EP4284309A1 - Dispositifs médicaux revêtus - Google Patents

Dispositifs médicaux revêtus

Info

Publication number
EP4284309A1
EP4284309A1 EP22702885.9A EP22702885A EP4284309A1 EP 4284309 A1 EP4284309 A1 EP 4284309A1 EP 22702885 A EP22702885 A EP 22702885A EP 4284309 A1 EP4284309 A1 EP 4284309A1
Authority
EP
European Patent Office
Prior art keywords
stent structure
functional layer
wires
struts
proximal
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
EP22702885.9A
Other languages
German (de)
English (en)
Inventor
Hans Henkes
Hermann Monstadt
Ralf Hannes
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.)
Phenox GmbH
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
Priority claimed from DE102021102458.7A external-priority patent/DE102021102458A1/de
Application filed by Phenox GmbH filed Critical Phenox GmbH
Publication of EP4284309A1 publication Critical patent/EP4284309A1/fr
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • 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
    • A61L31/08—Materials for coatings
    • A61L31/082—Inorganic materials
    • 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
    • A61L31/08—Materials for coatings
    • A61L31/10—Macromolecular materials
    • 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
    • A61F2210/0076—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof multilayered, e.g. laminated structures
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • 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
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0015—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in density or specific weight
    • A61F2250/0017—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in density or specific weight differing in yarn density
    • 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
    • A61F2250/0071—Additional features; Implant or prostheses properties not otherwise provided for breakable or frangible
    • 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
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00389—The prosthesis being coated or covered with a particular material
    • A61F2310/00395—Coating or prosthesis-covering structure made of metals or of alloys
    • 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
    • A61L2420/00—Materials or methods for coatings medical devices
    • A61L2420/08—Coatings comprising two or more layers

Definitions

  • the invention relates to a device with a stent structure which is intended for introduction into blood vessels of the human or animal body, the stent structure having an expanded state in which it rests against the inner wall of the blood vessel and a state of reduced diameter in which it is inside a Microcatheter is movable through the blood vessel, wherein the stent structure, preferably at its proximal end, is connected to an insertion aid.
  • stents are often used to treat vascular constrictions and are permanently implanted at the site of the vascular constriction in order to keep the vessel open.
  • stents are tubular in structure and are either laser cut to give a surface of struts with openings between them, or are made of wire mesh.
  • Stents can be delivered to the target site through a catheter and expanded there; in the case of self-expanding stents made of shape-memory materials, this expansion and the application to the inner wall of the vessel take place automatically.
  • stents can also be expanded using balloons onto which the stent is crimped, or other mechanical methods. After final placement, only the stent itself remains at the target site; Catheters, guidewires, and other devices are removed from the vascular system.
  • Implants with a basically similar structure are also used to close aneurysms by placing them in front of the neck of an aneurysm will.
  • flow diverters of this type usually have a higher surface density than stents for removing stenoses.
  • An example of a flow diverter is described in the application WO 2008/107172 A1.
  • Vasospasm is a spasmodic narrowing of a blood vessel. This is associated with the risk that subsequent vessels are no longer supplied with blood to a sufficient extent (ischemia), which can lead to necrosis of the tissue supplied with blood by the vessels. Especially in the cerebral area, a vasospasm can occur a few days after a subarachnoid hemorrhage (SAH), often as a result of the rupture of an aneurysm. Other causes of subarachnoid hemorrhage are craniocerebral trauma and bleeding from vascular malformations or tumors. Leaked blood in the subarachnoid space washes around the vessels running there and is considered the most important triggering factor of the vasospasm.
  • SAH subarachnoid hemorrhage
  • vasospasm is one of the main reasons for strokes and even fatalities occurring after a rupture of an aneurysm and/or bleeding from the same or an operation in this area.
  • a vasospasm is usually treated with drugs, in particular calcium channel blockers or drugs that increase the NO level in the blood.
  • drugs in particular calcium channel blockers or drugs that increase the NO level in the blood.
  • An example of a calcium channel blocker is nimodipine, which is often used after subarachnoid hemorrhage to prevent vasospasm.
  • drug treatment is associated with not inconsiderable side effects and is also costly and time-consuming.
  • Other options for treating a vasospasm are intensive care measures such as raising arterial blood pressure and increasing the circulating blood volume, dilating narrowed vessels with the help of a balloon, blocking the stellate ganglion and surgically destroying sympathetic nerve fibers (sympathicolysis). The effectiveness of these treatment methods varies from person to person, e.g. T.
  • the blockade of the stellate ganglion and the operative sympathicolysis are effective because the sympathetic nerve fibers in the wall of the cerebral arteries are significantly involved in the development of the cerebral vasospasm.
