JP5275795B2 - 止血特性を有する極めて多孔性の自己密着ウェブ材料 - Google Patents
止血特性を有する極めて多孔性の自己密着ウェブ材料 Download PDFInfo
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Description
止血性のために使用される場合、この極めて多孔性の伸長された自己密着生体吸収性ウェブ材料は出血している組織に対して配置され、そしてこの生体吸収性および/または非生体吸収性材料はウェブ材料に等しく圧力がかかるように止血されるまで失血箇所に押しつけられる。さらに好ましい実施態様において、非生体吸収性材料をこの極めて多孔性の伸長された自己密着生体吸収性ウェブ材料に解放可能なように付着させて、止血後数時間または数日で非生体吸収性材料を患者の体から傷をつけずに取り外すことを可能にする。この複合材料の非生体吸収性材料に、この極めて多孔性の伸長されたウェブ材料のためのキャリアーとして役に立つ材料を配置することができる。この非吸収性材料は、液体および/または細胞の内側への成長または細胞のプロセスに対する障壁としても役立つ(図22、アイテム30)。好ましい非生体吸収性材料は、フッ素重合体組成のものであるが、多孔性延伸ポリテトラフルオロエチレン(ePTEE)及び/又はフッ素化エチレンプロピレン(FEP)が最も好ましい。他の好ましいフッ素重合体材料はMcGregorらに付与された米国特許第5,429,869号に記載されたような多孔性の発泡材の形態であり、引用によりここに組み込まれる。多孔性の発泡したフッ素重合体材料は好ましくはポリテトラフルオロエチレン(PTEE)粒子の分散体を延伸可能なミクロスフィアとともに延伸することによって造られる。このミクロスフィアはPTFE分散体に配合されて、そして熱または他の好適なエネルギー源に晒される。このミクロスフィアは、延伸可能な液体またはガス状の揮発性流体を取り囲む可塑性コーティングを含む。Morehouseらに付与された米国特許第3,615,972号で説明されるとおり、熱可塑性のミクロスフィアは熱に晒されたときに劇的に延伸するように適合している。これらのミクロスフィアは、揮発性流体をカプセル化する樹脂を含む多数の材料を含む単細胞の粒子である。加熱されると、この熱可塑性ミクロスフィアの樹脂を含む材料が柔らかくなり、そしてその揮発性材料が延伸し、ミクロスフィア全体の寸法が実質的に増す。冷却すると、このミクロスフィアの殻の中の樹脂を含む材料が流れを止め、その拡大された寸法を維持する傾向にある;このミクロスフィア内部の揮発性の流体は凝縮する傾向にあり、ミクロスフィア内の圧力を下げる。通常、この結果としてもたらされる多孔性の発泡したPTFE材料は焼結を必要としない。他の好適な非生体吸収性材料は、ポリエチレン、ポリエチレンテレフタレート、ポリプロピレン、ポリアミドおよび炭素複合材を含むが、これらに限定はされない。
この例は、本発明の物品の形成について記述する。最初に、アニールされていない不織自己密着重合体前躯体ウェブを形成した。前駆体ウェブ材料をわずかに加熱し、ウェブ材料の多孔率を増大させるべく単一の又は1軸の方向での伸長に付した。極めて多孔性の自己密着ウェブ材料を次に熱で硬化させた。
希釈溶液を作るため、25mlのヘキサフルオロイソプロパノール(HFIP)に中に約29mgの上述の前躯体ウェブを溶解させた。該溶液は、30℃(+/−0.05℃)の水浴中に浸漬させたCanon Ubbelohde粘度計を用いて測定した場合に0.97dl/gの固有粘度(IV)を有していた。従って、IVは加工の間に、ペレット化された共重合体内での1.53dl/gの初期値から前躯体ウェブ内の0.97dl/gの値まで降下したことが観察された。
