JP2008543508A - 骨誘導および骨移植片一体化を促進するための骨移植片処理 - Google Patents
骨誘導および骨移植片一体化を促進するための骨移植片処理 Download PDFInfo
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- JP2008543508A JP2008543508A JP2008518409A JP2008518409A JP2008543508A JP 2008543508 A JP2008543508 A JP 2008543508A JP 2008518409 A JP2008518409 A JP 2008518409A JP 2008518409 A JP2008518409 A JP 2008518409A JP 2008543508 A JP2008543508 A JP 2008543508A
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- hole
- bone
- bone graft
- bioactive agent
- padding
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Abstract
Description
本発明の一実施形態では、孔は、該孔の形状が孔開口部に加わる流体の力を低減させ、かつ孔内に置かれた流体の保持を高めるように形成される。このような孔は、詰め物の有無にかかわらず、それらの孔内で生物活性剤を保持する。図2は、流体保持を高める形状を有する孔を示す。このような孔は、例えば、適切なサイズのボールエンドミルなど、様々な手段を使用して当業者が作り出すことができる。これらの孔は、一般に、孔12の基部の直径よりも小さい直径10をもつ開口部を有する。重力によってカラム内の流体が孔開口部を押すように上下逆さまにされるときには、加わる力は、孔内の流体の質量全体ではなく、開口部の真上にある流体のカラムの直径に基づく。
W=孔の入口の上方の流体カラムの重量(ダイン)
d=孔入口の上方の突き出た流体カラムの直径(cm)
A=孔入口での直径に基づいた孔の断面積(cm2)
ρ=孔内に含まれる流体の密度(g/cm3)
γ=孔内に含まれる流体の表面張力(ダイン/cm)
g=重力定数(cm/秒2)
h=流体カラムの高さ(cm)
これらの因子を使用すると、孔直径と孔高さとの関係を図5のようにグラフ化することができ、その際、所与の流体について孔の直径/高さ比が曲線よりも下の領域に位置する場合、孔開口部が下方に向けられたときに表面張力が孔内で流体を保持することになる。
安楽死させたヒツジからの脛骨および中足骨を、ラベル付けし、解剖からOrthopaedic Bioengineering Research Lab(コロラド州立大学(Colorado State University)、米国コロラド州フォートコリンズ(Fort Collins))に輸送した。術中外科用マーカと綿密な調査とによって、欠損を視覚的に識別した。欠損およびその周囲の骨を、Exakt Bone Saw(Exakt Technologies、米国オクラホマ州オクラホマシティ(Oklahoma City))を使用して慎重に切断した。生体力学的試験を受ける欠損については、試験固定具における据付けおよび方向付けの目的で、4〜5cmの宿主骨を保持するようにできる限り努めた。組織学的標本については、欠損を取り囲む1cm以下の骨を保持したにすぎない。生体力学的および組織学的な各標本を、矢状方向および冠状方向の両方で放射線撮影した。
