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WO2024260651A1 - Implant comprenant un revêtement avec des particules d'argent et procédé de fabrication d'un implant - Google Patents

Implant comprenant un revêtement avec des particules d'argent et procédé de fabrication d'un implant Download PDF

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Publication number
WO2024260651A1
WO2024260651A1 PCT/EP2024/063648 EP2024063648W WO2024260651A1 WO 2024260651 A1 WO2024260651 A1 WO 2024260651A1 EP 2024063648 W EP2024063648 W EP 2024063648W WO 2024260651 A1 WO2024260651 A1 WO 2024260651A1
Authority
WO
WIPO (PCT)
Prior art keywords
implant
layer
implant according
silver
coating
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/EP2024/063648
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 WO2024260651A1 publication Critical patent/WO2024260651A1/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
    • A61L31/14—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
    • 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
    • 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
    • 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
    • A61L2400/00—Materials characterised by their function or physical properties
    • A61L2400/18—Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
    • 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
    • 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
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants

Definitions

  • Implant comprising a coating with silver particles and method for producing an implant
  • the invention relates to an implant which comprises silver particles containing coating .
  • the invention relates to a method for producing an implant which is coated with a silver particle containing surface .
  • Implants with an antimicrobial coating which comprises silver particles .
  • 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, it is also not possible to increase the silver concentration to the point where also the areas with a small silver concentration have suf ficient anti-microbial properties .
  • the obj ect of the invention is achieved by an implant and by a method for producing an implant according to subj ect matter of the independent claims .
  • the invention relates to an implant with a metal substrate comprising a coating with silver, wherein the coating comprises at least one layer with silver particles with a silver content of 2 to 20 pg/ cm 2 in total .
  • the total concentration of silver can be determined by using SEM-EDX or XPS analysis .
  • optical emission spectrometry ICP-OES
  • ICP-OES optical emission spectrometry
  • the implant comprises an adhesion promoter layer between the metal substrate and the, at least one, silver layer.
  • the adhesion promoter layer is embodied as an anodized layer.
  • the implant comprises several layers with silver particles, in particular 3 to 20 layers, preferably 4 to 8 layers.
  • Such a multi-layer system also increases the silver contained from layer to layer even if all layers are applied in the same electrolytic bath. Without being bound on this theory, the inventors suspect that the concentration of oxides which are formed from the substrate material during the plasma electrolytic process decreases from layer to layer. Therefore, a high efficacy can be achieved by using such a multi-layer system, in particular by applying more than three layers.
  • 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 .
  • the anodized adhesion promoter layer has a silver content of less than 0.5 pg/cm 2 .
  • the anodized layer has a thickness of less than 0.5 pm, in particular between 0.05 pm to 0.5 pm.
  • the at least one layer with silver particles is preferably applied by plasma electrolytic deposition.
  • the silver layers preferably have a thickness between 1 and 50 pm, in particular preferred between 3 and 10 pm, in total.
  • the metal substrate is a titanium or a titanium alloy 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 several layers with silver particles have a silver content of 5 to 14, preferably 7 to 10 pg/ cm 2 in total.
  • the anodized first layer has 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 coating comprises 0.2 - 2 wt . - % Ag, preferably 0.5 - 1.5 wt.-% in total.
  • the coating may comprise:
  • the plasma electrolytic applied multi-layer system seems to serve as a protective coating and the amount of alloying elements of the substrate in the surface is reduced.
  • the concentration of alloying elements, such as aluminum and vanadium, in the substrate material can be increased without having the risk that harmful concentrations of these elements in the surrounding tissue occur. Hence, the mechanically stability of the implant can be increased.
  • the substrate comprises vanadium, and wherein the concentration of vanadium in the coating is less than 50 % of the concentration in the substrate .
  • the substrate comprises aluminum, and wherein the concentration of aluminum in the coating is less than 50 % of the concentration in the substrate .
  • adhesion promoter layer By using the adhesion promoter layer, it is possible to provide a uni form surface .
  • spotless may be defined as the coating having not more than 3 spots with a diameter between 1 and 3 mm .
  • the invention furthermore relates to a method for producing an implant with a silver containing coating .
  • an implant as described above is produced .
  • the method comprises the steps :
  • a multitude of layers with silver particles are deposited upon each other .
  • Fig. la and Fig. lb show exemplary embodiments of an implant.
  • Fig. 2 is a schematic illustration of the coating.
  • Fig. la is an explanatory embodiment of an implant which is embodied as a bone plate 10.
  • a bone plate 10 comprises at least two, preferably a multitude of holes Ila - lln, which can be used to introduce bone screws.
  • Hole Ila is embodied as a so-called compression hole.
  • This compression hole Ila serves in interaction with the bone screw (shown in Fig. lb) to move the fragments of the bone towards each other.
  • the holes Ila - lln comprise interior 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. lb shows an implant which is embodied as a bone screw 20.
  • 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.
  • a voltage is applied, which is so low that the formation of plasma is avoided.
  • a conventional anodization process results in a thin oxide layer 1 on the surface.
  • the voltage is increased and a multitude of layers which comprise silver particles 2a - 2n are applied. Since the amount of oxides which are formed by oxidizing the substrate material decreases from layer to layer, the silver content increases from layer to layer. This results in an increased anti-microbial efficiency.
  • the bone screw 20 comprises a shank 21.
  • the shank 21 comprises a thread for introducing into the bone.
  • the tooth base of the thread comprises a homogenous silver coating.
  • the bone screw 20 comprises a screw head 22.
  • the screw head 22 may comprise a head thread to engage an anglestable fixation in the respective hole.
  • the antimicrobial efficacy of the implant is high enough so that the implant has at least a log 3, preferably a log 4, efficiency 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 efficiency 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 ONORM 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.
  • 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 .
  • artificial wound fluid 5% BSA, 142 mM NaCl, 2.5 mM CaC12
  • 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 increased antimicrobial efficiency can be provided.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Vascular Medicine (AREA)
  • Epidemiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Inorganic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Molecular Biology (AREA)
  • Prostheses (AREA)

