EP1434607A1 - Implants osteophiles - Google Patents

Implants osteophiles

Info

Publication number
EP1434607A1
EP1434607A1 EP02764480A EP02764480A EP1434607A1 EP 1434607 A1 EP1434607 A1 EP 1434607A1 EP 02764480 A EP02764480 A EP 02764480A EP 02764480 A EP02764480 A EP 02764480A EP 1434607 A1 EP1434607 A1 EP 1434607A1
Authority
EP
European Patent Office
Prior art keywords
implant
range
titanium
hydroxylated
hydrophilic
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Withdrawn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
EP02764480A
Other languages
German (de)
English (en)
Inventor
Alain J. Denzer
James P. Simpson
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.)
Straumann Holding AG
Original Assignee
Straumann Holding 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 Straumann Holding AG filed Critical Straumann Holding AG
Publication of EP1434607A1 publication Critical patent/EP1434607A1/fr
Withdrawn legal-status Critical Current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
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C8/00—Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools
    • A61C8/0012—Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools characterised by the material or composition, e.g. ceramics, surface layer, metal alloy
    • 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
    • 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
    • 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
    • A61L27/06—Titanium or titanium alloys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C8/00—Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools
    • A61C8/0018—Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools characterised by the shape
    • A61C8/0037—Details of the shape
    • A61C2008/0046—Textured surface, e.g. roughness, microstructure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C8/00—Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools
    • A61C8/0012—Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools characterised by the material or composition, e.g. ceramics, surface layer, metal alloy
    • A61C8/0013—Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools characterised by the material or composition, e.g. ceramics, surface layer, metal alloy with a surface layer, coating
    • A61C8/0015—Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools characterised by the material or composition, e.g. ceramics, surface layer, metal alloy with a surface layer, coating being a conversion layer, e.g. oxide layer
    • 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
    • A61F2/0095—Packages or dispensers for prostheses or other implants
    • 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
    • A61F2/2803—Bones for mandibular reconstruction
    • 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
    • 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
    • A61F2/32—Joints for the hip
    • 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
    • A61F2/38—Joints for elbows or knees
    • 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
    • A61F2002/30838—Microstructures
    • 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
    • A61F2002/3084—Nanostructures
    • 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
    • A61F2002/3085—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with a threaded, e.g. self-tapping, bone-engaging surface, e.g. external surface
    • 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
    • A61F2002/30906—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth shot- sand- or grit-blasted
    • 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
    • A61F2002/30925—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth etched
    • 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
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00011—Metals or alloys
    • A61F2310/00023—Titanium or titanium-based alloys, e.g. Ti-Ni 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
    • 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
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    • 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