  • the procedures are inadequate for the complete avoidance and treatment of cerebral vasospasm, since the blockage of the stellate ganglion lasts only a few hours and surgical sympathectomy is limited to a narrowly circumscribed vessel segment, which must be surgically prepared for this purpose.
  • a device for treating a vasospasm is known from WO 2017/207689 A1, which is essentially a stent structure which, however, does not remain permanently in the blood vessel system, but is brought to the site of the vasospasm and expanded there, in order to then be removed again to be withdrawn. Such a treatment often has to be repeated at intervals of a few days or weeks.
  • a permanent implant was unsuitable for the treatment of vasospasm because of the risk of platelet aggregation associated with the insertion of an implant.
  • Platelet adhesion and platelet aggregation and thus the formation of blood clots, so-called thrombi can be observed in permanent implants because the platelets adhere to the surface of the inserted implant, which is marked by endogenous proteins (platelet adhesion), which can lead to the formation of a thrombus (platelet aggregation).
  • platelet adhesion endogenous proteins
  • platelet aggregation platelet aggregation inhibitors
  • ASA acetylsalicylic acid
  • clopidogrel clopidogrel
  • prasugel ticagrelor
  • a device with a stent structure which is intended for introduction into blood vessels of the human or animal body, the stent structure being in an expanded state in which it rests against the inner wall of the blood vessel and in a reduced-diameter state in which it can be moved through the blood vessel within a microcatheter, the stent structure being connected to an insertion aid, preferably at its proximal end, the device being usable for treating a vasospasm and the stent structure being detachable from the insertion aid, at least parts of the stent structure having a coating wear and the coating comprises a functional layer, wherein the functional layer comprises at least one sugar alcohol and / or is formed by an oligo- or polymerization of functionalized with polymerizable groups monosaccharides.
  • the device according to the invention essentially comprises at least one substrate as the basis of the actual device and a functional layer.
  • the functional layer gives the device the desired properties and has a biomimetic or biorepulsive effect.
  • the functional layer preferably essentially comprises a complex, highly branched, hydrophilic matrix with a large number of molecules, each with a main chain as the polymeric backbone and each with a plurality of side chains.
  • the main and/or side chains can form bonds with other main and/or side chains. Further matrix-forming mono-, oligo- and polymers can be bound into these main and side chains without themselves being covalent to be bound to the substrate.
  • the saccharides that form the functional layer with sugar alcohols also being understood as saccharides according to the invention, are functionalized with polymerizable groups that are able to bind to the surface of the stent structure and bring about a polymerization.
  • the side chains include, in particular, mono- and/or oligosaccharides, reduction products of mono- or oligosaccharides also being regarded as such, in particular sugar alcohols (alditols).
  • oxidized mono- and/or oligosaccharides can also occur, with the oxidized form also being regarded as a mono- or oligosaccharide for the purposes of the invention.
  • the advantage of the coating according to the invention is seen in the fact that the functional layer has biomimetic or biorepulsive properties and is not recognized by thrombocytes as being foreign to the body, but rather as being endogenous. Accordingly, the functional layer according to the invention does not trigger any reaction of the thrombocytes, in particular no adhesion reactions and also no aggregation reactions.
  • the biomimetic effect of the coating according to the invention is attributed to the fact that the functional layer according to the invention imitates the human glycocalyx.
  • the glycocalyx covers the cells of the blood vessels with a kind of mucous layer and consists of various polysaccharides that are covalently bound to the membrane proteins and membrane lipids. Accordingly, glycoproteins and glycolipids result.
  • the polymerization of the reactants of the functional layer solution essentially only takes place after the functional layer solution has been applied to the substrate.
  • the polymerization of the reactants results in a complex layer which is so similar to the glycocalyx that the adhesion of thrombocytes to surfaces provided with the coating according to the invention is significantly lower than to uncoated surfaces.
  • the biorepulsive effect of the coating according to the invention is attributed to the principle of steric repulsion.
  • the space available for the oligo- and polymers on the surface is reduced when a protein approaches, i. H. an approaching protein forces the oligo- and polymers on the surface to adopt an energetically less favorable conformation.
  • this results in a repulsive force in relation to proteins. It is also possible that the displacement of water molecules from the coating leads to a repulsive osmotic force towards proteins.
  • this principle of action means that thrombocytes cannot adhere because there are no or only a few proteins suitable for binding on the surface, as a result of which thrombocyte adhesion is significantly reduced.
  • the stent structure which is at least partially, preferably overall, cylindrical, generally has openings distributed over the surface area of the cylinder.
  • it is a grid or Mesh structure made up of struts, webs or wires, resulting in a large number of openings or meshes on the lateral surface of the cylinder.
