WO2005032424A1 - Stent a marqueurs de points se chevauchant - Google Patents

Stent a marqueurs de points se chevauchant Download PDF

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Publication number
WO2005032424A1
WO2005032424A1 PCT/US2003/027558 US0327558W WO2005032424A1 WO 2005032424 A1 WO2005032424 A1 WO 2005032424A1 US 0327558 W US0327558 W US 0327558W WO 2005032424 A1 WO2005032424 A1 WO 2005032424A1
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WO
WIPO (PCT)
Prior art keywords
end region
stent body
stent
medical device
marker
Prior art date
Application number
PCT/US2003/027558
Other languages
English (en)
Inventor
Peter M. Nicholas
Original Assignee
Boston Scientific Limited
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 Boston Scientific Limited filed Critical Boston Scientific Limited
Priority to CA002532028A priority Critical patent/CA2532028A1/fr
Priority to EP03818828A priority patent/EP1659984A1/fr
Priority to AU2003263072A priority patent/AU2003263072A1/en
Priority to PCT/US2003/027558 priority patent/WO2005032424A1/fr
Publication of WO2005032424A1 publication Critical patent/WO2005032424A1/fr

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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
    • 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
    • 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
    • A61F2002/821—Ostial stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2002/826—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents more than one stent being applied sequentially
    • 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
    • A61F2002/91525—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 within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
    • 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
    • A61F2002/91591—Locking connectors, e.g. using male-female connections
    • 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
    • A61F2250/0096—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

