JP2022537697A - 骨代用材のコラーゲンマトリクス又は顆粒状ブレンド - Google Patents
骨代用材のコラーゲンマトリクス又は顆粒状ブレンド Download PDFInfo
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- JP2022537697A JP2022537697A JP2021573817A JP2021573817A JP2022537697A JP 2022537697 A JP2022537697 A JP 2022537697A JP 2021573817 A JP2021573817 A JP 2021573817A JP 2021573817 A JP2021573817 A JP 2021573817A JP 2022537697 A JP2022537697 A JP 2022537697A
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Abstract
Description
a)焼結CAPコア材を調製する工程と、
d)任意で、工程c)でから得られた、分離された材料を滅菌する工程と
含むプロセスによって得られると教示されている。
- 上記の通り調製されたバルク焼結CAPコア材、
- 所望の形状及びサイズを有する焼結CAPコア材のプリフォーム、例えば、ネジ、ネイル、ピン、若しくは骨性の身体部分のプロファイルを有する構造
であってよい。
a)焼結CAPコア材を調製する工程と、
d)任意で、工程c)から得られた、分離された材料を滅菌する工程と
を含む、上記で定義されたCAP/HAP骨代用材を調製するプロセスに関する。
好ましくは、短鎖脂肪族アルコールは、エタノールである。
- AFMパラメータ:AFM由来の根平均二乗粗度(Rq)及びプロファイルの平均最大高さ(Rz)、
- SEMによって測定したときのエピタキシャル成長ナノ結晶板状ヒドロキシアパタイトのサイズ、並びに
- MIPによって測定したときの0.03~2μmの気孔の体積
は、変態溶液のバッファ溶液液中の短鎖脂肪族アルコールの割合を変更することによって簡便に調整することができる。
- 上記の通り調製されたバルク焼結CAPコア材、
- 所望の形状及びサイズを有する焼結CAPコア材のプリフォーム、例えば、ネジ、ネイル、ピン、若しくは骨性の身体部分のプロファイルを有する構造
であってよい。
- AFMパラメータ:AFM由来の根平均二乗粗度(Rq)及びプロファイルの平均最大高さ(Rz)、
- SEMによって測定したときのエピタキシャル成長ナノ結晶板状ヒドロキシアパタイトのサイズ、並びに
- MIPによって測定したときの0.03~2μmの気孔の体積
を簡便に調整することができる。
- 以下からなる群から選択される骨代用材の粒子(B):
を含むコラーゲンマトリクスに関する。
- XRDによって測定したときのHAPの割合は、CAP/HAP骨代用材の粒子(A)中2.0~6.0%であり、かつ
- XRDによって測定したときのHAPの割合は、CAP/HAP骨代用材の粒子(A)中2.0~6.0%であり、かつ
- 以下からなる群から選択される骨代用材の粒子(B):
と、を含む顆粒ブレンドに関する。
- XRDによって測定したときのHAPの割合は、CAP/HAP骨代用材の粒子(A)中2.0~6.0%であり、かつ
上記実施例1に記載の通り、相純度の高いα-TCPの1~2mmのサイズの多孔質顆粒を生成した。
1)3.0w/w% HAPを含有する高速再吸収性二相性CAP/HAP骨代用材の調製
パテ材を特定の量のヘパリン化血液と接触させ、その後、以下の工程を含む試験プロトコルを実施した:
1.濡れ性:発泡体を4分間以内にヘパリン化血液で濡らすことができる(操作なし)。
2.圧搾:追加の血液を絞り出すことができる。
3.粘着性:手袋又は器具にパテの塊が密着しない。
4.凝集性:パテが凝集性であり、そして、離れ落ちない。
5.成形性:成形可能なパテを、所望の形状に容易に成形することができる(最も困難な形態はボール状である)。
6.耐圧性:圧力を印加したとき、材料が横に押し出されなかった。
・ 図8では、欠損全体にわたって新たな骨の形成を観察することができる。
