JP4558694B2 - 強化した組織移植片およびその製造および使用の方法 - Google Patents
強化した組織移植片およびその製造および使用の方法 Download PDFInfo
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- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
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Description
本発明は以下の添付図面と共に考察して以下の詳細な説明を参考にすることよりさらに完全に理解することができる。
この実施例は生体崩壊性のメッシュの形態における補強材料を伴うおよび当該材料を伴わないそれぞれの三次元の弾性組織移植片の作成を示している。
凍結乾燥処理した40/60のポリカプロラクトン/ポリ乳酸(PCL/PLA)の発泡体、ならびに、埋め込まれたVICRYL編み状メッシュにより強化された同一の発泡体を実施例1に記載した方法と同様に作成した。これらの強化した移植片を縫合線引抜き強さおよび破裂強さについて試験し、実施例1の手順に従って作成した標準的なVICRYLメッシュおよび非強化状態の発泡体に対して比較した。
表1:縫合線引抜きデータ(ポンド(lbs))
時間 発泡体 メッシュ 発泡状のメッシュ
0日目 0.46 5.3±0.8 5.7±0.3
7日目 − 4.0±1.0 5.0±0.5
表2:破裂強さデータ(psi)
時間 ポイント編み状VICRYLメッシュ 発泡状の編み状メッシュ
0日目 1349.5 1366.8
7日目 1109.4 1279.6
メッシュ強化した発泡体移植片を動物体の調査において移植して現在使用されている骨盤床修復材料に対して比較した。この動物体の調査の目的は種々のポリマー支持骨格の皮下組織の反応および吸収を評価することであった。この組織の反応および吸収は背側の浅在筋膜内における移植後14日目および28日目において大まかに且つ組織学的に評価した。加えて、腹部の筋糸内の切開傷の破裂強さに関するこれらの支持骨格の作用を決定した。この破裂強さの試験は腹側に配置した各移植片および腹筋の接着層について14日目および28日目に行った。
表3:破裂強さ(PSI)
サンプル 14日目 28日目
メッシュ強化した発泡体 81.8±17.3 73±4.5
DermMatrix 70±4.0 70*
*1個のサンプルだけしか体外移植まで生存していなかったので標準偏差は有効でない。
この実施例はメッシュ強化した発泡体のハイブリッド構造の作成を記載している本発明の別の実施形態を説明している。
紡糸口金の電圧:25,000V
プレート電圧:接地状態
紡糸口金からマンドレルまでの距離:15cm
T形剥離試験(参考文献:ASTM D1876-95)に必要な初期的な把持を可能にするために一端部において別の方法で結合している層を分離してメッシュ強化した発泡体の剥離試験の試料を作成した。
(A) 生体適合性を有する組織移植片において、
連続気泡型の気孔構造を伴う気孔を有する生体吸収性の高分子発泡体部品と、
生体適合性を有しメッシュ含有の材料により形成されている補強部品を備えており、
前記発泡体部品の気孔が前記補強部品のメッシュの中に入り込んで当該補強部品に対して結合する様式で前記発泡体部品が前記補強部品と一体化されている移植片。
(1)前記発泡体部品が1個以上の層の中に存在している実施態様(A)に記載の移植片。
(2)前記補強部品が1個以上の層の中に存在している実施態様(A)に記載の移植片。
(3)前記隣接している発泡体の層が当該発泡体における気孔を形成しているウエブの少なくとも部分的な結合により互いに一体化している実施態様(1)に記載の移植片。
(4)前記発泡体部品が脂肪族ポリエステル、ポリ(アミノ酸)、コポリ(エーテル−エステル)、ポリアルキレン・オキサレート、ポリアミド、チロシン誘導型のポリカーボネート、ポリ(イミノカーボネート)、ポリオルトエステル、ポリオキサエステル、ポリアミドエステル、アミン基を含有しているポリオキサエステル、ポリ(酸無水物)、ポリホスファゼン、コラーゲン、エラスチン、生体吸収性のデンプン、およびこれらの組み合わせ物から成る群から選択されるポリマーにより形成されている実施態様(A)に記載の移植片。
