JP2015505511A - 注射用の生分解性骨セメントとそれを作製及び使用する方法 - Google Patents
注射用の生分解性骨セメントとそれを作製及び使用する方法 Download PDFInfo
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- JP2015505511A JP2015505511A JP2014555693A JP2014555693A JP2015505511A JP 2015505511 A JP2015505511 A JP 2015505511A JP 2014555693 A JP2014555693 A JP 2014555693A JP 2014555693 A JP2014555693 A JP 2014555693A JP 2015505511 A JP2015505511 A JP 2015505511A
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- Prior art keywords
- bone cement
- bone
- cement composition
- cement
- paste
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- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Classifications
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- 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
- A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
- A61L24/0047—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
- A61L24/0052—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material with an inorganic matrix
- A61L24/0063—Phosphorus containing materials, e.g. apatite
-
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Abstract
Description
[0001] 本発明は、米国仮特許出願番号:61/593,094(2012年1月31日出願)及び米国仮特許出願番号:61/697,059(2012年9月5日出願)の利益を特許請求する。上記出願の両方の開示内容は、参照により本明細書に組み込まれる。
[0002] 本発明は、いかなる政府支援も受けずになされたので、政府は、本発明において権利を有さない。
[0003] 本発明は、概して、骨セメント組成物と、骨セメント組成物を作製する、強化する、及び使用する方法に関する。
[0005] 背部痛に関連した諸症状は、他のどの筋骨格系症状より多くの入院件数を占める。背部は、作業関連障害が最も頻繁に関与する身体部分である。背部痛は、工業化された社会において最も蔓延した医学的障害である。米国人口の75%強がその生涯の経過を通して腰痛に罹病すると推定されている。米国立衛生研究所からの統計によれば、背部痛は、人々が治療を求める、二番目に多い医学的状態であって、年間5000万件以上の医院来診数を占める。腰痛は、50歳より若い人々における障害の主因である。
[0017] 当業者には、好ましい態様に関する以下の詳細な記載より、付帯の図面に照らして読むときに、本発明の様々な側面が明らかになろう。
[0018] 以下の図面は、点線で示される隠れた特徴又は要素を含有する場合があって、一点鎖線で示される様々な成分又は要素の局部透視図が含まれる場合がある。
[0060] 0.0032g クエン酸一水和物、6.0g NaHCO3、3.0mL H2O、及び12mL H3PO4(86.2%)を混合することによって、15mLの固化溶液を調製した。この固化溶液のpHは0.25±0.01であって、6ヶ月の貯蔵寿命にわたって安定していた。この固化溶液は、堅く蓋されるガラス瓶に保存した。
[0066] Ca(OH)2を固化溶液及び蒸留水とメノウ乳鉢においてメノウ乳棒を使用することによって手動で混合することによってセメントペーストを製造した。15mLの固化溶液を調製するために、0.0032gのクエン酸一水和物(CAM,C6H8O7・H2O,100%)、6gの重炭酸ナトリウム(NaHCO3>99.7%)、固化溶液を希釈するための1.95mLの蒸留水、及びリン酸塩の供給源としての13.05mLのリン酸(H3PO4,85%)をそれぞれ混合した。初めに、0.6175gのCa(OH)2を0.8mLの蒸留水と少なくとも2分間混合して、Ca(OH)2が水中に一様に分散したペーストを生成した。最後に、この材料へ0.75mLの固化溶液を加えた。
