WO1998038946A1 - Stents extensibles et auto-extensibles; procedes de fabrication et d'utilisation de ces derniers - Google Patents

Stents extensibles et auto-extensibles; procedes de fabrication et d'utilisation de ces derniers Download PDF

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Publication number
WO1998038946A1
WO1998038946A1 PCT/US1998/004151 US9804151W WO9838946A1 WO 1998038946 A1 WO1998038946 A1 WO 1998038946A1 US 9804151 W US9804151 W US 9804151W WO 9838946 A1 WO9838946 A1 WO 9838946A1
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WO
WIPO (PCT)
Prior art keywords
ring
stent
interconnected
cells
cell
Prior art date
Application number
PCT/US1998/004151
Other languages
English (en)
Inventor
Gladwin S. Das
Original Assignee
Stent Tech, Inc.
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 Stent Tech, Inc. filed Critical Stent Tech, Inc.
Publication of WO1998038946A1 publication Critical patent/WO1998038946A1/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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958—Inflatable balloons for placing stents or stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A61F2002/075—Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching
    • 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
    • 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
    • A61F2002/91558—Adjacent bands being connected to each other connected peak to peak
    • 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

  • the present invention relates to stents and, most preferably, to stents which can be
  • expanded for example, by expanding an internally positioned balloon, as well as, or
  • the heart functions as a pump to perfuse blood throughout the body through arteries.
  • the arteries of some patients are subject to stenosis, a localized
  • Atherosclerotic coronary artery disease condition is termed atherosclerotic coronary artery disease. It is a leading cause of morbidity
  • catheters have been widely used to correct stenotic conditions within arteries, particularly
  • An angioplasty procedure generally includes inserting a deflated balloon, mounted on
  • the redevelop the stenosis in a relative short period of time typically becomes evident within less than about 6 months after angioplasty and may affect 30 to 40 percent of patients.
  • the percentage of patients who have reoccurring stenoses is generally reduced by
  • mechanism for the benefit of stenting may be as simple as preventing immediate elastic recoil
  • hyperplasia induced by metallic or other stent materials.
  • Endovascular stents offer the following:
  • One challenge is to efficiently prepare a stent without compromising the present medical
  • Another challenge is to improve the medical effectiveness of stents.
  • intimal hypoplasmia Yet another challenge is to improve technics for delivery and deployment of stents.
  • jagged edges can result in snagged arteries and other complications during
  • a tear in an artery wall resulting either from a snag or expansion mishap may require emergency corrective surgery
  • the current medical prior art contains a number of insights into stent technology.
  • the device is formed from a memory
  • a self-expanding intraluminal prosthesis or stent which is tubular and has opposed ends and
  • the Burton stent is taught to be prepared by molding, or alternatively, laser
  • a third example is Wolff (U.S. Patent No. 5,104,404), which
  • the segments are connected by hinges to allow them to articulate.
  • the Wolff hinges can be
  • Palmaz U.S. Patent Nos. 4,733,665 and 4,739,762, each of which are hereby incorporated herein by reference.
  • Palmaz stent is in fairly wide use in the U.S. and elsewhere. However, this stent is
  • the stent should have the
  • Wiktor U.S. Patent Nos. 4,969,458; 4,886,062; and 5,133,732 also discloses
  • articulating expandable stents generally coexist of one or more low memory
  • a number of self-expanding stents also show significant ability to articulate once they
  • stents are free of the sheath in which they are delivered. These stents include those disclosed by
  • the following invention discloses stents and methods of producing stents which address
  • the present invention is concerned with expandable stents and methods for
  • the preferred stents of the present invention are expandable
  • the expandable stents of the present invention preferably have a plurality of expandable ring structures, the ring structures are joined end-to-end and feature an absence
  • the stents and ring structures of the stents are
  • the stents of the present invention are
  • the stents of the present invention in certain embodiments which may be desirable
  • the present invention is a stent expandable by enlarging an
  • the expandable balloon positioned within the stent.
  • the expandable stent includes a plurality of
  • Each of the modules have a plurality of individual cells radially interconnected to
  • Each of the individual cells include a continuous strand of a material, the continuous strand of material in each cell being interconnected with itself so as to surround a space central to the interconnected strand
  • the material employed is deformable, such that the ring can be
  • Each cell of the rings has an upper half and a lower half.
