WO2007124053A1 - Twin bifurcated stent graft - Google Patents

Twin bifurcated stent graft Download PDF

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Publication number
WO2007124053A1
WO2007124053A1 PCT/US2007/009665 US2007009665W WO2007124053A1 WO 2007124053 A1 WO2007124053 A1 WO 2007124053A1 US 2007009665 W US2007009665 W US 2007009665W WO 2007124053 A1 WO2007124053 A1 WO 2007124053A1
Authority
WO
WIPO (PCT)
Prior art keywords
leg
stent
sleeve
aperture
stent graft
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2007/009665
Other languages
English (en)
French (fr)
Inventor
Roy K. Greenberg
David Ernest Hartley
Michael Lawrence-Brown
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
William A Cook Australia Pty Ltd
Cleveland Clinic Foundation
Cook Inc
Original Assignee
William A Cook Australia Pty Ltd
Cleveland Clinic Foundation
Cook Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by William A Cook Australia Pty Ltd, Cleveland Clinic Foundation, Cook Inc filed Critical William A Cook Australia Pty Ltd
Priority to CA2649705A priority Critical patent/CA2649705C/en
Priority to EP07755802.1A priority patent/EP2007313B1/en
Priority to JP2009506603A priority patent/JP2009534104A/ja
Priority to CN2007800227121A priority patent/CN101484090B/zh
Priority to AU2007240703A priority patent/AU2007240703C1/en
Publication of WO2007124053A1 publication Critical patent/WO2007124053A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/954—Instruments specially adapted for placement or removal of stents or stent-grafts for placing stents or stent-grafts in a bifurcation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2476—Valves implantable in the body not otherwise provided for
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/89—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2002/061—Blood vessels provided with means for allowing access to secondary lumens
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2002/065—Y-shaped blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

Definitions

  • This invention relates to a medical device and more particularly a device which can be deployed by endovascular means into the vasculature of a patient.
  • bifurcated endovascular devices which can be deployed into the vasculature, particularly in the region of the aortic bifurcation, so that an aneurysm in the aorta can be bridged by placement of the endovascular device with a proximal portion which seals into a non-aneurysed portion of the aorta adjacent to the renal arteries, a first leg which extends down one iliac artery to a non-aneurysed portion of the iliac artery and another short leg into which a leg extension may be placed to extend into a non-aneurysed portion of the contralateral iliac artery.
  • the object of this invention is to provide a single endovascularly deployed medical device which can solve this problem or at least provide a physician with a useful alternative.
  • distal with respect to a portion of the aorta, a deployment device or a prosthesis means the end of the aorta, deployment device or prosthesis further away in the direction of blood flow away from the heart and the term proximal means the portion of the aorta, deployment device or end of the prosthesis nearer to the heart.
  • proximal means the portion of the aorta, deployment device or end of the prosthesis nearer to the heart.
  • the invention is said to reside in a stent graft comprising a tubular body of a biocompatible graft material defining a main lumen therethrough, a bifurcation in the tubular body at one end thereof and a first leg and a second leg extending from the bifurcation, the first leg being a long leg and the second leg being a short leg, the first and second legs having respective first and second lumens therethrough and the first and second lumens being in fluid communication with the main lumen, characterised by the first long leg comprising a side arm with a side arm lumen therethrough and the side arm lumen being in fluid communication with the first leg lumen, whereby the stent graft can be deployed into the vasculature of a patient with the tubular body being in an aorta of the patient, the first leg extending down an iliac artery, the second leg being directed towards a contralateral iliac artery and the side arm on the first leg directed to an internal artery of the ilia
  • the side arm comprises a tube of corrugated biocompatible graft material and the tube extends part helically around the first leg.
  • the side arm comprises a tube of biocompatible graft material and at least one self expanding stent on the tube of biocompatible graft material.
  • the first leg includes an aperture or fenestration proximally of the side arm and a valve arrangement to prevent fluid flow through the aperture from inside of the leg to outside of the leg.
  • the aperture includes a resilient reinforcement ring around the aperture.
  • the valve arrangement can comprise a sleeve of a biocompatible graft material within the first leg and a self expanding stent within the sleeve, the sleeve being fastened at its proximal end to the first leg proximal of the aperture and the self expanding stent being fastened to the sleeve, whereby the self expanding stent forces the sleeve against the inner surface of the first leg around the aperture to prevent fluid flow through the aperture from inside of the leg to outside of the leg.