  • a stent structure composed of webs or struts connected to one another can be produced by laser cutting in a basically known manner; one speaks in this context of cut structures. In this way, a large number of openings or a network structure is produced within the stent structure, with the openings being distributed over the circumference of the stent structure.
  • Other production methods are also conceivable, for example galvanic or lithographic production, 3D printing or rapid prototyping.
  • the stent structure can also be a mesh structure made of wires that form a mesh.
  • the wires typically run helically along the longitudinal axis, with wires running in opposite directions running over and under one another at the crossing points, so that honeycomb-shaped openings are formed between the wires.
  • the total number of wires is preferably 8 to 64.
  • the wires forming the mesh structure may be single wires made of metal, but it is also possible to provide stranded wires, i. H. a plurality of small diameter wires which together form a filament and are preferably twisted together.
  • aperture refers to the lattice structure, regardless of whether the aperture is isolated from the environment by a membrane, i. H. an opening covered by a membrane is also referred to as an opening. If required, a membrane can be applied to the outside or inside of the lattice structure. It is also possible to embed the lattice structure in a membrane.
  • the membranes can be made from a polymeric material such as polytetrafluoroethylene, polyesters, polyamides, polyurethanes, polyolefins or polysulfones. Polycarbonate urethanes (PCU) are particularly preferred.
  • a stent structure made of webs or struts connected to one another which is produced in particular by laser cutting, compared to a mesh structure made of wires is that a stent structure consists of Struts are less likely to contract in length than a mesh structure when expanded. The length contraction should be kept as small as possible, since the stent structure exposes the surrounding vessel wall to additional stress during a length contraction. Since a vasospasm is ultimately due to stimuli that are exerted on the vessel, additional stress should be avoided when treating the vasospasm.
  • a stent structure made up of interconnected struts is also advantageous in that the radial force exerted by such a stent structure with an otherwise comparable structure, strut-Zwire density and strut-Zwire thickness is higher than in the case of a mesh structure made up of wires.
  • the reason is that the struts are firmly connected at the intersection points, while the wires of a mesh structure usually only run over and under each other.
  • the openings formed in the stent structure between each strut or wire should have an inscribed diameter of 0.1 to 6 mm, the inscribed diameter being the diameter of the largest possible circle that can be placed in the opening.
  • the information relates to the stent structure in the expanded state, ie the state that the stent structure assumes when it is not exposed to any external constraints or restrictions.
  • the expanded state in the blood vessel system can differ from the expanded state without external restrictions may vary because the implant may not be able to assume its fully expanded state.
  • Apertures with an inscribed diameter of >1 mm are preferred, i. H. a relatively coarse-meshed stent structure, since this can exert a radial force of a suitable magnitude to treat a vasospasm.
  • the resulting openings in the stent structure can be closed all around, i. H. be surrounded by struts or wires without interruptions (so-called “closed-cell design”).
  • closed-cell design an “open cell design” is preferred, in which at least some struts/wires have an interruption, so that the cells formed by the struts/wires are at least partially open, ie not completely closed.
  • Such an open-cell design exhibits greater flexibility, which can be advantageous in the case of severely tortuous blood vessels.
  • stent structures with a closed-cell design have a tendency to adopt a rectilinear configuration, which can place some stress on the blood vessel, particularly when the blood vessel itself has a more curvilinear course.
  • struts or wires with a relatively large cross-section or diameter i. H. the use of relatively massive struts/wires.
  • struts or wires with an essentially rectangular cross section a height and width of the struts/wires of 30 to 300 ⁇ m have proven to be advantageous, with a rectangular cross section with rounded edges also being regarded as essentially rectangular.
  • the diameter should be between 30 and 300 ⁇ m.
  • the stent structure can also be a mesh structure made of wires that form a braid.
  • the stent structure can also be a mesh structure made of wires that form a braid.
  • Loose wire ends can be present at the proximal and distal ends of the stent structure, although these are preferably designed to be atraumatic should be used to avoid damaging the blood vessel.
  • the atraumatic configuration of the wire ends can be achieved, for example, by rounding off the wire ends.
  • Another option is to loop the wires at one or both ends of the stent structure and loop them back into the braid. Accordingly, the end of the stent structure no longer has free wire ends, so that the risk of damaging the blood vessel wall is reduced.
  • the density of the struts or wires of the stent structure can be such that the stent structure resembles a conventional stent used to keep vessels open, but they can also be significantly higher, making the stent structure more similar to a flow diverter placed in front of aneurysms to Cut off aneurysm from blood flow.
  • Flow diverters have higher surface coverage, often in the range of 20-65% when expanded, i.e. H. a correspondingly high proportion of the total surface of the flow diverter has material in the form of struts/wires between which the openings are located.
