EP4027910A1 - Implant pour le traitement d'anévrismes - Google Patents

Implant pour le traitement d'anévrismes

Info

Publication number
EP4027910A1
EP4027910A1 EP20800795.5A EP20800795A EP4027910A1 EP 4027910 A1 EP4027910 A1 EP 4027910A1 EP 20800795 A EP20800795 A EP 20800795A EP 4027910 A1 EP4027910 A1 EP 4027910A1
Authority
EP
European Patent Office
Prior art keywords
implant
implant according
aneurysm
membranes
surface segments
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
EP20800795.5A
Other languages
German (de)
English (en)
Inventor
Hans Henkes
Hermann Monstadt
Ralf Hannes
Volker Trösken
Cameron MENZIES
Ronald Kontek
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Femtos GmbH
Original Assignee
Femtos 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 Femtos GmbH filed Critical Femtos GmbH
Publication of EP4027910A1 publication Critical patent/EP4027910A1/fr
Pending legal-status Critical Current

Links

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
    • A61B17/1214—Coils or wires
    • A61B17/1215—Coils or wires comprising additional materials, e.g. thrombogenic, having filaments, having fibers, 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
    • 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
    • A61B17/12172—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
    • A61B17/12168—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
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/16—Biologically active materials, e.g. therapeutic substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00526—Methods of manufacturing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00893—Material properties pharmaceutically effective
    • 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
    • A61B2017/12054—Details concerning the detachment of the occluding device from the introduction device
    • A61B2017/12063—Details concerning the detachment of the occluding device from the introduction device electrolytically detachable
    • 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
    • A61B2017/12054—Details concerning the detachment of the occluding device from the introduction device
    • A61B2017/12068—Details concerning the detachment of the occluding device from the introduction device detachable by heat
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3966—Radiopaque markers visible in an X-ray image