Definitions

  • Stents are radially expandable endoprostheses which are typically intravascular implants capable of being implanted transluminally and enlarged radially after being introduced percutaneously.
  • Stents may be implanted in a variety of body lumens or vessels such as within the vascular system, urinary tracts, bile ducts, etc. Stents may be used to reinforce body vessels and to prevent restenosis following angioplasty in the vascular system.
  • Balloon expandable stents are typically disposed about a balloon which must be positioned and inflated to expand the stent radially outward. Self-expanding stents expand into place when unconstrained, without requiring assistance f om a balloon. Some stents may be characterized as hybrid stents which have some characteristics of both self-expandable and balloon expandable stents.
  • a stent or other endoluminal prosthesis is implanted in a vessel at the site of a stenosis or aneurysm by so-called “minimally invasive techniques" in which the stent is compressed radially inwards and is delivered by a catheter to the site where it is required.
  • minimally invasive techniques in which the stent is compressed radially inwards and is delivered by a catheter to the site where it is required.
  • the stent is caused or allowed to expand to a predetermined diameter in the vessel and the catheter is withdrawn.
  • stents have been generally tubular but have been composed of many configurations and have been made of many materials, including metals and plastic. Ordinary metals such as stainless steel have been used as have shape memory metals such as Nitinol and the like.
  • Stents have also been made of bio-absorbable plastic materials. Stents have been formed from wire, tube stock, etc. Stents have also been made from sheets of material which are rolled. h order to better provide for the precise placement of the stent within a body location some stents include radiopaque materials which may be detected through the use of fluoroscopy. In this manner the position of the stent within a body vessel may be identified. Radiopaque materials are well known and have been incorporated into stents in several ways. For example, in U.S. 6,402,777 rivets made of radiopaque material are positioned in stent openings; in U.S.
  • a stent is said to include a radiopaque material affixed to undeformed components at the distal or proximal end of the stent; and in U.S. 5,954,743 at least partially plating a stent with radiopaque material is described.
  • Stents are known to have a variety of shapes sizes and structural features. For example, stents may have a variety of lengths, diameters, cell configurations, end effects, etc. Stents may be branched or segmented for use in a vessel bifurcation. Such stents may also include one or more ports or crowns where additional stent bodies may be engaged.
  • stents having at least some of the structural features mentioned above are described in the following references: U.S. Pat. App. 10/084,766; U.S. Pat. App.10/083,707; U.S. Pat. App. 10/083,711.
  • U.S. Pat. App. 10/084,766 U.S. Pat. App.10/083,707
  • U.S. Pat. App. 10/083,711 In some cases it is necessary or desirable to place multiple stents, so that the stents are arranged in an end to end manner within a vessel or other body space.
  • Recent studies have shown that in some cases, such as in some applications of drug coated stents, prevention of restenosis maybe improved when the ends of adjacent stents are made to overlap one another according to a predetermined alignment.
  • some embodiments of the invention are directed to methods and systems for treating a stenosis by implanting at least two stents or stent bodies into a vessel, wherein the stent bodies are placed in an overlapping relationship.
  • the respective stent ends are provided with one or more alignment markers that allow the stent end to be overlappingly aligned in a very precise manner.
  • the markers may have a greater or lesser degree of radiopacity than the surrounding end regions.
  • the markers and/or other portions of the stent bodies may be MRI compatible.
  • the manner and degree, or length, of stent overlap may be varied.
  • the overlapping stent bodies are configured such that when they are overlapped, at least a portion of one stent is positioned radially within the lumen defined by another stent.
  • the overlapping stent bodies are configured such that when they are overlapped, the stent bodies are longitudinally adjacent to one another.
  • the diameter of each stent body is substantially the same.
  • the invention is directed to a bifurcated stent that defines a side opening, crown or branch.
  • the branch may be configured to overlap, or be overlapped by a secondary stent body.
  • at least a portion of at least one of the stents is drug coated.
  • the end of at least one stent is coated.
  • one or more ends of adjacent stents are selectively coated.
