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WO2002058751A2 - Greffe intraluminale enduite - Google Patents

Greffe intraluminale enduite Download PDF

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Publication number
WO2002058751A2
WO2002058751A2 PCT/US2001/002493 US0102493W WO02058751A2 WO 2002058751 A2 WO2002058751 A2 WO 2002058751A2 US 0102493 W US0102493 W US 0102493W WO 02058751 A2 WO02058751 A2 WO 02058751A2
Authority
WO
WIPO (PCT)
Prior art keywords
graft
expandable
shaped member
intraluminal graft
expandable intraluminal
Prior art date
Application number
PCT/US2001/002493
Other languages
English (en)
Inventor
Joseph G. Furst
Original Assignee
Icon Technologies, Llc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Icon Technologies, Llc filed Critical Icon Technologies, Llc
Priority to PCT/US2001/002493 priority Critical patent/WO2002058751A2/fr
Publication of WO2002058751A2 publication Critical patent/WO2002058751A2/fr

Links

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
    • A61F2/91—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 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • 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
    • A61F2/91—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 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—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 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • 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
    • A61L31/16—Biologically active materials, e.g. therapeutic substances
    • 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
    • A61F2/91—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 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—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 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/91533—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 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other characterised by the phase between adjacent bands
    • 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
    • A61F2/91—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 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—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 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/9155—Adjacent bands being connected to each other
    • A61F2002/91566—Adjacent bands being connected to each other connected trough to trough
    • 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
    • A61F2/91—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 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—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 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/9155—Adjacent bands being connected to each other
    • A61F2002/91575—Adjacent bands being connected to each other connected peak to trough
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/416—Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/42—Anti-thrombotic agents, anticoagulants, anti-platelet agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
    • A61L2300/606—Coatings

