WO1994004096A1 - Expansible tubular prosthesis - Google Patents

Expansible tubular prosthesis Download PDF

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Publication number
WO1994004096A1
WO1994004096A1 PCT/FR1993/000798 FR9300798W WO9404096A1 WO 1994004096 A1 WO1994004096 A1 WO 1994004096A1 FR 9300798 W FR9300798 W FR 9300798W WO 9404096 A1 WO9404096 A1 WO 9404096A1
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WO
WIPO (PCT)
Prior art keywords
prosthesis
diameter
prosthesis according
meters
state
Prior art date
Application number
PCT/FR1993/000798
Other languages
French (fr)
Inventor
Jean-Jacques Menou
Jean-François DUMON
Original Assignee
Novadis
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 Novadis filed Critical Novadis
Publication of WO1994004096A1 publication Critical patent/WO1994004096A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/92Stents in the form of a rolled-up sheet expanding after insertion into the vessel, e.g. with a spiral shape in cross-section
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0014Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
    • A61F2210/0019Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation

Definitions

  • the present invention relates to an expandable tubular prosthesis capable of being inserted into an anatomical conduit of the human body or of an animal, and its introduction device.
  • the technical field of the invention is that of the manufacture of anatomical prostheses.
  • the present invention relates in particular to tubular prostheses capable of expanding radially after having been introduced into an anatomical canal of the human body, for example such as a bronchus, the trachea, a blood vessel, the esophagus, etc.
  • a first category of prostheses is of cylindrical shape, elongated along the longitudinal axis of the cylinder; the profile or contour of the section of such a prosthesis, in a plane perpendicular to the longitudinal axis of the cylinder, is closed.
  • the radial expansion of the prosthesis is generally accompanied by a reduction in the length of the prosthesis; this expansion which may require significant mechanical forces is generally carried out by inflating a balloon that the prosthesis surrounds.
  • Such prostheses are for example described in US Pat. No. 5,123,917 (LEE) which relates to a prosthesis which has an inner tubular casing, possibly an outer tubular casing, as well as stiffening rings which are linked to at least one of the two tubular envelopes which are deformed beyond their elastic limit in the expanded state; the envelopes are made of polytetrafluoroethylene; the stiffening rings are either closed, in the form of a zigzag, or open, according to a helical line.
  • LEE US Pat. No. 5,123,917
  • the NIPPON ZEON documents describe a stent delivery catheter for permanently dilating a blood vessel;
  • the stent is made of shape memory material and consists of a helically wound wire, a leaf spring, a woven tube or a laminated and machined sheet; the prosthesis is expanded by heating using a physiological saline solution injected at a temperature of 50 °; the transition temperature of the material forming the prosthesis being between 38 and HB-C.
  • the ANGIOMED document describes a shape memory alloy prosthesis whose transition temperature is between ambient temperature and body temperature, for example between 30 and 35 ° C.
  • the prosthesis can pass from an unexpanded state, corresponding to a temperature below the transition temperature, in which it is wound, in the form of a spiral, to an expanded state, corresponding to a temperature higher than the transition temperature, in which it is in the form of a cylinder.
  • the object of the present invention is to improve the known tubular prostheses which are introduced into an anatomical duct, particularly into a duct of the respiratory or digestive tracts, in a folded (or wound) state in a spiral according to a diameter less than the diameter of the duct, and remedy the drawbacks of known prostheses.
  • Prostheses of the first category are very inflexible and require significant efforts for their expansion and are unsuitable for conforming to local irregularities, in terms of diameter and curvature of the longitudinal axis of an anatomical conduit.
  • this type of prosthesis is difficult to deposit once the installation has been carried out, which may be made necessary in particular in the case of the installation of a prosthesis intended to stem the development of tumor and as well as in a general case due to the development and tissue growth near this prosthesis.
  • the essentially metallic prostheses constituted by a winding of wires or a mesh of tubular shape are
  • REPLACEMENT SHEET quickly invaded and encompassed by the development of the tissues against which the prostheses are pressed during installation, which also prevents their subsequent removal.
  • Prostheses of the second category which are more flexible than those of the first category nevertheless remain relatively rigid and unsuitable for irregularities in an anatomical canal, particularly when they are made from a sheet or a metallic tissue.
  • the disadvantage of the prostheses described in the document ANGIOMED is that they do not prevent, in their expanded configuration of cylindrical shape, the proliferation of tissues and the invasion of the anatomical conduit by these tissues.
  • the problem posed therefore consists in providing a radially expandable tubular prosthesis, the walls of which are not too thick, which is very flexible, easy to implant, in particular using the operating channel of a fibroscope, which may possibly be subsequently deposited and which helps prevent tissue overgrowth.
  • the solution to the problem posed consists in providing a prosthesis, or endoprosthesis, of generally substantially cylindrical, tubular shape, intended to be introduced into an anatomical canal such as a bronchus, a trachea or a blood vessel of the human body or of an animal.
  • said prosthesis has a cross section in the form of a spiral, and the longitudinal edges of said prosthesis overlap or overlap in
  • said prosthesis further comprises a longitudinal reinforcement, preferably metallic and filiform, substantially rectilinear, which extends between the thin sheets in the vicinity of one of the longitudinal edges of said prosthesis, and at in the vicinity of one end of said circumferential or transverse reinforcement, which longitudinal reinforcement is not mechanically linked directly to said circumferential or transverse reinforcement.
  • a longitudinal reinforcement preferably metallic and filiform, substantially rectilinear, which extends between the thin sheets in the vicinity of one of the longitudinal edges of said prosthesis, and at in the vicinity of one end of said circumferential or transverse reinforcement, which longitudinal reinforcement is not mechanically linked directly to said circumferential or transverse reinforcement.
  • the two ends of said longitudinal reinforcement are curved, for example by an angle close to 30 ° to 90 ° and tapered, and said ends pass through the external sheet of said prosthesis and are prominent and protrude from said external sheet by a length measured radially and for example close to 2.10 ⁇ 4 meters to 5-10 ⁇ ⁇ meters, so as to facilitate mooring or anchoring of the prosthesis during its installation.
  • said transverse reinforcements are made of a material or alloy with shape memory, comprising of the order of 50 to 55% of nickel and comprising of the order of 4 to 50% of titanium.
  • Each of said sheets may comprise fibers, preferably woven fibers, of synthetic plastic material, impregnated with silicone.
  • said transverse elements or reinforcements are regularly spaced, are metallic, of small thickness and of flattened section.
  • each of said sheets has a thickness close to 1.10 " ⁇ meter (0.1 mm) to 1.10 ⁇ 3 meter (1 mm), preferably close to 2 to 3 10" ⁇ meter, and is cut into a substantially rectangular shape, and the total thickness of the prosthesis being less than 2.10 ⁇ 3 meter (2 mm), for example close to 4.10 " ⁇ meter to 5.10 ⁇ 4 meter.
  • said diameter Di in the folded or wound state is at least equal to 1.2, for example close to 2, said diameter D3 in the expanded state is slightly greater than the internal diameter D2 of the channel in which said prosthesis is intended to be introduced.
  • said fibers and / or said fabric mainly consist of dacron.
  • said sheets are assembled by a translucent silicone adhesive.
  • said transverse reinforcements are arranged substantially in planes perpendicular to the longitudinal axis of said substantially cylindrical prosthesis, and said inter-axis of said transverse reinforcements is between 3-10 ⁇ 3 meters and 1.10 -2 meters and preferably said between- axis is between 5-10 ⁇ 3 meter and 8.10 ⁇ 3 meter.
  • said transverse reinforcements and said longitudinal reinforcement have a thickness of the order of 1.10-4 meters to 2.10- meters and have a substantially rectangular or oval section close to 1 to 3-10 ⁇ 7 m 2 ; said longitudinal reinforcement can be mainly made of stainless steel, or of shape memory alloy.
  • Said fibers can be placed on the internal part of an internal sheet forming part of said sheets and can be placed on the external part of an external sheet, so that the internal face of said prosthesis is smooth, and so as to that the external face of said prosthesis is slightly rough.
  • a prosthesis according to the invention can be introduced by an introduction device which comprises a cannula, or "candle", preferably for single use, substantially cylindrical, flexible, for example made of PVC or polyethylene, tapered, or profiled, substantially frustoconical at one end and comprising at least one substantially circumferential groove, of substantially rectangular section, preferably located in a cylindrical part of said cannula, near said tapered frustoconical end, the depth of which is close to, for example little greater than , the total thickness of said prosthesis and the length of which is little greater than the length of said prosthesis; said cannula has an outer diameter D4 close, for example slightly greater, than said diameter D1 of said prosthesis to
  • REPLACEMENT SHEET the wound state which insertion device preferably further comprises a jacket, for example metallic, or a flexible tubular sheath, for example of polytetrafluoroethylene, of internal diameter D close to said external diameter D4 of said cannula, of small thickness, of length at least equal to the length of the cylindrical part of said cannula, which jacket is capable of intimately surrounding said cannula and said prosthesis in the coiled state disposed in said groove of said cannula, and capable of holding said prosthesis at inside said groove, until said prosthesis is positioned in the channel of the human or animal body in which it is to be implanted.
  • a jacket for example metallic, or a flexible tubular sheath, for example of polytetrafluoroethylene, of internal diameter D close to said external diameter D4 of said cannula, of small thickness, of length at least equal to the length of the cylindrical part of said cannula, which jacket is capable of intimately surrounding said cannula and said prosthesis in the c
  • this smooth internal surface makes it possible to avoid the deposition of secretions inside this prosthesis; the invention also makes it possible to obtain a prosthesis having a reduced wall thickness as well as easier positioning, not requiring a sophisticated and / or bulky tool or introduction device. Furthermore, thanks to the presence of said elastic transverse frames, despite the small thickness of the prosthesis, good resistance to crushing is provided.
