EP1434607A1 - Osteophilic implants - Google Patents

Osteophilic implants

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
surface
preferably
characterized
nm
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Withdrawn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)
French (fr)
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
Priority to CH187301 priority Critical
Priority to CH18732001 priority
Application filed by Straumann Holding AG filed Critical Straumann Holding AG
Priority to PCT/CH2002/000561 priority patent/WO2003030957A1/en
Publication of EP1434607A1 publication Critical patent/EP1434607A1/en
Application status is Withdrawn legal-status Critical

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61CDENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C8/00Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools
    • A61C8/0012Means 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surfaces, e.g. coating for improving bone ingrowth
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surfaces, e.g. coating for improving bone ingrowth
    • A61F2/30771Special external or bone-contacting surfaces, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • AHUMAN NECESSITIES
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    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/02Inorganic materials
    • A61L27/04Metals or alloys
    • A61L27/06Titanium or titanium alloys
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61CDENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C8/00Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools
    • A61C8/0018Means 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
    • A61C8/0037Details of the shape
    • A61C2008/0046Textured surface, e.g. roughness, microstructure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61CDENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C8/00Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools
    • A61C8/0012Means 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
    • A61C8/0013Means 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
    • A61C8/0015Means 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/0095Packages or dispensers for prostheses or other implants
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    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/28Bones
    • A61F2/2803Bones for mandibular reconstruction
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    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/3094Designing or manufacturing processes
    • AHUMAN NECESSITIES
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    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/32Joints for the hip
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/38Joints for elbows or knees
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surfaces, e.g. coating for improving bone ingrowth
    • A61F2/30771Special external or bone-contacting surfaces, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30838Microstructures
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surfaces, e.g. coating for improving bone ingrowth
    • A61F2/30771Special external or bone-contacting surfaces, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/3084Nanostructures
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surfaces, e.g. coating for improving bone ingrowth
    • A61F2/30771Special external or bone-contacting surfaces, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/3085Special external or bone-contacting surfaces, 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surfaces, e.g. coating for improving bone ingrowth
    • A61F2002/30906Special external or bone-contacting surfaces, e.g. coating for improving bone ingrowth shot- sand- or grit-blasted
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surfaces, e.g. coating for improving bone ingrowth
    • A61F2002/30925Special external or bone-contacting surfaces, e.g. coating for improving bone ingrowth etched
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005The prosthesis being constructed from a particular material
    • A61F2310/00011Metals or alloys
    • A61F2310/00023Titanium or titanium-based alloys, e.g. Ti-Ni alloys
    • AHUMAN NECESSITIES
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    • A61LMETHODS 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
    • A61L2400/00Materials characterised by their function or physical properties
    • A61L2400/18Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2430/00Materials or treatment for tissue regeneration
    • A61L2430/02Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants

Abstract

Osteophilic implant with a roughened hydroxilated and hydrophilic surface, made from titanium or a titanium alloy and suitable for implantation in bones, whereby the implant is characterised in that said implant is treated in the hydroxilated state with high-energy ultra-violet radiation.

Description

Osteophilic implants

The present invention relates osteophilic implants which are used for insertion into bone and which have substantially improved osteointegration properties, and to processes for their preparation.

Implants which are used for insertion into bone, such as hip or knee prostheses or screwed into the jaw pins for the construction of artificial teeth are known per se. Such implants are preferably made of titanium or titanium-based alloys, such as titanium gen / zirconium legierun-, which can contain niobium, tantalum or other tissue-compatible metallic additives in addition. A central feature of such implants is their osteointegration time, ie the time that elapses until the bone substance in sufficient strength and permanently connected to the implant surface that integrates means has.

As noted, the implant is anchored in the bone can be determined by mechanical measurements, namely, by measuring the force, whether as a train, pressure, shear or torque, which are necessary to draw out or anchored in the bone implant from its anchorage unscrewed, ie induce adhesive failure between the surface of the implant and the bone associated with this substance. Such measurement methods are known per se and, for example, in Brunski, Clinical Materials, Vol. 10, 1992, pp. Described 153-201. Measurements have shown that titanium implants with a smooth surface structure anchor inadequately in the bone, whereas implants with a roughened surface result in a in tensile strength significantly improved bone implant -Verbund. Accordingly, it is appropriate according to EP 0388576 on the implant surface in a first step by means of sandblasting a macro-roughness and superimposes this then by treatment in an acid bath with a micro roughness. The implant surface is roughened for example by sandblasting and then treated, for example, with an etchant, hydrofluoric acid or hydrochloric acid / sulfuric acid mixture. The thus provided with a defined roughness surface is then washed with water and solvents, and subjected to a sterilization treatment.

