WO1999055253A1 - Tubular and flexible vascular prosthesis - Google Patents

Tubular and flexible vascular prosthesis Download PDF

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Publication number
WO1999055253A1
WO1999055253A1 PCT/FR1999/000989 FR9900989W WO9955253A1 WO 1999055253 A1 WO1999055253 A1 WO 1999055253A1 FR 9900989 W FR9900989 W FR 9900989W WO 9955253 A1 WO9955253 A1 WO 9955253A1
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WO
WIPO (PCT)
Prior art keywords
lines
broken
straight lines
segments
endoprosthesis according
Prior art date
Application number
PCT/FR1999/000989
Other languages
French (fr)
Other versions
WO1999055253B1 (en
Inventor
Xavier Favereau
Original Assignee
Microval (S.A.R.L.)
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 Microval (S.A.R.L.) filed Critical Microval (S.A.R.L.)
Priority to AU34280/99A priority Critical patent/AU3428099A/en
Publication of WO1999055253A1 publication Critical patent/WO1999055253A1/en
Publication of WO1999055253B1 publication Critical patent/WO1999055253B1/en

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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
    • 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
    • A61F2002/91516—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 the meander having a change in frequency along the band
    • 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
    • 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0017—Angular shapes
    • 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

Definitions

  • the invention relates to the technical sector of stents also known as STENTS.
  • This type of endoprosthesis consists of tubular organs of small section forming an openwork metallic structure and designed to be implanted with the aim of strengthening the walls of the arteries and restoring their permeability, i.e. restoring arterial lumen to allow free circulation of blood.
  • these stents can be used in angioplasty after dilation of the artery thanks to the introduction of a balloon catheter to support the arterial walls, glue the dissections and restore the lumens in weakened areas partially occluded and collapsed or on the contrary abnormally dilated.
  • the aim is to restore the lumen of any physiological duct such as vein, artery, bile duct or urinary tract, tracheobronchial tree, digestive system and genitourinary system ...
  • stents are made of stainless steel and put in place by expansion of a balloon, or they are made of super-elastic, self-expanding alloy, or even of shape memory alloy.
  • the stent is placed coaxially around the balloon of a catheter by light crimping.
  • the catheter is introduced into the artery and brought to the implantation site by means of a flexible metal guide, under radiographic control of the operator.
  • the balloon is gradually inflated in order to dilate the artery and at the same time deploy the prosthetic structure to the desired diameter.
  • the balloon is then deflated and the catheter removed with the metal guide, leaving the stent open and in place.
  • a self-expanding stent In a second case of a self-expanding stent, the latter is placed coaxially around the end of a delivery catheter and held in this position by an external sheath. When the catheter is in place, a gradual withdrawal of the external sheath ensures the opening of the stent which then returns to its initial diameter.
  • a stent made of a thermal memory alloy the latter is modeled in a given configuration when cold which allows its implantation. After being heated to its transition temperature, the structure loses its malleability and returns to its initial configuration. It is this property that is used for fitting the self-expanding stent with shape memory. From this basic general design, there are essentially two main categories of endoprosthesis obtained from two different manufacturing techniques.
  • the endoprosthesis must be able to be placed without difficulty in sinuous and small diameter ducts such as the coronary arteries.
  • the radial force to guarantee the opening in calcified arteries and to allow the endoprosthesis to remain open after the installation, it must be sufficient to support the walls of the conduit, but limited all the same so as not to damage the tissues of the walls at the time of installation and / or after installation.
  • the length of the endoprosthesis should not vary at the time of its implantation, so, on the one hand, to avoid traumatizing the walls at the implantation site and, on the other hand, to ensure sufficient coverage in length of the site to be treated. Too much shrinkage requiring the operator either to implant another stent to cover the entire area to be treated, or to use a stent of a much greater length.
  • the final diameter is a function of the diameter of the balloon and the inflation pressure.
  • the endoprosthesis must have the smallest possible insertion diameter in order to control the trauma during its introduction and to facilitate its placement at the site to be treated.
  • the metal / artery ratio must be as low as possible, the stent should not generate turbulent flow likely to cause thrombosis (in the case of arterial or venous stents for example) and should not generate a proliferative tissue reaction likely to cause restenosis.
  • Endovascular prostheses as defined according to the state of the art do not have all of these characteristics combined.
  • articulated tubular stents have been developed.
  • the metal / artery ratio of mesh tubular stents is less favorable (10 to 25%) and can be inconvenient at the bifurcations for the passage of blood through the colateral arteries.
  • shrinkage is important (up to 40
  • the object of the invention is to remedy these drawbacks in a simple, safe, efficient and rational manner.
  • the problem which the invention proposes to solve is to produce a stent of the tubular type which is capable of offering all the desired characteristics in terms of flexibility, radial force, withdrawal, elastic recoil, profile, all by combining the advantages of other tubular mesh prostheses and the advantages of endoprostheses made from wires.
  • a stent with a mesh structure composed of a plurality of deformable patterns remarkable in that the structure is made up has been designed and developed.
