WO2009077845A2 - Implant de soutien, notamment endoprothèse vasculaire, et cathéter de greffage pour implant de soutien - Google Patents

Implant de soutien, notamment endoprothèse vasculaire, et cathéter de greffage pour implant de soutien Download PDF

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Publication number
WO2009077845A2
WO2009077845A2 PCT/IB2008/003497 IB2008003497W WO2009077845A2 WO 2009077845 A2 WO2009077845 A2 WO 2009077845A2 IB 2008003497 W IB2008003497 W IB 2008003497W WO 2009077845 A2 WO2009077845 A2 WO 2009077845A2
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WO
WIPO (PCT)
Prior art keywords
catheter
support implant
band
implantation
spring
Prior art date
Application number
PCT/IB2008/003497
Other languages
German (de)
English (en)
Other versions
WO2009077845A3 (fr
Inventor
Brigitte Walch
Original Assignee
Welldone Weartec N.V.
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Publication date
Application filed by Welldone Weartec N.V. filed Critical Welldone Weartec N.V.
Publication of WO2009077845A2 publication Critical patent/WO2009077845A2/fr
Publication of WO2009077845A3 publication Critical patent/WO2009077845A3/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/88—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils
    • A61F2/885—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils comprising a coil including a plurality of spiral or helical sections with alternate directions around a central axis
    • 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
    • A61F2/88—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
    • A61F2250/0068—Means for introducing or releasing pharmaceutical products into the body the pharmaceutical product being in a reservoir

Definitions

  • Support implant in particular stent, and implantation catheter for the support implant
  • the present invention relates to a supporting implant, in particular a stent and an implantation catheter according to the preambles of the independent claims.
  • wire spirals were used from the beginning to widen and stabilize the vessel walls.
  • laterally open-ended tubes similar to a tubular screen
  • wire mesh were used, which are partly made of fine wire wool.
  • a special form of a stent is a diamond-shaped tube which is open from the side and can be expanded in the diameter by longitudinal compression. With the exception of the latter stent, the aforementioned tubular implants are flexible in the longitudinal direction.
  • stents each with specific advantages and disadvantages, offer the surgeon a choice from which he can select the appropriate model for the respective application.
  • Important features of the stents are both the longitudinal flexibility and the properties that allow the small-diameter implant to be able to be introduced into the vessel full of deposits and, after successful installation, to be able to expand to the desired opening diameter of the vessel.
  • a catheter is used on which the stent is mounted prior to surgery.
  • the wire spirals must be kept at an even distance.
  • the mounted on the catheter support implant must mounted on the catheter as possible have a diameter that is significantly smaller than the final desired
  • Pressure on the vessel can be kept low.
  • the stent should not break or break. Such breakages can be pointed and sharp-edged and therefore injure a vessel.
  • Spirals and tube-like stents should experience no twisting (swirl) in the longitudinal direction when expanding to the final diameter, as this could also twist the vessels and thereby pinch off.
  • Stent is not always reliable to reach. - When removing the implant catheter, do not allow uneven longitudinal compression or distortion of the stent.
  • Vascular wall can be injured by these kinks. These inflammations, which frequently occur locally at the kinks, considerably impair the success of the operation because they can lead to swelling and renewed narrowing of the vessels. In order to support the healing of the injuries so-called “drug-eluting stents" were developed, which are coated on the surface with healing-promoting substances.
  • the design requirements mentioned above have not yet been realized in a stent at the same time, so the surgeon must choose between the different stents, for example:
  • the diamond-shaped stents are very well expandable but not flexible.
  • the spirals with side loops expand less well, but are flexible.
  • the tubes made of wire wool are flexible but hardly expandable.
  • the stents customary today must be implanted in sections for use in longer vessel sections.
  • the choice of materials used is difficult, since the requirements were very contradictory from the beginning. Namely, the material should be - biocompatible or biodegradable, have high strength and toughness for the spring force (seif expanding) and plastically lasting flexibility.
  • the usual metallic materials contain chromium and nickel. These materials are chemically resistant, tough but not solid. As alternatives, cobalt-chrome alloys, tantalum alloys have been developed, as well as special forms such as memory alloys. These stents are chemically resistant, tough and have a higher strength than CrNi alloys in the body for a long time.
  • the problem of the aforementioned metallic stents is that they are perceived in the organism as a foreign body and, especially if they are implanted in moving areas, even after years still allergies and inflammation can trigger. For this reason, biodegradable stents have been developed in the past, e.g. made of magnesium.
  • the implants must be clinically pure and therefore have stainless surfaces.