  • the overlapping ends of the stents maybe provided with amounts or concentrations of coating such that overlapping ends of the stent bodies provide a coated interface with the surrounding vessel that is substantially the same as the non-overlapped coated portions of the stent bodies, hi at least one embodiment the ends of the stent bodies maybe selectively coated to have different proportions of the drug coating relative to the proportion of coating on the remaining portions of the respective stent bodies, h at least one embodiment the proportionally amount of drug coating on the overlapped portion of the stents may be greater than or less than the amount of drug coating elsewhere on the stent bodies. In at least one embodiment at least a portion of the adjacent ends of the stent bodies are engaged to one another.
  • overlap of the ends of the stents is by frictional, mechanical, electromagnetic, chemical, or other engagement, hi at least one embodiment the at least one stent end is uniquely keyed to the end of an adjacent stent.
  • FIG. 1 is a side view of an embodiment of the invention.
  • FIG. 2 is a side view of the embodiment shown in FIG. 1 wherein the individual stent bodies are shown separated.
  • FIG. 3 is a cross-sectional view of an embodiment of the invention.
  • FIG. 4 is a cross-sectional view of an embodiment of the invention.
  • FIG. 5 is a close-up partial side view of an embodiment of the invention illustrating an example alignment of markers.
  • FIG. 6 is a close-up partial side view of an embodiment of the invention illustrating an example alignment of markers.
  • FIG. 7 is a close-up side view of an embodiment of the invention wherein the ends of the assembly are engaged to one another.
  • FIG. 8 is a close-up side view of an embodiment of the invention wherein the ends of the assembly are engaged to one another.
  • FIG. 9 is a side view of an embodiment of the invention.
  • FIG. 10 is a close-up side view of an embodiment of the invention wherein the assembly includes a coating.
  • FIG. 11 is a close-up side view of an embodiment of the invention wherein the assembly is includes a coating.
  • FIG. 1 An example of one such embodiment is shown in FIG. 1 wherein a stent assembly, indicated generally at 10, is shown.
  • stent assembly 10 may be comprised of two or more stents or stent bodies 12 and 14 such as is shown in FIG. 2.
  • Stent bodies maybe any sort of implantable prosthesis such as stents, grafts, stent-grafts, vena cava filters, etc.
  • Stent bodies 12 and 14 maybe balloon expandable stents, self- expandable, or hybrid expandable.
  • Stent bodies 12 and 14 may be single layer or multilayer devices. The bodies may have the same or different construction and expansion characteristics, h some embodiments, one or more of the stent bodies 12 and 14 may be at least partially constructed from a shape memory metal such as nitinol (Ni-Ti), or a shape-memory polymer.
  • stent bodies 12 and 14 are positioned together such that at least a portion of their respective end regions 16 and 18 at least partially overlap one another.
  • the manner and degree of end overlap may be varied.
  • the end regions 16 and 18 of each stent body 12 and 14 have a similar and complimentary configuration which allows at least a portion of the end regions 16 and 18 to interpenetrate one another.
  • the assembly 10 will be provided with substantially the same outer diameter through out its longitudinal length.
  • the overlap of end regions 16 and 18 need not always be longitudinally and/or radially aligned.
  • the stent bodies 16 and 18 may be aligned and overlapped to successfully form assembly 10 even though the stent bodies 16 and 18 have different longitudinal axes, represented as reference numerals 15a and 15b respectively, such as is shown in FIG. 3.
  • end region 18 of stent body 14 may be positioned radially within end region 16 of stent body 12.
  • the stent bodies 12 and 14 may have substantially the same longitudinal axis 15, but in the portion of the assembly 10 defined by the overlapping end regions 16 an 18 the diameter of stent 12 is less than the diameter of stent 16.
  • other configurations may be possible.
  • the stents, or portions thereof may include marker portions 28 that allow the end regions 16 and 18 to be visually or otherwise aligned, such as is shown in the various figures.
  • Markers 28 are preferably constructed from materials that are visually distinct or otherwise detectable.
  • the markers are at least partially constructed from one or more radiopaque materials such as radiopaque metals and/or radiopaque polymers.
  • markers 28 may be MRI compatible and detectable thereby, X-ray detectable, radio luminescent, may be visually distinct to the naked eye, etc.
  • the markers 28 are constructed of radiopaque material to make the markers 28 more visible during fluoroscopy or similar procedures, however in some embodiments, particularly those wherein the end regions 16 and 18 or other portions of the stents 12 and 14 are themselves radiopaque, the markers 28 maybe selected to be more or less radiopaque than the surrounding portions of the stents.
  • radiopaque markers 28 on the end regions 16 and 18 of the stent bodies 12 and 14 allows the operator or surgeon to position the second stent 14 in relation to the deployed first stent 12 in a precise overlapping alignment configuration, such as any of those described above.