  • a series of parallel straight lines regularly distributed over a circumference - the parallel straight lines are connected by symmetrical broken lines, all of said broken lines having a geometric shape and dimensions determined to ensure the deployment of the structure d '' a symmetrical and regular manner with an elastic recoil of less than 1%
  • - each straight line has, between the broken connecting lines and in a symmetrical manner, broken lines having a geometric shape and dimensions determined to give flexibility to the structure while prohibiting a variation in its length.
  • the endoprostheses being able to be used as well in arteries of small distal caliber, sinuous and or calcified as in arteries of larger caliber: venous grafts, arteries peripheral, aorta or other ducts.
  • the mesh of the structure as defined allows deployment without any shrinkage and an elastic recoil limited to 1% for a diameter of approximately 3 mm. It is also possible to obtain a reduced profile necessary for the insertion of the stent but also a favorable metal / artery ratio of less than 20%.
  • the patterns delimit two end zones and at least one intermediate zone, each zone consisting of broken lines.
  • the broken end connection lines are formed by two rectilinear segments delimiting a symmetrical V, the apex of which is directed inside the structure.
  • the broken intermediate connecting lines consist of three rectilinear segments delimiting two identical and opposite V's joined by a common segment, the other two segments of each of the two opposite V's, being connected to the corresponding parallel straight lines, by rectilinear segments of reduced length oriented perpendicular to said straight lines.
  • the broken lines of each of the straight lines are constituted by three rectilinear segments delimiting two identical and opposite Vs joined by a common segment and symmetrically by the other two segments to each of said straight lines.
  • the broken lines of each of the straight lines are arranged at equal distance from each of the broken connecting lines, the four parallel straight lines being regularly angularly offset around a circumference.
  • FIG. 1 on a large scale, is a perspective view of the stent
  • FIG. 2 is a schematic view showing the mesh principle of the tabular structure of the stent
  • FIG. 3 on a large scale, is a flat view of the endoprosthesis before it is deployed
  • Figure 4 is a flat view of the endoprosthesis shown in Figure 3 after deployment.
  • Figures 5 and 6 are partial views, on a very large scale, showing examples of details of embodiment of the broken lines.
  • the flexible and tabular stent has a mesh structure composed of a plurality of deformable patterns.
  • the mesh structure delimits end zones (A) and (C) and at least one intermediate zone (B).
  • end zones A and (C) and at least one intermediate zone (B).
  • the end zones are recommended since they are shaped, as will be indicated in the following description, to avoid any risk of injury or tearing during the introduction and / or removal of the stent.
  • the structure consists of a series of parallel straight lines (1) regularly distributed over a circumference.
  • the structure has four parallel straight lines regularly offset angularly around the circumference.
  • the diameter of the structure is substantially equal to 1.6 mm and can range up to 4 - 4.5 mm.
  • the length of the structure can be from 8 to 45 mm approximately.
  • the parallel straight lines (1) are connected at their free end by symmetrical broken lines (2).
  • the straight lines (1) are also connected, preferably at regular intervals, at the intermediate zones (B) by broken lines (3).
  • the geometric shapes and dimensions of the broken lines (2 and 3) are determined to ensure the deployment of the structure, in a symmetrical and regular manner, with an elastic recoil of less than 1%.
  • the broken end lines (2) are constituted by two rectilinear segments (2a - 2b) delimiting a symmetrical V whose apex is directed inside the structare.
  • V are connected to the ends of the corresponding parallel straight lines (1) and to the other V-shaped segments, by rectilinear segments (2c) of reduced length and oriented substantially perpendicular to said straight lines (1).
  • the broken lines (3) of intermediate connection consist of three rectilinear segments (3a), (3b) and (3c). These three segments delimit two
  • each straight line (1) has, between the broken connecting lines (2 and 3), and between the different intermediate broken lines (3), in a symmetrical manner, broken lines (4) having a geometric shape and dimensions determined to give flexibility to the structare while prohibiting a variation in its length.
  • the broken line (4) being constituted by three rectilinear segments (4a - 4b - 4c) delimiting identical and opposite 2V joined by the common segment (4b) and symmetrically by the two other segments (4a and
  • the different broken lines (4) are arranged at equal distance from each of the broken connecting lines (2 and / or 3).
  • the stent can be produced from a tube of diameter and thickness chosen according to the diameter to be reached after deployment. The choice of the number of central patterns over a given length will optimize the final flexibility and the total and symmetrical deployment of the endoprosthesis at a given diameter.
  • the stent can be made of any implantable material capable of being cut and / or shaped by any suitable means. It is preferably made of 316 LVM stainless steel with elastic characteristics suitable for this use. It can also be coated with any implantable material in order to improve its hemocompati bilitc or allow the diffusion of medicinal substances active against cell proliferation responsible for the phenomena of restenosis. Finally, it can be made of a biodegradable material for indications of temporary stents.
  • the mesh structure of the stent combines the advantages obtained in the case of tubular mesh endoprostheses and stents made from wires.
  • endoprosthesis in small distal, sinuous or calcified catheters, as well as in larger arteries such as venous grafts, peripheral arteries, aortas, or in any other conduit.