  • the upper and lower halves are
  • the plurality of modules includes at least
  • first and second modules where the individual cells of the first module are defined as first
  • module cells and the individual cells of the second module are defined as second module cells.
  • the modules are oriented side by side such that the second ends of the first module are located
  • At least one cell is interconnected with at least one of the plurality of the first ends. Further, at least one cell
  • the modules can articulate relative to one another such that the modules of the
  • expandable stent can pass through an otherwise tortuous passageway with many "sharp" turns
  • the expandable stent is such that one of the sides
  • each cell is a longitudinally oriented straight side. Other sides may be helical or curved.
  • the stent is such that the upper half and lower half of each cell are mirror
  • low memory metals such as tantalum, palladium,
  • a radiopaque marker may be present also, for example in the form of one or more tantalum rivets.
  • the present stents which are self-expanding the material of the continuous strand of the stent is selected
  • high memory elastic materials such as superelastic metal alloys, such as for example superelastic Nitinol (a mckel-titanium alloy), superelastic plastics, silastic
  • the present invention is an expandable stent.
  • the stent again being expandable by enlarging an expandable balloon positioned within the stent.
  • each of the individual cells including a continuous strand
  • Portions of any of the plurality of segments can be shared by adjacent cells in the ring and the
  • the material is deformable. That is, the ring can be deformed from a first configuration, wherein
  • the ring has a first circumference, to a second configuration wherein the ring has a second
  • Each cell has an upper half and a lower half, the upper half being a mirror image of the lower half, the upper and lower halves being
  • the cells have a greater number of cells that have a greater number of cells that have a greater number of cells that have a greater number of cells that have a greater number of cells that have a greater number of cells that have a greater number of cells that have a greater number of cells that have a greater number of cells that have a greater number of cells that have a greater number of cells that have a greater number of cells that have a greater number of cells that have a greater number of cells.
  • one of the segments of the cells include at least one longitudinally oriented straight
  • the longitudinal ends of the cells are curved, with the inside of the curve facing into the center of the cell.
  • the present invention is a prosthesis.
  • the embodiment includes
  • each of the independent rings has a first
  • Each of the rings includes at least one deformation component allowing the
  • the deformation component includes a frame defining an aperture
  • connections between rings of the plurality link the distal end of at least one ring to the
  • Each of the rings are interconnected
  • adjacent rings can articulate relative to one another such that the longitudinal axes of the
  • respective adjacent rings are non-coincident when said adjacent rings are articulated relative to one another.
  • the first "circumferential" structure is bounded by a
  • the prosthesis is characterized by a substantially uniform radial thickness.
  • each of the deformation components is identical.
  • each ring is identical.
  • the frame is composed only of a plurality of identical deformation components.
  • the frame is composed only of a plurality of identical deformation components.
  • the longitudinally oriented straight segment includes a longitudinally oriented straight segment.
  • the longitudinally oriented straight segment includes a longitudinally oriented straight segment.
  • the segment may be shared with an adjacent frame.
  • the frame may include a helical segment, if
  • the helical segment is connected to the longitudinally oriented straight
  • the frame is curved at its greatest longitudinal extent.
  • the present invention also is a method of making a prosthesis. The method first
  • the method includes the step of ehminating non-contiguous portions of material from the cylindrical walled tube to leave a desired structure.
  • the desired structure includes a plurality of individual cells
  • each of the individual cells having a continuous strand of a material.
  • the continuous strand
  • each cell is interconnected with itself so as to surround a space central to the
  • the ring can be deformed from a first configuration, wherein the ring has a first circumference, to a second configuration wherein the ring has a second circumference greater
  • Each cell of the structure has an upper half and a lower half
  • the rings are
  • interconnected rings are linked such that the rings modules can be articulated relative to each
  • One preferred method to accomplish the elimination of material is chemical etching.
  • an etch resistant protective coating is present upon desired structure to be retained in the resulting prosthesis.
  • the present invention is a prosthesis.
  • the prosthesis includes
  • each of the rings having a proximal end and a distal end
  • Each of the rings is a repeating series of frames, each
  • Each of the frames defining a cell, and each cell having a greater extent parallel to the common axis than "circumferential" to the common axis.