  • prostheses of which said large diameter D3 has been chosen very slightly greater than the internal diameter D2 of the conduit in which the prosthesis is implanted so, on the one hand, that it does not not reduce the free passage in the channel and on the other hand, not to cause significant mechanical force which would lead to significant local deformation of this channel; in fact the mechanical reaction exerted by the tissues in which a prosthesis is implanted generally ends up canceling out; therefore, one of the characteristics of the invention is to introduce said prosthesis into
  • said radially expandable tubular prosthesis is such that in its unfolded or unrolled state where it takes a substantially cylindrical tubular shape of circular section having for diameter said diameter D3, state in which said wall of said prosthesis, in particular said elastic reinforcements are in a state of substantially zero mechanical stress, and in which the longitudinal edges of said prosthesis are not placed edge to edge, but overlap (overlap) so as to constitute a channel substantially cylindrical; a fortiori, when said prosthesis is implanted in a tubular channel of the human or animal body, when it expands radially and takes as initial diameter (after its introduction into said channel) a diameter substantially equal to the diameter D2 of said channel, said edges longitudinal of said prosthesis also overlap, and still overlap when said prosthesis has reached its state of zero stress by residual radial expansion inside said channel where it was implanted, until it fits into said large diameter D3 so that any penetration or proliferation of living tissue inside the cylindrical duct of said prosthesis is thus avoided.
  • REPLACEMENT SHEET particular embodiments of prostheses according to the invention.
  • Figure 1 illustrates in plan view a prosthesis in a manufacturing stage prior to winding (to deformation) thereof.
  • Figure 2 is a section on II.II of Figure 1.
  • Figure 3 schematically illustrates a prosthesis according to the invention in its folded state in which it can be stored and introduced into a human or animal body, for example by 1 ' intermediary of the working channel of a fibroscope.
  • Figure 4 schematically illustrates a prosthesis according to the invention in its free state.
  • the figure schematically illustrates a prosthesis according to the invention implanted in a tubular channel.
  • FIG. 6 schematically illustrates a device for introducing a prosthesis according to the invention.
  • FIG. 7 illustrates in partial longitudinal section, a prosthesis equipped with a longitudinal reinforcement.
  • said prosthesis shown in this figure in an intermediate stage of manufacture before it is wound along an axis XXI which will constitute the substantially symmetrical longitudinal axis of said tubular prosthesis, said prosthesis represented in plan view and generally extending along a plane, comprises said sheets 3 cut in a substantially rectangular shape bounded by 2 longitudinal edges 31 and 2 transverse end edges 3t.
  • each of said sheets 3 qi is preferably made of medical grade silicone elastomer, translucent, for example of hardness of the order of 50 to 70 Shore A, can be reinforced with a fabric of dacron fiber and is cut to said rectangular shape according to a width 8 of sheet which will correspond to the length marked 8 of the tubular prosthesis in FIG. 3 after winding of the latter, and a transverse length 7 which is substantially greater than the circumference corresponding to said diameter D3 of the prosthesis wound in the free state (in the state of zero stress) so as to allow said overlapping of the longitudinal edges of the wound prosthesis (marked 3l in FIG. 4) corresponding to the longitudinal edges marked 3l of said rectangular sheet .
  • This overlap zone can for example be constituted by the longitudinal end of a first of said sheets, the length of which is greater than the length of the second sheet of said prosthesis, itself greater than said length 6 of said transverse reinforcements.
  • said overlap zone (marked 30 in FIG. 4) comprises a substantially straight, filiform frame 3, substantially parallel to the longitudinal axis XXI of said prosthesis, the central rectilinear part of which is located between said internal and external sheets. , in the vicinity of a 2nd end of said transverse reinforcements, without being rigidly linked to these; the ends ⁇ ⁇ 2 (marked 2 in FIG. 7) extending or ending said central part of said longitudinal reinforcement 31 (marked 1 in FIG. 7) are bent outwards, substantially radially, pass through said external sheet and are slightly prominent , so as to facilitate anchoring and immobilization of said prosthesis in said anatomical duct.
  • said ends 2 are curved towards the outside of said prosthesis, at an angle 50 of between 30 ° and 90 e , for example close to 45 ° to 75 ° •
  • said longitudinal reinforcement is made of flexible stainless steel so as to allow a curvature of said prosthesis along its longitudinal axis
  • said transverse reinforcements produced in a shape memory alloy are "educated” (by heat treatment for example, prior to their assembly with said sheets) so that at a temperature close to 37 ° C said transverse reinforcements are in a free state, elastic, curved according to a diameter D3, and so that at a temperature close to 20 ° C for example said transverse reinforcements are in a "plastic” state facilitating their handling and their winding according to a diameter Dl.
  • said width 8 of said sheet 3 corresponding to the length of the wound prosthesis may be of the order of 20 to 70 millimeters and the length 7 may be slightly greater than the circumference corresponding to diameters D3 ranging from 8 to 18 mm for example for bronchial prosthesis applications, said length 7 being greater than said
  • REPLACEMENT SHEET circumference from 2 to 6 millimeters approximately for example.
  • said prosthesis comprises transverse reinforcements 2 regularly spaced apart by a pitch 4, parallel to each other, of small width 5 for example close to a millimeter, and whose length 6 is less than the length 7 of said sheet 3 so as to leave at each longitudinal end of said sheet 3 a zone of width 9 devoid of said transverse reinforcements and in which said longitudinal reinforcement can extend; said transverse reinforcements extend perpendicular to the axis XXI which will constitute the axis of the cylindrical shape of the wound prosthesis and are arranged at a distance 10 from the transverse edges 3t for example of the order of at least 1 mm, said distance 4 separating 2 said adjacent transverse reinforcements 2 which can be of the order of approximately 5 mm to 10 mm depending on the applications; thanks to this structure it is possible to obtain, once said prosthesis is wound (as shown in FIGS.
  • a substantially cylindrical prosthesis which is radially expandable and which is capable of being bent, that is to say that said tubular prosthesis can be deformed along its longitudinal axis so as to be implanted in curved cylindrical conduits such as bent or curved channels.
  • said cylindrical prosthesis advantageously comprises said two sheets 3l and 32 of silicone comprising fibers 11 which can for example be woven, said reinforcements 2 being provided between said sheets 3l and 32 which can be assembled together and with said frames by a sterile translucent silicone adhesive.
  • each of said sheets 3l and 32 has a low thickness 14, for example close to 2.10 ⁇ 4 meters and each of the frames also has a relatively small thickness of the same order of magnitude so as to produce a prosthesis whose wall formed by the assembly said sheets and said reinforcements at a thickness of the order of about 0.5 millimeters.
  • said internal sheet 31 which is arranged in the lower part of the figure and which is intended to constitute the internal face 12 of said prosthesis once it has been wound up, is provided of said fibers
  • REPLACEMENT SHEET 11 which are located in the upper part of said sheet 31 so as not to be flush with the underside of said sheet 31 and thus ensure a surface or a soft, (smooth) face devoid of roughness; said second sheet 32 (external) on the other hand comprises, in this embodiment said fibers 11 arranged near the external face 13.
  • transverse reinforcements 2 can advantageously be of substantially rectangular section, and the angles of which can possibly be broken or rounded, which reinforcements can be produced from stainless steel for medical use, for example a cobalt steel alloy ( possibly containing molybdenum, nickel, chromium and manganese in particular) making it possible to provide it with high mechanical strength (for example of the order of 170 to 200 kg per millimeter 2 ), or else in a shape memory alloy.
  • a cobalt steel alloy possibly containing molybdenum, nickel, chromium and manganese in particular
  • said prosthesis once wound, can constitute a tubular conduit of length 8 and can pass from a wound state where it is inscribed in a cylinder of diameter Di advantageously less than 10 millimeters, in an unrolled state where it is substantially inscribed in a cylinder of diameter D3 which can for example vary from 12 to 16 millimeters in the case of bronchial prosthesis and this thanks to the elasticity of said transverse frames which have been preloaded beforehand in the case of steel frames; said prosthesis goes from the state shown in FIG. 3 to that shown in FIG.
  • said prosthesis which was introduced for example via the operating channel of a fibroscope, in the folded state, that is to say in a state where it occupies a diameter Di, was then released at the end of the fibroscope channel, in said anatomical tubular conduit 16, where it has expanded radially so as to press against the internal walls of said anatomical conduit 16 at a diameter D2; after this positioning of the prosthesis in the anatomical canal, due to the residual stresses existing in said elastic reinforcements (and / or the behavior of the shape memory material), said prosthesis continues to expand radially until it reaches said diameter D3 in which said reinforcements find zero stresses, while retaining a cross-sectional profile in the form of a spiral.
  • said prosthesis in a preferred mode of use of a prosthesis according to the invention, said prosthesis the is previously wound so as to occupy a substantially cylindrical volume whose diameter is said diameter Di, this inside a groove 19 provided in a cannula or candle 17 forming part of a device for introducing said prosthesis.
  • Said groove 19 is preferably arranged in the cylindrical part of said cannula 17. near the tapered end 18 thereof, which may have a substantially frustoconical shape; said groove 19 has a depth 20 close to the thickness (mark 15 in FIG. 2) and has a length 21 preferably close to the length (mark 8 in FIG. 3) of said prosthesis 1.
  • Said candle or cannula 17 is preferably hollow, crossed by a central channel 22 opening out, which allows the sliding inside said channel of a wire guide 24.
  • the introduction device also preferably comprises a flexible jacket 23, of reliable thickness, the internal diameter D5 of which is very close to the external diameter D of the cylindrical part of said cannula 17. so as to maintain said prosthesis inside said groove provided in said cannula, during the introduction of said prosthesis into the human or animal body.