  • the sleeve of a biocompatible graft material comprises a cylindrical form. In an alternative embodiment the sleeve of a biocompatible graft material comprises a semi-cylindrical form.
  • the valve can be formed from a self expanding stent to which a part cylindrical portion of biocompatible graft material is stitched along spaced apart struts of the self expanding stent. These two components together can form a valve assembly which can be stitched into the longer leg of the stent graft.
  • the valve assembly can further include a semi-circular resilient wire around the distal end of the part cylindrical portion of biocompatible graft material forming the valve member. This semi-circular resilient wire around the distal end of the part cylindrical portion of biocompatible graft material will assist with sealing off the fenestration by ensuring that the distal end of the valve member is held against the inside of the wall of the longer first leg of the stent graft.
  • the biocompatible graft material can include polytetrafluoroethylene, Dacron, polyamide or any other suitable biocompatible graft material.
  • a naturally occurring biomaterial such as collagen
  • ECM extracellular matrix
  • examples of ECM's include pericardium, stomach submucosa, liver basement membrane, urinary bladder submucosa, tissue mucosa, and dura mater.
  • SIS is particularly useful, and can be made in the fashion described in
  • the material can be made thicker by making multilaminate constructs, for example SIS constructs as described in US Patents 5,968,096; 5,955,1 10; 5,885,619; and 5,71 1 ,969.
  • multilaminate constructs for example SIS constructs as described in US Patents 5,968,096; 5,955,1 10; 5,885,619; and 5,71 1 ,969.
  • autologous tissue can be harvested as well, for use in forming the tubular graft material.
  • Elastin or Elastin-Like Polypetides (ELPs) and the like offer potential as a material to fabricate the tubular graft material to form a device with exceptional biocompatibility.
  • SIS is available from Cook Biotech, West Lafayette, Indiana, USA.
  • a stent graft which has a main bifurcation to allow access into each of the iliac arteries and in one of the legs extending from the bifurcation there is a further bifurcation or branch which will enable access into the internal iliac artery.
  • a stent graft which has a main bifurcation to allow access into each of the iliac arteries and in one of the legs extending from the bifurcation there is a further bifurcation or branch which will enable access into the internal iliac artery.
  • valve arrangement proximal of the side arm or side branch of the iliac leg of the bifurcated stent graft.
  • the valve allows an indwelling catheter to be provided through the sidearm in the iliac artery at the time of deployment to assist with deployment of leg extension into the internal iliac artery.
  • the indwelling catheter can be extended and its guide wire snared from the contra-lateral artery and the leg extension placed into the internal iliac artery before the leg extension is placed into the iliac artery.
  • the invention is said to reside in a stent graft comprising a tubular body of a biocompatible graft material defining a main lumen therethrough an aperture defining a fenestration in the tubular body and a valve arrangement to prevent fluid flow through the aperture.
  • the aperture includes a resilient reinforcement ring around the aperture.
  • the valve arrangement comprises a sleeve of a biocompatible graft material within the tubular body and a self expanding stent within the sleeve, the sleeve being fastened at its proximal end to the first leg proximal of the aperture and the self expanding stent being fastened to the sleeve, whereby the self expanding stent forces the sleeve against the inner surface of the tubular body around the aperture to prevent fluid flow through the aperture.
  • the sleeve of a biocompatible graft material can comprise a cylindrical form or alternatively a semi-cylindrical form.
  • valve arrangement comprises a valve assembly comprising a self expanding stent to which a part cylindrical portion of biocompatible graft material is stitched along spaced apart struts of the self expanding stent.
  • the valve assembly can further comprise a semi-circular resilient wire around the distal end of the part cylindrical portion of biocompatible graft material forming the valve member.
