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WO2002000139A1 - Stent expansible radialement pour le traitement d'anevrismes - Google Patents

Stent expansible radialement pour le traitement d'anevrismes Download PDF

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Publication number
WO2002000139A1
WO2002000139A1 PCT/US2001/041104 US0141104W WO0200139A1 WO 2002000139 A1 WO2002000139 A1 WO 2002000139A1 US 0141104 W US0141104 W US 0141104W WO 0200139 A1 WO0200139 A1 WO 0200139A1
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WIPO (PCT)
Prior art keywords
stent
tip
aneurysm
segments
cap
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Ceased
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PCT/US2001/041104
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English (en)
Inventor
John J. Frantzen
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Individual
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Individual
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Priority to AU2001279261A priority Critical patent/AU2001279261A1/en
Publication of WO2002000139A1 publication Critical patent/WO2002000139A1/fr
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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
    • A61F2/82—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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A61B17/12113—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A61B17/12113—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
    • A61B17/12118—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm for positioning in conjunction with a stent
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12172—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12181—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices
    • A61B17/1219—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices expandable in contact with liquids
    • 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
    • A61F2002/823—Stents, different from stent-grafts, adapted to cover an aneurysm
    • 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
    • A61F2230/0017—Angular shapes
    • A61F2230/0021—Angular shapes square
    • 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
    • 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
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0071—Three-dimensional shapes spherical
    • 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
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0086—Pyramidal, tetrahedral, or wedge-shaped

Definitions

  • the following invention relates to surgically implantable structures for treatment of aneurysms. More particularly, this invention relates to surgically implantable structures which include surfaces that block a neck of the aneurysm to preclude fluid flow into the aneurysm and prevent further expansion and/or rupture of the aneurysm.
  • Aneurysms are bulges in a body lumen, such as a blood vessel. Aneurysms are relatively common especially in the larger arteries throughout the body. Aneurysms are related to the absence of a muscular layer that makes up part of the blood vessels, that over time stretches and thins to create the aneurysm. Aneurysms can break resulting in internal bleeding and related complications.
  • Brain aneurysms are of particular concern because rupture of a brain aneurysm can cause a stroke or death.
  • Studies have shown that between 1% and 5% of the general population have brain aneurysms and that four hundred thousand people in the United States have brain aneurysms of a significant size. While smaller aneurysms (under 6 millimeters) are very unlikely to bleed, approximately thirty thousand people in the United States suffer from an aneurysm rupture every year. It has been estimated that 60% of such ruptures result in death and 20% of such ruptures result in disability. Accordingly, a need exists for effective treatment to reduce the incidence of brain aneurysm rupture.
  • Known prior art techniques for treatment of aneurysms include direct surgery and endovascular surgery.
  • the aneurysm is accessed by making incisions in the skin and opening the skull to locate the aneurysm.
  • the neck of the aneurysm is identified where the ballooned aneurysm connects to the blood vessel.
  • the aneurysm is repaired by placing a clip across the neck. Blood flow is then restricted from passing into the aneurysm and continuing to cause ballooning of the aneurysm, which leads to rupture.
  • a catheter enters the body, typically through a leg artery, and is passed up to the location of the aneurysm under x-ray guidance.
  • the aneurysm is then filled to decrease or eliminate blood flow into the aneurysm, which leads to aneurysm rupture. It is known in the prior art to fill the aneurysm with tiny coils of material or to fill tiny latex or silicone balloons within the aneurysm.
  • United States Patent No. 5,350,397 is directed to an axially detachable embolic coil assembly which can be discharged from a catheter and used to fill an aneurysm.
  • Other known prior art coil assemblies are disclosed in the following United States patents: 5,217,484; 5,234,437; 5,250,071; 5,261,916; 5,263,964; 5,562,698; 5,578,074; and 5,601,600.
  • aneurysm clips While direct surgery and use of aneurysm clips is generally effective, it requires invasive surgery and the attendant discomfort and risk of complications. While endovascular surgery is less invasive and can more effectively access some blood vessels and other body lumens, the known technique of filling the aneurysm with coils or balloons is not entirely satisfactory. Specifically, when the coils are utilized a risk of displacement exists and the coil can come out of the aneurysm and do damage within the blood vessel, including causing a stroke. The coils are not affixed in any manner within the aneurysm, enhancing this risk. When coils and balloons are utilized to fill the aneurysm, some risk exists that the aneurysm will rupture during the endovascular procedure.
