JP3997239B2 - 脊椎固定インプラント及び挿入及び修正用工具 - Google Patents
脊椎固定インプラント及び挿入及び修正用工具 Download PDFInfo
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- JP3997239B2 JP3997239B2 JP2005218632A JP2005218632A JP3997239B2 JP 3997239 B2 JP3997239 B2 JP 3997239B2 JP 2005218632 A JP2005218632 A JP 2005218632A JP 2005218632 A JP2005218632 A JP 2005218632A JP 3997239 B2 JP3997239 B2 JP 3997239B2
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- Prior art keywords
- cap
- opening
- bone
- fixation
- load support
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- A61L2430/00—Materials or treatment for tissue regeneration
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Landscapes
- Health & Medical Sciences (AREA)
- Biomedical Technology (AREA)
- Engineering & Computer Science (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Transplantation (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Neurology (AREA)
- Cardiology (AREA)
- Surgery (AREA)
- Epidemiology (AREA)
- Physical Education & Sports Medicine (AREA)
- Molecular Biology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medical Informatics (AREA)
- Dentistry (AREA)
- Chemical & Material Sciences (AREA)
- Dermatology (AREA)
- Medicinal Chemistry (AREA)
- Prostheses (AREA)
- Materials For Medical Uses (AREA)
- Surgical Instruments (AREA)
- Steroid Compounds (AREA)
Description
更に、別の実施例では、椎体間固定装置は中空ではなく中実であって、相互連結された孔内への骨の内部成長を可能にする多孔性の高強度材料から構成される。好適な一実施例では、斯かる材料は骨誘導材料で塗布される。
例1
外科技術: 本研究には21頭の成長した雌のアルペン山羊を使用した。山羊の体重は42乃至62キログラムであった。全ての山羊に導入用に静脈バリウム及びケタミンを使用して一般的な麻酔をかけ、吸入ハロタンを使用して麻酔の維持を図りつつ外科処置を施した。前部頸を無菌状態に消毒して外科処置の準備を行い、長手方向に皮膚を切開して右前外側から頚椎へ接近した。十分に発達したロンゴス・コリ(longus coli)筋肉を中央で切開して、C2−C3、C3−C4及びC4−C5の円板空間を露出した。最初に軟質円板を切除して、各レベルの前部頸椎間板を切開した。次いで、ポストの中央に位置決めされた8mmの伸延プラグを円板空間内へ軽く打入して、円板空間を伸延する。作業用管がポスト及び円板空間の上下の椎骨体内へ打入された管の端部のプロング上を通過させた。これらのプロングが中心ポスト及び伸延プラグが除去されると円板空間の伸延を維持した。円板空間及び椎骨体/端部プレートが次いで作業用管を介して10mmのリーマを使用してが拡張即ちリーミングがなされた。拡張した時に生じた骨屑を蓄えておき、移植片材料として使用した。次いで、拡張されたチャネルに雌ねじを切った後で、直径10mmのチタンBAK装置(ミネソタ州、ミネアポリス市のスパインテック社(SpineTech, Minneapolis, Minnesota))を挿入した。前部の長手方向の靭帯の切除または脊柱管の露出の試みはなされなかった。
放射線透過写真結果: どのグループのケージも正常位置からの移動はなかった。グループIではルーセンシを備えたケージは3つあった。グループIIではルーセンシを備えたケージは4つあった。グループIIではルーセンシを示したのは21のケージ中1つもなかった。
設計: 12頭の成長した雌の羊にシングルレベルの中間腰椎椎体間固定を行った。全ての外科的解剖を同一の無菌状態にて実施した。前部固定部位の準備に続いて、インプラントを挿入した。単一ケージで横方向の配向をした、タイプIの原線維コラーゲン(ヘリスタット)(n=6)上に担持されたrhBMP−2を含んだねじの切られた椎体間固定装置(TIBFD)を用いて腹膜の後ろから接近する方法で処置された。研究(全てn=6)の前の四肢は自原性骨プラグ、自原性骨プラグのみ、または、模擬(空)の固定部位を備えたTIBFDを含んでいた。羊は術後直ぐに草を食むことを許され、外部から動けなくすることは一切しなかった。全ての羊は外科手術後6カ月で屠殺された。死んだ羊から取った14の脊椎を追加して基本線の椎骨間の機械的剛性測定値を決定した。
