WO1997016579A1 - Living body contacting metal material - Google Patents

Living body contacting metal material Download PDF

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Publication number
WO1997016579A1
WO1997016579A1 PCT/JP1996/003175 JP9603175W WO9716579A1 WO 1997016579 A1 WO1997016579 A1 WO 1997016579A1 JP 9603175 W JP9603175 W JP 9603175W WO 9716579 A1 WO9716579 A1 WO 9716579A1
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WO
WIPO (PCT)
Prior art keywords
alloy
metal member
metal
living body
noble metal
Prior art date
Application number
PCT/JP1996/003175
Other languages
French (fr)
Japanese (ja)
Inventor
Sekio Fukuyo
Original Assignee
Sekio Fukuyo
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Publication date
Application filed by Sekio Fukuyo filed Critical Sekio Fukuyo
Publication of WO1997016579A1 publication Critical patent/WO1997016579A1/en

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Classifications

    • CCHEMISTRY; METALLURGY
    • C22METALLURGY; FERROUS OR NON-FERROUS ALLOYS; TREATMENT OF ALLOYS OR NON-FERROUS METALS
    • C22CALLOYS
    • C22C5/00Alloys based on noble metals
    • C22C5/02Alloys based on gold
    • 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
    • A61L27/02Inorganic materials
    • A61L27/04Metals or alloys
    • A61L27/06Titanium or titanium alloys
    • CCHEMISTRY; METALLURGY
    • C23COATING 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
    • C23CCOATING 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
    • C23C8/00Solid state diffusion of only non-metal elements into metallic material surfaces; Chemical surface treatment of metallic material by reaction of the surface with a reactive gas, leaving reaction products of surface material in the coating, e.g. conversion coatings, passivation of metals
    • C23C8/06Solid state diffusion of only non-metal elements into metallic material surfaces; Chemical surface treatment of metallic material by reaction of the surface with a reactive gas, leaving reaction products of surface material in the coating, e.g. conversion coatings, passivation of metals using gases
    • C23C8/08Solid state diffusion of only non-metal elements into metallic material surfaces; Chemical surface treatment of metallic material by reaction of the surface with a reactive gas, leaving reaction products of surface material in the coating, e.g. conversion coatings, passivation of metals using gases only one element being applied
    • C23C8/10Oxidising
    • 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

Definitions

  • the present invention relates to a biocontact metal member made of an alloy containing a noble metal as a main component.
  • alloys containing precious metals as main components for example, gold alloys such as Au-Ag-Cu alloys and Au-Pd-Ag alloys, have been used as materials for metal parts for medical and decorative purposes. It has been heavily used. For example, attention has been paid to the excellent formability and stability in the oral cavity of such gold alloys and the like, and medical metal members used for dental treatment such as inlays, crowns, bridge dentures, etc. It is widely used as a material to be given, or as a material for manufacturing metal members for decoration such as earrings, rings, necklaces, bracelets, watch bands, etc. by using gold or gold alloy or its excellent decorativeness. It is being done.
  • such a biocontact metal member is Since it is composed of a gold alloy, it is not only excellent in formability but also excellent in stability, and is used by being embedded in biological tissue such as bone. Although it has suitable properties as an imprint material, it is not actually applied at all, and as described above, the gold contained in such a metal member is ionized and eluted. There is a great reason for being swayed.
  • the characteristics of the noble metal such as gold contained in the metal member are utilized and used for various purposes.
  • the noble metal such as gold contained in the metal member.
  • it since it is ionized and eluted in the living body, there is a serious problem that a metal allergy is generated in the wearer, and that it cannot be used practically as an imprint material. Disclosure of the invention
  • the present invention has been made in view of the above-mentioned circumstances, and a solution of the present invention is to provide a medical metal member or decoration made of an alloy containing a precious metal such as gold as a main component.
  • a solution of the present invention is to provide a medical metal member or decoration made of an alloy containing a precious metal such as gold as a main component.
  • metal members for biological contact such as metal members and the like, the elution of metal ions such as gold ions from such metal members can be prevented in a favorable manner.
  • the present invention has been completed based on such findings, and is characterized by an alloy containing a noble metal as a main component, which is attached to a living body and brought into contact with a living tissue.
  • Ti is contained as an alloy component for the noble metal, and an oxide film layer of Ti is formed on the surface of the member by heat treatment.
  • the entire surface is covered with a Ti oxide film layer having a property capable of inhibiting elution of noble metal ions such as gold ions. It is being done.
  • the noble metal such as gold in the metal member can be effectively prevented from being ionized and eluted. It is possible to effectively prevent the occurrence of gold energies, and metal parts made of alloys containing precious metals as main components are extremely advantageous as imprint materials, which were previously inapplicable. It can be applied, and the imprint material is advantageously imparted with excellent compatibility with biological tissue such as bone, which is a conventionally known property of the oxide film layer of Ti. You can be squeezed. Therefore, by using the metal member for living body contact according to the present invention, it is possible to effectively prevent contact inflammation or the like from occurring on the mucous membrane or skin of the wearer due to a metal allergy due to a noble metal such as gold. In addition, an imprint material having good moldability, better biocompatibility, and even better compatibility with living tissue can be realized very advantageously.
  • a medical metal member made of an alloy containing a noble metal as a main component, which is attached to a living body and brought into contact with a living tissue, is provided.
  • Ti is contained as an alloy component for the noble gold alloy, and an oxide film layer of Ti is formed on the surface of the member by heat treatment.
  • the medical metal member is configured as an implant for a living body.
  • a bioimplant material that is more excellent in moldability and biocompatibility and more excellent in compatibility with living tissue can be advantageously realized.
  • the implant material for a living body is configured as a dental intraosseous implant, whereby the moldability and the biological properties are improved.
  • a dental intraosseous implant that is not only excellent in affinity but also excellent in compatibility with alveolar bone can be advantageously realized, so that dentures and the like attached to the implant can be more stable in the oral cavity It can be fixed.
  • a decorative metal member which is attached to a living body and is brought into contact with a biological tissue and which is made of an alloy containing a noble metal as a main component, contains Ti as an alloy component for the noble metal.
  • a Ti oxide layer is formed on the surface of the member by heat treatment.
  • the noble metal such as gold in the metal member can be ionized and eluted by the oxide film layer of Ti and being formed on the surface. Therefore, it is possible to effectively prevent the occurrence of metal allergy due to the noble metal in the wearer, and to cause contact inflammation or the like on the mucous membrane or skin of the wearer.
  • the decorative metal member is constituted by any one of a pierced earring, a ring, a necklace, a bracelet, and a watch band. That is to say, by wearing these ornaments, it is possible to effectively eliminate the possibility of producing metal allergies.
  • the alloy providing those metal members may be an Au—Ti alloy, an Au—Ag—C It is composed of u—Ti alloy or Au—Pd—Ag—Ti alloy so that each metal member for biological contact, medical use, and decoration can be used. It can be advantageously applied to conventional metal members made of an alloy such as, for example, metal members frequently used in ornaments and dental treatments. Characteristics can be very effectively demonstrated.
