WO1997037616A2 - Endoluminal prostheses having position indicating markers - Google Patents
Endoluminal prostheses having position indicating markers Download PDFInfo
- Publication number
- WO1997037616A2 WO1997037616A2 PCT/US1997/005377 US9705377W WO9737616A2 WO 1997037616 A2 WO1997037616 A2 WO 1997037616A2 US 9705377 W US9705377 W US 9705377W WO 9737616 A2 WO9737616 A2 WO 9737616A2
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- WIPO (PCT)
- Prior art keywords
- prosthesis
- marker
- body lumen
- lumen
- liner
- Prior art date
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
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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
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
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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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- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
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- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
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- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
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- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
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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
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
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- 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
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- 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
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- 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
- A61F2220/0041—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using additional screws, bolts, dowels or rivets, e.g. connecting screws
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- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
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- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
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- A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
- A61F2250/0098—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers
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- A61L2420/00—Materials or methods for coatings medical devices
- A61L2420/08—Coatings comprising two or more layers
Definitions
- the present invention relates generally to tubular prostheses, such as grafts, stents, stent-grafts, and the like. More particularly, the present invention provides endoluminal prostheses having discrete position indicating elements which facilitate orienting and deploying the prostheses within body lumens, particularly within branching blood vessels for the treatment of abdominal and other aneurysms.
- Proper radial orientation of endoluminal prostheses is also important, particularly when deploying branching and asymmetric prostheses within the tortuous vascular system. If the branches of branching prostheses are not oriented toward their respective branching body lumens, the surrounding body lumen may be distended to adapt to the misaligned prosthesis, or the prosthetic lumen may be distorted or even closed entirely. For example, if the trunk of a bifurcated prosthesis is deployed with a branch oriented 90° from the iliac arteries (i.e., angling dorsally rather than laterally), the prosthetic branch lumen may fold or kink, and will have to at least bend at a sharp angle to enter the laterally oriented iliac.
- branching prostheses are often assembled in situ , it may not be possible to introduce the branch prosthesis into such a misaligned branch port.
- recapture or repositioning of expanded endoluminal prostheses is often problematic, it may even be necessary to resort to an emergency invasive procedure to remedy such misalignment.
- Tubular endovascular prostheses are often formed as stent-grafts having a flexible tubular liner or "graft" which is supported by a perforate tubular frame or "stent".
- the frame perforations define radially expandable structures, while the frame often include metals which are, to some extent, visible under fluoroscopy.
- radiopaque lines or image markers to bifurcated grafts in the form of fine wire or chain, either woven into the cloth or applied after weaving, or as an inert paint or plastic.
- the liners of endoluminal prostheses must remain highly flexible, typically being folded when the prosthesis is compressed and unfolding during deployment. Wires, chains, or paints which are sufficiently flexible will generally provide only limited-contrast images when the graft is supported by the obscuring frame, and may become detached from the prosthesis once deployed in the body lumen, with potentially catastrophic consequences.
- imaging of such thin, flexible, low-contrast markers is particularly difficult when the prosthesis is in the high density, radially compressed configuration and disposed within a catheter, as is generally required for intravascular maneuvering.
- endoluminal prostheses For these reasons, it would be desirable to provide improved endoluminal prostheses and methods for their use. It would be particularly desirable to provide endoluminal prostheses having high-contrast orientation indicating imaging markers which do not interfere with radial compression or expansion, and which are securely and reliably attached to the prosthesis. It would further be desirable if such markers could clearly indicate both the position and orientation of the prosthesis, ideally while the prosthesis remains compressed in the delivery catheter, but without substantially increasing the size of the delivery system.
- WO 95/21,592 describes a bifurcated endoluminal prosthesis including a bifurcated stent and a second stent.
- One or more X-ray opaque coils or tubes may de disposed over an arm of the stent structure so that the stents can be aligned and engaged in situ under X-ray monitoring.
- U.S. Patent No. 5,387,235 describes a bifurcated graft having radiopaque lines and markers formed of fine wire or chains of inert metal, or of an inert paint or plastic.
- the present invention provides a tubular graft comprising a polyester fabric and a radiopaque marker disposed on the graft.
