JP4504418B2 - 骨組織再生用生物活性人工器官装置の製造方法およびその人工器官装置 - Google Patents
骨組織再生用生物活性人工器官装置の製造方法およびその人工器官装置 Download PDFInfo
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- JP4504418B2 JP4504418B2 JP2007505665A JP2007505665A JP4504418B2 JP 4504418 B2 JP4504418 B2 JP 4504418B2 JP 2007505665 A JP2007505665 A JP 2007505665A JP 2007505665 A JP2007505665 A JP 2007505665A JP 4504418 B2 JP4504418 B2 JP 4504418B2
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- Prior art keywords
- prosthetic device
- bone
- hydroxyapatite
- bioactive
- tissue regeneration
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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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- 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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- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
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Description
図1は、骨小腔がある患者の頭蓋骨のコンピュータモデルを示す図である。
図2および図3は、前図に示されるコンピュータモデルから得られる樹脂モデルを示す図である。
図4および図5は、本発明に係る方法の連続する2つの工程を示す図である。
図6は、図5に関連する工程中における上述の図に示される頭蓋骨の断面図である。
図7は、たとえば大腿骨などの長い骨に関連する本発明の別の適用として、特に中央部分が欠けている患者の大腿骨を示す図である。
図8は、前図に示され、本発明に係る人工器官装置を備えている大腿骨を示す図である。
図9は、欠けている中央部分(骨の小腔)を備える上述の図に示された大腿骨および人工器官装置のための制御用型のコンピュータモデルの正面図である。
図10は、前図に示された型の断面図である。
1.患者のCTスキャン(Computerised Axial Tomography)と、骨の一部および再建されるべき骨欠損2の3次元コンピュータモデル1(図1および図7)を表現するCTスキャンファイルとを作成する。
2.患者のCTスキャンから得られるデータおよび前記CTスキャンファイルを基にして、プロトタイプを作るよう制御された高速のメインソフトウェアおよびインターフェースソフトウェアが、患者の骨の関係する範囲のプロトタイプ樹脂モデル3(図2、3および9)を作製するために用いられる。たとえば、3次元立体描画技術を用いて、モデル3を得ても良い。
3.この樹脂製プロトタイプは、鋳込み成形技術を用いて、再建されるべき患者の骨欠損のモデル4(硫酸カルシウム、樹脂、あるいは、シリコーンゴム)を作製するために用いられる。
4.前ポイントのモデルは、硫酸カルシウム、樹脂、あるいは、シリコーンゴムから、患者の骨欠損の反転である型5を作製するために用いられ、さらに、鋳込み成形技術が用いられる。この型を得るために、一種の仕切り6(図5および6)、あるいは、閉じこめ型7(図9)は、骨欠損2の領域の周りに適当な材料(たとえば、粘土、プラスチシン、あるいは、モデリング用ペースト)を用いて作製される。硫酸カルシウム、樹脂、あるいは、シリコーンゴムから作られる型5は、この仕切り6(あるいは、閉じこめ型7)の中で、鋳込み成形され、人工器官装置の形状および寸法を制御する役目を果たすこととなる。前記制御のために、型5は、半製品と型5との間のいかなる接触点も検出することができる媒体8(図6および9)を有している。この媒体8は、たとえば、接触した点で着色されるトレース紙の被覆でもよい。
5.すでに焼成し気孔径が0.1〜125μmの範囲と125〜2500μmの範囲とにある制御された連通気孔率(30〜90%)を有しており、Ca/P基の生体活性セラミック材料から作られる半製品(図示省略)を製造する。これらの材料は、イタリア特許IT−1307292、あるいは、ヨーロッパ特許出願EP−1411035(および対応する出願としてイタリア特許出願BO2002A000650)で述べられている材料であってもよい。この工程において、半製品は、患者の骨欠損のモデルよりも寸法は大きく、そして形状は非常に近いように作られる。
6.補填されるべき患者の骨欠損に対応する最終セラミック要素を得るために、形状とサイズのコンパレータとして、患者の骨欠損の反転型(ポイント4)を用いて、焼成した半製品の機械加工および手動の仕上げがされる。この半製品は、制御された連通気孔率(30〜90%)を有する気孔径の双峰分布が0.1〜125μmの範囲と125〜2500μmとの範囲にあり、Ca/P基のセラミック材料から作られる。機械加工および仕上げが、ダイアモンド含有フライスカッターで余分な材料を除去することによりなされる。