  • the metal member for living body contact is contained in a proportion not exceeding 10% by weight of Ti.
  • the precious metal and Ti can be favorably and reliably alloyed without deteriorating the physical properties of the precious metal, which is the main component of the metal member for biological contact, so that the medical metal member ⁇ the decorative metal member and the like can be obtained. Therefore, it can be used very advantageously.
  • the biocontact metal member according to the present invention contains a noble metal as a main component and a Ti force ⁇ as an alloy component for the metal member, as described above.
  • the type of such a noble metal is not particularly limited, and may be, for example, Au, Ag, Pd, Pt, etc., which are usually included in metal members for medical use, decoration, etc. One type may be used alone, or two or more types may be used in combination. Au is preferably used as the noble metal.
  • alloy components generally contained in metal members for medical use, decoration, etc., such as Cu and other trace components are contained.
  • an alloy providing a biological contacting gold ⁇ material according to the present invention, as long as it is a noble metal and T i comprising been made to contain a composition of, the invention is not particularly limited
  • Various alloy compositions such as Ti, Au-Pt-Pd-Ag-Cu-Ti can be employed.
  • the composition ratio of each of the alloy components is not limited at all, and a general composition ratio can be appropriately adopted.
  • Ti is not limited to any alloy composition. It is preferable that the content is not more than 10% by weight. However, if the Ti content exceeds 10% by weight, the Ti will be excessively contained in the precious metal, which is the main component, and as a result, the precious metal will be alloyed with the Ti. Not only becomes difficult, but also due to the presence of large amounts of Ti in the alloy Therefore, the physical properties of the noble metal are impaired.
  • the content ratio of Ti is desirably preferably 5% by weight or less, particularly preferably 2% by weight or less. As described above, when the content ratio of Ti is set to 2% by weight or less, the color of the surface of the biocontact metal member can be effectively maintained at the color of the noble metal, and the metal member member ⁇ It can be used more effectively for decoration.
  • an oxide film layer of Ti is formed on the surface of the metal member by an appropriate heat treatment.
  • the heat treatment method for forming such an Ti oxide film layer is not particularly limited. That is, when heat treatment is performed on such a metal member, a one-piece heat treatment apparatus can be used, and the heat treatment temperature is determined by the melting point (melting point) of each alloy component. The heat treatment time is appropriately determined in consideration of such factors, and the appropriate heat treatment time is determined in accordance with the determined heat treatment temperature and the like. When the heat treatment is performed at a relatively high temperature for a short time, the color of the surface of the obtained metal member can be advantageously maintained at the color of the noble metal.
  • the thickness of the oxide layer of Ti formed on the surface of the biocontact metal member by the heat treatment is not limited at all, but is set to about 10 m at a time. .
  • the Ti oxide film layer formed in this manner has features that cannot be seen in other metal oxide films, such as being able to prevent elution of precious metal ions, as described above. Accordingly, in the metal member for biological contact having such an oxide film layer of T i formed on the surface, the ionization and elution of the noble metal in the metal member can be effectively prevented. It is. As a result, in such a metal member for living body contact, a metal allergy may occur in a wearer of the metal member.
  • An imprint material that can be effectively prevented has excellent moldability and biocompatibility, which are inherent properties of the metal, and also has convenient compatibility with biomaterials having an oxide layer of Ti. Can be used very advantageously.
  • a metal member for living body contact having such extremely excellent characteristics is attached to a living body, and is made of a metal member to be brought into contact with living tissue, for example, embedded in alveolar bone, and a denture or the like is placed in the alveolar bone.
  • alloys that use precious metals as the main component such as oral implants (dental endosseous implants) that are fixed to bones and bolts that are embedded in fractured bones to connect such bones, are not applicable.
  • a medical metal member such as a metal member for general dental treatment, such as a bioimplant material, an inlay, a crown, and a bridge denture, which has been made possible, and a pierced earring, a ring, a necklace, and a bracelet. It can be used very advantageously as a decorative metal member such as a watch band or a watch band.
  • Such a biocontact metal member according to the present invention is advantageously manufactured as follows.
  • T i and, if necessary, other alloy components are dissolved in a noble metal by a conventional method, for example, an arc melting method, to obtain a melt (molten metal).
  • a conventional method for example, an arc melting method
  • the dissolving operation needs to be performed in an inert gas atmosphere such as Ar gas.
  • the melt obtained in this manner is manufactured to obtain an ingot, and thereafter, the ingot is subjected to general plastic working, forming, or the like, for example, press forming to obtain a predetermined shape. Is obtained.
  • the surface thereof is polished by a known method, and then subjected to a general heat treatment in the air, so that the surface of the alloy member is Form an oxide layer of Ti for the purpose Is obtained.
  • the biocontact metal member configured according to the present invention may be an alloy member having a predetermined shape by using a general alloy molding and manufacturing method such as powder metallurgy, in addition to the above-described manufacturing method. It can also be manufactured by manufacturing the alloy member and then heat-treating the alloy member. Even when such a method is adopted, the method of heat treatment of the alloy member is not particularly limited, as in the above-described production method.
  • a general alloy molding and manufacturing method such as powder metallurgy
  • Au is used as a noble metal, and this Au is included as a main component, and at the same time, Ti or Ti and Ag are included as alloy components with respect to the Au, and these metals are used.
  • Each of Au, Ti, and Ag was separately charged into a predetermined crucible so as to obtain six kinds of alloys having the composition ratios shown in Table 1 below.
  • r Dissolution was performed by performing arc melting according to a conventional method in an atmosphere to obtain six types of melts (melts) having different component compositions from each other.
  • an alloy containing Au as a main component and containing Ti as an alloy component with respect to the Au has a low Ti content. Specifically, when the content of Ti is about 2% by weight or less, there is no remarkable decrease in physical properties even when compared with pure gold, and thus the physical properties of Au are effective. It is confirmed that the power has been secured.
  • the surface of each alloy was polished according to a conventional method, and then the alloys were polished in air at 800.degree. Heat treatment at 30 ° C for 30 minutes, and then mooring and cooling at 40 ° C for 20 minutes to obtain the desired six types of biological contact metals with different component compositions. A member was obtained.
  • the Ti film is formed on the surface by forming a Ti oxide film layer by heat treatment.
  • the oxide film layer of the metal member can effectively prevent ionization and elution of the noble metal such as gold in the metal member, thereby effectively preventing the wearer of the metal member from having gold II allergy. Can be effectively prevented, and precious money)!
  • a metal member made of an alloy containing as a main component can be extremely advantageously applied as an implant material, which has heretofore been impossible to be applied.
  • the excellent compatibility of the membrane layer with living tissue such as bone can be advantageously imparted.
  • the metal member for living body contact according to the present invention, it is possible to effectively prevent contact inflammation or the like from occurring on the mucous membrane or skin of the wearer due to metal allergy due to a noble metal such as gold. And good moldability, better biocompatibility, and even better compatibility with living tissue. An implant material with excellent compatibility can be realized very advantageously.