(5)前記脂肪族ポリエステルがラクチド、グリコリド、ε−カプロラクトン、p−ジオキサノン(1,4−ジオキサン−2−オン)、トリメチレン・カーボネート(1,3−ジオキサン−2−オン)、トリメチレン・カーボネートのアルキル誘導体、δ−バレロラクトン、β−ブチロラクトン、γ−ブチロラクトン、ε−デカラクトン、ヒドロキシブチレート、ヒドロキシバレレート、1,4−ジオキセパン−2−オン、1,5−ジオキセパン−2−オン、6,6−ジメチル−1,4−ジオキサン−2−オン、2,5−ジケトモルホリン、ピバロラクトン、α,α−ジエチルプロピオラクトン、エチレン・カーボネート、エチレン・オキサレート、3−メチル−1,4−ジオキサン−2,5−ジオン、3,3−ジエチル−1,4−ジオキサン−2,5−ジオン、6,8−ジオキサビシクロクタン−7−オンおよびこれらの組み合わせ物から成る群から選択されるホモポリマーまたはコポリマーである実施態様(4)に記載の移植片。
(7)前記発泡体部品を構成しているポリマーが約200パーセントを越える伸び率を有している実施態様(A)に記載の移植片。
(8)前記発泡体部品を構成しているポリマーが約500psi(3.5×106 パスカル)を越える引張強さを有している実施態様(7)に記載の移植片。
(9)前記発泡体部品を構成しているポリマーが約50ポンド/インチ(8.9キログラム/センチメートル)を越える引裂強さを有している実施態様(8)に記載の移植片。
(10)異なるポリマーにより分離している発泡体層が構成されている実施態様(3)に記載の移植片。
(12)前記補強部品が生体吸収性である実施態様(A)に記載の移植片。
(13)前記補強部品が内部に複数の開口部を形成した固体部品を有するメッシュ状の材料を含む実施態様(A)に記載の移植片。
(14)前記メッシュの固体部品がポリ乳酸、ポリグリコール酸、ポリカプロラクトン、ポリジオキサノン、トリメチレン・カーボネート、ポリビニル・アルコール、およびこれらのコポリマーおよびこれらの組み合わせ物から成る群から選択される材料により作成した繊維により形成されている実施態様(13)に記載の移植片。
(15)前記メッシュの固体部品が生体吸収性のケイ酸塩ガラス、生体吸収性のリン酸カルシウム・ガラス、およびこれらの組み合わせ物から成る群から選択される材料により作成した繊維により形成されている実施態様(13)に記載の移植片。
(17)前記繊維がポリグリコール酸およびポリ乳酸の90/10のコポリマーにより形成されている実施態様(14)に記載の移植片。
(18)前記繊維がポリ乳酸およびポリグリコール酸の95/5のコポリマーにより形成されている実施態様(14)に記載の移植片。
(19)前記メッシュ状の材料が約12%乃至約80%の範囲内のメッシュ密度を有している実施態様(13)に記載の移植片。
(20)前記固体部品が、第2の異なる速度で生物学的に吸収可能な第2の生体吸収性のポリマーにより形成されているシースにより囲まれている第1の速度で生物学的に吸収可能な第1の生体吸収性のポリマーにより作成したコアを有している同時押出成形した繊維により作成されている実施態様(13)に記載の移植片。
(22)前記布地のバリアが前記移植片の上面部および下面部の上に形成されている実施態様(21)に記載の移植片。
(23)前記布地のバリアが過形成および組織接着に対するバリアとして有効な高密度で繊維質の布地である実施態様(21)に記載の移植片。
(24)前記布地のバリアが静電的に紡糸処理した脂肪族ポリエステルにより形成されている実施態様(23)に記載の移植片。
(B) 生体適合性を有する組織移植片である強化発泡体を作成するための方法において、
適当な溶媒中において発泡体を形成する高分子材料の溶液を供給する工程と、
メッシュ状の補強材料を供給する工程と、
前記補強材料を金型の中において所望の位置および所望の配向に配置する工程と、
前記溶液を制御されている様式で前記金型の中に加える工程と、
前記溶液を凍結乾燥してメッシュ補強した発泡体部品を有する組織移植片を得る工程を含む方法。
(25)前記高分子材料がコポリマーを含む実施態様(B)に記載の方法。
(27)前記高分子の溶液が約50:50の範囲内のモル比におけるε−カプロラクトン−コ−グリコリドおよびε−カプロラクトン−コ−ラクチドの混合物である実施態様(26)に記載の方法。
(28)前記高分子の溶液がポリグリコール酸およびポリカプロラクトンの35:65のコポリマーを含有している実施態様(26)に記載の方法。
(29)前記高分子の溶液がポリグリコール酸およびポリカプロラクトンの35:65のコポリマーと40:60のε−カプロラクトン−コ−ラクチドとの50:50の混合物である実施態様(26)に記載の方法。
(30)前記溶液がさらに約50ミクロン乃至1mmの範囲内の平均直径を有する生体相容性の生体適合性を有する固体粒子を含有しており、当該固体粒子が前記溶液の約1乃至50容量パーセントで存在している実施態様(B)に記載の方法。
