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WO2024260650A1 - Procédé de fabrication d'un implant comprenant un revêtement avec des particules d'argent et implant avec revêtement contenant de l'argent - Google Patents

Procédé de fabrication d'un implant comprenant un revêtement avec des particules d'argent et implant avec revêtement contenant de l'argent Download PDF

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Publication number
WO2024260650A1
WO2024260650A1 PCT/EP2024/063647 EP2024063647W WO2024260650A1 WO 2024260650 A1 WO2024260650 A1 WO 2024260650A1 EP 2024063647 W EP2024063647 W EP 2024063647W WO 2024260650 A1 WO2024260650 A1 WO 2024260650A1
Authority
WO
WIPO (PCT)
Prior art keywords
implant
silver
layer
layers
silver particles
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
PCT/EP2024/063647
Other languages
English (en)
Inventor
Amir Eliezer
Michel LAFUENTE
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.)
Aap Implantate AG
Original Assignee
Aap Implantate AG
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 Aap Implantate AG filed Critical Aap Implantate AG
Publication of WO2024260650A1 publication Critical patent/WO2024260650A1/fr
Anticipated expiration legal-status Critical
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
    • 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
    • A61L31/02—Inorganic materials
    • A61L31/022—Metals or alloys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B17/866—Material or manufacture
    • 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
    • A61L27/02—Inorganic materials
    • A61L27/04—Metals or 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28—Materials for coating prostheses
    • A61L27/30—Inorganic materials
    • A61L27/306—Other specific inorganic materials not covered by A61L27/303 - A61L27/32
    • 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
    • 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
    • A61L31/088—Other specific inorganic materials not covered by A61L31/084 or A61L31/086
    • 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
    • C—CHEMISTRY; METALLURGY
    • C25—ELECTROLYTIC OR ELECTROPHORETIC PROCESSES; APPARATUS THEREFOR
    • C25D—PROCESSES FOR THE ELECTROLYTIC OR ELECTROPHORETIC PRODUCTION OF COATINGS; ELECTROFORMING; APPARATUS THEREFOR
    • C25D11/00—Electrolytic coating by surface reaction, i.e. forming conversion layers
    • C25D11/02—Anodisation
    • C25D11/026—Anodisation with spark discharge
    • C—CHEMISTRY; METALLURGY
    • C25—ELECTROLYTIC OR ELECTROPHORETIC PROCESSES; APPARATUS THEREFOR
    • C25D—PROCESSES FOR THE ELECTROLYTIC OR ELECTROPHORETIC PRODUCTION OF COATINGS; ELECTROFORMING; APPARATUS THEREFOR
    • C25D11/00—Electrolytic coating by surface reaction, i.e. forming conversion layers
    • C25D11/02—Anodisation
    • C25D11/26—Anodisation of refractory metals or alloys based thereon
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00526—Methods of manufacturing
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/10—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing inorganic materials
    • A61L2300/102—Metals or metal compounds, e.g. salts such as bicarbonates, carbonates, oxides, zeolites, silicates
    • A61L2300/104—Silver, e.g. silver sulfadiazine
    • 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 method for producing an implant which is coated with a silver particle containing surface .
  • the invention relates to an implant which comprises silver particles containing coating .
  • Implants with an antimicrobial coating which comprises silver particles are known .
  • Document WO 2010/ 139451 A2 discloses a method for producing such an implant by using a plasma electrolytic oxidation process .
  • the implant is immersed into an electrolyte which comprises colloidal dispersed silver particles .
  • an electrolyte which comprises colloidal dispersed silver particles .
  • the anti-microbial ef fect occurs in the tissue immediately adj acent to the surface of the implant . Due to the toxicity of silver, the silver content of the coating should be kept as low as possible .
  • the release of silver should be restricted with respect to the necessary time period after implantation and with respect to the concentration of released silver after the implantation .
  • the obj ect of the invention is achieved by a method for manufacturing an implant and by an implant according to the subj ect matter of the independent claims .
  • the invention relates to a method for producing an implant , which comprises a coating with silver .
  • the method comprises the steps :
  • the several layers with silver particles have a silver content of 5 to 14 , preferably 7 to 10 pg/cm 2 .
  • the inventors found out , that the concentration of silver increase from layer to layer towards the outer surface of the implant .
  • the silver concentration can increase from layer to layer towards the surface , in particular by 1 - 50 % , preferably 2 - 10 % .
  • the silver distribution can be examined by making a SIMS-depth profile .
  • an adhesion promoter layer applied onto the metal substrate by anodizing the metal substrate.
  • Such a thin oxide layer which is applied by anodization increases the binding of a layer which is applied onto the anodized layer. Cracks and larger uncoated areas can be avoided. Furthermore, it was observed that the anodized layer also improves the homogeneity of the silver layer. A uniform distribution can be achieved also in curved and rounded areas, in particular on interior surfaces of holes and on the base area of a thread.
  • the step of anodizing the metal substrate and the step of applying at least one layer with silver particles are performed in the same electrolytic bath.
  • the anodized layer is applied with a thickness of less than 0.5 pm, in particular with a thickness between 0.05 pm to 0.5 pm.
  • the layers comprising silver particles are thicker as the anodized adhesion promoter layer.
  • the at least one silver layer/s is/are applied with a thickness between 3 and 10 pm in total.
  • the implant can be embodied as a bone plate or a screw.
  • a titanium or a titanium alloy is provided as the metal substrate.