- the marker has been applied to the graft as a compound comprising radiopaque particles, a polyester matrix for affixing the radiopaque particles on the graft, and a polyester solvent.
- a protective overcoat is applied over the marker to prevent the compound from detaching from the graft when the graft flexes during deployment or from physiological movement.
- a pre- coat is applied before the compound, and the radiopaque particles comprise tantalum particles having an average diameter of between about l and 5 microns.
- the imagable bodies can be aligned with the openings of a perforate frame structure so that at least some of the imagable bodies are visible through associated openings, and need not actually be attached to the frame directly.
- Such imagable bodies are clearly visible when the prosthesis is deployed, and can also be sized to produce distinct images even when the frame is compressed within a delivery catheter, but should not interfere with the radial expansion of the frame during deployment.
- the imagable bodies optionally comprise a radiopaque material, or may alternatively produce enhanced ultrasound images.
- the frame and the imagable bodies will have a similar electromotive force (EMF) to avoid corrosion.
- EMF electromotive force
- the present invention provides an endoluminal prosthesis for deployment in a body lumen of a patient body, the prosthesis comprising a tubular fabric liner and a radially expandable frame supporting the liner.
- a plurality of radiopaque marker elements are stitched to the liner through the passage.
- the marker elements indicate a position of the prosthesis when the prosthesis is radiographically imaged within the body lumen.
- the marker elements comprise plates.
- the marker elements comprise wires having a plurality of loops which define the passages.
- the present invention provides an endoluminal prosthesis for deployment in a body lumen of a patient body, the prosthesis comprising a radially expandable tubular body defining a centerline and a plurality of radiopaque marker elements disposed on the body.
- the marker elements define a pattern when the prosthesis is imaged within the patient body, the pattern including a gate disposed adjacent to a distal or proximal port.
- the gate comprises radially separated marker elements on opposed sides of the centerline when the prosthesis is properly oriented to facilitate deployment of a secondary prosthetic module within the adjacent port of the prosthesis.
- the pattern may include two axially separated gates which define an allowable prosthetic overlap region therebetween. As the marker elements which define these gates are offset on opposite sides of the centerline, they remain highly visible when the delivery catheter containing the secondary prosthetic module is being positioned within the port.
- the present invention provides an endoluminal body lumen marker for use in positioning a later deployed endoluminal prosthesis in a body lumen.
- the lumen marker comprises a body which produces a sharp contrast when imaged within the lumen, and a support structure which maintains a position of the lumen marker within the body lumen until the prosthesis is positioned and deployed across the lumen marker.
- the body comprises a radiopaque button
- the support structure comprises a barbed protrusion for attaching the imagable body to the lumenal wall.
- the support structure comprises a radially expandable radiopaque band, preferably a helical coil, which engages the surrounding body lumen and which marks an axial target location for an end of the prosthesis.
- the present invention further provides a method for fabricating a position indicating endoluminal prosthesis, the method comprising providing a tubular graft comprising a polyester fabric and applying a compound to the graft, the compound comprising a polyester matrix, radiopaque particles, and a polyester solvent so that the polyester matrix adheres to the polyester fabric and permanently affixes the radiopaque particles to the graft.
- the method comprises introducing a first tubular endoluminal prosthetic module into the body lumen and positioning the first module adjacent to the target location.
- the first module is radially expanded to deploy the module adjacent to the target location, the expanded first module having first and second marker elements disposed adjacent to a port.
- a second tubular prosthetic module is introducing into the body lumen and positioned within the port of the first module by imaging the first module and axially advancing the second module between the first and second marker elements.
- the present invention provides a method for positioning a tubular endoluminal prosthesis at a target location of a body lumen.
- the method comprises introducing a guidewire through the body lumen and advancing the guidewire beyond the target location, and advancing the prosthesis over the guidewire so that the guidewire passes through a lumen of the prosthesis.
- the prosthesis is radially oriented by imaging the prosthesis within the body lumen and aligning an image of a marker element of the prosthesis with an image of the guidewire.
- the present invention provides a method for positioning a tubular endoluminal prosthesis at a target location of a body lumen, the method comprising introducing the prosthesis into the body lumen and positioning the prosthesis adjacent to the target location.