Definitions

  • This invention relates to an improved intraluminal graft for use within a body passageway, duct, blood vessel or other cavity and, more particularly, expandable traluminal grafts for use within a body passageway, duct, blood vessel or other cavity and, more particularly, expandable intraluminal grafts which are particularly useful for repairing blood vessels narrowed or occluded by disease and which graft is at least partially coated with a drug or compound that inhibits biological components capable of causing adverse clinical affects.
  • graft and “stent” are interchangeable.
  • Heart disease is still one of the most prevalent medical ailments in the world.
  • Intraluminal endo vascular grafting a type of angioplasty procedure, has been demonstrated by experimentation to present a possible alternative to conventional vascular surgery and is used to treat heart disease, mtraluminal endovascular grafting involves a tubular prosthetic graft and its delivery within the vascular system.
  • Advantages of this method over conventional vascular surgery include obviating the need for surgically exposing, incising, removing, replacing, or bypassing the defective blood vessel.
  • Over 20 million angioplasty or related procedures involving occluded vasculature have been performed worldwide.
  • a stent is an expandable metal tubular device that is mounted over an angioplasty balloon and deployed at the site of coronary narrowing. The balloon is inflated to expand the stent so as to physically open and return patency to the body passageway, duct or blood vessel.
  • the balloon is then deflated and the stent is permanently disposed to retain the passageway, duct or blood vessel open.
  • One particular type of stent is disclosed in United States Letters Patent No. 4,733,665. This stent overcame the problem associated with controlled expansion of the stent.
  • the expansion of a particular coiled spring-type stent was predetermined by the method of manufacturing, material and delivery system.
  • the amount of expansion was predetermined by the heat expansion properties of the particular alloy utilized in the manufacture of the intraluminal graft.
  • the expanded size of the graft cannot be increased. If the diameter of the desired narrow lumened body passageway had not been determined correctly, the graft might not expand enough to contact the interior surface of the body passageway, so as to be secured thereto.
  • the stent disclosed in the '665 patent overcame the problems associated with these past stent designs.
  • the stent based upon the '665 patent is currently being used in angioplasty procedures.
  • this stent has several shortcomings which contribute to procedural failure rates.
  • the currently used stents are not readily visible under fluoroscopic guidance procedurally. Stent placement is hindered as a result of poor visibility. These stents also shorten longitudinally after radial expansion, which is not desirable for their intended use.
  • in-stent restenosis wherein the passageway, which has been previously treated with a stent, renarrows or closes within the stented segment.
  • the renarrowing or closure of the passageway can be caused by a structural failure of the stent due to contractive forces by the passageway on the stent and/or by the passageway growing into the openings in the stent.
  • Other problems can include vascular narrowing and restenosis. Nascular narrowing is defined as a vascular segment that has not been previously treated by any interventional means and eventually closes preventing blood flow. Restenosis is the renarrowing of a previously treated vascular segment not involving a stent.
  • Both of these problems are the result of a passageway that was not treated with an invasive angioplasty, narrowing or closing. Both of the problems result from the insertion of a stent in one portion of the passageway causing vascular narrowing or restenosis in another part of the passageway.
  • PDGF platelet derived growth factors
  • the present invention pertains to an improved intraluminal graft that is designed to meet the present-day needs and demands relating to intraluminal grafts.
  • the present invention includes a geometrically shaped member, having first and second ends and a wall surface disposed between the first and second ends.
  • the wall surface is preferably formed by a plurality of intersecting elongated members, and at least some of the elongated members preferably intersect with one another at a point intermediate to the first and second ends of the tubular shaped member.
  • the tubular shaped member has a first diameter which permits intraluminal delivery of the tubular shaped member into a body passageway having a lumen and a second, expanded diameter. The expansion of the tubular shaped member can be accomplished in a variety of manners.
  • the tubular shaped member is expanded to its second diameter by a radially, outwardly extending force that is applied at least partially from the interior of the tubular shaped member.
  • the second diameter of the tubular shaped member is variable and dependent upon the amount of radially outward force applied to the tubular shaped member.
  • the tubular shaped member is expandable, to allow expansion of the lumen of the body passageway while retaining its, the tubular shaped member's, original length.
  • At least a portion of the graft is preferably coated with a substance which inhibits the occurrence of in-stent restenosis, vascular narrowing and/or restenosis.
  • the plurality of elongated members include a plurality of wires, and the wires may be fixedly secured to one another where the wires intersect with one another, hi one specific embodiment, the tubular member is at least partially made of a wire mesh tube.
  • the wire mesh tube may be utilized as the intraluminal graft.
  • the wire mesh tube can be radially expanded to a second diameter within the body passageway; the second, expanded diameter being variable and determined by the desired expanded internal diameter of the body passageway, duct, blood vessel, etc., whereby the expanded wire mesh tube will not migrate from the desired location within the body passageway, duct, blood vessel, etc., and the expansion of the intraluminal graft does not cause a rupture of the body passageway, duct, blood vessel, etc.
  • the plurality of elongated members includes a plurality of thin bars which are fixedly secured to one another where the bars intersect with one another.