Definitions

  • Implant for the treatment of aneurysms The invention relates to an implant for the treatment of arteriovenous malformations, in particular aneurysms, wherein the implant can be brought in a stretched state through a microcatheter to a destination in the blood vessel system of a patient and the implant is impressed with a secondary structure that it is released from Microcatheter and the associated elimination of external constraint, the implant is detachably connected to an insertion aid.
  • Aneurysms are mostly sack-like or spindle-shaped (fusiform) extensions of the vascular wall, which arise primarily at structurally weakened areas of the vascular wall due to the constant pressure of the blood.
  • the inner walls of the aneurysm are correspondingly sensitive and prone to injury.
  • the rupture of an aneurysm usually leads to considerable health impairments, in the case of cerebral aneurysms to neurological failures up to and including death of the patient.
  • aneurysm In addition to surgical interventions in which, for example, the aneurysm is clamped off by means of a clip, endovascular methods for treating aneurysms are known in particular, two approaches being pursued primarily.
  • the aneurysm can be filled with occlusion means, in particular so-called coils (platinum spirals).
  • the coils promote thrombus formation and thus ensure closure of the aneurysm.
  • it is known to close the access to the aneurysm for example the neck of a berry aneurysm, from the blood vessel side by means of stent-like implants and to decouple it from the blood flow. Both procedures serve to increase blood flow in the aneurysm and thus reducing the pressure on the aneurysm, ideally eliminating it, and thus reducing the risk of the aneurysm rupturing.
  • 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 protrude from a wide aneurysm neck 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 that are used to treat stenoses. Since the task of the flow diverters is not to keep a vessel open, but to close the aneurysm access on the blood vessel side, the mesh size is very narrow; alternatively, these implants are covered with a membrane. The disadvantage of these implants is the risk that branching branches in the immediate vicinity of the aneurysm to be treated are sometimes also covered and thus closed in the medium or long term.
  • WO 2012/034135 A1 discloses an implant which is composed of a first and a second section, which are arranged one behind the other within a catheter, but after release within the aneurysm assumes a three-dimensional, approximately spherical shape and thus fills the aneurysm.
  • the starting material for the three-dimensional implant is a mesh-like fabric; the exemplary embodiments and images are all based on a tube-like mesh made of shape memory material.
  • Aneurysms are rarely absolutely round, but a three-dimensional implant should be able to fit into the morphology of the aneurysm as best as possible.
  • the implant is too bulky for catheters of small caliber.
  • the implant for introduction into aneurysms is known from WO 2017/089451 A1.
  • the implant is made up of several sub-units, each of which has a framework of struts between which there is a covering.
  • the implant must first form several turns within an aneurysm until sufficient coverage of the surface of the aneurysm is achieved.
  • the object is to provide a further improved implant for introduction into aneurysms, which in particular ensures good coverage of the aneurysm wall and filling of the aneurysm interior.
  • this object is achieved by an implant for the treatment of arteriovenous malformations, in particular aneurysms, wherein the implant can be brought in a stretched state by a microcatheter to a destination in the blood vessel system of a patient and the implant is impressed with a secondary structure that is released from the microcatheter and the associated elimination of the external constraint, the implant being detachably connected to an insertion aid and the implant forming a surface structure running from proximal to distal, which is made up of several struts which form adjacent surface segments, at least some of the surface segments with the membrane filling the surface segments is provided and the secondary structure brings about an at least partial rolling up of the surface structure axially and radially to the longitudinal direction of the implant and the formation of a spherical structure.
  • the implant according to the invention is composed of several struts which result in adjacent surface segments. Together these form a surface structure that can be spread out flat and in this conformation Forms elongated element that resembles a longitudinally slotted and flat spread stent. Similar to this, a secondary structure impressed on the implant ensures that the surface structure has the tendency to roll up at least partially radially to the longitudinal direction of the implant, ie around the longitudinal axis. This rolling is normally done along the entire length of the surface structure. However, the rolling up does not have to go so far that the overlapping of the side edges of the surface structure results in a tube; it is usually sufficient to only bring about a partial rolling up of the surface structure over the secondary structure shown.
  • the surface structure in this case has side edges that are arched upward radially to the longitudinal direction and thus resembles a severed tree bark.
  • the surface structure is normally in a rolled up form, whereby, depending on the inner diameter of the microcatheter, the surface structure can also be more rolled up than specified according to the secondary structure.
  • the release from the microcatheter is associated with a widening along and perpendicular to the longitudinal direction of the implant, ie, to a certain extent, a rolling apart.
  • the aforementioned rolling up about the longitudinal axis is only one aspect of the secondary structure impressed on the implant.
  • a secondary structure is impressed on the surface structure, which has the tendency to roll up the structure not only at least partially radially around the longitudinal axis, but also axially, so that overall an approximately spherical structure results.
  • Rolling up in the axial direction is understood to mean rolling up about an axis which runs orthogonally to the longitudinal axis. There is thus a rolling up of the surface structure in the longitudinal direction of the implant and a curvature of the surface structure essentially on the longitudinal axis of the implant.
