JP6883290B2 - 生体に使用可能な合金製部材およびその製造方法 - Google Patents
生体に使用可能な合金製部材およびその製造方法 Download PDFInfo
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- JP6883290B2 JP6883290B2 JP2017535565A JP2017535565A JP6883290B2 JP 6883290 B2 JP6883290 B2 JP 6883290B2 JP 2017535565 A JP2017535565 A JP 2017535565A JP 2017535565 A JP2017535565 A JP 2017535565A JP 6883290 B2 JP6883290 B2 JP 6883290B2
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- protective layer
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- magnesium
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Description
マグネシウム: >90%
イットリウム: 3.7%〜5.5%
希土類: 1.5%〜4.4%
残分: <1%
のマグネシウム合金を有する金属材料を含有する支持構造を有する内部人工器官を開示する。
1.5重量パーセント〜5重量パーセントのネオジム、
0.1重量パーセント〜4重量パーセントのイットリウム、
0.1重量パーセント〜1重量パーセントのジルコニウム、および
0.1重量パーセント〜2重量パーセントのカルシウムを含み、亜鉛を含まない生分解性マグネシウム合金を、開示する。
前記基体の成分を由来とする酸化物もしくは酸化物および水酸化物の複合体を含む第1保護層と、
前記基体の成分を由来とする水酸化物を含む第2保護層と、を備える。
前記基体の成分を由来とする酸化物もしくは酸化物および水酸化物の複合体を含む第1保護層と、
前記基体の成分を由来とする水酸化物を含む第2保護層と、を備える。
前記第2保護層は、前記第1保護層の表面に形成される。
まず、実施の形態1における生体に使用可能な合金製部材(以下、「生体用合金製部材」という)の全体概要を説明する。図1は、本発明の実施の形態1における生体用合金製部材の模式図である。図1は、生体用合金製部材1の断面を模式的に示している。
基体2は、マグネシウム合金で形成される。例えば、マグネシウムに混合物が添加されたマグネシウム合金で形成される。このため、基体2は、マグネシウムを成分の軸としつつ、適宜、種々の混合物を含んだ組成を有する。
第1保護層3は、基体2の外側に形成される。特に、第1保護層3は、基体2の表面に形成されればよい。第1保護層3は、基体2由来の酸化物もしくは酸化物と水酸化物の複合体で形成される。このような組成であることで、第1保護層3は、安定な層となり、水分を基体2に到達させるのを低減できる。
第2保護層4は、最外周に設けられる。すなわち、第1保護層3の外側(表面)に設けられる。第2保護層4は、基体2由来の水酸化物で形成される。水酸化物は、マグネシウムの水酸化物を含む。あるいは、水酸化物は、希土類の水酸化物を含む。
従来技術の生体用合金製部材との構造とメカニズムの違いを説明する。
図6は、従来技術と本発明の生体用合金製部材での、使用耐久性と使用可能性の関係を示すグラフである。
実施例について説明する。
実施例1として、Mg−2Nd−1Y−0.5Mn−0.5Zn−0.4Zrによる生体用合金製部材を作成した。実施例1の生体用合金製部材は、Mg−2Nd−1Y−0.5Mn−0.5Zn−0.4Zrの組成によって基体が形成されている。
上述の組成の合金インゴットを製造し、インゴットを押し出しによって柱状部材とする。この柱状部材を圧延して、板状の生体用合金製部材の基体が製造された。このときの、製造条件が次の通りである。
押し出し製造条件:押し出し温度400℃ 押し出し比25
圧延条件:350℃
総圧力下落率城乾:90%
なまし処理条件:350℃×30分
上記の製造条件で製造された基体表面に、第1保護層および第2保護層を、表面処理によって形成する。この表面処理の条件は次の通りである。
5%硝酸水溶液に、30秒間基体を浸漬させる。
純水で洗浄後、2分間のアセトン洗浄を行う。
実施例1の試験サンプルサイズ:厚さ1mm板。並行部20mm、評点間距離10mm。
引き張り速度:1mm/分
試験内容:伸び率およびUTS
試験対象
次の条件で、浸漬試験を行った。
浸漬条件:牛血清 37℃中に1日浸漬
実施例2として、Mg−2.5Nd−1Gd−0.4Zrによる生体用合金製部材を作成した。実施例2の生体用合金製部材は、Mg−2.5Nd−1Gd−0.4Zrの組成によって基体が形成されている。
上述の組成の合金インゴットを製造し、インゴットを押し出しによって柱状部材とする。この柱状部材を圧延して、板状の生体用合金製部材の基体が製造された。このときの、製造条件が次の通りである。