トリミングしたサンプルを、70%エチルアルコール(ETOH)に1週間浸すことによって固定した。Technovit7000(包埋樹脂)の濃度を増加させながら、標本を段階的なETOH溶液(70%、95%、および100%)中で約3週間にわたって脱水した。最終溶液は、100%の包埋樹脂を含んでおり、光活性化を用いて重合させた。Exaktダイヤモンド刃骨鋸(Exakt Technologies、米国オクラホマ州オクラホマ)を使用して、標本ブロックから欠損の長手軸に沿って2つの切片を切り取った。Exaktマイクログラインダを使用して、切片を厚さ10〜20μmに研削し、骨基質への移植片一体化の質的評価、骨再生、および生体材料に対する組織反応の病理学的評価のために、変法Van Gieson骨染色液を使用して染色した。切片を変法Van Gieson染色液で染色して、骨(赤)、インプラント(不透明)、類骨(緑)、および繊維性組織(青)[データは示さず]の間に鮮明な色の対比をもたらした。
Image Pro Imagingシステム(Media Cybernetics、米国メリーランド州シルバースプリング(Silver Spring))、およびNikonE800顕微鏡(AG Heinze、米国カリフォルニア州レイクフォレスト(Lake Forest))、SpotRTデジタルカメラ(Diagnostic Instruments、米国ミシガン州スターリングハイツ(Sterling Heights))を使用して、組織学的画像を取得した。移植片と宿主組織とは、非常に似ていて、自動セグメンテーションを信頼できないものにしていたので、移植片組織の手作業による選択が必要であった。測定された組織形態学的パラメータには、移植片で満たされた欠損パーセント、骨で満たされた欠損パーセント、移植片で満たされた骨膜仮骨パーセント、骨で満たされた骨膜仮骨パーセント、移植片で満たされた骨内膜仮骨パーセント、移植片で満たされた骨内膜仮骨パーセント、骨膜仮骨の高さ(mm)、および骨内膜仮骨の高さ(mm)が含まれた。
次の指標を使用し、55個のスライドに基づいて、再生組織を正常性および移植片材料に対する細胞反応について評価した:同種移植片詰め物の存在(YまたはN);炎症細胞(0=なし、1=若干、2=多い);同種移植片吸収の程度(0=なし、1=0〜25%、2=25〜50%、3=50〜75%、4=75〜100%);同種移植片の一体化が優勢な表面(E=骨内膜、P=骨膜、B=E&P両方、H=宿主骨、A=すべての表面);同種移植片の活性な破骨細胞吸収(0=なし、1=若干、2=広範囲);活性な骨芽細胞の骨形成(0=なし、1=若干、2=広範囲);同種移植片内の新生骨の再建(0=100%繊維性骨、1=若干、主に繊維性、2=主に層状、いくらか繊維性、3=完全に層状骨へと再建されている);欠損内の繊維性または軟骨性組織の存在(YまたはN);同種移植片と宿主骨との統合(0=骨統合、1=繊維性の被膜形成、2=骨および繊維性統合の混合状態);同種移植片詰め物拡張(E=髄管内への拡張、P=骨膜表面からの拡張、C=皮質内に含まれる);仮骨の記述(0=仮骨なし、B=骨膜および骨内膜両方の仮骨、E=骨内膜仮骨、P=骨膜、X=評価できず);該当する場合、より大きな仮骨(E=骨内膜、P=骨膜;骨内膜仮骨のサイズ(0=なしまたは最小、1=皮質厚の0〜25%、2=皮質厚の25〜50%、3=皮質厚の50〜75%、4=皮質厚の75〜100%);骨膜仮骨のサイズ(0=なしまたは最小、1=皮質厚の0〜25%、2=皮質厚の25〜50%、3=皮質厚の50〜75%、4=皮質厚の75〜100%);仮骨の再建(0=100%繊維性骨、1=若干、主に繊維性、2=主に層状、いくらか繊維性、3=完全に層状骨へと再建されている)。
すべての生体力学的標本を安楽死の日に試験した。Exakt鋸上に配置して切断した後で、標本をタグ付けし、生理的食塩水を浸み込ませたガーゼで包んだ。荷重と垂直に交わる同種移植片構造物の向きを可能にするように、各標本を切断した。簡潔に言えば、脛骨または中足骨の矢状切片を、それぞれが2つの欠損をもつ遠位端および近位端へと横方向に切り分けた。皮質表面に対する詰め物移植片の垂直な載置を可能にするように、標本を位置合わせジグの上に据え付けた。骨膜表面(視覚化しやすい)上で詰め物移植片を方向付けることによって位置合わせを達成し、位置合わせした後には、試験標本を、骨内膜表面からの押出しのために180度反転させた。位置合わせジグは(依然として標本に取り付けられているが)、もはや実際の試験中には標本に支持も方向付けももたらさなかった。押出しのための同種移植片詰め物の位置合わせに関わる手順の詳細について、以下で論じる。
