JP2019528850A - ミクロ構造の粒子を有するカルシウム塩を含有する複合粉末を含むインプラント - Google Patents
ミクロ構造の粒子を有するカルシウム塩を含有する複合粉末を含むインプラント Download PDFInfo
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- JP2019528850A JP2019528850A JP2019512294A JP2019512294A JP2019528850A JP 2019528850 A JP2019528850 A JP 2019528850A JP 2019512294 A JP2019512294 A JP 2019512294A JP 2019512294 A JP2019512294 A JP 2019512294A JP 2019528850 A JP2019528850 A JP 2019528850A
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- particles
- composite powder
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- calcium carbonate
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Abstract
Description
例えば、国際公開第2012/126600号は、大きい粒子を小さい粒子に結合させる方法によって得ることができるミクロ構造の複合粒子について開示しており、ここで、
大きい粒子は、0.1μ〜10mmの範囲内の平均粒子直径を有し、
小さい粒子の平均粒子直径は、大きい粒子の平均粒子直径の1/10以下であり、
大きい粒子は、少なくとも1種のポリマーを含み、
小さい粒子は、炭酸カルシウムを含み、
小さい粒子は、大きい粒子の表面上に配置されており、及び/又は大きい粒子内に非均一に広がっており、
ここで、小さい粒子は、0.01μm〜1.0mmの範囲内の平均粒径を有する沈殿炭酸カルシウム粒子を含む。
さらに、国際公開第2012/126600号は、大きい粒子を小さい粒子に接続する方法によって得ることができるミクロ構造の複合粒子について記載しており、ここで、
大きい粒子は、0.1μm〜10mmの範囲内の平均粒子直径を有し、
小さい粒子の平均粒子直径は、大きい粒子の平均粒子直径の1/10以下であり、
大きい粒子は、少なくとも1種のポリマーを含み、
小さい粒子は、少なくとも1種のカルシウム塩を含み、
小さい粒子は、大きい粒子の表面上に配置されており、及び/又は大きい粒子内に非均一に広がっており、
ここで、大きい粒子は、500g/mol〜1,000,000g/molの範囲内の数平均分子量を有する少なくとも1種の吸収性ポリエステルを含む。
大きい粒子を小さい粒子に結合させるプロセスによって得ることができるミクロ構造の粒子を含む複合粉末(ここで、
大きい粒子は、10μm〜10mmの範囲の平均粒子直径を有し、
大きい粒子は、少なくとも1種のポリマーを含み、
小さい粒子は、大きい粒子の表面上に配置されており、及び/又は大きい粒子内に非均一に広がっており、
小さい粒子は、少なくとも1種のカルシウム塩を含み、
小さい粒子は、0.01μm〜1.0mmの範囲の平均粒径を有し、
ここで、複合粉末の粒子は、10μm〜200μm未満の範囲の平均粒径d50を有し、複合粉末の微細画分は、50容量%未満である)を提供することは、カルシウム塩を含有し、特にレーザー焼結方法における使用のために優れて適した改善された特性を有するミクロ構造の粒子を含む利用可能な複合粉末の作製において容易に予見可能な様式で成功しない。
本発明によると、ポリ−L−乳酸(PLLA)好ましくは、下記の構造
1)好ましくは、0.5dl/g〜2.5dl/gの範囲内、有望には、0.8dl/g〜2.0dl/gの範囲内、特に、0.8dl/g〜1.2dl/gの範囲内のインヘレント粘度(毎回、クロロホルム中0.1%で25℃にて測定)を有し、好ましくは、60℃〜65℃の範囲のガラス転移温度を有し、さらに好ましくは、180℃〜185℃の範囲の融解温度を有し、さらに好ましくは、エステル末端である、ポリ−L−ラクチド(PLLA);
