways previously described. As shown in FIG. 11 , the region 26 is located in the neck of the aorta adjacent to the renal arteries. The features of the region 26 , previously described, make possible the secure attachment of the prosthesis 56 , without migration.
- the prosthesis 56 desirable also includes other features of the prosthesis 10 already described, e.g., the main stent rings 22 , the end stent rings 24 , and the radiopaque markers 46 .
- the prosthesis 54 can also include a supra-renal stent 44 of the type shown in FIG. 5B .
- the targeted site of deployment is within the aorta adjacent the renal arteries.
- this targeted site of deployment is selected for purposes of illustrating the features of the prostheses 54 and 56 , and is not intended to be limiting.
Abstract
Description
- This application claims the benefit of U.S. patent application Ser. No. 10/693,255, filed Oct. 24, 2003, and entitled “Multi-Lumen Prosthesis Systems and Methods.”
- The invention relates generally to prostheses, and in particular, to prostheses used in the repair of diseased and/or damaged sections of a hollow body organ and/or a blood vessel.
- The weakening of a vessel wall from damage or disease can lead to vessel dilatation and the formation of an aneurysm. Left untreated, an aneurysm can grow in size and may eventually rupture.
- For example, aneurysms of the aorta primarily occur in abdominal region, usually in the infrarenal area between the renal arteries and the aortic bifurcation. Aneurysms can also occur in the thoracic region between the aortic arch and renal arteries. The rupture of an aortic aneurysm results in massive hemorrhaging and has a high rate of mortality.
- Open surgical replacement of a diseased or damaged section of vessel can eliminate the risk of vessel rupture. In this procedure, the diseased or damaged section of vessel is removed and a prosthetic graft, made either in a straight of bifurcated configuration, is installed and then permanently attached and sealed to the ends of the native vessel by suture. The prosthetic grafts for these procedures are usually unsupported woven tubes and are typically made from polyester, ePTFE or other suitable materials. The grafts are longitudinally unsupported so they can accommodate changes in the morphology of the aneurysm and native vessel. However, these procedures require a large surgical incision and have a high rate of morbidity and mortality. In addition, many patients are unsuitable for this type of major surgery due to other co-morbidities.
- Endovascular aneurysm repair has been introduced to overcome the problems associated with open surgical repair. The aneurysm is bridged with a vascular prosthesis, which is placed intraluminally. Typically these prosthetic grafts for aortic aneurysms are delivered collapsed on a catheter through the femoral artery. These grafts are usually designed with a fabric material attached to a metallic scaffolding (stent) structure, which expands or is expanded to contact the internal diameter of the vessel. Unlike open surgical aneurysm repair, intraluminally deployed grafts are not sutured to the native vessel, but rely on either barbs extending from the stent, which penetrate into the native vessel during deployment, or the radial expansion force of the stent itself is utilized to hold the graft in position. These graft attachment means do not provide the same level of attachment when compared to suture and can damage the native vessel upon deployment.
- The invention provides apparatus and methods for repairing diseased and/or damaged sections of a hollow body organ and/or a blood vessel.
- One aspect of the invention provides systems and methods that include a prosthesis for a blood vessel or hollow body organ. The prosthesis comprises a trunk that includes a prosthetic material and a scaffold. The scaffold supports the prosthetic material to define a lumen within the trunk. The trunk includes a main body region and a fastening region. The fastening region is configured differently than the main body region for the receipt and retention in the second region of at least one fastener implanted into tissue by an external fastener attachment assembly.
- The different configuration of the fastening region can comprise, e.g., a prosthetic material in the fastening region that is different than a prosthetic material in the main body region; and/or a prosthetic material in the fastening region that includes more layers than the prosthetic material in the main body region; and/or a prescribed weave pattern in the fastening region that is not present in the main body region; and/or a prescribed weave pattern in the fastening region that is denser that a weave pattern in the main body region; and/or a scaffold configuration in the fastening region that is different than a scaffold configuration in the main body region.
- Other features and advantages of the invention shall be apparent based upon the accompanying description, drawings, and claims.