  • the markers located in their respective end regions 16 and 18 maybe placed in overlapping alignment or some other recognizable configuration or pattern to ensure proper alignment of the stent bodies 12 and 14. In this manner the markers 28 act as guides to ensure that the proper overlapping arrangement of the end regions 16 and 18 has been achieved.
  • the extent end regions 16 and 18 are overlapped may depend on a variety of circumstances.
  • the length of overlap between the stent end regions 16 and 18 is between about 0.25 mm to about 10 mm, however when the assembly is placed in a peripheral vessel, the overlap may be as great as 20 mm.
  • the particular material, shape, arrangement, placement, etc. of markers 28 on the end regions 16 and 18 maybe any desired.
  • the markers 28 may be at least a portion of one or more individual stent members or be positioned extraneously thereon.
  • the markers may comprise a radiopaque material that is more or less radiopaque than that of the surrounding stent body or bodies 12 and 14.
  • the markers 28 may be an inherent portion of the end regions 16 and 18.
  • the end regions 16 and 18 or portions thereof may be selectively or entirely coated, plated, or otherwise provided with one or more markers 28, such as for example by providing and end region with one or more radiopaque rivets, welds, wires or other structures.
  • the markers 28 in the completed assembly 10 may be adjacent to one another in a substantially radial, circumferential, longitudinal or other manner.
  • the markers 28 may be positioned such that markers are spaced apart from one another according to a desired pattern, an example of which being illustrated in FIG. 5. In another embodiment shown in FIG.
  • the markers 28 are intermittently arranged in a pattern about the circumference of the stents 12 and 14, such that when viewed during fluoroscopy the markers 28 appear to form one or more lines, or other patterns.
  • Other configurations and arrangements are possible and are within the scope of this invention.
  • the formation of assembly 10 is accomplished by deploying the first stent body 12 into the vessel and then subsequently deploying the second stent body 14 in proximity to the first stent body 12 so that the end regions 16 and 18 overlap in the manner desired.
  • the alignment of the stents 12 and 14 within the vessel and any frictional engagement that may occur between contacting end regions 16 and 18 may be the primary forces acting to hold the stents together in precise alignment.
  • some embodiments of the invention employ various engagement mechanisms and devices to engage end regions 16 and 18 together.
  • the end regions 16 and 18 may be provided with engagement surfaces 22 that provide improved frictional, mechanical, chemical, and/or even electromagnetic interface between the end regions 16 and 18 or portions thereof.
  • An example of one form of engagement surface(s) 22, is illustrated in the embodiment shown in FIG. 8, wherein opposing end regions 16 and 18 are respectively provided with one or more protrusions 24 and receiving surfaces 26.
  • the interface of protrusions 24 and receiving surfaces 26 may provide increased frictional engagement between the regions 16 and 18.
  • the protrusions 24 and/or receiving surfaces 26 may be constructed of a shape memory material allowing the protrusions 24 and/or surfaces 26 to transform to a preset shape upon exposure to an environmental trigger such as a predetermined temperature, electric current, pH, etc. In this manner the protrusions 24 and/or receiving surfaces 26 may by made to actively and mechanically engage one another for improved securement of the overlapping regions 16 and 18.
  • the engagement surfaces 22 may include a coating which adhesively or otherwise aids in chemical engaging the overlapping surfaces together.
  • at least a portion of the end regions 16 and 18, such as engagement surfaces 22, are provided with opposing magnetic polarity to electro-magnetically engage the overlapping surfaces together.
  • the stent bodies 12 and 14 or portions thereof are bioabsorbable to allow the individual stent bodies 12 and 14 to be removed from the body or absorbed thereby at a point in time subsequent to placement of the assembly 10.
  • some embodiments of the invention are directed to bifurcated stent assemblies, an example of which is shown in FIG. 9.
  • a bifurcated assembly indicated generally at 10, comprises a first stent body 12 and a second stent body 14.
  • First stent body 12 defines a side opening 30.
  • the side opening 30 may be further defined by a crown or branch 32 of stent material.
  • the side opening 30, and/or crown 32 is at least partially defined by one or more markers 28.
  • the second stent body 14 includes an end region 18 which comprises one or more markers 28 as well.
  • the other body 12 or 14 is positioned adjacent thereto so that at least a portion of the end region 18 of the second stent body 14 and the opening 30 and/or crown 32 of the first stent body 12 are overlapped.