2)好ましくは、1.0dl/g〜3.0dl/gの範囲内、有望には、1.5dl/g〜2.5dl/gの範囲内、特に、1.8〜2.2dl/gの範囲内のインヘレント粘度(毎回、クロロホルム中0.1%で25℃にて測定)を有し、好ましくは、55℃〜60℃の範囲のガラス転移温度を有する、ポリ(D,L−ラクチド)、
ここで、最良の結果は、好ましくは、0.5dl/g〜2.5dl/gの範囲内、有望には、0.8dl/g〜2.0dl/gの範囲内、特に、0.8dl/g〜1.2dl/gの範囲内のインヘレント粘度(毎回、クロロホルム中0.1%で25℃にて測定)を有し、好ましくは、60℃〜65℃の範囲のガラス転移温度を有し、さらに好ましくは、180℃〜185℃の範囲の融解温度を有し、さらに好ましくは、エステル末端である、ポリ−L−ラクチドを使用して得られる。
カルボン酸基〜COOH、
カルボン酸基〜COO−、
スルホン酸基〜SO3H、
スルホン酸基〜SO3 −、
硫酸水素基〜OSO3H、
硫酸基〜OSO3 −、
ホスホン酸基〜PO3H2、
ホスホン酸基〜PO3H−、〜PO3 2−、
アミノ基〜NR1R2、及び
アンモニウム基〜N+R1R2R3、
特に、カルボン酸基、カルボン酸基、ホスホン酸基及びホスホン酸基。
a)Ca2+:>10mmol/l〜50mmol/l、好ましくは、15mmol/l〜45mmol/l、特に、17mmol/l〜35mmol/l;
b)炭酸ジアルキル及び/又は炭酸アルキレン:>10mmol/l〜50mmol/l、好ましくは、15mmol/l〜45mmol/l、特に、17mmol/l〜35mmol/l;
c)OH−:20mmol/l〜100mmol/l、好ましくは、20mmol/l〜50mmol/l、特に好ましくは、25mmol/l〜45mmol/l、特に、28mmol/l〜35mmol/l。
本発明のさらに特に好ましいバリアント内で、Ca(OH)2、好ましくは、石灰水、特に、飽和石灰水が、OH−源として使用される。反応のための成分は、下記の濃度で有望に使用される:
a)Ca(OH)2:>5mmol/l〜25mmol/l、好ましくは、7.5mmol/l〜22.5mmol/l、特に、8.5mmol/l〜15.5mmol/l;
b)炭酸ジアルキル及び/又は炭酸アルキレン:>5mmol/l〜25mmol/l、好ましくは、7.5mmol/l〜22.5mmol/l、特に、8.5mmol/l〜15.5mmol/l。
a.水性水酸化カルシウム懸濁液を提供するステップ、
b.ステップa.の懸濁液中に、二酸化炭素、又は二酸化炭素を含有するガス混合物を導入するステップ、及び
c.形成される炭酸カルシウム粒子を分離するステップ
である手順は、特にそれ自体で証明されてきており、ここで、さらなる0.3重量%〜0.7重量%、好ましくは、0.4重量%〜0.6重量%、特に、0.45重量%〜0.55重量%の少なくとも1種のアミノトリアルキレンホスホン酸を加える。
前記複合粉末は好ましくは、大きい粒子が小さい粒子と合わさっている方法によって得ることができ、ここで、
大きい粒子は、10μm〜10mmの範囲、有望には、20μm〜10mmの範囲、特に好ましくは、30μm〜2.0mmの範囲、特に、60.0μm〜500.0μmの範囲の平均粒子を有し、
小さい粒子の平均粒子直径は好ましくは、大きい粒子の平均粒子直径の1/5以下、好ましくは、1/10以下、特に好ましくは、1/20以下、特に、1/1000以下である。
最初に、熱可塑性材料より小さい粒子直径及びより良好な耐熱性を有する物質を、撹拌しながら、好ましくは、撹拌機及びヒーターを含む装置において、好ましくは、熱可塑性材料の軟化点以上の温度に加熱するステップ;
熱可塑性材料を装置に加えるステップ;
より良好な耐熱性を有する物質を熱可塑性材料の表面上へと添付するステップ。
本発明によるインプラントは、下記の特性:
優れた表面の質、
優れた表面仕上げ、
優れた成分密度、好ましくは、95%超、特に、97%超、
優れた収縮挙動、
優れた寸法安定性、
非常に少ない欠損、
非常に低い多孔度、
非常に低い含量の分解生成物、
優れた3点曲げ強度、好ましくは、60MPa超、特に好ましくは、65MPa超、特に、70MPa超、