  • the present invention relates to osteophilic implants which are used for insertion into bones and which have significantly improved osteointegration properties, and to methods for their production.
  • Implants which are used for insertion into bones, such as, for example, hip or knee prostheses or pins to be screwed into the jaw for the construction of artificial teeth, are known per se.
  • Such implants are preferably made of titanium or titanium-based alloys, e.g. Titanium / zirconium alloys, which may additionally contain niobium, tantalum or other tissue-compatible metallic additives.
  • a key property of such implants is their osteointegration time, that is, the time it takes for the bone substance to have sufficient strength and to be permanently bonded to the implant surface, that is, integrated.
  • How firmly the implant is anchored in the bone can be determined with mechanical measurements, namely by measuring the force, be it as tension, pressure, shear or torque, which are necessary to pull the implant anchored in the bone out of its anchoring or unscrew it, ie to bring about an adhesion break between the surface of the implant and the bone substance connected to it.
  • mechanical measurements namely by measuring the force, be it as tension, pressure, shear or torque, which are necessary to pull the implant anchored in the bone out of its anchoring or unscrew it, ie to bring about an adhesion break between the surface of the implant and the bone substance connected to it.
  • Such measurement methods are known per se and are described, for example, in Brunski, Clinical Materials, Vol. 10, 1992, pp. 153-201. Measurements have shown that titanium implants with a smooth surface structure anchor themselves insufficiently in the bone, while implants with a roughened surface result in a noticeably improved bone-implant bond in terms of tensile strength.
  • a macroroughness is applied to the implant surface in a first step by means of sandblasting and this is then superimposed with a microroughness by means of treatment in an acid bath.
  • the implant surface is roughened, for example, by means of sandblasting and then treated with an etching agent, for example with hydrofluoric acid or a hydrochloric acid / sulfuric acid mixture.
  • the surface thus provided with a defined roughness is then washed with water and solvents and subjected to a sterilization treatment.
  • a hydroxylated surface can only develop its full effect if it is in the “hydrophilic” state, that is, if it is not covered with volatile hydrocarbons and other compounds, such as sulfur dioxide or nitrogen monoxide, which are present in the air Other impurities can also get onto the implant surface at any stage of the manufacturing process, for example in the cleaning process, if the implant is treated with organic solvents such as methanol or acetone
  • a hydroxylated and hydrophilic surface for example of titanium or a titanium Tan alloy has biologically active properties or can be described as biologically active.
  • a hydroxylated and hydrophilic implant surface grows together with the bone substance to form a strong bond much faster than an identical hydroxylated but non-hydrophilic surface. The production of a hydroxylated and at the same time hydrophilic implant surface is described in WO 0044305 (PCT / EP00 / 00619).
  • a contamination-free, hydroxylated surface has a high surface energy, which means that volatile hydrocarbons and other contaminants that occur in unpurified air are quickly adsorbed. Initially, for example, the adsorbed hydrocarbons form a monomolecular layer (monolayer) on the hydroxylated surface, whereby the hydrophilic character of the surface is lost. However, the longer the implant is exposed to the air, the thicker the contamination layer.
  • a clean hydroxylated surface made of titanium is hydrophilic and has a contact angle of less than 50 ° when wetted with water, while a contaminated hydroxylated surface has a contact angle of over 70 ° and is referred to as hydrophobic.
  • the hydroxylated and hydrophilic surface and thus also its biological activity, can be maintained largely unchanged if this surface is sealed in a covering in such a way that contact of the surface with compounds which can impair the hydrophilic character of the implant surface is prevented becomes.
  • the covering is broken open, which is necessary shortly before the implantation, contact of the implant surface with the atmospheric outside air and thus a reduction in the hydrophilic character of the implant surface cannot be prevented.
  • There is therefore a need to convert the hydroxylated and hydrophilic implant To produce or treat the surface in such a way that its hydrophilic character is largely retained over an extended period of time even in contact with the atmospheric outside air.
  • a hydroxylated but contaminated, ie contaminated, hydrophobic implant surface acquires a hydrophilic character when this surface is treated with high-energy ultraviolet radiation (UV rays).
  • UV rays high-energy ultraviolet radiation
  • the stability of the hydrophilic character of a hydroxylated and hydrophilic implant surface obtained with acid etching increases significantly when treated in the hydrophilic state with high-energy ultraviolet radiation.
  • the present invention relates to an osteophilic implant with a particularly roughened, hydroxylated and hydrophilic surface, this implant preferably consisting of titanium or a titanium alloy and being suitable for implantation in bones, characterized in that the implant in the hydroxylated state with high-energy ultraviolet radiation was treated.
  • this implant preferably consisting of titanium or a titanium alloy and being suitable for implantation in bones, characterized in that the implant in the hydroxylated state with high-energy ultraviolet radiation was treated.
  • other materials for example other metals and ceramics, are also conceivable.
  • implant in the hydroxylated state denotes both an implant which has been produced with a hydroxylated surface but whose surface has a hydrophobic character, and also an implant with a hydroxylated and hydrophilic surface.
  • the implant according to the invention shows a significantly increased stability against the loss of the hydrophilic character and thus improved osteointegration properties.