パーキンエルマーDSC7示差走査熱量計(DSC)を用いたその熱分析を可能にするため、適切にサイズ決定された試料を上述の前躯体ウェブから得た。10℃/分で走査を実施し、計器の温度をIntracoolerII冷凍ユニットで加減した。摂氏マイナス20度(−20℃)と250℃の間で一回の走査を実施し、以下の結果(TABLE2)を得た。
この例では、例1で記述されたさまざまなベルト速度及び横方向延伸比を用いて生産された前駆体ウェブが、さまざまなウェブ密度及び伸長又は圧伸比について得られた。加工後に、本発明のこの実施形態の代表的部域の走査型電子顕微鏡写真(SEM)が生成された。本発明の伸長されたウェブ及び該ウェブを含むフィラメントのいくつかの特性が、以下の通りに定量化された。
Y=0.4726×-0.9979
という方程式により近似され得る冪関数に従うように見えることが発見された(図8参照)。この関係を用いかつ図8を参照すると、20ミクロンの横断面直径をもつフィラメントが約0.024の複屈折値を有するものと予期できるということが決定された。かくして、20ミクロン未満の横断面直径を有するフィラメントは、無理なく0.025超の複屈折値を有すると予期され得る。
例1に記述されている材料を伸長した結果として、単位面積あたりの重合体材料の量(面積密度)及び単位体積あたりの重合体材料の量(体積密度)の両方が削減された。(0.67フィート/分(20.4cm/分)のベルト速度で生産された)前駆体ウェブを、ウェブ材料を完全にアニール又は「熱硬化」させるべく25分間100℃に設定したオーブン内でさらに加工した。
(Ppolymer−Pscaffold)÷Ppolymer×100。
この例は、本発明の一軸伸長された(6:1の伸長比)ウェブ材料のための引張応力−ひずみデータの生成について記述している。該ウェブ材料は、ベルト速度が0.26フィート/分(7.9cm/秒)であったという点を除いて、例1に従って生産された。
等価厚み=面積密度/重合体の比重
この例は、50:50のポリ(グリコリド)対ポリ(トリメチレンカーボナート)(w/w)比を有するPGA:TMCのA生体吸収性3ブロック共重合体を用いた本発明の物品の形成について記述している。
この例は、前駆体ウェブ材料の多重層を用い実質的に直交する方向で層状化された材料を伸長することによる本発明の物品の形成について記述している。
この例は、第1の長手方向ウェブ伸長手順とそれに続く同じウェブの後続横方向伸長手順から生産された材料を描写している。このウェブ材料は本書では、「長手方向−横方向伸長ウェブ」と呼ばれる。アニールされていない未伸長自己密着前駆体ウェブ材料は、例1に従って調製され、本発明の材料を形成するために以下の通りに加工された。
この例は、本発明の2つの伸長された自己密着ウェブ材料の形成について記述する。ウェブ材料は、加工中に2方向(x軸及びy軸)において同時に2軸伸長された。
この例は、本発明の伸長されたウェブ材料の形成について記述している。伸長されたウェブ材料は、増大したロフト及びしなやかさを有し、加わった変形力が除去された時点で実質的にそのもとの形状を回復する。
この例は、全ての方向に同時に半径方向に前駆体ウェブ材料を伸長することによる。本発明の物品の形成について記述している。この例では、単一及び多重の両方の層状化された前駆体ウェブ材料が半径方向に伸長される。一部の実施形態においては、これらの多重層状化前駆体ウェブ材料は、完成ウェブ材料内で一緒に積層された状態となった。
この例は、本発明のさまざまな実施形態で観察される多孔率値を編集して提供している。最初は、例1に記述されている通りの前駆体ウェブ材料を7.9、14.0、20.4及び48.0cm/分のベルト速度で調製し、拘束下でアニールし、その後体積密度及び多孔性百分率について評価した。ガラス製顕微鏡スライド及び例8に記述されている通りの光学比較器を用いて完成ウェブ材料の高さを制御することによって多孔性百分率値を決定した。最高の多孔性百分率を有する本発明の伸長されたウェブ材料は、48.0/分というベルト速度で得られた。