  • a corresponding stent structure can also be used to be introduced into the blood vessel only briefly and to be expanded there.
  • a detachment point between the stent structure and the insertion aid is not absolutely necessary for a stent structure that is not intended to remain permanently in the blood vessel but is instead removed again after a few minutes.
  • Such an embodiment of the device with a stent structure that at least partially carries the described coating is also considered to be in accordance with the invention.
  • a detachment site can be advantageous in order to offer the treating physician different options depending on the situation, ie withdrawing the stent structure or, if withdrawal causes problems or the physician decides for a permanent residence of the stent for other reasons Stent structure in the blood vessel decides to detach the stent structure at the detachment site.
  • the insertion aid is typically an insertion wire, also called insertion wire or delivery wire.
  • insertion wires are known for implants.
  • the insertion aid is connected to the implant via a detachment point, it being possible for the detachment point to be provided for mechanical, thermal or electrolytic detachment.
  • the device of the invention has at least one such detachment site, with a single detachment site being preferred to facilitate detachment.
  • the insertion aid is preferably made of stainless steel, nitinol or a cobalt-chromium alloy.
  • the detachment point or points are preferably electrolytically corrodible detachment points.
  • the at least partial dissolution of the detachment point takes place by applying an electrical voltage, in that an electrical voltage is applied to the detachment point with the aid of a voltage source.
  • the detachment point is electrolytically corroded by applying a voltage, so that the implant detaches from the insertion aid. In most cases it is direct current, whereby a low current strength ( ⁇ 3 mA) is sufficient.
  • the detachment point is usually made of metal and forms the anode when the electrical voltage is applied, at which the oxidation and thus the dissolution of the metal takes place.
  • the electrolytic detachment of implants is well known from the prior art, for example for occlusion coils to close aneurysms, cf. e.g. WO 2011/147567 A1.
  • the principle is based on the fact that when a voltage is applied, a detachment point provided for this purpose made of a suitable material, in particular metal, usually undergoes dissolution by anodic oxidation to such an extent that the areas of the implant distal to the corresponding detachment point are released.
  • the detachment point can be made of stainless steel, magnesium, magnesium alloys or a cobalt-chromium alloy, for example.
  • a particularly preferred magnesium alloy is Resoloy®, which was developed by MeKo from Sarstedt/Germany (cf. WO 2013/024125 A1). It is an alloy of magnesium and, among other things, lanthanides, in particular dysprosium. Another advantage of using magnesium and magnesium alloys is that there are no physiological problems if magnesium residues remain in the body.
  • the cathode can e.g. B. be positioned on the body surface.
  • another area of the device can also form the cathode.
  • the point of detachment must be electrically conductively connected to the voltage source.
  • the insertion aid in particular the insertion wire itself, can serve as a conductor. Since the corrosion current that occurs when the cathode is placed on the surface of the body 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 some extent, the rate of dissolution of the delamination site can be controlled by adjusting the cathode area relative to the anode area.
  • the device according to the invention can thus also include a voltage source and possibly an electrode that can be placed on the body surface.
  • detachment points that can be separated mechanically, thermally or chemically.
  • a mechanical detachment there is typically a positive, non-positive or frictional connection, which is canceled when the stent structure is released, so that the stent structure is detached from the insertion aid.
  • the connection can be canceled by heating the Detachment takes place, whereupon it becomes so soft or melts that a separation occurs.
  • chemical detachment is also possible, in which detachment is brought about by a chemical reaction at the detachment point.
  • detachment for example electrolytic and mechanical detachment
  • electrolytic and mechanical detachment can also be combined with one another.
  • a mechanical connection is produced between the units, in particular via a positive fit, which lasts until an element maintaining the mechanical connection is electrolytically corroded.
  • a stent structure that is self-expanding and automatically changes to the expanded state after being released from the microcatheter.
  • a stent structure made of a material with shape-memory properties is advantageous for this purpose, and the use of nickel-titanium alloys known by the name of nitinol has proven particularly effective.
  • polymers with shape memory properties or other alloys are also conceivable.
  • the device according to the invention can be used in particular in the neurovascular area, but it can also be used in the cardiovascular or peripheral area.
  • the treatment is carried out in such a way that the device according to the invention is advanced within a microcatheter to the target site, ie the site of the vasospasm.
  • the stent structure is then released, which then expands and attaches itself to the inner wall of the vessel and treats the vasospasm.
  • the stent structure is left permanently or, in the case of temporary use, for a certain period of time, typically 1 to 10 minutes. If the stent structure is not to remain permanently in the blood vessel, the microcatheter is then moved distally again in order to fold in the stent structure. and the microcatheter and device are withdrawn.
