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
  • A61F2002/91525—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
  • A61F2002/91541—Adjacent bands are arranged out of phase
• • 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

Definitions

• the invention relates to a stent for a cavity or anatomical conduit, and in particular for a blood vessel.
• a stent for a cavity or anatomical conduit and in particular for a blood vessel.
• the invention applies in particular to wideners (or dilators) of vessels commonly called “stents”.
• the invention aims to provide a stent which effectively supports the vascular wall, which can be placed in tortuous places, which has a small footprint in its radially tightened implantation state, which can be radially deployed under the effect of a radial internal force (in particular obtained by means of at least one expansion balloon) and which has mechanical and shape characteristics such that it can adapt in particular to vessels coronary, that its implantation can be carried out safely and which does not risk disturbing the anatomical canal, once implanted.
• a radial internal force in particular obtained by means of at least one expansion balloon
• an important characteristic of the invention consists in that the endoprosthesis comprises a one-piece tabular structure having longitudinal stays, extending along a succession of broken lines (that is to say in the form of waves) overall. parallel to the general axis radially to which the structure is deployable, the broken lines having vertices connected by intermediate sections and being arranged substantially in phase (that is to say possibly with a slight phase shift), two adjacent struts, arranged side by side, being interconnected by crosspieces.
• this form was “in broken lines” (or in the form of waves in the radially tightened state of the stent) extending substantially in the longitudinal direction of the stent promotes the adaptation of the tortuous vessels and a efficient match between flexibility and mechanical strength of the prosthesis, while offering a very small diameter in the tightened state and cells of appropriate sizes in the radially deployed state.
• the endoprosthesis of the invention is such that its crosspieces are distributed by transverse lines (preferably directed generally substantially perpendicular to the general axis of the endoprosthesis, at least in the state radially constricted thereof) and that these same crosspieces are either first crosspieces defining cusps, each creating an axial discontinuity along the two struts thus connected, or second crosspieces connecting together two adjacent struts, while now maintaining the "axial" continuity of each of these struts.
• this line turns back at least twice, substantially as a hairpin, a first time at the location of a first axial discontinuity, then presenting two sections arranged side by side, up to another axial discontinuity, located at another location on the general axis of the structure, where said line will preferably turn back a second time substantially as a hairpin, then presenting a third section extending substantially parallel to the first two, next to them, up to a second crosspiece located in alignment of the first discontinuity in a transverse direction (substantially perpendicular) to the general axis of the structure.
• another preferred characteristic of the invention recommends that at least some of the crosspieces s 'extend, in an oblique direction relative to the general axis of the stent, each between two adjacent props.
• the shape of the stent in its radially deployed state is also characteristic.
• the endoprosthesis advantageously has a terminal flare at each of its free ends, at the place where this endoprosthesis has radial stages (respectively first and last) each materialized by strands of material drawing radial undulations (substantially large zig-zags) having a height (markedly) axially greater than that of the undulations of the intermediate stages.
• an additional characteristic of the invention advises that at least some of the aforementioned crosspieces connect two vertices located at the same level along the general axis and belonging to two adjacent props arranged side by side, these crosspieces s articulating between a radially constricted state of the endoprosthesis and a radially expanded state, to pass from an orientation substantially parallel to two sections (themselves parallel) belonging respectively to said two adjacent stays, to an orientation substantially perpendicular to the axis general of the stent.
• the struts and the crosspieces concerned define cells individually adding a substantially "Z" shape in a radially constricted state of the endoprosthesis and a substantially hexagonal shape in its radially deployed state.
• FIG. 1 an enlarged anatomical duct (or “stent”) according to the invention is illustrated, in a state radially constricted of it (representation developed flat),
• FIG. 2 is an enlarged view of the detail marked II in FIG. 1
• FIG. 3 is a view of the stent of FIG. 1 in a radially deployed state and on a reduced scale
• FIG. 4 shows an alternative embodiment of the expander in a view identical to that of Figure 1
• - Figure 5 shows in enlarged view the detail marked N in Figure 4 (radially tightened state of the expander).
• FIG. 6 shows another variant of FIG. 1,
• FIG. 9 shows a possibility of inclination of sleeper lines when at least some of them are located at the adjacent vertices of the broken lines of props
• - Figure 10 shows the endoprosthesis of Figure 3 closed on it- even, with its end flares (reduced scale, with cutouts)
• FIG. 11 shows on a reduced scale an alternative embodiment of the endoprosthesis of the invention
• FIG. 12 shows an enlarged view at the location of the reference XII of FIG. 11,
• FIG. 13 shows the shape of a stent cell in the radially expanded, or deployed, state thereof.
• FIGS. 1, 3, 4 and 6 the expander which has been shown has been shown in a view developed flat, the parts cut laterally to the left continuing at the right lateral end.