  • Still yet another feature of the present invention is that the elongated members form at least one parallelogram which upon expansion, retains the original longitudinal length of the graft.
  • the graft includes at least one set of slots arranged with respect to one another to maintain the original longitudinal length of the graft when the graft is expanded.
  • the graft is at least partially formed by an etching process and/or by laser cutting.
  • the intraluminal graft member has a biologically inert coating on at least a portion of its wall surface.
  • the coating can be used to reduce infection, irritation and/or rejection of the intraluminal graft.
  • Still yet another feature of the present invention is that the intraluminal graft, upon expansion, substantially maintains its original longitudinal length.
  • the intraluminal graft includes at least two tubular members that are connected together by at least one connector that allows transverse bending and flexibility invariant to the plane of bending.
  • the connector is a "U" shaped connector.
  • the tubular shaped member is made of and/or includes a material that is more visible under fluoroscopy in vivo than currently available stents.
  • the tubular member preferably includes a special material such as gold to enhance the visibility of the tubular member in a body passageway, duct, blood vessel, etc.
  • the material to make the tubular member includes a second material that is visible under fluoroscopy.
  • the second material is secured to at least a portion of the outer surface of the base material of the tubular member such as by adhering, mounting, welding, brazing or the like, to enhance the visibility of the tubular member under fluoroscopy.
  • the second material is secured to the other surface of the base material at a location so as to substantially only come in contact with the inner luminal surface of the vessel, and not any blood borne components that could accelerate stent failure rates.
  • the second material is at least partially located at at least one end, and preferably both ends, of the tubular member.
  • the second material is at least partially located on the outer surface of the tubular member at the connecting flexible joints of the tubular member. This location of the second material also enhances the critical placement of the stent around areas of high tortuosity so as to reduce the failure rate.
  • tubular member is at least partially treated with Gamma or Beta radiation to reduce the vascular narrowing of the stented section.
  • the radioactive treatment helps to inactivate the cell migration and properties thereof within about a 3 mm depth of the arterial wall.
  • the intraluminal graft can be inserted and expanded by standard procedures. Therefore, the intraluminal graft can be inserted into a body passageway, duct, blood vessel, etc. until it is disposed at the desired location within the body passageway. The intraluminal graft is then expanded outwardly into contact with the body passageway until the lumen of the body passageway at the desired location, luminal narrowing, has been expanded, whereby the intraluminal graft prevents the body passageway from collapsing.
  • the graft is at least partially coated with a substance that inhibits and/or reduces restenosis, vascular narrowing and/or in-stent restenosis.
  • a substance is at least partially coated onto the graft to inhibit PDGF activity in the passageway.
  • the stent may induce some irritation in the passageway.
  • the biological factor, PDGF is turned on due to such irritation and activates the components of clotting. These components can cause clotting in the stent area or in adjacent areas. This clotting can cause the passageway to narrow or ultimately close.
  • the substance coated on the stent is formulated to deactivate and/or inhibit the activity of the PDGF, thereby reducing the occurrence of in-stent restenosis, vascular narrowing and/or restenosis.
  • the PDGF inhibitor is preferably triazolopyrimidime (Trapidil).
  • Trapidil triazolopyrimidime
  • a damaged endothelium exposes the connective tissue to platelet aggregation and to local release of PDGF.
  • Numerous animal models have shown that platelet adhesion to the vascular wall of this damaged endothelium soon triggers the proliferation and migration of smooth muscle cells. If platelets are a source of PDGF, it has now been demonstrated that endothelial cells, macrophages and smooth muscle cells are also a source of
  • PDGF following vascular trauma.
  • the influence of Trapidil on platelet aggregation is linked to inhibition of the synthesis of thromboxane A2 and the partial blocking of thromboxane A2 receptors. Trapidil is able to normalize an incorrect balance between thromboxane A2 and prostacycline.
  • Thromboxane A2 is a powerful inducer of platelet aggregation. It is also responsible for the contraction of smooth muscles of vessels and stimulates the proliferation of the arterial intimal cells. Prostacyclin inhibits platelet aggregation and vasodilator properties. Trapidil also has antithrombotic properties.
  • Trapidil has other desirable properties such as vasodilation, a decrease in angina and an increase in HDL levels in patients with ischemic heart disease. Trapidil, at present, represents the most fully documented agent demonstrating a pharmacological and clinical effect in inhibition of restenosis.
  • Prior substances have been coated onto stents to address one or more problems associated with the use of stents. These substances include heparin, colchicine and dexamethazone, among others. These substances are used to inactivate platelets, stop cell division and prevent cell adhesion.
  • Heparin is not potent enough to extend a clinical affect.
  • Colchicine has been shown to kill the cells in the surrounding area and actually propagate the problem.
  • dexamethazone has not provided the desired restenosis prevention.
  • aspirin, colchicine, dexamethazone dipyridamocs, heparin and/or derivatives thereof can be substituted for, or used in combination, with Trapidil on the stent.
  • Trapidil has a affinity to exert clinical effects starting in the second hour of treatment. This inhibition of platelet aggregation is reflected in a significant increases in collagen and ADP. The platelet inhibition in the first day of treatment with Trapidil continues through the thirtieth day.
