JP4929286B2 - 複合人工骨 - Google Patents

複合人工骨 Download PDF

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Publication number
JP4929286B2
JP4929286B2 JP2008531956A JP2008531956A JP4929286B2 JP 4929286 B2 JP4929286 B2 JP 4929286B2 JP 2008531956 A JP2008531956 A JP 2008531956A JP 2008531956 A JP2008531956 A JP 2008531956A JP 4929286 B2 JP4929286 B2 JP 4929286B2
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Japan
Prior art keywords
bone
molded body
porous
titanium
molded
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Expired - Fee Related
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JP2008531956A
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JPWO2008026316A1 (ja
Inventor
正 小久保
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Japan Science and Technology Agency
Advanced Medix Inc
National Institute of Japan Science and Technology Agency
Chubu University
Original Assignee
Japan Science and Technology Agency
Advanced Medix Inc
National Institute of Japan Science and Technology Agency
Chubu University
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Publication of JPWO2008026316A1 publication Critical patent/JPWO2008026316A1/ja
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    • A61F2230/0063—Three-dimensional shapes
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0015—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in density or specific weight
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0023—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in porosity
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00011—Metals or alloys
    • A61F2310/00023—Titanium or titanium-based alloys, e.g. Ti-Ni alloys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants

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Description

【技術分野】
【０００１】
この発明は、チタン又はチタン合金からなり、緻密部と多孔部とが一体化された人工骨に関する。
【背景技術】
【０００２】
チタンは、セラミックスや樹脂よりも機械的強度が高く、しかもアルカリ処理するだけで骨形成能をもたせることが可能であることから、人工骨材料として期待されている。人工骨材料は、生体内に埋め込まれて生体骨を形成したり周囲の生体骨と結合したりする必要性から気孔率５０％以上の多孔体であることが望まれる。また、埋め込み場所にもよるが、人工骨に必要な機械的強度は脊椎代替用では４０ＭＰａ以上である。チタン多孔体は、チタン粉末を必要により気孔形成材と混合し、加圧成形した後、焼結することによって得られることが知られている（特許文献１）。
【特許文献１】
特開２００２−２８５２０３
【発明の開示】
【発明が解決しようとする課題】
【０００３】
しかし、金属といえども多孔体を単独で用いると、角や稜線に欠け、折れが生じやすく、信頼性に劣る。また、生体骨の弾性率は、皮質骨で１０〜２０ＧＰａ、海綿骨で０．２〜０．３ＧＰａと部位によってかけ離れていることから、人工骨の弾性率をこれに合わせるのは困難である。
それ故、この発明の課題は、生体骨と結合しやすく且つ生体骨の機械的性質に近似した人工骨を提供することにある。