この例は、表の形で本発明の物品の形成について記述している(図13)。
この例は、軸方向長さを変更する能力と組合せて、第1の初期直径から第2のより大きな直径まで直径を増大させる能力を有する管状形態での本発明の物品の形成について記述している。
この例は、物品に取込まれた少なくとも1つの枠組構成要素を有する管状形態の本発明の物品の形成について記述している(図16)。
この例は、ロープ又は可撓性ロッドの形をした本発明の伸長された自己密着ウェブ材料の形成について記述している(図14)。
この例は、非常に低い体積密度と非常に高い多孔性百分率を有する本発明のウェブ材料の形成について記述する(図19)。
この例は、被移植者の動脈内の出血を止めるための本発明の極めて多孔性のウェブ材料の使用について記述している。
器官裂傷のモデルとして、この例では、その他の急性血管開通研究のために使用された正常な活性凝固時間(ACT)をもつブタ及びイヌ科動物を使用した。器官裂傷を誘発するために改良されたトレフィンで被移植動物の肝臓又は脾臓に直径13mmの刺し傷をつけた。刺し傷から45秒間自由に出血させた。例16に記述されている極めて多孔性のウェブ材料約1グラムを、1分間圧縮しながら刺し傷内に手で適用した。その後圧力を緩め、創傷の出血を評価した。出血が止まらない場合、さらに1分間圧力を再度加え、評価をくり返した。
この例は、相対凝固時間(RCT)で表わされた結果を提供する比較インビトロ血液凝固試験の使用を通した、本発明の血栓特性を実証している。
この例は、第2の生体吸収性重合体材料を内含するための本発明の物品の形成について記述している(図9)。
この例は、上述の例5に従った7:1の完成ウェブ材料のすきま空間内へのカルボキシメチルセルロース(CMC)の吸収膨潤について記述している。この構造を作るためには、高粘度ナトリウムカルボキシメチルセルロース(「CMC」;Sigma Chemical Company、St Louis、MO)を、工業用配合機を用いて4パーセント(4%)の濃度(すなわち4g/100ml)で脱イオン水中に溶解させた。閉じ込められた空気を遠心分離によって除去した。ウェブの気孔に完全に充填するためのローラーを用いて完成ウェブ材料(3.8cm×10.2cm)内にCMC溶液を吸収膨潤させた。CMCを吸収膨潤させたウェブを16時間室温で空気乾燥してCMC吸収膨潤した自己密着遠心PGA:TMCウェブ材料を生産した。
この例は、例16に従った完成ウェブのすきま空間内へのカルボキシメチルセルロース(CMC)の吸収膨潤及びリン酸緩衝生理食塩水(PBS)溶液内へのウェブからの吸収膨潤したCMCの溶解について記述している。この構造を作るためには、空隙空間を完全に充填するべくローラーを用いて例16に従って作られた極めて多孔性のウェブ材料の試料内に4%のCMCを吸収膨潤させた。CMCで吸収膨潤された高多孔率の自己密着PGA:TMCウェブ材料を生産するため、6時間室温で、吸収膨潤したウェブを空気乾燥させた。その後、例16のCMCで吸収膨潤させたウェブを、PBS溶液中に浸漬させた。浸漬時点でCMCは膨潤してヒトロゲルが充填された高多孔率で自己密着のPGA:TMCウェブ材料を生産した。さらに10分間浸漬した後、CMCはPBS内に溶解しウェブ材料から溶出すると思われた。