Claims (41)
- 骨移植片において、
a)前記骨移植片の少なくとも1つの表面に形成された少なくとも1つの孔と、
b)前記孔内に置くための詰め物とを含む、骨移植片。 - 天然骨、合成材料、またはそれら両方の組合せから形成される、請求項1に記載の骨移植片。
- 前記詰め物が、海綿骨、多孔質コラーゲン、ゼラチン、ヒアルロン酸、セルロース、デンプン、リン酸カルシウム、多孔質合成物質、またはそれらの組合せから構成される群から選択される少なくとも1つの材料から形成される、請求項1に記載の骨移植片。
- 前記孔が生物活性剤を含む、請求項1に記載の骨移植片。
- 前記詰め物の挿入前に、生物活性剤が前記孔内に適用される、請求項1に記載の骨移植片。
- 前記詰め物が生物活性剤を含む、請求項1に記載の骨移植片。
- 前記詰め物が前記孔に挿入される前に、生物活性剤が前記詰め物に適用される、請求項1に記載の骨移植片。
- 前記詰め物が、前記孔に挿入される前に、少なくとも1つの生物活性剤を含む溶液に浸される、請求項7に記載の骨移植片。
- 前記詰め物が前記孔に挿入された後で、生物活性剤が前記詰め物に適用される、請求項1に記載の骨移植片。
- 前記詰め物の形状が、前記孔の形状に相補的である、請求項1に記載の骨移植片。
- 前記孔の内部表面が脱灰される、請求項1に記載の骨移植片。
- 前記孔が、前記孔の基部の直径よりも小さい開口部直径を有する、請求項1に記載の骨移植片。
- 外科的植込みの間に、少なくとも1つの生物活性剤を保持する骨移植片であって、骨移植片は、当該骨移植片の少なくとも1つの表面に形成された少なくとも1つの孔を含み、前記孔は、直径に対する深さの比が約2乃至1である、骨移植片。
- 骨移植片の表面で少なくとも1つの生物活性剤を保持するリザーバにおいて、
a)骨移植片の少なくとも1つの表面に形成された孔と、
b)詰め物と前記孔の底面との間に空間を形成するように、前記孔内に置かれた前記詰め物とを含む、リザーバ。 - 前記孔が、前記孔の基部の直径よりも小さい開口部直径を有する、請求項14に記載のリザーバ。
- 前記詰め物が多孔質である、請求項14に記載のリザーバ。
- 前記詰め物が、海綿骨、多孔質コラーゲン、ゼラチン、ヒアルロン酸、セルロース、デンプン、リン酸カルシウム、またはそれらの組合せから構成される群から選択される少なくとも1つの材料で形成される、請求項14に記載のリザーバ。
- 前記生物活性剤が、LIM石灰化タンパク質(LMP)、骨形成タンパク質(BMP)、成長分化因子(GDF)、CHRYSALIN(登録商標)、骨髄穿刺液、濃縮骨髄穿刺液、間葉細胞、脱灰骨基質(DBM)、粒子状骨、抗生物質、抗感染組成物、鎮痛剤、またはそれらの組合せから構成される群の中から選択される、請求項15に記載の骨移植片リザーバ。
- 骨移植片において、当該骨移植片の少なくとも1つの表面に形成された少なくとも1つの孔を含んでおり、前記孔内に流体が入れられて詰め物が挿入されたときに、前記孔が、前記孔開口部の上に孔開口部に加わる流体張力よりも小さい流体の正味重量をもたらす、骨移植片。
- 骨移植片孔内で少なくとも1つの生物活性剤を保持する、詰め物。
- 前記詰め物が多孔質である、請求項44に記載の詰め物。
- 前記詰め物が、海綿骨、多孔質コラーゲン、ゼラチン、ヒアルロン酸、セルロース、デンプン、リン酸カルシウム、多孔質合成物質、またはそれらの組合せから構成される群から選択される少なくとも1つの材料から形成される、請求項21に記載の詰め物。
- 送達システムにおいて、
a)少なくとも1つの孔を有する骨移植片であって、前記孔が、前記骨移植片の少なくとも1つの表面に形成される、骨移植片と、