Abstract

The invention concerns a tubular and flexible prosthesis with meshed structure consisting of a plurality of deformable units, characterised in that the structure consists of: a series of parallel straight lines (1) evenly distributed over a circumference; the parallel straight lines (1) are connected to symmetrical broken lines (2 and 3), the set of said broken lines having predetermined geometric form and dimensions to ensure that the structure unfolds symmetrically and uniformly by having an elastic slip less than 1 %; each straight line (1) has, between the connecting broken lines (2 and 3) and symmetrically, broken lines (4) having predetermined geometric form and dimensions for providing the structure with flexibility while preventing variation in its length.

Description

ENDOPROTHESE VASCULAIRE TUBULAIRE ET FLEXIBLE. TUBULAR AND FLEXIBLE VASCULAR ENDOPROSTHESIS.
L'invention se rattache au secteur technique des endoprothèses vasculaires connues également sous le nom de STENTS.The invention relates to the technical sector of stents also known as STENTS.
Ce type d'endoprothèses est constituée par des organes tubulaires de petite section formant une structure métallique ajourée et conçue pour être implantée dans le but de renforcer les parois des artères et d'en restaurer la perméabilité, c'est-à-dire de restaurer la lumière artérielle afin de permettre la libre circulation du sang.This type of endoprosthesis consists of tubular organs of small section forming an openwork metallic structure and designed to be implanted with the aim of strengthening the walls of the arteries and restoring their permeability, i.e. restoring arterial lumen to allow free circulation of blood.
De nombreuses applications peuvent être envisagées. Par exemple ces endoprothèses peuvent être utilisées en angioplastie après dilatation de l'artère grâce à l'introduction d'un cathéter à ballonnet pour étayer les parois artérielles, coller les dissections et restaurer les lumières dans des zones affaiblies partiellement occluses et collapsées ou au contraire anormalement dilatées.Many applications can be envisaged. For example, these stents can be used in angioplasty after dilation of the artery thanks to the introduction of a balloon catheter to support the arterial walls, glue the dissections and restore the lumens in weakened areas partially occluded and collapsed or on the contrary abnormally dilated.
Comme indiqué, le but recherché est de restaurer la lumière de tout conduit physiologique tel que veine, artère, canal biliaire ou urinaire, arbre trachéobronchique, digestif et système génito-urinaire...As indicated, the aim is to restore the lumen of any physiological duct such as vein, artery, bile duct or urinary tract, tracheobronchial tree, digestive system and genitourinary system ...
II existe à ce jour, de nombreux types d'endoprothèses vasculaires. Le plus souvent, elles sont en acier inoxydable et mises en place par dilatation d'un ballonnet, ou bien elles sont en alliage super-élastique, auto-expansible, ou encore en alliage à mémoire de forme.To date, there are many types of stents. Most often, they are made of stainless steel and put in place by expansion of a balloon, or they are made of super-elastic, self-expanding alloy, or even of shape memory alloy.
Dans un premier cas, l'endoprothèse est placée coaxialement autour du ballonnet d'un cathéter par un léger sertissage. Le cathéter est introduit dans l'artère et amené jusqu'au site d'implantation au moyen d'un guide métallique souple, sous contrôle radiographique de l'opérateur. Une fois en place, le ballonnet est gonflé progressivement afin de dilater l'artère et de déployer en même temps la structure prothétique au diamètre désiré. Le ballonnet est ensuite déglonfé et le cathéter retiré avec le guide métallique, laissant l'endoprothèse ouverte et en place.In a first case, the stent is placed coaxially around the balloon of a catheter by light crimping. The catheter is introduced into the artery and brought to the implantation site by means of a flexible metal guide, under radiographic control of the operator. Once in place, the balloon is gradually inflated in order to dilate the artery and at the same time deploy the prosthetic structure to the desired diameter. The balloon is then deflated and the catheter removed with the metal guide, leaving the stent open and in place.
Dans un deuxième cas d'une endoprothèse auto-expansible, cette dernière est placée coaxialement autour de l'extrémité d'un cathéter de mise en place et maintenue dans cette position par une gaine externe. Lorsque le cathéter est en place, un retrait progressif de la gaine externe assure l'ouverture de l'endoprothèse qui retrouve alors son diamètre initial.In a second case of a self-expanding stent, the latter is placed coaxially around the end of a delivery catheter and held in this position by an external sheath. When the catheter is in place, a gradual withdrawal of the external sheath ensures the opening of the stent which then returns to its initial diameter.
Dans un troisième cas, d'une endoprothèse réalisée dans un alliage à mémoire thermique, cette dernière est modelée dans une configuration donnée à froid qui permet son implantation. Après avoir été chauffée à sa température de transition, la structure perd sa malléabilité et retourne à sa configuration initiale. C'est cette propriété qui est utilisée pour la pose de l'endoprothèse auto-expansible à mémoire de forme. A partir de cette conception générale de base, on distingue essentiellement deux catégories principales d'endoprothèse obtenue à partir de deux techniques de fabrication différentes.In a third case, of a stent made of a thermal memory alloy, the latter is modeled in a given configuration when cold which allows its implantation. After being heated to its transition temperature, the structure loses its malleability and returns to its initial configuration. It is this property that is used for fitting the self-expanding stent with shape memory. From this basic general design, there are essentially two main categories of endoprosthesis obtained from two different manufacturing techniques.
C'est ainsi que l'on connaît, d'une part, les endoprothèses réalisées à partir de fils tressés ou enroulés et formant un grillage tubulaire perméable diamétralement et, d'autre part, les endoprothèses réalisées à partir de tubes métalliques cylindriques convenablement découpés pour former des maillages géométriques et déformables.This is how we know, on the one hand, stents made from braided or wound wires and forming a diametrically permeable tubular grid and, on the other hand, stents made from suitably cut cylindrical metal tubes to form geometric and deformable meshes.
