WO1997003624A1 - Adjustable and retrievable graft and graft delivery system for stent-graft system and methods of implantation - Google Patents

Adjustable and retrievable graft and graft delivery system for stent-graft system and methods of implantation Download PDF

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Publication number
WO1997003624A1
WO1997003624A1 PCT/US1996/011784 US9611784W WO9703624A1 WO 1997003624 A1 WO1997003624 A1 WO 1997003624A1 US 9611784 W US9611784 W US 9611784W WO 9703624 A1 WO9703624 A1 WO 9703624A1
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Prior art keywords
graft
manipulation
loop
lead
stent
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Ceased
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PCT/US1996/011784
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English (en)
French (fr)
Inventor
Renan Uflacker
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Individual
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Individual
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Application filed by Individual filed Critical Individual
Priority to AU66477/96A priority Critical patent/AU6647796A/en
Priority to EP96926085A priority patent/EP0957820B1/en
Priority to JP50680497A priority patent/JP3851659B2/ja
Priority to CA002227407A priority patent/CA2227407C/en
Priority to DE69637763T priority patent/DE69637763D1/de
Publication of WO1997003624A1 publication Critical patent/WO1997003624A1/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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2002/9505—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
    • A61F2002/9511—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument the retaining means being filaments or wires
    • 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
    • A61F2002/9528—Instruments specially adapted for placement or removal of stents or stent-grafts for retrieval of stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • 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
    • A61F2002/9534—Instruments specially adapted for placement or removal of stents or stent-grafts for repositioning of stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • A61F2002/9665—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod with additional retaining means
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028—Shapes in the form of latin or greek characters
    • A61F2230/0054—V-shaped