  • the stent of this invention includes a plurality of segments and/or ribs which are coupled together at junctions in a manner which allows the segments/ribs to flex relative to each other and cause the stent to radially expand.
  • the stent is first positioned intraluminalry at the site where implantation is desired, while the stent is held in a collapsed form within a delivery tube which resists radial expansion of the stent.
  • a tip of the stent is located adjacent to the aneurysm, and typically at least partially through a neck of the aneurysm and into the aneurysm itself. When the stent is radially expanded this tip is held in position adjacent the neck of the aneurysm.
  • At least a portion of the tip of the stent includes some form of surface which extends between the segments and/or ribs within the tip of the stent. This surface opposes blood flow into the aneurysm. This opposition has the immediate effect of protecting the aneurysm from further expansion and rupture. Additionally, with the reduced blood flow, the conditions are desirable for restenosis adjacent the tip of the stent for further blockage of blood flow into the aneurysm. Because the stent has a radially expandable characteristic and is biased toward its radially expanded configuration, the stent is securely held in place and risk of displacement of the stent is avoided.
  • the tip of the stent can be used alone and be radially expanded against the neck of the aneurysm to hold itself in place.
  • the tip can be coupled to a cylindrical base which is located within a generally cylindrical luminal section adjacent the aneurysm, where the cylindrical base can be radially expanded to securely hold its position relative to the adjacent body lumen.
  • the tip need not itself expand securely up against the neck of the aneurysm, but rather can freely rest within the aneurysm with secure support of the tip provided by the cylindrical base of the stent.
  • the tip can be provided alone and radially expanded within the aneurysm to a diameter greater than that of the neck, such that the tip is prevented from escape out of the aneurysm and does not place any forces upon the aneurysm which might lead to rupture.
  • the surface on the tip can be formed in a variety of ways, such as by providing a concave foam cap with ribs provided to give structural support to the cap.
  • the cap can be formed from a flexible polymeric hydrocarbon, such as parylene.
  • An interior of the cap can optionally be filled with a gel which expands and hardens somewhat when coming into contact with water containing fluids, such as blood.
  • the ribs are provided with a bias toward a curved contour which supports the cap in a spherical or other expanded configuration.
  • the surface can alternatively be provided by multiple facets separate with a layer of material such as parylene spanning the facets.
  • a faceted tip stent When such a faceted tip stent is radially expanded a plurality of distal corners of the facets remain together so that a closed tip with the surface layer spanning the facets between segments provides the surface for opposition of blood flow into the aneurysm.
  • the material forming the segments is biased toward this final configuration for the faceted tip.
  • Most of the segments are configured to follow a cylindrical contour. However, segments adjacent the distal corners are biased toward a configuration which converges in toward a central axis of the stent, such that when the faceted tip is released from the delivery tube it automatically deploys in the desired fashion to oppose blood flow into the aneurysm.
  • Figure 1 is a side elevation view of a tip of an aneurysm treatment stent of this invention with the tip being utilizable either alone or in conjunction with a cylindrical base ( Figures 6 and 7), and with the tip including a cap thereon for opposing blood flow into an aneurysm.
  • Figure 2 is a sectional view of the cap portion of Figure 1.
  • Figure 3 is a side elevation view of a portion of the stent of this invention when collapsed into a delivery tube.
  • Figure 4 is a full sectional view of a portion of the delivery tube shown in Figure 3 with the tube exhibiting a slightly less tapering contour and shown without the stent.
  • Figure 5 is a full sectional view of a portion of an alternative delivery tube to that which is shown in Figures 3 and 4.
  • Figure 6 is a side elevation view of a portion of the stent of this invention including the tip attached to the cylindrical base.
  • Figure 7 is a top plan view of the stent which is shown in Figure 6 with the stent deployed within a body lumen with the tip expanded within an aneurysm in the body lumen.
  • Figure 8 is a top plan view of a body lumen with a tip only expanded within an aneurysm having a width greater than a width of a neck of the aneurysm, and where the stent does not include the cylindrical base.
  • Figure 9 is a side elevation view of a first alternative embodiment of that which is shown in Figure 1.