  • the implant embodied as a bone plate comprises a substantially even topside and at least one hole with a rounded interior surface or threads, wherein the coating also covers the at least one hole and the topside, and wherein the silver content on the hole differs less than 2.5 pg/ cm 2 from the silver content of the topside.
  • the implant embodied as a screw comprises a screw head and a threaded shaft, wherein the coating also covers the threaded shaft and the screw head, and wherein the silver content of the threaded shaft differs less than 2.5 pg/cm 2 from the silver content of the screw head.
  • the anodized layer does not comprise a major silver content.
  • the anodized layer is applied with a silver content of less than 0.5 pg/cm 2 , in particular of 0.05 pg/cm 2 to 0.2 pg/cm 2 .
  • the entire coating is applied with a content of 0.2 - 2 wt.-% Ag, preferably 0.5 - 1.5 wt.-%.
  • the step of anodizing the metal substrate can be performed by applying a first voltage, and wherein the step of applying the layer with silver particles is performed with a second voltage which is higher than the first voltage.
  • the invention further relates to an implant being produced with a method as describes before.
  • the invention relates to an implant, wherein the implant comprises a metal substrate with a coating, wherein the coating comprises a multitude of layers with silver particles , and wherein the concentration of silver increases from layer to layer towards the outer surface of the implant .
  • the implant comprises several layers with silver particles , in particular 3 to 20 layers , preferably 4 to 8 layers .
  • the silver concentration increases from layer to layer towards the surface , in particular by 1 - 50 % , preferably 2 - 10 % .
  • the implant may comprise an adhesion promoter layer between the metal substrate and the multitude of layers with silver particles .
  • the adhesion promoter layer may be embodied as an anodi zed layer .
  • the anodi zed layer has a silver content of less than 0 . 5 pg/ cm 2 .
  • Fig . 1 is a flow chart , showing the steps of performing a method of producing an implant according to an embodiment of the invention .
  • Fig . 2 is a schematic illustration of the coating .
  • the antimicrobial efficiency of coated implants shall be explained in more detail.
  • Fig. 4a and Fig. 4b show exemplary embodiments of an implant.
  • Fig. 1 is a flowchart of producing an implant according to an embodiment of the invention.
  • An electrolytic bath containing dispersed nano-sized silver particles is provided.
  • the substrate is immersed into the bath.
  • an oxide layer is applied onto the substrate, which serves as an adhesion promoter layer for the following layers with silver particles.
  • the second higher voltage results in the formation of a plasma adjacent to the surface of the substrate.
  • a multitude of layers is applied by temporary switching on the second voltage.
  • four to eight layers may be applied.
  • a substrate is provided with a homogeneous coating which comprises silver particles in a concentration which increases from layer to layer towards the surface.
  • Fig. 2 is a schematic illustration of the surface area of the implant 10/20.
  • an adhesion promoter layer 1 is applied as a first layer.
  • this adhesion promoter layer 1 is applied in the same electrolytic bath in which also the layers with silver particles 2a - 2n are applied.
  • the antimicrobial efficacy of the implant is high enough so that the implant has at least a log 3, preferably a log 4, efficacy against Staphylococcus aureus DSM 799/ATCC 6538 with a concentration of 106 CFU/ml after preincubation in artificial wound fluid with 5% Bovine Serum Albumin (BSA) , 142 mM NaCl, 2.5 mM CaC12 for 3, in particular 7 days at 37 °C.
  • BSA Bovine Serum Albumin
  • the antimicrobial efficacy can be tested as follows :
  • the silver content of the sample in the layer system has to be determined.
  • Characteristic X-radiation of the elements can be used to analyze the elemental composition, in particular the silver content .
  • optical emission spectrometry can be used to determine the total silver content of the layers. In detail, this can be performed as follows:
  • the samples are cleaned with an acid solution. Then, measurements can be done using optical emission spectrometry (ICP-OES) according to 0NORM EN ISO 11885 (01.11.2009) using a validated method. The results are obtained in pg Ag absolute (per sample piece) .
  • ICP-OES optical emission spectrometry
  • the concentration of silver in pg Ag/cm 2 can be calculated.
  • the determination of the antibacterial effectiveness of silver coated samples can be tested with a proliferation assay.
  • Staphylococcus aureus DSM 799 / ATCC 6538 was used as microbial test strain.
  • test samples are incubated for the respective period (3 days or 7 days) in artificial wound fluid (5% BSA, 142 mM NaCl, 2.5 mM CaC12) in a volume to allow complete immersion of the test s amp 1 e .
  • bacteria solution is added to each sample and incubated at 37°C for Ih to allow bacterial cells to adhere to the sample surface.
  • Fig. 3 shows a proliferation assay based antimicrobial efficacy as net OD Onset hours of the silver concentration series on samples against Staphylococcus aureus.
  • the solid line indicates an antimicrobial activity of 3 log scales, the dotted line 4 log scales.
  • implants with an increase antimicrobial efficacy can be provided.
  • Fig. 4a is an explanatory illustration of an implant designed as a bone plate 10.
  • a bone plate 10 has at least two, preferably a plurality of holes Ila - lln which can be used for inserting bone screws.
  • the hole Ila is designed as a so-called compression hole.
  • This compression hole Ila serves in interaction with the bone screw (shown in Fig. 4b) to move the fragments of the bone towards each other.
  • the holes Ila - lln have inner surfaces which are at least partially rounded. According to the invention, the silver coating with an increased homogeneity also extends through these interior surfaces.
  • Fig. 4b shows an implant which is designed as a bone screw 20.
  • implants with an increased antimicrobial ef ficacy can be provided .