• the structure illustrated is presented as a tubular structure with a longitudinal axis la for the structure marked 1 in FIG. 1, with a form of cylindrical tube of circular section.
• it is a widener (or “stent") for blood vessel, and in particular for coronary or iliac vessel.
• the expander 1 is presented as a one-piece metal structure.
• it is a thermal shape memory alloy (usually called "NITINOL®") consisting of an alloy of nickel and titanium which can be obtained by laser cutting or by electroerosion, from a plate. planar which is then closed on itself or, directly, from a cylindrical tube of circular section with solid wall which is cut to obtain the desired design.
• NITINOL® thermal shape memory alloy
• the implant thus formed is a metal alloy which allows the implant thus formed to remain in an established (stable) austenitic state after being thermally activated.
• the alloy concerned makes it possible in particular to widen a conduit, such as a vessel.
• a conduit such as a vessel.
• shape memory alloys is also provided in column 5 lines 25 to 55 of EP-B-0 585 326.
• the thickness of the strands or branches of material 3 constituting the structure of the endoprosthesis 1 can be d '' about 0.2 to 0.3 mm, with a strand width h (see Figure 2) of about 0.1 to 0.15 mm.
• the length of the structure can be from 15 to 120 mm approximately.
• the structure 1 comprises a succession of props (3a, 3b, 3c ... 3g) extending along a succession of broken lines in the form of waves (location identical to that struts), these lines extending in a general direction parallel to the longitudinal axis la.
• each line is presented as a branch section having a succession of vertices, such as 5a, 5b, 5c, for part of the forestay 3f, these vertices (or apex) being separated in pairs by straight connecting sections such as 7a, 7b.
• the broken lines, or the props, thus defined are arranged side by side, in phase, that is to say that at the location of a line such as 9 perpendicular to the axis la, the was 3a ... 3g have a vertex, all the vertices along this line 9 being directed in the same direction, that is to say in this case with a fold oriented to the left of the figure.
• two adjacent forestays arranged side by side are interconnected by crosspieces, such as 11a and 11b for these transverse links located between the vertices 5c and 5d.
• the first sleepers on the contrary constitute, individually, each time a double bond which, while connecting two adjacent stays, arranged side by side, breaks the continuity of each of the stays concerned along its broken line, thus defining a cusp. rounded, as can be clearly seen in FIG. 2 at the place of the two elementary sleepers 11a, 11b which together form a so-called "first sleeper" between the stays 3e and 3f.
• both the second crosspieces (such as 13a, 13b) constitute not only a transverse connection of two stays between them, but also a "longitudinal” or “axial” connection by not interrupting the continuity of said stays along their line. respective broken, as much the first sleepers (such as lia, 11b) define discontinuities
• the second crosspieces their length, equal to the thickness e of the space (void) which they interrupt between two adjacent stays, will advantageously be in the radially tightened state of the prosthesis as illustrated in FIG. 2 , less than the width of these same second sleepers measured perpendicular to the thickness e. In particular, will be twice as large as e, thus ensuring a solid, full bond.
• the crosspieces are, by perpendicular lines thus defined, aligned by group of crosspieces, from place to place. place, along the axis la.
• the corresponding section of the elementary branch 3 of material which connects these crosspieces travels as follows: it is a broken line generally parallel to the axis la and that firstly follows part of the forestay 3d, up to the transverse line 15b where the section of forestay 3d turns back, substantially in a hairpin, at the location of th element of first cross-member forming a rounded apex 21a, thus allowing (by this cusp) a connection between the aforementioned section of forestay 3d and the adjacent section 3e of the forestay whose broken line, parallel to the first, extends up to the line of sleepers 15a where a second cusp area appears at the location of the element of the first sleeper (or discontinuity area) rounded already mentioned, 11b, where the forestay section 3e joins the section of forestay following 3f which, itself, descends (again parallel to the previous two) against the second (3rd) to join the second
• the structure presented defines closed cells as marked 23 and 25 in FIGS. 1 or 2, for two of them (these are cells located away from the free ends 10a and 10b). These two cells are identical to each other and to the others, except as regards the cells extending at the location of said free ends.
• these cells In the tightened state of the structure, these cells have a shape defined by several broken lines (that is to say in the form of waves) arranged side by side in a direction parallel to the axis la and which are connected between they, two by two adjacent, at the location of the first corresponding crosspieces that are found in this case along the line 15b, in the example illustrated.
• the cells that have just been presented have, in this tightened state of the structure, a sort of substantially "H” shape, the branches of the "H” each having a wavy shape, in waves.
• each wavy line defining a stage is presented as an uninterrupted succession of "N" oriented alternately towards an axial end 10a, then the other 10b.