- the prosthesis is radially oriented by imaging the prosthesis within the body lumen and aligning an image of a first marker element of the prosthesis with an image of a second marker element of the prosthesis, wherein the first and second marker elements are axially offset from each other.
- the present invention provides a method for verifying the radial orientation of a port of a branching tubular endoluminal prosthesis within a body lumen, the method comprising introducing the prosthesis into the body lumen and radially orienting the prosthesis.
- An end of the prosthesis which is separated from the port is deployed by axially withdrawing a surrounding sheath and allowing the prosthesis end to expand.
- At least one port orientation indicating marker element disposed on the expanded end of the prosthesis can then be imaged while the prosthesis adjacent the port remains in a compressed state, thereby clearly showing the radial orientation of the port while recompression of the prosthesis is still relatively easy.
- the present invention provides a method for deploying an endoluminal prosthesis, the method comprising introducing and deploying a marker element in a body lumen so as to mark a target location.
- the prosthesis is introduced into the body lumen and aligned with the marker element.
- marker elements which may comprise marker bands or barbed imagable bodies, are particularly useful in follow-up procedures to monitor migration of the prosthesis or changes in aneurysms or other disease conditions, which will often appear as changes in the relative positions of the marker element and the prosthesis.
- the present invention provides an endoluminal prosthesis comprising a high-strength frame material and a high-contrast image marker material.
- the electromotive force characteristics of the frame and marker element materials are substantially similar.
- the frame material comprises a shape memory alloy such as NitinolTM
- the marker element material comprises tantalum.
- FIG. 1 is a side view of an exemplary cylindrical vascular stent-graft having axially constant characteristics.
- Fig. 2 is a perspective view of an exemplary delivery catheter for use with the prostheses of the present invention, with a portion of the distal end broken away to disclose a prostheses therein.
- Fig. 3 illustrates a modular branching endoluminal prosthesis assembled from expansible prosthetic modules.
- Fig. 4 is a schematic illustration of a method for selectively expanding an integral prosthetic sealing cuff.
- Figs. 5 A-C illustrate orientation indicating stent- grafts having a liner that supports marker elements, the marker elements comprising imagable bodies which define a pattern that facilitates orienting and assembling the prostheses in situ when the prosthesis is imaged fluoroscopically within a body lumen.
- Fig. 6 illustrates an endoluminal stent-graft having an alternative orientation indicating marker element structure formed integrally with the frame, according to the principles of the present invention.
- Fig. 7 illustrates a method for applying a radiopaque marker element to a polyester liner of an endoluminal stent-graft by painting the liner with a radiopaque compound and covering the marker with an overcoat.
- Fig. 9 illustrates an alternative pattern of radiopaque marker elements to facilitate orientation and assembly of an endoluminal prosthesis.
- Figs. 10 A and B illustrate a still further alternative pattern of marker elements comprising wires having loops to facilitate stitching the marker elements to the liner.
- Fig. 11 illustrates an orientation indicating endoluminal prosthesis in small diameter configuration disposed within a delivery catheter, and shows a liner supported marker element which does not interfere with the expansion or compression of the prosthesis.
- Fig. 12 illustrates a method for radially orienting an endoluminal prosthesis by aligning a marker element of the prosthesis with a guidewire passing through the prosthesis while the prosthesis is disposed within the delivery catheter.
- Figs. 13 A and B illustrate a method for deploying a bifurcating prosthesis which includes verifying the orientation of a branch port with port orientation indicating markers while the branch port remains compressed within the delivery catheter, and by advancing a secondary prosthesis through a gate at the expanded port, the gate defined by marker elements on either side of the port centerline.
- Figs. 14 A and B illustrate a method for deploying an endoluminal prosthesis by first placing a marker band, and by then deploying an end of the prosthesis adjacent the marker band.
- Fig. 15 illustrates a method for deploying an endoluminal prosthesis similar to the method illustrated in Figs. 14 A and B, in which a conformal sponge-like sealing gasket is deployed with two marker bands to clearly mark a target region and to seal between the end of the prosthesis and an irregular surrounding body lumen.