  • Figure 10 is a side elevation view of a second alternative embodiment of that which shown in
  • Figure 11 is a cylindrical projection of a faceted tip which can either be utilized alone or in conjunction with a faceted tip stent including a cylindrical base.
  • Figure 12 is a cylindrical projection of that which is shown in Figure 11 before radial expansion as shown in Figure 11.
  • Figure 13 is a side elevation view of that which is shown in Figures 11 and 12, after radial expansion of the stent.
  • Figure 14 is a front elevation view of that which is shown in Figure 13.
  • Figure 15 is a top plan view of a body lumen with the stent of Figure 13 implanted within an aneurysm located in the body lumen.
  • Figure 16 is a top plan view of a body lumen with a faceted tip stent including both a faceted tip and a cylindrical base implanted within the body lumen with the faceted tip adjacent a neck of the aneurysm and blocking blood flow into the aneurysm.
  • Figure 17 is a perspective view of that which is shown in Figure 16.
  • Figure 18 is a cylindrical projection of that which is shown in Figure 17.
  • Figure 19 is a side elevation view of that which is shown in Figure 17.
  • Figure 20 is a cylindrical projection of a variation on the stent tip shown in Figure 11 where the bend line passes through junctions.
  • Figure 21 is an end elevation view of that which is shown in Figure 20.
  • Figure 22 is a perspective view of an alternative stent to that which is shown in Figure 17 with the bend line provided as shown in Figure 20.
  • reference numeral 10 is directed to blunt tip stent ( Figures 6 and 7) for implantation within a body lumen L adjacent an aneurysm X so that a tip 40 ( Figures 1-7) can oppose blood flow B into the aneurysm X.
  • a tip 40 Figures 1-7) can oppose blood flow B into the aneurysm X.
  • blood flow B into the aneurysm X is opposed, the aneurysm X is prevented from further expanding and rupture and effective treatment of the aneurysm X is provided.
  • the blunt tip stent 10 includes a cylindrical base 20 which has a generally cylindrical contour about a central axis C and is sufficiently radially expandable to engage walls W of a body lumen L for secure placement within the body lumen L.
  • An extension 30 extends from a distal end 28 ( Figure 6) of the cylindrical base 20.
  • a tip 40 is attached to the extension 30.
  • the tip 40 has a plurality of ribs which are biased toward a curved configuration as they extend from an attached end 44, where the ribs 42 are all joined together, to a free end 46 where the ribs 42 are spaced from each other.
  • a cap 50 has a perimeter 56 thereof held open by the free ends 46 of the ribs 42 which are embedded into bores 58 within the cap 50.
  • the cap 50 can be formed from an open-celled foam material, or can be formed from other bio-compatible flexible materials, such as parylene.
  • An interior 60 can be optionally filled with a gel having an ability to expand and solidify somewhat when coming into contact with water containing materials such as blood.
  • the blunt tip stent 10 can be radially collapsed, along arrow R ( Figure 6) sufficiently so that the stent 10 can be oriented within a delivery tube 100 ( Figures 3-5).
  • the delivery tube 100 is flexible to allow routing through small and sharply curving luminal pathways, such as blood vessels within the brain, and resists radial expansion due to forces generated by the stent 10 as it seeks its biased radially expanded configuration.
  • the stent 10 transitions from its first radially collapsed configuration to its second radially expanded configuration where it engages walls W of the lumen L and opposes blood flow into the aneurysm X.
  • the tip 40 can either be provided as one portion of the blunt tip stent 10 or can function alone as a radially expandable aneurysm treatment stent (Figure 8). While various different medical criteria might indicate the use of the tip 40 alone rather than in conjunction with the cylindrical base 20 and other portions of the blunt tip stent 10, a primary factor is the configuration of the aneurysm X.
  • the tip 40 can be provided with a diameter which is less than a diameter of the aneurysm X' and greater than the diameter of the neck N ⁇
  • the tip 40 can be expanded within the aneurysm X' and be trapped within the aneurysm X' due to the smaller size of the neck N' .
  • the tip 40 diameter being less than the diameter of the aneurysm X' ensures that forces are not exerted on the aneurysm X' by the tip 40 which might cause rupture or other damage to the aneurysm X'.
  • the tip 40 is less able to hold its own position within the aneurysm X.