  • Still yet another feature of this invention corresponds to the local delivery of the substance to inhibit and/or prevent restenosis, vascular narrowing and/or in-stent restenosis, such as Trapidil, through an angioplasty balloon with the physical capability to transfer solute of the substance through the balloon membrane to the affected sight.
  • This delivery can be in the form of a stream, a slow oozing delivery or a bolus injection.
  • the delivery can be made through magnetic, electrical or physical means.
  • the delivery is accomplished through a separate lumen capable of channeling the solute of the substance to the affected area.
  • This delivery through a balloon also delivers the substance to the sight of restenosis, vascular narrowing and or in-stent restenosis.
  • Still yet another feature of the present invention is that the substance to inhibit and/or reduce restenosis, vascular narrowing and/or in-stent restenosis may be partially coated on specific regions of the stent or may be totally coated on the stent.
  • the thickness of the coating is not as important as the concentration of the substance needed to acquire the desired affect.
  • Still another feature of the present invention is the substance to inhibit and/or reduce restenosis, vascular narrowing and/or in-stent restenosis is coated onto the stent by the use of an intermediate compound.
  • the compound is a synthetic or biocapatable material that does not adversely affect the substance or cause problems or adverse reactions in the passageway.
  • the present invention includes a radially expandable, tubular shaped prosthesis having first and second ends and a wall surface disposed between the first and second ends, the wall surface being formed by a plurality of intersecting elongated members and is at least partially coated with a substance that reduces stent failure and/or narrowing or closure of a non-treated portion of the passageway.
  • FIGURE 1 is a perspective view of an intraluminal graft which permits delivery of the graft, or prosthesis, into a body passageway;
  • FIGURE 2 is an enlarged perspective view of the graft of FIGURE 1 in a non-tubular state
  • FIGURE 3 is a sectional view of the graft of FIGURE 2 showing a connector used to connect the ends of two tubular sections of the graft;
  • FIGURE 4 is an enlarged sectional view of the graft of FIGURE 2 showing the parallelogram structure of the graft before and after expansion;
  • FIGURE 5 is a perspective view of an additional embodiment of the present invention
  • FIGURE 6 is an enlarged sectional view of the graft of FIGURE 5 showing a connection used to connect the ends of two sections of the graft together;
  • FIGURE 7 is a sectional view of the graft of FIGURE 5 showing the location and angular orientation of the opening in the graft;
  • FIGURE 8 is an enlarged sectional view of the graft of FIGURE 5 showing a part of the structure of the graft before and after expansion;
  • FIGURE 9 is a perspective view of an mfraluminal graft of FIGURE 1 showing a coating of a substance on the graft;
  • FIGURE 10 is a perspective view of an angioplasty balloon delivering fluid materials to a local site.
  • FIGURES 1-9 disclose an intraluminal graft, such as an expandable prosthesis, for a body passageway.
  • intraluminal graft such as an expandable prosthesis
  • the terms “expandable mfraluminal graft”, “expandable prosthesis” and “stent” are interchangeably used to some extent in describing the present invention.
  • the apparatus and structures of the present invention may be utilized not only in connection with an expandable intraluminal graft for expanding partially occluded segments of a blood vessel, or body passageway, but also for additional uses.
  • the expandable prostheses may be used for such purposes as 1) a supportive graft placement within a blocked vasculature opened by transluminal recanalization, which are likely to collapse in the absence of an internal support; 2) forming a catheter passage through mediastinal and/or other veins occluded by inoperable cancers; 3) reinforcement of catheter created intrahepatic communications between portal and/or hepatic veins in patients suffering from portal hypertension; 4) supportive graft placement of narrowing of the esophagus, the intestine, the ureter and/or the urethra; 5) and supportive graft reinforcement of reopened and previously obstructed bile ducts.
  • body passageway encompasses any duct within the human body, such as those previously described, as well as any vein, artery, and/or blood vessel within the human vascular system.
  • the expandable intraluminal graft as shown in the FIGURES 1, 2, 3 and 4 generally comprises a tubular shaped member 20 having a first end 30 and a second end 40 and a wall surface 50 disposed between the first and second ends.
  • the wall surface is formed by a plurality of intersecting elongated members 60 with at least some of the elongated members intersecting with one another intermediate the first and second ends of the tubular shaped member.
  • the tubular shaped member has a first diameter which permits intraluminal delivery of the tubular shaped member into a body passageway having a lumen.
  • FIGURE 1 shows a perspective view of a section of the tubular shaped member 20 which has a second, expanded diameter, which second diameter is variable in size.
  • Elongated members 60 which form the wall surface of the tubular shaped member may be any suitable material which is compatible with the human body and the bodily fluids with which the graft, or prosthesis, may come into contact.
  • the elongated members are made of a material, include and/or are coated with a material that is readily visible in vivo under fluoroscopic view.
  • the elongated members also are made of a material which has the requisite strength and elasticity characteristics to permit the tubular shaped member to be expanded from its original tubular form to its expanded tubular form, and to further to permit the tubular shaped member to retain its expanded configuration with the enlarged diameter.
  • Suitable materials for the fabrication of the tubular shaped structure of include tantalum, stainless steel, titanium or any suitable plastic material having the requisite characteristics previously described.
  • the tubular shaped structure is made of stainless steel.
  • Elongated members 60 are generally small diameter wires or bars that have a maximum cross-sectional length or diameter of up to about 0.02 inches, and preferably about 0.0005 to 0.008 inches. It should, of course, be understood that each elongated member can have a variety of different cross-sectional configurations, along part or the complete length of each member.