- Figs. 16 A-D illustrate barbed endoluminal imagable bodies and a method for their use to mark the target location for an endoluminal prosthesis, according to the principles of the present invention.
- the prosthetic structures of the present invention will find their most immediate use as endovascular prostheses for the treatment of diseases of the vasculature, particularly aneurysms, stenoses, and the like, and are especially well suited for therapies to treat abdominal aortic aneurysms adjacent the aortal/iliac junction.
- These prostheses will generally be radially expansible from a narrow diameter configuration to facilitate introduction into the body lumen, typically during surgical cutdown or percutaneous introduction procedures.
- prosthetic structures described hereinbelow will find use in axially uniform cylindrical prostheses, in preassembled bifurcated prostheses, and as prosthetic modules which are suitable for selective assembly either prior to deployment, or in situ , such selective assembly of prosthetic modules to form a customized endoluminal prosthesis is more fully described in co-pending U.S. Patent Application Serial Nos. 60/008,254 and 08/538,706 (Attorney Docket Nos. 16380-34 and 16380-38) the full disclosures of which have previously been incorporated herein by reference.
- Prostheses 10 comprises a perforate tubular frame 12 which includes a plurality of independent (non-connected) ring frames 14.
- the tubular frame 12 supports an inner liner 18.
- an outer liner is disposed over the ring frames, either inside of inner liner 18, or in combination therewith.
- the liner is typically sutured to the frame.
- a wide variety of alternative liner/frame attachment mechanisms are available, including adhesive bonding, heat welding, ultrasonic welding, and the like. Where inner and outer liners are used, the ring frames may be sandwiched between the liners and held in place by attaching the liners to each other.
- the prostheses 10 will typically have a length in the range from about 20 mm to 500 mm, preferably from 50 mm to 200 mm, with a relaxed diameter in the range from about 4 mm to 45 mm, preferably being in the range from about 5 mm to 38 mm.
- an exemplary delivery catheter 30 for use with the endoluminal prostheses of the present invention comprises a tubular cover 32 and a shaft 34.
- Cover 32 has a central lumen 36 extending from a proximal end 38 to a distal end 40.
- Shaft 34 is slidably received within central lumen 36 and extends proximally of cover 32.
- a plurality of runners 42 extend distally from shaft 34.
- Runners 42 line a portion of the inner surface of lumen 36, and slide within the lumen of the shaft.
- Shaft 34 also has a lumen, in which a core shaft 44 is slidably disposed.
- Core shaft 44 has a guide wire lumen 46.
- Nosecone 48 is fixed to the distal end of core shaft 44, and can therefore be manipulated independently of runners 42.
- Prostheses 10 is radially compressed and restrained within the plurality of runners 42.
- cover 32 prevents runners 42 from expanding outward.
- Runners 42 are formed from a hard material, and distribute the expansion load of prostheses 10 over the inner surface of central lumen 36.
- the deploying force is applied proximally against a slider 50 attached to a distal end 38 of cover 30, while holding a luer fitting 52 at the distal end of shaft 34, thereby withdrawing the cover proximally from over the prostheses.
- An additional luer adapter 54 at the distal end of core shaft 44 allows the core shaft to be manipulated independently, and to be releasibly secured to the shaft 34.
- branching prosthesis 60 allows individual tailoring of the common lumen, first branch lumen, and second branch lumen to match the geometry of the body lumen system. For example, a maximum perimeter of common lumen cuffed module 62 may be selected independently of the branching lumen perimeter limits. Additional sealing cuff structures and methods are described in co-pending U.S. Patent Application Serial No. 08/525,989, filed September 8, 1995, (Attorney Docket No. 16380-003000) , the full disclosure of which is also incorporated herein by reference.
- the orientation indication markers of the prostheses of the present invention are particularly advantageous for use with the radially expansible prosthesis shown schematically in Fig. 4.
- An expansible prosthesis 70 has frame rings 72 sutured to an expansible liner 74.
- Expansible liner 74 is formed from a material which expands plastically when subjected to a stress beyond a yield strength, and which remains expanded when the stress is removed, ideally exhibiting little or no spring back.