  • Figure 1 shows a first embodiment of stent graft according to the invention as it would be deployed into the vasculature before placement of an iliac side branch;
  • Figure 2 shows the embodiment of Figure 1 with the side branch installed into the internal iliac artery and the leg extension in the contralateral iliac artery;
  • Figure 3 shows a schematic view of part of the leg of the stent graft of the present invention in particular showing one embodiment of the valve arrangement
  • Figure 4 shows a cross-section of embodiment shown in Figure 3;
  • Figure 5 shows a same view as Figure 4 except with the indwelling catheter extending through the corrugated side arm and valve;
  • Figure 6 shows an alternative embodiment of stent graft deployed into a schematic vasculature with an alternative arrangement of side arm
  • Figure 7 shows embodiment of Figure 6 at the stage where the indwelling catheter has been snared and pulled down the contralateral artery and the indwelling catheter has been used to deploy an extension piece into internal iliac artery;
  • Figure 8 shows an alternative embodiment of valve arrangement suitable for the embodiment of stent graft shown in Figures 6 and 7;
  • Figure 9 shown a cross-section thought the valve arrangement of Figure 8;
  • Figure 10 shows the valve arrangement of Figures 8 and 9 with an indwelling catheter extending through it;
  • Figure 1 1 shows an alternative embodiment of valve arrangement suitable for the embodiment of stent graft shown in Figures 6 and 7;
  • Figure 12 shown a detail of the valve arrangement of Figure 1 1 showing the self expanding stent with a valve member mounted onto it;
  • Figure 13 shown a cross-section thought valve arrangement of Figure 1 1 ;
  • Figure 14 shows the valve arrangement of Figures 1 1 and 13 with an indwelling catheter extending through it:
  • Figure 1 5A to 1 5M show the various stages of deployment of a stent graft according to one embodiment of the present invention
  • Figure 16A to 16K show the various stages of deployment of a stent graft according to another embodiment of the present invention.
  • the vasculature comprises an aorta 10 in the region between the renal arteries 12 and the aortic bifurcation 14.
  • Common iliac arteries 16 and 18 extend down from the aortic bifurcation 14.
  • the aorta 10 has an aneurysm 20 which extends down into the common iliac artery 18 as far as the bifurcation 22 between the internal iliac artery 24 and the external iliac artery 26.
  • a twin bifurcated aortic stent graft 40 according to one embodiment of the present invention has been deployed into the aorta 10.
  • the introduction device which is used to deploy the stent graft into the vasculature has been omitted to assist clarity.
  • PCT Patent Publication No. WO 98/53761 entitled "A prosthesis and a method deploying a prosthesis” there is disclosed an introducer for a stent graft which is suitable for use with the present invention.
  • the proximal end 42 of the bifurcated stent graft 40 is engaged into non-aneurysed portion 28 of the aorta 10 just distal of the renal arteries 12.
  • stent graft 40 has a proximally extending supra-renal exposed stent 44 with barbs 46 engaging the wall of the aorta proximal of the renal arteries to provide a secure position to prevent migration of the stent graft.
  • the stent graft 40 has a short leg 50 and a long leg 52 extending from the graft bifurcation 54.
  • the longer Jeg 52 has a sealing surface 56 at its distal end which engages into a non-aneurysed portion of the external iliac artery 26.
  • the longer leg 52 has a side arm 60 which in this embodiment is in the form of a corrugated tube extending in a part helical manner from its connection at a fenestration 62 into the longer leg 52.
  • the side arm 60 extends in a distal direction and helically partly around the longer leg 52 and has a distal end 61 remote from its connection with the longer leg 52 which opens adjacent to the internal iliac artery 24.
  • a fenestration 64 is placed into the longer leg 52 proximal of the connection of the side arm 60 into the longer leg 52.
  • the fenestration 64 has a valve arrangement within it to close it off as will be discussed with reference to Figures 3 to 5.
  • an indwelling catheter 66 extends through the side arm 60 and out through the valved fenestration 64.
  • the indwelling catheter includes a guide wire 68.
  • Figure 2 shows the embodiment of Figure 1 but after deployment of a extension piece 70 into the corrugated side arm 60 and deployment of a leg extension 72 into the short leg 50 of the bifurcated stent graft 40 which seals into a non-aneurysed portion of the iliac artery 16.
  • United States Patent Application Serial No. 10/962,763 entitled “Introducer for Iliac Side Branch Device” discloses an arrangement for using an indwelling catheter to access an internal iliac artery. At this stage the indwelling catheter has been withdrawn and the fenestration 64 is closed off by the valve arrangement.
  • the extension piece 70 seals into a non-aneurysed portion of the internal iliac artery 24.
  • Figures 3, 4 and 5 show a first embodiment of valve arrangement suitable for the present invention.