  • the introduction process is as follows: first of all said filiform guide 24 is introduced into the anatomical duct 16 which is shown in FIG. 6 substantially cylindrical with an axis ZZ1; we
  • REPLACEMENT SHEET then introduces said cannula 17 carrying said prosthesis 1 in the wound state and coated externally with said jacket 23 holding said prosthesis, by sliding said cannula around said guide 24 through said channel 22 provided in said cannula; the sliding of said cannula relative to said guide 24 which takes place in the direction of the arrow Fi is stopped when a predetermined depth (which could for example have been identified on said cannula) has been reached, corresponding to the area of said anatomical canal 16 in which said prosthesis 1 is to be disposed; it is then possible, by pulling along arrow F2, keeping said cannula 17 substantially immobile, to remove said jacket 23 which causes the release of said prosthesis which unwinds and is pressed against the walls of said anatomical canal 16; said cannula and said metal guide can then be removed.
  • a predetermined depth which could for example have been identified on said cannula

Abstract

The present invention relates to an expansible tubular prosthesis capable of being introduced in an anatomical conduit of a human or animal body and to a device for introducing such prosthesis. A radially expansible tubular prosthesis (1) is comprised of a plurality of transversal elastic filiform braces (2) which are substantially parallel to each other, substantially similar, and a longitudinal brace (31) arranged between at least two thin sheets (3) of plastic material; the prosthesis is wound and its edges overlap. The technical field of the invention is the fabrication of anatomical prostheses.

Description

PROTHESE TUBULAIRE EXPANSIBLE EXPANDABLE TUBULAR PROSTHESIS
DESCRIPTION La présente invention est relative à une prothèse tubulaire expansible susceptible d'être introduite dans un conduit anatomique du corps humain ou d'un animal, et son dispositif d'introduction.DESCRIPTION The present invention relates to an expandable tubular prosthesis capable of being inserted into an anatomical conduit of the human body or of an animal, and its introduction device.
Le domaine technique de l'invention est celui de la fabrication de prothèses anatomiques.The technical field of the invention is that of the manufacture of anatomical prostheses.
La présente invention se rapporte notamment à des prothèses tubulaires susceptibles de s'expanser radialement après avoir été introduites dans un canal anatomique du corps humain par exemple tel qu' une bronche, la trachée, un vaisseau sanguin, l'oesophage....The present invention relates in particular to tubular prostheses capable of expanding radially after having been introduced into an anatomical canal of the human body, for example such as a bronchus, the trachea, a blood vessel, the esophagus, etc.
Parmi les prothèses tubulaires radialement expansibles connues, on peut distinguer deux catégories : une première catégorie de prothèses est de forme cylindrique, allongée selon l'axe longitudinal du cylindre; le profil ou contour de la section d'une telle prothèse, dans un plan perpendiculaire à l'axe longitudinal du cylindre, est fermé.Among the known radially expandable tubular prostheses, two categories can be distinguished: a first category of prostheses is of cylindrical shape, elongated along the longitudinal axis of the cylinder; the profile or contour of the section of such a prosthesis, in a plane perpendicular to the longitudinal axis of the cylinder, is closed.
De ce fait l'expansion radiale de la prothèse s'accompagne généralement d'une réduction de la longueur de la prothèse ; cette expansion pouvant nécessiter des efforts mécaniques importants est généralement effectuée par gonflage d'un ballonnet que la prothèse entoure.As a result, the radial expansion of the prosthesis is generally accompanied by a reduction in the length of the prosthesis; this expansion which may require significant mechanical forces is generally carried out by inflating a balloon that the prosthesis surrounds.
De telles prothèses sont par exemple décrites dans le brevet US5 123 917 (LEE) qui est relatif à une prothèse qui comporte une enveloppe tubulaire intérieure, éventuellement une enveloppe tubulaire extérieure, ainsi que des anneaux raidisseurs qui sont liés à l'une au moins des deux enveloppes tubulaires et qui sont déformés au delà de leur limite élastique dans l'état expansé ; les enveloppes sont réalisées en polytétrafluoroethylène ; les anneaux raidisseurs sont soit fermés, en forme de zigzag, soit ouverts, selon un tracé hélicoïdal.Such prostheses are for example described in US Pat. No. 5,123,917 (LEE) which relates to a prosthesis which has an inner tubular casing, possibly an outer tubular casing, as well as stiffening rings which are linked to at least one of the two tubular envelopes which are deformed beyond their elastic limit in the expanded state; the envelopes are made of polytetrafluoroethylene; the stiffening rings are either closed, in the form of a zigzag, or open, according to a helical line.
On connaît également des prothèses tubulaires radialement expansibles d'une deuxième catégorie dont le profil dans un plan perpendiculaire a leur axe longitudinal est en forme de spirale ; de telles prothèses sont par exemple décrites dans les brevets ou demandes de brevet FR2 617 721 et US4 969 890 (NIPPON ZE0N) ainsi queThere are also known radially expandable tubular prostheses of a second category whose profile in a plane perpendicular to their longitudinal axis is in the form of a spiral; such prostheses are for example described in the patents or patent applications FR2 617 721 and US4 969 890 (NIPPON ZE0N) as well as
FEUILLE DE REMPLACEMENT dans la demande de brevet EP 481 365 (ANGIOMED) .REPLACEMENT SHEET in patent application EP 481 365 (ANGIOMED).
Les documents NIPPON ZEON décrivent un cathéter de mise en place d'une endoprothèse permettant de dilater de façon permanente un vaisseau sanguin ; 1'endoprothèse est réalisée dans matériau à mémoire de forme et constitué par un fil enroulé en hélice, par un ressort en feuille, un tube tissé ou une feuille laminée et usinée ; la prothèse est expansée par chauffage à l'aide d'une solution saline physiologique injectée à une température de 50° ; la température de transition du matériau formant la prothèse étant comprise entre 38 et HB-C .The NIPPON ZEON documents describe a stent delivery catheter for permanently dilating a blood vessel; The stent is made of shape memory material and consists of a helically wound wire, a leaf spring, a woven tube or a laminated and machined sheet; the prosthesis is expanded by heating using a physiological saline solution injected at a temperature of 50 °; the transition temperature of the material forming the prosthesis being between 38 and HB-C.
Le document ANGIOMED décrit une prothèse en alliage à mémoire de forme dont la température de transition est comprise entre la température ambiante et la température du corps, par exemple comprise entre 30 et 35°C. Dans un mode de réalisation représenté figure 1 de ce document, la prothèse peut passer d'un état non expansé, correspondant à une température inférieure à la température de transition, dans laquelle elle est enroulée, en forme de spirale, à un état expansé, correspondant à une température supérieure à la température de transition, dans laquelle elle est en forme de cylindre.The ANGIOMED document describes a shape memory alloy prosthesis whose transition temperature is between ambient temperature and body temperature, for example between 30 and 35 ° C. In an embodiment shown in FIG. 1 of this document, the prosthesis can pass from an unexpanded state, corresponding to a temperature below the transition temperature, in which it is wound, in the form of a spiral, to an expanded state, corresponding to a temperature higher than the transition temperature, in which it is in the form of a cylinder.
La présente invention a pour objet d'améliorer les prothèses tubulaires connues qui sont introduites dans un conduit anatomique, particulièrement dans un conduit des voies respiratoires ou digestives, dans un état replié (ou enroulé) en spirale selon un diamètre inférieur au diamètre du conduit, et de remédier aux inconvénients des prothèses connues.The object of the present invention is to improve the known tubular prostheses which are introduced into an anatomical duct, particularly into a duct of the respiratory or digestive tracts, in a folded (or wound) state in a spiral according to a diameter less than the diameter of the duct, and remedy the drawbacks of known prostheses.
Les prothèses de la première catégorie sont très peu souples et nécessitent des efforts importants pour leur expansion et sont peu adaptées pour se conformer aux irrégularités locales, en termes de diamètre et de courbure de l'axe longitudinal d'un conduit anatomique.Prostheses of the first category are very inflexible and require significant efforts for their expansion and are unsuitable for conforming to local irregularities, in terms of diameter and curvature of the longitudinal axis of an anatomical conduit.
Par ailleurs ce type de prothèse est difficile à déposer une fois la pose effectuée, ce qui peut être rendu nécessaire notamment dans le cas de pose de prothèse destinée à endiguer le développement de tumeur et ainsi que dans un cas général du fait du développement et de la croissance des tissus à proximité de cette prothèse.Furthermore, this type of prosthesis is difficult to deposit once the installation has been carried out, which may be made necessary in particular in the case of the installation of a prosthesis intended to stem the development of tumor and as well as in a general case due to the development and tissue growth near this prosthesis.
Les prothèses essentiellement métalliques constituées par un enroulement de fils ou Dar un maillage de forme tubulaire sontThe essentially metallic prostheses constituted by a winding of wires or a mesh of tubular shape are
FEUILLE DE REMPLACEMENT rapidement envahies et englobées par le développement des tissus contre lesquels les prothèses sont appuyées lors de la pose, ce qui également empêche leur dépose ultérieure.REPLACEMENT SHEET quickly invaded and encompassed by the development of the tissues against which the prostheses are pressed during installation, which also prevents their subsequent removal.
Les prothèses de la deuxième catégorie, qui sont plus souples que celles de la première catégorie restent néanmoins relativement rigides et inadaptées aux irrégularités d'un conduit anatomique, particulièrement lorsqu'elles sont constituées à partir d'une feuille ou d'un tissu métallique.Prostheses of the second category, which are more flexible than those of the first category nevertheless remain relatively rigid and unsuitable for irregularities in an anatomical canal, particularly when they are made from a sheet or a metallic tissue.
