EP3355945A1 - Thermally sprayed ceramic layers - Google Patents

Thermally sprayed ceramic layers

Info

Publication number
EP3355945A1
EP3355945A1 EP16770931.0A EP16770931A EP3355945A1 EP 3355945 A1 EP3355945 A1 EP 3355945A1 EP 16770931 A EP16770931 A EP 16770931A EP 3355945 A1 EP3355945 A1 EP 3355945A1
Authority
EP
European Patent Office
Prior art keywords
ceramic layer
component
ceramic
layer according
materials
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.)
Withdrawn
Application number
EP16770931.0A
Other languages
German (de)
French (fr)
Inventor
Heinrich Wecker
Andreas Rempp
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.)
Ceramtec GmbH
Original Assignee
Ceramtec GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Ceramtec GmbH filed Critical Ceramtec GmbH
Publication of EP3355945A1 publication Critical patent/EP3355945A1/en
Withdrawn legal-status Critical Current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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/28—Bones
    • 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
    • A61L27/02—Inorganic materials
    • A61L27/10—Ceramics or glasses
    • 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
    • A61L27/28—Materials for coating prostheses
    • A61L27/30—Inorganic materials
    • A61L27/32—Phosphorus-containing materials, e.g. apatite
    • 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
    • A61L27/56—Porous materials, e.g. foams or sponges
    • C—CHEMISTRY; METALLURGY
    • C23—COATING METALLIC MATERIAL; COATING MATERIAL WITH METALLIC MATERIAL; CHEMICAL SURFACE TREATMENT; DIFFUSION TREATMENT OF METALLIC MATERIAL; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY ION IMPLANTATION OR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL; INHIBITING CORROSION OF METALLIC MATERIAL OR INCRUSTATION IN GENERAL
    • C23C—COATING METALLIC MATERIAL; COATING MATERIAL WITH METALLIC MATERIAL; SURFACE TREATMENT OF METALLIC MATERIAL BY DIFFUSION INTO THE SURFACE, BY CHEMICAL CONVERSION OR SUBSTITUTION; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY ION IMPLANTATION OR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL
    • C23C4/00—Coating by spraying the coating material in the molten state, e.g. by flame, plasma or electric discharge
    • C23C4/04—Coating by spraying the coating material in the molten state, e.g. by flame, plasma or electric discharge characterised by the coating material
    • C23C4/10—Oxides, borides, carbides, nitrides or silicides; Mixtures thereof
    • C23C4/11—Oxides
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30772—Apertures or holes, e.g. of circular cross section
    • A61F2002/30784—Plurality of holes
    • A61F2002/30785—Plurality of holes parallel
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
    • A61F2002/30971—Laminates, i.e. layered products
    • 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
    • A61F2310/00592—Coating or prosthesis-covering structure made of ceramics or of ceramic-like compounds
    • A61F2310/00598—Coating or prosthesis-covering structure made of compounds based on metal oxides or hydroxides
    • A61F2310/00604—Coating made of aluminium oxide or hydroxides
    • 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
    • A61F2310/00592—Coating or prosthesis-covering structure made of ceramics or of ceramic-like compounds
    • A61F2310/00598—Coating or prosthesis-covering structure made of compounds based on metal oxides or hydroxides
    • A61F2310/0061—Coating made of silicon oxide or hydroxides
    • 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
    • A61F2310/00592—Coating or prosthesis-covering structure made of ceramics or of ceramic-like compounds
    • A61F2310/00598—Coating or prosthesis-covering structure made of compounds based on metal oxides or hydroxides
    • A61F2310/00634—Coating made of zirconium oxide or hydroxides
    • 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
    • A61F2310/00592—Coating or prosthesis-covering structure made of ceramics or of ceramic-like compounds
    • A61F2310/00796—Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite
    • 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
    • A61F2310/00928—Coating or prosthesis-covering structure made of glass or of glass-containing compounds, e.g. of bioglass
    • 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
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants
    • 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
    • A61L2430/24—Materials or treatment for tissue regeneration for joint reconstruction
    • 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
    • A61L2430/38—Materials or treatment for tissue regeneration for reconstruction of the spine, vertebrae or intervertebral discs
    • C—CHEMISTRY; METALLURGY
    • C23—COATING METALLIC MATERIAL; COATING MATERIAL WITH METALLIC MATERIAL; CHEMICAL SURFACE TREATMENT; DIFFUSION TREATMENT OF METALLIC MATERIAL; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY ION IMPLANTATION OR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL; INHIBITING CORROSION OF METALLIC MATERIAL OR INCRUSTATION IN GENERAL
    • C23C—COATING METALLIC MATERIAL; COATING MATERIAL WITH METALLIC MATERIAL; SURFACE TREATMENT OF METALLIC MATERIAL BY DIFFUSION INTO THE SURFACE, BY CHEMICAL CONVERSION OR SUBSTITUTION; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY ION IMPLANTATION OR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL
    • C23C4/00—Coating by spraying the coating material in the molten state, e.g. by flame, plasma or electric discharge
    • C23C4/12—Coating by spraying the coating material in the molten state, e.g. by flame, plasma or electric discharge characterised by the method of spraying
    • C23C4/134—Plasma spraying