  • drug treatment can also be carried out, for example with nimodipine.
  • this can be applied intra-arterially at the site of the vasospasm.
  • the stent structure is open at both ends in order to disturb the blood flow as little as possible and to prevent an undersupply of subsequent blood vessels and the tissue supplied by them.
  • a stent structure that is not intended to remain permanently in the blood vessel can also be closed at the distal end; a closed structure is more atraumatic at the distal end.
  • Open is understood to mean that there are no struts or wires at the respective end of the stent structure and struts/wires are limited to the outer circumference of the stent structure.
  • struts or wires are also present in the center of the stent structure. Since there are openings between the struts or wires, even if the distal end is closed, this end is not completely sealed; blood can continue to flow through the openings.
  • the force acting radially outwards on the inner wall of the vessel through the expanded stent structure should be between 2 and 30 N/m, preferably between 5 and 10 N/m, based on a diameter of the stent structure of 2.00 mm.
  • the specification of the radial force refers to the force exerted radially per unit of length, ie it is the relative radial force. Only that part of the stent structure that is in contact with the inner wall of the vessel and is therefore able to exert forces on it (effective length) is taken into account. Along the effective length, the stent structure must be at least 50% one around the stent structure cover drawn cover. In contrast, the absolute radial force denotes the overall value of the stent structure.
  • the test setup of the V-block test consists of two polymethyl methacrylate (PMMA) blocks, each of which has a milled and smoothly polished 90° V-groove. These V-blocks are placed one on top of the other so that when the blocks come into contact, a square-section cavity is created. While one of the V-blocks is fixed, the other is equipped with a force sensor.
  • PMMA polymethyl methacrylate
  • a stent structure in which the radial force in the expanded state is essentially constant over the effective length, with the proximal end of the stent structure, at which the struts or wires typically no longer rest completely against the inner wall of the vessel, being disregarded for the radial force.
  • the proximal end thus designates the most proximal part of the stent structure, which no longer belongs to the effective length and in which the struts/wires run towards the insertion aid.
  • a typical length of this proximal end is 8 to 10 mm, ie the total length of the stent structure is approximately this amount longer than the effective length of the stent structure.
  • the struts or wires can have a larger cross section here than in the middle section.
  • the struts/wires are thus made more solid, as a result of which the basic tendency of a stent structure to exert higher radial forces in the central section is fully or partially compensated.
  • the density of the struts or wires can be higher in the proximal section than in the middle section. This measure also completely or partially compensates for the drop in the radial force in the proximal or distal direction that can be observed with conventional stents.
  • the stent structure with a slit that extends helically over the lateral surface of the stent structure or in the longitudinal direction along the lateral surface of the stent structure.
  • Individual struts or wires can span the slot in order to influence the course of the radial force.
  • the diameter of the stent structure in the freely expanded state is typically in the range of 2 to 8 mm, preferably in the range of 4 to 6 mm.
  • the overall length of the stent structure in the expanded state is generally 5 to 50 mm, preferably 10 to 45 mm, more preferably 20 to 40 mm.
  • the effective length, ie the length of the stent structure in the expanded state, which actually exerts radial forces on the inner wall of the vessel, is usually approx. 8 to 10 mm shorter.
  • a stent structure made of struts this can be cut, for example, from a tube with a wall thickness of 25 to 70 ⁇ m; in the case of a mesh structure of wires intertwined with one another, the wire thickness is preferably 20 to 70 ⁇ m.
  • a microcatheter through which the device can be brought to the target site in the compressed state has e.g. B. an inner diameter of 0.4 to 0.9 mm.
  • Another possibility is to integrate electrical conductors into the stent structure, via which electrical impulses, high-frequency impulses or ultrasonic impulses can be applied to nerve fibers running in the vessel wall of the blood vessel in order to temporarily or permanently reduce the function of the nerve fibers and prevent or reduce vasospasm treat.
  • electrical impulses, high-frequency impulses or ultrasonic impulses can be applied to nerve fibers running in the vessel wall of the blood vessel in order to temporarily or permanently reduce the function of the nerve fibers and prevent or reduce vasospasm treat.
  • the application of impulses to the nerve fibers can take the form of radiofrequency (HF) signals, direct current, alternating current or ultrasound.
  • HF radiofrequency
  • the denervation is ultimately based on heating of the vessel wall, which leads to the elimination or reduction in the function of the nerve fibers.
  • the application of high-frequency or ultrasound pulses is preferred insofar as energy maxima can be generated in the depth of the surrounding vessel wall, so that the nerve fibers are damaged in a targeted manner, but not the entire vessel wall.
  • the nerve fibers are those of the sympathetic nervous system.