- Suitable expansible liner materials include partially oriented polyester fibers, PTFE, or inexpansible fibers wrapped around an expansible fiber, a frangible fiber, or a dissolvable fiber, and the like.
- expansible prosthesis 70 may be performed prior to shipping the prosthesis as a production step, at the surgical site prior to introduction of the prosthesis within the patient body, or preferably, after deployment of the prosthesis within a body lumen using an angioplasty-type balloon catheter or other minimally invasive expansion device.
- Frame rings 72 of expansible prosthesis 70 may comprise a material which is resilient, malleable, or some combination of the two. When resilient, frame rings 72 will preferably be radially restrained by expansible liner 74, even after expansion of the liner to the predetermined limit. Such a liner-restrained stent-graft structure avoids any loosening of the liner after balloon 78 has been removed. As explained in co-pending U.S. Patent Application Serial No. 08/595,944, filed February 6, 1996 (Attorney Docket No.
- the cuff 76 of expansible prosthesis 70 often expands only to a predetermined limit, at which an element of either the liner 74 or the frame rings 72, or in some embodiments, the interface between the two, impedes further expansion.
- an orientation indicating bifurcated prosthesis 80 includes a plurality of discrete marker elements 82 which form an orientation indicating pattern 84 when imaged using fluoroscopy, ultrasound, or other imaging modalities.
- Such bifurcated prostheses will be particularly useful for reinforcing abdominal aortic aneurysms which extend into one or both iliac arteries, and will typically be used in combination with a secondary prosthetic module engaging port 85 to seal the port to the body lumen system.
- pattern 86 preferably indicates the axial location of the ends, and the axial and radial orientation of port 85, when the prosthesis is in a radially compressed configuration within a delivery catheter, and after deployment to assist deploying the secondary prosthesis within port 85.
- marker elements 82 are preferably aligned with perforations 86, ideally being substantially disposed within the perforations to maximize their image contrast against the generally radiographically clear liner 90.
- supporting the marker elements with the liner rather than attaching them directly to the frame, also helps avoid interference between the marker elements and the expansion of the surrounding frame structure. Additionally, supporting the marker elements on the liner so that they are separated from the frame will help to avoid erosion of the frame, as the marker elements will not rub against the frame with physiological movement.
- Pattern 84 defined by marker elements 82 includes several novel features.
- a port orientation indicator 92 is preferably disposed adjacent an end of the prosthesis which will be expanded before the port, and helps to verify that the orientation of port 85 will be aligned properly with the intended branching body lumen before the port is expanded in position. Fine rotational alignment of the prosthesis is facilitated by including roughly opposed marker elements 94, so that the preferred radial orientation of the prosthesis can be provided by orienting the imaging mechanism relative to the body lumen system. Surprisingly, in work done in connection with the present invention, such radial alignment has been found to be improved by axially offsetting opposed marker elements, so that the elements do not partially block each other's image during alignment, and to help distinguish a "front" marker element from a "back” marker element.
- Each of branch module 100 and trunk module 102 include marker elements 106 which produce an image which is aligned along a prosthetic centerline 104 when the prosthesis is properly positioned relative to the imaging apparatus.
- marker elements 106 may be aligned with a guidewire passing through the prosthetic lumen even if no other rotational alignment marker is provided, thereby minimizing the total number of markers.
- Asymmetric marker elements 108 are radially offset from the centerline markers, preferably defining a radial angle between about 15° and 70° with centerline markers 106, to ensure that the modules are not 180° out of rotational alignment, which could be problematic if the modules have a preferred bend angle or some other asymmetric structure.
- one optional structure for the marker element comprises an integral frame marker 110 formed by locally varying the perforation pattern of the frame.
- the frame marker 110 is generally wider than the surrounding frame structure, and will therefore provide an identifiable marker.
- the frame material will generally be selected for strength rather than imaging contrast (often comprising a high strength biocompatible alloy such as stainless steel, a shape memory alloy such as NitinolTM, or the like)
- imaging contrast often comprising a high strength biocompatible alloy such as stainless steel, a shape memory alloy such as NitinolTM, or the like
- the image contrast of such an integral marker element may be improved by selectively thickening, or by coating integral frame marker 110 with a high contrast material, such as gold, platinum, tantalum, or the like.
