EP3820539A1 - Revêtement pour dispositifs médicaux implantables, procédé pour leur fabrication ainsi que dispositifs médicaux implantables - Google Patents

Revêtement pour dispositifs médicaux implantables, procédé pour leur fabrication ainsi que dispositifs médicaux implantables

Info

Publication number
EP3820539A1
EP3820539A1 EP19730776.2A EP19730776A EP3820539A1 EP 3820539 A1 EP3820539 A1 EP 3820539A1 EP 19730776 A EP19730776 A EP 19730776A EP 3820539 A1 EP3820539 A1 EP 3820539A1
Authority
EP
European Patent Office
Prior art keywords
layer
polyelectrolyte
implantable medical
coating
deposited
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
EP19730776.2A
Other languages
German (de)
English (en)
Inventor
Sascha BALAKIN
Jörg Opitz
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.)
Fraunhofer Gesellschaft zur Forderung der Angewandten Forschung eV
Original Assignee
Fraunhofer Gesellschaft zur Forderung der Angewandten Forschung eV
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 Fraunhofer Gesellschaft zur Forderung der Angewandten Forschung eV filed Critical Fraunhofer Gesellschaft zur Forderung der Angewandten Forschung eV
Publication of EP3820539A1 publication Critical patent/EP3820539A1/fr
Pending legal-status Critical Current