  • Each of the frames has a first, generally linear
  • first helical segment also have a first helical segment, connected at a distal end to the proximal end of the first generally linear longitudinal segment and a second helical segment parallel to and displaced
  • first helical segment longitudinally and radially apart from the first helical segment, connected at a proximal end to the distal end of the second generally linear segment. Also present in the frame are a first helical segment, connected at a proximal end to the distal end of the second generally linear segment. Also present in the frame are a first helical segment, connected at a proximal end to the distal end of the second generally linear segment. Also present in the frame are a first helical segment, connected at a proximal end to the distal end of the second generally linear segment. Also present in the frame are a first helical segment, connected at a proximal end to the distal end of the second generally linear segment. Also present in the frame are a first helical segment, connected at a proximal end to the distal end of the second generally linear segment. Also present in the frame are a first helical segment, connected at a proximal end to the distal end of the second generally linear segment. Also present in
  • the first generally linear segment serves as a second
  • the distal end of the first counter helical segment and the second helical segment are connected to form a distal end of
  • first helical and first counter helical segments are each
  • the second helical segment of a first frame may
  • the physical link connecting a ring to an adjacent ring of the array connects
  • This may be a physical link connecting a ring to an adjacent ring of the array connects
  • array may connect between the distal end of a frame the ring and a proximal end of a linear
  • the present invention includes such sheaths which bend easily through coronary arteries while
  • therosclerotic peripheral vascular disease for example therosclerotic peripheral vascular disease; congenital stenosis of the
  • stent grafts can be used in conjunction with the respective stents of the present invention to
  • FIG. 1 is a schematic representation of a side view of a first embodiment of the present
  • FIG. 2 is a subsequent schematic representation of a side view of the embodiment
  • FIG. 3 is a schematic representation cross-sectional view of the schematic representation of Figure 1 ;
  • FIG. 4 is a schematic representation cross- sectional view of the schematic representation of Figure 2 as seen from the line 4-4;
  • FIG. 5 is a schematic view of an enlarged portion of the embodiment of Figure 1 as seen from the line 5-5 of Figure 3;
  • FIG. 6 is a schematic view of an enlarged portion of the expanded embodiment shown
  • FIG. 7 is a schematic view of an enlarged portion of another embodiment of the
  • FIG. 8 is a schematic view of an enlarged portion of the embodiment shown in Figure
  • FIG. 9 A is a schematic view similar to that shown in Figures 5 and 7 of an enlarged
  • FIG. 9B is a schematic view of further embodiment of the expandable stent of the
  • adjacent ring pairs are interconnected by only a single link between just two cells, one in each
  • FIG. 10 is a greatly enlarged detailed view of the portion of the embodiment shown in
  • FIG. 11 is a greatly enlarged detailed view of the portion of the embodiment shown in
  • FIG. 12 is a greatly enlarged detailed view of the portion of the embodiment shown in Figure 9 within the solid line circle 12;
  • FIG. 13 is a schematic view similar to that shown in Figure 5 of an enlarged portion
  • FIG. 14 is a schematic view similar to that shown in Figure 6 of an enlarged portion
  • FIG. 15 is a schematic view similar to that shown in Figure 6 of an enlarged portion
  • FIG. 16 is a schematic view similar to that shown in Figure 6 of an enlarged portion
  • FIG. 17A is a schematic view similar to that shown in Figure 5 of an enlarged portion
  • FIG. 17B is a schematic view similar to that shown in Figure 17A, but showing a
  • FIG. 18 is a schematic view similar to that shown in Figure 6 of an enlarged portion
  • FIG. 19 is a greatly enlarged detailed view of the portion of the embodiment shown in Figure 17 within the solid line circle 19;
  • FIG. 20 is a greatly enlarged detailed view of the portion of the embodiment shown in Figure 17 within the dashed line circle 20;
  • FIG. 21 is an enlarged detailed sectional view of the embodiment shown in Figure 20
  • FIG. 22 is a schematic representation of a self-expanding stent of the present invention.