  • the implant When it is released from the microcatheter, more and more of the implant emerges from the microcatheter, automatically rolling up in such a way that overall a spherical structure, in particular approximately a spherical shape, results.
  • This formation of the spherical structure takes place within the aneurysm.
  • the implant clings to the inner wall of the aneurysm and fills it out. Due to its flexibility, it can adapt to different aneurysm shapes and, in particular, also largely fill this out if it has a rather irregular shape.
  • the implant is flexible enough that an injury to the aneurysm wall can be ruled out.
  • the spherical structure is usually designed so that, if freely expanded, it would assume a larger diameter than the interior of the aneurysm.
  • the implant fixes itself positively in the aneurysm.
  • a spherical structure is understood to mean a structure which has approximately a spherical or also an ovoid shape, these shapes also being able to be irregular, ie. H. for example do not have to have a perfect spherical shape.
  • the spherical structure is three-dimensionally rounded and suitable for filling an aneurysm, whereby the structure that actually forms naturally also depends on the exact shape of the aneurysm.
  • a significant advantage over the use of coils known from the prior art for filling the aneurysm is that no coils can escape from the aneurysm and close a blood vessel at another location.
  • the secondary structure ensures that the aneurysm is almost completely filled and thus ensures that it closes quickly and safely.
  • the aneurysm can be closed by one or more implants according to the invention. It is also possible to combine the use of the implant with other methods of aneurysm treatment, for example by inserting other implants such as coils Introducing a liquid embolizate or placing a flow diverter or stent in front of the aneurysm.
  • a membrane is understood to be a thin structure with a flat extension, regardless of whether it is permeable, impermeable or partially permeable to liquids.
  • membranes are preferred which are completely or at least largely impermeable to liquids such as blood.
  • a membrane can also be provided with pores through which further occlusion means can be introduced. Another possibility is to design the membrane in such a way that it can be pierced with a microcatheter for the introduction of further occlusion means or with the occlusion means itself.
  • the membranes can be constructed from polymer fibers or films.
  • the membranes are preferably produced by electrospinning.
  • the struts are usually embedded in the membrane. This can be achieved by first presenting the surface structure, which is then wrapped or braided with fibers in such a way that a surface structure results, the individual surface segments of which are provided with a membrane.
  • electrospinning fibrils or fibers are deposited on a substrate from a polymer solution with the aid of an electric current. During the deposition, the fibrils stick together to form a fleece. As a rule, the fibrils have a diameter of 100 to 3,000 nm.
  • Membranes obtained by electrospinning are very uniform.
  • the membrane is tough and mechanically resilient and can be pierced mechanically without the opening becoming a 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.
  • the membranes can also be produced using a dipping or spraying process such as spray coating.
  • the material of the membranes it is important that they are not damaged by the mechanical stress when they are drawn into a microcatheter, discharged, unfolded, etc. The membranes should therefore have sufficient elasticity.
  • the membranes can be made from a polymer material such as polytetrafluoroethylene, polyesters, polyamides, polyurethanes or polyolefins. Polycarbonate urethanes (PCU) are particularly preferred.
  • PCU Polycarbonate urethanes
  • an integral connection of the membranes to the surface structure is desirable. Such an integral connection can be achieved by covalent bonds between the membranes and the surface structure.
  • the formation of covalent bonds is promoted by a silanization of the planar structure, that is to say by a chemical attachment of silicon, in particular silane compounds, to at least parts of the surface of the planar structure. Silicon and silane compounds bind to surfaces, for example to hydroxyl and carboxy groups. In addition to silanization, other methods of promoting adhesion between the surface structure and membranes are also conceivable.
  • the silane can have the general formula RS1X3.
  • corresponding compounds with several silicon atoms belong to the silane compounds.
  • silane derivatives in the form of organosilicon compounds are understood as silane compounds in this context. Additional substances that promote thrombogenization or endothelial formation can be embedded in the membranes or used up on the membranes.
  • the thrombogenization-promoting substances are advantageous because they support the formation of a thrombus within the aneurysm, which ensures a permanent closure of the aneurysm.
  • One example is nylon filaments. Since aneurysms are based on degenerative vascular wall diseases, in particular arteriosclerosis, the promotion of endothelial formation and the elimination of functional disorders 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 (stem vessel).
  • Substances that promote thrombogenization are preferably applied to the inside of the membrane, whereas substances that promote endothelial formation are applied to the outside of the membrane, with the outside being the side of a membrane facing the vessel wall in the implanted state and the inside being the side of a membrane facing the inside of the aneurysm.
  • thrombogenization promoting substances are collagens, while z.
  • B. Flyaluronic acid, statins (3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors) and other polymers can promote colonization with endothelial cells.
  • Polysaccharides, especially glycosaminoglycans, which are able to imitate the glycocalyx are particularly suitable as polymers.
  • POSS-PCU polyhedral oligomeric silsesquioxane poly (carbonate-urea) urethane
  • POSS-PCL polyhedral oligomeric silsesquioxane poly (caprolactone-urea) urethane