  • the usual stainless materials however, always contain chromium and nickel or even nickel-based alloys. The biological compatibility of such materials with a long residence time in the body is difficult to estimate.
  • requirements from the manufacturing technology of the implants must be considered. Fine wire meshes or spirals must be produced by multiple deformation (wire drawing by drawing dies) and necessarily require a heat treatment and recrystallization. A material alloy can only be chosen insofar as a sufficient deformation possibility is given physically. Even more difficult is the tube production of difficult to deform materials, such as magnesium. As a stent form, therefore, the production of a tube was designed with eg 5 mm diameter. In this tube laterally a diamond-shaped network is cut by laser, so that the resulting pipe network is expandable in diameter and length. It is then not flexible.
  • Stents made of plastic have the advantage of being biologically well tolerated. They are also limited deformable, so flexible. However, they are permanently stored as foreign bodies, as well as chromium / cobalt / nickel-metal alloys, and can therefore lead to medical complications.
  • plastic eg PTFE
  • poly (L-lactose) acid / PLLA has been developed (Zilberman et al., "Protein-loaded Bioresorbable Fibers and Expandable Stents: Mechanical properties and protein release” Journal of Biomedical Material Research Volume 69B Dec. 1996 / Sharkawi et al., Journal of Pharmaceutical Science Vol. 96 P. 2829 - 2837, Aug.
  • drug-eluting stents which are coated on the surface with healing-promoting substances, and even locally occurring inflammations considerably impair the success of the operation because they can cause swelling and re-constriction of the vessels.
  • a perforated band-shaped element for a stent is known from WO2005 / 079387. Depending on the application, this band can be used as a coil-like, thread-like, reticulated or differently shaped medication delivery device.
  • a disadvantage of this device is that the coils of the coil-shaped coiled strip twist when expanding in a vessel this.
  • wire-Stens are known which have sections in which the wire has alternating left- and right-handed helices. In the transition, the wire is bent perpendicular to the spiral bend.
  • a support implant for controlling the passage width of a gastrointestinal passage is known. This has two spouts into each other, of which the outer spout is formed by a plurality of parallel to each other left-handed rotation and the inner spout by a plurality of parallel to each other clockwise wound wires.
  • a disadvantage of this support implant is that the same direction is present in the helices over the entire length of the implant and therefore the wall of a vessel supported thereby is twisted when the implant is widened.
  • the invention has for its object to provide a design for a support implant that irritates the supported tissue as little as possible in the implanted state.
  • a further object is, if the support implant is biodegradable, to be able to locally influence the degradation of the implant material during its lifetime by chemical means.
  • it is an object to provide a support implant, in particular a stent, which does not twist when inserting the stent into a vessel, when opening the band spring, this vessel.
  • Another objective is to propose an implantation catheter for introducing such a stent.
  • Another object is to provide a longer support implant, in particular a stent, flexible in the longitudinal direction, without kinks or denominations.
  • a support implant according to the invention may be a stent, i. a support implant supporting the wall of a blood vessel (artery or vein), or a supporting implant supporting the bone of a long bone from the inside.
  • the support implant has a helically shaped element around a virtual axis in the manner of known stents.
  • This coiled element is a band element whose width is directed in the direction of the axis and whose thickness is perpendicular to the direction of the axis.
  • the band element is advantageously a spring, so that it can be turned down against the spring force reducing the radius and jumps up in the cavity by the spring force and presses against the wall of the cavity.
  • Such a helical band element with spring character is often called helical band spring in this description.
  • Such a belt element has the advantages that it may have perforations, that it may have a low material thickness and therefore can be uniformly degraded when the material is degradable and that it presses flat against the wall of the cavity. Thanks to flat pressing, the support surface is enlarged in comparison to stents with a round cross-section and the local irritation is thereby reduced.
  • the helical strip spring in contrast to wire springs have perforations (round holes, slots, etc.). These perforations can be made by fine blanking, laser cutting, etc., and can be used for various tasks: A first possibility is to accommodate differently thick microdots in these perforations.
  • the different thickness microdepots make it possible to predict the dissolution or delivery time desired for a particular pharmaceutical, such as anti-inflammatory agents sirolimus, ABT-578, etc. This is of great advantage, in particular with biodegradable stents, over the currently used surface layer of pharmaceuticals in the case of wire stents.
  • a surface layer of drugs is produced by immersion in an appropriate solution. Thus, the entire wire spiral is surrounded with this drug film. Therefore, before the stent material can be degraded, the pharmaceutical surface must first disappear completely.
  • Stent Zerf all then left fragments, which in turn to
  • pharmaceuticals can be accommodated in the perforations in the inventive helical band spring.