  • the longer leg 52 of the bifurcated stent graft 40 as shown in Figure 1 has a fenestration 64 defined by a peripheral resilient ring 80 which is stitched into the tube of the longer leg 52.
  • a semi- circular portion of biocompatible graft material 82 and a resilient self-expanding zigzag stent 85 which engages with the semi-circular biocompatible graft material 82 and engages it against the inside wall of the longer leg 52 and in particular over the fenestration 64.
  • the semi-circular piece 82 is stitched by stitching 83 at its proximal end to the inner wall of the longer leg 52.
  • FIG. 5 shows the embodiment as shown in Figure 4 except that an indwelling catheter 66 and guide wire 68 through the indwelling catheter extend through the side arm 60 and through the fenestration 64 and this lifts the valve 82 off the fenestration 64 against the restoring force of the resilient self expanding stent 85.
  • FIGs 6 and 7 show an alternative embodiment of bifurcated stent graft according to the present invention in the vasculature of a patient.
  • the vasculature and the bifurcated stent graft are similar to the earlier embodiment shown in Figures 1 and 2 and the same reference numerals are used for corresponding items.
  • the vasculature comprises an aorta 10 in the region between the renal arteries 12 and the aortic bifurcation 14.
  • Common iliac arteries 16 and 18 extend down from the aortic bifurcation.
  • the aorta 10 has an aneurysm 20 which extends down into the common iliac artery 18 so far as the bifurcation 22 between the internal iliac artery 24 and the external iliac artery 26.
  • a bifurcated aortic stent graft 40 has been deployed into the aorta 10.
  • the proximal end 42 of the bifurcated stent graft 40 is engaged into non-aneurysed portion 28 of the aorta 10 just distal of the renal arteries 12.
  • stent graft 40 has a proximally extending suprarenal exposed stent 44 with barbs 46 engaging the wall of the aorta proximal of the renal arteries to provide a secure position to prevent migration of the stent graft.
  • the stent graft 40 has a short leg 50 and a long leg 52 extending from the graft bifurcation 54.
  • the longer leg 52 has a sealing surface 56 at its distal end which engages into a non-aneurysed portion of the external iliac artery 26.
  • the longer leg 52 has a side arm 90 which in this embodiment is in the form of a stented tube extending from a fenestration 92 in the longer leg 52.
  • the side arm 90 extends in a distal direction and has an end 94 remote from its connection with the longer leg 52 which opens adjacent to the internal iliac artery 24.
  • a fenestration 64 is placed into the longer leg 52 proximal of the connection of the side arm 90 into the longer leg 52.
  • the fenestration 64 has a valve arrangement within it to close it off as will be discussed with reference to Figures 8 to 10.
  • an in- dwelling catheter 66 extends through the side arm 90 and out through the valved fenestration 64.
  • the indwelling catheter includes a guide wire 68 therethrough.
  • Figure 7 shows the embodiment of Figure 6 but after deployment of a extension piece 70 into the side arm 90.
  • United States Patent Application Serial No. 10/962,763 entitled "Introducer for Iliac Side Branch Device” discloses an arrangement for using an indwelling catheter to access an internal iliac artery. At this stage the indwelling catheter has been withdrawn and the fenestration 64 is closed off by the valve arrangement. The extension piece 70 seals into a non- aneurysed portion of the internal iliac artery 24.
  • FIGS 8, 9 and 10 show an alternative embodiment of valve arrangement suitable for the present invention.
  • the longer leg 52 of the bifurcated stent graft 40 as shown in Figure 6 has a fenestration 64 defined by a peripheral resilient ring 80 which is stitched into the tubular wall of the longer leg 52.
  • a cylindrical portion of biocompatible graft material 96 and a self-expanding zigzag stent 98 which engages with the cylindrical biocompatible graft material 96 and engages it against the inside wall of the longer leg 52 and in particular over the fenestration 64.
  • the cylindrical portion of biocompatible graft material 96 is stitched by stitching 99 at its proximal end to the inner wall of the longer leg 52.
  • Figure 10 shows the embodiment as shown in Figure 9 except that an indwelling catheter 66 and guide wire 68 through the catheter extend through the side arm 60 and through the fenestration 64 and this lifts the valve 96 for the fenestration 64.
  • Figures 1 1 to 14 show a further embodiment of valve arrangement suitable for the present invention.