好ましくは、3420N/mm2、特に好ましくは、3750N/mm2超、有望には、4000N/mm2超、特に、4500N/mm2超の優れた弾性率、
優れたpH安定性、
優れた生体適合性、
優れた骨伝導、
優れた吸収能力、
優れた生分解性
によって適当には優れている。
使用される材料:
粒状体1(ポリ(L−ラクチド);インヘレント粘度:0.8〜1.2dl/g(クロロホルム中0.1%、25℃);Tg:60〜65℃;Tm:180〜185℃)
粒状体2(ポリ(L−ラクチド);インヘレント粘度1.5〜2.0dl/g(クロロホルム中0.1%;25℃));Tg:60〜65℃;
粒状体3(ポリ(D,L−ラクチド);インヘレント粘度1.8〜2.2dl/g(クロロホルム中0.1%;25℃));Tg:55〜60℃;融点を伴わないアモルファスポリマー
ポリラクチド粒状体1〜3のそれぞれの平均粒子直径は、1〜6mmの範囲内であった。
流動性:試料の流動性は、Erichsenによる起電性フィルムアプリケーターによって判断した。200μm、及び個々に、500μmのドクターブレードを、この目的のために使用した。ホイルタイプ255(Leneta)への付着速度は、12.5mm/sであった。下記のようなレーティング:1=優れた、2=良好、3=満足な;4=十分;5=乏しい
射出成形標本における機械的特性の決定:
3点曲げ強度及びE弾性率は、テクスチャーアナライザーTA.XTplus(Stable Micro Systems、Godalming(UK))を用いて決定した。使用したロードセルの能力は、50kgであった。Exponent6.1.9.0ソフトウェアを使用した。測定の詳細を、下記の表1において示す。
細胞毒性試験(FDA/GelRed)を、下記の通りに行った。
使用した参照、及び個々に、陰性対照は、組織培養用ポリスチレン(TCPS)であった。4つの複製を各試料のために使用し、4つのTCPS(4×)を対照のために使用した。
1.非無菌の試料は、24ウェルマイクロタイタープレートにおいて利用可能となった。同じように、試料及びTCPSプレートを、70%エタノールで無菌化(不変性)し、次いで、2×30分間、1×PBS(リン酸緩衝食塩水)ですすぎ、その後、無菌のα培地で平衡化した。次いで、試料を、25,000個の細胞/cm2(50,000個の細胞/ml)の播種被覆のMC3T3−E1細胞で播種した。部分的培地交換(1:2)を、2日目に行った。
2.細胞培養物中で1日及び4日後、細胞毒性を決定した。
3.生体染色を、FDA及びGelRedの合わせた染色を用いて標準的プロトコルによって1日目及び4日目に行った。
4.顕微鏡画像を、Observer Z1m/LSM700において生成した。
レンズ:EC Plan−Neofluar10×;
像はカメラAxioCam HRcによって撮影する:
緑色蛍光の励起:LED Colibri470;フィルターセットFS10(AF488)
赤色蛍光の励起:LED Colibri530;フィルターセットFS14(AF546)
像はレーザースキャンモードでスキャンする:
トラック1:レーザー:488nm、DBS560nm、PMT1:488〜560nm、
トラック2:レーザー555nm、DBS565nm、PMT2:565〜800nm
5.下記の細胞毒性スケールによって評価を行った:
受入れ:材料は、細胞毒性ではない(最大5%の死細胞)
わずかな阻害:材料は、わずかに毒性である(5%〜20%の死細胞)
有意な阻害:材料は、中程度に毒性である(20%〜50%の死細胞)
毒性:材料は、高度に細胞毒性である(>50%〜100%の死細胞)
6.細胞数は、撮影するか又はスキャンした像の詳細に関する。
SEM像は、高電圧電子顕微鏡(Zeiss、DSM962)によって15kVにて撮影した。試料を金−パラジウム層で噴霧した。