Claims (15)
- 焼結CAPコアと、前記焼結CAPコアの外面上に堆積したナノ結晶HAPの閉鎖エピタキシャル成長層とを含み、それによって、エピタキシャル成長したナノ結晶がヒトの骨塩と同じサイズ及び形態を有する二相性リン酸カルシウム/ヒドロキシアパタイト(CAP/HAP)骨代用材の粒子を含むコラーゲンマトリクスであって、前記焼結CAPコアの外面上に堆積したナノ結晶HAPの閉鎖エピタキシャル成長層が平坦な板状結晶を含む均質な粗外面を有する、コラーゲンマトリクス。
- 前記コラーゲンが、酸性溶液によって処理された天然に架橋されたコラーゲンである、請求項1記載のコラーゲンマトリクス。
- 前記コラーゲンが、脱水熱処理(DHT)により物理的に架橋されているか又は化学的に架橋されている天然に架橋されたコラーゲンである、請求項1記載のコラーゲンマトリクス。
- 60~97w/w% 骨代用材と3~40w/w% コラーゲンとを含む、請求項1~3のいずれか記載のコラーゲンマトリクス。
- 前記二相性リン酸カルシウム/ヒドロキシアパタイト(CAP/HAP)骨代用材において、前記粗面が、走査型電子顕微鏡(SEM)によって測定したときに0.2~20μmのサイズを有する板のインターロック網目構造を形成するエピタキシャル成長ナノ結晶板状ヒドロキシアパタイトを含む、請求項1~4のいずれかに記載のコラーゲンマトリクス。
- 前記二相性リン酸カルシウム/ヒドロキシアパタイト(CAP/HAP)骨代用材において、前記均質な粗外面が、水銀圧入ポロシメトリー(MIP)によって測定したときに0.03~2μmの気孔を含有するインターロック網目構造を形成するエピタキシャル成長板状ヒドロキシアパタイトを含む、請求項1~5のいずれか記載のコラーゲンマトリクス。
- 前記二相性リン酸カルシウム/ヒドロキシアパタイト(CAP/HAP)骨代用材において、前記均質な粗外面が、原子間力顕微鏡(AFM)によって特徴付けられ、AFM由来の根平均二乗粗度Rqが50~400nmの範囲であり、そして、プロファイルの平均最大高さRzが500~2000nmの範囲である、請求項1~6のいずれか記載のコラーゲンマトリクス。
- 前記二相性リン酸カルシウム/ヒドロキシアパタイト(CAP/HAP)骨代用材において、XRDによって測定したときのHAPの割合が1.0~10.0%である、請求項1~7のいずれか記載のコラーゲンマトリクス。
- - 焼結CAPコアと、前記焼結CAPコアの外面上に堆積したナノ結晶HAPの閉鎖エピタキシャル成長層とを含み、それによって、エピタキシャル成長したナノ結晶がヒトの骨塩と同じサイズ及び形態を有するCAP/HAP骨代用材の粒子(A)であって、前記焼結CAPコアの外面上に堆積したナノ結晶HAPの閉鎖エピタキシャル成長層が、平坦な板状結晶を含む均質な粗外面を有し、XRDによって測定したときのHAPの割合が2.0~6.0%である、粒子(A)と、
- 以下からなる群から選択される骨代用材の粒子(B):
- 焼結CAPコアと、前記焼結CAPコアの外面上に堆積したナノ結晶HAPの少なくとも1つの閉鎖エピタキシャル成長層とを含み、それによって、エピタキシャル成長したナノ結晶がヒトの骨塩と同じサイズ及び形態を有し、XRDによって測定したときのHAPの割合が10~40%である二相性CAP/HAP骨代用材、並びに
- 天然骨に由来し、そして、天然骨の元の結晶構造及び鉱物微細構造を実質的に保持すると同時に、150ppm未満の有機不純物の含有量及び135ppm未満のタンパク質の含有量を有する骨塩
とを含む、請求項1~8のいずれか記載のコラーゲンマトリクス。 - - XRDによって測定したときのHAPの割合が、前記CAP/HAP骨代用材の粒子(A)中2.0~6.0%であり、かつ
- 前記骨代用材の粒子(B)が、焼結CAPコアと、前記焼結CAPコアの外面上に堆積したナノ結晶HAPの少なくとも1つの閉鎖エピタキシャル成長層とを含み、それによって、エピタキシャル成長したナノ結晶がヒトの骨塩と同じサイズ及び形態を有し、XRDによって測定したときのHAPの割合が30~40%である二相性CAP/HAP骨代用材の粒子である、請求項9記載のコラーゲンマトリクス。 - - XRDによって測定したときのHAPの割合が、前記CAP/HAP骨代用材の粒子(A)中2.0~6.0%であり、かつ