Definitions

  • the present invention relates generally to non-invasive techniques for repairing aneurysms occurring in hollow-body biological organs or vessels, for example, the abdominal aorta, and for repairing arterio-venous fistulas. More particularly, the present invention relates to methods and apparatus for repairing aneurysms and fistulas that permit adjustment and/or retrieval of the graft even after a deployment of the graft component of a stent-graft system.
  • deployment of the graft or the stent in Clouse system
  • a typical previously known stent-graft system may include a central delivery shaft having a diameter of 1.5-1.75 mm, a deployment balloon having a thickness of 0.5- 0.75 mm, an anchoring stent with a thickness of 0.3- 0.6 mm, a synthetic graft with a thickness of 0.25-0.5 mm, and a delivery sheath having a thickness of 0.5- 0.75 mm.
  • the stacking of these thicknesses results in a combined thicknes ⁇ of 4-7 mm, which must be inserted through a vascular system generally having a diameter in a range of 5-7 mm.
  • the large-diameter introducer catheters needed for such previously known stent-graft systems create problems in delivering such systems transluminally via the femoral arteries, and the thicker diameters also reduce the clinician's ability to maneuver the stent- graft system into position along a tortuous path. See, for example, Chapter 3 of the foregoing text at pp. 40- 41, 44 and 48, incorporated herein by reference, which describes spasm and delivery problems associated with the use of large introducer catheters employed with previously known stent-graft systems.
  • graft apparatus, delivery devices and method ⁇ for use in a stent-graft system for repairing an aneurysm that enable the graft position to be adjusted after deployment of the graft from an introducer catheter.
  • graft apparatus, delivery devices and methods for use in a stent-graft sy ⁇ tem for repairing aneurysms that enable the use of much smaller diameter introducer catheters than used with previously known stent-graft systems, thereby reducing problems associated with the use of large diameter introducer catheters.
  • graft apparatus, delivery devices and methods for use in stent-graft systems for repairing aneurysms that enable the graft to be entirely retrieved after initial deployment, for example, to be exchanged for a graft of a different size.
  • thi ⁇ invention provides to provide graft apparatu ⁇ , delivery devices and methods for use in a ⁇ tent-graft system for repairing aneurysms and fistulas that enable the graft position to be adjusted after deployment of the graft from an introducer catheter. It i ⁇ a further object of the pre ⁇ ent invention to provide graft apparatu ⁇ , delivery devices and methods for use in a stent-graft system for repairing aneurysm ⁇ and fi ⁇ tula ⁇ that enable the u ⁇ e of much smaller diameter introducer catheters than used with previously known stent-graft system ⁇ , thereby reducing problems associated with the use of large diameter introducer catheters.
  • the clinician may adju ⁇ t the graft, or if the ⁇ ize i ⁇ thought to be inappropriate, the clinician may even completely withdraw the graft and ⁇ ub ⁇ titute a graft of a different ⁇ ize.
  • the graft and stent components of a stent-graft system are separately delivered transluminally to the site of an aneurysm using small diameter catheter ⁇ (e.g., 12-16 French for the graft, about 9-10 French for the stent) .
  • the graft component is removably engaged with proximal and distal manipulation lead ⁇ that permit the location of the graft to be freely manipulated by the clinician after deployment from an introducer catheter. These manipulation lead ⁇ even enable the graft to be fully retracted into its a ⁇ sociated introducer catheter after deployment.
  • the ⁇ tent component of the ⁇ ystem is likewise delivered transluminally to the site of the aneurysm via a small diameter introducer catheter, and permits use of a wide range of conventional stent designs to permanently fix the graft in position.
  • the invention further includes alternative embodiments of graft delivery device ⁇ ⁇ uitable for u ⁇ e with a graft con ⁇ tructed in accordance with the present invention. These delivery devices provide complete control of over positioning of the graft, and permit quick release of the graft once its permanent po ⁇ ition i ⁇ selected.
  • FIGS. IA, IB and IC are, respectively, illustrative views of the deployment of a graft and delivery device con ⁇ tructed in accordance with the method ⁇ and apparatu ⁇ of the present invention.
  • FIGS. 2A, 2B, 2C and 2D are, respectively, alternative embodiments for engaging the graft of FIGS. 1 to the manipulation lead ⁇ of a delivery device constructed in accordance with the present invention.
  • FIG. 3 is an elevational view, partly in section, showing positioning of the graft of FIGS. 1 being po ⁇ itioned in an abdominal aortic aneurysm.
  • FIG. 4 is an elevational view, partly in section, showing deployment of the graft of FIG. 3.
  • FIG. 5 i ⁇ an elevational view of a graft constructed in accordance with the present invention, as permanently implanted in the aorta.
  • FIGS. 6A, 6B and 6C are, respectively, an elevational view and detail views of an alternative embodiment of the graft and delivery device of the present invention.
  • the present invention provides methods and apparatu ⁇ for treatment of aneury ⁇ m ⁇ occurring in hollow-body organ ⁇ or vessels, and for the treatment of arterio-venous fi ⁇ tulas, that overcome certain limitations of previously known non-invasive methods.