Par ailleurs, l'inconvénient des prothèses décrites dans le document ANGIOMED est qu'elles n'empêchent pas, dans leur configuration expansée de forme cylindrique, la prolifération des tissus et l'envahissement du conduit anatomique par ces tissus.Furthermore, the disadvantage of the prostheses described in the document ANGIOMED is that they do not prevent, in their expanded configuration of cylindrical shape, the proliferation of tissues and the invasion of the anatomical conduit by these tissues.
Le problème posé consiste donc à procurer une prothèse tubulaire radialement expansible, dont les parois ne sont pas trop épaisses, qui soit très souple, facile à implanter notamment à l'aide du canal opérateur d'un fibroscope, qui soit éventuellement ultérieurement déposable et qui permette d'éviter la prolifération des tissus.The problem posed therefore consists in providing a radially expandable tubular prosthesis, the walls of which are not too thick, which is very flexible, easy to implant, in particular using the operating channel of a fibroscope, which may possibly be subsequently deposited and which helps prevent tissue overgrowth.
La solution au problème posé consiste à procurer une prothèse, ou endoprothèse, de forme générale sensiblement cylindrique, tubulaire, destinée à être introduite dans un canal anatomique tel qu'une bronche, une trachée ou un vaisseau sanguin du corps humain ou d'un animal, radialement expansible, de manière à pouvoir être conformée selon au moins deux états, un état replié ou enroulé de sorte qu'une section transversale de ladite prothèse a un profil en spirale et où ladite prothèse s'inscrit dans un cylindre de diamètre Di faible, et un état expansé (ou déroulé) où ladite prothèse s'inscrit dans une cylindre de diamètre D3 supérieur audit diamètre Di, laquelle prothèse est essentiellement constituée par plusieurs éléments (ou armatures) circonférentiels (ou transversaux) filiformes, élastiques, mécaniquement indépendants (c'est-à-dire distincts ou disjoints, c'est-à-dire ni jointifs ni rigidement liés entre eux), sensiblement parallèles entre eux, et perpendiculaires à l'axe longitudinal de ladite prothèse, sensiblement identiques, disposés entre au moins deux feuilles minces en matière plastique, assemblées par collage. Selon une des caractéristiques essentielles de l'invention, ladite prothèse a une section transversale en forme de spirale, et les bords longitudinaux de ladite prothèse se recouvrent ou se chevauchent dansThe solution to the problem posed consists in providing a prosthesis, or endoprosthesis, of generally substantially cylindrical, tubular shape, intended to be introduced into an anatomical canal such as a bronchus, a trachea or a blood vessel of the human body or of an animal. , radially expandable, so that it can be shaped according to at least two states, a folded or rolled up state so that a cross section of said prosthesis has a spiral profile and where said prosthesis is inscribed in a cylinder of small diameter Di , and an expanded (or unrolled) state where said prosthesis is inscribed in a cylinder of diameter D3 greater than said diameter Di, which prosthesis is essentially constituted by several circumferential (or transverse) filiform, elastic, mechanically independent elements (or transverse) ( that is to say distinct or disjoint, that is to say neither contiguous nor rigidly linked together), substantially parallel between e them, and perpendicular to the longitudinal axis of said prosthesis, substantially identical, arranged between at least two thin plastic sheets, assembled by gluing. According to one of the essential characteristics of the invention, said prosthesis has a cross section in the form of a spiral, and the longitudinal edges of said prosthesis overlap or overlap in
FEUILLE DE REMPLACEMENT la position ou l'état enroulé (ou comprimé) bien sur, mais également dans la position ou état déroulé (ou état libre) , de manière à éviter ou tout le moins à entraver la prolifération tissulaire à l'intérieur de la cavité sensiblement cylindrique délimitée par la paroi ou feuille interne de ladite prothèse.REPLACEMENT SHEET the rolled up (or compressed) position or state of course, but also in the unwound position or state (or free state), so as to avoid or at least hamper tissue proliferation inside the substantially cylindrical cavity delimited by the wall or internal sheet of said prosthesis.
Selon un mode préférentiel de l'invention, ladite prothèse comporte en outre une armature longitudinale, de préférence métallique et filiforme, sensiblement rectiligne, qui s'étend entre les feuilles minces au voisinage de l'un des bords longitudinaux de ladite prothèse, et au voisinage d'une extrémité desdites armatures circonférentielles ou transversales, laquelle armature longitudinale n'est pas liée mécaniquement directement auxdites armatures circonférentielles ou transversales.According to a preferred embodiment of the invention, said prosthesis further comprises a longitudinal reinforcement, preferably metallic and filiform, substantially rectilinear, which extends between the thin sheets in the vicinity of one of the longitudinal edges of said prosthesis, and at in the vicinity of one end of said circumferential or transverse reinforcement, which longitudinal reinforcement is not mechanically linked directly to said circumferential or transverse reinforcement.
Avantageusement, les deux extrémités de ladite armature longitudinale sont recourbées, par exemple d'un angle voisin de 30° à 90° et effilées, et lesdites extrémités traversent la feuille externe de ladite prothèse et sont proéminentes et dépassent de ladite feuille externe d'une longueur mesurée radialement et par exemple voisine de 2.10~4 mètres à 5-10~^ mètres, de manière à faciliter l'amarrage ou l'ancrage de la prothèse lors de sa mise en place.Advantageously, the two ends of said longitudinal reinforcement are curved, for example by an angle close to 30 ° to 90 ° and tapered, and said ends pass through the external sheet of said prosthesis and are prominent and protrude from said external sheet by a length measured radially and for example close to 2.10 ~ 4 meters to 5-10 ~ ^ meters, so as to facilitate mooring or anchoring of the prosthesis during its installation.
- Selon un mode particulier de réalisation, lesdites armatures transversales sont réalisées dans un matériau ou alliage à mémoire de forme, comportant de l'ordre de 50 à 55 % de nickel et comportant de l'ordre de 4 à 50 % de titane. Chacune desdites feuilles peut comporter des fibres, de préférence des fibres tissées, en matière plastique synthétique, imprégnées de silicone.- According to a particular embodiment, said transverse reinforcements are made of a material or alloy with shape memory, comprising of the order of 50 to 55% of nickel and comprising of the order of 4 to 50% of titanium. Each of said sheets may comprise fibers, preferably woven fibers, of synthetic plastic material, impregnated with silicone.
Selon un mode de réalisation de l'invention, lesdits éléments ou armatures transversaux sont régulièrement espacés, sont métalliques, de faible épaisseur et de section aplatie.According to one embodiment of the invention, said transverse elements or reinforcements are regularly spaced, are metallic, of small thickness and of flattened section.
Avantageusement chacune desdites feuilles a une épaisseur voisine de 1.10"^ mètre (0,1 mm) à 1.10~3 mètre (1 mm), de préférence voisine de 2 à 3 10"^ mètre, et est découpée selon une forme sensiblement rectangulaire, et l'épaisseur totale de la prothèse étant inférieure à 2.10~3 mètre (2 mm), par exemple voisine de 4.10"^ mètre à 5.10~4 mètre.Advantageously, each of said sheets has a thickness close to 1.10 "^ meter (0.1 mm) to 1.10 ~ 3 meter (1 mm), preferably close to 2 to 3 10" ^ meter, and is cut into a substantially rectangular shape, and the total thickness of the prosthesis being less than 2.10 ~ 3 meter (2 mm), for example close to 4.10 "^ meter to 5.10 ~ 4 meter.
Avantageusement, le rapport dudit diamètre D3 à l'état expanséAdvantageously, the ratio of said diameter D3 to the expanded state
FEUILLE DE REMPLACEMENT audit diamètre Di à l'état replié ou enroulé est au moins égal à 1,2, par exemple voisin de 2, ledit diamètre D3 à l'état expansé est légèrement supérieur au diamètre D2 interne du canal dans lequel ladite prothèse est destinée à être introduite. Avantageusement, lesdites fibres et/ou ledit tissu sont principalement constitués de dacron.REPLACEMENT SHEET said diameter Di in the folded or wound state is at least equal to 1.2, for example close to 2, said diameter D3 in the expanded state is slightly greater than the internal diameter D2 of the channel in which said prosthesis is intended to be introduced. Advantageously, said fibers and / or said fabric mainly consist of dacron.
Avantageusement lesdites feuilles sont assemblées par une colle silicone translucide.Advantageously, said sheets are assembled by a translucent silicone adhesive.
Avantageusement lesdites armatures transversales sont disposées sensiblement dans des plans perpendiculaires à l'axe longitudinal de ladite prothèse sensiblement cylindrique, et ledit entre-axe desdites armatures transversales est compris entre 3-10~3 mètre et 1.10-2 mètre et de préférence ledit entre-axe est compris entre 5-10~3 mètre et 8.10~3 mètre. Avantageusement, lesdites armatures transversales et ladite armature longitudinale ont une épaisseur de l'ordre de 1.10-4 mètre à 2.10- mètre et ont une section sensiblement rectangulaire ou ovale voisine de 1 à 3-10~7 m2 ; ladite armature longitudinale peut être principalement constituée d'acier inoxydable, ou bien d'alliage à mémoire de forme.Advantageously, said transverse reinforcements are arranged substantially in planes perpendicular to the longitudinal axis of said substantially cylindrical prosthesis, and said inter-axis of said transverse reinforcements is between 3-10 ~ 3 meters and 1.10 -2 meters and preferably said between- axis is between 5-10 ~ 3 meter and 8.10 ~ 3 meter. Advantageously, said transverse reinforcements and said longitudinal reinforcement have a thickness of the order of 1.10-4 meters to 2.10- meters and have a substantially rectangular or oval section close to 1 to 3-10 ~ 7 m 2 ; said longitudinal reinforcement can be mainly made of stainless steel, or of shape memory alloy.