Links

Classifications

    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28—Materials for coating prostheses
    • A61L27/34—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
    • 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
    • A61F2/0077—Special surfaces of prostheses, e.g. for improving ingrowth
    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28—Materials for coating prostheses
    • A61L27/30—Inorganic materials
    • A61L27/303—Carbon
    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/54—Biologically active materials, e.g. therapeutic substances
    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/58—Materials at least partially resorbable by the body
    • 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
    • A61L31/084—Carbon; Graphite
    • 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
    • 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
    • A61L31/148—Materials at least partially resorbable by the body
    • 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
    • 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
    • A61F2/0077—Special surfaces of prostheses, e.g. for improving ingrowth
    • A61F2002/0081—Special surfaces of prostheses, e.g. for improving ingrowth directly machined on the prosthetic surface, e.g. holes, grooves
    • 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
    • A61L2400/00—Materials characterised by their function or physical properties
    • A61L2400/12—Nanosized materials, e.g. nanofibres, nanoparticles, nanowires, nanotubes; Nanostructured surfaces
    • 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
    • A61L2420/02—Methods for coating medical devices
    • 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 present invention relates to a coating for implantable medical devices.
  • the coating contains a layer complex which comprises at least one polyelectrolyte multilayer and at least layer of functionalized nanodiamonds.
  • the at least one polyelectrolyte multilayer consists of alternately positively and negatively charged polyelectrolyte monolayers.
  • the functionalized nanodiamonds are functionalized with at least one bioactive agent.
  • the invention also relates to a method for producing such a coating for implantable medical devices, the use of such a coating and an implantable medical device which has such a coating.
  • Implantable medical devices help in the therapy of patients, for example by supporting damaged organs or their functions. take over. According to the prior art, such
  • implantable medical devices can be coated with active ingredients.
  • a fundamental problem of such known coatings is that the active ingredient is released in a very uncontrolled manner.
  • such an uncontrolled release leads to a (local) overdosing of the active substances in the patient and also to an uneconomical use of the active substances.
  • a polymer blend is applied to the implant surface at the same time as the active ingredients by spray or dip coating.
  • a polymer blend is applied to the implant surface at the same time as the active ingredients by spray or dip coating.
  • One example is the polymer-based drug-releasing stent Eluvia TM (Boston Scientific) for the treatment and restoration of bleeding from the peripheral arteries above the knee, in particular the superficial femoral artery (SFA) and the proximal popliteal artery (PPA).
  • SFA superficial femoral artery
  • PPA proximal popliteal artery
  • the Eluvia stent system is coated with the anti-restenotic drug paclitaxel in conjunction with a polymer.
  • a disadvantage of such coatings is the continuous release of active ingredient, which usually takes place within 30-60 days. This is only useful for stents, but not applicable in the case of patient / disease-specific active substances or antibiotics, growth factors etc.
  • a coating for implantable medical see devices specified.
  • the coating contains a layer complex which comprises at least one polyelectrolyte multilayer and at least one layer of functionalized nanodiamonds.
  • Polyelectrolyte multilayer consists of alternating positively and negatively charged polyelectrolyte monolayers.
  • the functionalized nanodiamonds are functionalized with at least one bioactive agent.
  • the polyelectrolyte multilayer can also be referred to as a “polyelectrolyte multilayer (PEM) film”.
  • PEM polyelectrolyte multilayer
  • the at least one polyelectrolyte multilayer consists of polyelectrolyte monolayers.
  • the polyelectrolyte multilayer contains at least one positively charged polyelectrolyte monolayer and at least one negatively charged polyelectrolyte monolayer.
  • the polyelectrolyte monolayers are now arranged alternately with regard to their charge. This means that the at least one polyelectrolyte multilayer alternately always a positively charged polyelectrolyte monolayer and a negatively charged one
  • Polyelectrolyte monolayer are arranged one after the other.
  • the layer complex preferably consists of at least one
  • Polyelectrolyte multilayer and at least one layer of functionalized nanodiamonds are preferably arranged or deposited on the at least one polyelectrolyte multilayer.
  • the layer complex can comprise one or more polyelectrolyte multilayers and comprise one or more layers of functionalized nanodiamonds. If the layer complex comprises several polyelectrolyte multilayers and / or several layers of functionalized nanodiamonds or if the layer complex consists of several polyelectrolyte multilayers and / or several layers of functionalized nanodiamonds, the different layers are preferably alternating, i.e. alternating, arranged.
  • the layer complex can thus comprise or consist of one or more bi-layers (“bi-layers”), each of the bi-layers comprising or consisting of a polyelectrolyte multilayer and a layer of functionalized nanodiamonds.
  • Nanodiamonds can also be called diamond nanoparticles. Nanodiamonds are less than 1 pm in size.
  • the nanodiamonds are functionalized with at least one bioactive agent, i.e. the at least one bioactive agent is bound to the nanodiamonds.
  • a connection can take place, for example, by physisorption, by electrostatic interactions and / or by covalent interactions.
  • a bioactive agent is understood to mean a substance that has a biological activity, e.g. a pharmaceutical agent, a biological agent, a diagnostic agent, a therapeutic agent or mixtures thereof.
  • the at least one polyelectrolyte multilayer in combination with functionalized nanodiamonds gives a particularly advantageous coating for implantable medical devices.
  • the functionalized nanodiamonds can be immobilized by the polyelectrolyte multilayer on the surface of the implantable medical device, the subsequent delivery of the bioactive substance being controlled by the surface of the implantable medical device. This enables the bioactive material to be dispensed in a controlled or discrete manner in terms of time and location.
  • the antimicrobial properties of the surface of the implantable medical device can be set in this way. Such an adjustment can be made, for example, via the partial oxidation of the nano-diamonds. As a result, the patient tolerance of the implants is increased and the functional and structural bond between the organized tissue and the surface of the implant is formed more quickly. As a result, the number of revision operations and thus the total costs can be reduced.
  • the at least one polyelectrolyte multilayer is self-regulating in the layer thickness and is independent of the substrate used and the ten nanoparticles (alternating electrical charges).
  • an immobilization technique of nanoparticles for a wide range of applications is created.
  • the immobilization of the nanoparticles is achieved through electrostatic interactions with the polyelectrolyte multilayer.
  • various bioactive agents or active ingredients as well as proteins / peptides can be immobilized. Multifunctional layers with several active ingredients can thus be produced simultaneously.
  • the polyelectrolyte multilayers also enable controlled release of the functionalized nanoparticles due to the electrostatic interactions, which ultimately also enables the release of the bioactive agent to be better controlled.
  • Polyelectrolyte multilayers can be produced locally on various materials. This results in a high application potential in medical technology and technical products.
  • the nanodiamonds offer simple functionalization strategies (carbon chemistry) and large surfaces for attaching (e.g. covalently, adsorbed) bioactive agents or functional groups of such bioactive agents.
  • the bioactive agent can thus be easily bound to the nanodiamonds and thus integrated into the coating.
  • the nanodiamonds functionalized with the bioactive agent are released from the coating, there is a constant and long-lasting release of the bioactive agent from the surface of the nanodiamonds.
  • the active agent can thus be dispensed in a more controlled and discrete manner. This results in increased efficiency with the same amount of active ingredients or bioactive agents. As soon as the functionalized nanodiamonds are released into the body, the complex denatures and the active ingredient or bioactive agent unfolds its effect.