b)前記孔に挿入するための少なくとも1つの詰め物とを含む、システム。 - 生物活性剤をさらに含む、請求項23に記載のシステム。
- 前記骨移植片が前記表面上に複数の孔を有する、請求項23に記載のシステム。
- 前記複数の孔が、前記骨移植片の表面上で均等に離隔される、請求項25に記載のシステム。
- 前記複数の孔が、隣接骨表面との接触を最大にするような構成で離隔される、請求項25に記載のシステム。
- 前記複数の変形すべてが詰め物を有する、請求項25に記載のシステム。
- 前記複数の変形の一部分が詰め物を有する、請求項25に記載のシステム。
- 前記詰め物が、前記少なくとも1つの孔内で生物活性剤を吸収もしくは吸着して保持する、請求項25に記載のシステム。
- 前記少なくとも1つの孔が、生物活性剤を収容可能な形状を有する、請求項25に記載のシステム。
- 前記少なくとも1つの孔が、流体保持を促進する形状を有する、請求項25に記載のシステム。
- 前記形状が、流体静力学的引力による生物活性剤の保持を高める、請求項32に記載のシステム。
- 前記少なくとも1つの孔の前記形状が、不規則形状、規則形状、くさび形、円筒形、楕円形、湾曲形、直線形、四角形、ピラミッド形、およびそれらの組合せから構成される群から選択される、請求項32に記載のシステム。
- 前記詰め物が、前記少なくとも1つの孔の前記形状に対応する形状を有する、請求項34に記載のシステム。
- 前記少なくとも1つの孔が、脱灰された内部表面を有する、請求項25に記載のシステム。
- 前記内部表面が、塩酸を適用することによって脱灰される、請求項36に記載のシステム。
- 前記骨移植片が椎体間癒合装置である、請求項23に記載のシステム。
- 骨移植片において、
a)少なくとも1つの孔を有する少なくとも1つの表面であって、前記少なくとも1つの孔は、少なくとも1つの生物活性剤を受けるように適合される、少なくとも1つの表面と、
b)任意で、前記孔のための詰め物と、
c)前記少なくとも1つの孔内に含まれる少なくとも1つの生物活性剤とを含む、骨移植片。 - 骨移植片において、
a)少なくとも1つの孔を有する少なくとも1つの表面であって、前記孔の形状が、前記孔内での少なくとも1つの生物活性剤の保持を高めるように適合される、少なくとも1つの表面と、
b)前記少なくとも1つの孔内に含まれる少なくとも1つの生物活性剤とを含む、骨移植片。 - 送達システムにおいて、
a)少なくとも1つの孔を有する少なくとも1つの表面を含む骨移植片であって、前記孔の形状が、前記孔内での少なくとも1つの生物活性剤の保持を高めるように適合される、骨移植片と、
b)前記孔内に配置された少なくとも1つの生物活性剤とを含む、送達システム。
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Also Published As
Publication number | Publication date |
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EP1909860A2 (en) | 2008-04-16 |
JP2012139539A (ja) | 2012-07-26 |
WO2007002339A2 (en) | 2007-01-04 |
CN101287506A (zh) | 2008-10-15 |
CA2612688A1 (en) | 2007-01-04 |
AU2006262079A1 (en) | 2007-01-04 |
JP5319815B2 (ja) | 2013-10-16 |
WO2007002339A3 (en) | 2008-03-06 |
US8092548B2 (en) | 2012-01-10 |
US20060293757A1 (en) | 2006-12-28 |
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