  • the present invention can effectively prevent the occurrence of metal allergy due to a noble metal in a wearer of a biological contact metal member, and has excellent moldability and biocompatibility.

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  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Metallurgy (AREA)
  • Mechanical Engineering (AREA)
  • Materials Engineering (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Transplantation (AREA)
  • Medicinal Chemistry (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Adornments (AREA)
  • Materials For Medical Uses (AREA)
  • Prostheses (AREA)
  • Dental Prosthetics (AREA)

Abstract

A living body contacting metal material is provided which is capable of easily preventing the elution of noble metal ions, effectively preventing the occurrence of allergy due to a noble metal, and being advantageously used as an implantation material. The gist of the construction of this material which solves the problems encountered in a prior art material of this kind resides in that it is formed out of an alloy containing a nobel metal as a main component and Ti as an alloy component with respect to the noble metal, this alloy being heat treated so as to form a film layer of Ti oxide on the surface thereof.

Description

明 細 害 発明の名称  Description Damage Title of Invention
生体接触用金厲部材 技術分野  Metal parts for biological contact Technical field
本発明は、 貴金属を主要成分とした合金からなる生体接触用金厲部材 に関するものである。 背景技術  The present invention relates to a biocontact metal member made of an alloy containing a noble metal as a main component. Background art
従来より、 貴金属を主要成分とした合金、 例えば、 A u - A g - C u 合金、 A u - P d - A g合金等の金合金は、 医療用や装飾用等の金属部 材の材料として、 多用されてきている。 例えば、 それらの金合金等が、 それの有する優れた成形加工性や口腔内における安定性等か着目されて、 主に、 インレー、 冠、 橋義歯等、 歯科治療に用いられる医療用金属部材 を与える材料として、 また、 金或いは金合金か、 その優れた装飾性を利 用して、 ピアス、 指輪、 ネックレス、 ブレスレツ ト、 時計バンド等の装 飾用金厲部材の製造材料として、 それぞれ広く用いられているのである。  Conventionally, alloys containing precious metals as main components, for example, gold alloys such as Au-Ag-Cu alloys and Au-Pd-Ag alloys, have been used as materials for metal parts for medical and decorative purposes. It has been heavily used. For example, attention has been paid to the excellent formability and stability in the oral cavity of such gold alloys and the like, and medical metal members used for dental treatment such as inlays, crowns, bridge dentures, etc. It is widely used as a material to be given, or as a material for manufacturing metal members for decoration such as earrings, rings, necklaces, bracelets, watch bands, etc. by using gold or gold alloy or its excellent decorativeness. It is being done.
ところで、 近年では、 そのような金や金合金から成る医療用金厲部材 や装飾用金厲部材等、 生体に取り付けられて、 生体組織に接触せしめら れる、 所謂生体接触用金厲部材の装着者が、 金属アレルギーを起こし、 それによつて、 発疹、 びらん、 潸瘥等が、 かかる装着者の拈膜ゃ皮 に 接触性炎症として生じるといった報告が、 頻繁に為されている。 これは、 かかる生体接触用金厲部材中の金がイオン化して、 溶出することに原因 があると、 考えられている。  By the way, in recent years, the mounting of so-called biological contact metal members, such as medical metal members and decorative metal members made of gold or gold alloy, which are attached to the living body and brought into contact with living tissue. It has been frequently reported that the wearer develops a metal allergy, resulting in rashes, erosions, eruptions, etc., as contact inflammation on the skin of the wearer's restrictive membrane. It is believed that this is due to the ionization and elution of the gold in the biocontact metal member.
また、 よく知られているように、 そのような生体接触用金厲部材に あっては、 金合金にて構成されることによって、 成形加工性に優れてい るばかりでなく、 安定性にも優れている等、 骨等の生体組維内に埋入さ れて使用されるインブラント材として、 好適な特性を有するものの、 実 際には、 全く適用されてはいないのであり、 これも、 上述の如く、 かか る金厲部材において、 それに含まれる金がイオン化して溶出せしめられ るところに、 大きな理由があるのである。 Also, as is well known, such a biocontact metal member is Since it is composed of a gold alloy, it is not only excellent in formability but also excellent in stability, and is used by being embedded in biological tissue such as bone. Although it has suitable properties as an imprint material, it is not actually applied at all, and as described above, the gold contained in such a metal member is ionized and eluted. There is a great reason for being swayed.
このように、 従来の生体接触用金厲部材にあっては、 それに含まれる 金等の貴金属の有する特性が活用されて、 各種の用途に使用されている のではあるか、 その反面、 かかる貴金属が、 生体内でイオン化して溶出 せしめられることから、 その装着者において金属アレルギーが生せしめ られ、 また、 インブラント材として実用に供され得ないといった、 大き な問題が内在していたのである。 発明の開示  As described above, in the conventional biocontact metal member, the characteristics of the noble metal such as gold contained in the metal member are utilized and used for various purposes. However, since it is ionized and eluted in the living body, there is a serious problem that a metal allergy is generated in the wearer, and that it cannot be used practically as an imprint material. Disclosure of the invention
ここにおいて、 本発明は、 上述の如き事情を背景にして為されたもの であって、 その解决課題とするところは、 金等の貴金属を主要成分とし た合金から成る医療用金厲部材や装飾用金厲部材等を始めとする生体接 触用金厲部材において、 それらの金属部材中からの金イオン等の賨金属 イオンの溶出が良好に阻止され得るように為し、 以てかかる金属部材の 装着者における金属ァレルギ一の発生を効果的に阻止させ得ると共に、 該金厲部材をィンブラン ト材として有利に適用せしめ得る技術を提供す ることにある。  Here, the present invention has been made in view of the above-mentioned circumstances, and a solution of the present invention is to provide a medical metal member or decoration made of an alloy containing a precious metal such as gold as a main component. In metal members for biological contact, such as metal members and the like, the elution of metal ions such as gold ions from such metal members can be prevented in a favorable manner. It is an object of the present invention to provide a technique capable of effectively preventing the occurrence of metal allergies in a wearer of the present invention and effectively applying the metal member as an imprint material.
そして、 本発明者らが、 上述の如き課題を解決するために、 種々の検 討を重ねた結果、 貴金属を主要成分とし、 且つ該貴金属に対する合金成 分として T iを含む合金を熱処理することよって、 かかる合金の表面に、 T iの酸化膜層が形成され、 しかも、 そのような T iの酸化膜層か、 貴 金属イオンの溶出を有利に咀止せしめ得ることを、 見い出したのである。 すなわち、 本発明は、 そのような知見に基づいて完成されたもので あって、 その特徴とするところは、 生体に取り付けられて、 生体組維に 接触せしめられる、 貴金属を主要成分とした合金からなる生体接触用金 属部材において、 該貴金属に対する合金成分として T iを含有すると共 に、 該部材の表面に、 熱処理によって T iの酸化膜層を形成せしめたこ とにある。 As a result of various studies conducted by the present inventors in order to solve the above-described problems, heat treatment is performed on an alloy containing a noble metal as a main component and containing Ti as an alloy component for the noble metal. Therefore, a Ti oxide film layer is formed on the surface of such an alloy. It has been found that the elution of metal ions can be advantageously suppressed. That is, the present invention has been completed based on such findings, and is characterized by an alloy containing a noble metal as a main component, which is attached to a living body and brought into contact with a living tissue. In the metal member for living body contact, Ti is contained as an alloy component for the noble metal, and an oxide film layer of Ti is formed on the surface of the member by heat treatment.