1.最終セラミック要素、すなわち、人工器官装置9(図8)の最終検査は、寸法および形状に関して、ポイント2で作製された、患者の骨の関係する範囲の樹脂モデル上で直接に装着され検査される。さらに、ポイント4で得られる反転型5を用いて検査される。
その形状および寸法は、患者の骨の関係する範囲のモデルから由来している。ラピッドプロトタイピング技術を用いて得られるモデルである。その構造は、気孔径が0.1〜125μmの範囲と125〜2500μmの範囲とにある双峰分布を有する所定の連通気孔率(30〜90%)を有しており、多孔質担体(セルロース、ポリウレタン、樹脂)、ゲルキャスティング、低圧射出成形の含浸/膨潤技術を用いて、Ca/P基セラミック合成材料(ハイドロキシアパタイト、リン酸三カルシウムあるいはそれらの混合物)から作られる。
患者のCTスキャンを行い、CTスキャンファイルを作成する(図1)。
CTスキャンファイルを読み取り、骨欠損の範囲を調べる。
ラピッドプロトタイピングの樹脂を用いて患者の骨の関係する範囲のモデルを作製する(図2および図3)。
硫酸カルシウム、樹脂、あるいは、シリコーンゴムを用いた骨欠損のモデルを作製する(図4)。
硫酸カルシウム、樹脂、あるいは、シリコーンゴムを用いた骨欠損の反転型を作製する(図5および図6)。
骨欠損よりも大きいサイズで、骨欠損に類似する形状を持ち、気孔径が0.1〜125μmの範囲と125〜2500μmの範囲とにある制御された連通気孔率(30〜90%)を有し、Ca/P基セラミック材料を用いた、焼成した半製品を作製する。
材料を除去するための機械加工と多孔質セラミック要素の仕上げを行う。
患者の骨の関係する範囲の樹脂モデルに装着して多孔質セラミック要素のサイズおよび形状の検査を行い、さらに骨欠損の反転を用いて行う。
多孔質セラミック要素の洗浄、乾燥、包装を行う。
ガンマ線による殺菌を行う。
2… 骨欠損
3… プロトタイプ樹脂モデル
4… モデル
5… 反転型
6… 仕切り
7… 閉じこめ型
8… 媒体
9… 人工器官装置
Claims (12)
- 骨組織再生用生物活性人工器官装置を製造する方法であって、
骨の一部および再建されるべき骨欠損(2)の3次元コンピュータモデル(1)を得るために、患者のCTスキャンを行う工程と、
患者の骨の関係する範囲のプロトタイプの樹脂モデル(3)を、プロトタイピングを通じて作製する工程と、
前記再建されるべき患者の骨欠損(2)のモデル(4)を作製する工程と、
前記再建されるべき患者の骨欠損(2)の反転型(5)を作製する工程と、
気孔径が0.1〜125μmの範囲と125〜2500μmの範囲とにある双峰分布を有する制御された連通気孔率(30〜90%)を有し、前もって焼成されたセラミック半製品を作製する工程と、を有し、
前記工程で得られる前記半製品が、前記骨欠損(2)の寸法および形状よりも若干大きい寸法および形状を持ち、
前記骨欠損(2)の正確な寸法および形状を得るために、前記焼成された半製品の機械加工および手動での仕上げを行う工程をさらに有する骨組織再生用生物活性人工器官装置の製造方法。 - プロトタイプの前記樹脂モデル(3)を、プロトタイピングを通じて作製する工程が、3次元立体描画技術を用いてなされる請求項1に記載の骨組織再生用生物活性人工器官装置の製造方法。
- 前記モデル(4)を作製する工程および/または前記反転型(5)を作製する工程が、鋳込み成形を用いてなされる請求項1または2に記載の骨組織再生用生物活性人工器官装置の製造方法。
- 前記機械加工および手動での仕上げが、高速回転するダイアモンド含有フライスカッターを用いて、余分な材料を除去することにより実行される請求項1〜3のいずれかに記載の骨組織再生用生物活性人工器官装置の製造方法。
- 前記患者の骨欠損(2)の反転型(5)が、前記半製品と前記反転型(5)との間のいかなる接触点も検出することができる媒体(8)を有している請求項1〜4のいずれかに記載の骨組織再生用生物活性人工器官装置の製造方法。
- 前記半製品と前記反転型(5)との間のいかなる接触点も検出することができる前記媒体(8)が、前記接触点で着色されるトレース紙の被覆を有する請求項5に記載の骨組織再生用生物活性人工器官装置の製造方法。
- 前記人工器官装置を作製するために用いられる材料が、Ca/P基の生体活性セラミック材料である請求項1〜6のいずれかに記載の骨組織再生用生物活性人工器官装置の製造方法。
- 前記装置を作製するために用いられる材料が、化学量論的ハイドロキシアパタイト、非化学量論的ハイドロキシアパタイト、炭酸化ハイドロキシアパタイト、マグネシウムあるいは塩化物リッチハイドロキシアパタイト、ストロンチウムあるいはナトリウムリッチハイドロキシアパタイト、マグネシウムリッチ炭酸化ハイドロキシアパタイト、割合比が50%−50%、70%−30%、30%−70%であるハイドロキシアパタイト/βリン酸三カルシウム、αリン酸三カルシウム(αTCP)、βリン酸三カルシウム(βTCP)、αリン酸三カルシウム(αTCP)とβリン酸三カルシウム(βTCP)との混合物からなる群から選ばれるセラミック材料である請求項1〜7のいずれかに記載の骨組織再生用生物活性人工器官装置の製造方法。
- 寸法および形状に関して前記人工器官装置要素を最終検査する工程をさらに有し、前記検査が、患者の骨の関係する範囲の樹脂モデルに装着して検査され、さらに反転型(5)を用いる請求項1〜8のいずれかに記載の骨組織再生用生物活性人工器官装置の製造方法。
- 請求項1〜9のいずれかの方法により製造された骨組織再生用生物活性人工器官装置であって、
その寸法および形状が患者の骨の関係する範囲のモデルに由来し、前記モデルが、ラピッドプロトタイピング技術を用いて得られ、
前記人工器官装置が、気孔径が0.1〜125μmの範囲と125〜2500μmの範囲とにある双峰分布を有する所定の連通気孔率(30〜90%)を有し、