[0069] Mg(OH)2を固化溶液及び蒸留水とメノウ乳鉢においてメノウ乳棒を使用することによって手動で混合することによってセメントペーストを製造した。15mLの固化溶液を調製するために、0.0032gのクエン酸一水和物(CAM,C6H8O7・H2O,100%)、6gの重炭酸ナトリウム(NaHCO3>99.7%)、固化溶液を希釈するための1.95mLの蒸留水、及びリン酸塩の供給源としての13.05mLのリン酸(H3PO4,85%)をそれぞれ混合した。2mLの蒸留水と3mLの固化溶液の混合物へ2.47gのMg(OH)2を加えて、ペーストを生成した。
[0072] 0.5mL蒸留水と1.5mL固化溶液の混合物へ1.235g Mg(OH)2を加えることによって、セメントペーストを製造した。このペーストをディスク試料へ硬化させた。新たに製造した同じペーストをマイクロ波で10分間処理して、粉末を製造した。合成した粉末の1gを0.4mL蒸留水と混合してペーストを生成して、硬化塊へ固化させた。図面13は、マイクロ波処理後に生成したMg−P前駆体、Mg(OH)2及びH3PO4との直接混合によって生成したMg−Pセメント、及びマイクロ波処理後に硬化したMg−PセメントのXRDパターンを比較する。図面14は、先の前駆体、直接混合によって生成したセメント、及びマイクロ波処理後に生成したセメントのSEM画像を示す。生成したMg−Pは、ニューベリーアイト(MgHPO4・3H2O)である。
[0075] 蒸留水の固化溶液を使用して、ストロンチウム含有セメントを製造した。反応体は、Mg(OH)2とH3PO4の結晶であった。前駆体の製造において、3g Mg(OH)2と3.36g H3PO4を3mLの水と混合した。1分の混合の後で、生成したペーストを5分間の最高出力での加熱処理のためにマイクロ波オーブンへ送った。生成した脆性の粉末を微粉末へ砕いた。この粉末を、SrCl2を含有する水(1mLの水に対して0.01g SrCl2)と3g/mLの重量/容量比で混合してペーストを生成すると、これは5分後に固化した。そのような少量のSrCl2を加えたので、生じるセメントXRDパターンに変化を見ることができない。
Claims (36)
- カルシウム、マグネシウム、又はストロンチウムの塩基源を含んでなる粉末;
H3PO4及び緩衝液を含んでなる固化溶液;及び
該固化溶液へ取り込まれている生体適合性ポリマー;
を含んでなる骨セメント組成物であって、
ここで該粉末は、該固化溶液と混合されて骨セメントペーストを生成し、これは、(a)硬化塊へ固化するか又は(b)電磁放射線を照射されて乾燥粉末を生成し、次いで該乾燥粉末は、第二の固化溶液と混合されて、硬化塊へ固化する放射線補助骨セメントペーストを生成する、前記骨セメント組成物。 - 粉末が、Ca(OH)2、Mg(OH)2、又はSr(OH)2を含む、請求項1の骨セメント。
- 粉末がCa(OH)2を含んで、硬化塊がモネタイト(CaHPO4)を含む、請求項1の骨セメント。
- 生体適合性ポリマーがキトサンを含む、請求項1の骨セメント。
- 生体適合性ポリマーが固化溶液へ取り込まれるのに先立って表面リン酸化される、請求項1の骨セメント。
- 固化溶液がクエン酸一水和物をさらに含む、請求項1の骨セメント。
- 緩衝液がNaHCO3を含む、請求項1の骨セメント。
- 生体適合性ポリマーが全組成物の約0重量%〜約20重量%の濃度で固化溶液へ取り込まれている、請求項1の骨セメント。
- 生体適合性ポリマーが全組成物の約1重量%〜約5重量%の濃度で固化溶液へ取り込まれている、請求項1の骨セメント。
- タンパク質、骨誘導材料、骨伝導材料、X線不透過剤、医薬品、支持又は強化フィラー材料、結晶成長調節剤、粘度調整剤、気孔形成剤、抗生物質、防腐剤、増殖因子、化学療法剤、骨吸収阻害剤、変色剤、浸漬液、カルボン酸塩、カルボン酸、α−ヒドロキシル酸、コラーゲン、ピロリン酸塩、硫酸塩、及び金属イオンからなる群より選択される添加物をさらに含んでなる、請求項1の骨セメント組成物。
- 第二の固化溶液がナノシリカゾルを含む、請求項1の骨セメント組成物。
- 第二の固化溶液が水又は生理食塩水を含む、請求項1の骨セメント組成物。
- グリセリン及び/又はプロピレングリコールを含んでなる非水性増量剤をさらに含んでなり、水の添加時に固化可能な予混合パテである、請求項1の骨セメント組成物。
- 骨セメントペーストが約30分〜約60分の固化時間を有する、請求項1の骨セメント組成物。
- 解剖学的部位の中又は上で硬化塊へ固化した後で、治癒プロセスの間に骨セメントが骨を再吸収して骨に置き換わる、請求項1の骨セメント組成物。
- 骨セメントを作製する方法であって:
生体高分子の表面をリン酸化して、表面リン酸化生体高分子を得る工程;
この表面リン酸化生体高分子を固化溶液へ取り込む工程;及び
この固化溶液と単一粉末成分を混合して、硬化塊へ固化する骨セメントペーストを生成する工程;
を含んでなる、前記方法。 - 粉末成分が、Ca(OH)2、Mg(OH)2、又はSr(OH)2を含み;そして
固化溶液がH3PO4を含む、
請求項16の方法。 - 骨セメントを作製する方法であって:
骨セメントペーストに電磁放射線を照射して、乾燥粉末を生成する工程、ここで骨セメントペーストは、酸−塩基反応によってすでに作製されている;及び
この乾燥粉末を水、生理食塩水、又はナノシリカゾルを含んでなる固化溶液と混合して、硬化塊へ固化する放射線補助骨セメントペーストを生成する工程;
を含んでなる、前記方法。 - 固化プロセスが、骨セメント周囲の生組織に対して壊死を引き起こさないように、極小の熱を放出する、請求項18の方法。