  • the drugs with targeted residence time and healing support can be selected and incorporated into the perforation so that any inflammation that may occur during stent disintegration does not even occur.
  • the stent After insertion of the stent, the stent rapidly engrafts with the vascular tissue, i. The stent is enclosed inside and outside with tissue. Therefore, the properly selected drugs along with the perforated stent fragments remain in the tissue until everything is broken down. Consequence: No pain, no renewed constriction of the vessels.
  • micro-depots of chemically active substances may be placed in the perforations that can control (accelerate or decelerate) the degradation process of the biodegradable support implant of the helical ribbon spring sections: oxidation or salt formation may be controlled at both the surface of the helical ribbon spring and at the soldered turning regions ,
  • the support implant according to the invention has two or more sections, each with a coiled band element, wherein in successive sections, the directions of rotation of the helices are opposite to each other. This has the advantage that the rotation during expansion of the implant in the vessel there is at most too small and possibly opposite to each other twists, which can easily accommodate the vessel and lead to no significant stress and irritation of the vessel wall.
  • Particularly preferred stents have a plurality of sections with oppositely coiled band elements in successive sections and in a second layer, the oppositely coiled sections of a second band member. These two coils with opposite direction of rotation on the one hand reduce the mentioned slight rotation of the vessel when expanding the implant, and also lead to a net-like support of the vessel wall.
  • This multi-section net assembly of uncoupled and oppositely coiled inner and outer band members results in a tubular support implant whose cross-section is expandable, which is stretchable and compressible in length, and which can participate in movements and curvatures of the vessel (eg in joints or in joints) Heart muscle area) and which nevertheless supports the vessel wall in a narrow cross grid.
  • the ends of the sections are welded together, soldered or folded.
  • holes are provided at the ends of the spiral strip spring sections in order to be able to introduce solder.
  • the band When folding, the band is preferably first wound in a single pass directly to the mounting catheter to the right, then folded in the other direction, and further wound to the left.
  • the folded portions (turning portions) of the spiral ribbon spring portions may be locally recrystallized heat-treated (eg, by heating in the laser beam, induction coil, etc.) where the band member is folded to enable crack-free bending and folding. It can be formed by two folds the turning area. This has the advantage that the angles between the longitudinal edges of the band member and the fold fail blunter than when the band member is folded almost at right angles in a fold.
  • the obtuse angles have the advantage over the near-right angles that they cause less irritation and less often injury to the vessel wall.
  • helical coil springs for the representation of a nearly closed flexible stent tube are mirror-inverted wrapped.
  • This has the advantage that a flexible, twist-free double helical band spring is formed.
  • Each spread-apart section advantageously comprises at least one coil and a maximum of three coils, preferably between one and two coils.
  • the edges of the coil spring can be rounded. This has the advantage that injury to the vessel can be prevented when inserting the stent.
  • the helical band spring is made by rolling.
  • Such a support implant forms a surface element consisting of two or more band elements which are joined together along their longitudinal edges, in particular welded together.
  • the material of the band member is biodegradable organic.
  • the design of the support implant is specially designed, because advantageously the appropriate metal alloys (magnesium-SE base or iron mixed crystal with Al / Si and steel refiners) to high elastic yield strength solidified with appropriate spring force for self-opening and permanent elastic mobility.
  • the design can also be advantageously used for biodegradable polymers (eg PLLA) if they are reinforced, for example, with nanoparticulate carbon short fibers (Maynard et al., Nature Nanotechnology May 2008), since these do not lead to asbestos-like, pathological tissue changes.
  • the design of the support implant is used particularly advantageously for such high-strength elastic CCFC (Curly Carbon Fiber Composites).
  • CCFC Chemical Carbon Fiber Composites
  • a plastic deformation is not required for the function, after the biodegradation of the matrix remains a kind of wool from carbon fibers in the neW waxy vascular tissue, which is biochemically harmless as pure carbon and can be slowly absorbed over the years without causing damage in the
  • the carbon wool is provided with a pharmaceutical impregnation prior to being combined with the PLLA matrix, the biocompatible ingrowth into the surrounding tissue may still be aided.
  • the subject matter of the present invention is also an implantation catheter for implantation of a stent according to the invention, which is characterized in that the implantation catheter has an elastically stretchable swelling ring at the tip which can be inflated via a first pressure line running in the catheter interior.
  • the present catheter has the advantage that vessels can be widened in a targeted manner.
  • an opening is provided at the tip of the catheter, which is in communication with a second pressure line.
  • a second pressure line is connected to a control device for the catheter.
