WO2019121320A1 - Implant destiné a des anévrismes - Google Patents

Implant destiné a des anévrismes Download PDF

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Publication number
WO2019121320A1
WO2019121320A1 PCT/EP2018/084754 EP2018084754W WO2019121320A1 WO 2019121320 A1 WO2019121320 A1 WO 2019121320A1 EP 2018084754 W EP2018084754 W EP 2018084754W WO 2019121320 A1 WO2019121320 A1 WO 2019121320A1
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WO
WIPO (PCT)
Prior art keywords
support structure
implant according
implant
occlusion unit
membrane
Prior art date
Application number
PCT/EP2018/084754
Other languages
German (de)
English (en)
Inventor
Ronald Kontek
Volker Trösken
Hans Henkes
Hermann Monstadt
Ralf Hannes
Original Assignee
Phenox Gmbh
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 Phenox Gmbh filed Critical Phenox Gmbh
Publication of WO2019121320A1 publication Critical patent/WO2019121320A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A61B17/12113—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/1214—Coils or wires
    • A61B17/12145—Coils or wires having a pre-set deployed three-dimensional shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12172—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12163—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a string of elements connected to each other
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12177—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205—Introduction devices

Definitions

  • the invention relates to an implant for treating arteriovenous malformations, in particular aneurysms, with an occlusion unit having an inner support structure extending in the longitudinal direction of the occlusion unit and a tubular casing extending in the longitudinal direction of the occlusion unit on the outside of the support structure in the stretched state by a microcatheter to a destination in the blood vessel system of a patient brought and the inner support structure is imprinted a secondary structure, which occupies the support structure after elimination of the external constraint by the microcatheter.
  • Aneurysms are usually bag-like or fusiform (fusiform) expansions of the vessel wall, which arise primarily at structurally weakened sites of the vessel wall by the constant pressure of the blood. Accordingly, the vessel inner walls of an aneurysm are correspondingly sensitive and prone to injury. The rupture of an aneurysm usually leads to significant health problems, in the case of cerebral aneurysms to neurological deficits to the death of the patient.
  • aneurysm In addition to surgical procedures in which, for example, the aneurysm is clamped by means of a clip, in particular endovascular methods for the treatment of aneurysms are known, with two approaches being pursued in the first place.
  • the aneurysm can be filled with occlusion agents, in particular so-called coils (platinum spirals).
  • the coils promote thrombus formation and thus provide closure of the aneurysm.
  • access to the aneurysm such as the neck of a berry aneurysm, is known Close blood vessel side by stent-like implants and decouple from the blood flow.
  • Both methods serve to reduce blood flow into the aneurysm and thus pressure on the aneurysm, ideally to eliminate it and thus to reduce the risk of rupture of the aneurysm.
  • the filling of the aneurysm is insufficient, allowing the supply of blood into the aneurysm and thus a continuing pressure on the inner wall.
  • the danger of a continuous enlargement of the aneurysm and finally its rupture persists, albeit in a weakened form.
  • the treatment method is primarily suitable for aneurysms with a relatively narrow neck - so-called berry aneurysms - because otherwise there is a risk that the coils from a wide Aneurysmahals protrude into the blood vessel and thrombogenize there, which can lead to occlusions in the vessel. In the worst case, a coil is completely flushed out of the aneurysm and closes vessels elsewhere.
  • the aneurysm neck is often additionally covered with a special stent.
  • Another intravascular treatment approach relies on so-called flow diverters. These implants are similar in appearance to stents used to treat stenosis. However, since the task of the flow diverter is not the keeping open of a vessel, but the occlusion of the aneurysm access on the side of the blood vessel, the mesh size is very narrow, alternatively these implants are covered with a membrane. A disadvantage of these implants is the risk that outgoing side branches in the immediate vicinity of the aneurysm to be treated sometimes covered and thereby closed medium or long term.
  • an implant which is composed of a first and a second section, which are arranged one behind the other within a catheter, after release within the aneurysm, however, assumes a three-dimensional, approximately spherical shape and thus fills the aneurysm.