  • Use of the tip 40 in conjunction with the cylindrical base 20 of the blunt tip stent 10 is thus indicated, with the cylindrical base 20 radially expanded against walls W of the body lumen L adjacent the aneurysm X so that the cylindrical base 20 of the blunt tip stent 10 securely holds the tip 40 within the aneurysm X. It is not necessary that the tip 40 extend all the way into the aneurysm X. Rather, it is merely necessary that the tip 40 be located sufficiently within or beyond the neck N that blood flow B is diverted from passing into the aneurysm X and kept within the desired luminal pathways.
  • the tip 40 first requires a configuration which facilitates radial expansion between a first collapsed diameter and a second radially expanded diameter, along arrow R ( Figure 1). Second, the tip 40 must have some form of surface which is oriented to be non-parallel to the central axis C of the tip 40 so that the surface at least partially opposes blood flow B into the aneurysm X when the tip 40 is located adjacent the aneurysm X.
  • the tip 40 includes a plurality of ribs 42 which each include an attached end 44 and a free end 46.
  • Each of the ribs 42 are joined together at their attached ends 44 and are spaced from each other at their free ends 46.
  • Each of the ribs 42 follows a curving contour with the ribs 42 generally adjacent the central axis C at the attached end 44 and extending out radially as the ribs 42 extend axially toward the cap 50.
  • the ribs 42 can be formed from a shape memory material, such as nickel titanium, with the ribs 42 biased toward their final curving contour. Details of use of nickel titanium shape memory materials are described in United States Patent No. 6,042,606, incorporated herein by reference.
  • the ribs 42 When the ribs 42 are cooled below a transition temperature, as is known in the art, the ribs 42 can be easily oriented axially, along arrow A, and collapsed along with other portions of the tip 40 before implantation.
  • the ribs 42 When the ribs 42 are heated above their transition temperature and released from the delivery tube 100 or other restraint, the ribs 42 assume their biased curving configuration (Figure 1) and deploy the cap 50.
  • the cap 50 is preferably a concave structure having a substantially constant wall thickness between the inside surface 52 and an outside surface 54 ( Figure 2).
  • a perimeter 56 defines an edge of the cap 50 into which the free ends 46 of the ribs 42 extend. Bores 58 receive the free ends 46 of the ribs 42 therein.
  • An interior 60 is thus provided by the cap 50.
  • the cap 50 is preferably formed from an open-celled foam material which is sufficiently flexible and compressible to be compressed down into the delivery tube 100, and sufficiently flexible and resilient to return to its substantially hemispherical concave form after release from the delivery tube 100.
  • the ribs 42 additionally encourage the foam forming the cap 50 to return to the desired, substantially spherical concave form, when the tip 40 is released from the delivery tube 100.
  • the cap 50 When the cap 50 is formed from an open-celled foam, this foam can be impregnated with a gel material which is capable of expansion and hardening when exposed to. water within body fluids.
  • a gel material which is capable of expansion and hardening when exposed to. water within body fluids.
  • One such gel is Tecogel 2000, provided by Thermedics, Inc. of Woburn, Massachusetts.
  • the gel can be both within the cells of the foam cap 50 or within the interior 60 of the concave cap 50, or both.
  • the hardened gel further discourages blood flow B into the aneurysm X.
  • Various different foams are available having varying densities and varying different open cell sizes and with varying different hardnesses to suit the desires of the medical professional.
  • the foam desirably avoids providing damagingly high pressure against the aneurysm X, while providing a structure which diverts blood flow B away from the aneurysm X and provides a structure which can encourage restenosis.
  • the cap 50 can be formed from a flexible layer of non-permeable material.
  • the cap 50 can be formed from parylene.
  • This parylene film can be between 0.0001 and 0.002 inches thick, with 0.0005 inches considered an ideal thickness.
  • Parylene is the generic name for members of a family of polymeric di-para-zylylenes. Parylene refers to such thermoplastic polymers that can be formed on surfaces exposed to a rarefied gas in a vacuum.
  • the parylene can be deposited onto a mandrel or other deposition surface laying adjacent where the cap 50 is to be formed during the vacuum deposition process.
  • a thin flexible base layer can be located where the cap 50 is to be formed and then the parylene can be deposited directly onto this base layer to create the parylene surface layer forming the cap 50.
  • the entire stent 10, including the segments 22, junctions 24 and ribs 42 can be coated with the parylene that forms the surface layer also.