Definitions

  • the invention relates to thermally sprayed ceramic layers and a process for their preparation.
  • the ceramic layers are preferably used for the functionalization of medical products, in particular of prostheses and implants.
  • Coatings on medical components, in particular on prostheses and implants are well known.
  • such coatings on prostheses and implants of metals such as titanium and ceramics such as titanium oxide, Triclaciumphospaht or materials from the group of bioglasses.
  • the medical-technical components are either cemented and comprise an additional bone cement, which is to ensure the connection to the bone structures, or cement-free, so that adjusts the connection by bone growth (osseoconductivity).
  • the use of metals is generally not unproblematic, but may cause the coating does not adhere to the component surface, but it comes to a delamination of the layer.
  • the use of metallic coatings is associated with a higher risk of allergies and infection.
  • graded structures eg course of porous to dense
  • layer structures that are suitable for certain applications, not without major Create effort.
  • the object of the present invention was therefore to provide a coating which does not have the aforementioned problems, in particular an improvement of the layer adhesion for the prevention of delamination and an improved biocompatibility should be achieved.
  • the coating should be suitable for both cemented and cementless components and contribute to improved bone growth (osseoconductivity) cement-free components or lead in cemented components to an improved chemical bonding of the cement used to the ceramic layer.
  • the present invention should also allow the setting of certain desired layer structures and even graded layer structures, which tailor-made layer characteristics can be adjusted for different applications and also the production of patient-specific prostheses or implants would be possible.
  • the underlying object of the present invention is achieved according to claim 1 by providing a ceramic layer on a component, wherein the ceramic layer is applied by means of a thermal spraying method on the surface of the component.
  • the spraying of the coating is used in particular the roughening and targeted structuring of the component surface.
  • the coating takes place on a component, which is preferably a medical product.
  • the component is a prosthesis or an implant.
  • the implant can be a joint surface implant, which serves for the partial renewal of joint surfaces in the human body.
  • the joint surfaces may, for example, be surfaces of the shoulder, hip, knee, elbow and the entire hand (in particular finger) foot area.
  • the component according to the invention can also be used for total disk replacements in the region of the spine. Likewise, use of the component according to the invention in the area of fusion (stiffening) in trauma therapy or for the spine is possible.
  • the component can be both a metallic component or a ceramic component. This also matches the same type of coatings, ie the ceramic Material of the component and the coating are identical, possible.
  • the advantage is that, due to the same thermophysical properties, lower failure probabilities can be achieved by layer delamination.
  • the coating is produced by means of thermal spraying (for example plasma-based processes in the atmosphere or in a vacuum), the deposition taking place in a vacuum, in particular for graded and / or columnar structures, partly from the gas phase and pressures of ⁇ 50 mbar prevailing, in particular in the coating of cementless implants.
  • thermal spraying for example plasma-based processes in the atmosphere or in a vacuum
  • the deposition taking place in a vacuum, in particular for graded and / or columnar structures, partly from the gas phase and pressures of ⁇ 50 mbar prevailing, in particular in the coating of cementless implants.
  • the coating materials are ceramic materials, preferably the materials of the ceramic layer are pure oxide or mixed oxide ceramics, particularly preferably selected from the group consisting of Al 2 O 3 , ZrO 2 , SiO 2 , bioglasses, calcium phosphates (eg TCP and hydroxyapatite), Mixtures of said materials, their starting materials and mixtures of said materials, which additionally contain adjuvants such as known stabilizers from the group of rare earths z. B. ZrO 2 included.
  • the layer structure of the sprayed-on ceramic layer can be either homogeneously dense or graded (course from one to the other layer structure), that is to say include, for example, a course from porous to dense structures.
  • the porous structure comprises structures with high open porosity, for example by a columnar layer structure with a correspondingly typical morphology and topography.
  • the porous structures are particularly preferred in cementless prostheses and implants.
  • the ceramic layer also has a certain roughness of the surface, in particular in cemented prostheses and implants. Particularly preferred is a roughness R a of »0.03 ⁇ . An increased surface improves the clamping in the bone or in the bone cement and thus improves the connection.