  • Such configurations include circular, oval, diamond, triangular, square, rectangular, hexagonal, etc.
  • a plurality of elongated members can be connected together to form the tubular member.
  • the elongated members are connected together by a connector.
  • One such connector is a "U" shaped member 70 where the elongated members 60 join with one another as shown in FIGURES 1-3.
  • the elongated members can be formed by a variety of processes. Preferably, the elongated members are formed by etching a single tubular piece of material so that each individual intersections of the elongated members need not be welded.
  • a tubular shaped member is initially formed from a thin-walled metal tube, and the openings between the intersecting bars are formed by a conventional etching process, such as electromechanical or laser etching, whereby the resultant structure is a tubular shaped member having a plurality of intersecting elongated members as shown in FIGURES 1 and 2. This technique enhances the structural integrity of the tubular structure and reduces the number of rough surfaces at the intersection points.
  • FIGURES 1 and 2 One particular design of the pattern of the tubular member is shown in FIGURES 1 and 2.
  • the openings between the intersecting bars are preferably generally parallelogram in shape.
  • the openings are positioned to form a pattern as shown in the FIGURE 4.
  • this parallelogram pattern allows the tubular shaped members to be expanded without the members having a reduction in length in the longitudinal direction. Since a parallelogram is a four sided figure with opposite sides parallel, the longitudinal axis of structure of member 60 will remain the same as the sides are elongated and as the angle of the parallelogram changes during expansion.
  • the surface of the tubular member is formed by a plurality of parallelograms.
  • the arrangement for connecting two tubular members 60 together is by at least one "TJ" shaped member 70 to increase the flexibility of the graft.
  • the connector is shown to be a "U" shaped member 70 that connects two ends of the tubular members 60 together.
  • a plurality of "U” shaped members 70 are used to connect a set of two adjacently positioned ends of one tubular member to a corresponding set of adjacently positioned ends in the other tubular member. This configuration allows at least two tubular members that are connected together by at least one set of circularly distributed "U" shaped connector to transverse bend and improve flexibility invariant to the plane of bending.
  • the size of the "U" shaped connector is a function of the size and spacing of the elongated members.
  • the length of the "U” shaped member is preferably about the sum of twice the thickness of the wire or bars of the elongated members plus the height of the parallelogram in the non-expanded shape (2a + b).
  • the spacing of a non- connected end of an elongated member from the "U" shaped member when the tubular shaped member 20 is in a non-expanded position is about equal to the thickness of the elongated member. The spacing and configuration enables the desired flexibility of the tubular member and proper expansion of the tubular member.
  • a graft 100 includes two sections 110, 112. However, graft 100 may include more than two sections.
  • the two sections 110, 112 are connected together by a connector 120.
  • connector 120 is arcuate in shape and more preferably is "U" shaped.
  • sections 110, 112 are substantially symmetrical to one another and preferably have substantially identical dimensions.
  • Each section includes a plurality of slots 130, 132. Slots 130, 132 are preferably equal in length and width.
  • Each series of slots 130 are arranged substantially parallel to one another.
  • Each series of slots 132 are also arranged substantially parallel to one another.
  • Slots 130 and 132 are positioned relative to one another to form an angle between 0-90° when the graft is in the unexpanded position as shown in FIGURE 5.
  • the slot arrangement between ends 140 and 142 of graft 100 allow the graft, when expanded radially, to retain its original pre-expanded length.
  • the configuration of the slots 130, 132 in the pre-expanded and post-expanded position is shown in FIGURE 8.
  • the slots can be formed in a variety of manners. Preferably, the slots are formed by laser cutting.
  • the formation of slots 130, 132 by use of a laser is shown in FIGURE 7.
  • the configuration of connectors 120 is shown in FIGURE 6.
  • connectors 120 are secured to an extension bar 150 and to end 140 of the second section 112 or to end 142 of the first section 110.
  • Extension bar 150 alternates connection between end 142 of the first section 110 and end 140 of the second section 112.
  • a tubular member 200 is shown to include a compound 210 on the elongated members 220 and connector 230 of the tubular member.
  • Compound 210 is a substance that inhibits and/or prevents restnosis, vascular narrowing and/or in-stent restenosis.
  • One preferable compound is a PDGF inhibitor such as Trapidil.
  • the amount of PDGF inhibitor delivered to a certain region of a passageway can be controlled by varying the coating thickness, drug concentration of the PDGF inhibitor and/or the amount of surface area of the tubular member 200 is coated with the PDGF inhibitor.
  • the PDGF inhibitor can be combined with or at least partially coated with a substance that affects the rate to which the PDGF inhibitor is released from the surface of the stent.
  • a bonding compound can be used on conjunction with compound 210 to assist in binding compound 210 to tubular member 200.
  • the bonding compound can be used to control the release of compound 210 into the body passageways.
  • the bonding compound is biodegradable and dissolves over the course of time.
  • the bonding agent is coated at one or more thicknesses over compound 210 to delay delivery of compound 210 into a body passageway.
  • compound 210 is delivered into a body passageway A via balloon 250.
  • Balloon 250 includes one or more slots 260 to allow delivery of compound 210 into body passageway A.
  • Balloon 250 can be used to both deliver compound 210 and expand tubular member 200, or be used in conjunction with another balloon or tubular member expanding device. Due to the properties of the PDGF inhibitor, local delivery of the inhibitor by a stent is highly advantageous.