The chemical state of surfaces, such as titanium or titanium-based alloys is complex. It is assumed that the surface area of ​​titanium metal in air and water and that then oxidizes spontaneously on the surface, that is to say in the äu- ssersten atomic layer, a reaction takes place with water, hydroxyl groups are formed. These hydroxyl-containing surface is "hydroxylated" surface referred to in the literature as. See HP Boeh, Acidic and Basic prop erties of hydroxylated Metal Oxide Surfaces, Discussions Faraday Society, Vol. 52, 1971, pp. 264-275. However, a hydroxylated surface can only be fully effective when condition is in the "hydrophilic", that is, if they are not covered with volatile hydrocarbons and other compounds, such as sulfur dioxide or nitrogen monoxide, which are present in the air, is. also other contaminants may enter at any stage of the manufacturing process to the implant surface, for example in the purification process when the implant with organic solvents such as methanol or acetone, is treated. a hydroxylated and hydrophilic surface, for example of titanium or a titanium tanlegierung comprises biologically active properties and can be used as biologically active are designated. a hydroxylated and hydrophilic implant surface is growing significantly faster with the bone substance to a strong bond together, however, than an equal hydroxylated non-hydrophilic surface. the preparation of a hydroxylated and hydrophilic implant surface at the same time is described in WO 0044305 (PCT / EP00 / 00619).

A contamination-free, hydroxylated surface has high surface energy, resulting in that volatile hydrocarbons and other contaminants that are found in impure air can be adsorbed quickly. Initially form, for example, the hydrocarbons adsorbed to the hydroxylated surface of a monomolecular layer (monolayer) wherein the hydrophilic character of the surface is lost. The longer the implant is, however, exposed to the air, so as dictated ker the contamination layer. A clean hydroxylated surface of titanium is hydrophilic and has at the wetting with water a contact angle of less than 50 °, while a contaminated hydroxylated surface has a contact angle of about 70 °, and is referred to as hydrophobic. Although it is possible the hydroxylated and hydrophilic surface, and thus, largely to obtain well as their biological activity unchanged, if, it closes off said surface in such a manner in a wrapping that a contact of the surface with compounds which can affect the hydrophilic character of the implant surface prevents becomes. But if the envelope broken, which is necessary just prior to implantation, this can be a contact of the implant surface with the atmospheric outside air, and thus a decrease in the hydrophilic character of the implant surface, does not prevent. There is therefore a need, the hydroxylated and hydrophilic implant surface to produce or to treat such that their hydrophilic character ssenluft also in contact with the atmospheric Au is substantially retained over a prolonged period of time.

It has now been found, however, that a hydroxylated contaminated, ie with impurities occupied hydrophobic implant surface obtains a hydrophilic character, if this surface with high-energy ultraviolet radiation (UV rays) is treated. Surprisingly, the thus obtained ^ hydroxylated and hydrophilic surface against the occupancy by foreign substances atmosphärichen the outside air is significantly less sensitive than a hydroxylated and hydrophilic implant surface, which has been obtained for example by acid etching. It was also found that the stability of hydrophilic character hydroxylated obtained with an acid etch and hydrophilic implant surface significantly increases, if one treats them in the hydrophilic state by high-energy ultraviolet radiation. Another advantage of this treatment is that can be dispensed with an additional sterilization of the implants.

The present invention is defined in the claims. Specifically, the present invention relates to a osteophilic implant with a particular roughened, hydroxylated and hydrophilic surface, wherein this implant is preferably made of titanium or a titanium alloy and is suitable for implantation in bones, characterized in that the implant is in the hydroxylated state with high-energy ultraviolet radiation was treated. However, other materials such as other metals and ceramics conceivable. The term "implant in the hydroxylated state" refers to both an implant which has been prepared with a hydroxylated surface, but the surface has a hydrophobic character, as well as an implant with a hydroxylated and hydrophilic surface. The present invention implant shows a significantly increased stability against the loss of the hydrophilic character, and hence improved osteointegration.