- the prostheses of the present invention will often include different materials for the frame and for the marker elements.
- the frame material will often comprise a high strength metal
- the marker elements will generally comprise a radiopaque metal or a metal which produces an enhanced ultrasound image.
- One potential problem with known endoluminal prostheses having such dissimilar metals is that a substantial difference in
- Electromotive Force (EMF) of adjacent metallic materials may promote corrosion.
- the present invention provides endoluminal prostheses with frames and marker element having similar EMF characteristics.
- a particularly preferred combination combines frames which include Nitinol and marker elements which include tantalum. These materials exhibit excellent strength and i agability, respectively, and are of sufficiently similar characteristics to avoid electrolytic corrosion.
- FIG. 6 An alternative frame supported marker element, perforation cross-member 112, is also illustrated in Fig. 6.
- This structure will also attach directly to the frame, but will generally have a coiled or otherwise deformable structure to accommodate the changes in perforation size during deployment.
- frame supported marker elements will tend to interfere to some extent with the radial expansibility of the frame.
- the present invention also provides radiopaque ink marker elements 114 a ⁇ illustrated in Fig. 7.
- the radiopaque particles comprise tantalum, the particles ideally being between about 1 and 5 microns, and are continuously blended with the compound before application to the liner.
- a suitable polyester matrix may comprise a polyester such as DacronTM, while the solvent may include hexofluoro 2-propanol, methylene chloride, a combination of both, or the like.
- a preferred marker element structure comprising an imagable body attached to the liner will be described with reference to Figs. 8-8 C.
- the plates will often be sewn to the outer surface of the liner material to avoid interference with the vascular flow or the generation of thrombus.
- the prosthetic lumen remains uninterrupted.
- the plates are generally attached along a radius of the liner, they should not substantially interfere with expansion of the liner material.
- expansible sutures such as a partially oriented polyester yarn may be used to attach the plates.
- the imagable bodies of the present invention could comprise a variety of alternative shapes and liner attachment mechanisms. Snaps, rivets, staples, and the like could attach through the liner, or knobs or other shapes could be sewn, adhesively bonded, or otherwise affixed to the liner within the scope of the present invention. Plates 130 having at least one passage 136 are generally preferred, however, a ⁇ they provide a relatively large image, do not substantially distort or interrupt the prosthetic lumen, and can be very securely attached to the liner.
- FIG. 9 An alternative orientation indicating pattern is illustrated in Fig. 9, the pattern including opposed marker elements 142 which axially overlap when the prosthesis is rotationally aligned relative to the imaging system. Additionally, the port orientation is here indicated by alternating front port orientation markers 144 and rear port orientation markers 146. When these alternating port markers are lined up and evenly spaced, the prosthesis is aligned and the port is on the side of the prosthesis toward which the line of port orientation markers slant.
- FIG. 10 A and B A still further marker element and pattern are illustrated in Figs. 10 A and B.
- Pattern 150 is defined by the images of wires 152 having loops 154 for attachment to the liner.
- the contrast of the wires may be enhanced by windings 156, the wires and windings comprising a high contrast material, often including gold, platinum, tantalum, or the like.
- a single gate 96 formed with such wire marker elements may indicate an axial overlap range by careful selection of the length of the wires.
- one advantage of the liner supported marker elements of the present invention is that the marker element can fold out of the way of the frame with the liner. Ring frame 14 can be tightly compressed within sheath 32, leaving little space between the frame arms.
- FIGs. 13 A and B A method of deploying branching prosthesis 80 and branch module 100 for treatment of an abdominal aortic aneurysm AAA is illustrated in Figs. 13 A and B.
- Aneurysm AAA extends along the aortic artery A from below the renal arteries R and onto the iliacs I.
- the imaging system is typically oriented toward the plane of the aorta/iliac bifurcation.
- the catheter is introduced and axially positioned under fluoroscopy so that the prosthesis extends along the weakened aorta and into one of the iliacs.
- the port indicator marker elements 92 By rotating the catheter until the port indicator marker elements 92 are generally on the side of the opposite iliac, the port can be generally oriented to accept branch module 100.