- The invention will be understood from the following detailed description of preferred embodiments, taken in conjunction with the accompanying drawings, wherein:
-
FIG. 1 is a perspective view of a tissue reinforcement prosthesis having a fastening region that accommodates the introduction of one or more fasteners. -
FIG. 2 is a perspective view of a prosthesis system that includes the tissue reinforcement prosthesis shown inFIG. 1 and an auxiliary prosthesis that, in use, is telescopically anchored and supported by the tissue reinforcement prosthesis. -
FIG. 3 is a perspective view of the tissue reinforcement prosthesis shown inFIG. 1 , showing the attachment of fasteners in the fastening region. -
FIG. 4 is a perspective view of the tissue reinforcement prosthesis shown inFIG. 1 positioned within a hollow body organ by use of fasteners. -
FIG. 5A is a perspective view of the tissue reinforcement prosthesis shown inFIG. 1 positioned within the proximal neck of an abdominal aortic aneurysm. -
FIG. 5B is a perspective view of the tissue reinforcement prosthesis shown inFIG. 5A , with the inclusion of an optional supra-renal stent. -
FIG. 6A is a perspective view of a prosthesis system that includes the tissue reinforcement prosthesis shown inFIG. 5A positioned within a proximal neck of the abdominal aortic aneurysm and an auxiliary prosthesis that is telescopically anchored and supported by the tissue reinforcement prosthesis and that bridges the aneurysm. -
FIG. 6B is an enlarged view of the system shown inFIG. 6A , showing the telescopic fitment of the auxiliary prosthesis in the tissue reinforcement prosthesis. -
FIG. 6C is an enlarged view of the system shown inFIG. 6A , showing a telescopic, interlocking fitment of the auxiliary prosthesis in the tissue reinforcement prosthesis. -
FIGS. 7, 8 , and 9 are perspective views of the deployment of the system shown inFIG. 6A by the sequential use of various intra-vascular catheters, one to deploy the tissue reinforcement prosthesis (FIG. 7 ), another to apply fasteners to the tissue reinforcement prosthesis (FIG. 8 ), and another to deploy the auxiliary prosthesis (FIG. 9 ). -
FIG. 10 is a perspective view of prosthesis positioned within an abdominal aortic aneurysm, the prosthesis having a fastening region that accommodates the introduction of one or more fasteners. -
FIG. 11 is a perspective view of prosthesis positioned within an abdominal aortic aneurysm, the prosthesis having a tapered trunk located, at its proximal end, within the aorta and, at its distal end, in an iliac, the prosthesis also having a fastening region that accommodates the introduction of one or more fasteners. - I. Tissue Reinforcement Prosthesis
- A. Structure
-
FIG. 1 shows atissue reinforcement prosthesis 10 that embodies features of the invention. Theprosthesis 10 serves to reinforce a region of a vessel wall or hollow body organ which has been weakened by disease or damage. As will be described in greater detail later, theprosthesis 10 desirable provides a platform on which to deploy a second prosthesis 36 (seeFIG. 2 ) in the vessel or hollow body organ. In this arrangement, thereinforcement prosthesis 10 comprises a component part of anoverall prosthesis system 52. - In the illustrated embodiment (see
FIG. 1 ), theprosthesis 10 comprises atubular trunk 12. Thetrunk 12 is sized and configured to fit within a targeted region of a hollow body organ and/or a blood vessel. The targeted region is selected on the basis of certain anatomic characteristics. These characteristics include a weakened conditioned caused, e.g., by disease or damage. - The
trunk 12 forms a generally cylindrical structure with an openinterior lumen 18. Thetrunk 12 fortifies the body organ or blood vessel in the targeted region, to keep it from collapsing. - In the illustrated embodiment, the
trunk 12 includes aprosthetic material 14 supported by ascaffold 16. Theprosthetic material 14 is selected on the basis of its biocompatibility, durability, and flexible mechanical properties. The material 14 can comprise, e.g., woven polyester. Alternatively, a material comprising ePTFE can be used. - The
scaffold 16 is desirable sized and configured to permit non-invasive deployment of theprosthesis 10 by an intra-vascular catheter. With this criteria in mind, thescaffold 16 is sized and configured to assume a compressed or collapsed, low profile condition, to permit its intra-vascular introduction into the hollow body organ and/or blood vessel by a catheter, as will be described in greater detail later. - Also with this criteria in mind, the
scaffold 16 is sized and configured for expansion in situ from its collapsed condition into an expanded condition in contact with tissue in the targeted region, as will also be described in greater detail later. - In this respect, the