The present invention also relates to methods for the preparation of an osteophilic implant with a particular roughened, hydroxylated and hydrophilic surface, wherein this implant is preferably made of titanium or a titanium alloy and is suitable for implantation in bones, characterized in that the implant is in the hydroxylated state treated with high-energy ultraviolet radiation.

Preferably, the inventive implants are made of a titanium alloy, preferably tion of a titanium / Zirkonlegie-, which may additionally contain niobium, tantalum or other tissue-compatible metallic additives. Other suitable materials may also be used within the scope of the invention. These implants are preferably used as hip or knee prostheses or as screwed into the jaw pins for the construction of artificial teeth. Such implants, the nature and the metallic materials used for their production are known per se and, for example, in J. Black, G. Hastings, Handbook of Biomaterials Properties, pages 135-200, published by Chapman & Hall, London, described the 1998th

The structural and functional anchor, eg a dental implant, in the bone is usually by attaching a macro-roughness, such as a screw thread or deepen levies in the surface and / or optionally an additional micro-roughness, wherein the microroughness either in an additive process is attached by means of plasma technology, or in a subtractive process by chemical etching on the surface. Attaching a macro-roughness, such as a screw thread or depressions in the surface, and optionally an additional microroughness is known per se. For the embodiment of the present invention, that is, for producing an implant, which is provided with a macro which additionally a micro-roughness is superimposed, it is preferably such as disclosed in EP 0388576 or (in WO 0044305 PCT / EP00 / 00619) is described. The implant thus obtained may then be treated According to the invention with high-energy ultraviolet radiation.

Preferably, the inventive implant surface comprises a macro-roughness in the range of 5 microns to lOOμm (each peak to valley), in particular in the range of 20 .mu.m to 40 .mu.m and a superimposed microroughness in the range of 0.5μm to 20 .mu.m, in particular in the range of 0.5μm to lOμm, particularly about 2 .mu.m.

These two overlapping roughness can be made in two stages. For example, the macro-roughness of the implant surface is created by sand blasting with corundum grains having an average grain size in the range of 0.25-0.5mm wherein subsequently, the microroughness by treatment with an aqueous hydrochloric acid / - sulfuric acid mixture in a ratio of HC1: H 2 S0: H 2 0 2 : 1: 1, at a temperature ranging from 80 ° C to about 110 ° C for about five minutes. After the acid bath, the surface-structured titanium parts, respectively. the implants, thoroughly washed with pure water until neutral, optionally treated with alcohol, acetone or another organic solvent or a disinfectant, and dried in hot air. The implants thus obtained can be finally packaged, and optionally sterilized with gamma rays. In this method, a hydrophilic implant surface when washed after the acid bath, the implant surface rinse with pure water until neutral and dried in over the hydrophilic surface of an inert atmosphere and stored the implant in an inert atmosphere. In the treatment with alcohol, acetone or another organic solvent or a disinfectant as well as when drying in hot atmospheric air, a hydrophobic implant surface is obtained.

The "pure" water used for washing is preferably distilled several times or prepared via reverse osmosis water, which was preferably in an inert atmosphere, that is, for example, under reduced pressure, in a nitrogen or noble gas atmosphere prepared. Furthermore, the pure water has an electrical resistivity of at least 2 cm Moh (electrical resistance> 2 Mohm cm) and a total content (total organic carbon, TOC) of organic carbon of at most 10 ppb (<10 ppb).

According to the invention the implant in the hydroxylated state is treated with high-energy ultraviolet radiation. The high-energy ultraviolet radiation (UV radiation) causes the implant surface is hydrophilic and which is present on the surface contaminants are removed. As high-energy UV radiation is used in the present invention UV radiation having a wavelength in the range of 150 nm to 300 nm, preferably in the range of 170 nm to 260 nm and in particular UV-rays in the range of the absorption maximum of oxygen, that is, with a wavelength of about 184.9 nm and in the region of the absorption maximum of ozone, that is, with a wavelength of about 253.7nm. Wavelengths in this range promote the simultaneous formation and decomposition of ozone and are capable of energy-rich chemical bonds, such as, for example, break up the ethylenic carbon-carbon double bond. Wavelengths in the aforementioned areas are produced by so-called xenon lamps, which are commercially available.