20%のCO2及び80%のN2を含有するCO2ガス混合物を、10℃の当初の温度にて、75g/lのCaOの濃度を有する4lの水酸化カルシウム懸濁液に導入した。気体流動は、300l/時間であった。反応混合物を350rpmで撹拌し、反応の間に反応熱を消失させた。コンダクタンスの突然の低下(30秒以内に0.5mS/cm/分超の低下、及び0.25mS/cm超でのコンダクタンスの減少)によって、CaOをベースとして(理論的参照値として)0.7%のアミノトリ(メチレンホスホン酸)を、懸濁液に加える。反応混合物が球形の炭酸カルシウム粒子中に定量的に炭酸塩化されたとき、球形の炭酸カルシウム粒子中への反応は完了したが、ここで次いで、反応混合物は、7〜9のpH値を示した。この場合において、約2時間後に反応は完了し、反応混合物は反応の終わりにおいて7のpH値を有した。
500mlのVE(脱塩)水を、1000mlのビーカーで提供した。125gの実施例1による球形の炭酸カルシウム粒子を撹拌しながら加え、このように得られた混合物を5分間撹拌した。37.5gの10%メタリン酸ナトリウム(NaPO3)n溶液をゆっくりと加え、このように得られた混合物を10分間撹拌した。75.0gの10%リン酸をゆっくりと加え、このように得られた混合物を20時間撹拌した。沈殿物を分離し、乾燥キャビネット中で一晩130℃にて乾燥させる。このように得られた球形の炭酸カルシウム粒子は、12μmの平均粒子直径を同等に有した。
球形の炭酸カルシウム粒子及びポリラクチド(PLLA)の複合粉末を、NHS−1装置を使用して、特開昭62083029号公報に記載されている方法によって調製した。それを水で12℃にて冷却した。ポリラクチド粒状体1を母粒子として使用し、実施例1の球形の炭酸カルシウム粒子を子粒子(充填剤)として使用した。
さらなる複合粉末を実施例3と類似して調製したが、ここで実施例5において、冷却は約20℃にて行われた。それぞれの場合において、30gのポリラクチド粒状体を20gのCaCO3粉末と混合した。NHS−1の粉砕チャンバー内で達した最大温度は、実施例4について33℃、実施例5について58℃、実施例6について35℃、及び実施例7について35℃であった。生成物をふるい分けして、可能であれば、粗い画分>250μmを除去した(250μmのふるいを通した手動の乾燥ふるい分け)。実施例4、6及び7において、さらに、可能であれば、流動によって(空気分離を用いて)又はふるい分けによって(空気ジェットふるい分け機械を用いて)、画分<20μmを分類した。使用した材料、ふるい分け/空気分離を伴う又は伴わない調製の実行、及び得られた複合粉末の特性を、下記の表3において列挙する。
実施例1の球形の炭酸カルシウム粒子及びアモルファスポリラクチド(PDLLA)のミクロ構造の複合粒子は、NHS−1装置を使用して特開昭62083029号公報に記載されている方法によって調製した。それを12℃にて水で冷却した。ポリラクチド粒状体3を母粒子として使用し、実施例1の球形の炭酸カルシウム粒子を子粒子として使用した。
β−リン酸三カルシウム粒子及びポリラクチド(PDLLA)の複合粉末は、NHS−1装置を使用して特開昭62083029号公報に記載されている方法によって調製した。これを12℃にて水で冷却した。ポリラクチド粒状体3を、母粒子として使用し、β−リン酸三カルシウム(β−TCP;d20=30μm;d50=141μm;d90=544μm)を子粒子として使用した。使用したβ−TCPのSEM像を、図9a及び図9bにおいて示す。
菱面体炭酸カルシウム粒子及びポリラクチド(PDLLA)の複合粉末を、NHS−1装置を使用して特開昭62083029号公報に記載されている方法によって調製した。これを12℃にて水で冷却した。ポリラクチド粒状体3を母粒子として使用し、菱面体炭酸カルシウム粒子(d20=11μm;d50=16μm;d90=32μm)を子粒子として使用した。
重質炭酸カルシウム粒子及びポリラクチド(PDLLA)の複合粉末を、NHS−1装置を使用して特開昭62083029号公報に記載されている方法によって調製した。それを水で12℃にて冷却した。ポリラクチド粒状体3を母粒子として使用し、重質炭酸カルシウム(GCC;d20=15μm;d50=46μm;d90=146μm)を子粒子として使用した。
Claims (14)
- 大きい粒子を小さい粒子に結合させるプロセスによって得られるミクロ構造の粒子を有する複合粉末を含有するインプラントであって、
前記大きい粒子は、10μm〜10mmの範囲の平均粒子直径を有し、
前記大きい粒子は、少なくとも1種のポリマーを含み、