• These "Vs, which are slightly oblique, have broken apex zones, tilted sideways alternately to the right, then to the left in the figure, depending on whether you follow an" erect V “or, following it "Inverted V” (see references 51, 52).
• two adjacent stages 30, 40 or 40, 50 are periodically connected to each other (in this case all three “erect V"), by a "second crosspiece” , such as 13c, 13e, therefore each defined by an oblique "H” (see also 13f, 13g).
• the prosthesis 1 is flared, that is to say that it has substantially two truncated cones widening towards the corresponding free end.
• the guidelines of these "truncated cones" can be arched, with an internal convexity.
• the prosthesis will thus be better pressed against the internal wall of the vessel, at these ends.
• first sleepers but only “second sleepers” at the location of the sleeper lines identical to those of the two aforementioned figures.
• the adjacent struts such as 3 ′ a, 3 ′ b, 3 ′ c, 3 ′ are successively connected two by two (3 'a, 3'b and 3'c, 3'd) only by a "second crosspiece", respectively 13'a and 13'b, these crosspieces, like the others, in no way interrupting the axial continuity of the props, this which gives a more rigid structure.
• the cells thus defined by the struts and crosspieces are therefore themselves different from those of structure 1.
• FIG. 6 differs from that of FIG. 1 in that the sleepers of the sleeper lines 15'a, 15'b, 15'c, are the image in the mirror of the sleeper lines 15 ' d, 15'e, 15'f (that is to say symmetrical with respect to a plane perpendicular to the axis l'b of the prosthesis 100 shown). 13
• this prosthesis 100 in its radially deployed state will appear like prosthesis 1 in FIG. 3, except as regards the orientation of the second crosspieces substantially in the shape of "H" located on the lower part, this orientation corresponding of course to that shown in Figure 6 (lines 15'a, 15'b, 15'c).
• FIG. 7 has a "stent" zone been shown at the location of such a vertex which could, for example, correspond to the line of vertices comprising the apex 5c of FIG. 2, with the exception that in the embodiment of Figure 7, the "cross lines” and the “vertex lines” (both perpendicular to the general axis of the stent cylinder) are merged.
• FIG. 7 is it found successively, along the line 71, perpendicular to the general axis schematized the c of the stent, a double first cross-member ll "a, ll" b, a second cross-member 13 "a, arched, then again two first double sleepers.
• Such an embodiment cannot in particular constitute a transition zone between the lower and upper parts of the widener 100 of FIG. 6, thus making it possible to pass from an inclination in one direction to an inclination in the other, of the second crosspieces , between the top and the bottom of the figure.
• second sleepers such as 130a, 130b, 130c, arranged in staggered rows, as are the second sleepers of Figures 1, 3, 4 or 6, in particular. Note the orientation alternately to the left, then to the right, of these curved crosspieces, similarly for the double "first crosspieces", at each remaining vertex
• the stent 20 of Figure 11 shown there in its constricted state is a one-piece structure defined by a metallic design capable of being obtained by chemical erosion and / or laser cutting.
• the metal used can be stainless steel (INOX 316L), or even other materials which can be used in anatomical conduits, such as, for example, "NITINOL®"
• the structure is tubular, of circular section, of longitudinal axis la and can be deployable (if made of steel) under the effect of a radial deployment force which can be obtained via a catheter terminated by an inflatable balloon around which the stent 1 is arranged for its implantation, as described in particular in US-A-4,733,665.
• the longitudinal struts in "zigzags" 22a, 22b, ..., 22d of the stent 20 are arranged substantially in phase, from one broken line to the other, along the axis 20a.
• crosspieces connect at least some of the convex zones, in this case substantially the vertex zones 26, of two adjacent zigzag struts, that is to say neighbors (such as struts 22a and 22b or 22b and 22c, by example.
• the cross section of the crosspieces is first of all less than that of the stays (for example, less width for the same thickness).
• the crosspieces also have two opposite articulation zones, such as 24a, 24b for the crosspiece 24 at the top left in FIG. 12.
• each cross member is essentially rectilinear, except at the location of its articulation ends (such as 24a, 24b) where it is attached to the vertices 26 of corresponding props, said cross members individually have a generally " S “or” Z "in the radially tightened state of the structure.
• each cross member extends essentially in a manner substantially parallel to the sections of forestay whose summits it connects, on the convex side. 16
• the crosspieces are well deformed so as to be substantially straight in this case and oriented essentially perpendicular to the axis 20a of the structure.
• each cell of the structure is defined by two sleepers staggered along two neighboring stays, this on two sides, and by the sections of these stays located between said two sleepers, on the four other sides.

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• 1999
  • 1999-02-02 WO PCT/FR1999/000207 patent/WO1999039660A1/fr not_active Application Discontinuation
  • 1999-02-02 EP EP99901682A patent/EP1052950A1/de not_active Withdrawn

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