  • POSS-PCU or POSS-PCL nanocomposite polymers are poorly suited for direct immobilization on the surface of an implant, which is why it has been found to be 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 endothelial formation (cf. Solouk et al., Mater Sei Eng C Mater Biol Appl. 2015; 46 : 400-408).
  • proximal and distal are to be understood in such a way that when the implant is being inserted, parts facing the attending physician are referred to as proximal and parts facing away from the attending physician are referred to as distal.
  • the implant is thus typically advanced in the distal direction through a microcatheter.
  • the longitudinal direction of the implant is the direction from proximal to distal.
  • the microcatheter can e.g. B. be a microcatheter with an inner diameter of 0.021 "or 0.027".
  • axial refers to the longitudinal axis of the implant, which runs from proximal to distal when the implant is stretched; “Radial” denotes a direction orthogonal to this.
  • At least some surface segments have central struts which each extend from an edge region of a surface segment to a further, usually opposite edge region of the same surface segment.
  • These central struts support the shaping of the implant and in particular the application of the membranes to the inner wall of the aneurysm.
  • the shear stability of the implant is also improved.
  • the central struts do not have to be straight from an edge area of a
  • the struts and central struts can form individual nodes at each of which a surface segment ends.
  • the number of struts / center struts that each run towards the node from one direction and meet at the nodes is typically 2 to 4.
  • a further surface segment can begin at each node, but there can also be a short intermediate area that extends between the junction of one
  • Area segment extends.
  • the individual surface segments are preferably arranged offset from one another in the longitudinal direction.
  • the next surface segment can be arranged proximally and distally offset, while the next but one surface segment again lies on the same line running parallel to the longitudinal axis of the implant.
  • the surface segment, which is offset from the first surface segment can in turn, together with other surface segments, also lie on a line oriented parallel to the longitudinal axis of the implant.
  • a maximum of two surface segments are preferably located next to one another, where next to one another refers to the direction orthogonal to the longitudinal axis.
  • the size of the individual surface segments can vary across the implant.
  • the size of the surface segments can increase from distal to proximal. In this way it is ensured that the distally lying surface segments, which are the first to leave the microcatheter when being introduced into the aneurysm, can roll up as tightly as possible.
  • the size of the individual surface segments varies orthogonally to the longitudinal direction, for example between two surface segments arranged one behind the other in the longitudinal direction, proximally and distally offset surface segments have a different size than the two surface segments lying one behind the other. As far as the size of the surface segments is mentioned, this relates to the surface of the surface segments when the surface structure is spread out flat.
  • the spherical structure also follows the shape of the aneurysm.
  • the secondary structure can be designed in such a way that the individual surface segments in the spherical structure overlap to a certain extent. This ensures that the entire surface of the inner wall of the aneurysm is covered by the surface segments and the membranes filling the surface segments. If necessary, it can also be sufficient if smaller gaps remain between the individual surface segments in the spherical structure, as long as at least extensive coverage of the surface of the inner wall of the aneurysm is ensured. Providing the surface segments with a membrane is particularly important for the surface segments that ultimately come to lie on the outer surface of the spherical structure.
  • the membrane in contrast to this, in the case of surface segments that lie in the interior after the spherical structure has been formed, the membrane can also be completely or partially dispensed with. Of course, it is also possible to equip the entire surface structure with membranes spanning all surface segments. The latter has advantages in terms of manufacturing technology in particular.
  • the spherical structure When the implant is fully released, the spherical structure typically has a diameter in the range from 4 to 25 mm. Such a diameter is sufficient to fill typical aneurysms, especially those that occur in the intracranial area.
  • the diameter actually occupied within the aneurysm can vary, so that the implant can be used for the treatment of aneurysms of different sizes and with different aneurysm neck sizes.
  • the struts of the implant are preferably made at least partially from shape memory materials. This makes it possible to impress the desired secondary structure on the implant, which it automatically assumes again after leaving the microcatheter.
  • Shape memory metals in particular are well known in the field of medical technology; Particularly noteworthy in this regard are nickel-titanium alloys, such as those used under the name Nitinol.
  • the struts of the implant can in particular be produced by laser cutting techniques. However, it is also possible to produce the surface structure built up from the struts as a braided structure, in which individual struts are interwoven or interwoven in order to form the desired surface structure overall. Other production methods are also conceivable, for example galvanic or lithographic production, 3D printing or rapid prototyping.
  • the struts can have a round, oval, square or rectangular cross-section, and in the case of a square or rectangular cross-section, the edges can be rounded.
  • the individual struts can also be composed of several individual filaments that are twisted with one another or also run in parallel.
  • the implant usefully has one or more radiopaque markings to enable the attending physician to visualize it.
  • This can be, for example, a helix, spiral or a rivet made of a radiopaque material, which are attached to the struts of the implant.
  • the radiopaque markings can e.g. B. made of 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 made of a radiopaque material, for example with a gold coating. This can e.g. B. have a thickness of 1 to 6 pm.