機械的試験データの結果: グループを関数とした平均標準変位を表IIIに表す。全体及び対の統計的比較からの結果を表IVに表す。平均剛性は各モードの試験(p=0.005、p=0.0001、p=0.0001、p=0.0001)共グループ(2つの処置及び手術なしでの制御)間で著しく差があった。
開放多孔性ポリ乳酸ポリマー(OPLA)を無菌の12.0mm×6.5mm×30mmのストリップパッケージを作る(各パッケージに2本のストリップ)。純OPLAをガンマ照射で無菌とする。rhBMP−2を凍結乾燥して粉末状にすると共に、無菌水で手術中に再構成をし、緩衝ビークル(vehicle)溶液で補足する。rhBMP−2を担体材料中へ導入すると共に、該担体を金属固定ケージ装置の中空内部へ設置する。次いで、該装置を固定部位へ移植する。
rhBMP−2コラーゲンインプラントをヘリスタットを吸収可能なコラーゲンヘモスタティック剤(Helistat Absorbaly Collagen Hemostatic Agent)(インテグラ・ライフサイエンス社(Integra LifeScience Corporation)及びrhBMP−2から作製する。コラーゲン担体を金属固定ケージ装置の中空内部へ設置する。該装置を固定部位へ移植する。
試験理由
rhBMP−2を湿潤したコラーゲンスポンジによる排除に対するエンドキャップの抵抗を測定して、測定した抵抗を公知のウレタン製のエンドキャップと比較するために試験を行った。
試験A
プレス嵌めエンドキャップの押出試験
本試験は、ポリエチレン製のプレス嵌めされたエンドキャップをBAK(登録商標)(ミネソタ州、ミネアポリス市のスパインテック社(Spine Tech,Minneapolis,Minnesota)装置から外すのに必要な静的力を決定するためになされた。エンドキャップはBAK装置にスナップ嵌めされ、軸線方向の荷重がBAK装置のキャビティを介してエンドキャップに加えられた。5つの試料の押出(push−out)荷重は約5.4432乃至16.7832kgf(12乃至37ポンドf)の範囲であった。
試験B
試験のセットアップ及び方法
チタン製の12mmのエンドキャップ(894−120、米国ソファモデネク)(894−XXX、米国、テネシー州、メンフィス市ソファモデネク)の試料を5つを、図18及び図19に図示した如き12mmのチタン製ノバス(NOVUS)(登録商標)LT(米国、サファモデネク)インプラント内へそれぞれ設置した。12mmのインプラントを閉ループサーボ油圧試験機の台に堅牢に固定した。試験機のアクチュエータをエンドキャップ内に螺入されたアダプタを介してエンドキャップへ取り付けた。軸線方向の荷重をかけて25mm/分の速度でエンドキャップが12mmのインプラントから完全に外れるまでエンドキャップを引き出した。最大荷重及び変位を含んだデータを記録してスーパスコープII(Superscope II)データ収集ソフトを使用して作図した。
試験C
試験Bの方法を9つの試料について繰り返し行ったが、使用した荷重は引き出し速度で12.5mm/分であった。平均引き出し荷重は平均で約13.87kgf(30.57lbf)であった。
検討及び結論
試験結果は本発明のエンドキャップが2つの理由で生体内排除に抗することを示している。第1は、椎骨間円板は複雑で複合された荷重を受けることは公知のことである。しかしながら、円板空間に作用する荷重のいずれもインプラントのエンドキャップに直接作用してエンドキャップを排除することはない。第2の理由は、rhBMP−2を湿潤したコラーゲンスポンジが177N(41.99ポンドf)の力を作用させてエンドキャップを排除することはあり得ない。
Claims (26)
- 隣接する椎骨間の椎間板空間内で関節固定を容易にするための固定装置であって、
一定の長さと、ほぼ全長に亘って伸長する室及び該室と連絡した開口部を画成する内側面を有する中空荷重支持体と、
前記室に配置されると共に、担体内に骨形態発生タンパク質を含んでいる骨形成材料とを備えている固定装置において、
前記荷重支持体は、該荷重支持体のほぼ全長に沿って伸長する一対の対向する円筒形部を備えた外側面と、該外側面の前記一対の対向する円筒形部上に画成され、前記荷重支持体のほぼ全長に沿って伸長する外側ねじと、前記対向する円筒形部間に連結され、前記荷重支持体の前記長さのかなりの部分に沿って伸長している一対のほぼ平らで対向する側壁とを備えていることを特徴とする固定装置。 - 前記骨形態発生タンパク質がrhBMP−2、rhBMP−7またはそれらの混合物であることを特徴とする請求項1に記載の装置。
- 前記担体がコラーゲンスポンジであることを特徴とする請求項1に記載の装置。
- 前記担体がヒドロキシアパタイト及びトリカルシウム燐酸エステルを含んだ二相セラミックであることを特徴とする請求項1に記載の装置。
- 前記荷重支持体がカルシウム燐酸エステル組成物を備えていることを特徴とする請求項1に記載の装置。
- 前記荷重支持体が、
第1の端部の第1の径と、該第1の端部に対向した第2の端部の、より大きな第2の径とを有しており、前記第1及び第2の径が前記隣接する椎骨間の前記空間より大きなサイズにされていることを特徴とする請求項1に記載の装置。 - 前記円筒形部は、前記長さのかなりの部分に沿ってテーパが付けられ、且つ、該円筒形部の第2の端部に前記第1の径より大きな第2の径を画成していることを特徴とする請求項1に記載の装置。
- 更に、前記開口部を閉塞するキャップであって、該キャップが前記開口部に接触するサイズ及び形状にされた閉塞体と、該閉塞体から突出し、前記閉塞体に結合された第1の端部と、前記荷重支持体に係合して前記開口部内で前記閉塞体を保持する係合手段を有する、対向する第2の端部とを含む細長いアンカーを有するキャップを備えていることを特