  • a preferred embodiment of the coating according to the invention is characterized in that the positively charged polyelectrolyte monolayers have positively charged polyelectrolytes selected from the group consisting of polydiallyldimethylammonium chloride (PDDA),
  • PDDA polydiallyldimethylammonium chloride
  • Polyallylamine hydrochloride PAH
  • PEI polyethyleneimine
  • PES polystyrene sulfonate
  • PAA polyallylamine hydrochloride
  • PVS potassium polyvinyl sulfate
  • heparin alginates
  • pectins inorganic clay
  • organic clay organic clay and mixtures thereof.
  • the at least one polyelectrolyte multilayer contains biodegradable
  • the polyelectrolyte multilayer can thus be easily broken down and the functionalized nanoparticles released.
  • a further preferred embodiment of the coating according to the invention is characterized in that the at least one bioactive agent is selected from the group consisting of pharmaceutical active ingredients, biological active ingredients, diagnostic active ingredients, therapeutic active ingredients and mixtures thereof.
  • the layer complex comprises a plurality of polyelectrolyte multilayers and a plurality of layers of functionalized nanodiamonds, the polyelectrolyte multilayers and the layers of functionalized nanodiamonds being arranged alternately.
  • the regret of the bioactive agent can be significantly extended.
  • the timing of the delivery can be better controlled.
  • An alternating arrangement is understood here to mean that the polyelectrolyte multilayers and the layers of functionalized nanodiamonds are arranged alternately one after the other or one on top of the other.
  • the top layer of such a layer complex can either be a
  • Polyelectrolyte multilayer or a layer of functionalized nano diamonds is preferably a polyelectrolyte multilayer.
  • the polyelectrolyte monolayers each have a layer thickness of 5 nm to 5 pm and / or the at least one Layer of functionalized nanodiamonds has a layer thickness of 2 nm to 300 nm.
  • the layer thickness of the respective layers can be varied via the field strength of the external electrical field (in the case of electrophoretic deposition of the layers).
  • the coating additionally has at least one
  • Biopolymer layer which contains at least one biopolymer or consists of it, which is selected from the group consisting of biopolyesters, proteins, polysaccharides and mixtures thereof.
  • the release of the nanodiamonds can be further influenced and controlled through this additional biopolymer layer.
  • the layer complex is preferably arranged on the at least one biopolymer layer.
  • the at least one biopolymer layer comprises at least two biopolymer layers, the layer complex being arranged between the at least two biopolymer layers.
  • the layer complex represents an intermediate layer of a conventional coating.
  • a further preferred embodiment of the coating according to the invention is characterized in that the coating additionally has a cover layer, the material of the cover layer preferably being selected from the group consisting of
  • Polylactide polycaprolactone, poly (lactide-co-glycolide), natural polymers, preferably chitin, chitosan, alginates,
  • the cover layer functions here, for example, as a protective layer that protects the other layers from damage.
  • the top layer represents the outermost or the top layer of the coating.
  • the present invention also relates to a method for producing a coating according to the invention on an implantable medical device, in which a layer complex is deposited on an implantable medical device by:
  • At least one polyelectrolyte multilayer which consists of alternately positively and negatively charged polyelectrolyte monolayers, is deposited on the implantable medical device or on a layer deposited on the implantable medical device, and
  • At least one layer of nanodiamonds functionalized with at least one bioactive agent is deposited on the polyelectrolyte multilayer.
  • step b) the sequence of steps a) and b) is repeated at least once.
  • step a) and step b) are carried out first and then step a) and step b) are carried out at least once more.
  • a layer complex can be obtained which comprises a plurality of polyelectrolyte multilayers and a plurality of layers of functionalized nanodiamonds, the different layers alternating, i.e. alternately, are arranged.
  • Polyelectrolyte multilayer in step a) takes place in that alternately positively charged polyelectrolytes are deposited as positively charged polyelectrolyte monolayer and negatively charged polyelectrolytes as negatively charged polyelectrolyte monolayer. In this way, the alternating or alternating arrangement of the positively and negatively charged NEN polyelectrolyte monolayers can be achieved in a simple manner.
  • the at least one polyelectrolyte layer in step a) and / or the at least one layer of functionalized nanodiamonds in step b) are deposited via electrostatic interactions and / or by means of an external electric field.
  • Another preferred variant of the method according to the invention is characterized in that at least one biopolymer layer is additionally deposited which contains or consists of at least one biopolymer, which is selected from the group consisting of biopolyesters, proteins, polysaccharides and mixtures thereof.
  • the biopolymer layer is preferably deposited on the implantable medical device before step a).
  • At least two biopolymer layers are deposited, the deposition taking place in such a way that the layer complex is arranged between the at least two biopolymer layers.
  • At least one biopolymer layer can be deposited on the implantable medical device before step a) and at least one further biopolymer layer can be deposited on the layer complex after step b).
  • At least one cover layer is additionally deposited, the material of the cover layer being selected from the group consisting of
  • synthetic polymers preferably polyglycolic acid, polylactide, polycaprolactone, poly (lactide-co-glycolide), natural polymers, preferably chitin, chitosan, alginates, colagens, gelatin, aerogels, and
  • the cover layer can be deposited on the layer complex or on an additional biopolymer layer, if this is present.
  • the present invention also relates to an implantable medical device which has a coating according to the invention.
  • the layer complex is deposited on the implantable medical device or on a layer deposited on the implantable medical device.
  • the coating can, for example, have at least one biopolymer layer and a cover layer, the at least one biopolymer layer on the surface of the implantable medical device and / or is arranged on the layer complex, the layer complex is arranged on the surface of the implantable medical device and / or on the at least one biopolymer layer, and the cover layer on the layer complex or on the at least one
  • Biopolymer layer is arranged or deposited. Most preferably, the at least one biopolymer layer is arranged or deposited on the surface of the implantable medical device, the layer complex on the at least one biopolymer layer, and the cover layer on the layer complex.
  • the present invention relates to the use of a coating according to the invention or an implantable medical device according to the invention for the controlled and / or discrete-time delivery of a bioactive agent, which is preferably selected from the group consisting of pharmaceutical active ingredients, biological active ingredients, diagnostic active ingredients, therapeutic agents and mixtures here from.
  • a bioactive agent which is preferably selected from the group consisting of pharmaceutical active ingredients, biological active ingredients, diagnostic active ingredients, therapeutic agents and mixtures here from.
  • This ent contains a layer complex 1, which consists of a polyelectrolyte multilayer 2 and a layer 3 of functionalized nanodiamonds.
  • Polyelectrolyte multilayer 2 consists of alternatingly positive and negatively charged polyelectrolyte monolayers.
  • the functionalized nanodiamonds are functionalized with at least one bioactive agent.
  • the coating can be on a substrate, e.g. an implantable medical device 6.
  • the coating 2 shows a second exemplary embodiment of the coating according to the invention for implantable medical devices.
  • the coating is here on an implantable medical device 6 arranged or deposited.
  • the coating here contains a layer plex 1, which consists of several polyelectrolyte multilayers and several layers of functionalized nanodiamonds, these being arranged alternately.
  • the layer complex 1 comprises a plurality of bi layers, each consisting of a polyelectrolyte multilayer and a layer of functionalized nanodiamonds.
  • Multilayers and the layers of functionalized nanodiamonds or the exact structure of the layer complex are not shown in FIG. 2 for reasons of clarity.
  • the coating also has a
  • Biopolymer layer 4 which contains or consists of at least one biopolymer, which is selected from the group consisting of biopolyesters, proteins, polysaccharides and mixtures thereof.
  • the layer complex 1 is arranged or deposited on the biopolymer layer 4, the biopolymer layer 4 being arranged or deposited on the surface of the implantable medical device 6.
  • the coating additionally has a cover layer 5), which is on the layer complex