押し出し製造条件:押し出し温度400℃ 押し出し比25
圧延条件:350℃
総圧力下落率城乾:90%
上記の製造条件で製造された基体表面に、第1保護層および第2保護層を、表面処理によって形成する。この表面処理の条件は次の通りである。
5%硝酸水溶液に、30秒間基体を浸漬させる。
純水で洗浄後、2分間のアセトン洗浄を行う。
次の条件で、浸漬試験を行った。
浸漬条件:牛血清 37℃中に1日浸漬
実施例3として、Mg−2Nd−1Y−0.5Mn−0.5Zn−0.4Zrによる生体用合金製部材を作成した。実施例2の生体用合金製部材は、Mg−2Nd−1Y−0.5Mn−0.5Zn−0.4Zrの組成によって基体が形成されている。
上述の組成の合金インゴットを製造し、インゴットを押出しによって棒状部材とする。この棒状部材を再度押出し後、引抜きと加工熱処理を繰り返し、線状の生体用合金製部材の基体が製造された。このときの、製造条件が次の通りである。
押出し製造条件(一回目):押出し温度400℃ 押出し比25
押出し製造条件(二回目):押出し温度450℃ 押出し比25
引抜き加工条件:総減面率75%、焼き鈍し温度400℃
上記の製造条件で製造された基体表面に、第1保護層および第2保護層を、表面処理によって形成する。この表面処理の条件は次の通りである。
次の条件で、浸漬試験を行った。
実施例3の試験サンプルのサイズ:直径1×20mm 線状
浸漬条件:培地(DMEM+10%牛血清) 37℃、5%CO2中に2か月間浸漬
基体は0.5〜5.0重量パーセントのNd、0.1〜5.0重量パーセントのY,0.1〜1.0%のMn、0.1〜4.0重量パーセントのZn,0.1〜1.0重量パーセントのZrを含有する組成である。
2 基体
3 第1保護層
4 第2保護層
11 血管用ステント
Claims (11)
- マグネシウムに混合物としてNd、Y、Mn、Zn、およびZrが添加されたマグネシウム合金を含む基体と、
前記基体のマグネシウム及び前記混合物のMnを由来とする酸化物複合体を含む第1保護層と、
前記基体のマグネシウム及び前記混合物のNd、Zn、Mn、Yを由来とする水酸化物複合体を含む第2保護層と、を備える、生体に使用可能な合金製部材。 - マグネシウムに混合物としてNd、Gd、Zrが添加されたマグネシウム合金を含む基体と、
前記基体のマグネシウム及び前記混合物のNd、Gdを由来とする酸化物複合体を含む第1保護層と、
前記基体のマグネシウム及び前記混合物のNd、Gdを由来とする水酸化物複合体を含む第2保護層と、を備える、生体に使用可能な合金製部材。 - 前記第1保護層は、前記基体の表面にあり、
前記第2保護層は、前記第1保護層の表面にある、請求項1又は2記載の生体に使用可能な合金製部材。 - 前記基体は、生体組織内水分により、水酸化物および酸化物の少なくとも一方を形成可能である、請求項1又は2記載の生体に使用可能な合金製部材。
- 前記基体は、0.5〜5.0重量パーセントのNd、0.1〜5.0重量パーセントのY、0.1〜1.0%のMn、0.1〜4.0重量パーセントのZn、および0.1〜1.0重量パーセントのZrを含有する、請求項1記載の生体に使用可能な合金製部材。
- 前記基体は、0.5〜5.0重量パーセントのNd、0.1〜5.0重量パーセントのGd、および0.1〜1.0重量パーセントのZrを含有する、請求項2記載の生体に使用可能な合金製部材。
- 前記合金製部材は、生分解性を必要とする生体埋植デバイスに用いられる、請求項1から6のいずれか記載の生体に使用可能な合金製部材。
- 前記合金製部材は、人工血管、ステント、生体の縫合材、血管用閉塞コイル、クリップ、封止材、生体の結合材および骨の結合材、メッシュシート、骨の矯正材、中実もしくは多孔体の骨の支持材、生体内で細胞が保持され増殖するスキャフォールドの少なくとも1つに使用される、請求項1から7のいずれか記載の生体に使用可能な合金製部材。
- 前記合金製部材は、再生医療に用いられる、請求項1から8のいずれか記載の生体に使用可能な合金製部材。
- マグネシウムに混合物としてNd、Y、Mn、Zn、およびZrが添加されたマグネシウム合金を含む基体上に、前記基体のマグネシウム及び前記混合物のMnを由来とする酸化物複合体を含む第1保護層を形成する工程と、
前記第1保護層上に、前記基体のマグネシウム及び前記混合物のNd、Zn、Mn、Yを由来とする水酸化物複合体を含む第2保護層を形成する工程と、
を備える、生体に使用可能な合金製部材の製造方法。 - マグネシウムに混合物としてNd、Gd、Zrが添加されたマグネシウム合金を含む基体上に、前記基体のマグネシウム及び前記混合物のNd、Gdを由来とする酸化物複合体を含む第1保護層を形成する工程と、
前記第1保護層上に、前記基体のマグネシウム及び前記混合物のNd、Gdを由来とする水酸化物複合体を含む第2保護層を形成する工程と、
を備える、生体に使用可能な合金製部材の製造方法。
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