  • a dehvery catheter having a sheath and positioned in a stenotic region within
  • FIG. 23 is a schematic representation of the stent shown in Figure 22 and 23, but after
  • the sheath is fully withdrawn to allow the self-expanding stent to expand within the diseased
  • FIG. 24 is a further schematic representation of an alternate self-expanding stent
  • the device 30 includes a proximal end 32 and a distal end 34.
  • the device 30 is
  • the device 30 is also shown closely associated within a portion of an
  • proximal and distal radiopaque markers 36 and 38 associated with the device 30, and in particular, adjacent the proximal and distal ends 32 and 34, respectively.
  • the artery 50 is appropriately located in the lumen of the artery 50, preferably spanning the stenosis 52, the
  • device 30 can be expanded radially outwardly expanded by inflating the balloon 44 of the
  • balloon catheter 40 The inflation of balloon 44 is accomplished by application of fluid
  • catheter 40 pressure to its interior by the surgeon, acting at the proximal end (not shown) of catheter 40
  • device 30 is also expanded
  • stenosis 52 is reformed to a more desirable shape and size, i.e. more nearly
  • the relatively narrow, initial radius of the device 30 positioned coaxially, about axis
  • the balloon 44 will be relieved and reduced.
  • the balloon 44 will contract radially toward axis
  • the expandable stent 30 generally retains the expanded radius and does not
  • the retained expanded condition of the device 30 serves to hold the stenosis
  • balloon catheter 40 is now possible. Even after the balloon catheter 40 is withdrawn from the patient, patency remains in the artery 50 and more appropriate circulation is possible for the tissues served by the treated artery 50.
  • the device 30 remains as a support or scaffolding for
  • the artery 50 may also inhibit reformation of the stenosis 52.
  • radial thickness means the difference in the distance
  • cells means the structure defining an aperture or a frame about an
  • frames may have curved sides, many straight sides or combinations of curved and straight
  • straight means having flat surfaces which reside within a
  • helical and counter helical mean paths having many points, each of which is spaced an
  • ring and “module” mean a plurality of cells
  • the term "shared side" means a structural component which is a member
  • independent rings or “independent modules” means rings which can deform, for example by expanding on the order of, for example but without limit, a 10% increase in radius, without an adjacent ring or module be expanded.
  • independent rings or “independent modules” means rings which can deform, for example by expanding on the order of, for example but without limit, a 10% increase in radius, without an adjacent ring or module be expanded.
  • the device 30 is made up of a plurality of modules
  • rings 60 which are closed loops and circumferentially extend about a central axis 45.
  • each of the rings 60 has a proximal end 62 and a distal end 64.
  • Each of the rings 60 has at least one
  • a cell 66 has a frame defining an aperture
  • the cell 66 in the expandable stent 30 deforms when radial force is applied
  • each ring 60 has a plurality of expansion cells and, most preferably, each
  • ring consists of a plurality of identical or nearly identical expansion cells, lined in series in the
  • expansion cell 66 is characterized by a greater longitudinal extent "L" (71) than
  • the cell 66 generally corresponds to the distance between the proximal and distal ends 62 and 64 of the ring 60.
  • each of the cells 66 have an upper half or first portion 67a and a lower half or second portion 67b.
  • the first portion 67a which may be a complex curve
  • 30 may be positioned between a first radius and a second, slightly larger radius, from an axis
  • the respective rings can articulate with respect to one another, such that respective axes of each adjacent module do not
  • the cell 66 second portion 67b of the cell 66 which is preferably a mirror image of the first
  • portion 67a is joined to first portion 67a at its longitudinal extremes, namely the distal
  • the rings 60 of the device 30 are linked at the proximal end 62 to the distal end of an adjoining or adjacent proximally located ring, if any.
  • the link is a small common region, shared by the most proximal extent of each expansion cell 66 of a ring 60 and the most distal extent of each expansion cell 66 of an adjoining proximally located ring 60.
  • each expansion cell 66 of a ring 60 to the adjoining expansion cell 66 of the same ring 60.
  • each of the respective circumferentially adjacent cells are joined together at the
  • the device 160 have fewer rings or rows of cells, e.g. the device 160 with three rows 161a,
  • the device 160 undergoes a change in the cells 166 such that the longitudinal extent
  • the present invention include as few as one module or ring and as many as 2, 3, 4, 5, 6, 7, 8,
  • ring or module may include any practical number of cells.