  • the radiopaque markers can e.g. B. platinum, palladium, platinum iridium, tantalum, gold, tungsten or other radiopaque metals.
  • radiopaque coils may be attached at various points on the device.
  • the stent structure in particular the struts or wires of the stent structure, with a coating of a radiopaque material, for example a gold coating. This can e.g. B. have a thickness of 1 to 6 pm.
  • the coating with a radiopaque material need not encompass the entire stent structure; it is of particular importance in the areas of the stent structure which touch the inner wall of the vessel, ie essentially in the cylindrical part of the stent structure. However, even when a radiopaque coating is provided, it can be useful to additionally attach one or more radiopaque markings to the device, in particular to the distal end of the stent structure.
  • struts made of a metal with shape-memory properties, in particular a corresponding nickel-titanium alloy, which at least partially have a platinum core.
  • the invention also relates to a method for treating vasospasm, using a device of the type described above.
  • the stent structure of the device is brought to the position of the vasospasm by means of the insertion aid and expanded there, which is usually done by pulling back the microcatheter in which the device is accommodated in a proximal direction.
  • the stent structure is then detached from the insertion aid. This can be done electrolytically in particular, d. H. by applying an electrical voltage to the detachment point located between the stent structure and the insertion aid.
  • a structure of the device and a corresponding coating, as described above in connection with the treatment of a vasospasm, can also be used for other purposes. These include, in particular, the treatment of a stenosis (narrowing of blood vessels) or the treatment of aneurysms.
  • the device serves as a kind of conventional stent, which, however, has the coating described in order to prevent the attachment of thrombocytes and thus the formation of blood clots, which would endanger the success of the treatment.
  • it can be a (laser) cut stent structure, in which case a closed-cell or at least a partially open-cell design can be used.
  • a braided stent structure is also possible, which can have loose wire ends at the proximal and/or distal end, but in which the wires at the proximal and/or distal end of the stent structure can also be fed back into the braid.
  • a flow diverter for the treatment of aneurysms.
  • a flow diverter typically has a larger surface coverage or surface density than a conventional stent.
  • the flow diverter is placed in front of the neck of the aneurysm to ensure that blood flow bypasses the aneurysm. This ensures that the aneurysm ultimately obliterates.
  • Another potential function of a stent structure or flow diverter placed in front of an aneurysm is to contain occlusive devices introduced into the aneurysm, such as e.g. B. to prevent occlusion coils from escaping the aneurysm.
  • Such an escape of occlusion means from the aneurysm can have undesired consequences if, for example, the occlusion means is carried by the bloodstream into more distally located areas and causes a occlusion of the blood vessel or an injury to the blood vessel wall there.
  • the stent structure can be permanently implanted in the blood vessel, but it is also possible to place a device only temporarily in front of the aneurysm after inserting a microcatheter into the aneurysm, through which occlusion means are to be introduced into the aneurysm. In this way, the device prevents leakage of occlusion agents from the aneurysm.
  • occlusion devices usually coils
  • they will interlock and thus prevent each other from exiting the aneurysm, ie once the aneurysm has been completely filled, it may be possible to dispense with further covering of the aneurysm neck.
  • Such a technique is also referred to as "jailing".
  • a detachment point for the insertion aid is not absolutely necessary; according to a further embodiment, such a device is also considered inventive if the stent structure at least partially carries the described coating.
  • bifurcation flow diverter Another form of flow diverter is the so-called bifurcation flow diverter, which is placed in front of aneurysms that are located at a vascular branch (bifurcation).
  • a bifurcation flow diverter or bifurcation implant is z. B. described in WO 2014/029835 A1.
  • Such an implant has a distal section which is radially widened compared to a section arranged further proximally. The distal section is designed to at least partially occlude the neck of the aneurysm.
  • the coating described for avoiding platelet adhesion and aggregation is also useful for such a bifurcation implant.
  • adhesion promoters are other examples.
  • Suitable adhesion promotion can take place, for example, via silanization, ie chemical bonding of silicon, in particular silane, compounds to at least parts of their surface. On surfaces, silicon and silane compounds bind, for example, to hydroxy and carboxy groups.
  • Coatable substrates within the meaning of the invention can accordingly be a wide variety of substrates, in particular oxidizable substrates, and combinations thereof.
  • a metal can also be coated with another metal, with the coating according to the invention being applied to the outer metal layer, preferably consisting of the carrier layer and the functional layer.
  • Coatable metals are also understood to mean those substrates in which the actual metal is covered by an oxide layer.
  • Other coatable substrates are glasses.
  • a particularly preferred embodiment relates to a device which has a gold coating, in whole or in part, which ensures radiopacity.