Dans le cas d'endoprothèses réalisées à partir de fils, on peut citer à titre indicatif, nullement limitatif, le stent de Gianturco-Roubin réalisé avec un fil de 0,15 mm de diamètre en acier inoxydable enroulé de façon à réaliser une spirale flexible. On peut citer également le stent de Strecker (brevet US N. 4922905) réalisé avec un fil de tantale de 0,07 mm tricoté en treillis, le stent Wiktor réalisé avec un fil de Tantale de 0,125 mm de forme sinusoïdale enroulé en hélice, le stent XT Bard réalisé avec en acier inoxydable de 0,15 mm.In the case of endoprostheses made from wires, we can cite by way of indication, in no way limiting, the Gianturco-Roubin stent produced with a wire of 0.15 mm in diameter made of stainless steel wound so as to produce a flexible spiral . We can also cite the Strecker stent (US patent N. 4922905) produced with a tantalum wire of 0.07 mm knitted in a lattice, the Wiktor stent produced with a Tantalum wire of 0.125 mm sinusoidal shape wound in a helix, XT Bard stent made with 0.15 mm stainless steel.
Dans le cas d'endoprothèses réalisées à partir d'organes tubulaires à maillage, on peut citer le brevet US 4.776.337 réalisé dans un tube rigide en acier inoxydable présentant une structure ajourée sous forme d'un treillis dont les mailles rectangulaires et coaxiales, avant implantation, deviennent diagonales après déploiement de l'endoprothèse. On peut citer également l'enseignement des Brevets WO 97/41803, WO 97/32544 et WO 97/32543.In the case of endoprostheses produced from tubular members with a mesh, mention may be made of US Pat. No. 4,776,337 produced in a rigid stainless steel tube having an openwork structure in the form of a trellis whose rectangular and coaxial meshes, before implantation, become diagonal after deployment of the stent. We can also cite the teaching of Patents WO 97/41803, WO 97/32544 and WO 97/32543.
Compte tenu des applications envisagées pour ce type d'endoprothèses endovaculaires, les caractéristiques suivantes sont attendues :Given the applications envisaged for this type of endovacular endoprosthesis, the following characteristics are expected:
- La souplesse : pour assurer une mise en place aisée et sans dommage pour le patient, l'endoprothèse doit pouvoir être placée sans difficulté dans des conduits sinueux et de faible diamètre comme les artères coronaires.- Flexibility: to ensure easy placement and without damage to the patient, the endoprosthesis must be able to be placed without difficulty in sinuous and small diameter ducts such as the coronary arteries.
- La force radiale : pour garantir l'ouverture dans des artères calcifiées et permettre à l'endoprothèse de rester ouverte après la pose, elle doit être suffisante pour étayer les parois du conduit, mais limitée tout de même pour ne pas endommager les tissus des parois au moment de la pose et/ou après la pose.- The radial force: to guarantee the opening in calcified arteries and to allow the endoprosthesis to remain open after the installation, it must be sufficient to support the walls of the conduit, but limited all the same so as not to damage the tissues of the walls at the time of installation and / or after installation.
- Le retrait : idéalement, la longueur de l'endoprothèse ne doit pas varier au moment de son implantation, de façon, d'une part, à éviter de traumatiser les parois au niveau du site d'implantation et, d'autre part, d'assurer une couverture suffisante en longueur du site à traiter. Un retrait trop important nécessitant pour l'opérateur, soit d'implanter une autre endoprothèse pour couvrir toute la zone à traiter, soit d'utiliser une endoprothèse d'une longueur beaucoup plus importante.- Removal: ideally, the length of the endoprosthesis should not vary at the time of its implantation, so, on the one hand, to avoid traumatizing the walls at the implantation site and, on the other hand, to ensure sufficient coverage in length of the site to be treated. Too much shrinkage requiring the operator either to implant another stent to cover the entire area to be treated, or to use a stent of a much greater length.
- Le recul élastique : il est lié aux propriétés élastiques du matériau. Lorsque l'endoprothèse métallique est déployée par ballonnet, le recul sera d'autant plus important que le métal n'a pas subi de déformation plastique. L'endoprothèse aura alors tendance à se refermer favorisant la thrombose et la resténose.- Elastic recoil: it is linked to the elastic properties of the material. When the metal endoprosthesis is deployed by balloon, the retreat will be all the more important as the metal has not undergone plastic deformation. The stent will then tend to close favoring thrombosis and restenosis.
Pour les endoprothèses déployés par ballonnet, le diamètre final est fonction du diamètre du ballonnet et de la pression d'inflation. Ainsi, on doit s'assurer que pour un diamètre donné et une pression donnée, l'endoprothèse déployée a bien subi une déformation plastique au delà de sa limite élastique afin d'obtenir un recul inférieur à 4%.For balloon stents, the final diameter is a function of the diameter of the balloon and the inflation pressure. Thus, it must be ensured that for a given diameter and a given pressure, the deployed endoprosthesis has indeed undergone plastic deformation beyond its elastic limit in order to obtain a setback of less than 4%.
- Le profil : l'endoprothèse doit présenter un diamètre d'insertion le plus faible possible afin de contrôler le traumatisme lors de son introduction et de faciliter son placement au niveau du site à traiter. Le rapport métal / artère doit être le plus faible possible, le stent ne devant pas générer de flux turbulents susceptibles de provoquer une thrombose (dans le cas des endoprothèses artérielles ou veineuses par exemple) et ne devant pas générer de réaction tissulaire proliférative susceptible de provoquer une resténose.- The profile: the endoprosthesis must have the smallest possible insertion diameter in order to control the trauma during its introduction and to facilitate its placement at the site to be treated. The metal / artery ratio must be as low as possible, the stent should not generate turbulent flow likely to cause thrombosis (in the case of arterial or venous stents for example) and should not generate a proliferative tissue reaction likely to cause restenosis.
Les prothèses endovasculaires telles que définies selon l'état de la technique ne présentent pas toutes ces caractéristiques combinées.Endovascular prostheses as defined according to the state of the art do not have all of these characteristics combined.