(32)前記抽出可能な固形物が無毒性の塩類、単糖類、二糖類、多糖類、および水溶性タンパク質から成る群から選択される実施態様(31)に記載の方法。
(33)前記生体適合性を有する金属がステンレス・スチール、コバルト−クロム、チタン、およびチタン合金から成る群から選択される実施態様(31)に記載の方法。
(34)前記生体不活性なセラミックがアルミナ、ジルコニア、および硫酸カルシウムから成る群から選択される実施態様(31)に記載の方法。
(35)前記非生体吸収性のポリマーがポリ酢酸ビニル、ポリメチルメタクリレート、シリコーン、ポリエチレンオキシド、ポリエチレン・グリコール、ポリウレタン、ポリビニル・アルコール、弗素化ポリマー、弗素化コポリマー、セルロース、キチン、ケラチン、シルク、およびコラーゲンから成る群から選択される実施態様(31)に記載の方法。
(37)前記補強材料が、少なくとも部分的に、前記金型の底部から上方に宙吊りの状態になっている実施態様(36)に記載の方法。
(38)前記溶液が気泡を形成不能にする様式で前記金型に加えられる実施態様(36)に記載の方法。
(39)前記溶液を加えている間に前記金型が傾斜している実施態様(38)に記載の方法。
(40)前記高分子材料がポリグリコール酸およびポリカプロラクトンの35:65のコポリマーであり、前記補強材料がポリジオキサノン・メッシュである実施態様(B)に記載の方法。
(42)1種以上の指示手段が、当該移植片中で、所望の特性を有する前記移植片の配向状態を示す方向に埋め込まれている実施態様(B)に記載の方法。
(C) 組織の裂傷を修復する方法において、
連続気泡型の気孔構造を伴う気孔を有する生体吸収性の高分子発泡体部品および生体適合性を有しメッシュ含有の材料により形成されている補強部品を備えている生体適合性を有する組織移植片を供給する工程を含み、前記発泡体部品の気孔が前記補強部品のメッシュの中に入り込んで当該補強部品に対して結合する様式で前記発泡体部品が前記補強部品と一体化されており、さらに、
前記移植片を組織の裂傷に対して所望の位置に配置する工程と、
前記所望の位置における移植片を縫合する工程を含む方法。
(43)前記移植片が生体吸収性である実施態様(C)に記載の方法。
11 ウエブまたは壁部
12 高分子発泡体部品
13 気孔
14 補強部品
18 金型
Claims (17)
- 生体適合性を有する組織移植片において、
連続気泡型の気孔構造を伴う気孔を有する生体吸収性の高分子発泡体部品と、
生体適合性を有し、12%乃至80%の範囲内のメッシュ密度を有するメッシュ含有の材料により形成されている補強部品を備えており、
前記発泡体部品の気孔が前記補強部品のメッシュの中に入り込んで当該補強部品に対して結合する様式で前記発泡体部品が前記補強部品と一体化されており、
前記発泡体部品が2個以上の層として存在しており、
前記発泡体部品の層の少なくとも一つが、前記発泡体部品の他の層の少なくとも一つとは異なるポリマーにより構成されており、
前記発泡体部品の層が互いに隣接しており、当該隣接している発泡体の層が、当該発泡体における気孔を形成しているウエブの少なくとも部分的な結合により互いに一体化している、
移植片。 - 請求項1に記載の移植片において、前記補強部品が1個以上の層として存在している、移植片。
- 請求項1または2に記載の移植片において、前記発泡体部品のそれぞれの層が、脂肪族ポリエステル、ポリ(アミノ酸)、コポリ(エーテル−エステル)、ポリアルキレン・オキサレート、ポリアミド、チロシン誘導型のポリカーボネート、ポリ(イミノカーボネート)、ポリオルトエステル、ポリオキサエステル、ポリアミドエステル、アミン基を含有しているポリオキサエステル、ポリ(酸無水物)、ポリホスファゼン、コラーゲン、エラスチン、生体吸収性のデンプン、およびこれらの組み合わせ物から成る群から選択されるポリマーにより形成されている、移植片。
- 請求項3に記載の移植片において、前記発泡体部品のそれぞれの層が、ラクチド、グリコリド、ε−カプロラクトン、p−ジオキサノン(1,4−ジオキサン−2−オン)、トリメチレン・カーボネート(1,3−ジオキサン−2−オン)、トリメチレン・カーボネートのアルキル誘導体、δ−バレロラクトン、β−ブチロラクトン、γ−ブチロラクトン、ε−デカラクトン、ヒドロキシブチレート、ヒドロキシバレレート、1,4−ジオキセパン−2−オン、1,5−ジオキセパン−2−オン、6,6−ジメチル−1,4−ジオキサン−2−オン、2,5−ジケトモルホリン、ピバロラクトン、α,α−ジエチルプロピオラクトン、エチレン・カーボネート、エチレン・オキサレート、3−メチル−1,4−ジオキサン−2,5−ジオン、3,3−ジエチル−1,4−ジオキサン−2,5−ジオン、6,8−ジオキサビシクロオクタン−7−オンおよびこれらの組み合わせ物から成る群から選択されるホモポリマーまたはコポリマーである脂肪族ポリエステルから形成されたものである、移植片。