Abstract

La divulgation concerne un implant avec un substrat métallique comprenant un revêtement avec de l'argent, le revêtement comprenant au moins une couche avec des particules d'argent ayant une teneur en argent de 2 à 20 µg/cm2 au total. L'implant comprend une couche de promoteur d'adhérence entre le substrat métallique et la ou les couches d'argent. La couche de promoteur d'adhérence se présente sous la forme d'une couche anodisée.
PCT/EP2024/063648 2023-06-21 2024-05-17 Implant comprenant un revêtement avec des particules d'argent et procédé de fabrication d'un implant Pending WO2024260651A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102023116193 2023-06-21
DE102023116193.8 2023-06-21

Publications (1)

Publication Number Publication Date
WO2024260651A1 true WO2024260651A1 (fr) 2024-12-26

Family

ID=91247970

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2024/063648 Pending WO2024260651A1 (fr) 2023-06-21 2024-05-17 Implant comprenant un revêtement avec des particules d'argent et procédé de fabrication d'un implant

Country Status (1)

Country Link
WO (1) WO2024260651A1 (fr)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003094774A1 (fr) * 2002-05-10 2003-11-20 Plasma Coatings Limited Implant dentaire ou orthopedique
WO2010139451A2 (fr) 2009-06-02 2010-12-09 Aap Biomaterials Gmbh Ostéosynthèse avec de l'argent nanométrique
CA2654235C (fr) * 2006-06-12 2015-01-06 Accentus Plc Implant metallique comprenant une surface d'oxyde anodise revetue de ceramique et contenant des ions metalliques biocides
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 (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003094774A1 (fr) * 2002-05-10 2003-11-20 Plasma Coatings Limited Implant dentaire ou orthopedique
CA2654235C (fr) * 2006-06-12 2015-01-06 Accentus Plc Implant metallique comprenant une surface d'oxyde anodise revetue de ceramique et contenant des ions metalliques biocides
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

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
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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