  • the apparatus and methods of the present invention enable a clinician to adjust the positioning of a graft component of a stent-graft system once deployed from it ⁇ a ⁇ ociated introducer catheter, and even enable the clinician to entirely retrieve the graft ⁇ hould it be decided that a graft of a different size is required.
  • Graft 10 is preferably a polyester fabric, such as DACRON®, a registered trademark of the E.I. duPont de Nemour ⁇ Company, Wilmington, or other biocompatible material, such as PTFE (polytetrafluoroethylene) or tightly-woven wire mesh.
  • DACRON® a registered trademark of the E.I. duPont de Nemour ⁇ Company
  • PTFE polytetrafluoroethylene
  • graft 10 includes two loops 11 and 12 located near its proximal and distal ends that are used for positioning the graft once it is deployed from it ⁇ delivery device.
  • proximal is used to refer, for example, in the context of the abdominal aorta, to the portion of the aorta nearer the renal arteries, while di ⁇ tal refers to the portion nearer to the iliac bifurcation.
  • Loops 11 and 12 are formed of a flexible and sturdy material and are connected to graft 10, for example, by sutures, by incorporation into the wall of graft 10, by being weaved into the fabric of graft 10 or other suitable means.
  • loops 11 and 12 comprise a nitinol (i.e., nickel-titanium) alloy wire.
  • loops 11 and 12 may comprise a different metal alloy or a high strength pla ⁇ tic material.
  • Loops 11 and 12 may be connected to the outer surface of graft 10, or alternatively may be connected to the interior surface of graft 10. In the latter case, the manipulation leads, described hereinafter, would be disposed within graft 10.
  • loops 11 and 12 mu ⁇ t be made of a sufficiently resilient material to undergo significant elastic deformation, while retaining their ability to deploy graft 10.
  • loops 11 and 12 may be plated with a high contrast metal, for example, gold, platinum or tantalum.
  • Graft 10 is delivered transluminally to the site of an aneurysm in a hollow-body organ or vessel, for example, the abdominal aorta, while folded within delivery system 15 comprising introducer catheter 20 and manipulation leads 21 and 22, described in greater detail hereinafter.
  • Introducer catheter 20 is shown in outline only in FIGS.
  • Introducer catheter 20 may be of conventional construction and, in accordance with the present invention, is of a size between 12 and 16 French.
  • Manipulation leads 21 and 22 are preferably constructed of a durable yet sturdy material, such as a nickel-titanium alloy.
  • loop 11 is releasably engaged to manipulation lead 21, while loop 12 is likewise releasably engaged to manipulation lead 22.
  • loops 11 and 12 are elastically deformed to fit within the catheter.
  • FIG. IB when introducer catheter 20 i ⁇ withdrawn in a di ⁇ tal direction, the proximal end of graft 10 and loop 11 are deployed from the catheter, cau ⁇ ing loop 11 to resume an approximately circular shape.
  • loop 11 recovers its original shape, graft 10 is opened from its folded shape.
  • FIG. IC when introducer catheter 20 is withdrawn further in the distal direction, loop 12 and the distal portion of graft 10 are also deployed.
  • graft 10 When loop 12 opens upon deployment, graft 10 i ⁇ preferably completely unfolded. Whereas with previously known graft members, complete deployment of the graft (as in FIG. IC) would terminate the clinician's ability to adjust or retrieve the graft member, in accordance with the present invention, graft 10 remains coupled to manipulation leads 21 and 22. Thus, even though graft 10 is deployed, its position may be adjusted within the aneury ⁇ , by pulling (or pushing) one or both of manipulation leads 21 and 22 in the proximal or distal directions.
  • graft 10 may be completely recovered within introducer catheter 20 by advancing catheter 20 in the proximal direction while retaining manipulation leads 21 and 22 against proximal movement. Graft 10 will accordingly be retracted within introducer catheter 20 as the catheter advance ⁇ in the proximal direction.
  • loop 12 connected to the distal end of graft 10 is preferably located at or near the lower end of the graft to facilitate retraction of graft 10 within introducer catheter 20.
  • loop 11 is preferably connected to the graft at a distance below the proximal edge of graft 10, thus creating an overhang region 13 (see FIGS. IB and IC) of approximately 15-20 mm.
  • Overhang region may have a length of about two-thirds of the length of the stent to be used in fixing graft 10 in place within the aorta. This positioning of loop 11 on graft 10 i ⁇ expected to prevent interference between loop 11 and the stent to be implanted.
  • loop 11 is located at or near the proximal (upper) end of graft 10, so as to prevent potential flutter of the overhang when introduced into high flow rate environments.
  • loop 11 is captured and expanded by the proximal stent when it is deployed, and loop 11 includes elongated leads that traverse the length of the overhang and permit the engagement means to engage loop 11 at a point distal to overhang region 13.
  • FIGS. 2A, 2B, 2C and 2D several alternative embodiments are described for relea ⁇ ably engaging loop ⁇ 11 and 12 of graft 10 to manipulation lead ⁇ 21 and 22, respectively.
  • loop 11 is discu ⁇ sed here, although loop 12 may include a similar engagement arrangement.
  • Manipulation lead 21 includes outer sheath 23, push wire 24 and ball 25.
  • the distal end of manipulation lead 21 extend ⁇ outside of the patients' body via an introducer sheath.