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  • Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Vascular Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Cardiology (AREA)
  • Physics & Mathematics (AREA)
  • Optics & Photonics (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Surgery (AREA)
  • Molecular Biology (AREA)
  • Chemical & Material Sciences (AREA)
  • Prostheses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

La présente invention concerne une greffe intraluminale expansible destinée à être utilisée dans une cavité corporelle présentant un élément tubulaire avec deux extrémités et une surface de paroi disposée entre les extrémités. L'élément tubulaire possède un premier diamètre permettant la libération intraluminale de l'élément dans une cavité corporelle, et un second diamètre expansé. La surface de l'élément tubulaire est enduite d'une substance empêchant et/ou diminuant la resténose, le rétrécissement vasculaire et/ou la resténose intra-stent.
PCT/US2001/002493 2001-01-25 2001-01-25 Greffe intraluminale enduite WO2002058751A2 (fr)

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Application Number Priority Date Filing Date Title
PCT/US2001/002493 WO2002058751A2 (fr) 2001-01-25 2001-01-25 Greffe intraluminale enduite

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Application Number Priority Date Filing Date Title
PCT/US2001/002493 WO2002058751A2 (fr) 2001-01-25 2001-01-25 Greffe intraluminale enduite

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3338820A1 (fr) * 2016-12-21 2018-06-27 Danmarks Tekniske Universitet Préparation in situ d'endoprothèses à élution médicamenteuse avec hydrogels photo réticulés biocompatibles

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3338820A1 (fr) * 2016-12-21 2018-06-27 Danmarks Tekniske Universitet Préparation in situ d'endoprothèses à élution médicamenteuse avec hydrogels photo réticulés biocompatibles

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