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Dermatology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Inorganic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Ceramic Engineering (AREA)
  • Dispersion Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Plasma & Fusion (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Materials Engineering (AREA)
  • Mechanical Engineering (AREA)
  • Metallurgy (AREA)
  • Organic Chemistry (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Cardiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Materials For Medical Uses (AREA)
  • Prostheses (AREA)
  • Coating By Spraying Or Casting (AREA)

Abstract

The invention relates to thermally sprayed ceramic layers and a method for the production thereof.

Description

Thermisch gespritzte Keramikschichten  Thermally sprayed ceramic layers
Die Erfindung betrifft thermisch gespritzte Keramikschichten und ein Verfahren zu deren Herstellung. Die Keramikschichten dienen vorzugsweise der Funktionalisierung von medizintechnischen Produkten, insbesondere von Prothesen und Implantaten. The invention relates to thermally sprayed ceramic layers and a process for their preparation. The ceramic layers are preferably used for the functionalization of medical products, in particular of prostheses and implants.
Beschichtungen auf medizintechnischen Bauteilen, insbesondere auf Prothesen und Implantaten, sind hinlänglich bekannt. Typischerweise bestehen solche Beschichtungen auf Prothesen und Implantaten aus Metallen wie beipielsweise Titan und Keramiken wie Titanoxid, Triclaciumphospaht oder Materialien aus der Gruppe der Biogläser. Die medizintechnischen Bauteile sind dabei entweder zementiert und umfassen ein zusäzlichen Knochenzement, welcher die Anbindung an die Knochenstrukturen sicherstellen soll, oder zementfrei, so dass sich die Anbindung durch Knochenanwachsen (Osseokonduktivität) einstellt. Die Verwendung von Metallen ist im Allgemeinen jedoch nicht unproblematisch, sondern kann dazu führen, dass die Beschichtung nicht an der Bauteiloberfläche haften bleibt, sondern es zu einer Delamination der Schicht kommt. Zudem geht mit der Verwendung von metallischen Beschichtungen ein höheres Risiko von Allergien und Infektion einher. Daneben ergibt sich immer wieder das Problem, dass bei den bekannten Schichten auf medizintechnischen Bauteilen gradierte Strukturen (z. B. Verlauf von porös bis dicht) nur schwer zu erreichen sind oder, dass sich Schichtstrukturen, die sich für bestimmte Anwendungsgebiete eignen, nicht ohne größeren Aufwand erzeugen lassen. Coatings on medical components, in particular on prostheses and implants, are well known. Typically, such coatings on prostheses and implants of metals such as titanium and ceramics such as titanium oxide, Triclaciumphospaht or materials from the group of bioglasses. The medical-technical components are either cemented and comprise an additional bone cement, which is to ensure the connection to the bone structures, or cement-free, so that adjusts the connection by bone growth (osseoconductivity). However, the use of metals is generally not unproblematic, but may cause the coating does not adhere to the component surface, but it comes to a delamination of the layer. In addition, the use of metallic coatings is associated with a higher risk of allergies and infection. In addition, there is always the problem that in the known layers on medical components graded structures (eg course of porous to dense) are difficult to achieve or that layer structures that are suitable for certain applications, not without major Create effort.