  • the particular configuration of overlap between stent bodies 12 and 14 may include any configuration such as those described above.
  • crown 32 defines a longitudinal axis 15c which the longitudinal axis 15b of the second stent body may or may not be aligned with such as in the manners previously described in FIGs. 3 and 4.
  • the overlap of the bodies 12 and 14 forming the completed bifurcated assembly 10 of FIG. 9 may include a physical overlap and/or engagement of the bodies 12 and 14 such as is shown in FIGs. 7 and 8.
  • the assembly 10 is at least partially coated with a drug or other substance, the extent that the stent bodies 12 and 14 are coated with a drug or other coating may also affect the manner and degree of the stent overlap.
  • the extent or length of the overlap of the end regions 16 and 18 may be of particular importance.
  • Drugs and coatings thereof are well known. The application of such a coating to a stent allows the stent to deliver the drug directly to a desired location within the vessel. However, in many applications it may be of importance to ensure that the concentration, amount, or exposure of the drug along a given length of the stent is substantially consistent.
  • the assembly 10 employs a coating 21 of drug that extends across the overlapping end regions 16 and 18.
  • the end regions 16 and 18 are selectively coated to an extent less than adjacent regions of the respective stent bodies 12 and 14, such that when regions 16 and 18 are overlapped to form assembly 10 the exposure of the coating is substantially equal along the entire coated length of the assembly 10. It should be noted, that where a consistent concentration or exposure of a coating is desired, the end regions 16 and 18 need not be selectively coated to an equal proportion. For example, in the embodiment shown in FIG. 11, end region 16 is fully coated (one hundred percent), whereas end region 18 is not at all coated (zero percent). However, the extent of exposure of coating 21 remains substantially constant along the length of the completed assembly 10.
  • end regions 16 and 18 may be provided with other proportions of coating, hi one example for instance, end region 16 may be provided with a 75 percent coating, whereas end region 18 has only 25 percent. hi other embodiments, it may be desired to provide a greater or lesser concentration or exposure of coating 21. In such embodiments, the end regions 16 and 18 may be selectively coated so that when they are overlapped to form assembly 10 the concentration of coating at the overlapped regions 16 and 18 is different than that of the concentration elsewhere along the length of the assembly 10.
  • drug coating 21 may be comprised of any or all of a variety of drugs, genetic material, non-genetic therapeutic agents, cells and/or cellular material, polymer coatings, viruses, retro-viruses, and/or other substances.
  • coating 21 is at least partially radiopaque.
  • materials suitable for use as a coating include but are not limited to: anti-thrombogenic agents such as heparin, heparin derivatives, urokinase, PPack (dextrophenylalanine proline arginine chloromethylketone), etc.; anti-proliferative agents such as enoxaprin, angiopeptin, or monoclonal antibodies capable of blocking smooth muscle cell proliferation, hirudin, acetylsalicylic acid, etc.; anti-inflammatory agents such as dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, mesalamine, etc.; antineoplastic/antiproliferative/anti-miotic agents such as paclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine, epothilones, endostatin
  • polycarboxyhc acids including cellulose acetate and cellulose nitrate
  • gelatin polyvinylpyrrolidone; cross-linked polyvinylpyrrolidone
  • polyanhydrides including maleic anhydride polymers
  • polyamides polyvinyl alcohols; copolymers of vinyl monomers such as EVA
  • polyvinyl ethers polyvinyl aromatics
  • polyethylene oxides glycosaminoglycans
  • polysaccharides polyesters including polyethylene terephthalate; polyacrylamides; polyethers; polyether sulfone; polycarbonate; polyalkylenes including polypropylene, polyethylene and high molecular weight polyethylene; halogenated polyalkylenes including polytetrafluoroethylene; polyurethanes; polyorthoesters; proteins; polypeptides; silicones; siloxane polymers
  • any dependent claim which follows should be taken as alternatively written in a multiple dependent form from all prior claims which possess all antecedents referenced in such dependent claim if such multiple dependent format is an accepted format within the jurisdiction (e.g. each claim depending directly from claim 1 should be alternatively taken as depending from all previous claims), jurisdictions where multiple dependent claim formats are restricted, the following dependent claims should each be also taken as alternatively written in each singly dependent claim format which creates a dependency from a prior antecedent-possessing claim other than the specific claim listed in such dependent claim below.