scaffold 16 can comprise, e.g., a malleable plastic or metal material that expands in the presence of an applied force. In this arrangement, the deployment catheter can include, e.g., an expandable body, such as a balloon, to apply the expansion force to thescaffold 16 in situ. - Alternatively, the
scaffold 16 can comprise a self-expanding plastic or metal material that can be compressed in the presence of a force, but self-expands upon removal of the compressive force. In this arrangement, the deployment catheter can include, e.g., a sleeve that can be manipulated to enclosed thescaffold 16 in a collapsed condition, thereby applying the compressive force, and to release thescaffold 16 when desired to allow thescaffold 16 to self-expand in situ. - For self-expansion, the
scaffold 16 can include individual self-expanding, zigzag type main stent rings 22. The main stent rings 22 can be made, e.g., from Nitinol® wire. Still, other materials, manufacturing methods and designs can be used. - The main stent rings 22 need not be attached to one another throughout the
prosthesis material 14. The individual main stent rings 22 allow for longitudinal compliance while maintaining radial support of the openinterior lumen 18. This technical feature allows theprosthesis 10 to more readily accommodate changes in morphology in the targeted region. Still, it may be desirable in certain locations within the prosthesis structure to have attachments between the individual main stent rings 22 to provide enhanced stability and/or additional radial support. - Each of the main stent rings 22 can be, e.g., sewn onto
prosthetic material 14. In the illustrated embodiment, in which theprosthetic material 14 is woven polyester, the attachment of the main stent rings 22 can be made, e.g., with polyester suture. - However, it is also contemplated that other attachment means could be utilized to secure the main stent rings 22 to the
prosthetic material 14. These means include bonding; capturing the main stent rings 22 between two layers ofprosthetic material 14; and incorporating the main stent rings 22 directly into theprosthetic material 14. - In certain locations it is desired to have the main stent rings 22 attached to the outer diameter of the
prosthetic material 14. Still, it is also contemplated that the main stent rings 22 could be attached to the inner diameter of theprosthetic material 22. - At least one end of the
trunk 12 desirably also includes one or more end stent rings 24. The principal purpose of anend stent ring 24 is to provide a seal between thetrunk 12 and adjoining tissue. This sealing function is particularly desirable when theprosthesis 10 is deployed in a blood vessel or other body organ, where body fluids are intended to reside or pass through theprosthesis 10. The end sentrings 24 can also serve, with the main stent rings 22, to help maintain the position of theprosthesis 10 in the targeted region. - Since the end stent rings 24 desirably serve more of a sealing function than a retention function, the end stent rings 24 are desirably more compliant than the main stent rings 22. The end stent rings 24 also desirably occupy a minimum of area on the
trunk 12. - The trunk 12 (
material 14 and/or scaffold 16) can carryradiopaque markers 46 to help fluoroscopically position theprosthesis 10. Themarkers 46 can take the form, e.g. of marker bands, tight wound coils, or wire made from radiopaque materials such as platinum, platinum/iridium, or gold. - The
trunk 12 also desirably includes at least onefastening region 26 that accommodates the introduction of one ormore fasteners 28 to anchor theprosthesis 10 in place (seeFIG. 3 ). It is desirable that thisregion 26 of thetrunk 12 be specially sized and configured for the receipt and retention offasteners 28. For example, the size and spacing of ring stent patterns can be configured in theregion 26 to specially accommodate the placement of fasteners; and/or woven fibers with an “X-pattern” or a “sinusoidal pattern” can be used in theregion 26 to specially accommodate placement of fasteners; and/or theprosthetic material 14 can be folded-over to form multiple layers, to reinforce the prosthesis in theregion 26 where fasteners are placed; and/or denser weave patterns or stronger fibers can be used, selected from, e.g., Kevlar™ material or Vectran™ material or metallic wire woven alone or interwoven with typical polyester fibers in theregion 26 were fasteners are placed. It may also be desirable to fluoroscopically indicate thisregion 26 with auxiliaryradiopaque markers 30 on theprosthetic material 14, and/or auxiliary stent rings 32 to aid in positioning the fasteners. - The
fasteners 28 can be variously constructed. They can, e.g., comprise helical fasteners or staples. - Desirably, like the