徴とする請求項6に記載の装置。 - 前記係合手段が前記第2の端部から突出するリップを備えていることを特徴とする請求項8に記載の装置。
- 前記荷重支持体の前記外側面が前記室と連絡した通し穴を画成し、前記アンカーが、前記キャップが前記開口部内へ挿入されて、前記リップが前記通し穴内へ係合した時に、前記閉塞体から前記通し穴まで到達する一定の長さを有していることを特徴とする請求項9に記載の装置。
- 更に、前記閉塞体の周囲から突出するフランジを備えていることを特徴とする請求項8に記載の装置。
- 前記外側壁が、前記リップが前記通し穴内へ係合されると、前記開口部と面一になることを特徴とする請求項8に記載の装置。
- 前記閉塞体が骨内部成長及びタンパク質の退出を可能にするサイズにされた該閉塞体を貫通する骨形成開口部を画成することを特徴とする請求項8に記載の装置。
- 前記閉塞体が駆動工具を収容する工具穴を画成することを特徴とする請求項8に記載の装置。
- 更に、前記開口部を閉塞するキャップであって、該キャップが前記開口部に接触するサイズ及び形状にされた閉塞体と、該閉塞体から突出し、前記閉塞体に結合された第1の端部と、前記荷重支持体に係合して前記開口部内で前記閉塞体を保持する係合手段を有する、対向する第2の端部とを含む細長いアンカーを有するキャップを備えていることを特徴とする請求項1に記載の装置。
- 前記係合手段が前記第2の端部から突出するリップを備えていることを特徴とする請求項15に記載の装置。
- 前記荷重支持体の前記外側面が前記室と連絡した通し穴を画成し、前記アンカーが、前記キャップが前記開口部内へ挿入されて、前記リップが前記通し穴内へ係合した時に、前記閉塞体から前記通し穴まで到達する一定の長さを有していることを特徴とする請求項16に記載の装置。
- 更に、前記閉塞体の周囲から突出するフランジを備えていることを特徴とする請求項15に記載の装置。
- 前記外側壁が、前記リップが前記通し穴内へ係合されると、前記開口部と面一になることを特徴とする請求項15に記載の装置。
- 前記閉塞体が骨内部成長及びタンパク質の退出を可能にするサイズにされた該閉塞体を貫通する骨形成開口部を画成することを特徴とする請求項15に記載の装置。
- 前記閉塞体が駆動工具を収容する工具穴を画成することを特徴とする請求項15に記載の装置。
- 前記担体は、前記室に合致するように折り疊まれた少くとも1枚のシートの形態であることを特徴とする請求項1に記載の装置。
- 前記少くとも1枚のシートの形態の前記担体は、ほぼ完全に前記室を満たしていることを特徴とする請求項22に記載の装置。
- 前記少くとも1枚のシートの形態の前記担体は、前記中空荷重支持体の前記開口部内へ少くとも部分的に伸長していることを特徴とする請求項22に記載の装置。
- 前記開口部は、前記一対の対向する円筒形部を貫通していることを特徴とする請求項24に記載の装置。
- 前記少くとも1枚のシートは単一のシートであることを特徴とする請求項22の装置。
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EP (2) | EP0888099B1 (ja) |
JP (2) | JP3808103B2 (ja) |
AT (2) | ATE286696T1 (ja) |
DE (2) | DE69737756T2 (ja) |
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- 1997-02-19 WO PCT/US1997/002672 patent/WO1997031517A2/en active IP Right Grant
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2000
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2003
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2008
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ES2236792T3 (es) | 2005-07-16 |
DE69737756D1 (de) | 2007-07-05 |
DE69732226D1 (de) | 2005-02-17 |
WO1997031517A2 (en) | 1997-08-28 |
JP2001508319A (ja) | 2001-06-26 |
JP3808103B2 (ja) | 2006-08-09 |
DE69732226T2 (de) | 2005-12-22 |
EP1504732B1 (en) | 2007-05-23 |
ES2287636T3 (es) | 2007-12-16 |
DE69737756T2 (de) | 2008-01-31 |
WO1997031517A3 (en) | 1997-10-23 |
ATE362740T1 (de) | 2007-06-15 |
ATE286696T1 (de) | 2005-01-15 |
EP1504732A1 (en) | 2005-02-09 |
JP2006006963A (ja) | 2006-01-12 |
EP0888099B1 (en) | 2005-01-12 |
PT1504732E (pt) | 2007-08-30 |
US6613091B1 (en) | 2003-09-02 |
US20050192669A1 (en) | 2005-09-01 |
EP0888099A2 (en) | 1999-01-07 |
US20090043394A1 (en) | 2009-02-12 |
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