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Inorganic Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Vascular Medicine (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Dermatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Metallurgy (AREA)
  • Materials Engineering (AREA)
  • Electrochemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Medical Informatics (AREA)
  • Neurology (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne un procédé de production d'un implant comprenant un revêtement avec de l'argent, comprenant les étapes consistant à : - fournir un substrat métallique, - appliquer plusieurs couches avec des particules d'argent ayant une concentration d'argent de 2 à 20 µg/cm2 au total par oxydation électrolytique au plasma dans un bain électrolytique, les couches avec des particules d'argent étant appliquées en un seul bain électrolytique.
PCT/EP2024/063647 2023-06-21 2024-05-17 Procédé de fabrication d'un implant comprenant un revêtement avec des particules d'argent et implant avec revêtement contenant de l'argent Pending WO2024260650A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102023116194 2023-06-21
DE102023116194.6 2023-06-21

Publications (1)

Publication Number Publication Date
WO2024260650A1 true WO2024260650A1 (fr) 2024-12-26

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2024/063647 Pending WO2024260650A1 (fr) 2023-06-21 2024-05-17 Procédé de fabrication d'un implant comprenant un revêtement avec des particules d'argent et implant avec revêtement contenant de l'argent

Country Status (1)

Country Link
WO (1) WO2024260650A1 (fr)

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010139451A2 (fr) 2009-06-02 2010-12-09 Aap Biomaterials Gmbh Ostéosynthèse avec de l'argent nanométrique
WO2017050610A1 (fr) 2015-09-21 2017-03-30 Aap Implantate Ag Méthode permettant de traiter une surface, et corps métallique comprenant une surface métallique traitée

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010139451A2 (fr) 2009-06-02 2010-12-09 Aap Biomaterials Gmbh Ostéosynthèse avec de l'argent nanométrique
WO2017050610A1 (fr) 2015-09-21 2017-03-30 Aap Implantate Ag Méthode permettant de traiter une surface, et corps métallique comprenant une surface métallique traitée
US20180256781A1 (en) * 2015-09-21 2018-09-13 Aap Implantate Ag Method for treating a metal surface and body, comprising a treated metal surface

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
GNEDENKOV SERGEY V. ET AL: "Plasma Electrolytic Oxidation Coatings on Titanium Formed with Microsecond Current Pulses", SOLID STATE PHENOMENA - MATERIALS STRUCTURE AND MICROMECHANICS OF FRACTURE VIII2017TRANS TECH PUBLICATIONS LTDCHE, vol. 213, 1 March 2014 (2014-03-01), Solid State Phenomena - Materials Structure and Micromechanics of Fracture VIII2017Trans Tech Publications Ltdche, pages 149 - 153, XP093192563, ISSN: 1012-0394, Retrieved from the Internet <URL:https://dx.doi.org/10.4028/www.scientific.net/SSP.213.149> DOI: 10.4028/www.scientific.net/SSP.213.149 *
YU SEN ET AL: "Enhancing Antibacterial Performance and Biocompatibility of Pure Titanium by a Two-Step Electrochemical Surface Coating", APPLIED MATERIALS & INTERFACES, vol. 12, no. 40, 11 September 2020 (2020-09-11), US, pages 44433 - 44446, XP093192916, ISSN: 1944-8244, DOI: 10.1021/acsami.0c10032 *

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