- Further alignment can be provided by aligning axially offset opposed markers 94.
- the distal end of the prosthesis is deployed.
- this provides a clear view of port orientation indicating marker elements 92 well before the port itself is expanded. If further rotational adjustment is necessary, it may be possibly to simply rotate the expanded prosthesis end against the healthy tissue beyond the aneurysm. Alternatively, the expanded end may be withdrawn into the catheter and repositioned or replaced much easier than if the sheath is withdrawn beyond the port itself.
- the port orientation indicating markers may instead be disposed adjacent the prosthetic branch end within the iliac to provide similar benefits.
- the gates 96 adjacent the port on prosthesis 80 clearly indicate the path of the port axis to facilitate introduction of guidewire 134 and the delivery catheter for the branch module.
- the marker elements which define the gate can remain visible even when the delivery catheter is disposed in the port. This significantly eases positioning marker elements 82 adjacent the end of the branch module axially between gates 96, thereby assuring that the prosthetic overlap is within the predetermined allowable range.
- a body lumen marker comprising a helical marker band 140 may be deployed with a catheter 142 to mark the specific target location for an end of the branching prosthesis 80.
- the marker band delivery catheter 142 may incorporate intravascular ultrasound (IVUS) imaging capabilities to more accurately determine the extent of aneurysm AAA than is possible using fluoroscopy alone.
- IVUS intravascular ultrasound
- the marker band generally comprising a radiopaque material.
- a sealing gasket material is deployed with marker band 140 to seal between the later-deployed prosthesis and the surrounding body lumen, as shown in Fig. 15.
- a sealing gasket preferably comprises a sponge-like silicone or other polymer, as more fully explained in co- pending U.S. Patent Application Serial No. 08/525,989,
- FIGs. 16 A-D Alternative endoluminal body lumen markers are illustrated in Figs. 16 A-D.
- these endoluminal markers 150 comprise imagable bodies 152 which are held in position by barbed protrusions 154 which penetrate at least partially into the lumenal wall W.
- the tubular endoluminal prosthesis may be positioned over the body lumen markers, thereby helping to hold them in position against the body lumen wall.
- the body lumen markers may include hooks 156 or other prosthesis engaging structures opposite the barbed protrusion 154 to maintain the position of the subsequently deployed prosthesis within the body lumen.
- the body lumen markers will typically comprise a radiographic material such as tantalum, gold, platinum, or the like, and may be deployed using a high torque, high control delivery catheter, a balloon catheter, or the like.
- a radiographic material such as tantalum, gold, platinum, or the like
- the marker bands 140 and endoluminal markers 150 may also find use in measuring or verifying the actual diameter of the vessel prior to prosthesis.
- Such independent marker elements which engage the lumenal wall will also be useful in follow-up procedures to determine whether the prosthesis has migrated, whether there has been any change in length or diameter of the aneurysm or the prosthesis over time.
Abstract
Description
Claims
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
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DE69716725T DE69716725T2 (en) | 1996-04-05 | 1997-04-01 | ENDOLUMINAL PROSTHESIS WITH MARKINGS FOR INDICATING POSITION |
EP97917782A EP0901352B1 (en) | 1996-04-05 | 1997-04-01 | Endoluminal prostheses having position indicating markers |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US08/628,797 US5824042A (en) | 1996-04-05 | 1996-04-05 | Endoluminal prostheses having position indicating markers |
US08/628,797 | 1996-04-05 |