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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)
  • Epidemiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Surgery (AREA)
  • Dermatology (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Cardiology (AREA)
  • Materials For Medical Uses (AREA)
  • Medicinal Preparation (AREA)

Abstract

La présente invention concerne un revêtement pour dispositifs médicaux implantables. Le revêtement contient un ensemble de couches, lequel comprend au moins une multicouche de polyélectrolytes ainsi qu'au moins une couche de nanodiamants fonctionnalisés. L'au moins une multicouche de polyélectrolytes est composée de monocouches de polyélectrolytes chargées alternativement positivement et négativement. De plus, les nanodiamants fonctionnalisés sont fonctionnalisés avec au moins un agent bioactif. L'invention concerne en outre un procédé pour la fabrication d'un tel revêtement pour dispositifs médicaux implantables, l'utilisation d'un tel revêtement ainsi qu'un dispositif médical implantable comprenant un tel revêtement.
EP19730776.2A 2018-07-11 2019-06-14 Revêtement pour dispositifs médicaux implantables, procédé pour leur fabrication ainsi que dispositifs médicaux implantables Pending EP3820539A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102018211526.5A DE102018211526A1 (de) 2018-07-11 2018-07-11 Beschichtung für implantierbare medizinische Geräte, Verfahren zu deren Herstellung sowie implantierbares medizinisches Gerät
PCT/EP2019/065722 WO2020011486A1 (fr) 2018-07-11 2019-06-14 Revêtement pour dispositifs médicaux implantables, procédé pour leur fabrication ainsi que dispositifs médicaux implantables

Publications (1)

Publication Number Publication Date
EP3820539A1 true EP3820539A1 (fr) 2021-05-19

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
EP19730776.2A Pending EP3820539A1 (fr) 2018-07-11 2019-06-14 Revêtement pour dispositifs médicaux implantables, procédé pour leur fabrication ainsi que dispositifs médicaux implantables

Country Status (5)

Country Link
US (1) US20210268146A1 (fr)
EP (1) EP3820539A1 (fr)
KR (1) KR20210032999A (fr)
DE (1) DE102018211526A1 (fr)
WO (1) WO2020011486A1 (fr)

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