- 前記骨代用材の粒子(B)が、天然骨に由来し、そして、天然骨の元の結晶構造及び鉱物微細構造を実質的に保持すると同時に、150ppm未満の有機不純物の含有量及び135ppm未満のタンパク質の含有量を有する骨塩の粒子である、請求項9記載のコラーゲンマトリクス。 - 前記CAP/HAP骨代用材の粒子(A)の前記骨代用材の粒子(B)に対するw/w比が、0.1~9.9である、請求項9~11のいずれか記載のコラーゲンマトリクス。
- パテとして使用するための請求項1、2、及び4~12のいずれか記載のコラーゲンマトリクスを調製するプロセスであって、例えばコラーゲンスラリーを生成するために、ネイティブの天然に架橋されたコラーゲンのコラーゲン繊維をpH2~5の酸性溶液に分散させることと、例えばコラーゲン/CAP/HAPスラリーを生成するために、前記コラーゲンスラリーを前記二相性CAP/HAP骨代用材の粒子と混合し、そして、ホモジナイズすることと、前記スラリーを凍結乾燥させ、そして、ガンマ線若しくはX線の照射又はエチレンオキシド処理によって滅菌することと、を含むプロセス。
- - 焼結CAPコアと、前記焼結CAPコアの外面上に堆積したナノ結晶HAPの閉鎖エピタキシャル成長層とを含み、それによって、エピタキシャル成長したナノ結晶がヒトの骨塩と同じサイズ及び形態を有する二相性(CAP/HAP)骨代用材の粒子(A)であって、前記焼結CAPコアの外面上に堆積したナノ結晶HAPの閉鎖エピタキシャル成長層が、平坦な板状結晶を含む均質な粗外面を有し、XRDによって測定したときのHAPの割合が2.0~6.0%である粒子と、
- 以下からなる群から選択される骨代用材の粒子(B):
- 焼結CAPコアと、前記焼結CAPコアの外面上に堆積したナノ結晶HAPの少なくとも1つの閉鎖エピタキシャル成長層とを含み、それによって、エピタキシャル成長したナノ結晶がヒトの骨塩と同じサイズ及び形態を有し、XRDによって測定したときのHAPの割合が10~40%である二相性CAP/HAP骨代用材、並びに
- 天然骨に由来し、そして、天然骨の元の結晶構造及び鉱物微細構造を実質的に保持すると同時に、150ppm未満の有機不純物の含有量及び135ppm未満のタンパク質の含有量を有する骨塩
との混合物を含む顆粒ブレンド。 - 前記CAP/HAP骨代用材の粒子(A)の前記骨代用材の粒子(B)に対するw/w比が、0.1~9.9である、請求項14記載の顆粒ブレンド。
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CN111511415B (zh) | 2017-12-14 | 2021-04-20 | 盖斯特里希医药公司 | 干式植入物组合物和可注射的水性植入物制剂 |
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AU2020293633A1 (en) | 2021-12-16 |
EP3946488B1 (en) | 2022-12-28 |
CN114761048A (zh) | 2022-07-15 |
EP3946488A1 (en) | 2022-02-09 |
BR112021021629B1 (pt) | 2024-01-30 |
CA3140519A1 (en) | 2020-12-17 |
CN114761048B (zh) | 2023-05-02 |
JP7476240B2 (ja) | 2024-04-30 |
AU2020293633B2 (en) | 2023-02-02 |
US10960107B2 (en) | 2021-03-30 |
US20200390934A1 (en) | 2020-12-17 |
ES2939266T3 (es) | 2023-04-20 |
WO2020249716A1 (en) | 2020-12-17 |
KR20220021914A (ko) | 2022-02-22 |
TW202112404A (zh) | 2021-04-01 |
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