  • expandable stent 200 of the present invention has multiple rings 260.
  • Each of the rings 260 is a "circumferential" array of expansion cells 266 linked to each of two circumferentially
  • an isthmus 267 in called an isthmus 267 and may in other embodiments have greater width or height.
  • the rings 260 are not linked at the ends or the greatest longitudinal extent of each expansion cell 266. Rather, the links between the respective rings 260 are selective.
  • 66, 166 and 266 is the presence of a significant longitudinally oriented strand or portion at some point along the first and second portions (for example 67a
  • curvature may be present, the area where a tangent to the inward face
  • cells 266 would have a longitudinal length or extent, proximal to distal, of about 2 niillimeters (which would correspond to about 7 or 8 rings) and a "circumferential" distance
  • a typical row can have from about 4 to about 16
  • Links between rings might be on the order of 0.033 millimeters or even smaller, in such an embodiment. Longer or shorter, or wider or narrower
  • the expandable stent 200 shown in Figure 9A has seven rings or modules 260, all of
  • Each ring or row 260 has 12 cells and is interconnected
  • each ring in each ring, or two immediately circumferentially adjacent cells on both sides of each
  • the succeeding ring is interconnected or linked to the second of the two first
  • the various alternate embodiments can be selected to lend different qualities to the stents of the present invention, among the qualities are strength to provide appropriate "scaffolding"
  • present invention may have similar ring to ring interconnections as previously described, but
  • each ring could be joined to each adjacent ring by one, two, three, four
  • These links may align perfectly on one side of the stent, or they
  • Figure 9B has one link 282 between adjacent cells in each pair of adjacent rings 290, and all
  • This stent 280 has perhaps the most flexibility to pass through
  • the stents will articulate in spiral fashion which may be desirable to deliver a stent through a particularly torturous arterial passageway.
  • each ring 290 articulates or pivot on the hinge provided by the interconnection between adjacent cells of the respective adjacent ring pairs.
  • Each ring 290 has
  • Stent 280 also includes a graft material 327 which is shown partially in phantom. The
  • graft material 327 is secured the stent 280 on the inside of the stent 280 using a threading
  • graft materials may be used.
  • the expandable stent 330 has three
  • each cell 366 has a first portion or upper half 372 having
  • the first portion 372 has a
  • a helical segment 382 Extending distally from distal end 378 is a helical segment 382 which has a proximal
  • 374 is a counter helical portion 392, generally a mirror image of helical segment 382 and
  • the cell 366 also includes a lower half which is a mirror image of the upper half or first portion 372 to complete the frame or cell 366.
  • straight segments 374 also serve a second function as a portion of the circumferentially adjoining or adjacent cell. This is a distinction from the structure schematically represented
  • the illustrated portion of a stent 430 has a plurality of rings 460n, 460n+ l,
  • the straight segments 474 have distal and proximal ends 476 and
  • the cells 466 also have helical segments 482, with proximal and distal ends
  • the stent 430 has a limited number of links 498 interconnecting
  • links 498 to provide a hinge for articulation between the adjacent rings because the links 498
  • Figure 16 shows an another alternate embodiment similar to that shown in Figure 15, but with links 598 connecting distally located longitudinal extremes 586 of cells 596 of ring
  • This arrangement has somewhat less end-to-end longitudinal shortening, on a per ring basis
  • the links 598 provide articulation between the rings 560n and 560n+l because the links 598 and 599 are only present between a limited
  • this invention the number of cells, rings and links, and the arrangement of cells rings and links
  • cells 506 of a ring As schematically shown in Figure 17A, in another embodiment 500, cells 506 of a ring
  • each mirror image portions halves (upper and lower)
  • the curved ends form a continuous curve.
  • trailing ends of each of the cells of the rings are blunted and have a reduced tendency to snag
  • radiopaque markers 536 are added,
  • the preferred radiopaque markers 536 of the present invention include rivets 537, installed in receivers 538 having radially
  • Links 598 can be extremely short, or in the alternative lengthened. Because the links 508
  • the device 500 can articulate between two adjoining rings.
  • FIG. 17B Another embodiment 500' is schematically shown in Figure 17B.
  • this embodiment is schematically shown in Figure 17B.