Die Aufgabe der vorliegenden Erfindung bestand deshalb darin, eine Beschichtung bereitzustellen, die die vorgenannten Probleme nicht aufweist, wobei insbesondere eine Verbesserung der Schichtanhaftung zur Verhinderung von Delamination und eine verbesserte Biokompatibilität erreicht werden sollte. Außerdem sollte die Beschichtung sowohl für zementierte als auch für zementfreie Bauteile geeignet sein und zu einem verbesserten Knochenanwachsen (Osseokonduktivität) bei zementfreien Bauteilen oder bei zementierten Bauteilen zu einer verbesserten chemischen Anbindung des eingesetzten Zements an die Keramikschicht führen. The object of the present invention was therefore to provide a coating which does not have the aforementioned problems, in particular an improvement of the layer adhesion for the prevention of delamination and an improved biocompatibility should be achieved. In addition, the coating should be suitable for both cemented and cementless components and contribute to improved bone growth (osseoconductivity) cement-free components or lead in cemented components to an improved chemical bonding of the cement used to the ceramic layer.
Die vorliegende Erfindung sollte zudem die Einstellung bestimmter gewünschter Schichtstrukturen und sogar gradierter Schichtstrukturen ermöglichen, womit maßgeschneiderte Schichtcharakteristika für unterschiedliche Anwendungsgebiete eingestellt werden können und auch die Herstellung patientenspezifischer Prothesen oder Implantate möglich wäre. The present invention should also allow the setting of certain desired layer structures and even graded layer structures, which tailor-made layer characteristics can be adjusted for different applications and also the production of patient-specific prostheses or implants would be possible.
Die zugrundeliegende Aufgabe der vorliegenden Erfindung wird gemäß Anspruch 1 durch die Bereitstellung einer Keramikschicht auf einem Bauteil gelöst, wobei die Keramikschicht mittels einem thermischen Spritzverfahren auf die Oberfläche des Bauteils aufgebracht wird. Das Aufspritzen der Beschichtung dient dabei insbesondere der Aufrauung und gezielten Strukturierung der Bauteiloberfläche. Bevorzugte Ausführungsformen sind in den Unteransprüchen angegeben. The underlying object of the present invention is achieved according to claim 1 by providing a ceramic layer on a component, wherein the ceramic layer is applied by means of a thermal spraying method on the surface of the component. The spraying of the coating is used in particular the roughening and targeted structuring of the component surface. Preferred embodiments are specified in the subclaims.
Die Beschichtung erfolgt auf einem Bauteil, welches vorzugsweise ein medizintechnisches Produkt ist. Besonders bevorzugt ist das Bauteil eine Prothese oder ein Implantat. Bezogen auf die Prothesen sind Endoprothesen bevorzugt, wobei diese zementiert oder zementfrei sein können. Das Implantat kann insbesondere ein Gelenksflächen-Implantat sein, was zur teilweisen Erneuerung von Gelenksflächen im menschlichen Körper dient. Bei den Gelenksflächen kann es sich beispielsweise um Flächen aus dem Schulter-, Hüft-, Knie-, Ellenbogen- und dem gesamten Hand- (insbesondere Finger) Fußbereich handeln. The coating takes place on a component, which is preferably a medical product. Particularly preferably, the component is a prosthesis or an implant. Relative to the prostheses endoprostheses are preferred, which may be cemented or cementless. In particular, the implant can be a joint surface implant, which serves for the partial renewal of joint surfaces in the human body. The joint surfaces may, for example, be surfaces of the shoulder, hip, knee, elbow and the entire hand (in particular finger) foot area.
Das erfindungsgemäße Bauteil kann auch für Total Disk Replacements im Bereich der Wirbelsäule verwendet werden. Ebenso ist eine Verwendung des erfindungsgemäßen Bauteils im Bereich der Fusion (Versteifung) in der Traumatherapie oder für die Wirbelsäule möglich. The component according to the invention can also be used for total disk replacements in the region of the spine. Likewise, use of the component according to the invention in the area of fusion (stiffening) in trauma therapy or for the spine is possible.