Lesdites fibres peuvent être disposées sur la partie interne d'une feuille interne faisant partie desdites feuilles et peuvent être disposées sur la partie externe d'une feuille externe, de manière à ce que la face interne de ladite prothèse soit lisse, et de manière à ce que la face externe de ladite prothèse soit légèrement rugueuse.Said fibers can be placed on the internal part of an internal sheet forming part of said sheets and can be placed on the external part of an external sheet, so that the internal face of said prosthesis is smooth, and so as to that the external face of said prosthesis is slightly rough.
Une prothèse selon l'invention peut être introduite par un dispositif d'introduction qui comporte une canule, ou "bougie", de préférence à usage unique, sensiblement cylindrique, souple, par exemple réalisée en PVC ou polyéthylène, effilée, ou profilée, sensiblement tronconique à une extrémité et comportant au moins une rainure sensiblement circonférencielle, de section sensiblement rectangulaire, de préférence situé dans une partie cylindrique de ladite canule, à proximité de ladite extrémité tronconique effilée, dont la profondeur, est voisine de, par exemple peu supérieure à, l'épaisseur totale de ladite prothèse et dont la longueur est peu supérieure à la longueur de ladite prothèse ; ladite canule a un diamètre extérieur D4 voisin, par exemple peu supérieur, dudit diamètre Dl de ladite prothèse àA prosthesis according to the invention can be introduced by an introduction device which comprises a cannula, or "candle", preferably for single use, substantially cylindrical, flexible, for example made of PVC or polyethylene, tapered, or profiled, substantially frustoconical at one end and comprising at least one substantially circumferential groove, of substantially rectangular section, preferably located in a cylindrical part of said cannula, near said tapered frustoconical end, the depth of which is close to, for example little greater than , the total thickness of said prosthesis and the length of which is little greater than the length of said prosthesis; said cannula has an outer diameter D4 close, for example slightly greater, than said diameter D1 of said prosthesis to
FEUILLE DE REMPLACEMENT l'état enroulé, lequel dispositif d'introduction comporte de préférence en outre une chemise, par exemple métallique, ou une gaine tubulaire souple, par exemple en polytétrafluoroéthylène, de diamètre interne D voisin dudit diamètre externe D4 de ladite canule, de faible épaisseur, de longueur au moins égale à la longueur de la partie cylindrique de ladite canule, laquelle chemise est susceptible d'entourer intimement ladite canule et ladite prothèse à l'état enroulé disposée dans ladite rainure de ladite canule, et susceptible de maintenir ladite prothèse à l'intérieur de ladite rainure, jusqu'à ce que ladite prothèse soit positionnée dans le canal du corps humain ou animal dans lequel elle doit être implantée.REPLACEMENT SHEET the wound state, which insertion device preferably further comprises a jacket, for example metallic, or a flexible tubular sheath, for example of polytetrafluoroethylene, of internal diameter D close to said external diameter D4 of said cannula, of small thickness, of length at least equal to the length of the cylindrical part of said cannula, which jacket is capable of intimately surrounding said cannula and said prosthesis in the coiled state disposed in said groove of said cannula, and capable of holding said prosthesis at inside said groove, until said prosthesis is positioned in the channel of the human or animal body in which it is to be implanted.
Parmi les nombreux avantages procurés par l'invention il faut noter que grâce aux parois pleines ou étanches de la prothèse selon l'invention et le recouvrement résiduel, à l'état expansé, des bords longitudinaux, on évite l'envahissement ou la croissance des tissus de façon intime au contact de cette prothèse et on permet ainsi la dépose ultérieure éventuelle de la prothèse.Among the many advantages provided by the invention, it should be noted that thanks to the solid or sealed walls of the prosthesis according to the invention and the residual covering, in the expanded state, of the longitudinal edges, the invasion or growth of tissues in an intimate way in contact with this prosthesis and thus allows the possible subsequent removal of the prosthesis.
Par ailleurs lorsqu'on dispose d'une prothèse à paroi interne lisse selon un mode préférentiel de réalisation de l'invention, cette surface interne lisse permet d'éviter le dépôt de sécrétions à l'intérieur de cette prothèse ; l'invention permet d'obtenir également une prothèse ayant une épaisseur de paroi réduite ainsi qu'un positionnement facilité, ne nécessitant pas un outillage ou dispositif d'introduction sophistiqué et/ou volumineux. Par ailleurs grâce à la présence desdites armatures transversales élastiques, malgré la faible épaisseur de la prothèse, on procure une bonne résistance à l'écrasement.Furthermore, when a prosthesis with a smooth internal wall is available according to a preferred embodiment of the invention, this smooth internal surface makes it possible to avoid the deposition of secretions inside this prosthesis; the invention also makes it possible to obtain a prosthesis having a reduced wall thickness as well as easier positioning, not requiring a sophisticated and / or bulky tool or introduction device. Furthermore, thanks to the presence of said elastic transverse frames, despite the small thickness of the prosthesis, good resistance to crushing is provided.
De plus selon une caractéristique importante de l'invention, on peut implanter des prothèses dont ledit grand diamètre D3 a été choisi très légèrement supérieur au diamètre interne D2 du conduit dans lequel la prothèse est implantée, de manière, d'une part, à ne pas réduire le passage libre dans le canal et d'autre part, à ne pas provoquer d'effort mécanique important qui conduirait à une déformation locale importante de ce canal ; en effet la réaction mécanique exercé par les tissus au sein desquels une prothèse est implantée finit généralement par s'annuler ; de ce fait, une des caractéristiques de l'invention est d'introduire ladite prothèse dansIn addition, according to an important characteristic of the invention, it is possible to implant prostheses of which said large diameter D3 has been chosen very slightly greater than the internal diameter D2 of the conduit in which the prosthesis is implanted, so, on the one hand, that it does not not reduce the free passage in the channel and on the other hand, not to cause significant mechanical force which would lead to significant local deformation of this channel; in fact the mechanical reaction exerted by the tissues in which a prosthesis is implanted generally ends up canceling out; therefore, one of the characteristics of the invention is to introduce said prosthesis into
FEUILLE DE REMPLACEMENT le conduit, en la disposant contre la paroi des tissus, donc sensiblement à un diamètre D2 correspondant au diamètre dudit conduit, dans un état légèrement précontraint, laquelle prothèse tendra, postérieurement à l'implantation, à s'ouvrir jusqu'à atteindre ledit diamètre D3, très peu supérieur audit diamètre D2, dans lequel les contraintes mécaniques internes à la prothèse se seront annulées et par conséquent la progression ou la déformation de celle-ci sera ainsi stoppée.REPLACEMENT SHEET the conduit, by placing it against the wall of the tissues, therefore substantially at a diameter D2 corresponding to the diameter of said conduit, in a slightly prestressed state, which prosthesis will tend, after implantation, to open until it reaches said diameter D3, very little greater than said diameter D2, in which the mechanical stresses internal to the prosthesis will be canceled and consequently the progression or the deformation of the latter will thus be stopped.
Il faut également noter que grâce à une caractéristique essentielle de l'invention, ladite prothèse tubulaire radialement expansible est telle que dans son état déplié ou déroulé où elle prend une forme tubulaire sensiblement cylindrique de section circulaire ayant pour diamètre ledit diamètre D3, état dans lequel ladite paroi de ladite prothèse, notamment lesdites armatures élastiques sont dans un état de contrainte mécanique sensiblement nulle, et dans lequel les bords longitudinaux de ladite prothèse ne sont pas placés bord à bord, mais se recouvrent (se chevauchent) de manière à constituer un canal sensiblement cylindrique ; à fortiori, lorsque ladite prothèse est implantée dans un canal tubulaire du corps humain ou animal, lorsqu'elle s'expanse radialement et prend comme diamètre initial (après son introduction dans ledit canal) un diamètre sensiblement égal au diamètre D2 dudit canal, lesdits bords longitudinaux de ladite prothèse se chevauchent également, et se chevauchent encore lorsque ladite prothèse a atteint son état de contrainte nul par une expansion radiale résiduelle à l'intérieur dudit canal où elle a été implantée, jusqu'à s'inscrire dans ledit grand diamètre D3 de sorte qu'on évite ainsi toute pénétration ou prolifération des tissus vivants à l'intérieur du conduit cylindrique de ladite prothèse.It should also be noted that thanks to an essential characteristic of the invention, said radially expandable tubular prosthesis is such that in its unfolded or unrolled state where it takes a substantially cylindrical tubular shape of circular section having for diameter said diameter D3, state in which said wall of said prosthesis, in particular said elastic reinforcements are in a state of substantially zero mechanical stress, and in which the longitudinal edges of said prosthesis are not placed edge to edge, but overlap (overlap) so as to constitute a channel substantially cylindrical; a fortiori, when said prosthesis is implanted in a tubular channel of the human or animal body, when it expands radially and takes as initial diameter (after its introduction into said channel) a diameter substantially equal to the diameter D2 of said channel, said edges longitudinal of said prosthesis also overlap, and still overlap when said prosthesis has reached its state of zero stress by residual radial expansion inside said channel where it was implanted, until it fits into said large diameter D3 so that any penetration or proliferation of living tissue inside the cylindrical duct of said prosthesis is thus avoided.