  • the present invention also relates to methods for producing an osteophilic implant with a roughened, hydroxylated and hydrophilic surface in particular, wherein this implant preferably consists of titanium or a titanium alloy and is suitable for implantation in bone, characterized in that the implant is in the hydroxylated state treated with high-energy ultraviolet radiation.
  • the implants according to the invention preferably consist of a titanium alloy, preferably of a titanium / zirconium alloy, which may additionally contain niobium, tantalum or other tissue-compatible metallic additives. Other suitable materials can also be used in the context of the invention. These implants are preferably used as hip or knee prostheses or as pins to be screwed into the jaw for building artificial teeth. Such implants, their nature and the metallic materials used for their production are known per se and are described, for example, in J. Black, G. Hastings, Handbook of Biomaterials Properties, pages 135-200, Chapman & Hall, London, 1998.
  • the structural and functional anchoring for example a dental implant, in the bone is usually achieved by attaching a macro roughness, such as a screw thread or a recess. Formations in the surface and / or optionally an additional microroughness is achieved, the microroughness being applied to the surface either in an additive process by means of plasma technology or in a subtractive process by chemical etching.
  • a macro roughness such as a screw thread or of depressions in the surface and, if appropriate, an additional micro roughness is known per se.
  • the procedure is preferably as described in EP 0 388 576 or in WO 0044305 (PCT / EP00 / 00619).
  • the implant obtained in this way can then be treated according to the invention with high-energy ultraviolet radiation.
  • the implant surface according to the invention preferably has a macro roughness in the range from 5 ⁇ m to 100 ⁇ m (in each case peak to valley), in particular in the range from 20 ⁇ m to 40 ⁇ m and a superimposed micro roughness in the range from 0.5 ⁇ m to 20 ⁇ m, in particular in the range from 0.5 ⁇ m to 10 ⁇ m, in particular approximately 2 .mu.m.
  • the macro-roughness of the implant surface is generated by sandblasting with corundum grains with an average grain size in the range of 0.25-0.5 mm, after which the micro-roughness can be achieved by treatment with an aqueous hydrochloric acid / sulfuric acid mixture in the ratio of HC1: H 2 S0: H 2 0 of 2 : 1: 1 at a temperature in the range of 80 ° C to about 110 ° C for about five minutes.
  • the surface-structured titanium parts washed thoroughly with pure water until neutral, if necessary treated with alcohol, acetone or another organic solvent or disinfectant, and dried in hot air.
  • a hydrophilic implant surface is obtained if, after the acid bath, the implant surface is washed thoroughly with neutral water and dried in an atmosphere which is inert to the hydrophilic surface and the implant is kept in an inert atmosphere.
  • a hydrophobic implant surface is obtained when treated with alcohol, acetone or another organic solvent or a disinfectant and when dried in hot atmospheric air.
  • the "pure" water used for washing is preferably multiply distilled water or water produced by inverse osmosis, which is preferably in an inert atmosphere, i.e. e.g. was produced under reduced pressure, in a nitrogen or inert gas atmosphere. Furthermore, the pure water has an electrical resistance of at least 2 Moh cm (electrical resistance> 2 Mohm cm) and a total organic carbon (TOC) content of at most 10 ppb ( ⁇ 10 ppb).
  • the implant is treated in the hydroxylated state with high-energy ultraviolet radiation.
  • the high-energy ultraviolet radiation (UV radiation) causes the implant surface to become hydrophilic and the impurities on the surface to be removed.
  • the high-energy UV radiation used is UV radiation with a wavelength in the range from 150 nm to 300 nm, preferably in the range from 170 nm to 260 nm, and in particular UV radiation in the range of the absorption maximum of acid. Material, that is with a wavelength of about 184.9nm and in the range of the absorption maximum of ozone, that is with a wavelength of about 253.7nm.
  • Wavelengths in this range promote the simultaneous formation or decay of ozone and are able to break high-energy chemical bonds, such as the ethylenic carbon-carbon double bond. Wavelengths in the ranges mentioned are generated by so-called xenon radiators, which are commercially available.
  • the distance of the implant surface to be treated from the UV source is kept small, for example in the range of approximately 1 mm.
  • the duration of the UV treatment depends on the type and thickness of the contamination layer and can easily be determined or optimized by a person skilled in the art. In general, the irradiation time is in the range from 1 minute to 15 minutes.
  • the treatment according to the invention of a hydrophilic (and thus already relatively clean) surface also results in a cleaner product compared to the treatment of a contaminated surface.
  • XPS X-ray excited Photoelectron Specroscopy
  • AES Auger Electron Spectroscopy
  • An implant surface such as that which occurs immediately after acid etching and is hydroxylated and hydrophilic, has a wetting angle with water of less than 50 ° ( ⁇ 50 °) when the water drop penetrates the surface or less than 20 ° ( ⁇ 20 °) in the case of the regressing drop, and has a remarkable biological activity.
  • Chen whose hydrophilic character remains in contact with the atmospheric outside air according to the invention over a prolonged period of time.
  • the hydroxylated and hydrophilic implant surface obtained according to the invention preferably contains at most 20 atomic% carbon, measured by spectroscopic methods such as XPS or AES or other spectroscopic methods known per se.
  • the implant obtained is preferably stored in a casing filled with gases which are inert to the implant surface.
  • gases which are inert to the implant surface.
  • gases which are inert gases are for example nitrogen, oxygen or noble gas, such as e.g. Argon.
  • the casing is preferably impermeable to gases and liquids.