前記小さい粒子は、前記大きい粒子の表面上に配置されており、及び/又は前記大きい粒子内に非均一に広がっており、
前記小さい粒子は、カルシウム塩を含み、
前記小さい粒子は、0.01μm〜1.0mmの範囲の平均粒径を有し、
前記複合粉末の前記粒子は、10μm〜200μm未満の範囲の平均粒径d50を有し、前記複合粉末の微細画分は、50容量%未満であることを特徴とする、インプラント。 - 前記複合粉末の前記粒子が、350μm未満の粒径d90を有することを特徴とする、請求項1に記載のインプラント。
- 前記複合粉末の前記粒子が、20μm〜150μm未満の範囲内の平均粒径d50を有することを特徴とする、請求項1又は2に記載のインプラント。
- 前記複合粉末の前記粒子が、100%未満のd20/d50比を有し、及び/又は前記カルシウム塩が、5未満のアスペクト比を有し、及び/又は前記カルシウム塩が、球形の炭酸カルシウムを含み、及び/又は前記カルシウム塩が、リン酸カルシウムを含むことを特徴とする、請求項1〜3のいずれか一項に記載のインプラント。
- 前記大きい粒子が、少なくとも1種の熱可塑性ポリマーを含むことを特徴とする、請求項1〜4のいずれか一項に記載のインプラント。
- 前記大きい粒子が、少なくとも1種の吸収性ポリマーを含むことを特徴とする、請求項1〜5のいずれか一項に記載のインプラント。
- 前記吸収性ポリマーが、クロロホルム中で25℃、0.1%ポリマー濃度にて測定して、0.3dl/g〜8.0dl/gの範囲内のインヘレント粘度を有することを特徴とする、請求項6に記載のインプラント。
- 前記大きい粒子が、ポリ−D、ポリ−L及び/又はポリ−D,L−乳酸を含むことを特徴とする、請求項1〜7のいずれか一項に記載のインプラント。
- 前記大きい粒子が、500g/mol〜1,000,000g/molの範囲の数平均分子量を有する少なくとも1種の吸収性ポリエステルを含むことを特徴とする、請求項1〜8のいずれか一項に記載のインプラント。
- 前記大きい粒子が、少なくとも1種のポリアミドを含むことを特徴とする、請求項1〜9のいずれか一項に記載のインプラント。
- 前記大きい粒子が、少なくとも1種のポリウレタンを含むことを特徴とする、請求項1〜10のいずれか一項に記載のインプラント。
- 前記カルシウム塩粒子の重量パーセントが、前記複合粉末の総重量に対して、少なくとも0.1重量%であることを特徴とする、請求項1〜11のいずれか一項に記載のインプラント。
- 前記複合粉末が、前記複合粉末の総重量に対して、40.0重量%〜80.0重量%のPLLA、及び20.0重量%〜60.0重量%の炭酸カルシウム粒子を含むことを特徴とする、請求項1〜12のいずれか一項に記載のインプラント。
- 複合粉末を含む組成物の選択的レーザー焼結によって得られる、請求項1〜13のいずれか一項に記載のインプラント。
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JP7409590B2 (ja) | 2024-01-09 |
CN109689123A (zh) | 2019-04-26 |
BR112019004499A2 (pt) | 2019-05-28 |
RU2019110367A3 (ja) | 2020-11-03 |
US20200009297A1 (en) | 2020-01-09 |
ES2955235T3 (es) | 2023-11-29 |
WO2018046238A1 (de) | 2018-03-15 |
RU2019110367A (ru) | 2020-10-08 |
US11471566B2 (en) | 2022-10-18 |
CN109689123B (zh) | 2022-08-05 |
EP3509654B1 (de) | 2023-07-12 |
BR112019004499B1 (pt) | 2022-07-12 |
CA3035617A1 (en) | 2018-03-15 |
RU2755895C2 (ru) | 2021-09-22 |
EP3509654A1 (de) | 2019-07-17 |
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