  • the coating with a radiopaque material does not have to encompass the entire support structure. Even if a radiopaque coating is provided, however, it can be useful to additionally apply one or more radiopaque markers to the implant, in particular to the distal end of the implant.
  • Another possibility of making the implant X-ray visible is to embed radio-opaque substances, for example heavy metal salts such as barium sulfate, in the membrane. Such substances are z. B. known as a contrast agent in X-ray technology.
  • Another option consists in the use of struts made of a metal with shape memory properties, in particular a corresponding nickel-titanium alloy, which in any case partially have a platinum core.
  • DFT drawn filled tubing
  • the implant is detachably connected to an insertion aid via a detachment point.
  • This insertion aid can be a conventional guide wire with which the implant can be advanced through the blood vessel system to the desired location.
  • the implant can be detached from the insertion aid electrolytically, thermally, mechanically or chemically.
  • the detachment point is electrolytically corroded by applying a voltage, so that the implant detaches from the insertion aid. In order to avoid anodic oxidation of the implant, it should be electrically isolated from the detachment point and the insertion aid.
  • the electrolytic detachment of implants is well known from the prior art, especially for coils for closing aneurysms. Corresponding separation points are z. B.
  • a separation point provided for this purpose made of a suitable material, in particular metal, is usually at least dissolved by anodic oxidation to such an extent that the areas of the implant distal to the corresponding separation point are released.
  • the separation point can be made of stainless steel, magnesium, magnesium alloys or a cobalt-chromium alloy, for example.
  • the separation point is dissolved by applying an electrical voltage. This can be either an alternating current or a direct current, with a low current strength ( ⁇ 3 mA) being sufficient.
  • the separation point is usually the anode where the oxidation and dissolution of the metal takes place.
  • the separation point is connected to a voltage source in an electrically conductive manner, in particular via the insertion aid.
  • the insertion aid itself must also be designed to be electrically conductive. Since the resulting 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 anode. To a certain extent, the rate of dissolution of the separation point can be controlled by adjusting the cathode area in relation to the anode area.
  • the invention accordingly also relates to a device which comprises a voltage source and optionally an electrode that can be placed on the body surface.
  • detachment for example electrolytic and mechanical detachment
  • electrolytic and mechanical detachment can also be combined with one another.
  • a mechanical connection is established between the units, in particular via a form fit, which exists until an element maintaining the mechanical connection is electrolytically corroded.
  • the invention also relates to the use of the implant for treating arteriovenous malformations, in particular aneurysms, and a method for producing the implant.
  • a surface structure is first created from several struts, which is constructed as described above.
  • the surface structure is then converted into a spherical structure, subjected to a heat treatment and finally provided with membranes.
  • the conversion into a spherical structure can take place unprecedented in that the surface structure is placed over a sphere and guided around it.
  • the finished implant can finally be inserted into a microcatheter; when it leaves this, however, it has the tendency to automatically resume the previously imprinted secondary structure.
  • 1 shows an implant according to the invention in a flat, spread-out form
  • 2 shows a further implant according to the invention in a flat, spread-out form with radiopaque markers
  • FIG. 3 shows a further implant according to the invention in a flat, spread-out form with radiopaque markers
  • an implant 1 according to the invention is shown in an expanded form.
  • the surface structure 2 made up of the individual struts 3 can be seen.
  • the struts 3 form various surface segments 4 arranged offset to one another, the struts 3 converging at nodes 5 arranged between the surface segments 4.
  • the surface segments 4 are provided with membranes 6.
  • the shape of the individual surface segments 4 is improved by means of central struts 10, which at the same time increase the shear stability when the implant 1 is advanced from proximal to distal. At the proximal end of the implant 1 shown below, this is connected to an insertion aid 9.
  • FIG. 2 shows an alternative embodiment of the implant 1 according to the invention, which largely corresponds to the first embodiment.
  • the struts 3 form surface segments 4 which are provided with membranes 6, the totality of the surface segments 4 forming the surface structure 2.
  • only a few surface segments 4 are provided with central struts 10 here.
  • this is in turn connected to an insertion aid 9.
  • radiopaque markers can be seen in FIG. 2, on the one hand in the form of radiopaque marker spirals 7 and on the other hand in the form of radiopaque markers Rivets 8 which are arranged at various points on the implant 1 in order to enable the attending physician to visualize it.
  • FIG. 1 At the proximal end, shown here below, the implant 1 is again connected to the insertion aid 9. Some of the surface segments 4 have central struts 10, the radiopaque marker spirals 7 being attached around the central struts 10. A radiopaque rivet 8 is also located at the distal end of the implant 1 shown here above.
  • FIGS. 4 to 8 show how the implant 1 is introduced into an aneurysm 11.
  • the implant 1 is pushed out of the aneurysm 11 by means of the insertion aid 9 through the microcatheter 12 placed in front of the aneurysm 11, so that it can unfold in the aneurysm 11.
  • the implant 1 is provided with membranes 6.
  • the implant 1 rolls up on the one hand radially, but also axially, so that it forms a spherical structure which practically completely fills the aneurysm 11. The process progresses further, the more the implant 1 is pushed out of the microcatheter 12, as can be seen in FIGS. 5 to 7.