  • pumps and the necessary controls are provided to inflate the Schwellring and relieve resp. pump medical solutions into the vessel or aspirate material out of the vessel.
  • a wedge ring is slidably mounted on the implantation catheter, which is in communication with a cable running in the catheter.
  • the wedge ring serves to strip the stent from the catheter.
  • the cable slots may be provided in the catheter tube at a distance from the Schwellring through which lead the Seilzugb selected from the outside inwards.
  • grooves may be provided in the catheter wall in which the cable extends longitudinally. The cable thus runs on the one hand in the interior of the catheter in a groove on the inside of the catheter wall and on the other hand on the outside of the catheter wall in a groove on the outside of the catheter wall.
  • the subject matter of the present invention is at the same time also a method for implanting a helical-band spring stent, which is characterized in that the helical-band spring is pretensioned (turned up) and fastened on an implantation catheter.
  • the helical band spring is fastened to the implantation catheter.
  • the attachment is done by gluing.
  • the connection points of the left- and right-rotating spring sections and the beginning and the end of the helical band spring are attached to the implantation catheter.
  • the spiral band spring is wound up, stretched Glued state and clamped until the adhesive stops. In this case, even a bias of the stent in the longitudinal direction is possible. Such a bias facilitates withdrawal of the catheter especially in curved vessels.
  • the lubricant may be mixed with a solvent which dissolves the adhesive at a predetermined interval (as desired by the surgeon).
  • the lubricant containing the solvent must be distributed on the catheter just before it enters the vessel. This handling is made easier for the surgeon by a tear-open cartridge in the catheter package.
  • FIG. 1a shows a simple helical band stent made of a helical band made of resilient material
  • FIG. 1b shows a simple spiral band stent made of a perforated spiral band
  • FIG. 2 shows a first embodiment of a stent according to the invention in the form of a
  • Fig. 3 shows a second embodiment of a stent according to the invention in the form of a
  • FIG. 4 shows a third embodiment of a stent in the form of a helical strip spring with left- and right-handed spiral-band spring sections, in whose turning regions the helical strip spring is folded twice;
  • FIG. 5 shows a fourth embodiment of a stent in the form of a double
  • FIG. 6 shows a fifth embodiment of a stent in the form of a double
  • FIG. 7 shows a sixth embodiment of a stent in the form of a double stent.
  • Fig. 8 shows a portion of a stent or bone support implant in which the longitudinal edges of adjacent helical band springs are welded together.
  • 9 shows a longitudinal section through an implantation catheter, with enclosing
  • Wedge ring with cables in front of the widened swelling ring; 10 shows a cross section through the implantation catheter before the displaceable
  • Keilring Fig. 11 shows a cross section through the implantation catheter and the displaceable
  • Wedge ring shows a section through the wedge ring in the longitudinal direction of the catheter (detail of FIG. 9);
  • FIG. 13 shows the section through the wedge ring shown in FIG
  • Catheter is attached and coated with a lubricating gel layer.
  • the support implant, or the stent according to FIG. 1a consists of a helical band spring 17, which is wound in a cylindrical fashion from a band element 12.
  • the band shape of the band member 12 allows the production of perforations in the band member for better connection of the vessel wall and the interior of the vessel, but also for receiving chemically active substances.
  • a helical band spring with holes therein is shown in FIG.
  • the band element is helically wound and may have a perforation or perforation. In this case, the flat sides of the band member 12 to the outside respectively. inside and the perforation penetrates this band element 12 from the outside inwards.
  • the support implant consists of a helical band spring 17, which is constructed alternately from left and right rotating sections 15a and 15b.
  • a helical band spring 17 is shown by way of example from FIG. 2 of left-handed sections 15a and a right-handed section 15b.
  • one end 21 of the first portion 15a is fixedly connected to the beginning 22 of the second portion 15b.
  • the end 23 of the second section 15b is in turn connected to the beginning (24) of the third section 15a.
  • any number of spiral strip spring sections can be lined up in such a way
  • the stent according to FIG. 2 can be obtained by first winding a band element 12 around the left, folding it around (turning area 20a), wound around it to the right, folded around (turning area 20b), folded over and then wound up again to the left.
  • a metal strip used for spring manufacture may be solidified and brittle by deformation over its entire length. So that no cracks or breakages occur during folding, the material can be heat treated locally, so that a crack-free Umfalz is possible.
  • the turning areas are therefore preferably somewhat softer and tougher, so that the risk of cracking is reduced.
  • the solidified sections between the turning areas are preferably equipped with high spring force.
  • the two superimposed regions of the band element 12 can also be welded or soldered together.