Dans le cas de prothèses endovasculaires réalisées à partir de fils tressés et enroulés, la structure obtenue est très souple et maniable, et présente une faible force radiale, ce qui est gênant pour leur déploiement au niveau des sites calcifiés. Cette endoprothèse présente un recul élastique non négligeable mais un rapport métal-artère favorable (10 à 15 %) pour les colatérales. A l'inverse les endoprothèses tubulaires à maillage sont plus rigides et moins maniables gênants ainsi leur mise en place dans des sites sinueux. Par contre, ce type de prothèses présente une force radiale importante.In the case of endovascular prostheses produced from braided and wound wires, the structure obtained is very flexible and manageable, and has a low radial force, which is troublesome for their deployment at the calcified sites. This endoprosthesis presents a significant elastic recoil but a favorable metal-artery ratio (10 to 15%) for the colaterals. Conversely, tubular mesh stents are more rigid and less manageable, thus hampering their placement in sinuous sites. On the other hand, this type of prosthesis has a significant radial force.
Pour palier au défaut de rigidité, les endoprothèses tubulaires articulées ont été développées. Le rapport métal/artère d'endoprothèses tubulaires à maillage est moins favorable (10 à 25 %) et peut être gênant au niveau des bifurcations pour le passage du sang dans les artères colatérales.To overcome the lack of rigidity, articulated tubular stents have been developed. The metal / artery ratio of mesh tubular stents is less favorable (10 to 25%) and can be inconvenient at the bifurcations for the passage of blood through the colateral arteries.
Dans ces deux types d'endoprothèses, le retrait est important (jusqu'à 40In these two types of stents, shrinkage is important (up to 40
% pour certains modèles( et le recul élastique non négligeable (jusqu'à 15 %).% for certain models (and significant elastic recoil (up to 15%).
L'invention s'est fixée pour but de remédier à ces inconvénients, d'une manière simple, sûre, efficace et rationnelle.The object of the invention is to remedy these drawbacks in a simple, safe, efficient and rational manner.
Le problème que se propose de résoudre l'invention est de réaliser une endoprothèse vasculaire du type tubulaire qui soit apte à offrir toutes les caractéristiques souhaitées au niveau de la souplesse, de la force radiale, du retrait, du recul élastique, du profil, tout en combinant les avantages des autres prothèses tubulaires à maillage et les avantages des endoprothèses réalisées à partir de fils.The problem which the invention proposes to solve is to produce a stent of the tubular type which is capable of offering all the desired characteristics in terms of flexibility, radial force, withdrawal, elastic recoil, profile, all by combining the advantages of other tubular mesh prostheses and the advantages of endoprostheses made from wires.
Pour résoudre un tel problème, il a été conçu et mis au point une endoprothèse présentant une strucure maillée composée d'une pluralité de motifs déformables remarquable en ce que la structure est constituée : - d'une série de lignes droites parallèles régulièrement réparties sur une circonférence, - les lignes droites parallèles sont raccordées par des lignes brisées symétriques, l'ensemble desdites lignes brisées présentant une forme géométrique et des dimensions déterminées pour assurer le déploiement de la structure d'une manière symétrique et régulière en ayant un recul élastique inférieur à 1%, - chaque ligne droite présente, entre les lignes brisées de raccordement et d'une manière symétrique, des lignes brisées présentant une forme géométrique et des dimensions déterminées pour conférer une souplesse à la structure tout en interdisant une variation de sa longueur.To solve such a problem, a stent with a mesh structure composed of a plurality of deformable patterns remarkable in that the structure is made up has been designed and developed. - a series of parallel straight lines regularly distributed over a circumference, - the parallel straight lines are connected by symmetrical broken lines, all of said broken lines having a geometric shape and dimensions determined to ensure the deployment of the structure d '' a symmetrical and regular manner with an elastic recoil of less than 1%, - each straight line has, between the broken connecting lines and in a symmetrical manner, broken lines having a geometric shape and dimensions determined to give flexibility to the structure while prohibiting a variation in its length.
Compte tenu de ces caractéristiques, il est possible d'élargir les indications thérapeutiques et chirurgicales, les endoprothèses pouvant aussi bien être utilisées dans des artères de petit calibre distal, sinueuses et ou calcifiées que dans des artères de plus gros calibres : greffons veineux, artères périphériques, aortes ou dans d'autres conduits.Given these characteristics, it is possible to broaden the therapeutic and surgical indications, the endoprostheses being able to be used as well in arteries of small distal caliber, sinuous and or calcified as in arteries of larger caliber: venous grafts, arteries peripheral, aorta or other ducts.
Il en résulte que le maillage de la structure telle que définie permet un déploiement sans aucun retrait et un recul élastique limité à 1 % pour un diamètre de 3 mm environ. Il est également possible d'obtenir un profil réduit nécessaire à l'insertion de l'endroprothèse mais aussi un rapport métal/artère favorable et inférieur à 20 %.It follows that the mesh of the structure as defined allows deployment without any shrinkage and an elastic recoil limited to 1% for a diameter of approximately 3 mm. It is also possible to obtain a reduced profile necessary for the insertion of the stent but also a favorable metal / artery ratio of less than 20%.
Pour résoudre le problème posé d'éviter tout risque de déchirure ou autre au moment de l'insertion, les motifs délimitent deux zones d'extrémité et au moins une zone intermédiaire, chaque zone étant constituée par les lignes brisées.To solve the problem posed of avoiding any risk of tearing or the like at the time of insertion, the patterns delimit two end zones and at least one intermediate zone, each zone consisting of broken lines.
Avantageusement, les lignes brisées de raccordement d'extrémités sont constituées par deux segments rectilignes délimitant un V symétrique dont le sommet est dirigé à l'intérieur de la structure.Advantageously, the broken end connection lines are formed by two rectilinear segments delimiting a symmetrical V, the apex of which is directed inside the structure.
Pour résoudre le problème posé d'assurer le déploiement de la structure d'une manière symétrique et régulière en ayant un recul élastique inférieur àTo solve the problem posed of ensuring the deployment of the structure in a symmetrical and regular manner by having an elastic recoil less than