多孔質担体(セルロース、ポリウレタン、樹脂)、ゲルキャスティング、低圧射出成形の含浸/膨潤技術を用いて、Ca/P基セラミック合成材料から作られる骨組織再生用生物活性人工器官装置。 - 前記人工器官装置が、化学量論的ハイドロキシアパタイト、非化学量論的ハイドロキシアパタイト、炭酸化ハイドロキシアパタイト、マグネシウムあるいは塩化物リッチハイドロキシアパタイト、ストロンチウムあるいはナトリウムリッチハイドロキシアパタイト、マグネシウムリッチ炭酸化ハイドロキシアパタイト、割合比が50%−50%、70%−30%、30%−70%であるハイドロキシアパタイト/βリン酸三カルシウム、αリン酸三カルシウム(αTCP)、βリン酸三カルシウム(βTCP)、αリン酸三カルシウム(αTCP)とβリン酸三カルシウム(βTCP)との混合物からなる群から選ばれるセラミック材料から作られる請求項10に記載の骨組織再生用生物活性人工器官装置。
- 医学的または腫瘍学的療法において、薬物および/または化学療法物質が結合されてもよい「薬物放出」のための骨伝導効果および/または担体を作り出すために、前記人工器官装置が、細胞および/または成長因子の付着のための担体(足場)を構成している請求項10または11に記載の骨組織再生用生物活性人工器官装置。
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EP04425224A EP1584308B1 (en) | 2004-03-30 | 2004-03-30 | A method for the production of a biologically active prosthetic device for the reconstruction of bone tissue and the prosthetic device itself |
PCT/IB2005/000852 WO2005094730A1 (en) | 2004-03-30 | 2005-03-29 | A method for the production of a biologically active prosthetic device for the reconstruction of bone tissue and the prosthetic device itself |
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BRPI0802517A2 (pt) * | 2008-07-29 | 2011-08-23 | Alberto Blay | processo de obtenção de complemento ósseo a ser utilizado (enxerto) |
EP2518792B1 (en) | 2009-12-24 | 2019-05-15 | GS Yuasa International Ltd. | Lid for storage battery, injection-molding method for the lid, storage battery with the lid, and terminal section for storage battery |
ITMI20110094A1 (it) * | 2011-01-27 | 2012-07-28 | Ghimas Spa | Procedimento di realizzazione di sostituti e/o riempitivi ossei realizzati su misura in materiali bioattivi e biomimetici. |
FR2975893B1 (fr) | 2011-05-30 | 2013-07-12 | 3Dceram | Implant renforce en ceramique biocompatible et son procede de fabrication |
WO2013041906A1 (en) * | 2011-09-19 | 2013-03-28 | Tecres S.P.A. | Modular spacer device for the treatment of infections of the prosthesis of the human limbs |
WO2013052361A1 (en) * | 2011-10-03 | 2013-04-11 | The Cleveland Clinic Foundation | Synthetic bone model and method for providing same |
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CN103584930B (zh) * | 2013-10-23 | 2016-01-06 | 华南理工大学 | 一种个性化全膝关节植入假体逆向设计与制造方法 |
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CN106580523B (zh) * | 2016-11-30 | 2019-07-23 | 北京爱康宜诚医疗器材有限公司 | 股骨髁前脸骨缺损填充假体 |
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US20080243458A1 (en) | 2008-10-02 |
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ZA200608619B (en) | 2007-12-27 |
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