  • the device 500' is a single ring with cells 506' similar analogous to those of Figure 17 A.
  • each upper and lower half have a straight, longitudinally oriented segment 504' ,
  • the upper and lower halves are mirror images.
  • segment 504' is a shared segment between circumferentially adjacent cells 506'.
  • the present invention also includes a method of preparing a stent.
  • the method includes
  • the stent to be made.
  • the stent is prepared by removal of material from the cylindrical wall which
  • the cutting or material removal is more automated.
  • a computer aided laser cutting device is one option.
  • a computer aided water-jet cutting device is another option. In each case, software which guides the cutting tool will assure that only
  • a removal technique is
  • an etching agent might be one of a number of acids which are well known
  • a chemically protective agent for example, a hydrophobic coating, such as a
  • the protective wax may be applied over the entire exterior surface of the cylinder.
  • the protective wax may be applied over the entire exterior surface of the cylinder.
  • the protective coating is removed. If the coating is wax, the
  • wax may be removed by heating or by a wax solvent which does not further affect the metal.
  • Chemical etching is a suitable production method for low volume production. Higher volume
  • tubing wall thickness is considered an important means of obtaining stiffness or easier
  • thin wall tubing is
  • Provision for accepting radiopaque markers, preferable in the form of rivets can also occur in the etching or material removal method.
  • the generation of a hole 535 for accepting a radiopaque marker rivet 537 might occur by etching or cutting, or by a separate drilling or punching operation.
  • tantalum, silver and the like are also believed to be suitable. Desirable features of the
  • material selected are deformability and the ability to hold the shape once deformed.
  • the radiopaque markers may be of tantalum or other well known radiopaque materials
  • markers are placed
  • expandable stents herein described, except that the materials used will be high memory
  • the present invention may be made in the larger configuration out of materials which have high memory characteristics such as superelastic polymers or alloys, spring steel and the like, using
  • the stents must be compressed and then constrained in a lower profile configuration for delivery into the diseased
  • nitinol alloys however, a small cylinder of nitinol may be etched to
  • the catheter 110 includes a delivery sheath 115
  • the sheath 115 acts to constrain the self-expanding stent 30'
  • self-expanding stent 30' can be released to reduce the obstruction 53' within the vessel 50' and
  • the delivery catheter 110 can
  • self-expanding stent 30' also includes proximal and distal radiopaque markers 636 and 638.
  • the self -expanding stent will be flexible, perhaps at least partially because of the inclusion of the structural characteristics which lend themselves to easy
  • the stent 30' will be at least as likely as not to be more flexible
  • graft material means a
  • the material can be linen, Gortex ® or PTFE,
  • Dacron ® polyester other suitable biologically compatible materials, or the like.
  • the graft material 327' is secured the stent 30" on the inside of
  • graft material may also be secured to, or even loosely associated with,
  • expanding stent 30" also includes proximal and distal radiopaque markers 636' and 638' . It is understood that even though numerous characteristics and advantages of various embodiments of the present invention have been set forth in the foregoing description, together

Abstract

Cette invention concerne des stents (30) extensibles et auto-extensibles facultativement dotés d'une capacité de commande du rétrécissement d'un bout à l'autre pendant l'extension. Les stents (30) comportent une pluralité d'anneaux (60) disposés en réseau, des liaisons sélectives existant entre les anneaux (60) pour assurer une articulation appropriée. Les anneaux (60) comprennent une et de préférence plusieurs cellules d'extension (66). Ces cellules (66) peuvent être une structure fondée sur une courbe complexe, une combinaison de segments droits, hélicoïdaux et contre-hélicoïdaux ou des constructions hybrides de ces structures. On décrit également des procédés de fabrication de ces dispositifs comprenant plusieurs procédés d'attaque chimique.