1 %, les lignes brisées de raccordement intermédiaires sont constituées par trois segments rectilignes délimitant deux V identiques et opposés réunis par un segment commun, les deux autres segments de chacun des deux V opposés, étant raccordés aux lignes droits parallèles correspondantes, par des segments rectilignes de longueur réduites orientées perpendiculairement auxdites lignes droites.1%, the broken intermediate connecting lines consist of three rectilinear segments delimiting two identical and opposite V's joined by a common segment, the other two segments of each of the two opposite V's, being connected to the corresponding parallel straight lines, by rectilinear segments of reduced length oriented perpendicular to said straight lines.
Pour résoudre le problème posé d'obtenir une structure relativement souple tout en interdisant une variation de sa longueur, les lignes brisées de chacune des lignes droites, sont constituées par trois segments rectilignes délimitant deux V identiques et opposés réunis par un segment commun et symétriquement par les deux autres segments à chacune desdites lignes droites.To solve the problem of obtaining a relatively flexible structure while prohibiting a variation in its length, the broken lines of each of the straight lines, are constituted by three rectilinear segments delimiting two identical and opposite Vs joined by a common segment and symmetrically by the other two segments to each of said straight lines.
Avantageusement, les lignes brisées de chacune des lignes droites sont disposées à égale distance de chacune des lignes brisées de raccordement, les quatre lignes droites parallèles étant régulièrement décalées angulairement sur une circonférence.Advantageously, the broken lines of each of the straight lines are arranged at equal distance from each of the broken connecting lines, the four parallel straight lines being regularly angularly offset around a circumference.
L'invention est exposée ci-après plus en détail dans les dessins annexés dans lesquels :The invention is set out below in more detail in the appended drawings in which:
• la figure 1, à grande échelle, est une vue en perspective de l'endoprothèse vasculaire,FIG. 1, on a large scale, is a perspective view of the stent,
• la figure 2 est une vue à caractère schématique montrant le principe de maillage de la structure tabulaire de l'endoprothèse,FIG. 2 is a schematic view showing the mesh principle of the tabular structure of the stent,
• la figure 3, à grande échelle, est une vue développée à plat de l'endoprothèse avant son déploiement,FIG. 3, on a large scale, is a flat view of the endoprosthesis before it is deployed,
• la figure 4 est une vue développée à plat de l'endoprothèse représentée figure 3 après déploiement. • les figures 5 et 6 sont des vues partielles, à très grande échelle, montrant des exemples de détails de réalisation des lignes brisées.• Figure 4 is a flat view of the endoprosthesis shown in Figure 3 after deployment. • Figures 5 and 6 are partial views, on a very large scale, showing examples of details of embodiment of the broken lines.
Selon l'invention, l'endoprothèse vasculaire tabulaire et flexible présente une structure maillée composée d'une pluralité de motifs déformables. Dans l'exemple illustré, la structure maillée délimite des zones d'extrémité(A) et (C) et au moins une zone intermédiaire (B). On n'exclut pas de réaliser une endoprothèse ne présentant pas de zones d'extrémité, mais uniquement des cellules ou modules conformes à la ou aux zones intermédiaires (B). Toutefois, les zones d'extrémité sont recommandées étant donné qu'elles sont conformées, comme il sera indiqué dans la suite de la description, pour éviter tout risque de blessure ou de déchirement au moment de l'introduction et/ou retrait de l'endoprothèse.According to the invention, the flexible and tabular stent has a mesh structure composed of a plurality of deformable patterns. In the example illustrated, the mesh structure delimits end zones (A) and (C) and at least one intermediate zone (B). We do not rule out making a endoprosthesis having no end zones, but only cells or modules conforming to the intermediate zone (s) (B). However, the end zones are recommended since they are shaped, as will be indicated in the following description, to avoid any risk of injury or tearing during the introduction and / or removal of the stent.
La structure est constituée d'une série de lignes droites parallèles (1) régulièrement réparties sur une circonférence. Par exemple, la structure présente quatre lignes droites parallèles régulièrement décalées angulairement sur la circonférence. A titre indicatif, le diamètre de la structure est sensiblement égal à 1,6 mm et peut aller jusqu'à 4 - 4, 5 mm. La longueur de la structure peut être de 8 à 45 mm environ.The structure consists of a series of parallel straight lines (1) regularly distributed over a circumference. For example, the structure has four parallel straight lines regularly offset angularly around the circumference. As an indication, the diameter of the structure is substantially equal to 1.6 mm and can range up to 4 - 4.5 mm. The length of the structure can be from 8 to 45 mm approximately.
Ces valeurs numériques sont données à titre d'exemple indicatif, d'une manière non limitative.These numerical values are given by way of an indicative example, in a nonlimiting manner.
Les lignes droites parallèles (1) sont raccordées à leur extrémité libre par des lignes brisées symétriques (2). Les lignes droites (1) sont également raccordées, de préférence à intervalles réguliers, au niveau des zones intermédiaires (B) par des lignes brisées (3). Les formes géométriques et les dimensions des lignes brisées (2 et 3) sont déterminées pour assurer le déploiement de la structure, d'une manière symétrique et régulière, en ayant un recul élastique inférieur à 1 %.The parallel straight lines (1) are connected at their free end by symmetrical broken lines (2). The straight lines (1) are also connected, preferably at regular intervals, at the intermediate zones (B) by broken lines (3). The geometric shapes and dimensions of the broken lines (2 and 3) are determined to ensure the deployment of the structure, in a symmetrical and regular manner, with an elastic recoil of less than 1%.
Ainsi, les lignes brisées d'extrémité (2) sont constituées par deux segments rectilignes (2a - 2b) délimitant un V symétrique dont le sommet est dirigé à l'intérieur de la structare. Les deux segments (2a et 2b) de chacun desThus, the broken end lines (2) are constituted by two rectilinear segments (2a - 2b) delimiting a symmetrical V whose apex is directed inside the structare. The two segments (2a and 2b) of each of the
V sont raccordés aux extrémités des lignes droites parallèles correspondantes (1) et aux autres segments en V, par des segments rectilignes (2c) de longueur réduite et orientés sensiblement perpendiculairement auxdites lignes droites (1).V are connected to the ends of the corresponding parallel straight lines (1) and to the other V-shaped segments, by rectilinear segments (2c) of reduced length and oriented substantially perpendicular to said straight lines (1).