Grâce à 1'absence de liaison mécanique rigide entre lesdites armatures transversales d'une part, ainsi qu'entre ladite armature longitudinale et lesdites armatures transversales d'autre part, on obtient une prothèse très souple (notamment selon son axe longitudinal) qui s'adapte parfaitement à la configuration et aux irrégularités du conduit anatomique où elle est mise en place. Les nombreux avantages procurés par l'invention seront mieux compris au travers de la description suivante qui se réfère aux dessins annexés qui illustrent sans aucun caractère limitatif desThanks to the absence of rigid mechanical connection between said transverse reinforcements on the one hand, and between said longitudinal reinforcement and said transverse reinforcements on the other hand, a very flexible prosthesis is obtained (in particular along its longitudinal axis) which adapts perfectly to the configuration and irregularities of the anatomical duct where it is placed. The numerous advantages provided by the invention will be better understood through the following description which refers to the appended drawings which illustrate without any limiting character the
FEUILLE DE REMPLACEMENT modes particuliers de réalisation de prothèses selon l'invention.REPLACEMENT SHEET particular embodiments of prostheses according to the invention.
La figure 1 illustre en vue en plan une prothèse dans un stade de fabrication préalable à l'enroulement (à la déformation) de celle-ci. La figure 2 est une coupe selon II.II de la figure 1. La figure 3 illustre schématiquement une prothèse selon l'invention dans son état replié dans lequel elle peut être stockée et introduite dans un corps humain ou animal, par exemple par 1'intermédiaire du canal opérateur d'un fibroscope.Figure 1 illustrates in plan view a prosthesis in a manufacturing stage prior to winding (to deformation) thereof. Figure 2 is a section on II.II of Figure 1. Figure 3 schematically illustrates a prosthesis according to the invention in its folded state in which it can be stored and introduced into a human or animal body, for example by 1 ' intermediary of the working channel of a fibroscope.
La figure 4 illustre schématiquement une prothèse selon l'invention dans son état libre.Figure 4 schematically illustrates a prosthesis according to the invention in its free state.
La figure illustre schématiquement une prothèse selon l'invention implantée dans un canal tubulaire.The figure schematically illustrates a prosthesis according to the invention implanted in a tubular channel.
La figure 6 illustre schématiquement un dispositif d'introduction d'une prothèse selon l'invention. La figure 7 illustre en coupe longitudinale partielle, une prothèse équipée d'une armature longitudinale.FIG. 6 schematically illustrates a device for introducing a prosthesis according to the invention. FIG. 7 illustrates in partial longitudinal section, a prosthesis equipped with a longitudinal reinforcement.
Par référence à la figure 1 on voit que conformément à l'invention ladite prothèse représentée sur cette figure dans un stade intermédiaire de fabrication avant son enroulement selon un axe XXI qui constituera l'axe longitudinal sensiblement de symétrie de ladite prothèse tubulaire, ladite prothèse représentée en vue en plan et s'étendant généralement selon un plan, comporte lesdites feuilles 3 découpées selon une forme sensiblement rectangulaire limitées par 2 bords longitudinaux 31 et 2 bords transversaux d'extrémité 3t. On voit sur cette figure que chacune desdites feuilles 3 q i est de préférence réalisée en élastomère de silicone de qualité médicale, translucide, par exemple de dureté de l'ordre de 50 à 70 Shore A, peut être renforcée par un tissu de fibre de dacron et est découpée à ladite forme rectangulaire selon une largeur 8 de feuille qui correspondra à la longueur repérée 8 de la prothèse tubulaire sur la figure 3 après enroulement de celle-ci, et une longueur transversale 7 qui est sensiblement supérieure à la circonférence correspondant audit diamètre D3 de la prothèse enroulée à l'état libre (à l'état de contrainte nul) de manière à permettre ledit recouvrement des bords longitudinaux de la prothèse enroulée (repérés 3l sur la figure 4) correspondant aux bords longitudinaux repérés 3l de ladite feuille rectangulaire.With reference to FIG. 1, it can be seen that, according to the invention, said prosthesis shown in this figure in an intermediate stage of manufacture before it is wound along an axis XXI which will constitute the substantially symmetrical longitudinal axis of said tubular prosthesis, said prosthesis represented in plan view and generally extending along a plane, comprises said sheets 3 cut in a substantially rectangular shape bounded by 2 longitudinal edges 31 and 2 transverse end edges 3t. We see in this figure that each of said sheets 3 qi is preferably made of medical grade silicone elastomer, translucent, for example of hardness of the order of 50 to 70 Shore A, can be reinforced with a fabric of dacron fiber and is cut to said rectangular shape according to a width 8 of sheet which will correspond to the length marked 8 of the tubular prosthesis in FIG. 3 after winding of the latter, and a transverse length 7 which is substantially greater than the circumference corresponding to said diameter D3 of the prosthesis wound in the free state (in the state of zero stress) so as to allow said overlapping of the longitudinal edges of the wound prosthesis (marked 3l in FIG. 4) corresponding to the longitudinal edges marked 3l of said rectangular sheet .
FEUILLE DE REMPLACEMENT Cette zone de recouvrement peut par exemple être constituée par l'extrémité longitudinale d'une première desdites feuilles dont la longueur est supérieure à la longueur de la deuxième feuille de ladite prothèse, elle-même supérieure à ladite longueur 6 desdites armatures transversales.REPLACEMENT SHEET This overlap zone can for example be constituted by the longitudinal end of a first of said sheets, the length of which is greater than the length of the second sheet of said prosthesis, itself greater than said length 6 of said transverse reinforcements.
Selon un mode préférentiel, ladite zone de recouvrement (repérée 30 sur la figure 4) comporte une armature 3 filiforme sensiblement rectiligne, sensiblement parallèle à l'axe longitudinal XXI de ladite prothèse, dont la partie centrale rectiligne est située entre lesdites feuilles interne et externe, au voisinage d'une extrémité 2e desdites armatures transversales, sans être liée rigidement à celles-ci ; les extrémités ~\2 (repérées 2 sur la figure 7) prolongeant ou terminant ladite partie centrale de ladite armature longitudinale 31 (repérée 1 sur la figure 7) sont recourbées vers l'extérieur, sensiblement radialement, traversent ladite feuille externe et sont légèrement proéminentes, de manière à faciliter l'ancrage et l'immobilisation de ladite prothèse dans ledit conduit anatomique.According to a preferred embodiment, said overlap zone (marked 30 in FIG. 4) comprises a substantially straight, filiform frame 3, substantially parallel to the longitudinal axis XXI of said prosthesis, the central rectilinear part of which is located between said internal and external sheets. , in the vicinity of a 2nd end of said transverse reinforcements, without being rigidly linked to these; the ends ~ \ 2 (marked 2 in FIG. 7) extending or ending said central part of said longitudinal reinforcement 31 (marked 1 in FIG. 7) are bent outwards, substantially radially, pass through said external sheet and are slightly prominent , so as to facilitate anchoring and immobilization of said prosthesis in said anatomical duct.
Par référence à la figure 7. lesdites extrémités 2 sont courbées vers l'extérieur de ladite prothèse, d'un angle 50 compris entre 30° et 90e, par exemple voisin de 45° à 75° •With reference to FIG. 7. said ends 2 are curved towards the outside of said prosthesis, at an angle 50 of between 30 ° and 90 e , for example close to 45 ° to 75 ° •
Avantageusement ladite armature longitudinale est en acier inoxydable souple de manière à autoriser une courbure de ladite prothèse selon son axe longitudinal, et lesdites armatures transversales réalisées dans un alliage à mémoire de forme sont "éduquées" (par traitement thermique par exemple, préalablement à leur assemblage avec lesdites feuilles) de manière à ce qu'à une température voisine de 37°C lesdites armatures transversales soient dans un état libre, élastiques, incurvées selon un diamètre D3, et de manière à ce qu'à une température voisine de 20°C par exemple lesdites armatures transversales soient dans un état "plastique" facilitant leur manipulation et leur enroulement selon un diamètre Dl.Advantageously, said longitudinal reinforcement is made of flexible stainless steel so as to allow a curvature of said prosthesis along its longitudinal axis, and said transverse reinforcements produced in a shape memory alloy are "educated" (by heat treatment for example, prior to their assembly with said sheets) so that at a temperature close to 37 ° C said transverse reinforcements are in a free state, elastic, curved according to a diameter D3, and so that at a temperature close to 20 ° C for example said transverse reinforcements are in a "plastic" state facilitating their handling and their winding according to a diameter Dl.
A titre d'exemple ladite largeur 8 de ladite feuille 3 correspondant à la longueur de la prothèse enroulée peut-être de l'ordre de 20 à 70 millimètres et la longueur 7 peut être légèrement supérieure à la circonférence correspondant à des diamètres D3 allant de 8 à 18 mm par exemple pour des applications de prothèses bronchiques, ladite longueur 7 étant supérieure à laditeBy way of example, said width 8 of said sheet 3 corresponding to the length of the wound prosthesis may be of the order of 20 to 70 millimeters and the length 7 may be slightly greater than the circumference corresponding to diameters D3 ranging from 8 to 18 mm for example for bronchial prosthesis applications, said length 7 being greater than said
FEUILLE DE REMPLACEMENT circonférence, de 2 à 6 millimètres environ par exemple.REPLACEMENT SHEET circumference, from 2 to 6 millimeters approximately for example.
