JP2017507711A - 骨移植片ならびに骨移植片を作製及び使用する方法 - Google Patents
骨移植片ならびに骨移植片を作製及び使用する方法 Download PDFInfo
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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Abstract
Description
これらの実施形態によると、任意選択の成分であるDBMを添加し、例えば1000rpmの速度で約5分間剪断混合器で混合することにより、この混合物を混合/均質化する。次いで、鉱物成分を添加し、再び混合する。混合は、ここでも、例えば、500rpmで2分間剪断混合器で混合することによって達成することができる。次いで、これらの実施形態における混合物を、−40℃の温度で12時間凍結させてもよく、また混合物は、例えば、48時間凍結乾燥させてもよい。
使用方法
本骨移植片のいずれかを、骨移植片を必要とする哺乳動物に挿入することを含む方法もまた、本明細書に提供される。例として、本骨移植片は、本骨移植片のうちの1つ以上を、それを必要とする哺乳動物、例えば哺乳動物に挿入することによって、哺乳動物に挿入または適用され得る。骨移植片は、例えば、例として切片、パテ、ゲル、及び/またはスポンジの形態の移植片により挿入または適用されてもよく、あるいは骨移植片は、インプラントと共に、例えば、その中または上に(例えばコーティングとして)組み込まれた状態でも、利用可能であり得る。骨移植片は、骨移植片の必要性、骨移植片の種類、及び患者を考慮して医師により決定される、有効量で挿入され得る。
インプラント
なおもさらなる例示的な実施形態は、本明細書に提供される骨移植片のうちの1つ以上を含むインプラントまたは他のデバイスもしくは製品を対象とし、本骨移植片はインプラントの中もしくは上に組み込まれるか、または製品もしくはインプラントと共に使用される。例えば、本骨移植片代替物は、インプラント内への、またはその中の移植片として使用することができる。非限定的な例として、骨移植片は、圧迫骨折の治療のための椎体間スペーサと共に使用することができる。
キット
なおもさらなる実施形態は、本骨移植片のうちの1つ以上またはその1つ以上の構成要素もしくは成分を含む、キットを対象とする。
非限定的な実施形態によると、I型コラーゲンならびに1つ以上の異なる溶解速度及び/または1つ以上のサイズを有する1つ以上の異なる種類の鉱物を含む骨移植片が調製される。本方法は、以下を含む:
(1)ウシ及びブタ源に由来するI型コラーゲンを、皮膚(真皮)または腱のいずれかから得る。
a)鉱物としては、組み合わせまたは単独で、例えば、以下のもののうち任意のものが挙げられる:
β−リン酸三カルシウム(75nm〜500μmの範囲のサイズ)、
炭酸アパタイト(75nm〜500μmの範囲のサイズ)、及び
炭酸カルシウム(75nm〜500μmの範囲のサイズ)。
Claims (14)
- 骨移植片であって、
前記骨移植片の総重量に対して20重量%〜95重量%のI型コラーゲンと、
それぞれが異なる溶解特性及び/またはサイズを有する、前記骨移植片の総重量に対して20重量%〜95重量%の1つ以上の鉱物と、を含む、骨移植片。 - 前記骨移植片の総重量に対して0.2〜20重量%のヒアルロン酸と、
0.1〜20重量%の量の酸または塩基と、
前記骨移植片の総重量に対して20重量%〜95重量%の、前記骨移植片の総重量に対するDBMと、からなる群から選択される、少なくとも1つのさらなる成分をさらに含む、請求項1に記載の骨移植片。 - 前記I型コラーゲンが、ウシまたはブタ源に由来し、皮膚(真皮)または腱のいずれかから得られる、請求項1に記載の骨移植片。
- 前記1つ以上の鉱物が、75nm〜500μmの範囲のサイズを有するβ−リン酸三カルシウム、75nm〜500μmの範囲のサイズを有する炭酸アパタイト、及び75nm〜500μmの範囲のサイズを有する炭酸カルシウムからなる群から選択される、少なくとも1つの鉱物を含む、請求項1に記載の骨移植片。
- 20重量%〜95重量%のI型コラーゲンを少なくとも1つの鉱物と混合して、混合物を形成することと、
前記混合物を30分間〜5時間冷蔵することと、
前記混合物を6.5〜8.5のpHに中和することと、
前記混合物を1時間〜24時間冷蔵することと、
前記混合物を−20℃未満の温度で1時間〜最大24時間急速冷凍することと、
前記混合物を24〜72時間凍結乾燥させることと、
前記混合物を物理的または化学的に架橋することと、
前記混合物を凍結乾燥させることと、を含む、請求項1に記載の骨移植片を作製する方法。 - 前記中和が、前記混合物にHClまたはNaOHを添加することによって達成される、請求項5に記載の方法。