  • Starting material for the three-dimensional implant is a mesh-like fabric, the embodiments and figures are all related to a tubular braid made of shape memory material.
  • a disadvantage has been found in this prior art that it has a disadvantageous rigidity. Aneurysms are rarely completely round, but a three-dimensional implant should be able to fit into the morphology of the aneurysm as best as possible. In addition, the implant is too bulky for low caliber catheters.
  • the implant is composed of several subunits, each having a framework of struts, between which a string is located.
  • the object is to provide a further improved implant for introduction into aneurysms.
  • the object is achieved according to the invention by an implant for treating arteriovenous malformations, in particular aneurysms, with an occlusion unit having an inner support structure extending in the longitudinal direction of the occlusion unit and a tubular enclosure extending in the longitudinal direction of the occlusion unit on the outer side of the support structure in the extended state by a microcatheter to a destination in the blood vessel system of a patient and the inner support structure is imprinted on a secondary structure, which occupies the support structure after elimination of external constraint by the microcatheter, the tubular enclosure having a mesh structure over the length of the mesh structure is provided with a membrane.
  • An essential core idea of the invention is that the membrane covering, unlike in WO 2017/089451 A1 is no longer provided between the individual struts, but around the inner support structure as a whole an outer tubular enclosure is used. This has a mesh structure, whereby the membrane is much more resistant and durable than without braid structure. Furthermore, the friction of the envelope against the Reduced catheter wall, through which the implant to the
  • the membrane having a mesh structure according to the invention has a higher resistance.
  • the membrane is less prone to collapse and therefore conforms well to the inner wall of the aneurysm, with a slight pressure being exerted on the one hand due to the tendency to pitch, which on the one hand is large enough to promote leaning against the inner walls of the aneurysm, but on the other hand is not so great achieved that threatens an injury to the aneurysm.
  • the inner support structure After release of the implant in the aneurysm, d. H. usually after application from the microcatheter used for the introduction of the implant, the inner support structure takes on a previously impressed secondary structure. While the implant in the microcatheter essentially has a stretched state, the secondary structure after release has a significantly greater spatial extent. Accordingly, it is well able to fill the interior of the aneurysm and provide as much closure as possible.
  • the imprint of the secondary structure is possible in particular by heat treatment.
  • a typical diameter of an occlusion unit after taking the secondary structure may, for. B. for filling intracranial aneurysms 4 to 25 mm.
  • proximal and distal are to be understood as meaning that, when the implant is introduced to the attending physician, parts are referred to as proximal, parts facing away from the attending physician are referred to as distal.
  • the implant is thus typically advanced distally through a microcatheter.
  • the hose-like sheath attached to the outside of the support structure also assumes a significantly greater spatial extent as compared to the state in the catheter due to the assumption of the secondary structure by the inner support structure. This additionally improves the filling of the aneurysm.
  • Another advantage of the braid structure is that it prevents contraction of the membrane. Because the braid structure is such Contraction already prevented, it is possible to make the inner support structure less massive than would be necessary without additional braid structure in the tubular enclosure. In other words, the braid structure already provides for a certain support of the membrane, which would have to be achieved without braid structure solely by the inner support structure and therefore would require a more massive support structure.
  • the braid structure is embedded in the membrane. This can be achieved by initially introducing a braided structure, which is then braided or braided with fibers such that a membrane with embedded braid structure results. Corresponding methods are well known from the prior art, for example the so-called electrospinning.
  • fibrils or fibers are deposited from a polymer solution by means of electric current on a substrate. During deposition, the fibrils stick together to form a fleece. As a rule, the fibrils have a diameter of 100 to 3,000 nm. Electrospinning membranes are very uniform. The membrane is tough and mechanically strong and can be pierced mechanically, without the opening becomes the starting point for further cracks. The thickness of the fibrils as well as the degree of porosity can be controlled by selecting the process parameters. In connection with the creation of the membrane and the materials suitable therefor, particular attention is drawn to WO 2008/049386 A1, DE 28 06 030 A1 and the literature cited therein.