【課題を解決するための手段】
【０００４】
その課題を解決するために、この発明の人工骨は、
チタン又はチタン合金からなり、生体骨の外面の一部に近似した枠状をなす密度９５％以上の緻密部と、
互いに焼結したチタン又は前記チタン合金と同一もしくは異なる組成のチタン合金の粒子からなり、前記生体骨の残部に近似した形状をなす気孔率４０％以上の多孔部とを備え、
緻密部と多孔部との界面において緻密部と多孔部の粒子とが互いに焼結していることを特徴とする。
前記生体骨の外面の一部とは通常生体骨の皮質骨の一部であり、前記生体骨の残部は通常生体骨の皮質骨の残部及び海綿骨である。
［０００５］
発明者の実験によると、純チタン多孔体に４０ＭＰａ以上の圧縮強度をもたせるためには、図１に示すように気孔率を５５％以下にしなければならない。また、弾性率は図２に示すように気孔率４０％までは気孔率とともに低下し、４０％を超えると徐々に減少し７０％では２ＧＰａ程度になる。
一方、この発明の人工骨は、枠状をなす緻密部と気孔率４０％以上の多孔部を備えているので、枠の開口部より生体骨や体液などの生体組織が多孔部に侵入し、多孔部と結合する。そして、緻密部が荷重を支えるので、全体としての気孔率の高い割に圧縮強度も高い。しかも、多孔部と緻密部の体積比を適当に定めることによって、弾性率を生体骨の弾性率に合わせることもできる。また、生体骨の角、稜線又は表面に相当する部分を緻密部で構成すれば、欠けや折れを防止することができる。更にまた、緻密部の一方の端面に尖った突起を一体的に形成することにより、この突起を生体骨に食い込ませて初期固定を行うことができる。
［０００６］
このような人工骨は、気孔形成剤を含まないチタン又はチタン合金粉末（以下、「チタン粉末等」）の成形体ａと、チタン粉末等及び気孔形成剤を含む混合物の成形体ｂを組み合わせた後、焼成することにより製造される。
この製造方法により、成形体ａに由来する部分は、気孔形成剤を含まないので、焼成後は緻密部となる。成形体ｂに由来する部分は、気孔形成剤を含むので、焼成後は多孔部となる。そして、成形体ａと成形体ｂとが組合わせられて一緒に焼成されるので、各成形体内部の粒子同士が焼結すると同時に、成形体ａ内の粒子と成形体ｂ内の粒子とが界面において焼結する。従って、緻密部と多孔部とが、それらの遷移層を除いて他物を介することなく接合される。
［０００７］
各成形体の成形は、他方の成形体との組み合わせ前に行ってもよいし、組み合わせと同時であってもよい。各成形体の個別の成形手段は、射出成形、加圧成形、押し出し成形、流し込み成形、シート成形などの公知の適宜の手段であってよい。特に、成形体ｂは、金型内に成形体ａを装填し、その残部空間に前記粉末混合物を充填し、加圧成形することにより、成形と同時に成形体ａと組み合わせられると好ましい。成形体ａが複雑形状であっても成形体ｂと組み合わせ可能だからである。また、個別に成形後に組み合わせる場合は、組み合わせた後、焼成する前に流体圧成形するとよい。
［０００８］
成形体ａ及び成形体ｂは、一方又は双方が有機バインダーを含んでいてもよく、双方ともに含む場合の有機バインダーは、互いに同じであっても又は異なっていてもよい。双方がバインダーを含む場合、前記加圧成形をそのバインダーが軟化する温度で行うとよい。成形段階で界面の粒子同士がより強く密着し、焼結が進みやすくなるからである。
発明の効果
［０００９］
この発明の人工骨は、生体骨と結合しやすく且つ生体骨の機械的性質に近似しているので、これを装着する患者の負担が著しく軽減される。
【図面の簡単な説明】
［００１０］
［図１］チタン多孔体の気孔率と圧縮耐力の関係を示すグラフである。
［図２］チタン多孔体の気孔率と弾性率の関係を示すグラフである。
［図３］実施例１の人工骨の製造方法の初期工程を示す図である。
［図４］同じく中期工程を示す図である。
［図５］中期工程で得られた焼結体を示すＣＴ画像写真である。
［図６］実施例３の人工骨の製造方法の初期工程を示す図であり、（ｂ）は（ａ）のＢ部拡大図である。
［図７］参考例の人工骨の製造方法を示し、（ａ）は緻密部単独、（ｂ）は多孔部単独、（ｃ）は人工骨の各写真である。
発明を実施するための最良の形態
［００１１］
有機バインダーとしては、ポリアセタール０〜５０ｖｏｌ％、ポリプロピレン０〜５０ｖｏｌ％及びワックス類５０〜７０ｖｏｌ％から成る。金型内に成形体ａを装填し、その残部空間に成形体ｂとなる粉末混合物を充填し、加圧成形する場合の圧力は、２０〜１００ＭＰａが好ましい。２０ＭＰａに満たないと多孔部と緻密部との結合が不十分となるし、１００ＭＰａを超えると、成形体ａに掛かる負荷が大きくなりすぎ、成形体ａが破損するからである。有機バインダーを含有させて成形した場合は、組み合わせ体を焼成する前に大気中で加熱することにより有機バインダーを脱脂するのが望ましい。焼結は、非酸化雰囲気中１２００〜１４００℃の温度で行う。
［００１２］
［実施例１］
最大粒径４５μｍのＪＩＳ２種（米国規格ＡＳＴＭＧ１に相当する。）純チタン粉末と、ポリアセタール２０ｖｏｌ％、ポリプロピレン２０ｖｏｌ％及びワックス類６０ｖｏｌ％からなる有機バインダーとを体積比で６５対３５になるように混合し、緻密部用混合物とした。体積比は各々の真密度と重量から算出した。そして、緻密部用混合物を１６５℃で射出成形することにより、図３に示すように幅１．５０ｍｍの正四角柱からなる四角枠部の四隅に同幅の正四角柱の脚が立てられた外寸法９．６ｍｍ×１２．０ｍｍ×２４．０ｍｍ（幅×奥行き×高さ）の成形体ａ１を得た。