  • the individual sections 15a, 15b have perforations 13. In the turning areas 20a, b, these perforations may be missing as shown. But the spring band can also be perforated throughout ( Figure 4), so that the turning areas are also perforated.
  • the perforations 13 may serve to accommodate drug microdeposits and / or chemicals.
  • the embodiment of Figure 3 differs from that of Figure 2 in that the individual helical band spring portions are formed of separate helical band springs, the ends of which are connected to each other at the turning portions 30a, b by soldering or welding.
  • the embodiment according to FIG. 4 differs from the exemplary embodiment according to FIG. 2 in that the helical band spring 17 is likewise wound and folded from a band element 12, at which point it is folded twice at the turning regions 20a, b. This results in less sharp corners after the fold line.
  • FIG. 5 shows a preferred embodiment of a stent, which consists of two helical band springs 17 wound in mirror-inverted fashion.
  • Each helical band spring 17 in turn consists of left- and right-handed helical band spring portions 15a and 15b.
  • the left- and right-rotating spring sections 15a, 15b are made of a continuous metal strip 12, which is folded over at the turning areas 20a, b. The folded turning areas are opposite each other.
  • a first helical band spring 17 forms an inner sleeve 40
  • a second helical band spring forms an outer sleeve 41. Both sleeves 40, 41 together form a largely closed support tube (stent), which remains flexible.
  • the stent according to FIG. 6 differs from that of FIG. 5 only in that the ends of the band elements of adjacent helical band edge sections are connected to one another by soldering (soldering points 30 a, b).
  • the stent according to FIG. 7 differs from that of FIG. 5 only in that the band element is turned between two adjacent spiral strip spring sections by double folding.
  • the inner and outer spout are here shifted from each other to distinguish the individual coil springs 17 better from each other.
  • the two spouts 40, 41 may be interconnected at the ends of the tubular stent formed therethrough. It may also be the outer spout directly in connection to the inner spout from a wound by both spigot band element 12 to be wound.
  • FIG. 8 shows a bundle of helical band springs 17, which are wound so tightly against one another in sections desired by the surgeon that the edges are adjacent
  • Band members 12 can be welded together (e.g., by laser welding). The stiffening achieved thereby allows the support, for example, of fragments of a long bone from the inside. The sections adjoining such a stiffened section can remain flexible and, if necessary, be adapted to a curvature of a long bone. Such a rigid tube can also be achieved by a single band member 12, which is wound so tightly that the longitudinal edges 25,26 of the band member 12 abut each other in the coil spring 17. The existing perforation also allows the introduction of active ingredients for healing promotion and / or degradation control of the biodegradable material of the support implant in this use of the support implant.
  • FIGS 5, 6 and 7 show the preferred embodiments for stents, consisting of two superimposed wound coil springs 17, which form an inner spout 40 and an outer spout 41, so that in each case two oppositely wound Kombandfederabitese 15a, 15b are superimposed.
  • Each helical band spring 17 consists of at least 2 to 3 left and right-handed spiral band spring portions 15a, 15b.
  • Spiral band springs 17, which are wound mirror-inverted, represent an almost closed, flexible stent tube.
  • This embodiment has the advantage that the vessel wall is widened and supported uniformly everywhere. The turns of these spiral band springs 17 prevent the penetration of the remaining deposits during movement of the vessels.
  • Such stents have the advantage that they are largely symmetrical and transmit symmetrical forces during expansion of the vessel on this.
  • the stent is prestressed in the radial and longitudinal directions, as well as transversely and longitudinally flexible like a millipede. By the left and right rotating spring sections, the stent can be expanded without generating a twist in a vessel (artery).
  • FIG. 9 shows schematically and in section a front part of a catheter 56.
  • the catheter 56 consists of a flexible tube (not shown) which merges with the front end of the catheter into a rigid catheter head 58 which forms a catheter tip 75.
  • an inflatable swelling ring 77 is integrally formed or glued.
  • the swelling ring 77 is connected via a first pressure line 73, which is filled with a pressure oil, with a pump not shown in connection. By means of the pump, the swelling ring 77 can be inflated. This inflation of the swelling ring 77 serves to widen a vessel in order to be able to advance the catheter further in this vessel with a subsequently relaxed swelling ring. In the relaxed state, the swelling ring 77 bears against the outer jacket of the catheter tip 75.
  • a wedge ring 60 is slidably placed, which encloses the implantation catheter.
  • the wedge ring 60 is by means of several cables 67 on the catheter head 58 back and forth movable.