On voit également sur cette figure que ladite prothèse comporte des armatures transversales 2 régulièrement espacées d'un pas 4, parallèles entre elles, de faible largeur 5 par exemple voisine d'un millimètre, et dont la longueur 6 est inférieure à la longueur 7 de ladite feuille 3 de manière à laisser à chaque extrémité longitudinale de ladite feuille 3 une zone de largeur 9 dénuée desdites armatures transversales et dans laquelle peut s'étendre ladite armature longitudinale ; lesdites armatures transversales s'étendent perpendiculairement à l'axe XXI qui constituera l'axe de la forme cylindrique de la prothèse enroulée et sont disposées à une distance 10 des bords transversaux 3t par exemple de l'ordre de 1 mm au moins, ladite distance 4 séparant 2 lesdites armatures transversales 2 adjacentes pouvant être de l'ordre de 5 mm à 10 mm environ selon les applications ; grâce à cette structure on peut obtenir, une fois ladite prothèse enroulée (comme représentée aux figures 3 et 4 notamment) , une prothèse sensiblement cylindrique qui est radialement expansible et qui est susceptible d'être coudée, c'est-à-dire que ladite prothèse tubulaire peut être déformée selon son axe longitudinal de manière à être implantée dans des conduits cylindriques courbes tels que des canaux coudés ou incurvés.It can also be seen in this figure that said prosthesis comprises transverse reinforcements 2 regularly spaced apart by a pitch 4, parallel to each other, of small width 5 for example close to a millimeter, and whose length 6 is less than the length 7 of said sheet 3 so as to leave at each longitudinal end of said sheet 3 a zone of width 9 devoid of said transverse reinforcements and in which said longitudinal reinforcement can extend; said transverse reinforcements extend perpendicular to the axis XXI which will constitute the axis of the cylindrical shape of the wound prosthesis and are arranged at a distance 10 from the transverse edges 3t for example of the order of at least 1 mm, said distance 4 separating 2 said adjacent transverse reinforcements 2 which can be of the order of approximately 5 mm to 10 mm depending on the applications; thanks to this structure it is possible to obtain, once said prosthesis is wound (as shown in FIGS. 3 and 4 in particular), a substantially cylindrical prosthesis which is radially expandable and which is capable of being bent, that is to say that said tubular prosthesis can be deformed along its longitudinal axis so as to be implanted in curved cylindrical conduits such as bent or curved channels.
Par référence à la figure 2 on voit que ladite prothèse cylindrique comporte avantageusement lesdites deux feuilles 3l et 32 de silicone comportant des fibres 11 qui peuvent être par exemple tissées, lesdites armatures 2 étant prévues entre lesdites feuilles 3l et 32 qui peuvent être assemblées entre elles et avec lesdites armatures par une colle silicone translucide stérile.With reference to FIG. 2, it can be seen that said cylindrical prosthesis advantageously comprises said two sheets 3l and 32 of silicone comprising fibers 11 which can for example be woven, said reinforcements 2 being provided between said sheets 3l and 32 which can be assembled together and with said frames by a sterile translucent silicone adhesive.
Avantageusement chacune desdites feuilles 3l et 32 a une épaisseur 14 faible, par exemple voisine de 2.10~4 mètre et chacune des armatures a également une épaisseur relativement faible du même ordre de grandeur de manière à réaliser une prothèse dont la paroi constituée par l'assemblage desdites feuilles et desdites armatures à une épaisseur 15 de l'ordre de 0,5 millimètres environ.Advantageously, each of said sheets 3l and 32 has a low thickness 14, for example close to 2.10 ~ 4 meters and each of the frames also has a relatively small thickness of the same order of magnitude so as to produce a prosthesis whose wall formed by the assembly said sheets and said reinforcements at a thickness of the order of about 0.5 millimeters.
Dans le mode de réalisation illustré à la figure 2, on voit que ladite feuille 3l interne qui est disposée dans la partie inférieure de la figure et qui est destinée à constituer la face interne 12 de ladite prothèse une fois celle-ci enroulée, est dotée desdites fibresIn the embodiment illustrated in FIG. 2, it can be seen that said internal sheet 31 which is arranged in the lower part of the figure and which is intended to constitute the internal face 12 of said prosthesis once it has been wound up, is provided of said fibers
FEUILLE DE REMPLACEMENT 11 qui sont situées dans la partie supérieure de ladite feuille 3l afin de ne pas affleurer sur la face inférieure de ladite feuille 3l et d'assurer ainsi une surface ou une face douce, (lisse) dénuée d'aspérités ; ladite deuxième feuille 32 (externe) par contre comporte, dans cet exemple de réalisation lesdites fibres 11 disposées à proximité de la face externe 13. qui constituera la face externe de la prothèse une fois enroulée, et qui peut être avantageusement rugueuse ; on voit également que lesdites armatures transversales 2 peuvent être avantageusement de section sensiblement rectangulaire, et dont les angles peuvent être éventuellement cassés ou arrondis, lesquelles armatures peuvent être réalisées dans un acier inoxydable à usage médical, par exemple un alliage d'acier au cobalt (contenant éventuellement molybdène, nickel, chrome et manganèse notamment) permettant de lui assurer une haute résistance mécanique (par exemple de l'ordre de 170 à 200 kg par millimètres2), ou bien en alliage à mémoire de forme.REPLACEMENT SHEET 11 which are located in the upper part of said sheet 31 so as not to be flush with the underside of said sheet 31 and thus ensure a surface or a soft, (smooth) face devoid of roughness; said second sheet 32 (external) on the other hand comprises, in this embodiment said fibers 11 arranged near the external face 13. which will constitute the external face of the prosthesis once wound, and which may advantageously be rough; it can also be seen that said transverse reinforcements 2 can advantageously be of substantially rectangular section, and the angles of which can possibly be broken or rounded, which reinforcements can be produced from stainless steel for medical use, for example a cobalt steel alloy ( possibly containing molybdenum, nickel, chromium and manganese in particular) making it possible to provide it with high mechanical strength (for example of the order of 170 to 200 kg per millimeter 2 ), or else in a shape memory alloy.
On voit (comme illustré aux figures 3 et 4) que ladite prothèse une fois enroulée, peut constituer un conduit tubulaire de longueur 8 et peut passer d'un état enroulé où elle est inscrite dans un cylindre de diamètre Di avantageusement inférieur à 10 millimètres, à un état déroulé où elle est sensiblement inscrite dans un cylindre de diamètre D3 pouvant par exemple varier de 12 à 16 millimètres dans le cas de prothèse bronchique et ceci grâce à l'élasticité desdites armatures transversales qui ont été préalablement précontraintes dans le cas d'armatures en acier ; ladite prothèse passe de l'état représenté à la figure 3 à celui représenté à la figure 4, par déformation desdites armatures jusqu'à ce que celles-ci retrouvent un état de contrainte sensiblement nulle, état dans lequel les bords longitudinaux 3l de ladite prothèse se chevauchent par exemple de 2 millimètres au moins ; ladite déformation est obtenue, dans le cas d'armatures en matériaux à mémoire de forme, par le réchauffement des armatures par le corps du patient, jusqu'à 37°C, température pour laquelle elles ont été préconditionnées afin de s'étendre sensiblement circonférentiellement, selon ledit diamètre D3- Par référence à la figure on voit que postérieurement à 1'implantation d'une prothèse selon l'invention dans un conduit tubulaire anatomique 16 sensiblement cylindrique de diamètre intérieurIt is seen (as illustrated in FIGS. 3 and 4) that said prosthesis once wound, can constitute a tubular conduit of length 8 and can pass from a wound state where it is inscribed in a cylinder of diameter Di advantageously less than 10 millimeters, in an unrolled state where it is substantially inscribed in a cylinder of diameter D3 which can for example vary from 12 to 16 millimeters in the case of bronchial prosthesis and this thanks to the elasticity of said transverse frames which have been preloaded beforehand in the case of steel frames; said prosthesis goes from the state shown in FIG. 3 to that shown in FIG. 4, by deformation of said frames until they return to a state of substantially zero stress, a state in which the longitudinal edges 31 of said prosthesis overlap for example by at least 2 millimeters; said deformation is obtained, in the case of reinforcements made of shape memory materials, by the heating of the reinforcements by the patient's body, up to 37 ° C., the temperature for which they have been preconditioned in order to extend substantially circumferentially , according to said diameter D3 - With reference to the figure, it can be seen that after implantation of a prosthesis according to the invention in a substantially cylindrical anatomical tubular conduit 16 of internal diameter
FEUILLE DE REMPLACEMENT "naturel" D2. ladite prothèse qui a été introduite par exemple par l'intermédiaire du canal opérateur d'un fibroscope, à l'état replié, c'est-à-dire dans un état où elle occupe un diamètre Di, a été ensuite libérée à l'extrémité du canal du fibroscope, dans ledit conduit tubulaire anatomique 16, où elle s'est expansée radialement pour venir se plaquer contre les parois internes dudit conduit anatomique 16 à un diamètre D2; postérieurement à cette mise en place de la prothèse dans le conduit anatomique, du fait des contraintes résiduelles existant dans lesdites armatures élastiques (et/ou du comportement du matériau à mémoire de forme), ladite prothèse continue de s'expanser radialement jusqu'à atteindre ledit diamètre D3 dans lequel lesdites armatures retrouvent des contraintes nulles, tout en conservant un profil de section transversale en forme de spirale.REPLACEMENT SHEET "natural" D2. said prosthesis which was introduced for example via the operating channel of a fibroscope, in the folded state, that is to say in a state where it occupies a diameter Di, was then released at the end of the fibroscope channel, in said anatomical tubular conduit 16, where it has expanded radially so as to press against the internal walls of said anatomical conduit 16 at a diameter D2; after this positioning of the prosthesis in the anatomical canal, due to the residual stresses existing in said elastic reinforcements (and / or the behavior of the shape memory material), said prosthesis continues to expand radially until it reaches said diameter D3 in which said reinforcements find zero stresses, while retaining a cross-sectional profile in the form of a spiral.