要するに、 本発明に従う生体接触用金属部材においては、 その表面の 全面が、 金ィォン等の貴金属イオンの溶出を阻止せしめ得る特性を有す る T iの酸化膜層にて湲われて、 ill成されているのである。  In short, in the metal member for living body contact according to the present invention, the entire surface is covered with a Ti oxide film layer having a property capable of inhibiting elution of noble metal ions such as gold ions. It is being done.
それ故、 かかる生体接触用金属部材にあっては、 該金属部材中の金等 の貴金属がイオン化して溶出することが有効に阻止され得、 それによつ て、 該金厲部材の装着者において金厲ァレルギ一が生じるようなことか 効果的に防止され得ると共に、 貴金属を主要成分とした合金からなる金 属部材では、 従来、 適用不可能とされていたィンブラント材として、 極 めて有利に適用され得るのであり、 しかも、 かかるインブラン ト材に対 して、 T iの酸化膜層の有する、 従来から知られた特性である、 骨等の 生体組維に対する優れた適合性が有利に付与せしめられ得るのである。 従って、 本発明に従う生体接触用金属部材を使用することによって、 金等の貴金属による金属アレルギーに起因して、 装着者の粘膜や皮膚に 接触性炎症等が起こるようなことが効果的に防止され得るのであり、 ま た良好な成形加工性と、 より優れた生体親和性と、 更には生体組織に対 する優れた適合性とを有するインブラント材か、 極めて有利に実現され 得るのである。  Therefore, in such a metal member for living body contact, the noble metal such as gold in the metal member can be effectively prevented from being ionized and eluted. It is possible to effectively prevent the occurrence of gold energies, and metal parts made of alloys containing precious metals as main components are extremely advantageous as imprint materials, which were previously inapplicable. It can be applied, and the imprint material is advantageously imparted with excellent compatibility with biological tissue such as bone, which is a conventionally known property of the oxide film layer of Ti. You can be squeezed. Therefore, by using the metal member for living body contact according to the present invention, it is possible to effectively prevent contact inflammation or the like from occurring on the mucous membrane or skin of the wearer due to a metal allergy due to a noble metal such as gold. In addition, an imprint material having good moldability, better biocompatibility, and even better compatibility with living tissue can be realized very advantageously.
また、 本発明にあっては、 生体に取り付けられて、 生体組織に接触せ しめられる、 貴金属を主要成分とした合金からなる医療用金属部材にお いて、 該貴金展に対する合金成分として T iを含有すると共に、 該部材 の表面に、 熱処理によって T iの酸化膜層を形成せしめたことをも、 そ の特徴とするものである。 Further, in the present invention, a medical metal member made of an alloy containing a noble metal as a main component, which is attached to a living body and brought into contact with a living tissue, is provided. In addition, Ti is contained as an alloy component for the noble gold alloy, and an oxide film layer of Ti is formed on the surface of the member by heat treatment.
そのような本発明に従う医療用金厲部材にあっても、 T iの酸化膜層 力 \ 表面に形成されていることによって、 該金属部材中の金等の貴金属 がイオン化して溶出することか効果的に阻止され得、 その結果として、 その装着者に金厲ァレルギ一が生じるようなことが効果的に防止され得 るのであり、 また、 良好な成形加工性とより優れた生体親和性、 更には 生体組織に対する優れた適合性とを有するィンブラント材として、 極め て有利に適用され得るのである。  Even in such a medical metal member according to the present invention, whether or not the noble metal such as gold in the metal member is ionized and eluted by being formed on the surface of the oxide film layer of Ti. It can be effectively prevented, and as a result, it is possible to effectively prevent the wearer from generating gold allergy, and also has good moldability and better biocompatibility, Furthermore, it can be applied extremely advantageously as an imprint material having excellent compatibility with living tissues.
なお、 この本発明に係る医療用金厲部材の好ましい第一の態樣によれ ば、 前記医療用金厲部材が、 生体用インブラント材として構成されるの であり、 それによつて、 従来品よりも成形加工性や生体親和性に優れ、 しかも生体組辗に対する適合性に優れた生体用インブラント材が、 有利 に実現され得るのでる。  According to a preferred first aspect of the medical metal member according to the present invention, the medical metal member is configured as an implant for a living body. Thus, a bioimplant material that is more excellent in moldability and biocompatibility and more excellent in compatibility with living tissue can be advantageously realized.
さらに、 本発明に係る医療用金厲部材の望ましい第二の憨樣によれば、 前記生体用ィンプラント材が、 歯科用骨内ィンプラントとして構成され るのであり、 それによつて、 成形加工性や生体親和性に優れるばかりで なく、 歯槽骨に対する適合性にも優れた歯科用骨内インブラントが有利 に実現され得、 以て該インブラントに対して取り付けられる義歯等が、 口腔内において、 より安定的に固定され得るのである。  Further, according to a preferred second aspect of the medical metal member according to the present invention, the implant material for a living body is configured as a dental intraosseous implant, whereby the moldability and the biological properties are improved. A dental intraosseous implant that is not only excellent in affinity but also excellent in compatibility with alveolar bone can be advantageously realized, so that dentures and the like attached to the implant can be more stable in the oral cavity It can be fixed.
そしてまた、 本発明にあっては、 生体に取り付けられて、 生体組維に 接触せしめられる、 貴金属を主要成分とした合金からなる装飾用金属部 材において、 該貴金属に対する合金成分として T iを含有すると共に、 該部材の表面に、 熱処理によって T iの酸化膜層を形成せしめたことを も、 その特徴とするものである。 このような本発明に従う装飾用金厲部材にあっては、 T iの酸化膜層 力、 表面に形成されていることによって、 該金属部材中の金等の貴金属 がイオン化して溶出することが効果的に阻止され得るのであり、 以て該 貴金属による金属ァレルギ一が装着者に生じて、 該装着者の粘膜や皮膚 に接触性炎症等が起こるようなことが極めて有効に防止され得るのであ る c Further, according to the present invention, a decorative metal member which is attached to a living body and is brought into contact with a biological tissue and which is made of an alloy containing a noble metal as a main component, contains Ti as an alloy component for the noble metal. In addition, a Ti oxide layer is formed on the surface of the member by heat treatment. In such a decorative metal member according to the present invention, the noble metal such as gold in the metal member can be ionized and eluted by the oxide film layer of Ti and being formed on the surface. Therefore, it is possible to effectively prevent the occurrence of metal allergy due to the noble metal in the wearer, and to cause contact inflammation or the like on the mucous membrane or skin of the wearer. C
なお、 かかる本発明に従う装飾用金厲部材の望ましい第一の態様によ れば、 前記装飾用金厲部材が、 ピアス、 指輪、 ネックレス、 ブレスレツ 卜、 時計バンドのうちの何れかにて構成されることとなるのであり、 そ れによって、 それらの装飾品を身に付けることによって、 金属アレル ギ一が生ぜしめられるようなことが、 効果的に皆無ならしめられ得るの である。  According to a preferred first aspect of the decorative metal member according to the present invention, the decorative metal member is constituted by any one of a pierced earring, a ring, a necklace, a bracelet, and a watch band. That is to say, by wearing these ornaments, it is possible to effectively eliminate the possibility of producing metal allergies.