  • the threads or bands 62, 63, 64, 65 of the cables 67 each extend inside the catheter and the delivery tube, from there through a slot 78 in the catheter wall 68 of the catheter head 58 to the outside and outside in longitudinal grooves 61 to the control unit of the catheter 56th
  • Each cable 67 is fixedly connected to the wedge ring 60.
  • the wedge ring 60 can be moved forwards or backwards. According to the embodiment shown, a total of four cables are provided.
  • the provision of three or four cables 67 allows the wedge ring to be moved evenly on the catheter head and prevents tilting of the wedge ring on the catheter head.
  • the running edges 66 of the wedge ring 60 run in four grooves 61 extending in the longitudinal direction of the catheter.
  • a second pressure line 72 extends to the catheter tip 75, where it has an axial opening 70. Through the opening 70 of the pressure line 72, blood plasma or rinsing fluid (possibly with medication) can be introduced into the vessel.
  • Figures 10 and 11 are cross-sections through this catheter head.
  • the cross-section according to FIG. 10 cuts the catheter head perpendicular to the longitudinal extent of the catheter through the slots 78.
  • the view is directed away from the catheter tip 75.
  • the outer circle represents the circumference of the wedge ring 60.
  • the wedge ring 60 sits the catheter head 58 enclosing on this and engages with its running edges 66 in the longitudinal grooves 61 (see Figs.ll and 9).
  • the visible in the figure drawstrings 62,63,64,65 of the cables 67 are guided through the slots 78 and engage from the tip of the catheter forth on the wedge ring.
  • On the back of the wedge ring 60 again attack such drawstrings that together with the front attacking each form a cable 67.
  • the first line 73 serves to supply pressure to the swelling ring and is filled with pressure oil.
  • the second conduit 72 has an axial opening in the catheter tip 75 and may be used to supply the vessel through which the catheter 56 is inserted.
  • the cutting plane is laid through the wedge ring 60, so that the slotted bands of the cable 67 can be seen on the inside of the catheter wall 68.
  • the running edges 66 are shown, as shown in the
  • the running edges 66 may be formed by the bands 62, 63, 64 and 65.
  • Figures 12 and 13 show a detail section through the catheter head 58.
  • the wedge ring is shown in an advanced position, as it is approximately after the expansion of the stent by means of the wedge ring.
  • the wedge ring is shown in a rearward position and the catheter head 58 still carries the tightly wound stent 11.
  • a protective layer of lubricant 55 is placed.
  • the second line 72 is shown in section. Of the first line 73, however, only a part of the outer surface is visible. Both lines are in the interior 57 of the catheter 56.
  • the wall 68 of the catheter head 58 has an opening, called slot 78, through which the inner band of the cable 67 is guided to the outside.
  • This slot 78 has a cylindrical sliding surface on the side of the cable 67.
  • the longitudinal grooves 61 terminate in the slots 78, so that the cables 67 are guided in the longitudinal grooves and the slots with the least possible friction.
  • a stent is placed in a vessel as follows:
  • An inventive coil spring 17 is biased between the sill ring and the wedge ring wound on the catheter 56 and glued to the ends or optionally at the ends and the turning areas 20 a, b / 30 a, b on the catheter tube 59.
  • a soluble adhesive is used, which can be dissolved by a predetermined solvent by the operator after a predetermined time. This solvent is in the lubricant that is applied before implantation.
  • the swelling ring Upon introduction into the vessel, the swelling ring can be pressurized and enlarged via the pressure feed line 73 running inside the catheter in order to stretch the vessel and possibly displace protruding deposits. Spiky particles protruding into the blood stream may be broken off and advanced during introduction or sucked through the pressure line 72. Where the push through stubborn deposits is not immediately possible, the swelling ring 77 can be made smaller and pushed through between the deposits. Subsequently, this constricted area of the vessel can be widened and the stent introduced.
  • Undesirable particles in the blood can be sucked off with the pressure feed line 72. If necessary, blood plasma, stored blood or medication can be delivered into the space between the catheter and the point where the vessel is pinched off. If complications occur, this blood supply can be reestablished, if necessary, through the implantation catheter 72.
  • the wedge ring 60 can be pulled through the stent from the introducer side. This is for safe opening of the stent and for diameter control.
  • the movement of the wedge ring is done by means of the cables 67th
  • the wedge ring with the cables 67 is moved back completely behind the stent.
  • the uniform opening of the spiral coil spring or double helical coil spring (stent) is secured.
  • the swelling ring 77 is then shrunk to the smallest diameter, so that the catheter can be easily pulled out.