  • the surface layer forming the cap 50 can be formed as a silicone film or from high strength copolymers of silicone and a polycarbonate, such as products marketed under the trademark Chronoflex manufactured by Cardiotech International, Inc. of Woburn, Massachusetts.
  • Other appropriate materials such as polyesters or polytetrafluoroethylene, or any other appropriate flexible surface materials can be utilized to create the surface layer forming the cap 50.
  • Figure 9 depicts a first alternative tip 240 which is similar to the tip 40 of the preferred embodiment except that the ribs 42 are replaced with longer ribs 242 which extend all the way back to the center line C where the free ends 246 of the ribs 242 are then joined together.
  • the ribs 242 thus are coupled together both at their attached ends 244 and at their free ends 246 which join together within the cap 50.
  • This first alternative tip 240 includes additional structural support provided by the longer ribs 242.
  • the second alternative tip 340 includes ribs 342 which have attached ends 344 joined together and free ends 346 which are also joined together within the cap 50. With the second alternative tip 340, the ribs 342 do not terminate facing in toward each other, but rather bend back toward an orientation parallel to the central axis C before terminating at the free ends 346. Numerous different variations and different patterns for ribs 42, 242, 342 can be provided to provide additional structural support for the tips 40, 240, 340 and for the cap 50, and to provide desirable flexibility, radiopacity, geometry and other characteristics desired by the medical professional.
  • the attached end 44 of the ribs 42 would be joined to a bridge 36 of the extension 30.
  • the extension 30 includes segments 22 and junctions 24 following a pattern similar to that for the cylindrical base 20 with the exception that axial segments 32 are preferably provided to enhance rigidity of the extension 30.
  • the extension 30 spans a gap 34 with minimal blockage of the gap 34. Hence, blood flow B ( Figure 7) is not blocked between different pathways of the body lumen L.
  • the bridge 36 couples to the segments 22 forming the extension 30 so that the tip 40 is secured to the cylindrical base 20.
  • the base 20 exhibits a generally cylindrical form with a plurality of segments 22 extending between junctions 24 to make up the cylindrical form of the base 20.
  • the cylinder formed by the base 20 is not walled or enclosed. Rather, the segments 22 and junctions 24 are merely located so that they each lie in a manner which, when they are all considered together, lie along a common substantially cylindrical contour.
  • Stents have been proposed and manufactured having a variety of different segment and junction configurations. For instance, a single segment can extend helically to form a cylindrical stent. A full discussion of various stent segment patterns is provided in Handbook of Coronary Stents, Second Edition. Any of the prior art stents disclosed in that reference or otherwise known in the prior art which exhibit radial expandability could conceivably be adapted for use within the stent 10 of this invention.
  • a base 20 having a multiple linear segment 22 pattern is provided with junctions 24 between ends of each of the segments 22.
  • the segments 22 are oriented substantially axially (along arrow A of Figure 6) before radial expansion, along arrow R of Figure 6 (see portions of the base 20 located within the delivery tube 100 of Figure 3).
  • the segments 22 transition into an orientation which is less axially aligned.
  • the base 20 radially expands to the point where the segments 22 diverge from an axial orientation by 19° when the base 20 is radially expanded.
  • each segment 22 extends approximately 0.1000 inches axially when the base 20 is radially expanded.
  • Each segment 22 preferably is 0.0020 inches thick with areas of increased stress optionally made thicker (i.e. 0.0030 inches thick).
  • the base 20 preferably has a compressed diameter of 0.012 inches and an expanded diameter of 0.120 inches. When radially expanded, the length and width of the segments 22, along with the expanded angular deviation from axial orientation of 19° provides the base 20 with an approximately ten times expansion coefficient.
  • the amount of radial expansion, along arrow R of Figure 6, can be increased by increasing the length of the segments 22 or by increasing an amount of angular displacement of the segments 22 away from the axial orientation when radially expanded.
  • the segments 22 and junctions 24 which form the stent 10 can be made from a variety of different bio-compatible materials.
  • the segments 22, junctions 24 and ribs 42 of the stent 10 are formed from a shape memory nickel titanium alloy.
  • Such nickel titanium alloys are unique in that they can be treated in a manner which gives the stent a preferred form to which the stent 10 is biased, when a particular temperature, in this case body temperature, is attached.