【００１３】
別途、前記純チタン粉末と篩にて５００〜１５００μｍの粒径に調整した炭酸水素アンモニウムとを体積比で３４対６６になるように混合し、多孔部用混合物とした。図４に示すように、成形体ａ１を、内寸が成形体ａ１の外寸より僅かに大きい金型に装填し、多孔体用混合物を残部空間に充填し、９０ＭＰａの圧力を加えることにより、成形体ａ１の内側に略直方体状の成形体ｂ１が成形された組み合わせ体を得た。
【００１４】
この組み合わせ体をアルゴンガス雰囲気中１２５０℃で２時間保持することにより、焼成した。得られた焼結体のＣＴ画像を観察すると、図５に示すように稜線部（緻密部分）及び中間部（多孔部分）はそれぞれ成形体ａ１及びｂ１に由来する形状を維持して焼結していた。同時に、互いの界面における粒子同士も境界を判別しがたいほどに焼結しており、緻密部と多孔部が一体化された１０ｍｍ×８ｍｍ×２０ｍｍの人工骨が得られた。この人工骨のＣＴ断面画像を複数枚数撮影し、得られた画像上で気孔の定方向最大径（一定方向の線による空隙部の最大長さ）を測定したところ、多孔部の気孔径は２００〜５００μｍの範囲であった。この人工骨を圧縮速度１ｍｍ／分で軸方向に圧縮したところ、圧縮強度は、５３．３ＭＰａであった。成形体ａ１、ｂ１を組み合わせることなく、個別に成形し、前記と同一条件で焼成し、得られた焼結体の密度又は気孔率を重量とチタンの真密度とから算出したところ、緻密部相当の焼結体の密度は９６％、多孔部相当の焼結体の気孔率は６０％であった。また、緻密部及び多孔部の弾性率をそれぞれ個別に測定して得た１０８ＧＰａ及び４．２ＧＰａに基づいて、得られた焼結体の弾性率を算出したところ、１５．８ＧＰａであった。
【００１５】
次に、得られた人工骨を、温度６０℃、濃度５ＭのＮａＯＨ水溶液に２４時間浸け、続いて４０℃の純水に１２時間浸けた後、６００℃の大気炉中で１時間加熱した。人工骨を炉から取り出してヒトの体液とほぼ等しい無機イオン濃度を有する擬似体液（特許第２７７５５２３、第６欄第４３行〜４９行）に浸けたところ、３日後に緻密部及び多孔部にアパタイト相が析出していることが確認された。
【００１６】
［実施例２］
多孔部用混合物のチタン粉末と炭酸水素アンモニウムの体積比を４３対５７とした以外は、実施例１と同一条件で成形体ａ１の内側に略直方体状の成形体ｂ２が成形された組み合わせ体を得た。この組み合わせ体をアルゴンガス雰囲気中１２５０℃で２時間保持することにより、焼成した。緻密部相当の焼結体の密度は９６％、多孔部相当の焼結体の気孔率は５０．５％であった。
得られた人工骨を実施例１におけると同様にアルカリ・加熱処理し、擬似体液に浸けたところ、３日後に緻密部及び多孔部にアパタイト相が析出していることが確認された。
【００１７】
［実施例３］
実施例１で調合した緻密部用混合物を１６５℃で射出成形することにより、図６に示すように幅３ｍｍの正四角柱からなる直方体枠部の一方の端面に一辺１．５ｍｍの多数の正四角錐が立てられた外寸法３０ｍｍ×２０ｍｍ×１５ｍｍの成形体ａ３を得た。
成形体ａ３を、内寸が成形体ａ３の外寸より僅かに大きい金型に装填し、実施例１で調合した多孔体用混合物を残部空間に充填し、８５ＭＰａの圧力を加えることにより、成形体ａ３の内側に略直方体状の成形体ｂ３が成形された組み合わせ体を得た。
この組み合わせ体を実施例１と同一条件で焼成した。緻密部相当の焼結体の密度は９７％、多孔部相当の焼結体の気孔率は６１％であった。圧縮強度は７３ＭＰａ、多孔部の気孔径は２００〜５００μｍの範囲であった。
得られた人工骨を実施例１におけると同様にアルカリ・加熱処理し、擬似体液に浸けたところ、３日後に緻密部及び多孔部にアパタイト相が析出していることが確認された。
［００１８］
［参考例］
ＪＩＳ２種（米国規格ＡＳＴＭＧ１に相当する。）純チタン展伸材を加工することにより、図７（ａ）に写真で示すように平面視大豆状で側面に複数の大きな孔が形成された成形体ａ４を得た。
別途、実施例１におけるものと同一条件で多孔部用混合物を準備し、金型に充填して９０ＭＰａの圧力を加えた後、アルゴンガス中９００℃で２時間加熱することにより、図７（ｂ）に写真で示すように高さが成形体ａ４より０．５ｍｍ高い以外は成形体ａ４の内周面と相補する外形の仮焼結体Ｂ４を得た。
成形体ａ４と仮焼結体Ｂ４を嵌合し、４７ＭＰａの圧力を高さ方向に加えた後、アルゴンガス中１１５０℃で２時間加熱することにより、図７（ｃ）に示す人工骨を製造した。
得られた人工骨の多孔部の気孔率は６０％であった。また緻密部と多孔部はミクロ組織的に結合していることを確認した。

Claims (3)

  1. 生体骨と相補する内面を有する型を準備する工程と、
    前記生体骨の外面の一部に近似した枠状をなし、気孔形成剤を含まないチタン又はチタン合金粉末の成形体ａを、前記型に装填する工程と、
    チタン又はチタン合金粉末及び気孔形成剤を含む混合物を前記型の残部空間に充填する工程と、
    混合物を加圧成形することにより成形体ｂを得ると同時に成形体ａと組み合わせる工程と、
    組み合わせ体を焼成する工程と
    を備えることを特徴とする人工骨の製造方法。
  2. 前記生体骨の外面の一部が、生体骨の角、稜線又は表面を含む部分である請求項１に記載の方法。
  3. 前記成形体ａが、一方の端面に尖った突起を有する請求項４に記載の方法。
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