prosthesis 10 itself, thefasteners 28 are introduced by an intra-vascular fastener attachment assembly. Details of a fastener attachment assembly that deploys helical fasteners can be found in U.S. patent application Ser. No. 10/307,226, filed Nov. 29, 2002, which is incorporated herein by reference. - B. Use of the Tissue Reinforcement Prosthesis
- The targeted region for deployment of the
tissue reinforcement prosthesis 10 as just described can vary. For example, the targeted region can comprise a damaged or weakened area within a given body organ, asFIG. 4 shows. In this embodiment, the presence ofprosthesis 10 provides reinforcement to the body organ where damage or weakness exists. - As another example (see
FIG. 5A ), the targeted region can comprise an aorta with an aneurysm. The use of atissue reinforcement prosthesis 10 in this targeted region could be indicated, e.g., when the neck proximal to the aneurysm (i.e., closest to the head) is either too short or otherwise has a native anatomic feature that interferes with the secure placement of a conventional endovascular prosthesis to bridge the aneurysm. In this embodiment, the presence ofprosthesis 10 provides reinforcement to the proximal neck of the aneurysmal aorta adjacent the renal arteries. - When used for this purpose (see
FIG. 6A ), thereinforcement prosthesis 10 can also serve to anchor and support anauxiliary prosthesis structure 36 that, in the absence of thereinforcement prosthesis 10, could not be deployed, due to native anatomic features of the vessel. In the illustrated embodiment, theauxiliary prosthesis structure 36 comprises an endovascular graft that, when deployed, bridges the aneurysm. Together, thereinforcement prosthesis 10 and thegraft 36 form aprosthesis system 52, as shown inFIG. 6A . - In this arrangement, the
graft 36 includes aproximal end 38 that is sized and configured to be telescopically fitted within thelumen 18 of thetrunk 12. Thelumen 18 of thetrunk 12, provides an interface region or socket 40 (seeFIG. 6B ) that is fully enclosed within the body of thetrunk 12 itself. Thelumen 18 is therefore not prone to kinking or twisting or other kinds of movement independent of thetrunk 12. - It is desirable that the
socket region 40 of thetrunk 12 be specially sized and configured for the receipt and retention of theauxiliary graft 36, e.g., by the use of folded-over materials to form multiple layers, and/or the use of denser weave patters or stronger fibers from, e.g., Kevlar™ material or Vectran™ material or metallic wire woven alone or interwoven with typical polyester fibers in thesocket region 40, additional stent rings, and the like, to reinforce the prosthesis in thesocket region 40 where hooks orbarbs 60 of thegraft 36 can obtain purchase; and/or by the use of radiopaque markers 42 to fluoroscopically identify thesocket region 40 on theprosthetic material 14; and/or the use of auxiliary stent rings on the inside of theprosthetic material 14 in thesocket region 40 that interfere with exterior stent rings on thegraft 36, to resist migration ofgraft 36 from theprosthesis 10. - Being telescopically fitted within the socket region 40 (see
FIG. 6B ), and being also enclosed within thetrunk 12 itself, the mechanical properties of thegraft 36 are supplemented by the reinforcement, support, and integrity of thesocket region 40 andtrunk 12 themselves, and vice versa. Coupled together, thetrunk 12 and thegraft 36 provide enhanced resistance to migration and/or separation of thegraft 36 from thetrunk 12. Seated within theenclosed socket region 40, thegraft 36 is peripherally sealed within thetrunk 12 to resist leaks or seepage of fluids around thegraft 36. - To enhance the fitment between the
trunk 12 and thegraft 36 within thesocket region 40, a mechanically interlocking relationship can be established. For example (as shown inFIG. 6C ), a supplemental main stent ring 22A on the interior of thesocket region 40—which would comprise the distal-most main stent ring of thetrunk 12—could be provided to mechanically engage or nest with a supplemental main stent ring 22B on the exterior of the proximal end of theauxiliary prosthesis structure 36. The mechanical interference between the supplemental stent rings 22A and 22B serves to capture theauxiliary prosthesis structure 36 within thetrunk 12, preventing both distal and proximal migration between the twoprostheses prostheses auxiliary prosthesis structure 36 can be deployed first, and theprosthesis 10 deployed second to nest within an end of theauxiliary prosthesis structure 36, thereby elongating and reinforcing the neck region. - In this arrangement (see
FIG. 5B ), thetrunk 12 may include a supra-renal stent 44 at its proximal end, which extends beyond theprosthetic material 14. When deployed within the aorta, thisstent 44 would extend above the level of the renal arteries. The supra-renal stent 44 orients theprosthesis 10 within the lumen and aids in maintaining the position of theprosthesis 10 in the aorta without obstructing the normal blood flow into the renal arteries. - During use (see