Since the intensity of the radiation with the distance from the UV source decreases exponentially, it is advantageous that the distance is small implant surface to be treated to the ultraviolet source, for example in the range of about 1 mm held. The duration of the UV-treatment depends on the type and thickness of the contamination layer, and can be determined by the skilled person or readily optimized. In general, the irradiation time is in the range of 1 minute to 15 minutes. Usually surface is a cleaner product obtained as compared with the treatment of a contaminated surface in the inventive treatment of a hydrophilic (and thus already relatively pure).

For analysis of patients treated with UV rays implant surfaces is used to advantage XPS (X-ray excited photoelectron spec troscopy) or Auger electron spectroscopy (AES). An implant surface, such as is obtained, for example, immediately after the acid-etching and hydroxylated and is hydrophilic, has a wetting angle with water of less than 50 ° (<50 °) in advance of the drop of water in contact with the surface, respectively, of less than 20 ° (<20 °) in the case of the back-forming droplet, and has a remarkable biological activity. The same applies to a treated with UV rays implant surface chen, their hydrophilic character but in contact with the atmospheric ambient air according to the invention is maintained over an extended period.

Industrially produced surfaces of titanium and titanium alloys for processing in laboratories and hospitals generally have on impurities which consist essentially of carbon compounds and traces of nitrogen, calcium, sulfur, phosphorus and silicon. These contaminants are concentrated in the outermost metal oxide layer. Preferably, the hydroxylated and hydrophilic implant surface according to the invention obtained contains a maximum of 20 atomic% of carbon as measured by spectroscopic methods such as XPS or AES or other art-known spectroscopic methods.

Following the UV irradiation, the implant obtained is preferably stored in a filled with respect to the implant surface inert gases enclosure. Such inert gases, that is, gases which do not affect the hydrophilic character of the surface or its biological activity are, for example nitrogen, oxygen or a noble gas such as argon. The enclosure is preferably impermeable to gases and liquids. Compounds which may interfere with the biological activity of the implant surface, are, for example, as already mentioned, methanol, ethanol, acetone and related ketones as well as numerous other organic compounds, or carbon dioxide.

The sheath may optionally be partially or completely filled with pure water, which may optionally contain additives, wherein at least such a quantity of water is present, the wetting or wetting of the roughened implant surface is ensured. Suitable additives are, for example, monovalent alkali metal cations such as Na + or K +, liumchlorat with corresponding anions in the form of inorganic salts such as sodium chloride, potassium chloride, sodium or potassium, sodium or potassium nitrate, sodium or potassium phosphate or a mixture of such salts. Similarly, divalent cations with the form of water-soluble inorganic salts may be added. Suitable cations are, in particular, Mg +2, Ca +2, Sr +2, and / or Mn + 2 in the form of chlorides or mixtures thereof. Suitable anions are phosphate and phosphonate wherein each including also Mono orthophosphate anions and phosphate anions or Diortho- Monoorthophosphonat anions and Diortho- phosphonate anions are to be understood in combination with the above-mentioned cations.

Cations and anions which already occur in body fluid, especially in the respective physiological concentration and at physiological acid value (pH) in the range of preferably 4 to 9, and preferably at an acid value in the range 6 to 8 Preferred cations are preferred are Na +, K +, Mg +2 and Ca +2. The preferred anion is Cl ". Preferably, the total amount of said cations or anions respectively in the range of about 50 mEq / 1 to 250 mEq / 1, preferably about 100 mEq / 1 to 200 mEq / 1, and preferably at about 150 mEq / 1. In this case, Eq / is 1 (formula) equivalent weight or Eq / 1 corresponds to the atomic weight of the unit formula divided by the valency. mEq / 1 means Milliäquivanlentgewicht per liter. If the envelope contains divalent cations, especially Mg +2, Ca +2, Sr +2, and / or Mn +2, alone or in combination with the above-mentioned monovalent cations, the total amount of divalent cations present preferably ranges from 1 mEq / 1 to 20 mEq /. 1

The gas- and liquid-tight covering is preferably a sealed ampoule made of glass, metal, a synthetic polyvinyl lymeren or other gas- and liquid-tight material, or consists of a combination of these materials. The metal is preferably present as a thin metal film, polymethyl re materials and metallic foils, as well as glass, can be combined together to form a suitable packaging in a conventional manner.