  • the widening of the device in the blood vessel can be visualized in this way, so that the treating doctor can see whether the widening is taking place in the desired form.
  • the coating according to the invention including the functional layer and in most cases also a carrier layer, is then in turn applied to the gold coating.
  • the base material of the device, to which the gold coating is applied can be a common metal or a common metal alloy for corresponding medical products, for example a nickel-titanium alloy, a cobalt-chromium alloy or stainless steel.
  • Coatable substrates according to the invention can also be a wide variety of plastics, such as polyamides (PA), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polylactide (PLA), polyester, polyether, polyurethane, polyolefins, and also corresponding block copolymers.
  • plastics such as polyamides (PA), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polylactide (PLA), polyester, polyether, polyurethane, polyolefins, and also corresponding block copolymers.
  • Suitable adhesion promotion can take place, for example, via silanization, ie chemical bonding of silicon, in particular silane, compounds to at least parts of their surface. On surfaces, silicon and silane compounds bind, for example, to hydroxy and carboxy groups.
  • Polyolefins can also be used as adhesion promoters, including chlorinated polyolefins (CPO) or acrylated polyolefins (APO).
  • CPO chlorinated polyolefins
  • APO acrylated polyolefins
  • the silane can have the general formula RSiXs.
  • corresponding compounds with several silicon atoms belong to the silane compounds within the meaning of the invention.
  • silane derivatives in the form of organosilicon compounds are regarded as silane compounds within the meaning of the invention. According to the invention, silane compounds are not only to be understood as meaning substances which consist of a basic silicon structure and hydrogen and are called silanes.
  • the matrix of the functional layer is preferably covalently bonded to the carrier layer or the substrate and is preferably synthesized by means of graft polymerisation, the functional layer being produced on the carrier layer or the substrate.
  • Sugar alcohols (alditols) are reduction products of sugars in which an aldehyde function has been reduced to alcohol.
  • the functional layer preferably essentially comprises a complex, highly branched, hydrophilic matrix comprising a multiplicity of molecules each having a main chain as the polymeric backbone and in each case a plurality of side chains.
  • the main and/or side chains can form bonds with other main and/or side chains.
  • Other matrix-forming mono-, oligo- and polymers can be incorporated into these main and side chains without themselves being covalently bonded to the backing layer.
  • the main chain can comprise at least partially polymerized vinyl, allyl, acrylic or methacrylic compounds or their derivatives and/or their isomers or also combinations thereof.
  • the side chains include, in particular, mono- and/or oligosaccharides, reduction products of mono- or oligosaccharides also being regarded as such, in particular sugar alcohols (alditols).
  • oxidized mono- and/or oligosaccharides can also occur, with the oxidized form also being regarded as a mono- or oligosaccharide for the purposes of the invention.
  • the device according to the invention comprises at least one substrate with a coating, the coating preferably comprising a carrier layer located on the substrate and a functional layer located on the carrier layer.
  • the carrier layer essentially comprises the adhesion promoters, which are mostly covalently bonded to the substrate.
  • non-covalently binding adhesion promoters are also known, for example those which bind to the substrate via a complex bond.
  • Preferred adhesion promoters are silicon compounds and polyolefinic adhesion promoters.
  • the functional layer comprises at least one functionalized sugar alcohol, via which the functional layer is covalently bonded to the carrier layer.
  • a preferred sugar alcohol of the functional layer corresponds to a sugar alcohol with the molecular formula CeHOe, for example sorbitol (sorbitol), and/or its derivatives, for example sorbitan.
  • Other sugar alcohols may be mannitol (mannitol), lactitol, xylitol (xylitol), threitol, erythritol, or arabitol.
  • the structure of sorbitol is given below:
  • “In its non-functionalized form” means that the stated molecular formula represents the molecular formula of the non-functionalized sugar alcohol, but should also include its derivatives and/or its isomers. Functionalization is understood to mean the introduction of a function into the compound which allows linking to the substrate, the carrier layer and/or compounds already bonded to the carrier layer or the substrate beforehand.
  • the functional layer according to the invention can include functionalized variants of the sugar alcohol with the molecular formula CeHOe and/or its derivatives and/or its isomers.
  • the functional layer can comprise a complex matrix, which can result from the polymerization of the applied, functionalized sugar alcohols.
  • Sorbitol acrylates (with one or more acrylate group/s), where the acrylate group/s can be in different positions.
  • Another advantage of the coating according to the invention is that, via the intermediate step of promoting adhesion, the coating covers only those surfaces and structures of the devices which can be activated for the corresponding adhesion promoters and, in particular, have also been activated.
  • the coating covers only those surfaces and structures of the devices which can be activated for the corresponding adhesion promoters and, in particular, have also been activated.