FIG. 7 ), afirst catheter 20 is navigated over aguide wire 48 through an iliac to the desired location within the aorta near the renal arteries. Thecatheter 20 carries thereinforcement prosthesis 10 in a radially reduced configuration. At the targeted site, thecatheter 20 releases thereinforcement prosthesis 10, which expands radially into the position shown inFIG. 5A . When thereinforcement prosthesis 10 ultimately serves to anchor anauxiliary graft 36, thetrunk 12 of theprosthesis 10 desirable extends distally from the proximal neck and partially into the aneurysm sac. - A
fastener assembly 34 is next deployed (seeFIG. 8 ) to placefasteners 28 into theend region 28 of thetrunk 12. Theprosthesis 10 is thereby secured in position. - The
auxiliary graft 36 is carried in a radially compressed condition by another over-the-wire catheter 50 (seeFIG. 9 ). Thecatheter 50 deploys thegraft 36, such that the proximal end of thegraft 36 is telescopically received within thesocket region 40 of thetrunk 12. Theprosthesis system 52 is thereby formed. - II. Other Prostheses
- A. Tubular Prosthesis for General Use
- Any given tubular prosthesis 54 (see
FIG. 10 ) can include atrunk 56 having aregion 26 that is specially sized and configured for the receipt and retention offasteners 28, in the ways previously described. InFIG. 10 , thetrunk 56 is sized and configured to extend, for purposes of illustration, in the aorta adjacent the renal arteries distally to a location proximal the natural bifurcation of the iliac arteries. As shown inFIG. 10 , theregion 26 is located in the neck of the aorta adjacent to the renal arteries. The features of theregion 26, previously described, make possible the secure attachment of theprosthesis 54, without migration. - The
prosthesis 54 desirable also includes other features of theprosthesis 10 already described, e.g., the main stent rings 22, the end stent rings 24, and theradiopaque markers 46. Theprosthesis 54 can also include a supra-renal stent 44 of the type shown inFIG. 5B . - B. Aorta Iliac Prosthesis
- As shown in
FIG. 11 , thetrunk 58 of a givenprosthesis 56 may be tapered, changing diameter from the proximal region to the distal region. In the embodiment shown inFIG. 11 , the taper reduces the diameter of thetrunk 58 in the proximal to distal direction. This taper direction is well suited for placement of theprosthesis 56, at its proximal end, in the aorta adjacent the renal arteries and, at its distal end, in an iliac artery, asFIG. 11 shows. - The
trunk 58 of theprosthesis 56 desirable also includes aregion 26 that is specially sized and configured for the receipt and retention offasteners 28, in the ways previously described. As shown inFIG. 11 , theregion 26 is located in the neck of the aorta adjacent to the renal arteries. The features of theregion 26, previously described, make possible the secure attachment of theprosthesis 56, without migration. - The
prosthesis 56 desirable also includes other features of theprosthesis 10 already described, e.g., the main stent rings 22, the end stent rings 24, and theradiopaque markers 46. Theprosthesis 54 can also include a supra-renal stent 44 of the type shown inFIG. 5B . - As described with respect to
FIGS. 10 and 11 , the targeted site of deployment is within the aorta adjacent the renal arteries. However, this targeted site of deployment is selected for purposes of illustrating the features of theprostheses - The preferred embodiments of the invention are described above in detail for the purpose of setting forth a complete disclosure and for the sake of explanation and clarity. Those skilled in the art will envision other modifications within the scope and sprit of the present disclosure.
- The above described embodiments of this invention are merely descriptive of its principles and are not to be limited. The scope of this invention instead shall be determined from the scope of the following claims, including their equivalents.
Claims (27)
Priority Applications (9)
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JP2008323278A JP2009095684A (en) | 2004-01-06 | 2008-12-19 | Prosthesis systems and methods sized and configured for the receipt and retention of fasteners |
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Also Published As
Publication number | Publication date |
---|---|
US20080065191A1 (en) | 2008-03-13 |
CA2551685A1 (en) | 2005-07-28 |
WO2005067660A2 (en) | 2005-07-28 |
AU2005204615A1 (en) | 2005-07-28 |
JP2007523694A (en) | 2007-08-23 |
US9848869B2 (en) | 2017-12-26 |
WO2005067660A3 (en) | 2007-04-05 |
JP2009095684A (en) | 2009-05-07 |
JP4284366B2 (en) | 2009-06-24 |
EP1708625A4 (en) | 2011-09-28 |
CN101151002A (en) | 2008-03-26 |
EP1708625A2 (en) | 2006-10-11 |
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