また、 本発明に従う生体接触用、 医療用、 並びに装飾用の各金属部材 の有利な態様によれば、 それらの金属部材を与える合金が、 A u—T i 合金、 A u— A g— C u— T i合金、 または A u— P d — A g— T i合 金にて構成されるのであり、 それによつて、 生体接触用、 医療用、 並び に装飾用の各金属部材が、 それらの合金にて榱成される従来の金属部材、 例えば、 装飾品や歯科治療等に多用される金属部材等に対して、 有利に 適用され得て、 そのような金属部材において、 上述の如き優れた特徴が 極めて効果的に発揮され得るのである。  Further, according to an advantageous embodiment of each metal member for living body contact, medical use, and decoration according to the present invention, the alloy providing those metal members may be an Au—Ti alloy, an Au—Ag—C It is composed of u—Ti alloy or Au—Pd—Ag—Ti alloy so that each metal member for biological contact, medical use, and decoration can be used. It can be advantageously applied to conventional metal members made of an alloy such as, for example, metal members frequently used in ornaments and dental treatments. Characteristics can be very effectively demonstrated.
さらに、 本発明に従う生体接触用金属部材の好ましい態様の一つによ れば、 前記 T iカ^ 1 0重量%を越えない割合において含有せしめられ ることとなるのであり、 それによつて、 該生体接触用金属部材の主要成 分たる貴金属の有する物性を損なうことなく、 該貴金属と T i とが良好 に且つ確実に合金化され得、 以て医療用金属部材ゃ装飾用金属部材等と して、 極めて有利に使用され得ることとなるのである。 発明を実施するための最良の形態 Further, according to one preferred embodiment of the metal member for living body contact according to the present invention, the metal member is contained in a proportion not exceeding 10% by weight of Ti. The precious metal and Ti can be favorably and reliably alloyed without deteriorating the physical properties of the precious metal, which is the main component of the metal member for biological contact, so that the medical metal member 医療 the decorative metal member and the like can be obtained. Therefore, it can be used very advantageously. BEST MODE FOR CARRYING OUT THE INVENTION
ところで、 本発明に従う生体接触用金厲部材にあっては、 前述の如く、 主要成分として、 貴金属が、 また該責金厲に対する合金成分として、 T i力 <、 それぞれ含有せしめられて成るものであるが、 そのような貴金属 の種類は、 特に限定されるものではなく、 例えば、 Au、 Ag、 Pd、 P t等、 医療用や装飾用等の金厲部材中に通常含まれるものの中から、 1種類が単独で、 若しくは 2種類以上のものが組み合わされて、 用いら れることとなる。 なお、 貴金属の好適なものとしては、 Auが用いられ る。  By the way, the biocontact metal member according to the present invention contains a noble metal as a main component and a Ti force <as an alloy component for the metal member, as described above. However, the type of such a noble metal is not particularly limited, and may be, for example, Au, Ag, Pd, Pt, etc., which are usually included in metal members for medical use, decoration, etc. One type may be used alone, or two or more types may be used in combination. Au is preferably used as the noble metal.
また、 かかる生体接触用金属部材においては、 それら貴金属や T iの 他、 医療用や装飾用等の金属部材中に一般に含まれる合金成分、 例えば C uやその他の微量成分等か含有せしめられていても、 何等差支えない c 要するに、 本発明に従う生体接触用金厲部材を与える合金は、 貴金属 と T i とが含有せしめられて成るものであれば、 その組成が、 特に限定 されるものではなく、 例えば、 Au— T i系合金を始め、 Au— Ag— Cu - T i、 Au-Pd-Ag-T i, Au - P t - Ag— Cu - T i、 Au - Pd - Ag - Cu - T i、 Au - P t - Pd - Ag - Cu - T i 等の各種の合金組成が、 採用され得るのである。 Further, in such a metal member for biological contact, in addition to the noble metal and Ti, alloy components generally contained in metal members for medical use, decoration, etc., such as Cu and other trace components, are contained. be, whatever permissible not c short, an alloy providing a biological contacting gold厲部material according to the present invention, as long as it is a noble metal and T i comprising been made to contain a composition of, the invention is not particularly limited For example, Au—Ti-based alloys, Au—Ag—Cu—Ti, Au—Pd—Ag—Ti, Au—Pt—Ag—Cu—Ti, Au—Pd—Ag—Cu— Various alloy compositions such as Ti, Au-Pt-Pd-Ag-Cu-Ti can be employed.
さらに、 そのような各合金成分の組成割合も、 何等限定されるもので はなく、 一般的な組成割合が、 適宜に採用され得るのであるが、 特に、 T iは、 何れの合金組成においても、 1 0重量%越えない範囲において 含有せしめられていること力^ 好ましい。 けだし、 T i力 1 0重量%を 越えて含有せしめられる場合、 主要成分たる貴金属に対して、 T iが過 剰に含有せしめられることとなり、 それによつて、 貴金属と T iとの合 金化が困難となるばかりでなく、 合金中における多量の T iの存在に よって、 貴金属の物性が損なわれることとなるからである。 なお、 その 意味において、 T iの含有割合は、 有利には 5重量%以下とされている ことが望ましく、 特に望ましくは、 2重量%以下である。 このように、 T iの含有割合が 2重量%以下とされている場合には、 生体接触用金属 部材の表面の色が、 効果的に貴金属の色に保たれ得て、 かかる金厲部材 カ^ 装飾用として、 より有効に利用され得ることとなる。 Further, the composition ratio of each of the alloy components is not limited at all, and a general composition ratio can be appropriately adopted.In particular, Ti is not limited to any alloy composition. It is preferable that the content is not more than 10% by weight. However, if the Ti content exceeds 10% by weight, the Ti will be excessively contained in the precious metal, which is the main component, and as a result, the precious metal will be alloyed with the Ti. Not only becomes difficult, but also due to the presence of large amounts of Ti in the alloy Therefore, the physical properties of the noble metal are impaired. In this sense, the content ratio of Ti is desirably preferably 5% by weight or less, particularly preferably 2% by weight or less. As described above, when the content ratio of Ti is set to 2% by weight or less, the color of the surface of the biocontact metal member can be effectively maintained at the color of the noble metal, and the metal member member ^ It can be used more effectively for decoration.