  • the distal ends of manipulation leads 21 and 22 each include mechanism 26, for example, a spring-loaded shaft, for relea ⁇ ing the grip of manipulation lead ⁇ 21 and 22 on loop ⁇ 11 and 12, re ⁇ pectively.
  • Push wire 24 i ⁇ bia ⁇ ed in a distal direction so that when beads 14 of loop 11 are inserted within the proximal end of outer sheath 23, ball 25 captures the beads within the outer ⁇ heath, thu ⁇ releasably engaging loop 11 to manipulation lead 21.
  • mechanism 26 is later actuated, for example, by pu ⁇ hing push wire 24 in a proximal direction, ball 25 i ⁇ lifted away from the proximal end of outer sheath 25, and beads 14 and loop 11 are set free.
  • manipulation lead 21 can be pulled in the proximal and distal directions to adjust the positioning of proximal end of graft 10 via it ⁇ engagement with loop 11.
  • mechani ⁇ m 26 is actuated to release loop 11.
  • Loop 11 is retained on the outer surface of graft 10.
  • Becau ⁇ e bead ⁇ 14 may be separately formed on the ends of loop 11, loop 11 may be opened to an even larger diameter when a stent i ⁇ expanded into po ⁇ ition within graft 10.
  • FIG. 2B an alternative embodiment of the engagement means for coupling loop 11 to manipulation lead 21 i ⁇ de ⁇ cribed. A ⁇ ⁇ een in FIG.
  • loop 11 is designed for placement at the proximal end of graft 10, thereby omitting overhang region 13. Instead, loop 11 includes elongated lead ⁇ lla that extend distally for approximately the same length as the now omitted overhang region 13, for example 15-20 mm, depending upon the type of stent to be used. Loop 11 therefore keeps proximal end 11 of graft 10 patent even in high flow environments, while elongated leads lla permit loop 11 to remain engaged with manipulation lead 21 until after the proximal stent is fixed into position.
  • Manipulation device 21 includes outer sheath 23', wire 24' and threaded socket 25'.
  • the distal end of manipulation lead 21 terminates in mechanism 26' that enables wire 24' to be rotated within outer sheath 23'.
  • manipulation lead 21 may be uncoupled from loop 11 without interfering with the deployed proximal stent.
  • FIG. 2C another alternative embodiment of an engagement means suitable for use with graft 10 of the pre ⁇ ent invention i ⁇ de ⁇ cribed.
  • loop 11 terminates with elongated right-angled lengths 14 • ' .
  • Manipulation lead 21 includes outer ⁇ heath 23' ', pu ⁇ h wire 24' ' and collet 25' '. The distal end of manipulation lead 21 terminates in mechanism 26' ', for example a spring- loaded shaft.
  • Collet 25' ' is illustratively formed of four opposing members, while push wire 24' ' is biased in a distal direction.
  • Thi ⁇ biasing of push wire 24' ' causes the outer surfaces of the opposing member ⁇ of collet 25' ' to be urged again ⁇ t the inner ⁇ urface of outer sheath 23 ' ' , thereby urging the opposing members comprising collet 25' ' into contact with one another.
  • push wire 24' ' is first urged in a proximal direction, relieving the contact forces between the opposing members of collet 25' • to permit right-angled ends 14' ' to be inserted therebetween.
  • Push wire is then permitted to return to its biased position, thereby capturing right-angled ends 14' ' within collet 25' ' and thus releasably engaging loop 11 to manipulation lead 21.
  • mechanism 26' ' is ⁇ ubsequently actuated (after deployment of graft 10) , for example, by urging push wire 24' ' in a proximal direction, the opposing members of collet 25 • ' relax their grip on right-angled ends 14' ' of loop 11, thus ⁇ etting loop 11 free.
  • FIG 2D a yet further alternative embodiment of an engagement mean ⁇ ⁇ uitable for u ⁇ e with the present invention is described.
  • FIG. 1 a yet further alternative embodiment of an engagement mean ⁇ ⁇ uitable for u ⁇ e with the present invention is described.
  • loop 11 terminates in beads 14' ' ' that are captured in snare 25' ' ' connected to the proximal end of push wire 24' ' '.
  • Manipulation lead 21 includes an actuation mechanism 26' ' ' at its di ⁇ tal end that biases ⁇ nare 25''' in a di ⁇ tal direction, thereby engaging bead ⁇ 14 ' * ' within ⁇ nare 25'''.
  • Manipulation lead 21, including outer sheath 23 ' ' ' , snare 25 * ' ' , beads 14 * ' • and loop 11 are therefore movable as a unit in the proximal and distal directions, while actuation of mechanism 26''' causes snare 25' '' to release beads 14* • ' .
  • any of the above-de ⁇ cribed engagement mean ⁇ could be u ⁇ ed with a graft having overhang region 13, or loop 11 could instead have elongated lead ⁇ lla, thereby enabling omission of overhang region 13.
  • graft 11 also may have integrated within it elastic fibers that assist the graft in opening once it is deployed.
  • loops 11 and 12 may then consist of, for example, a flexible thread or wire.
  • the flexible thread or wire could be removed completely from graft 10, for example, by cutting the wire at the distal end and pulling the entire length of wire out through the introducer sheath.
  • FIGS. 3-5 a method of implanting a graft constructed in accordance with the present invention within an abdominal aorta aneurysm is described.
  • graft 10 of the stent-graft system i ⁇ disposed across the region of aneurysm 101 in aorta 100, which is located between renal arteries 102 and iliac arteries 103.
  • Aneurysm 101 includes a proximal nondilated region of aorta 100 above the aneurysm referred to as "proximal neck” 104, and a distal region just above the bifurcation for iliac arteries 103 referred to as "distal cuff" 105.