Abstract

L'invention concerne un dispositif médical et un procédé de fabrication associé qui comprennent un premier corps de stent (12) et un second corps de stent (16), ledit dispositif médical étant formé lorsque la première partie du marqueur (28) et la seconde partie du marqueur (28) des corps du stent sont positionnées dans un alignement prédéterminé. Le premier corps du stent et le second corps du stent sont alignés sur pratiquement le même axe longitudinal et au moins une partie de la première zone d'extrémité et au moins une partie de la seconde zone d'extrémité des corps de stent respectifs sont disposées de façon à se chevaucher pour fournir au dispositif médical une longueur longitudinale inférieure à celle de la somme de la longueur du premier corps du stent et de la longueur du second corps du stent.
PCT/US2003/027558 2003-09-03 2003-09-03 Stent a marqueurs de points se chevauchant WO2005032424A1 (fr)

Priority Applications (4)

Application Number Priority Date Filing Date Title
CA002532028A CA2532028A1 (fr) 2003-09-03 2003-09-03 Stent a marqueurs de points se chevauchant
EP03818828A EP1659984A1 (fr) 2003-09-03 2003-09-03 Stent a marqueurs de points se chevauchant
AU2003263072A AU2003263072A1 (en) 2003-09-03 2003-09-03 Stent with overlapped point markers
PCT/US2003/027558 WO2005032424A1 (fr) 2003-09-03 2003-09-03 Stent a marqueurs de points se chevauchant

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2003/027558 WO2005032424A1 (fr) 2003-09-03 2003-09-03 Stent a marqueurs de points se chevauchant

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AU (1) AU2003263072A1 (fr)
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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007059483A3 (fr) * 2005-11-14 2007-07-26 Ev3 Inc Stent et systeme d'administration de stent destines a des sites ostiaux situes dans un conduit
WO2009009311A2 (fr) * 2007-07-06 2009-01-15 Boston Scientific Limited Endoprothèse vasculaire à deux branches avec organes bioabsorbables
US7731981B2 (en) 2002-11-15 2010-06-08 Warsaw Orthopedic, Inc. Collagen-based materials and methods for treating synovial joints
US8206428B2 (en) * 2005-09-02 2012-06-26 Medtronic Vascular, Inc. Tabbed stent with minimum compressed profile
WO2020233523A1 (fr) * 2019-05-17 2020-11-26 先健科技(深圳)有限公司 Instrument implantable et son procédé de préparation
WO2023114711A3 (fr) * 2021-12-13 2023-07-27 Occam Labs LLC Systèmes, dispositifs et procédés faisant intervenir des éléments de structure d'endoprothèse

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Publication number Priority date Publication date Assignee Title
US6203568B1 (en) * 1996-04-05 2001-03-20 Medtronic, Inc. Endoluminal prostheses having position indicating markers

Patent Citations (1)

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Publication number Priority date Publication date Assignee Title
US6203568B1 (en) * 1996-04-05 2001-03-20 Medtronic, Inc. Endoluminal prostheses having position indicating markers

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7731981B2 (en) 2002-11-15 2010-06-08 Warsaw Orthopedic, Inc. Collagen-based materials and methods for treating synovial joints
US8206428B2 (en) * 2005-09-02 2012-06-26 Medtronic Vascular, Inc. Tabbed stent with minimum compressed profile
WO2007059483A3 (fr) * 2005-11-14 2007-07-26 Ev3 Inc Stent et systeme d'administration de stent destines a des sites ostiaux situes dans un conduit
US7632302B2 (en) 2005-11-14 2009-12-15 Ev3 Inc. Stent and stent delivery system for ostial locations in a conduit
WO2009009311A2 (fr) * 2007-07-06 2009-01-15 Boston Scientific Limited Endoprothèse vasculaire à deux branches avec organes bioabsorbables
WO2009009311A3 (fr) * 2007-07-06 2009-03-05 Boston Scient Scimed Inc Endoprothèse vasculaire à deux branches avec organes bioabsorbables
US7632305B2 (en) 2007-07-06 2009-12-15 Boston Scientific Scimed, Inc. Biodegradable connectors
WO2020233523A1 (fr) * 2019-05-17 2020-11-26 先健科技(深圳)有限公司 Instrument implantable et son procédé de préparation
WO2023114711A3 (fr) * 2021-12-13 2023-07-27 Occam Labs LLC Systèmes, dispositifs et procédés faisant intervenir des éléments de structure d'endoprothèse

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EP1659984A1 (fr) 2006-05-31
CA2532028A1 (fr) 2005-04-14
AU2003263072A1 (en) 2005-04-21

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