- 薬物の必要な被験者へ薬物を送達する方法であって:
請求項1の骨セメント組成物に、このペーストが固化する前に薬物を溶かす工程;
この薬物の必要な被験者の解剖学的部位の上又は中へこのペーストを配置するか又は注射する工程;及び
この骨セメントペーストを硬化塊へ固化させて、該薬物をその必要な被験者へ送達する工程;
を含んでなる、前記方法。 - 薬物の必要な被験者へ薬物を送達する方法であって:
請求項1の骨セメント組成物を硬化塊へ固化させる工程;
この硬化塊を、薬物を含んでなる溶液に浸漬する工程;及び
この薬物の必要な被験者の解剖学的部位の上又は中へ該硬化塊を配置して、該薬物の必要な被験者へそれを送達する工程;
を含んでなる、前記方法。 - チタンインプラントの生体適合性を高める方法であって:
請求項1の骨セメント組成物を、この骨セメント組成物が固化する前に、チタンインプラント上でコートする工程;及び
この骨セメント組成物を硬化塊へ固化させて、チタンインプラントの生体適合性を高める工程;
を含んでなる、前記方法。 - 硫酸カルシウム無水物セメントの強度を高める方法であって:
請求項1の骨セメント組成物を、その骨セメント組成物が固化する前に、硫酸カルシウム無水物セメントへ加える工程;及び
この骨セメント組成物を硬化塊へ固化させて、この硫酸カルシウム無水物セメントの強度を高める工程;
を含んでなる、前記方法。 - 標的にした解剖学的部位の上又は中へ請求項1の骨セメント組成物を手動で注射するか又は適用する工程を含んでなる、標的にした解剖学的部位を生分解性組成物で処置するための方法。
- 被験者を治療するための方法であって:
骨中の穴又は腔を、請求項1の骨セメント組成物で、その骨セメント組成物が固化する前に充填する工程;及び
この骨セメント組成物をそのような治療の必要な穴又は腔中で硬く固化させる工程;
を含んでなる、前記方法。 - 整形外科的又は歯科的治療を行う方法であって:
請求項1の骨セメント組成物を硬化塊へ固化させる工程;及び
被験者の骨中の穴又は腔を充填するために、この硬化塊をその骨の中へ埋め込む工程;
を含んでなる、前記方法。 - 前記埋め込む工程が、硬化した骨セメントをペレットへ粉砕する工程と、被験者の骨中の穴又は腔をこのペレットで充填する工程を含む、請求項26の方法。
- 弱化又は崩壊した脊椎を強化、置換、又は治療するための方法であって:
請求項1の骨セメント組成物を、この骨セメント組成物が固化する前に、1以上の脊椎の上又は中へ注射する工程;及び
この骨セメント組成物を堅い塊へ固化させて、弱化又は崩壊した脊椎を強化、置換、又は治療する工程;
を含んでなる、前記方法。 - 歯欠損を充填するための方法であって:
請求項1の骨セメント組成物のある量を、欠損のある歯の中へ注射する工程;及び
この骨セメント組成物をその歯の中で硬化塊へ固化させて、その中の欠損を充填する工程;
を含んでなる、前記方法。 - 頭蓋顎顔面骨欠損を修復するための方法であって:
請求項1の骨セメント組成物を欠損のある頭蓋顎顔面骨の上又は中へ配置するか又は注射する工程;及び
この骨セメント組成物をその骨の中で硬化塊へ固化させて、その中の欠損を修復する工程;
を含んでなる、前記方法。 - 注射用骨セメントペーストを調製するためのキットであって:
カルシウム、マグネシウム、又はストロンチウムの塩基源を含んでなる粉末成分を含んでなる第一容器;
H3PO4を含有する液体成分を含んでなる第二容器;
キトサン生体高分子を含んでなる第三容器;
ここで、該粉末成分、液体成分、及びキトサン生体高分子は、組合せ可能であって、哺乳動物中の標的にした解剖学的部位の上又は中への手動注射に適した初期粘度を有する骨セメントペーストを生成する;及び
任意選択的に、骨にセメントを注射するのに適合した1以上のシリンジ;
を含んでなる、前記キット。 - 注射用骨セメントペーストを調製するためのキットであって:
予混合パテを含んでなる第一容器;
水を含んでなる第二容器;
ここでこの予混合パテは、その水と組合せ可能であって、哺乳動物中の標的部位の上又は中への手動注射に適した初期粘度を有するモネタイト骨セメントペーストを生成する;及び
任意選択的に、骨にセメントを注射するのに適合したシリンジ;
を含んでなる、前記キット。 - 請求項31又は請求項32のキットであって、さらに、その中のどの容器にも、タンパク質、骨誘導材料、骨伝導材料、X線不透過剤、医薬品、支持又は強化フィラー材料、結晶成長調節剤、粘度調整剤、気孔形成剤、抗生物質、防腐剤、増殖因子、化学療法剤、骨吸収阻害剤、変色剤、浸漬液、カルボン酸塩、カルボン酸、α−ヒドロキシル酸、コラーゲン、ピロリン酸塩、硫酸塩、及び金属イオンからなる群より選択される添加物を含んでなる、キット。
- 被験者を治療する方法であって:
請求項31、32、又は33のキットより骨セメント組成物を生成する工程;
この骨セメント組成物を、その骨セメント組成物が固化する前に、被験者中の標的にした解剖学的部位の中又は上へ注射するか又は適用する工程;及び
この骨セメント組成物の必要な被験者の標的にした解剖学的部位の中でそれを硬化塊へ固化させる工程;
を含んでなる、前記方法。 - 請求項1の骨セメント組成物を充填したシリンジ。
- 請求項1の骨セメント組成物によって修復された欠損を含んでなる非ヒト骨。
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