そして、 本発明に従う生体接触用金厲部材にあっては、 該金厲部材の 表面に、 適当な熱処理によって、 T iの酸化膜層か形成されて、 構成さ れているのであるが、 そのような T iの酸化膜層を形成するための熱処 理方法も、 特に限定されるものではない。 つまり、 かかる金厲部材に対 して熱処理を行う際には、 一股的な加熱処理装置が用いられ得るもので あり、 また、 その加熱処理温度が、 各合金成分の溶解点 (溶融点) 等を 考慮して適宜に决定され、 更に、 决定された加熱処理温度等に応じて、 適当な加熱処理時間が決定されるのである。 なお、 比較的高い温度で、 短時間に加熱処理される場合には、 得られる金厲部材の表面の色が、 貴 金属の色に有利に保たれ得ることとなる。  In the metal member for biological contact according to the present invention, an oxide film layer of Ti is formed on the surface of the metal member by an appropriate heat treatment. The heat treatment method for forming such an Ti oxide film layer is not particularly limited. That is, when heat treatment is performed on such a metal member, a one-piece heat treatment apparatus can be used, and the heat treatment temperature is determined by the melting point (melting point) of each alloy component. The heat treatment time is appropriately determined in consideration of such factors, and the appropriate heat treatment time is determined in accordance with the determined heat treatment temperature and the like. When the heat treatment is performed at a relatively high temperature for a short time, the color of the surface of the obtained metal member can be advantageously maintained at the color of the noble metal.
また、 かかる熱処理によって、 生体接触用金厲部材の表面に形成され る T iの酸化腠層の膜厚も、 何等限定されるものではないものの、 一股 には、 1 0 m程度とされる。  The thickness of the oxide layer of Ti formed on the surface of the biocontact metal member by the heat treatment is not limited at all, but is set to about 10 m at a time. .
ところで、 このようにして形成された T iの酸化膜層は、 前述の如く、 貴金属ィオンの溶出を阻止せしめ得るといった、 他の金属の酸化膜には 見られない特徴を有しているのであり、 それによつて、 そのような T i の酸化膜層が表面に形成されて成る生体接触用金厲部材において、 該金 厲部材中の貴金属がイオン化して溶出することが有効に阻止され得るの である。 そして、 その結果として、 かかる生体接触用金属部材にあって は、 該金厲部材の装着者において金属ァレルギ一が生じるようなことが 効果的に防止され得ると共に、 賁金厲固有の特性たる優れた成形加工性 と生体親和性を備え、 更には T iの酸化膜層の有する生体組維に対する 便れた適合性とを兼備したィンブラント材として、 極めて有利に用いら れ得るのである。 By the way, the Ti oxide film layer formed in this manner has features that cannot be seen in other metal oxide films, such as being able to prevent elution of precious metal ions, as described above. Accordingly, in the metal member for biological contact having such an oxide film layer of T i formed on the surface, the ionization and elution of the noble metal in the metal member can be effectively prevented. It is. As a result, in such a metal member for living body contact, a metal allergy may occur in a wearer of the metal member. An imprint material that can be effectively prevented, has excellent moldability and biocompatibility, which are inherent properties of the metal, and also has convenient compatibility with biomaterials having an oxide layer of Ti. Can be used very advantageously.
そして、 そのような極めて優れた特徴を有する生体接触用金厲部材が、 生体に取り付けられて、 生体組織に接触せしめられる金属部材、 例えば、 歯槽骨内に埋入されて、 義歯等を該歯槽骨に固定する口腔インブラント (歯科用骨内インプラント) や、 骨折せしめられた骨内に埋入されて、 かかる骨を互いに連結せしめるボルト等、 従来、 貴金属を主要成分とす る合金では適用不可能とされていた生体用インブラント材ゃ、 インレ一、 冠、 橋義歯等の一般的な歯科治療用の金厲部材等の医療用金厲部材とし て、 また、 ピアス、 指輪、 ネックレス、 ブレスレツ ト、 時計バンド等の 装飾用金厲部材等として、 極めて有利に使用され得るのである。  Then, a metal member for living body contact having such extremely excellent characteristics is attached to a living body, and is made of a metal member to be brought into contact with living tissue, for example, embedded in alveolar bone, and a denture or the like is placed in the alveolar bone. Conventionally, alloys that use precious metals as the main component, such as oral implants (dental endosseous implants) that are fixed to bones and bolts that are embedded in fractured bones to connect such bones, are not applicable. As a medical metal member such as a metal member for general dental treatment, such as a bioimplant material, an inlay, a crown, and a bridge denture, which has been made possible, and a pierced earring, a ring, a necklace, and a bracelet. It can be used very advantageously as a decorative metal member such as a watch band or a watch band.
ところで、 かかる本発明に従う生体接触用金厲部材は、 有利には、 以 下の如く して、 製造されることとなる。  By the way, such a biocontact metal member according to the present invention is advantageously manufactured as follows.
すなわち、 先ず、 貴金属に対して、 T i と、 必要に応じて、 その他の 合金成分とを、 常法により、 例えばアーク溶解等の手法にて溶解せしめ て、 溶解物 (溶湯) を得る。 なお、 この溶解操作中での T iの酸化を回 避するため、 かかる溶解操作は、 A rガス等、 不活性ガス雰囲気中で行 う必要がある。  That is, first, T i and, if necessary, other alloy components are dissolved in a noble metal by a conventional method, for example, an arc melting method, to obtain a melt (molten metal). In order to avoid oxidation of Ti during the dissolving operation, the dissolving operation needs to be performed in an inert gas atmosphere such as Ar gas.
次いで、 かく して得られた溶解物を铸造して、 インゴッ トを得、 その 後、 このインゴッ トに対して一般的な塑性加工、 成形加工等、 例えばプ レス成形を行なって、 所定の形状を有する合金部材を得る。  Next, the melt obtained in this manner is manufactured to obtain an ingot, and thereafter, the ingot is subjected to general plastic working, forming, or the like, for example, press forming to obtain a predetermined shape. Is obtained.
そして、 その後、 この得られた合金部材を用い、 その表面に対して、 公知の手法による研磨加工を施した後、 大気中で、 一般的な加熱処理を 行って、 該合金部材の表面に、 T iの酸化膜層を形成せしめ、 以て目的 とする生体接触用金厲部材を得るのである。 Then, using the obtained alloy member, the surface thereof is polished by a known method, and then subjected to a general heat treatment in the air, so that the surface of the alloy member is Form an oxide layer of Ti for the purpose Is obtained.