Das Bauteil kann dabei sowohl ein metallisches Bauteil oder ein keramisches Bauteil sein. Damit sind auch artgleiche Beschichtungen, d.h. der keramische Werkstoff des Bauteils und der Besch ichtung sind artgleich, möglich. Der Vorteil ist, dass, bedingt durch die gleichen thermophysikalischen Eigenschaften, geringere Ausfallwahrscheinlichkeiten durch Schichtdelamination erreicht werden können. The component can be both a metallic component or a ceramic component. This also matches the same type of coatings, ie the ceramic Material of the component and the coating are identical, possible. The advantage is that, due to the same thermophysical properties, lower failure probabilities can be achieved by layer delamination.
Die Beschichtung wird mittels Verfahren des Thermischen Spritzens (z. B. plasmabasierte Verfahren an Atmosphäre oder im Vakuum) erzeugt, wobei die Abscheidung im Vakuum insbesondere für gradierte und / oder kolumnare Strukturen teilweise aus der Gasphase erfolgt und Drücke von < 50 mbar vorherrschen, insbesondere bei der Beschichtung von zementfreien Implantaten. The coating is produced by means of thermal spraying (for example plasma-based processes in the atmosphere or in a vacuum), the deposition taking place in a vacuum, in particular for graded and / or columnar structures, partly from the gas phase and pressures of <50 mbar prevailing, in particular in the coating of cementless implants.
Die Schichtwerkstoffe sind keramische Materialien, vorzugsweise sind die Werkstoffe der Keramikschicht reine Oxid- oder Mischoxidkeramiken, besonders bevorzugt ausgewählt aus der Gruppe bestehend aus AI2O3, ZrO2, SiO2, Biogläser, Calciumphosphate (z. B. TCP und Hydroxylapatit), Mischungen der genannten Materialien, deren Ausgangsstoffe sowie Mischungen der genannten Materialien, die zusätzlich Hilfstoffe wie bekannte Stabilisierungsmittel aus der Stoffgruppe der Seltenerden z. B. ZrO2 enthalten. The coating materials are ceramic materials, preferably the materials of the ceramic layer are pure oxide or mixed oxide ceramics, particularly preferably selected from the group consisting of Al 2 O 3 , ZrO 2 , SiO 2 , bioglasses, calcium phosphates (eg TCP and hydroxyapatite), Mixtures of said materials, their starting materials and mixtures of said materials, which additionally contain adjuvants such as known stabilizers from the group of rare earths z. B. ZrO 2 included.
Die Schichtstruktur der aufgespritzten Keramikschicht kann sowohl homogen dicht oder gradiert (Verlauf von einer in die andere Schichtstruktur) sein, also beispielsweise einen Verlauf von porös bis hin zu dichten Strukturen umfassen. Die poröse Struktur umfasst insbesondere Strukturen mit hoher offener Porosität, beispielsweise durch einen kolumnaren Schichtaufbau mit entsprechend typischer Morphologie und Topographie. Die porösen Strukturen sind besonders bevorzugt bei zementfreien Prothesen und Implantaten erwünscht. The layer structure of the sprayed-on ceramic layer can be either homogeneously dense or graded (course from one to the other layer structure), that is to say include, for example, a course from porous to dense structures. In particular, the porous structure comprises structures with high open porosity, for example by a columnar layer structure with a correspondingly typical morphology and topography. The porous structures are particularly preferred in cementless prostheses and implants.
Die Keramikschicht weist außerdem eine bestimmte Rauheit der Oberfläche auf, insbesondere bei zementierten Prothesen und Implantaten. Besonders bevorzugt ist eine Rauheit Ra von » 0,03 μιτι. Eine erhöhte Oberfläche verbessert die Verklammerung im Knochen bzw. im Knochenzement und sorgt so für eine Verbesserung der Anbindung. The ceramic layer also has a certain roughness of the surface, in particular in cemented prostheses and implants. Particularly preferred is a roughness R a of »0.03 μιτι. An increased surface improves the clamping in the bone or in the bone cement and thus improves the connection.