  • Graft 10 includes proximal and distal loops 11 and 12 connected to manipulation leads 21 and 22, as described hereinabove. Graft 10 is threaded through a femoral artery in introducer catheter 20 via introducer sheath 30 along guidewire 40, so that graft 10 is positioned across aneurysm 101. In accordance with the present invention, graft 10 permits introducer catheter 20 to have a smaller diameter, for example 12-16
  • introducer catheter 20 within aneurysm 101 may be determined using standard fluoroscopic techniques and a suitable high contrast agent on introducer catheter 20 or graft 10.
  • graft 10 is shown fully deployed from introducer catheter 20 (which has been removed) .
  • Manipulation leads 21 and 22 are used to maneuver graft 10 to a desired location across aneurysm 101, by moving manipulation leads 21 and 22 in the proximal and distal directions under fluoroscopic guidance.
  • catheter 50 containing collapsed stent 51 and deployment balloon 52 i ⁇ inserted along guidewire 40 so that the stent is po ⁇ itioned overlapping the proximal end of graft 10.
  • the po ⁇ ition of graft 10 may be adju ⁇ ted, or the graft entirely withdrawn, at any point up to implantation of proximal ⁇ tent 51.
  • Stent 51 suitable for use with graft 10 of the present invention may be of any de ⁇ ign that will cause fixation of graft 10 to the walls of aorta 100.
  • ⁇ tent 51 may compri ⁇ e an elastically balloon-expanded rolled sheet, as described, for example in Krea er U.S. Patent Re. 34,327, a pla ⁇ tically balloon-deformable wire me ⁇ h, a ⁇ described for example, in Palmaz U.S. Patent 4,733,665 and Gianturco U.S. Patent 5,314,444, a thermally activated stent as de ⁇ cribed in Dotter U.S.
  • Stent ⁇ ⁇ uitable for u ⁇ e with the graft system of the present invention preferably employ a delivery catheter having a diameter of about 9-10 French.
  • graft 10 of FIG. 4 is shown affixed to the wall ⁇ of aorta 100 by ⁇ tent ⁇ 51 and 54.
  • Stent ⁇ 51 and 54 may be po ⁇ itioned and expanded into appo ⁇ ition with graft 10 and the wall ⁇ of aorta 100 through introducer catheter 30 a ⁇ de ⁇ cribed above with re ⁇ pect to FIG. 4.
  • the delivery catheter and ⁇ tents 51 and 54 may be delivered to the respective end ⁇ of graft 10 via the femoral artery as ⁇ ociated with the right branch of the iliac artery, or even from above via the brachial/carotid artery.
  • manipulation leads 21 and 22 of the graft sy ⁇ tem are held in po ⁇ ition, for example, under fluoroscopic guidance, to prevent flow-induced migration of graft 10.
  • mechanism 26 of manipulation lead 21 is actuated to release loop 11, and the manipulation lead is then withdrawn.
  • stent 51 may be expanded into position prior to releasing loop 11 from manipulation lead 21. Manipulation lead is then uncoupled from loop 11 once the proximal stent has been deployed.
  • FIGS. 6A to 6C a yet further alternative embodiment of the graft and delivery system of the present invention is described.
  • graft 10 is shown fully deployed from introducer catheter and engaged with manipulation lead ⁇ 21 and 22.
  • a ⁇ ⁇ hown in detail in FIG. 6B, fold 10a of graft 10 i ⁇ pinched between hook 60 of wire 61 and outer sheath 62 of manipulation lead 21.
  • the hook 60 is connected via wire 61 to an actuation mechani ⁇ m at the di ⁇ tal end of manipulation lead 21.
  • Wire 61 and hook 60 may be ⁇ pring-biased in the distal direction to graspingly engage graft 10 near its proximal end.
  • the distal portion of graft 10 is manipulated using snare 63 that grasps the distal portion of the graft.
  • Snare 63 is di ⁇ posed within outer ⁇ heath 64 , and is operable via a suitable mechanism located at the distal end of manipulation lead 22.
  • Snare 63 is not connected to graft 10 other than by operation of snare 63 , so that when snare 62 is expanded, snare 63 may slide off of graft 10.
  • Implantation of the graft of FIGS. 6 is accomplished in a manner similar to that described i-bove with respect to FIGS. 3-5.
  • the introducer catheter is delivered transluminally to the site of the aneury ⁇ m.
  • the introducer catheter i ⁇ then retracted while manipulation leads 21 and 22 are held in position, so that graft 10 is deployed as shown in FIG. 6A.
  • Manipulation lead ⁇ 21 and 22 may be moved in the proximal or di ⁇ tal directions to adjust the location of graft 10, or may even be fully retracted within the introducer catheter to retrieve the graft.
  • introducer catheter is transported along a suitable guidewire, so that the guidewire is disposed with graft 10 once it is deployed from the introducer catheter.
  • a stent delivery catheter i ⁇ tran ⁇ ported either along the guidewire already disposed through graft 10, or a separate guidewire delivered via the same or a different access artery.
  • a proximal stent is then deployed to engage the proximal neck of the aneurysm and the proximal end of graft 10 (in overhang region 13) .
  • Manipulation lead 21 is then actuated so that hook 60 release ⁇ it ⁇ gra ⁇ p on graft 10, and manipulation lead 21 and the stent delivery catheter are withdrawn.
  • snare 63 is opened and manipulation lead 22 retracted in the distal direction. These operations permit snare 63 to slide off the distal end of graft 10, while the guidewire remains disposed through the interior of graft 10. A distal stent delivery device is then transported along the same or a different guidewire into position at the di ⁇ tal end of graft 10, and a di ⁇ tal ⁇ tent i ⁇ deployed.
  • the methods and apparatus of the present invention are equally applicable to gastro- inte ⁇ tinal, re ⁇ piratory, reproductive organ and urethral application ⁇ and el ⁇ ewhere where i ⁇ de ⁇ irable to "reline" a hollow-body organ or ve ⁇ el, and for repairing arterio-venous fistula ⁇ .