Abstract

L'invention concerne un implant (1) pour le traitement de malformations artérioveineuses, en particulier des anévrismes (11). L'implant (1) peut être délivré dans un état étiré à un emplacement spécifique dans le système circulatoire d'un patient à l'aide d'un microcathéter (12), et une structure secondaire est imposée sur l'implant (1), ledit implant étant en prise avec la structure secondaire lorsque l'implant est libéré du microcathéter (12) et, par conséquent, la pression externe du microcathéter cesse d'agir sur l'implant, l'implant (1) est relié à un moyen d'aide à l'insertion (9) de manière amovible, et l'implant (1) forme une structure plate (2) qui s'étend d'une extrémité proximale à une extrémité distale, ladite structure plate étant constituée de multiples entretoises (3) qui forment des segments plats (4) adjacents les uns aux autres. Au moins certains des segments plats (4) sont pourvus de membranes (6) qui remplissent les segments plats (4), et la structure secondaire amène la structure plate (2) à s'enrouler au moins partiellement axialement et radialement par rapport à la direction longitudinale de l'implant (1) et produit une structure sphérique. L'implant (1) selon l'invention est adapté pour s'adapter à la paroi interne d'un anévrisme (11) et remplir un anévrisme (11) pratiquement dans sa totalité.
EP20800795.5A 2019-10-17 2020-10-14 Implant pour le traitement d'anévrismes Pending EP4027910A1 (fr)

Applications Claiming Priority (2)

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DE102019128102.4A DE102019128102A1 (de) 2019-10-17 2019-10-17 Implantat zur Behandlung von Aneurysmen
PCT/EP2020/078894 WO2021074219A1 (fr) 2019-10-17 2020-10-14 Implant pour le traitement d'anévrismes

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EP4027910A1 true EP4027910A1 (fr) 2022-07-20

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US (1) US20220330947A1 (fr)
EP (1) EP4027910A1 (fr)
CN (1) CN114554980A (fr)
DE (1) DE102019128102A1 (fr)
WO (1) WO2021074219A1 (fr)

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US20230061363A1 (en) * 2021-08-31 2023-03-02 Incumedx Inc. Embolic device with improved neck coverage

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US9687245B2 (en) * 2012-03-23 2017-06-27 Covidien Lp Occlusive devices and methods of use
DE102012016555A1 (de) * 2012-08-22 2014-02-27 Phenox Gmbh Implantat
US9713475B2 (en) * 2014-04-18 2017-07-25 Covidien Lp Embolic medical devices
DE102015120554A1 (de) * 2015-11-26 2017-06-01 Phenox Gmbh Bandförmiges Okklusionsmittel
JP7144404B2 (ja) * 2016-05-26 2022-09-29 ナノストラクチャーズ・インコーポレイテッド 神経動脈瘤を塞栓閉塞するためのシステムおよび方法
WO2018051187A1 (fr) * 2016-09-14 2018-03-22 Medinol Ltd. Dispositif de fermeture d'anévrisme
US20180161185A1 (en) * 2016-12-14 2018-06-14 eLum Technologies, Inc. Electrospun stents, flow diverters, and occlusion devices and methods of making the same
US10299799B1 (en) * 2017-07-07 2019-05-28 John S. DeMeritt Micro-macro endovascular occlusion device and methodology
DE102017130564A1 (de) * 2017-12-19 2019-06-19 Phenox Gmbh Implantat für Aneurysmen

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WO2021074219A1 (fr) 2021-04-22
CN114554980A (zh) 2022-05-27
US20220330947A1 (en) 2022-10-20
DE102019128102A1 (de) 2021-04-22

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