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 PDF

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Publication number
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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US
United States
Prior art keywords
prosthesis
region
trunk
main body
prosthetic material
Prior art date
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Abandoned
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US10/752,435
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English (en)
Inventor
Lee Bolduc
Juan Parodi
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Aptus Endosystems Inc
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Aptus Endosystems Inc
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Publication date
Priority claimed from US10/271,334 external-priority patent/US6960217B2/en
Priority claimed from US10/693,255 external-priority patent/US6929661B2/en
Priority to US10/752,435 priority Critical patent/US20050070992A1/en
Application filed by Aptus Endosystems Inc filed Critical Aptus Endosystems Inc
Assigned to APTUS ENDOSYSTEMS, INC. reassignment APTUS ENDOSYSTEMS, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: PARODI, JUAN, BOLDUC, LEE
Priority to AU2005204615A priority patent/AU2005204615A1/en
Priority to JP2006547608A priority patent/JP4284366B2/ja
Priority to EP05704902A priority patent/EP1708625A4/en
Priority to CA002551685A priority patent/CA2551685A1/en
Priority to PCT/US2005/000059 priority patent/WO2005067660A2/en
Priority to CNA2005800020269A priority patent/CN101151002A/zh
Publication of US20050070992A1 publication Critical patent/US20050070992A1/en
Assigned to PRESIDIO MANAGEMENT GROUP, INC. reassignment PRESIDIO MANAGEMENT GROUP, INC. SECURITY AGREEMENT Assignors: APTUS ENDOSYSTEMS, INC.
Priority to US11/981,112 priority patent/US9848869B2/en
Priority to JP2008323278A priority patent/JP2009095684A/ja
Assigned to COMERICA BANK reassignment COMERICA BANK SECURITY AGREEMENT Assignors: APTUS ENDOSYSTEMS, INC.
Assigned to APTUS ENDOSYSTEMS, INC. reassignment APTUS ENDOSYSTEMS, INC. RELEASE BY SECURED PARTY (SEE DOCUMENT FOR DETAILS). Assignors: PRESIDIO MANAGEMENT GROUP, INC.
Assigned to APTUS ENDOSYSTEMS, INC. reassignment APTUS ENDOSYSTEMS, INC. RELEASE BY SECURED PARTY (SEE DOCUMENT FOR DETAILS). Assignors: COMERICA BANK
Abandoned legal-status Critical Current

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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • 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
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    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/003—Steerable
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    • A61B2017/0646—Surgical staples, i.e. penetrating the tissue for insertion into cartillege, e.g. meniscus
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    • 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
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    • 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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    • 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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    • 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
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    • 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
    • A61F2002/067—Y-shaped blood vessels modular
    • 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
    • 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.

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US10/752,435 US20050070992A1 (en) 2001-11-28 2004-01-06 Prosthesis systems and methods sized and configured for the receipt and retention of fasteners
CNA2005800020269A CN101151002A (zh) 2004-01-06 2005-01-03 大小和构造适于接收和保持紧固件的修补物系统和方法
PCT/US2005/000059 WO2005067660A2 (en) 2004-01-06 2005-01-03 Prosthesis systems and methods sized and configured for the receipt and retention of fasteners
AU2005204615A AU2005204615A1 (en) 2004-01-06 2005-01-03 Prosthesis systems and methods sized and configured for the receipt and retention of fasteners
CA002551685A CA2551685A1 (en) 2004-01-06 2005-01-03 Prosthesis systems and methods sized and configured for the receipt and retention of fasteners
EP05704902A EP1708625A4 (en) 2004-01-06 2005-01-03 DIMENSIONED AND CONFIGURED PROSTHESIS SYSTEMS AND METHODS FOR RECEIVING AND RETAINING FIXATIONS
JP2006547608A JP4284366B2 (ja) 2004-01-06 2005-01-03 ファスナーの受け取りおよび保持のためにサイズ決めされ構成されたプロテーゼシステムおよび方法
US11/981,112 US9848869B2 (en) 2001-11-28 2007-10-31 Prosthesis systems and methods
JP2008323278A JP2009095684A (ja) 2004-01-06 2008-12-19 ファスナーの受け取りおよび保持のためにサイズ決めされ構成されたプロテーゼシステムおよび方法

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US33393701P 2001-11-28 2001-11-28
US10/271,334 US6960217B2 (en) 2001-11-28 2002-10-15 Endovascular aneurysm repair system
US48901103P 2003-07-21 2003-07-21
US10/693,255 US6929661B2 (en) 2001-11-28 2003-10-24 Multi-lumen prosthesis systems and methods
US10/752,435 US20050070992A1 (en) 2001-11-28 2004-01-06 Prosthesis systems and methods sized and configured for the receipt and retention of fasteners

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