  • the membrane can also be made via a dipping or spraying process, such as spraycoats.
  • the membrane may be made of a polymeric material such as polytetrafluoroethylene, polyesters, polyamides, polyurethanes or polyolefins. Particularly preferred are polycarbonate urethanes (PCU).
  • PCU polycarbonate urethanes
  • an integral connection of the membrane with the braid structure is desirable.
  • Embedded in the membrane may be additional substances promoting thrombogenesis or endothelium formation.
  • the thrombogenisation-promoting substances are advantageous because they support the formation of a thrombus within the aneurysm, which ensures a permanent closure of the aneurysm.
  • aneurysms are based on degenerative vascular wall diseases, in particular atherosclerosis, the promotion of endothelium formation and the repair of dysfunction of the endothelium can also have positive effects. This applies in particular to the area where the aneurysm has contact with the bloodstream in the actual blood vessel (parent vessel).
  • substances that promote thrombogenesis are collagens, while z.
  • statins 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors
  • other polymers can promote colonization with endothelial cells.
  • Particularly suitable as polymers are polysaccharides, especially glycosaminoglycans, which are able to mimic the glycocalyx.
  • POSS-PCU polyhedral oligomeric silsesquioxane poly (carbonate urea) urethanes
  • POSS-PCL polyhedral oligomeric silsesquioxane poly (caprolactone-urea) urethanes
  • POSS-PCU or POSS-PCL nanocomposite polymers are poorly suited for direct immobilization on the surface of an implant, which is why it has proven advantageous to combine polymers such as polyacrylic acid (poly-AA) with the nanocomposite. This can be done for example by plasma polymerization of acrylic acid.
  • a poly-AA-g-POSS-PCU surface obtained in this way promotes the binding of collagen (in particular collagen type 1) and thus the endothelium formation (see Solouk et al., Mater Sei Eng C Mater Biol Appl. 2015; 46 : 400-408).
  • Some additives for example collagen or hyaluronic acid, are also advantageous because they can improve the friction of the tubular casing, for example, against the inside of a catheter during the advancement and the biocompatibility of the implant.
  • the braid structure itself may be constructed in particular of polymer, metal or carbon threads.
  • the threads typically run helically along the longitudinal axis, wherein threads running in opposite directions extend above and below each other at the points of intersection, so that honeycombs form between the threads.
  • a substantially longitudinal course of the threads is conceivable, ie from proximal to distal.
  • the individual threads should expediently have a diameter between 0.05 and 0.4 mm, preferably between 0.1 and 0.2 mm.
  • the tensile strength is preferably between 0.07 and 0.6 N.
  • the filaments themselves may in turn consist of individual filaments, ie. H. the threads can be monofilament or polyfil. In the case of multiple filaments forming a thread, the filaments may be twisted together. Particularly preferred is the use of a polyamide, in particular nylon
  • Polyhexamethylenadipinklamid because this additionally acts thrombogenic.
  • Other polymers which can be used are polypropylene and polyester, polyglycolic acid, polylactide or PLGA (polylactide-co-glycolide) or other polylactide copolymers, which are known as surgical sutures and are correspondingly biocompatible.
  • metal threads or metal wires wherein as the metal, for example, platinum, platinum-iridium, stainless steel or nickel-titanium alloys can be used.
  • the tubular sheath is formed so that a guidewire and a microcatheter can penetrate them to introduce further occlusion means, such as conventional coils, into the aneurysm.
  • the membrane density and the braid structure should be selected accordingly.
  • the braiding angle is understood to be the angle that two threads have in the longitudinal direction of the implant viewed in the point of intersection.
  • the size of the honeycomb formed in the braid between the threads is suitably 0.3 to 1.2 mm, preferably 0.5 to 1.0 mm.
  • the size of a honeycomb, which results from the intertwining of the threads with each other, while the length of a diagonal is understood in the honeycomb, which is in doubt to use the longer of the two diagonals.