  • the stent 10 When the stent 10 is cooled to below a transition temperature, the stent 10 becomes much more malleable and can be easily collapsed. When the stent 10 is heated back to its transition temperature, it elastically seeks the form for which it was originally biased. The details associated with the formation and biasing of such shape memory stents are disclosed in detail in United States Patent No. 6,042,606, incorporated herein by reference.
  • the stent 10 can be formed from plastically deformable metal alloys, such as stainless steel.
  • a faceted tip stent 110 can either be utilized with the faceted tip 120 alone or with the faceted tip 120 in conjunction with a cylindrical base 20 and extension 30 identical to the cylindrical base 20 and extension 30 described in detail above.
  • the faceted tip 120 is preferably formed from a plurality of segments 122 joined together at junctions 124. Angles at which the segments 122 join to the junctions 124 are flexibly adjustable to allow the faceted tip 120 to radial expand and contract relative to the central axis C ( Figures 11- 13).
  • the segments 122 extend at one end of the tip 120 to distal corners 126 and at another end of the faceted tip 120 to proximal corners 128.
  • the faceted tip 120 preferably maintains a substantially cylindrical contour defined by the orientation of the segments 122 and junctions 124 except adjacent the distal corners 126.
  • a bend line 129 is provided which defines a location where the segments 122 extend away from the cylindrical contour and in toward the central axis C.
  • the segments 122 extend in toward the central axis C sufficiently so that the distal corners 126 are adjacent each other and adjacent the central axis C ( Figure 13).
  • the segments 122 can be formed from appropriate shape-memory materials, such as nickel titanium, so that the segments 122 are biased toward this configuration, as shown in Figure 13.
  • the distal corners 126 would remain adjacent the central axis C and other portions of the faceted tip 120 would radially expand (along arrow R) to form the desired configuration.
  • the distal corners 126 can be welded together or held together with a fastener coupling the distal corners 126 together.
  • Space between segments 122 which join together at the distal corners 126 is preferably spanned by a layer 130, such as the parylene layer discussed in detail above.
  • This layer 130 extends all the way into the distal corner 126 and out to a proximal edge 132.
  • the proximal edge 132 is preferably adjacent to the bend line 129 at which the segments 122 diverge from the cylindrical contour and in toward the centerline C.
  • the layers 130 between the segments 122 which extend to the distal corners 126 will cause approximately half of the faceted tip 120 to be closed by the layer 130.
  • Blood flow B is thus disrupted so that it cannot freely pass into the aneurysm X without opposition and will decrease pressure on the aneurysm X which would otherwise tend to expand and encourage rupture of the aneurysm X.
  • the faceted tip 120 is utilized in conjunction with the faceted tip stent 110, at least some of the proximal comers 128 are joined to portions of the extension 30 ( Figures 17-19) so that the faceted tip 120 can be securely held in position relative to aneurysms X which are not appropriately configured to allow a faceted tip 120 to securely hold within the aneurysm X without additional support provided by the cylindrical base 20.
  • the faceted tip stent 110 includes the gap 34 adjacent the extension 30 so that blood flow B between side branches adjacent the aneurysm X is not disrupted by the cylindrical base 20 of the faceted tip stent 110, which is within the lumen L to hold the faceted tip 120 in position.
  • a first alternative to the faceted tip stent 110 is provided.
  • This alternative faceted tip stent 410 is similar to the faceted tip stent 110 of the preferred embodiment except that it has a unique first alternative faceted tip 420.
  • this alternative faceted tip 420 has a bend line 429 which passes through junctions 424 rather than with the faceted tip 120 where the bend line 129 passes through segments 122.
  • a surface layer 430 extends from a distal comer 426 to the bend line 429.
  • This alternative faceted tip 420 illustrates a second of many conceivable alternative configurations for the faceted tip stent 110, 410.
  • the bend line 129, 429 can be moved closer to the distal corner 126, 426.
  • the bend line 129, 429 is moved toward the junctions 424 which are closest to the distal comers 426.
  • a medical professional would utilize appropriate diagnostic techniques to identify aneurysms X, X' to be treated.
  • an aneurysm X, X' has been selected which requires treatment, the size and contour of the aneurysm X, X' will be evaluated. Based on this evaluation, the medical professional will choose a stent 10, 110 and stent tip 40, 120 having a size and configuration which will most effectively oppose blood flow into the aneurysm X, X' .
  • the tip 40 ( Figure 8) may be deployable alone to treat the aneurysm.