However, a particular advantage of the present invention is that can be dispensed to a package of the implant in a gas- and liquid-tight envelope, as this is described advancing when the implant following the inventive treatment with UV rays within a useful period of time, for example, within one hour, implanted. As mentioned above, the inventiveness treated according to implant surface retains surprisingly during that time also in contact with atmospheric air its hydrophilic character largely unchanged. Suitable comparatively compact UV devices are available today and can be installed in the doctor's office without further ado. It is sufficient, therefore, an provided with a roughened surface, however, hydrophobic implant, the preparation described advancing and is known per se to package dust. The surgeon (dental surgeon) can treat provided with a hydrophobic surface implant immediately before the implantation in the UV-device according to the invention with ultraviolet rays, wherein an aseptic (sterilized) implant is obtained with a hydroxylated and hydrophilic surface. This hydroxylated and hydrophilic state of the implant surface, and thus their biological activity is thus largely maintained until implantation.

The present invention also relates to a method for implanting an osteophilic implant with a roughened hydroxylated and hydrophilic surface in this sense, said implant is made of titanium or a titanium alloy and is suitable for implantation in bones, characterized in that the implant is in the hydroxylated treated state with high-energy ultraviolet radiation, and directly thereafter implanted at this treatment in the bone. The following examples illustrate the invention.

example 1

A common form of a tooth implant in the form of a screw of 4 mm diameter and 10 mm length was prepared. The crude form was obtained by turning and milling by machining the cylindrical blank in a known manner. The inserted into the bone surface has been provided according to EP 0388576 with a macro by being sandblasted with a particle of average particle size 0.25-0.5 mm. Subsequently, the roughened surface, that is the macro-roughness, with an aqueous hydrochloric acid / sulfuric acid mixture at a ratio of HC1: H 2 0 2: H 2 S0 4 1: treated for 1 at a temperature of 95 ° C for five minutes, so was that a ratio of the roughened implant surface to the comparable polished surface of 3.6, measured by voltammetry in aqueous electrolyte with 0.15M NaCl, (corresponding to a ratio of 3.9, as measured by impedance in 0.1 molar Na 2 S0 4 electrolyte) obtained. The implant thus formed was washed with pure water carefully neutral, then dried in atmospheric air at 110 ° C and free of dust packaged in a glass ampoule. Several identical implants were produced in this way. After 4 weeks, the vials were opened.

a) Part of the implants were unchanged implanted (comparative experiment). b) The other part of the implants was for five minutes in a Xenon-lamp from Radium (Lampenwerk Wipperfuerth, Germany) treated with UV radiation having an emission maximum at 172 nm at a distance of 0.1 mm in atmospheric air.

The samples according to test a) [without UV treatment] exhibited a wetting angle of about 70 ° (> 70 °) and a content of 20-40 atomic% of carbon on the surface. The samples according to test b) [after UV treatment] were completely wettable, ie, had a contact angle of 0 ° (zero degrees) and containing 8-13 atomic% of carbon on the surface. The low carbon state of the surfaces of the samples according to test b) remained virtually unchanged over a period of at least one day.

The implants according to the tests a) and b) were implanted in the upper jaw of a mini pig. The anchoring in the bone was measured as the release torque of the implanted in the upper jaw of the minipig screw. The results obtained are shown in Table 1 below.

Table 1

* The anchorage is given as the loosening torque in Ncm (averages).