Les lignes brisées (3) de raccordement intermédiaire sont constituées par trois segments rectilignes (3a), (3b) et (3c). Ces trois segments délimitent deuxThe broken lines (3) of intermediate connection consist of three rectilinear segments (3a), (3b) and (3c). These three segments delimit two
V identiques et opposés, et réunis par le segment commun (3b). Les deux autres segments (3a - 3c) de chacun des deux V opposés et de longueur égal à la moitié de la longueur du segment commun (3b), sont accordés aux lignes droites parallèles correspondantes (1) et aux autres lignes brisées (3) par des segments rectilignes de longueur réduite (3d). Ces segments (3d) sont orientés très sensiblement perpendiculairement aux lignes droites (1).V identical and opposite, and united by the common segment (3b). The two other segments (3a - 3c) of each of the two opposite V and of length equal to half the length of the common segment (3b), are granted to the corresponding parallel straight lines (1) and to the other broken lines (3) by rectilinear segments of reduced length (3d). These segments (3d) are oriented very substantially perpendicular to the straight lines (1).
Selon une autre caractéristique importante de l'invention, chaque ligne droite (1) présente, entre les lignes brisées de raccordement (2 et 3), et entre les différentes lignes brisées intermédiaires (3), d'une manière symétrique, des lignes brisées (4) présentant une forme géométrique et des dimensions déterminées pour conférer une souplesse à la structare tout en interdisant une variation de sa longueur.According to another important characteristic of the invention, each straight line (1) has, between the broken connecting lines (2 and 3), and between the different intermediate broken lines (3), in a symmetrical manner, broken lines (4) having a geometric shape and dimensions determined to give flexibility to the structare while prohibiting a variation in its length.
Dans ce but, la ligne brisée (4) étant constituée par trois segments rectilignes (4a - 4b - 4c) délimitant 2V identiques et opposés réunis par le segment commun (4b) et symétriquement par les deux autres segments (4a etFor this purpose, the broken line (4) being constituted by three rectilinear segments (4a - 4b - 4c) delimiting identical and opposite 2V joined by the common segment (4b) and symmetrically by the two other segments (4a and
4c) à chacune des lignes droites ( 1 ). Les différentes lignes brisées (4) sont disposées à égale distance de chacune des lignes brisées de raccordement (2et/ou 3).4c) to each of the straight lines (1). The different broken lines (4) are arranged at equal distance from each of the broken connecting lines (2 and / or 3).
Il en résulte que le déploiement total et symétrique par déformation élastique de la structare repose sur un calcul précis des longueurs des différents segments (2a - 2b) et (3a - 3b - 3c).It follows that the total and symmetrical deployment by elastic deformation of the structare is based on a precise calculation of the lengths of the different segments (2a - 2b) and (3a - 3b - 3c).
Ces dispositions permettent, comme indiqué, de restreindre le recul élastique par exemple environ 1% pour un diamètre de 3mm à l'état déployé. De même un calcul précis de la longueur des segments (4a - 4b - 4c) interdit toute variation de la longueur totale de l'endoprothèse en cours et après implantation.These arrangements make it possible, as indicated, to restrict the elastic recoil, for example around 1% for a diameter of 3 mm in the deployed state. Similarly, a precise calculation of the length of the segments (4a - 4b - 4c) prohibits any variation in the total length of the endoprosthesis during and after implantation.
En effet, la variation de longueur susceptible de se produire au cours de la dilatation est absorbée par la déformation des lignes brisées correspondantes.Indeed, the variation in length likely to occur during expansion is absorbed by the deformation of the corresponding broken lines.
L'endoprothèse peut être réalisée à partir d'un tube de diamètre et d'épaisseur choisis en fonction du diamètre à atteindre après déploiement. Le choix du nombre de motifs centraux sur une longueur donnée permettra d'optimiser la souplesse finale et le déploiement total et symétrique de l'endoprothèse à un diamètre donné.The stent can be produced from a tube of diameter and thickness chosen according to the diameter to be reached after deployment. The choice of the number of central patterns over a given length will optimize the final flexibility and the total and symmetrical deployment of the endoprosthesis at a given diameter.
L'endoprothèse peut être réalisée dans tout matériau implantable propre à être découpé et/ou mis en forme par tout moyen approprié. Il est préférentiellement réalisé en acier inoxydable 316 LVM aux caractéristiques élastiques adaptées à cette utilisation. Il peut également être revêta par tout matériau implantable dans le but d'améliorer son hémocompati bilitc ou de permettre la diffusion de substances médicamenteuses actives contre la prolifération cellulaire responsable des phénomènes de resténoses. Il peut enfin être réalisé dans un matériau biodégradable pour des indications de stents temporaires.The stent can be made of any implantable material capable of being cut and / or shaped by any suitable means. It is preferably made of 316 LVM stainless steel with elastic characteristics suitable for this use. It can also be coated with any implantable material in order to improve its hemocompati bilitc or allow the diffusion of medicinal substances active against cell proliferation responsible for the phenomena of restenosis. Finally, it can be made of a biodegradable material for indications of temporary stents.
Les avantages ressortent bien de la description, en particulier on souligne et on rappelle :The advantages clearly emerge from the description, in particular it is emphasized and recalled:
- la structare maillée de l'endoprothèse vasculaire combine les avantages obtenus dans le cas d'endoprohèses tubulaires à maillage et des endoprothèses réalisées à partir de fils.- the mesh structure of the stent combines the advantages obtained in the case of tubular mesh endoprostheses and stents made from wires.
- la possibilité d'utiliser l'endoprothèse dans des cathéters de petit calibre distales, sinueuses ou calcifiées, ainsi que dans des artères de plus gros calibres tels que greffons veineux, artères périphériques, aortes, ou dans tout autre conduit. - the possibility of using the endoprosthesis in small distal, sinuous or calcified catheters, as well as in larger arteries such as venous grafts, peripheral arteries, aortas, or in any other conduit.