Par référence à la figure 6, dans un mode préférentiel d'utilisation d'une prothèse selon l'invention, ladite prothèse l'est préalablement enroulée de manière a occuper un volume sensiblement cylindrique ayant pour diamètre ledit diamètre Di, ceci à l'intérieur d'une rainure 19 prévue dans une canule ou bougie 17 faisant partie d'un dispositif d'introduction de ladite prothèse. Ladite rainure 19 est de préférence aménagée dans la partie cylindrique de ladite canule 17. à proximité de l'extrémité effilée 18 de celle-ci, qui peut avoir une forme sensiblement tronconique ; ladite rainure 19 a une profondeur 20 voisine de l'épaisseur (repère 15 de la figure 2) et a une longueur 21 de préférence voisine de la longueur (repère 8 de la figure 3) de ladite prothèse 1.Referring to Figure 6, in a preferred mode of use of a prosthesis according to the invention, said prosthesis the is previously wound so as to occupy a substantially cylindrical volume whose diameter is said diameter Di, this inside a groove 19 provided in a cannula or candle 17 forming part of a device for introducing said prosthesis. Said groove 19 is preferably arranged in the cylindrical part of said cannula 17. near the tapered end 18 thereof, which may have a substantially frustoconical shape; said groove 19 has a depth 20 close to the thickness (mark 15 in FIG. 2) and has a length 21 preferably close to the length (mark 8 in FIG. 3) of said prosthesis 1.
Ladite bougie ou canule 17 est de préférence creuse, traversée par un canal central 22 débouchant, qui permet le coulissement à l'intérieur dudit canal d'un guide métallique 24 filiforme.Said candle or cannula 17 is preferably hollow, crossed by a central channel 22 opening out, which allows the sliding inside said channel of a wire guide 24.
Le dispositif d'introduction comporte également de préférence une chemise souple 23, de fiable épaisseur, dont le diamètre intérieur D5 est très voisin du diamètre extérieur D de la partie cylindrique de ladite canule 17. de manière à maintenir ladite prothèse à l'intérieur de ladite rainure prévue dans ladite canule, pendant l'introduction de ladite prothèse dans le corps humain ou animal. Le procédé d'introduction est le suivant : on introduit tout d'abord ledit guide 24 filiforme dans le conduit anatomique 16 qui est représenté à la figure 6 sensiblement cylindrique d'axe ZZ1 ; onThe introduction device also preferably comprises a flexible jacket 23, of reliable thickness, the internal diameter D5 of which is very close to the external diameter D of the cylindrical part of said cannula 17. so as to maintain said prosthesis inside said groove provided in said cannula, during the introduction of said prosthesis into the human or animal body. The introduction process is as follows: first of all said filiform guide 24 is introduced into the anatomical duct 16 which is shown in FIG. 6 substantially cylindrical with an axis ZZ1; we
FEUILLE DE REMPLACEMENT introduit ensuite ladite canule 17 portant ladite prothèse 1 à l'état enroulé et revêtue extérieurement de ladite chemise 23 maintenant ladite prothèse, par coulissement de ladite canule autour dudit guide 24 grâce audit canal 22 prévu dans ladite canule ; le coulissement de ladite canule par rapport audit guide 24 qui s'effectue selon la flèche Fi est stoppé lorsqu'une profondeur prédéterminée (qui a pu par exemple faire l'objet d'un repérage sur ladite canule) a été atteinte, correspondant à la zone dudit canal anatomique 16 dans laquelle doit être disposée ladite prothèse 1 ; on peut alors par une traction selon la flèche F2, en maintenant ladite canule 17 sensiblement immobile, retirer ladite chemise 23 ce qui provoque la libération de ladite prothèse qui se déroule et vient se plaquer contre les parois dudit canal anatomique 16 ; on peut ensuite retirer ladite canule et ledit guide métallique.REPLACEMENT SHEET then introduces said cannula 17 carrying said prosthesis 1 in the wound state and coated externally with said jacket 23 holding said prosthesis, by sliding said cannula around said guide 24 through said channel 22 provided in said cannula; the sliding of said cannula relative to said guide 24 which takes place in the direction of the arrow Fi is stopped when a predetermined depth (which could for example have been identified on said cannula) has been reached, corresponding to the area of said anatomical canal 16 in which said prosthesis 1 is to be disposed; it is then possible, by pulling along arrow F2, keeping said cannula 17 substantially immobile, to remove said jacket 23 which causes the release of said prosthesis which unwinds and is pressed against the walls of said anatomical canal 16; said cannula and said metal guide can then be removed.
FEUILLE DE REMPLACEMENT REPLACEMENT SHEET

Claims

REVENDICATIONS
1. Prothèse (1) tubulaire radialement expansible, essentiellement constituée par plusieurs armatures filiformes (2) transversales indépendantes, sensiblement parallèles entre elles et sensiblement identiques, disposées entre au moins deux feuilles (3) minces en matière plastique, laquelle prothèse s'étend en spirale et dont les bords longitudinaux se recouvrent à l'état comprimé et à l'état libre.1. Radially expandable tubular prosthesis (1), essentially constituted by several independent transverse filamentary reinforcements (2), substantially parallel to one another and substantially identical, arranged between at least two thin sheets (3) of plastic material, which prosthesis extends in spiral and whose longitudinal edges overlap in the compressed state and in the free state.
2. Prothèse selon la revendication 1 comportant en outre une armature (31) filiforme longitudinale, métallique, dont les extrémités (32, 52) sont courbées vers l'extérieur, et qui est mécaniquement indépendante desdites armatures transversales.2. The prosthesis according to claim 1 further comprising a longitudinal, metallic, threadlike frame (31), the ends (32, 52) of which are curved outward, and which is mechanically independent of said transverse frames.
3- Prothèse selon l'une quelconque des revendications 1 à 2 dans laquelle lesdites armatures transversales sont réalisées dans un matériau à mémoire de forme.3- Prosthesis according to any one of claims 1 to 2 wherein said transverse frames are made of a shape memory material.
4. Prothèse selon l'une quelconque des revendications 1 à 3 dans laquelle lesdites armatures transversales sont régulièrement espacés d'un pas (4), sont de faible épaisseur, et de section aplatie.4. Prosthesis according to any one of claims 1 to 3 wherein said transverse frames are regularly spaced by a pitch (4), are thin, and of flattened section.
5- Prothèse selon l'une quelconque des revendications 1 à 4 dans laquelle chacune desdites feuilles a une épaisseur (14) voisine de 1.10"4 mètre à 1.10~3 mètre et est découpée selon une forme sensiblement rectangulaire, et dans laquelle l'épaisseur totale (15) de ladite prothèse est inférieure à 2.10"3 mètre.5- Prosthesis according to any one of claims 1 to 4 wherein each of said sheets has a thickness (14) close to 1.10 "4 meters to 1.10 ~ 3 meters and is cut into a substantially rectangular shape, and in which the thickness total (15) of said prosthesis is less than 2.10 "3 meters.
6. Prothèse selon 1'une quelconque des revendications 1 à 5 dans laquelle le rapport dudit diamètre D3 à l'état expansé audit diamètre Di à l'état replié est voisin de 2, et dans laquelle ledit diamètre D3 à l'état expansé est légèrement supérieur au diamètre D2 interne du canal dans lequel ladite prothèse est destinée à être introduite.6. Prosthesis according to any one of claims 1 to 5 in which the ratio of said diameter D3 in the expanded state to said diameter Di in the folded state is close to 2, and in which said diameter D3 in the expanded state is slightly greater than the internal diameter D2 of the channel into which said prosthesis is intended to be introduced.
7. Prothèse selon l'une quelconque des revendications 1 à 6 dans laquelle lesdites fibres sont principalement constituées de dacron, et dans laquelle lesdites feuilles sont assemblées par une colle silicone.7. Prosthesis according to any one of claims 1 to 6 in which said fibers consist mainly of dacron, and in which said sheets are assembled by a silicone adhesive.
8. Prothèse selon l'une quelconque des revendications 1 à 7 dans laquelle lesdites armatures transversales sont disposées8. Prosthesis according to any one of claims 1 to 7 wherein said transverse frames are arranged
FEUILLE DE REMPLACEMENT sensiblement perpendiculaires à l'axe (XXI) de ladite prothèse sensiblement cylindrique, et dans laquelle ledit entre-axe (4) desdites armatures est compris entre 3-10"3 mètre et 1.10"2 mètre.REPLACEMENT SHEET substantially perpendicular to the axis (XXI) of said substantially cylindrical prosthesis, and in which said inter-axis (4) of said frames is between 3-10 "3 meters and 1.10" 2 meters.
9. Prothèse selon l'une quelconque des revendications 1 à 8 dans laquelle lesdites armatures ont une section rectangulaire.9. Prosthesis according to any one of claims 1 to 8 wherein said frames have a rectangular section.
10. Dispositif d'introduction d'une prothèse selon l'une quelconque des revendications 1 à 9. comportant une canule (17) sensiblement cylindrique, souple, effilée à une extrémité (18) et comportant au moins une rainure (19) sensiblement circonférencielle dont la profondeur (20) est voisine de l'épaisseur total (15) de ladite prothèse et dont la longueur (21) est peu supérieure à la longueur (8) de ladite prothèse.10. Device for introducing a prosthesis according to any one of claims 1 to 9. comprising a cannula (17) substantially cylindrical, flexible, tapered at one end (18) and comprising at least one groove (19) substantially circumferential whose depth (20) is close to the total thickness (15) of said prosthesis and whose length (21) is little greater than the length (8) of said prosthesis.
FEUILLE DE REMPLACEMENT REPLACEMENT SHEET
PCT/FR1993/000798 1992-08-11 1993-08-06 Expansible tubular prosthesis WO1994004096A1 (en)

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FR9210092A FR2694688B1 (en) 1992-08-11 1992-08-11 Expandable tubular prosthesis.

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FR2694688B1 (en) 1994-11-10

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