  • Compounds that can impair the biological activity of the implant surface include, as already mentioned, methanol, ethanol, acetone and related ketones, as well as numerous other organic compounds, or carbon dioxide.
  • the covering can, if appropriate, be partially or completely filled with pure water, which may optionally contain additives, at least such an amount of water being present that the roughened implant surface is kept moist or wetted.
  • Suitable additives are, for example, monovalent alkali cations, such as Na + or K + , with corresponding anions in the form of inorganic salts, such as, for example, sodium chloride, potassium chloride, sodium or potassium chlorate, sodium or potassium nitrate, sodium or potassium phosphate or a mixture of such salts.
  • Divalent cations in the form of water-soluble inorganic salts can also be added.
  • Suitable cations are in particular Mg +2 , Ca +2 , Sr +2 and / or Mn +2 in the form of the chlorides or their mixtures.
  • Suitable anions are also phosphate and phosphonate anions, which in each case also include monoorthophosphate anions and diorthophosphate anions or monoorthophosphonate anions and diorthophosphonate anions, in combination with the cations mentioned.
  • Cations and anions which are already present in the body fluid are preferred, in particular in the respective physiological concentration and at a physiological acid value (pH value) in the range from preferably 4 to 9 and preferably at an acid value in the range from 6 to 8.
  • Preferred cations are Na + , K + , Mg +2 and Ca +2 .
  • the preferred anion is Cl " .
  • the total amount of the cations or anions mentioned is in each case in the range from about 50 mEq / 1 to 250 mEq / 1, preferably about 100 mEq / 1 to 200 mEq / 1 and preferably about 150 mEq / 1 1.
  • Eq / 1 means (formula) equivalent weight or Eq / 1 corresponds to the atomic weight of the formula unit divided by the valency.
  • MEq / 1 means milliequivalents per liter.
  • the gas- and liquid-tight envelope is preferably a welded ampoule made of glass, metal, a synthetic polymer. lymeren or another gas- and liquid-tight material or consists of a combination of these materials.
  • the metal is preferably in the form of a thin metal foil, it being possible for polymeric materials and metallic foils, but also glass, to be combined with one another in a manner known per se to form suitable packaging.
  • a particular advantage of the present invention is that packaging of the implant in a gas- and liquid-tight envelope, as described above, can be dispensed with if the implant within a useful period following the treatment according to the invention with UV rays Time period, for example within an hour, is implanted.
  • the implant surface treated according to the invention surprisingly retains its hydrophilic character largely unchanged during this time even in contact with atmospheric air.
  • Suitable comparatively compact UV devices are available today and can be easily installed in the doctor's office. It is therefore sufficient to pack an implant provided with a roughened but hydrophobic surface, the manufacture of which has been described above and is known per se, in a dust-free manner.
  • the operating physician can treat the implant provided with a hydrophobic surface with the UV rays according to the invention immediately before the implantation in the UV device, a sterile (sterilized) implant with a hydroxylated and hydrophilic surface being obtained.
  • This hydroxylated and hydrophilic state of the implant surface, and thus also its biological activity, is thus largely retained until the implantation.
  • the present invention also relates to a method for implanting an osteophilic implant with a roughened hydroxylated and hydrophilic surface, whereby this implant consists of titanium or a titanium alloy and is suitable for implantation in bones, characterized in that the implant is treated in the hydroxylated state with high-energy ultraviolet radiation and immediately after this treatment implanted in the bone.
  • this implant consists of titanium or a titanium alloy and is suitable for implantation in bones, characterized in that the implant is treated in the hydroxylated state with high-energy ultraviolet radiation and immediately after this treatment implanted in the bone.
  • a common form of a dental implant in the form of a screw 4 mm in diameter and 10 mm in length was produced.
  • the raw form was obtained by machining and turning the cylindrical blank in a manner known per se.
  • the surface to be used in the bones was provided with a macroroughness by sandblasting with a grain of the average grain size 0.25-0.5 mm.
  • the roughened surface that is to say the macroroughness, was then treated with an aqueous hydrochloric acid / sulfuric acid mixture with a ratio of HC1: H 2 S0 4 : H 2 0 of 2: 1: 1 at a temperature of 95 ° C.
  • the low-carbon state of the surfaces of the samples according to test b) remained practically unchanged over a period of at least one day.
  • the implants according to experiments a) and b) were implanted in the upper jaw of a mini pig.
  • the anchorage in the bone was measured as the loosening torque of the screw implanted in the upper jaw of the mini-pig. The results obtained are shown in Table 1.

Abstract

L'invention concerne un implant ostéophile présentant une surface hydrophile hydroxylée rendue rugueuse, composé de titane ou d'un alliage de titane et conçu pour être implanté dans des os. L'implant selon l'invention est caractérisé en ce qu'il est traité par rayonnement ultraviolet haute énergie à l'état hydroxylé.
EP02764480A 2001-10-11 2002-10-11 Implants osteophiles Withdrawn EP1434607A1 (fr)

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CH18732001 2001-10-11
CH187301 2001-10-11
PCT/CH2002/000561 WO2003030957A1 (fr) 2001-10-11 2002-10-11 Implants osteophiles

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EP (1) EP1434607A1 (fr)
JP (1) JP2005505352A (fr)
CN (1) CN100366300C (fr)
AU (1) AU2002328762B2 (fr)
HK (1) HK1071526A1 (fr)
WO (1) WO2003030957A1 (fr)

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US20040210309A1 (en) 2004-10-21
AU2002328762B2 (en) 2007-08-23
CN100366300C (zh) 2008-02-06
WO2003030957A1 (fr) 2003-04-17
JP2005505352A (ja) 2005-02-24
CN1568200A (zh) 2005-01-19
HK1071526A1 (en) 2005-07-22

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