  • the stent according to the invention may also be used in other vascular systems of the body (e.g., lymphatic system, bladder, kidneys, penis and other glandular systems) and in a particular vascular systems of the body (e.g., lymphatic system, bladder, kidneys, penis and other glandular systems) and in a particular vascular systems of the body (e.g., lymphatic system, bladder, kidneys, penis and other glandular systems) and in a particular
  • Form can be used as internal stabilization in tubular fractures.
  • the perforated helical band springs are wound so tightly that the windings lie edge to edge against each other ( Figure 8) and can be welded at the edges. This can be made between the turning areas stiff sections, if the stabilization of the bone fracture requires.

Abstract

L'invention concerne un implant de soutien (11), destiné à soutenir un élément corporel tubulaire, notamment une endoprothèse vasculaire destinée au soutien d'un vaisseau. L'implant de soutien comporte un élément (17) hélicoïdal enroulé autour d'un axe virtuel et se présentant sous forme de bande (12) dont la largeur est supérieure à l'épaisseur et qui est enroulée pour former un élément bande hélicoïdal (17). La largeur de la bande (12) est orientée dans le sens de l'axe et son épaisseur est perpendiculaire au sens de l'axe. La bande (12) est conçue de manière fonctionnelle comme un ressort et elle présente une perforation (13) dont les orifices la traversent dans le sens de son épaisseur, les orifices pouvant comporter des dépôts pour agents actifs. L'élément bande hélicoïdal (17) présente l'avantage d'avoir des sections (15a,15b) enroulées en sens inverses les unes par rapport aux autres. De manière particulièrement avantageuse, ledit implant de soutien possède un tulle interne (40) et un tulle externe (41) et les spirales superposées sont enroulées en sens inverses, cet implant étant alors un double élément bande hélicoïdal.
PCT/IB2008/003497 2007-12-14 2008-12-15 Implant de soutien, notamment endoprothèse vasculaire, et cathéter de greffage pour implant de soutien WO2009077845A2 (fr)

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CH01946/07 2007-12-14
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DE102009052002A1 (de) * 2009-11-05 2011-05-19 Acandis Gmbh & Co. Kg Medizinische Vorrichtung zum Rekanalisieren von Körperhohlräumen und Set umfassend eine derartige Vorrichtung
CN103356315A (zh) * 2013-07-23 2013-10-23 苏州英络医疗器械有限公司 用于介入手术的血管支架及其使用方法、及制造方法和制造设备
CN103815958A (zh) * 2012-11-19 2014-05-28 苏芳庆 螺旋式骨折固定器
US8984733B2 (en) 2013-02-05 2015-03-24 Artventive Medical Group, Inc. Bodily lumen occlusion
US9017351B2 (en) 2010-06-29 2015-04-28 Artventive Medical Group, Inc. Reducing flow through a tubular structure
US9095344B2 (en) 2013-02-05 2015-08-04 Artventive Medical Group, Inc. Methods and apparatuses for blood vessel occlusion
US9149277B2 (en) 2010-10-18 2015-10-06 Artventive Medical Group, Inc. Expandable device delivery
US9247942B2 (en) 2010-06-29 2016-02-02 Artventive Medical Group, Inc. Reversible tubal contraceptive device
TWI568406B (zh) * 2012-11-13 2017-02-01 國立成功大學 螺旋式骨折固定器
EP3021790A4 (fr) * 2013-07-19 2017-03-15 Aperiam Medical, Inc. Implants intraluminaux et méthodes associées
US9636116B2 (en) 2013-06-14 2017-05-02 Artventive Medical Group, Inc. Implantable luminal devices
US9737306B2 (en) 2013-06-14 2017-08-22 Artventive Medical Group, Inc. Implantable luminal devices
US9737308B2 (en) 2013-06-14 2017-08-22 Artventive Medical Group, Inc. Catheter-assisted tumor treatment
US10149968B2 (en) 2013-06-14 2018-12-11 Artventive Medical Group, Inc. Catheter-assisted tumor treatment
US10363043B2 (en) 2014-05-01 2019-07-30 Artventive Medical Group, Inc. Treatment of incompetent vessels