  • the coverage rate of the membrane is usefully between 50 and 100%, preferably between 70 and 90%. In this way, on the one hand good coverage of the aneurysm is achieved, on the other hand, the introduction of further occlusion means by means of a microcatheter through the membrane remains possible. In addition, such a membrane has sufficient flexibility. Coverage rate is the ratio of closed membrane area to the total surface of the membrane.
  • the mentioned parameters for braid angle, pore size and coverage rate have proven to be particularly suitable with regard to probability by means of guidewire and micro catheter, flexibility, durability and stability. In particular, the pore size, but possibly also the braiding angle and the coverage rate can vary between the different regions of the implant.
  • the information on braid angle, pore size and coverage rate refer to the occlusion unit in the expanded state, d. H. the condition that the occlusion unit assumes as a secondary structure when it is not exposed to external constraints.
  • the inner support structure is connected to the tubular casing only at the proximal and distal ends in the sense that there is a firm connection. This can be done for example by gluing, knotting, crimping or other joining methods.
  • the inner support structure is made of a shape memory material, in particular a shape memory metal.
  • the support structure can be imprinted with a secondary structure, which automatically assumes it after release from the microcatheter, ie after removal of the external force exerted by the catheter.
  • the inner support structure may be formed from a plurality of struts which extend in the longitudinal direction of the occlusion unit, wherein the struts may form a certain spatial structure.
  • the support structure can be formed from wires or also produced by laser cutting.
  • the struts or wires may have a round, oval, square or rectangular cross section, wherein in the case of a square or rectangular cross section, the edges may be rounded.
  • the inner support structure can have a plurality of elements (subunits) arranged one behind the other in the longitudinal direction of the occlusion unit and connected to one another.
  • This may in principle be a sequence of any geometric shapes, such as polyhedra or irregular spherical shells, but together form a secondary structure, in particular a spherical structure.
  • Particularly suitable for the occlusion unit are longitudinally extending struts that form sinusoidal wave forms from proximal to distal, which are arranged parallel to one another. Because the inflection points of the sinusoidal waveforms are superposed, in other words, the sinusoidal waveforms are the same Have phase, formed between the turning points three-dimensional elements.
  • connection with the tubular casing may also be present in each case between the individual elements as well as at the proximal and distal end of the support structure.
  • the size of the elements forming the occlusion unit arranged one behind the other can vary, in particular increase from the distal to the proximal end or from the proximal to the distal end. Preferred is an increase in size from the distal to the proximal end.
  • the smaller distal three-dimensional elements are first released from the microcatheter so that the aneurysm initially forms a smaller three-dimensional, in particular spherical, structure.
  • the individual successively released elements of the occlusion unit can be arranged one above the other layer by layer and overlapping each other.
  • the implant can be supported in the stretched state by an additional, after implantation retractable support wire in its shape.
  • This arrangement can facilitate the transport of the stretched implant through a catheter.
  • the support wire runs parallel to the implant during transport and has no impressed three-dimensional shape.
  • a straight or curved extension in particular a helix, is mounted, the outer diameter of which is smaller than the inner support structure and which does not have a tube-like covering.
  • the extension serves for the attending physician as optical control in which direction the secondary structure of the occlusion unit is formed.
  • the extension is aligned with and usually connected to the support structure such that it comes to lie during release internally, ideally in the center of the spherical secondary structure of the occlusion unit. It is preferable at the extension to a small helix.
  • the extension or the helix can also be made fibrous, ie individual fibers can be attached to the extension / helix, with respect to the materials of the fibers being said to the threads of the braided structure.
  • the fibers can be inserted between the turns of the helix. They are preferably fibers which promote thrombogenesis, for example polyamide fibers such as nylon fibers.
  • the helix turns typically resemble approximately the direction in which the implant itself curls up taking the secondary structure as it is released from the microcatheter. In the case of a differently shaped extension, it likewise applies that it usefully bends in the direction in which the implant rolls up.