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WO1997037616A2 true WO1997037616A2 (en) | 1997-10-16 |
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PCT/US1997/005377 WO1997037616A2 (en) | 1996-04-05 | 1997-04-01 | Endoluminal prostheses having position indicating markers |
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- 1997-04-01 WO PCT/US1997/005377 patent/WO1997037616A2/en active IP Right Grant
- 1997-04-01 EP EP97917782A patent/EP0901352B1/en not_active Expired - Lifetime
- 1997-04-01 DE DE69716725T patent/DE69716725T2/en not_active Expired - Lifetime
-
1998
- 1998-07-24 US US09/122,337 patent/US6203568B1/en not_active Expired - Lifetime
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Cited By (23)
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WO1999001073A1 (en) * | 1997-07-03 | 1999-01-14 | Medtronic, Inc. | Measurement confirmation devices and methods for fluoroscopically directed surgery |
US9867727B2 (en) | 1998-02-09 | 2018-01-16 | Trivascular, Inc. | Endovascular graft |
US10548750B2 (en) | 1998-02-09 | 2020-02-04 | Trivascular, Inc. | Endovascular graft |
EP1025811A3 (en) * | 1999-02-05 | 2001-05-09 | Medtronic, Inc. | Endoluminal prosthesis having radiopaque marker |
WO2000051514A1 (en) * | 1999-03-01 | 2000-09-08 | Lucent Medical Systems, Inc. | Magnetic anatomical marker and method of use |
JP2003515386A (en) * | 1999-12-03 | 2003-05-07 | テラメッド・インコーポレイテッド | Endovascular graft system |
WO2001056503A1 (en) * | 2000-02-03 | 2001-08-09 | Medtronic Ave Inc. | Endoluminal prostheses having radiopaque marker |
DE10321119A1 (en) * | 2003-05-09 | 2004-11-25 | Phytis Medical Devices Gmbh | Marker for identifying functional points on implants, is arranged on catheter within functional point area of implant e.g. stent for easy arrangement and positioning of implant in human or animal body |
US8267989B2 (en) | 2004-01-30 | 2012-09-18 | Trivascular, Inc. | Inflatable porous implants and methods for drug delivery |
US8579959B2 (en) | 2008-09-12 | 2013-11-12 | Cook Medical Technologies Llc | Radiopaque reinforcing member |
WO2010030370A1 (en) * | 2008-09-12 | 2010-03-18 | William A. Cook Australia Pty. Ltd. | Radiopaque reinforcing member |
JP2013537450A (en) * | 2010-08-05 | 2013-10-03 | ウイリアム エー クック オーストラリア ピィティワイ リミテッド | Stent graft with marker and reinforcement and marker ring |
WO2012019090A1 (en) * | 2010-08-05 | 2012-02-09 | William A. Cook Australia Pty. Ltd. | Stent graft having a marker and a reinforcing and marker ring |
EP3378437B1 (en) * | 2010-08-05 | 2022-12-14 | Cook Medical Technologies LLC | Stent graft having a marker and a reinforcing and marker ring |
CN110121316A (en) * | 2017-01-11 | 2019-08-13 | 百多力股份公司 | X-ray marker for bracket |
WO2018130489A1 (en) * | 2017-01-11 | 2018-07-19 | Biotronik Ag | X-ray markers for scaffolds |
JP2020503935A (en) * | 2017-01-11 | 2020-02-06 | バイオトロニック アクチェンゲゼルシャフト | X-ray marker for scaffold |
CN110121316B (en) * | 2017-01-11 | 2022-02-18 | 百多力股份公司 | X-ray marker for stents, method for producing same, semi-finished product and medical implant |
EP3348239A1 (en) * | 2017-01-11 | 2018-07-18 | Biotronik AG | X-ray markers for scaffolds |
US11951024B2 (en) | 2017-01-11 | 2024-04-09 | Biotronik Ag | X-ray markers for scaffolds |
WO2021173126A1 (en) * | 2020-02-26 | 2021-09-02 | C.R. Bard, Inc. | Stent grafts having a radiopaque marker and methods of producing |
JP2023507672A (en) * | 2020-02-26 | 2023-02-24 | シー・アール・バード・インコーポレーテッド | Stent graft with radiopaque markers and method of manufacture |
JP7255033B2 (en) | 2020-02-26 | 2023-04-10 | シー・アール・バード・インコーポレーテッド | Stent graft with radiopaque markers and method of manufacture |
Also Published As
Publication number | Publication date |
---|---|
DE69716725T2 (en) | 2003-07-03 |
DE69716725D1 (en) | 2002-12-05 |
US5824042A (en) | 1998-10-20 |
WO1997037616A3 (en) | 1997-11-13 |
EP0901352A2 (en) | 1999-03-17 |
EP0901352B1 (en) | 2002-10-30 |
US6203568B1 (en) | 2001-03-20 |
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