  • the medical professional may choose a stent such as the stent 10, 110 which includes the cylindrical base 20 for securely holding the tip 40, 120 in position.
  • the appropriate stent 10, 110 can be provided from a pre- manufactured set of stents 10, 110 or can be specially manufactured to the medical professional's specifications.
  • the structural elements are initially configured as desired utilizing known techniques such as laser etching, and other techniques as specifically disclosed in United States Patent Application No. 6,042,606 incorporated herein by reference.
  • the foam or other materials forming the cap 50 or layer 130 are coupled to the structural portions of the tip 40, 120.
  • the stent 10, 110 is then cooled below its transition temperature and radially collapsed and inserted into the delivery tube 100. Utilizing intralu inal surgical techniques, the delivery tube 100 with the included stent 10, 110 or tip 40, 120 alone is routed to the stent delivery site. The delivery tube 100 is then retracted and the stent 10, 110 or tip 40, 120 alone is allowed to expand radially (along arrow R) in its desired final position.
  • the stent 10, 110 or tip 40, 120 are then in position to oppose blood flow B into the aneurysm X, X' and the aneurysm X, X' is effectively treated.
  • This invention exhibits industrial applicability in that it provides a radially expandable stent which includes a covering surface which can be flexibly deployed when the stent is radially expanded to block a neck of an aneurysm, such as a brain aneurysm within a blood vessel.
  • Another object of the present invention is to provide a stent which can radially collapsed sufficiently to pass through small arterial pathways within a delivery tube, such as arterial pathways leading to brain aneurysm sites, and be radially expanded to a diameter sufficiently large to securely hold position within the blood vessel adjacent the aneurysm.
  • Another object of the present invention is to provide a stent for treatment of aneurysms which can be implanted without direct surgery and which can be securely held in position adjacent the aneurysm without imparting any damaging stresses upon the aneurysm itself which might cause rupture of the aneurysm.
  • Another object of the present invention is to provide a stent which can block an aneurysm in a blood vessel with a branching side pathway nearby and not block blood flow in the side pathway.
  • Another object of the present invention is to provide a stent which includes a covering tip which extends at least partially in towards the center line of the stent when the stent is radially expanded, such that a central pathway through the stent is at least partially blocked by the covering tip.
  • Another object of the present invention is to provide a radially expandable stent which can be implanted within a body lumen, such as a blood vessel, which is faced by a neck of an aneurysm and with various branches of the lumen on either side of the aneurysm with the stent covering the neck of the aneurysm and leaving the lumen branches substantially unobstmcted adjacent the aneurysm.
  • a body lumen such as a blood vessel
  • Another object of the present invention is to provide a radially expandable stent which can have a tip thereof located within the aneurysm and which, when radially expanded at least partially opposes blood flow into the aneurysm.

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Abstract

L'invention concerne un stent expansible radialement pour le traitement d'anévrismes. Ce stent peut se présenter sous différentes formes, par exemple sous la forme d'un stent à extrémité arrondie (10) ou d'un stent à extrémité à facettes (110). Une extrémité (40) ou une extrémité à facettes (120) s'étendent au moins partiellement dans l'anévrisme (X, X') et subissent une expansion dans le sens radial pour s'opposer à l'écoulement de sang B à l'intérieur de l'anévrisme (X, X'). Cette extrémité (40, 120) peut être utilisée seule ou être supportée par une base cylindrique (20) qui subit une expansion radiale à l'intérieur d'une lumière (L) du corps, adjacente à l'anévrisme (X, X'), afin de maintenir en place l'extrémité (40, 120) de manière sûre. Cette extrémité (40) comporte des nervures (42) qui assurent un support structurel à un élément de recouvrement (50) empêchant l'écoulement de sang B de pénétrer dans l'anévrisme (X). L'extrémité à facettes (120) comprend des segments (122) entre lesquels se trouve une couche souple (130). Les facettes formées par les segments (122), séparés par la couche (130), s'étendent vers une ligne médiane (C) de l'extrémité à facettes (120).
PCT/US2001/041104 2000-06-23 2001-06-22 Stent expansible radialement pour le traitement d'anevrismes Ceased WO2002000139A1 (fr)

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AU2001279261A AU2001279261A1 (en) 2000-06-23 2001-06-22 Radially expandable aneurysm treatment stent

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US09/602,767 2000-06-23

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