- 前記1つ以上の鉱物が、75nm〜500μmの範囲のサイズを有するβ−リン酸三カルシウム、75nm〜500μmの範囲のサイズを有する炭酸アパタイト、及び75nm〜500μmの範囲のサイズを有する炭酸カルシウムからなる群から選択される、少なくとも1つの鉱物を含む、請求項5に記載の方法。
- 前記骨移植片中の鉱物の総重量パーセントが、前記骨移植片の総重量に対して20重量%〜95重量%である、請求項5に記載の方法。
- 前記骨移植片の総重量に対して20重量%〜95重量%のI型コラーゲンを、所望される稠度に達し、前記混合物の所望のpHが得られるまで、0.2〜20重量%のヒアルロン酸と混合することと、
前記混合物を20時間〜72時間冷蔵することと、
さらに混合して均質なコラーゲン混合物を形成することと、
少なくとも1つの鉱物及び脱塩骨基質(DBM)を秤量することと、
前記鉱物(複数可)を前記コラーゲン混合物と混合することと、
前記混合物を30分間〜5時間冷蔵することと、
前記混合物を6.5〜8.5のpHに中和することと、
前記混合物を1時間〜24時間冷蔵することと、
前記混合物を−20℃以下の温度で1時間〜最大24時間急速冷凍することと、
前記混合物を24〜72時間凍結乾燥させて、乾燥パッド混合物を形成することと、
前記混合物を物理的または化学的に架橋することと、
前記混合物を凍結乾燥させることと、を含む、請求項5に記載の方法。 - 前記混合物を所望の寸法に打ち抜くか、または切り出すことをさらに含む、請求項9に記載の方法。
- 前記骨移植片中のDBMの総重量が、20〜95%である、請求項9に記載の方法。
- 請求項11に記載の少なくとも1つの骨移植片を、前記骨移植片を必要とする哺乳動物に挿入することを含む、方法。
- インプラントと請求項1に記載の骨移植片とを含む、製品。
- 請求項1に記載の少なくとも1つの骨移植片またはその構成要素と、
前記骨移植片の調製のための説明書、ならびに前記骨移植片の作製または使用を補助するための1つ以上のツール、デバイス、または他の構成要素からなる群から選択される、少なくとも1つの追加の構成要素と、を含む、キット。
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US14/177,967 | 2014-02-11 | ||
US14/177,967 US9463264B2 (en) | 2014-02-11 | 2014-02-11 | Bone grafts and methods of making and using bone grafts |
PCT/US2015/015495 WO2015123351A1 (en) | 2014-02-11 | 2015-02-11 | Bone grafts and methods of making and using bone grafts |
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EP (1) | EP3104902B1 (ja) |
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US10016529B2 (en) * | 2015-06-10 | 2018-07-10 | Globus Medical, Inc. | Biomaterial compositions, implants, and methods of making the same |
US10743996B2 (en) | 2017-03-24 | 2020-08-18 | Robert L. Bundy | Amnion putty for cartilage repair |
CN110201228A (zh) * | 2019-04-19 | 2019-09-06 | 湖北联结生物材料有限公司 | 一种含脱钙骨基质的磷酸钙骨水泥及其制备方法和应用 |
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US20170007740A1 (en) | 2017-01-12 |
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US20150223937A1 (en) | 2015-08-13 |
EP3104902A1 (en) | 2016-12-21 |
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EP3104902B1 (en) | 2021-04-14 |
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