Claims

R E V E N D I C A T I O N SR E V E N D I C A T I O N S
-1- Endoprothèse vasculaire tabulaire et flexible présentant une structare maillée composée d'une pluralité de motifs déformables, caractérisé en ce que la structare est constituée :-1- Tabular and flexible stent with a mesh structare composed of a plurality of deformable patterns, characterized in that the structare consists of:
- d'une série de lignes droites parallèles (1) régulièrement réparties sur une circonférence,- a series of parallel straight lines (1) regularly distributed over a circumference,
- les lignes droites parallèles (1) sont raccordées par des lignes brisées symétriques (2 et 3), l'ensemble desdites lignes brisées présentant une forme géométrique et des dimensions déterminées pour assurer le déploiement de la structare d'une manière symétrique et régulière en ayant un recul élastique inférieur à 1%,- the parallel straight lines (1) are connected by symmetrical broken lines (2 and 3), all of said broken lines having a geometric shape and dimensions determined to ensure the deployment of the structare in a symmetrical and regular manner having an elastic recoil of less than 1%,
- chaque ligne droite (1) présente, entre les lignes brisées de raccordement (2 et 3) et d'une manière symétrique, des lignes brisées (4) présentant une forme géométrique et des dimensions déterminées pour conférer une souplesse à la structure tout en interdisant une variation de sa longueur.- each straight line (1) has, between the broken connecting lines (2 and 3) and in a symmetrical manner, broken lines (4) having a geometric shape and determined dimensions to give flexibility to the structure while prohibiting a variation of its length.
-2- Endoprothèse selon la revendication 1, caractérisée en ce que les motifs délimitent deux zones d'extrémité et au moins une zone intermédiaire, chaque zone étant constituée par les lignes brisées (2 et 3).-2- Endoprosthesis according to claim 1, characterized in that the patterns delimit two end zones and at least one intermediate zone, each zone consisting of the broken lines (2 and 3).
-3- Endoprothèse selon la revendication 2, caractérisée en ce que les lignes brisées de raccordement d'extrémités (2) sont constituées par deux segments rectilignes (2a - 2b) délimitant un V symétrique dont le sommet est dirigé à l'intérieur de la structare. -4- Endoprothèse selon la revendication 3, caractérisée en ce que les deux segments (2a - 2b) du V sont raccordés aux extrémités des lignes droites parallèles (1) correspondante par des segments rectilignes de longueur réduite orientés perpendiculairement auxdites lignes droites (1).-3- Endoprosthesis according to claim 2, characterized in that the broken end connection lines (2) consist of two rectilinear segments (2a - 2b) delimiting a symmetrical V whose apex is directed inside the structare. -4- Endoprosthesis according to claim 3, characterized in that the two segments (2a - 2b) of the V are connected to the ends of the parallel straight lines (1) corresponding by rectilinear segments of reduced length oriented perpendicular to said straight lines (1) .
-5- Endoprothèse selon la revendication 2, caractérisée en ce que les lignes brisées de raccordement intermédiaires (3) sont constitaées par trois segments rectilignes (3a - 3b - 3c) délimitant deux V identiques et opposés réunis par un segment commun (3b).-5- Endoprosthesis according to claim 2, characterized in that the broken intermediate connecting lines (3) are constituted by three rectilinear segments (3a - 3b - 3c) delimiting two identical and opposite V's joined by a common segment (3b).
-6- Endoprothèse selon la revendication 5, caractérisée en ce que les deux segments (3 - 3c) de chacun des deux V opposés, sont raccordés aux lignes droites parallèles correspondantes (1), par des segments rectilignes de longueur réduites orientés perpendiculairement auxdites lignes droites (1).-6- Endoprosthesis according to claim 5, characterized in that the two segments (3 - 3c) of each of the two opposite V's, are connected to the corresponding parallel straight lines (1), by rectilinear segments of reduced length oriented perpendicular to said lines straight (1).
-7- Endoprothèse selon la revendication 1, caractérisée en ce que les lignes brisées (4) de chacune des lignes droites (1), sont constituées par trois segments rectilignes (4a - 4b - 4c) délimitant deux V identiques et opposés réunis par un segment commun (4c) et symétriquement par les deux autres segments (4a --7- Endoprosthesis according to claim 1, characterized in that the broken lines (4) of each of the straight lines (1), are constituted by three rectilinear segments (4a - 4b - 4c) delimiting two identical and opposite V joined together by a common segment (4c) and symmetrically by the other two segments (4a -
4c) à chacune desdites lignes droites (1).4c) to each of said straight lines (1).
-8- Endoprothèse selon la revendication 1, caractérisée en ce que les lignes brisées (4) de chacune des lignes droites (1) sont disposées à égales distance de chacune des lignes brisées de raccordement (2 - 3). -9- Endoprothèse selon la revendication 1 , caractérisée en ce que quatre lignes droites parallèles (1) sont régulièrement décalées angulairement sur une circonférence. -8- Endoprosthesis according to claim 1, characterized in that the broken lines (4) of each of the straight lines (1) are arranged at equal distance from each of the broken connecting lines (2 - 3). -9- Endoprosthesis according to claim 1, characterized in that four parallel straight lines (1) are regularly angularly offset around a circumference.
PCT/FR1999/000989 1998-04-27 1999-04-27 Tubular and flexible vascular prosthesis WO1999055253A1 (en)

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FR9805588A FR2777771B1 (en) 1998-04-27 1998-04-27 TUBULAR AND FLEXIBLE VASCULAR ENDOPROSTHESIS

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US10213327B2 (en) 2000-08-17 2019-02-26 Angiomed Gmbh & Co. Medizintechnik Kg Implant with attached element and method of making such an implant
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US10231854B2 (en) 2006-05-18 2019-03-19 C. R. Bard, Inc. Bend-capable stent prosthesis
US9364353B2 (en) 2006-05-18 2016-06-14 C.R. Bard, Inc. Bend-capable stent prosthesis
US8152842B2 (en) 2006-08-21 2012-04-10 C. R. Bard, Inc. Self-expanding stent
US9254207B2 (en) 2006-08-29 2016-02-09 C.R. Bard, Inc. Annular mesh
US8500793B2 (en) 2006-09-07 2013-08-06 C. R. Bard, Inc. Helical implant having different ends
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US8721709B2 (en) 2007-09-07 2014-05-13 C. R. Bard, Inc. Self-expansible stent with radiopaque markers and method of making such a stent
US10314947B2 (en) 2010-04-19 2019-06-11 Angioscore, Inc. Coating formulations for scoring or cutting balloon catheters
US10471184B2 (en) 2010-04-19 2019-11-12 Angioscore, Inc. Coating formulations for scoring or cutting balloon catheters
US9173977B2 (en) 2010-04-19 2015-11-03 Angioscore, Inc. Coating formulations for scoring or cutting balloon catheters
US9364254B2 (en) 2010-09-21 2016-06-14 Angioscore, Inc. Method and system for treating valve stenosis
US10736652B2 (en) 2010-09-21 2020-08-11 Angioscore, Inc. Method and system for treating valve stenosis
US10485571B2 (en) 2013-10-08 2019-11-26 Angioscore, Inc. Balloon catheter with non-deployable stent having improved stability
US10117668B2 (en) 2013-10-08 2018-11-06 The Spectranetics Corporation Balloon catheter with non-deployable stent having improved stability

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FR2777771B1 (en) 2000-08-25
WO1999055253B1 (en) 1999-12-02
AU3428099A (en) 1999-11-16

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