  • ⁇ Figure 1 has a fenestration 202 defined by a peripheral resilient ring 204 which is stitched into the tube of the longer leg 200.
  • a self expanding stent 206 which has a plurality of struts 208 and bends 210.
  • the self expanding stent 206 is shown in Figure 12.
  • the self expanding stent 206 has a valve member 21 2 formed from a piece of biocompatible graft material stitched onto spaced apart struts 208 to provide a part cylindrical surface on the self expanding stent 206 to form a valve assembly 214.
  • valve member 212 Around the lower circumference of the valve member 212 is a portion of resilient wire 213 retained by stitching 21 5 to assist with retaining the part circular shape of the valve member to endure good sealing against the inside surface of the tubular body of the longer leg 200.
  • This valve assembly is stitched into the tubular body of the longer leg 200 by stitching 216 at the bends 210 so that the valve member underlies the fenestration 202 and closes off the fenestration to flow therethrough from inside the longer leg to outside.
  • a cross section of the valve at this stage is shown in Figure 1 3.
  • a side arm 218 extends from a fenestration 220 in the tubular longer leg 200.
  • the side arm 218 is in this embodiment formed from a corrugated graft material.
  • Figure 14 shows the embodiment as shown in Figure 13 except that an indwelling catheter 66 and guide wire 68 through the indwelling catheter extend through the side arm 218 and through the fenestration 202 and this lifts the valve member 212 off the fenestration 202 against the restoring force of the resilient self expanding stent 206.
  • Figure 1 5A to 1 5M show the various stages of deployment of a stent graft according to one embodiment of the present invention.
  • FIG 15A shows a schematic version of one embodiment of a stent graft according to the present invention loaded onto a delivery device.
  • the delivery device 100 has a nose cone dilator 102 at its proximal end and a stent graft assembly according to one embodiment of the present invention 104 is mounted onto the deployment device.
  • This embodiment of stent graft 104 has an helical side arm 106 on the longer leg 108 of the stent graft 104.
  • An indwelling catheter 1 10 extends from the deployment device 100 through the helical side arm 106 exiting at valved aperture 1 12 and extending to a groove 1 14 in the nose cone dilator 102 outside of the stent graft 104.
  • the indwelling catheter 1 10 has a flexible curved proximal end 1 16.
  • FIG. 15B Detail of the tubular side arm 106 and valve arrangement 1 12 are shown in Figure 15B.
  • the tubular side arm 106 extends around the longer leg 108 from a fenestration 107 and the indwelling catheter 1 10 extends into the tubular side arm and out through the valved aperture 1 12.
  • the valved aperture 1 12 has a flap valve 1 13 on its inside to ensure that the aperture is closed when the indwelling catheter is removed.
  • the flap valve is substantially the same as the as the construction shown in Figures 3 to 6.
  • Figure 1 5C shows a schematic vasculature of a patient including an aorta
  • iliac arteries 16 and 18 Extending from the aortic bifurcation are iliac arteries 16 and 18.
  • the aorta has an aneurysm 20 which extends down the iliac artery to the position of the internal iliac artery 24.
  • the iliac bifurcation 22 defines the bifurcation between the internatal iliac artery 24 and the external iliac artery 26.
  • the deployment device 100 has been deployed over a guide wire 1 20 so that its nose cone 102 extends up into the aneurysm 20 and the distal end of the nose cone 102 is substantially adjacent to the aortic bifurcation 14.
  • the indwelling catheter and particularly its curved tip 1 1 6 has been compressed by the sheath 122 into the groove 1 14 in the nose cone dilator.
  • the sheath 122 of the deployment device has been withdrawn slightly to release the curved tip 1 16 of the indwelling catheter 1 10 and the indwelling guide wire 124 from the indwelling catheter 1 10 has been extended.
  • the indwelling guide wire 1 24 has extended down the contra-lateral iliac artery 16.
  • a snare catheter 1 28 has been deployed into the contra-lateral common iliac artery and a snare 130 of the snare catheter 128 has been extended to grasp the guide wire 1 24.
  • the guide wire 124 is extracted via the snare catheter 1 28 so that it becomes a through-and-through guide wire. It is important at this stage to ensure there is slack maintained in the guide wire at the aortic bifurcation to prevent damage to the aortic bifurcation. This position is shown in Figure 15E.