なお、 本発明に従う構成とされた生体接触用金厲部材は、 上述の如き 製法の他にも、 粉末冶金等、 一般的な合金の造型、 製造手法を利用して、 所定形状を呈する合金部材を製造し、 その後、 この合金部材を加熱処理 することによつても、 製造され得るものである。 また、 そのような手法 を採用する場合にあっても、 上述の如き製法と同様に、 合金部材に対す る加熱処理の方法は、 特に限定されるものではない。 実施例  The biocontact metal member configured according to the present invention may be an alloy member having a predetermined shape by using a general alloy molding and manufacturing method such as powder metallurgy, in addition to the above-described manufacturing method. It can also be manufactured by manufacturing the alloy member and then heat-treating the alloy member. Even when such a method is adopted, the method of heat treatment of the alloy member is not particularly limited, as in the above-described production method. Example
以下に、 本発明の代表的な実施例を示し、 本発明を更に具体的に明ら かにすることとするが、 本発明か、 そのような実施例の記載によって、 何等の制約をも受けるものでないことは、 言うまでもないところである。 また、 本発明には、 以下の実施例の他にも、 更には上記の具体的記述以 外にも、 本発明の趣旨を逸脱しない限りにおいて、 当業者の知識に基づ いて、 種々なる変更、 修正、 改良等を加え得るものであることが、 理解 されるべきてある。  Hereinafter, typical examples of the present invention will be described to clarify the present invention more specifically. However, the present invention is not limited by the description of such examples. It is needless to say that it is not a thing. In addition, in addition to the following examples, the present invention may be variously modified based on the knowledge of those skilled in the art without departing from the spirit of the present invention. It should be understood that modifications, improvements, etc. can be made.
先す、 貴金属として、 A uを用い、 この A uを主要成分として含むと 共に、 該 A uに対する合金成分として、 T iを、 または T i と A gとを 含み、 且つそれらの金属か、 下記表 1に示される如き組成割合にて含有 せしめられる 6種類の合金が得られるように、 A u、 T i、 A gの各金 厲を、 所定の坩堝にそれぞれ別個に投入した後、 A r雰囲気中において、 常法に従ってアーク溶解を行なうことにより溶解せしめて、 互いに成分 組成の異なる 6種類の溶解物 (溶湯) を得た。 次いで、 この 6種類の溶 解物を冷却して、 6個のインゴッ トを得た後、 それらのインゴッ トに対 して、 それぞれ、 一股的なプレス加工を行ない、 1 mm x 5 mm x 5 mmの大 きさを有する小片伏の合金を成形した。 そして、 それら成分組成の互い に異なる 6種類の合金を、 それぞれ合金 1 〜 6とした c 表 1As described above, Au is used as a noble metal, and this Au is included as a main component, and at the same time, Ti or Ti and Ag are included as alloy components with respect to the Au, and these metals are used. Each of Au, Ti, and Ag was separately charged into a predetermined crucible so as to obtain six kinds of alloys having the composition ratios shown in Table 1 below. r Dissolution was performed by performing arc melting according to a conventional method in an atmosphere to obtain six types of melts (melts) having different component compositions from each other. Next, the six types of melts were cooled to obtain six ingots, and each of the ingots was subjected to a single press process to obtain a 1 mm x 5 mm x A small piece alloy having a size of 5 mm was formed. And the composition of each component Different Six alloy, c Table 1 were respectively alloys 1-6
Figure imgf000012_0001
Figure imgf000012_0001
そして、 かく して得られた 6種類の合金 (合金 1 〜 6 ) と、 比較のた めに純金とを用い、 各合金と純金の表面の色を観察し、 また常法に従つ て、 それらの金属のビッカース硬度を調べ、 更に、 各金厲を 9 0 ° に折 り曲げて、 その際の破断の発生の有無を調べた。 その結果を、 下記表 2 に示す。 なお、 かかる表 2には、 ビッカース硬度として、 各金属のビッ カース硬度を 3回測定した際の値を、 それぞれ示した。 表 2 Then, using the six kinds of alloys (alloys 1 to 6) thus obtained and pure gold for comparison, observing the color of each alloy and the surface of the pure gold, and following the usual method, The Vickers hardness of these metals was examined, and each metal was bent at 90 °, and the occurrence of fracture at that time was examined. The results are shown in Table 2 below. In Table 2, values obtained by measuring the Vickers hardness of each metal three times are shown as the Vickers hardness. Table 2
Figure imgf000013_0001
かかる表 2の結果からも明らかなように、 主要成分として A uが含ま れ、 そして該 A uに対する合金成分として、 T iが含有せしめられて成 る合金において、 T iの含有量が少ないもの、 具体的には、 T iの含有 量が 2重量%程度以下のものにあっては、 純金と比べても、 著しい物性 の低下が見られず、 それによつて、 A uの物性が効果的に確保され得て いること力 確認される。 次に、 上述の如く して得られた 6種類の合金 (合金 1〜6 ) を用い、 各合金の表面を常法に従って研磨した後、 それらの合金に対して、 大気 中で、 8 0 0 'C、 3 0分間、 加熱処理を行ない、 その後、 4 0 O 'Cの温 度にて 2 0分間係留除冷して、 互いに成分組成の異なる、 目的とする 6 種類の生体接触用金厲部材を得た。 そして、 かかる 6種類の生体接触用 金厲部材と、 比較のために純金にて構成された生体接触用金厲部材とを 用い、 それらの表面構造を、 X棣マイクロアナライザ一にて、 観察した。 その結果、 本発明に従う成分組成を有し、 且つ加熱処理が為された合 金からなる生体接触用金厲部材にあっては、 その表面の全面に、 約 1 0 i mの厚さを有する T iの酸化膜層が形成されていることが、 観察され た。 一方、 純金製の生体接触用金厲部材においては、 その表面に、 その ような T iの酸化膜層か、 何等認められなかった。
Figure imgf000013_0001
As is evident from the results in Table 2, an alloy containing Au as a main component and containing Ti as an alloy component with respect to the Au has a low Ti content. Specifically, when the content of Ti is about 2% by weight or less, there is no remarkable decrease in physical properties even when compared with pure gold, and thus the physical properties of Au are effective. It is confirmed that the power has been secured. Next, using the six kinds of alloys (alloys 1 to 6) obtained as described above, the surface of each alloy was polished according to a conventional method, and then the alloys were polished in air at 800.degree. Heat treatment at 30 ° C for 30 minutes, and then mooring and cooling at 40 ° C for 20 minutes to obtain the desired six types of biological contact metals with different component compositions. A member was obtained. Then, using these six types of metal members for biological contact and a metal member for biological contact made of pure gold for comparison, their surface structures were observed with an XDi microanalyzer. . As a result, in the case of a metal member for living body contact having a component composition according to the present invention and made of a heat-treated alloy, the entire surface of the member has a thickness of about 10 im. It was observed that the oxide film layer of i was formed. On the other hand, in the case of the metal member for living body made of pure gold, no such oxide film layer of Ti was found on the surface.