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Pulmonology (AREA)
  • Prostheses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
PCT/US1996/011784 1995-07-19 1996-07-17 Adjustable and retrievable graft and graft delivery system for stent-graft system and methods of implantation Ceased WO1997003624A1 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
AU66477/96A AU6647796A (en) 1995-07-19 1996-07-17 Adjustable and retrievable graft and graft delivery system for stent-graft system and methods of implantation
EP96926085A EP0957820B1 (en) 1995-07-19 1996-07-17 Adjustable and retrievable graft and graft delivery system for stent-graft system
JP50680497A JP3851659B2 (ja) 1995-07-19 1996-07-17 調節可能かつ回収可能なグラフトためのグラフト送達システム
CA002227407A CA2227407C (en) 1995-07-19 1996-07-17 Adjustable and retrievable graft and graft delivery system for stent-graft system and methods of implantation
DE69637763T DE69637763D1 (de) 1995-07-19 1996-07-17 Anpassbares und entfernbares implantat und implantatsystem für ein stentimplantat

Applications Claiming Priority (2)

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US08/504,396 US5713948A (en) 1995-07-19 1995-07-19 Adjustable and retrievable graft and graft delivery system for stent-graft system
US08/504,396 1995-07-19

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WO1997003624A1 true WO1997003624A1 (en) 1997-02-06

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US (2) US5713948A (enExample)
EP (1) EP0957820B1 (enExample)
JP (2) JP3851659B2 (enExample)
AU (1) AU6647796A (enExample)
CA (1) CA2227407C (enExample)
DE (1) DE69637763D1 (enExample)
WO (1) WO1997003624A1 (enExample)

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US5713948A (en) 1998-02-03
EP0957820B1 (en) 2008-11-26
EP0957820A1 (en) 1999-11-24
JPH11509450A (ja) 1999-08-24
US5776186A (en) 1998-07-07
JP3851659B2 (ja) 2006-11-29
JP2006051371A (ja) 2006-02-23
AU6647796A (en) 1997-02-18
EP0957820A4 (en) 2000-04-12
CA2227407C (en) 2007-03-27
CA2227407A1 (en) 1997-02-06
DE69637763D1 (de) 2009-01-08

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