  • the treating physician determines that the first extension released from the microcatheter is not placed in the desired manner in the aneurysm, so that the correct formation of the secondary structure of the implant also appears to be at risk, he can retract the implant into the microcatheter and gently change the placement of the microcatheter again in the aneurysm release. Since the appendage is placed in the center of the spherical structure when the implant is properly placed in the aneurysm, there is no danger of the appendage extending out of the aneurysm into the blood vessel from which the aneurysm has formed.
  • the projection fixed distally on the occlusion unit, in particular the support structure is at least partially made of a radiopaque material such as platinum, platinum-iridium or the like. It can also consist of a combination of different metals or polymers, among other things, polyamides such as nylon can be used.
  • the diameter of the helix is typically 1/4 to 3/4 of the outer diameter of the implant in the stretched state, more preferably about half.
  • An implant with an appendage attached to the distal end of the occlusion unit, in particular a helix as described above, can also be realized independently of the remainder of the invention, for example with any implants having an occlusion unit, independently of the other features described in connection with the invention , These features, such as the tubular enclosure and its structure, can hereby However, this is not absolutely necessary.
  • the subject matter of the invention is therefore also an occlusion unit which, for example, has a support structure elongated within a microcatheter with a corresponding extension at the distal end, even if it does not have a tubular covering.
  • the occlusion unit of the implant is preferably detachably connected to an insertion unit via a detachment point.
  • This introduction unit can be a conventional guide wire with which the occlusion unit can be advanced through the blood vessel system to the desired location.
  • the replacement of the occlusion unit of the insertion is electrolytically, thermally or mechanically possible.
  • the release site is electrolytically corroded by application of a voltage so that the occlusion unit disengages from the insertion unit.
  • the electrolytic detachment of implants is well known in the art, especially for coils for occluding aneurysms. Corresponding detachment points are z. As described in WO 2011/147567 A1.
  • the principle is based on the fact that when applying a voltage provided for this purpose release point of a suitable material, in particular metal, usually by anodic oxidation undergoes at least so far resolution that the distal of the corresponding release point located areas of the implant are released.
  • the release point can be made for example of stainless steel, magnesium, magnesium alloys or a cobalt-chromium alloy.
  • the resolution of the separation point is done by applying an electrical voltage. This can be both AC and DC, with a low current ( ⁇ 3 mA) is sufficient.
  • the detachment point is usually the anode, at the oxidation and
  • the detachment point is electrically conductively connected, in particular via the insertion aid, to a voltage source.
  • the insertion must also be designed to be electrically conductive in this case. Since the adjusting corrosion current is controlled by the area of the cathode, the area of the cathode should be chosen to be significantly larger than the area of the cathode
  • the dissolution rate of the release site can be controlled by adjusting the cathode area in relation to the anode area.
  • the invention also relates to a device which comprises a voltage source and optionally an electrode which can be placed on the body surface.
  • a device which comprises a voltage source and optionally an electrode which can be placed on the body surface.
  • there is typically a positive connection which is released when the occlusion unit is released, so that the occlusion unit is released from the insertion unit.
  • detachment points as thermal detachment points.
  • the connection between longitudinally adjacent portions of the implant can be canceled by heating the release site, whereupon it becomes so soft or melts that separation occurs.
  • detachment such as electrolytic and mechanical detachment
  • electrolytic and mechanical detachment can also be combined.
  • a mechanical connection in particular via positive engagement, is produced between the units, which exists until an element which maintains the mechanical connection is electrolytically corroded.
  • the implant may have one or more radiopaque markings to allow the attending physician to visualize it.
  • the radiopaque markers may, for. B. from platinum, palladium, platinum-iridium, tantalum, gold, tungsten or other radiopaque metals. It is also possible to provide the implant, in particular the struts or wires of the support structure with a coating of a radiopaque material, for example with a gold coating. This can, for. B. have a thickness of 1 to 6 pm.
  • the coating with a radiopaque material need not cover the entire support structure. However, even when providing a radiopaque coating, it may be useful to additionally attach one or more radiopaque markers to the implant, in particular at the distal end of the implant and the appendage attached there.