Claims

claims
1. osteophilic implant with a hydroxylated surface consisting of titanium or a titanium alloy, preferably with a rough, suitable for implantation into bone surface, characterized in that the implant is hydrophilic, that is substantially free of located on the surface impurities.
2. osteophilic implant having a rough surface comprised of titanium or a titanium alloy, produced by a production and delivery process, which summarizes a environmentally until implantation effective surface treatment method, comprising the steps of:
(A) hydroxylating the surface of the implant and
(B) treating the surface of the implant by ultraviolet radiation to provide a hydrophilic surface, in particular for the destruction and / or removal of organic contaminants.
includes 3. Implant according to claim 1 or 2, characterized in that the treated implant surface has a content of less than 20 atomic% carbon, preferably less than 13 atomic%.
4. The implant according to one of claims 1 or 3, characterized in that the surface with UV radiation is treated so as to achieve hydrophilicity and to rid the surface of impurities.
5. implants according to one of claims 1-4, characterized in that it consists of a titanium alloy, preferably a titanium / zirconium alloy, which optionally additionally contains niobium, tantalum or other tissue-friendly, in particular metallic additives.
6. The implant according to one of claims 1-5, characterized in that it is a hip or knee prosthesis, or egg NEN introduced into the jaw pin for the construction of artificial teeth.
7. The implant according to any one of claims 1-6, characterized in that the implant surface with a macro-roughness, preferably a screw thread or with depressions in the surface, and optionally additional superimposed with a macro-roughness of the microroughness is provided.
8. The implant according to claim 7, characterized in that the macro-roughness in the range of 5 microns to lOOμm (each peak to valley), in particular in the range of 20 .mu.m to 40 .mu.m and the superimposed microroughness in the range of 0.5μm to 20 .mu.m, in particular in the range of 0.5 microns to lOμm, in particular of about 2 microns is located.
9. The implant according to one of claims 1-8, characterized in that, as UV-rays, those having a wavelength ranging from 150 nm to 300 nm, preferably in the range of 170 nm to 260 nm, and in particular, UV rays having a wavelength of about 184.9nm and about 253.7 nm, were used.
10. The implant according to any one of claims 1-9, characterized in that irradiated during an irradiation time of 1 minute to 15 minutes.
11. The implant according to any one of claims 1-10, characterized in that this, filled in with respect to the implant surface inert gases, preferably nitrogen, oxygen or a noble gas, impermeable to gases and liquids, wrapper is packaged.
12. The implant according to claim 11, characterized in that the covering is partially or completely filled with pure water, which optionally contains additives.
13. The implant according to claim 12, characterized in that the water is alkaline cations, preferably Na + or K +, with corresponding anions in the form of inorganic salts, preferably sodium chloride, potassium chloride, sodium or potassium chlorate, sodium or potassium nitrate, sodium or potassium phosphate or a mixture of such salts, or with divalent cations form of wassserlöslichen inorganic salts, preferably Mg 2+, Ca 2+, Sr 2+ and / or Mn 2+, preferably in the form of chlorides, or water-soluble phosphates and / or phosphonates, contains.
14. The implant of claim 12 or 13, characterized in that the total amount of the cations or anions respectively in the range of 50 meq / 1 to 250 mEq / 1, preferably in the range of 100 mEq / 1 to 200 mEq / 1 and preferably at about 150 mEq / 1.
15. An implant according to any of claims 11-14, characterized in that the gas- and liquid-tight envelope is an ampoule made of glass, metal, a synthetic polymer or another gas-tight and liquid-tight material, or consists of a combination of these materials.
16. osteophilic implant according to any one of claims 1-15 with a roughened hydroxylated and hydrophilic surface, wherein said implant is made of titanium or a titanium alloy, characterized in that the implant is in the hydroxylated state with high-energy ultraviolet radiation treated.
17. A method for implanting an osteophilic implant with a hydroxylated and hydrophilic, preferably with a rough, suitable for implantation into bone surface, wherein said implant is made of titanium or a titanium alloy, characterized in that the implant is in the hydroxylated state with ultraviolet radiation treated, with those having a wavelength ranging from 150 nm to 300 nm, preferably in the range of 170 nm to 260 nm, and in particular, UV rays having a wavelength of about 184.9nm to about 253.7nm used as UV rays and can be directly identified, the implant then implanted this treatment in the bone.
18. A method for implanting an osteophilic implant with a hydroxylated and hydrophilic, preferably with a rough, suitable for implantation into bone surface, wherein said implant is made of titanium or a titanium alloy, characterized in that the implant is in the hydroxylated state with ultraviolet radiation treated, with those having a wavelength ranging from 150 nm to 300 nm, preferably in the range of 170 nm to 260 nm, and in particular, UV rays having a wavelength of about 184.9nm to about 253.7nm used as UV rays and to the results achieved in such a way conserved hydrophilic state of the surface by suitable bearing, wherein the implant in the bone is carried out at a later time.
9. Use of an osteophilic implant consisting of titanium or a titanium alloy, preferably organic with a form suitable for implantation rough surface, wherein the surface is hydroxylated and by such UV radiation, insbesonere a high-energy irradiation is applied in such a way that located on the surface impurities destroyed or rendered ineffective for implanting a dental implant.
EP02764480A 2001-10-11 2002-10-11 Osteophilic implants Withdrawn EP1434607A1 (en)

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WO2003030957A1 (en) 2003-04-17
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