JP2020044335A (ja) * 2018-09-20 2020-03-26 デピュイ・シンセス・プロダクツ・インコーポレイテッド 成形されたワイヤを有するステント
US10813644B2 (en) 2016-04-01 2020-10-27 Artventive Medical Group, Inc. Occlusive implant and delivery system
CN113413256A (zh) * 2019-01-31 2021-09-21 深圳市科奕顿生物医疗科技有限公司 一种自扩张支架

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US5674242A (en) * 1995-06-06 1997-10-07 Quanam Medical Corporation Endoprosthetic device with therapeutic compound
US6063101A (en) * 1998-11-20 2000-05-16 Precision Vascular Systems, Inc. Stent apparatus and method
WO2008112500A2 (fr) * 2007-03-09 2008-09-18 Novostent Corporation Prothèse vasculaire et procédés d'utilisation

Cited By (31)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102009052002B4 (de) * 2009-11-05 2012-09-27 Acandis Gmbh & Co. Kg Medizinische Vorrichtung zum Rekanalisieren von Körperhohlräumen und Set umfassend eine derartige Vorrichtung
DE102009052002A1 (de) * 2009-11-05 2011-05-19 Acandis Gmbh & Co. Kg Medizinische Vorrichtung zum Rekanalisieren von Körperhohlräumen und Set umfassend eine derartige Vorrichtung
US9451965B2 (en) 2010-06-29 2016-09-27 Artventive Medical Group, Inc. Reducing flow through a tubular structure
US9017351B2 (en) 2010-06-29 2015-04-28 Artventive Medical Group, Inc. Reducing flow through a tubular structure
US9247942B2 (en) 2010-06-29 2016-02-02 Artventive Medical Group, Inc. Reversible tubal contraceptive device
US9149277B2 (en) 2010-10-18 2015-10-06 Artventive Medical Group, Inc. Expandable device delivery
TWI568406B (zh) * 2012-11-13 2017-02-01 國立成功大學 螺旋式骨折固定器
CN103815958A (zh) * 2012-11-19 2014-05-28 苏芳庆 螺旋式骨折固定器
CN103815958B (zh) * 2012-11-19 2016-08-03 苏芳庆 螺旋式骨折固定器
US9107669B2 (en) 2013-02-05 2015-08-18 Artventive Medical Group, Inc. Blood vessel occlusion
US9095344B2 (en) 2013-02-05 2015-08-04 Artventive Medical Group, Inc. Methods and apparatuses for blood vessel occlusion
US9737307B2 (en) 2013-02-05 2017-08-22 Artventive Medical Group, Inc. Blood vessel occlusion
US8984733B2 (en) 2013-02-05 2015-03-24 Artventive Medical Group, Inc. Bodily lumen occlusion
US10441290B2 (en) 2013-06-14 2019-10-15 Artventive Medical Group, Inc. Implantable luminal devices
US9636116B2 (en) 2013-06-14 2017-05-02 Artventive Medical Group, Inc. Implantable luminal devices
US9737306B2 (en) 2013-06-14 2017-08-22 Artventive Medical Group, Inc. Implantable luminal devices
US9737308B2 (en) 2013-06-14 2017-08-22 Artventive Medical Group, Inc. Catheter-assisted tumor treatment
US10149968B2 (en) 2013-06-14 2018-12-11 Artventive Medical Group, Inc. Catheter-assisted tumor treatment
EP3021790A4 (fr) * 2013-07-19 2017-03-15 Aperiam Medical, Inc. Implants intraluminaux et méthodes associées
CN103356315B (zh) * 2013-07-23 2016-05-25 苏州茵络医疗器械有限公司 用于介入手术的血管支架及其使用方法、及制造方法和制造设备
CN103356315A (zh) * 2013-07-23 2013-10-23 苏州英络医疗器械有限公司 用于介入手术的血管支架及其使用方法、及制造方法和制造设备
US10363043B2 (en) 2014-05-01 2019-07-30 Artventive Medical Group, Inc. Treatment of incompetent vessels
US11224438B2 (en) 2014-05-01 2022-01-18 Artventive Medical Group, Inc. Treatment of incompetent vessels
US10813644B2 (en) 2016-04-01 2020-10-27 Artventive Medical Group, Inc. Occlusive implant and delivery system
JP2020044335A (ja) * 2018-09-20 2020-03-26 デピュイ・シンセス・プロダクツ・インコーポレイテッド 成形されたワイヤを有するステント
EP3626212A3 (fr) * 2018-09-20 2020-07-22 DePuy Synthes Products, Inc. Endoprothèse avec des fils formés
CN110916861A (zh) * 2018-09-20 2020-03-27 德普伊新特斯产品公司 具有成型导丝的支架
US11590007B2 (en) 2018-09-20 2023-02-28 DePuy Synthes Products, Inc. Stent with shaped wires
CN110916861B (zh) * 2018-09-20 2024-03-22 德普伊新特斯产品公司 具有成型导丝的支架
CN113413256A (zh) * 2019-01-31 2021-09-21 深圳市科奕顿生物医疗科技有限公司 一种自扩张支架
CN113413256B (zh) * 2019-01-31 2023-06-02 深圳市科奕顿生物医疗科技有限公司 一种自扩张支架

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