  • the deployment device 100 in then advanced so that the nose cone dilator 102 is proximal of the renal arteries 12. This draws the indwelling guide wire 124 also up into the aorta 10.
  • the sheath 122 of the deployment device 1 10 is then withdrawn to release the shorter leg 109 of the stent graft 104. This stage is shown in Figure 15G.
  • the indwelling catheter is withdrawn down into the contra-lateral iliac artery 16 and the sheath 122 is withdrawn so that it is distal of the distal end of the side arm 106 while still retaining the distal end of the longer leg 108.
  • a dilator and sheath introducer 130 is advanced over the guide wire 124 in the contra-lateral iliac artery 16 and the indwelling catheter 1 10 and extension arm deployment device are tracked over the guide wire 1 24 so that the nose cone 132 of the sheath introducer enters the valved aperture 1 12 and tracks over the guide wire 124 into the side arm 106 until it exits the distal end of the side arm 134 as shown in Figure 15J.
  • sheath introducer nose cone 132 is then withdrawn leaving the sheath 130 in place.
  • the indwelling guide wire 1 24 is still in a through-and-through position.
  • another guide wire 136 is introduced through the sheath 130 and extended from the sheath 130 to enter into the internal iliac artery 24.
  • a side arm deployment device is deployed over the guide wire 136 into the internal iliac artery 24 so that balloon expandable covered stent 140 extends into the internal iliac artery 24 from the side arm 106.
  • the indwelling guide wire 124 is then removed and the position of the distal end of the longer leg 108 is set into the external iliac artery 26 and the balloon expandable covered stent 140 is expanded.
  • the sheath 130 is then withdrawn and the valve 1 12 automatically closes.
  • a leg extension 144 is then placed into the short leg 107 of the graft 104.
  • the proximal end 146 of the stent graft is also released from the deployment device 100 such that a portion of the graft seals into a non-aneurysed portion of the aorta 10 distal of the renal arteries 12 while an uncovered suprarenal stent 148 extends over the renal arteries to provide secure fixation.
  • Figures 16A to 16K show an alternative embodiment of stent graft according to the present invention and the process of deploying such a stent graft in the vasculature of a patient.
  • the stent graft in this embodiment comprises a two piece body with a proximal portion 150 and a distal portion 1 52 which when joined together into the vasculature of the patient provide a composite stent graft.
  • the proximal portion 150 has the proximally extending suprarenal stents 154 and the distal portion 152 is bifurcated with a shorter leg 1 56 and longer leg 158.
  • the longer leg 1 58 has the helical side arm 160 and the valved aperture 162 through which the indwelling catheter 164 extends.
  • the process of deployment of the stent graft of this embodiment is substantially similar to that shown in Figures 15 C to 1 5M except that, as shown in Figure 16C, as a first stage the proximal portion 150 is deployed and released into the aorta. Subsequently a separate device 170 with an indwelling catheter 164 is introduced which carries the distal portion 152 and the process of snaring the indwelling guide wire, release of the main stent graft and deployment of a side arm extension into the internal iliac artery as shown in Figures 16D to 16J is substantially the same as shown in Figures 1 5C to 1 5L.
  • the final stage as shown in Figure 16K of the deployment of the two piece stent graft includes release of the distal portion 152 inside the proximal portion 150 and the deployment of a leg extension 172 into the short leg 156 and release of the distal end of the longer leg 158.

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PCT/US2007/009665 2006-04-19 2007-04-19 Twin bifurcated stent graft Ceased WO2007124053A1 (en)

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CA2649705A CA2649705C (en) 2006-04-19 2007-04-19 Twin bifurcated stent graft
EP07755802.1A EP2007313B1 (en) 2006-04-19 2007-04-19 Stent graft
JP2009506603A JP2009534104A (ja) 2006-04-19 2007-04-19 二重に分岐したステントグラフト
CN2007800227121A CN101484090B (zh) 2006-04-19 2007-04-19 双分叉支架移植物
AU2007240703A AU2007240703C1 (en) 2006-04-19 2007-04-19 Twin bifurcated stent graft

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US20070250154A1 (en) 2007-10-25
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US10143576B2 (en) 2018-12-04
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CA2649705C (en) 2015-12-01
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US20170325978A1 (en) 2017-11-16
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JP5707584B2 (ja) 2015-04-30
US9707113B2 (en) 2017-07-18

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