以上の説明から明らかなように、 本発明に従う生体接触用金厲都材に あっては、 表面に、 熱処理によって T iの酸化膜層か形成されて、 構成 されているところから、 かかる T iの酸化膜層により、 該金属部材中の 金等の貴金属かイオン化して溶出することが有効に阻止され得、 それに よって、 該金厲部材の装着者が金 IIアレルギーを起こすようなことが効 果的に防止され得ると共に、 貴金)!を主要成分とした合金からなる金属 部材では、 従来、 適用不可能とされていたインプラン ト材として、 極め て有利に適用され得るのであり、 しかも、 かかるインプラント材に対し て、 T iの酸化膜層の有する、 骨等の生体組織に対する優れた適合性が 有利に付与せしめられ得るのである。  As is clear from the above description, in the biocontact metal material according to the present invention, the Ti film is formed on the surface by forming a Ti oxide film layer by heat treatment. The oxide film layer of the metal member can effectively prevent ionization and elution of the noble metal such as gold in the metal member, thereby effectively preventing the wearer of the metal member from having gold II allergy. Can be effectively prevented, and precious money)! A metal member made of an alloy containing as a main component can be extremely advantageously applied as an implant material, which has heretofore been impossible to be applied. The excellent compatibility of the membrane layer with living tissue such as bone can be advantageously imparted.
従って、 本発明に従う生体接触用金厲部材を使用することによって、 金等の貴金属による金属アレルギーに起因して、 装着者の粘膜や皮膚に 接触性炎症等が生ずるようなことが効果的に防止され得るのであり、 ま た良好な成形加工性と、 より優れた生体親和性と、 更には生体組織に対 する優れた適合性とを有するインプラント材が、 極めて有利に実現され 得るのである。 Therefore, by using the metal member for living body contact according to the present invention, it is possible to effectively prevent contact inflammation or the like from occurring on the mucous membrane or skin of the wearer due to metal allergy due to a noble metal such as gold. And good moldability, better biocompatibility, and even better compatibility with living tissue. An implant material with excellent compatibility can be realized very advantageously.
そして、 そのような本発明に従う生体接触用金厲部材か、 特に、 医療 用金属部材ゃ装飾用金厲部材等として使用されることによって、 それら の金属部材において、 上述の如き優れた特徴が、 極めて効果的に発揮さ れ得るのである。 産業上の利用可能性  And, by using such a metal member for living body contact according to the present invention, in particular, a metal member for medical use, a metal member for decoration, and the like, the above-mentioned excellent features of the metal members are as follows. It can be very effective. Industrial applicability
上述の説明から明らかなように、 本発明は、 生体接触用金属部材の装 着者における貴金属による金属アレルギーの発生を効果的に阻止し得る と共に、 成形加工性と生体親和性とに優れた、 とりわけインプラン ト材 として有利に適用することが出来る生体接触用金属部材を有利に提供し 得るものである。  As is apparent from the above description, the present invention can effectively prevent the occurrence of metal allergy due to a noble metal in a wearer of a biological contact metal member, and has excellent moldability and biocompatibility. In particular, it is possible to advantageously provide a metal member for biological contact that can be advantageously applied as an implant material.

Claims

請求の範囲 The scope of the claims
1. 生体に取り付けられて、 生体組織に接触せしめられる、 貴金属を主 要成分とした合金からなる生体接触用金属部材にして、 該貴金属に対す る合金成分として T iを含有すると共に、 該部材の表面に、 熱処理に よって T iの酸化膜層が形成されてなることを特徴とする生体接触用金 属部材。  1. A metal member for living body contact which is attached to a living body and brought into contact with a living tissue and is made of an alloy containing a noble metal as a main component. The metal member contains Ti as an alloy component for the noble metal and the member. A metal member for living body contact, characterized in that a Ti oxide film layer is formed on a surface of the substrate by heat treatment.
2. 生体に取り付けられて、 生体組維に接触せしめられる、 貴金属を主 要成分とした合金からなる医療用金厲部材にして、 該貴金属に対する合 金成分として T iを含有すると共に、 該部材の表面に、 熱処理によって T iの酸化膜層が形成されてなることを特徴とする医療用金属部材。 2. A medical metal member made of an alloy containing a noble metal as a main component, which is attached to a living body and brought into contact with a living tissue, containing Ti as an alloy component for the noble metal, and A metal member for medical use, characterized in that a Ti oxide film layer is formed by heat treatment on the surface of the metal member.
3. 前記医療用金厲部材が生体用インブラント材である請求項 2に記載 の医療用金属部材。 3. The medical metal member according to claim 2, wherein the medical metal member is a bioimplant material.
4. 前記生体用インブラント材が歯科用骨内インブラン 卜である請求項 3に記載の医療用金属部材。  4. The medical metal member according to claim 3, wherein the implant material for a living body is a dental intraosseous implant.
5. 生体に取り付けられて、 生体組織に接触せしめられる、 貴金属を主 要成分とした合金からなる装飾用金厲部材にして、 該貴金 IIに対する合 金成分として T iを含有すると共に、 該部材の表面に、 熱処理によって T iの酸化膜層が形成されてなることを特徴とする装飾用金厲部材。5. A decorative metal member made of an alloy containing a noble metal as a main component that is attached to a living body and brought into contact with a living tissue, containing Ti as an alloying component for the noble metal II, and A decorative metal member, wherein a Ti oxide film layer is formed on a surface of the member by heat treatment.
6. 前記装飾用金属部材が、 ピアス、 指輪、 ネッ ク レス、 ブレスレッ ト、 及び時計バンドのうちの何れかである請求項 5に記載の装飾用金厲部材。6. The decorative metal member according to claim 5, wherein the decorative metal member is any one of a pierced earring, a ring, a necklace, a breathlet, and a watch band.
7. 前記金属部材を与える合金が、 八リー丁 1合金、 Au - Ag - Cu -T i合金、 または A u - Pd-Ag-T i合金である請求項 1に記載 の生体接触用金厲部材。 7. The biocontact metal according to claim 1, wherein the alloy that provides the metal member is Hachiryu 1 alloy, Au-Ag-Cu-Ti alloy, or Au-Pd-Ag-Ti alloy. Element.
8. 前記金厲部材を与える合金が、 八1_1—丁〖合金、 Au - Ag - Cu - T i合金、 または Au - P d - Ag - T i合金である請求項 2乃至請 求項 4の何れかに記載の医療用金属部材。 8. The alloy according to claim 2, wherein the alloy that provides the metal member is an eighteen-one alloy, an Au-Ag-Cu-Ti alloy, or an Au-Pd-Ag-Ti alloy. The medical metal member according to any one of the above.
9. 前記金厲部材を与える合金が、 Au -T i合金、 Au - Ag - C u -T i合金、 または Au— P d - Ag— T i合金である請求項 5又は請 求項 6に記載の装飾用金属部材。 9. The method according to claim 5, wherein the alloy that provides the metal member is an Au-Ti alloy, an Au-Ag-Cu-Ti alloy, or an Au-Pd-Ag-Ti alloy. The decorative metal member as described in the above.
1 0. 前記 T i力 1 0重量%を越えない割合において含有せしられて いる請求項 1又は請求項 7に記載の生体接触用金)!部材。  10. The biocontact metal according to claim 1 or 7, wherein the Ti force is contained in a ratio not exceeding 10% by weight. Element.
PCT/JP1996/003175 1995-11-01 1996-10-30 Living body contacting metal material WO1997016579A1 (en)

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