  • Radiopaque substances for example, heavy metal salts such as barium sulfate.
  • Such substances are for. B. known as a contrast agent in X-ray technology.
  • Fig. 1 shows the separate representation of inner
  • Fig. 2 an inner support structure
  • FIG. 7 shows an aneurysm after further filling with additional occlusion means.
  • FIG. 1 shows the occlusion unit 1 according to the invention, wherein the inner support structure 3 and the tubular enclosure 4 are shown separated from one another.
  • the inner support structure 3 is inserted into the tubular sheath 4 and thus passes through the interior of the sheath 4.
  • the inner support structure 3 is composed of individual elements 8 in the form of subunits, the size of which decreases from proximal to distal. Attached to the distal end of the inner support structure 3 is an appendix 9 which is in the form of a helix and serves to indicate to the attending physician whether the occlusion unit 1 unfolds in the aneurysm in the correct manner after release.
  • the Tubular sheath 4 is composed of a mesh structure which is embedded in a membrane.
  • the inner support structure 3 is shown in more detail in FIG. It consists of several proximally to distally extending struts, which come together at certain nodes and thus a total of several individual (here 5) elements 8 form, the size of which decreases from proximal to distal.
  • the nodal points are the points of inflection within the sinusoidal course of the struts from proximal to distal.
  • the inner support structure 3 assumes a total of a spherical shape, wherein the individual elements 8 superimpose a spherical shell.
  • the extension 9 in the form of a helix.
  • FIG. 3 shows the structure of the tube-like sheath 4. This is composed of a braided structure 6 and a membrane 7, wherein the braid structure 6 is embedded in the membrane 7.
  • FIG. 4 shows the occlusion unit 1 partially released from the microcatheter 5 into the aneurysm 2.
  • the occlusion unit 1 is led out of the microcatheter 5 in the direction of the arrow, whereby it assumes the previously impressed secondary structure, which essentially represents a spherical shape.
  • the occlusion unit 1 follows the curvature of the extension 9, wherein the individual elements 8 superimposed so that they form a total of a ball.
  • the occlusion unit 1 has already been completely released into the aneurysm 2, but no detachment of the occlusion unit 1 from the insertion unit, here the guide wire 11, has taken place.
  • the occlusion unit 1 forms a total of a ball.
  • FIG. 6 shows how the occlusion unit 1 in the aneurysm 2, after detachment from the guide wire 11 and retraction of the microcatheter 5, continues to adapt to the shape of the aneurysm 2 in order to optimally fill it.
  • FIG. 7 shows the filled aneurysm from FIG. 6 once again, in which case further occlusion means 10 were additionally introduced into the aneurysm 2. These provide additional backfilling and thus thrombogenisation of the aneurysm 2.
  • the introduction of the additional occlusion means 10 can take place through the membrane 7 of the occlusion unit 1, ie the membrane 7 of the occlusion unit 1 is such that it can be punctured with a microcatheter 5 in order to introduce additional occlusion means 10 into the aneurysm 2.

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Abstract

L'invention concerne un implant pour le traitement de malformations artérioveineuses, en particulier d'anévrismes (2), présentant une unité d'occlusion (1) qui présente une structure support interne (3) s'étendant dans la direction longitudinale de l'unité d'occlusion (1) et, sur le côté externe de la structure support (3), une enveloppe (4) en forme de tuyau flexible, s'étendant dans la direction longitudinale de l'unité d'occlusion (1). L'implant peut être amené, dans l'état étiré, par un microcathéter (5) en un lieu de destination dans le système vasculaire d'un patient. Une structure secondaire est imprimée sur la structure support interne (3), qui est adoptée par la structure support (3) après suppression de la contrainte externe imposée par le microcathéter (5), l'enveloppe en forme de flexible (4) présentant une structure de tresse (3) qui est pourvue d'une membrane (7) sur la longueur de la structure de tresse (6).
PCT/EP2018/084754 2017-12-19 2018-12-13 Implant destiné a des anévrismes WO2019121320A1 (fr)

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