  • Such a selective coating or a coating method that is selective in this way has the advantage described above in a large number of devices, at least in those that comprise different materials, but a coating is only intended to take place on certain of these materials.
  • the coating according to the invention leaves possibilities for activating only those parts of the device which are later also intended to carry the functional layer. It is also conceivable that the device is already designed in such a way that substances that can be activated for adhesion promotion are selected for the parts to be coated.
  • Devices with a coating according to the invention can be used in particular for endovascular, neurovascular and cardiovascular use, but the coating according to the invention can always be useful for a device if the corresponding device comes into contact with blood.
  • In vitro test series were carried out with the coating according to the invention in order to test the effectiveness of the coating according to the invention.
  • an uncoated nitinol platelet and a nitinol platelet silanized according to the invention and then coated with polymerized sorbitol acrylate were incubated for 10 minutes with heparinized whole blood for each test series.
  • the adhesion of thrombocytes was then determined by means of fluorescence microscopy using fluorescence-labeled CD61 antibodies.
  • FIG. 2 shows a coated nitinol plate after 10 minutes incubation time with heparinized whole blood at 10 ⁇ magnification under the fluorescence microscope. Only a few attached CD61 positive platelets can be seen.
  • FIG. 3 shows the device 1 according to the invention in a side view as an example.
  • the device has a stent structure 2 and an insertion aid 3 in the form of an insertion wire.
  • the stent structure 2 is laser-cut and is composed of struts, which together result in a continuous honeycomb structure.
  • the insertion aid 3 is eccentric, i. H. connected in the edge area to the stent structure 2 at its proximal end via a detachment point 4 . By applying an electrical voltage to the detachment point 4, the stent structure 2 can be detached from the insertion aid 3 and permanently implanted in the blood vessel.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Surgery (AREA)
  • Epidemiology (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
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  • Optics & Photonics (AREA)
  • Physics & Mathematics (AREA)
  • Prostheses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'invention se rapporte à un dispositif (1) ayant une structure d'endoprothèse (2) destinée à être introduite dans des vaisseaux sanguins du corps humain ou animal, la structure d'endoprothèse (2) ayant un état expansé dans lequel elle est en contact avec la paroi interne du vaisseau sanguin et un état à diamètre réduit dans lequel elle est mobile à travers le vaisseau sanguin à l'intérieur d'un microcathéter, la structure d'endoprothèse (2), de préférence son extrémité proximale, étant reliée à un moyen d'aide à l'insertion (3), le dispositif (1) étant utilisable pour le traitement d'un vasospasme et la structure d'endoprothèse (2) étant détachable du moyen d'aide à l'insertion (3), au moins des parties de la structure d'endoprothèse (2) portant un revêtement et le revêtement comprenant une couche fonctionnelle, la couche fonctionnelle comprenant au moins un alcool de sucre et/ou étant formée par oligomérisation ou polymérisation de monosaccharides fonctionnalisés par des groupes polymérisables. L'invention se rapporte également à une méthode correspondante destinée au traitement d'un vasospasme.
EP22702885.9A 2021-01-26 2022-01-18 Dispositifs médicaux revêtus Pending EP4284309A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE102021101691 2021-01-26
DE102021102458.7A DE102021102458A1 (de) 2021-01-26 2021-02-03 Beschichtete medizinische Vorrichtungen
PCT/EP2022/050972 WO2022161813A1 (fr) 2021-01-26 2022-01-18 Dispositifs médicaux revêtus

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Publication number Priority date Publication date Assignee Title
DE102007012964A1 (de) 2007-03-06 2008-09-11 Phenox Gmbh Implantat zur Beeinflussung des Blutflusses
DE102010021947A1 (de) 2010-05-28 2011-12-01 Phenox Gmbh Implantatablösung
JP6114274B2 (ja) 2011-08-15 2017-04-12 メコ ラーザーシュトラール−マテリアルベアルバイトゥンゲン エー．カー． マグネシウム合金を含む吸収性ステント
KR102156453B1 (ko) 2012-08-22 2020-09-16 페녹시 게엠베하 임플란트
DE102016110199A1 (de) 2016-06-02 2017-12-07 Phenox Gmbh Vasospasmusbehandlung
DE102016111568A1 (de) * 2016-06-23 2017-12-28 Phenox Gmbh Implantat mit Ablösemechanismus
DE102016116871A1 (de) 2016-09-08 2018-03-08 Phenox Gmbh Vorrichtung und Verfahren zur Vorbeugung und Behandlung eines Vasospasmus
DE102017111486A1 (de) * 2017-05-17 2018-11-22 Phenox Gmbh Beschichtung für Medizinprodukte

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