Claims

Ansprüche claims
1 . Keramikschicht auf einem Bauteil, dadurch gekennzeichnet, dass die Keramikschicht mittels einem thermischen Spritzverfahren auf die Oberfläche des Bauteils aufgebracht wird. 1 . Ceramic layer on a component, characterized in that the ceramic layer is applied by means of a thermal spraying process on the surface of the component.
2. Keramikschicht nach Anspruch 1 , dadurch gekennzeichnet, dass das Bauteil ein medizintechnisches Produkt ist, besonders bevorzugt eine Prothese oder ein Implantat. 2. Ceramic layer according to claim 1, characterized in that the component is a medical product, particularly preferably a prosthesis or an implant.
3. Keramikschicht nach Anspruch 2, dadurch gekennzeichnet, dass das Bauteil eine zementierte oder zementfreie Endoprothesen ist. 3. Ceramic layer according to claim 2, characterized in that the component is a cemented or cementless endoprostheses.
4. Keramikschicht nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass das Bauteil ein metallisches Bauteil oder ein keramisches Bauteil ist. 4. Ceramic layer according to one of the preceding claims, characterized in that the component is a metallic component or a ceramic component.
5. Keramikschicht nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass die Keramikschicht mittels Vakuumplasmapsritzen erzeugt wird, bevorzugt bei Drücken < 50 mbar. 5. Ceramic layer according to one of the preceding claims, characterized in that the ceramic layer is produced by means of Vakuumplasmapsritzen, preferably at pressures <50 mbar.
6. Keramikschicht nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass die Schichtwerkstoffe keramische Materialien, vorzugsweise reine Oxid- oder Mischoxidkeramiken, besonders bevorzugt Keramiken ausgewählt aus der Gruppe bestehend aus AI2O3, ZrO2, SiO2, Biogläser, Calciumphosphate (z. B. TCP und Hydroxylapatit) und Mischungen der genannten Materialien und deren Ausgangsstoffe sind. 6. Ceramic layer according to one of the preceding claims, characterized in that the coating materials ceramic materials, preferably pure oxide or mixed oxide ceramics, more preferably ceramics selected from the group consisting of Al 2 O 3 , ZrO 2 , SiO 2 , Biogläser, calcium phosphates (z B. TCP and hydroxyapatite) and mixtures of the materials mentioned and their starting materials.
7. Keramikschicht nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass die Schichtstruktur der Keramikschicht homogen dicht, porös oder gradiert (Verlauf von einer in die andere Schichtstruktur) ist. 7. Ceramic layer according to one of the preceding claims, characterized in that the layer structure of the ceramic layer is homogeneously dense, porous or graded (course from one to the other layer structure).
8. Kerannikschicht nach Anspruch 7, dadurch gekennzeichnet, dass die poröse Struktur einen kolumnaren Schichtaufbau umfasst. 8. Kerannikschicht according to claim 7, characterized in that the porous structure comprises a columnar layer structure.
9. Kerannikschicht nach Anspruch 7, dadurch gekennzeichnet, dass die dichte Struktur eine bestimmte Rauheit der Oberfläche, bevorzugt eine Rauheit Ra von » 0,03 μιτι aufweist. 9. Kerannikschicht according to claim 7, characterized in that the dense structure has a certain roughness of the surface, preferably a roughness R a of »0.03 μιτι.
10. Verfahren zur Herstellung der Keramikschicht nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass die Keramikschicht mittels Verfahren des Thermischen Spritzens (z. B. plasmabasierte Verfahren an Atmosphäre oder im Vakuum) erzeugt wird. 10. A method for producing the ceramic layer according to one of the preceding claims, characterized in that the ceramic layer by means of thermal spraying (eg., Plasma-based method in an atmosphere or in a vacuum) is generated.
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