PCT/US1998/004151 1997-03-05 1998-03-04 Stents extensibles et auto-extensibles; procedes de fabrication et d'utilisation de ces derniers WO1998038946A1 (fr)

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Application Number Priority Date Filing Date Title
US81081997A 1997-03-05 1997-03-05
US08/810,819 1997-03-05

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Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2788216A1 (fr) * 1999-01-08 2000-07-13 Balt Extrusion Dispositif permettant d'obturer un anevrisme ou analogue dans un vaisseau sanguin comme une artere
WO2000042948A3 (fr) * 1999-01-22 2000-12-07 Gore Enterprise Holdings Inc Combinaison de stent et de prothese endovasculaire a profil mince
WO2001074272A3 (fr) * 2000-03-30 2002-08-15 Advanced Cardiovascular System Prothèses intraluminales composites
EP1236447A3 (fr) * 2001-03-02 2004-01-21 Cordis Corporation Stent flexible et procédé de fabrication
US6790227B2 (en) 2001-03-01 2004-09-14 Cordis Corporation Flexible stent
WO2008027188A2 (fr) * 2006-08-29 2008-03-06 C. R. Bard, Inc. Greffe de stent hélicoïdale à résistance élevée à la fatigue
JP2013006035A (ja) * 2006-03-06 2013-01-10 David Elmaleh ネットシステムを有する脈管内デバイス
US8900292B2 (en) 2007-08-03 2014-12-02 Boston Scientific Scimed, Inc. Coating for medical device having increased surface area
US8920491B2 (en) 2008-04-22 2014-12-30 Boston Scientific Scimed, Inc. Medical devices having a coating of inorganic material
US8932346B2 (en) 2008-04-24 2015-01-13 Boston Scientific Scimed, Inc. Medical devices having inorganic particle layers
US9284409B2 (en) 2007-07-19 2016-03-15 Boston Scientific Scimed, Inc. Endoprosthesis having a non-fouling surface

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5195984A (en) * 1988-10-04 1993-03-23 Expandable Grafts Partnership Expandable intraluminal graft
US5632771A (en) * 1993-07-23 1997-05-27 Cook Incorporated Flexible stent having a pattern formed from a sheet of material

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5195984A (en) * 1988-10-04 1993-03-23 Expandable Grafts Partnership Expandable intraluminal graft
US5632771A (en) * 1993-07-23 1997-05-27 Cook Incorporated Flexible stent having a pattern formed from a sheet of material

Cited By (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2788216A1 (fr) * 1999-01-08 2000-07-13 Balt Extrusion Dispositif permettant d'obturer un anevrisme ou analogue dans un vaisseau sanguin comme une artere
WO2000042948A3 (fr) * 1999-01-22 2000-12-07 Gore Enterprise Holdings Inc Combinaison de stent et de prothese endovasculaire a profil mince
US9056001B2 (en) 1999-01-22 2015-06-16 W. L. Gore & Associates, Inc. Method of producing low profile stent and graft combination
WO2001074272A3 (fr) * 2000-03-30 2002-08-15 Advanced Cardiovascular System Prothèses intraluminales composites
US6790227B2 (en) 2001-03-01 2004-09-14 Cordis Corporation Flexible stent
EP1236447A3 (fr) * 2001-03-02 2004-01-21 Cordis Corporation Stent flexible et procédé de fabrication
JP2013006035A (ja) * 2006-03-06 2013-01-10 David Elmaleh ネットシステムを有する脈管内デバイス
WO2008027188A3 (fr) * 2006-08-29 2008-04-24 Bard Inc C R Greffe de stent hélicoïdale à résistance élevée à la fatigue
US8696733B2 (en) 2006-08-29 2014-04-15 C. R. Bard, Inc. Helical high fatigue stent-graft
WO2008027188A2 (fr) * 2006-08-29 2008-03-06 C. R. Bard, Inc. Greffe de stent hélicoïdale à résistance élevée à la fatigue
US10206797B2 (en) 2006-08-29 2019-02-19 C. R. Bard, Inc. Helical high fatigue stent-graft
US9284409B2 (en) 2007-07-19 2016-03-15 Boston Scientific Scimed, Inc. Endoprosthesis having a non-fouling surface
US8900292B2 (en) 2007-08-03 2014-12-02 Boston Scientific Scimed, Inc. Coating for medical device having increased surface area
US8920491B2 (en) 2008-04-22 2014-12-30 Boston Scientific Scimed, Inc. Medical devices having a coating of inorganic material
US8932346B2 (en) 2008-04-24 2015-01-13 Boston Scientific Scimed, Inc. Medical devices having inorganic particle layers

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