- 請求項1〜4のいずれかに記載の移植片において、前記発泡体部品のそれぞれの層が、ε−カプロラクトン−コ−グリコリド、ε−カプロラクトン−コ−ラクチド、p−ジオキサノン(1,4−ジオキサン−2−オン)−コ−ラクチド、ε−カプロラクトン−コ−p−ジオキサノン、p−ジオキサノン−コ−トリメチレン・カーボネート、トリメチレン・カーボネート−コ−グリコリド、トリメチレン・カーボネート−コ−ラクチド、およびこれらの組み合わせ物から成る群から選択される弾性コポリマーにより形成されている、移植片。
- 請求項1〜5のいずれかに記載の移植片において、前記発泡体部品を構成しているポリマーのそれぞれが200パーセントを超える伸び率を有している、移植片。
- 請求項1〜6のいずれかに記載の移植片において、前記発泡体部品を構成しているポリマーのそれぞれが500psi(3.5×106 パスカル)を超える引張強さを有している、移植片。
- 請求項1〜7のいずれかに記載の移植片において、前記発泡体部品を構成しているポリマーのそれぞれが50ポンド/インチ(8.9キログラム/センチメートル)を超える引裂強さを有している、移植片。
- 請求項1〜8のいずれかに記載の移植片において、前記補強部品が生体吸収性である、移植片。
- 請求項1〜9のいずれかに記載の移植片において、前記補強部品が、内部に複数の開口部を形成したメッシュ状の材料であって固体部品を有するメッシュ状の材料を含む、記載の移植片。
- 請求項10に記載の移植片において、前記メッシュの固体部品がポリ乳酸、ポリグリコール酸、ポリカプロラクトン、ポリジオキサノン、トリメチレン・カーボネート、ポリビニル・アルコール、およびこれらのコポリマーならびにこれらの組み合わせ物から成る群から選択される材料により作成した繊維により形成されている、移植片。
- 請求項10に記載の移植片において、前記メッシュの固体部品が生体吸収性のケイ酸塩ガラス、生体吸収性のリン酸カルシウム・ガラス、およびこれらの組み合わせ物から成る群から選択される材料により作成した繊維により形成されている、移植片。
- 請求項12に記載の移植片において、前記繊維が生体吸収性のケイ酸塩ガラスおよび生体吸収性のリン酸カルシウム・ガラスから成る群から選択され、前記固体部品が、鉄、ナトリウム、マグネシウム、カリウム、およびこれらの組み合わせから成る群から選択される1乃至50容量パーセントの元素をさらに含む、移植片。
- 請求項11に記載の移植片において、前記繊維がポリグリコール酸およびポリ乳酸の90/10のコポリマーにより形成されている、移植片。
- 請求項11に記載の移植片において、前記繊維がポリ乳酸およびポリグリコール酸の95/5のコポリマーにより形成されている、移植片。
- 請求項10に記載の移植片において、前記固体部品が、第2の異なる速度で生物学的に吸収可能な第2の生体吸収性のポリマーにより形成されているシースにより囲まれている第1の速度で生物学的に吸収可能な第1の生体吸収性のポリマーにより作成したコアを有している同時押出成形した繊維により作成されている、移植片。
- 請求項1〜16のいずれかに記載の移植片において、前記移植片の少なくとも1個の表面上に布地のバリア層をさらに備えている、移植片。
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US6599323B2 (en) | 2003-07-29 |
JP2006334430A (ja) | 2006-12-14 |
CA2365543C (en) | 2005-06-14 |
CA2365543A1 (en) | 2002-06-21 |
EP1987850A1 (en) | 2008-11-05 |
EP1216717A1 (en) | 2002-06-26 |
EP1987850B1 (en) | 2016-06-29 |
US20030193104A1 (en) | 2003-10-16 |
EP1216717B1 (en) | 2008-07-09 |
JP2002272833A (ja) | 2002-09-24 |
AU762895B2 (en) | 2003-07-10 |
DE60134710D1 (de) | 2008-08-21 |
JP4480928B2 (ja) | 2010-06-16 |
US20020120348A1 (en) | 2002-08-29 |
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