この例は、例16に従ったウェブ材料のすきま空間内へのカルボキシメチルセルロース(CMC)の吸収膨潤について記述している。この構造を作るためには、極めて多孔性のウェブ材料のすきま空間を完全に充填するようにローラーを用いて例16に従って作られる極めて多孔性のウェブ材料の試料内に8パーセント(8%)のCMC溶液を吸収膨潤させた。吸収膨潤されたウェブを次に40℃で真空下で乾燥させて、CMCで吸収膨潤させた高多孔率の自己密着PGA:TMCウェブ材料を生産した。PBS内への浸漬時点で、CMCは膨潤して、ヒドロゲル充填されたウェブを生産した。さらに10分間浸漬した時点で、CMCは溶解し、ウェブ材料から溶出した。
この例は、例21に従ったウェブ材料のすきま空間内へのカルボキシメチルセルロース(CMC)の吸収膨潤及びウェブ材料内部でのCMCの自己架橋について記述している。この構造を作るためには、例21に従った完成材料を得、Reidに対し発行され本書に参考として内含されている米国特許第3,379,720号(U.S. Patent No. 3,379,720)の中で教示されている通りに化学的架橋に付した。このプロセス内で、37パーセント(37%)のHClの滴下による添加を用いて、4パーセント(4%)のCMC溶液のpHをpH4に調整した。ひとたびCMCを例20に従って吸収膨潤させ空気乾燥させたならば、CMC化学主鎖上に存在するカルボン酸基とアルコール基の間でのエステル架橋を誘発するために1時間摂氏100度(100℃)に設定したオーブン内に該複合材を置いた。結果として、内部に架橋されたCMC材料が含有された高多孔率の自己密着伸長PGA:TMCウェブ材料が得られた。
この例は、PBS中での例24の架橋したCMCウェブ材料の膨潤について記述している。例24の材料を数分間PBS中に浸漬した。浸漬時点で、CMCは膨潤してヒドロゲルの充填されたウェブを生産した。さらに2日間浸漬した時点で、CMC材料の架橋された化学基は、CMCをウェブ内に保持させた。架橋されたヒドロゲルがひとたび充填された時点で、ウェブ材料の中にPBSが流れることはできなかった。この実施形態のウェブ材料は、流体バリヤとして有効に機能した。
この例は、例6に従った7:1の完成ウェブのすきま空間内へのポリビニルアルコール(PVA)の吸収膨潤について記述している。この構造を作るためには、Spectrum Chemical Company(Gardena、CA)からUSPグレードのポリビニルアルコール(PVA)を得た。熱及び攪拌を用いて10パーセント(10%)の濃度(すなわち10g/100ml)で脱イオン水中にPVAを溶解させた。遠心分離により、閉じ込められた空気を除去した。極めて多孔性のウェブの空隙空間を完全に充填するために、ローラーを用いて、例5に従ったウェブ材料(3.8cm×10.2cm)内にPVA溶液を吸収膨潤させた。吸収膨潤されたウェブを16時間室温で空気乾燥させて、PVAが吸収膨潤された自己密着PGA:TMCウェブ材料を生産した。
この例は、例26に従ったウェブのすきま空間内へのポリビニルアルコール(PVA)の吸収膨潤及びリン酸緩衝生理食塩水(PBS)溶液内へのウェブからのPVAの溶解について記述している。PBS溶液中に、例26のPVAを吸収膨潤させたウェブ材料を浸漬した。浸漬時点でPVAは膨潤してヒドロゲルの充填された自己密着伸長PGA:TMCウェブ材料を生産した。さらに10分間浸漬した時点で、PVAはPBS中に溶解し、ウェブ材料から溶出した。
この例は、例26に従ったPVAを吸収膨潤させた材料とコハク酸の架橋について記述している。例26に従ったウェブ材料内にPVAがひとたび吸収膨潤されたならば、PVAは、Izardに発行され本書に参考として内含されている米国特許第2,169,250号(U.S. Patent No. 2,169,250)の教示に従って、ジカルボン酸であるコハク酸と化学的に架橋された。
この例は、例26に従ったPVAを吸収膨潤させた材料とクエン酸の架橋について記述している。例26に従ったウェブ材料内にPVAがひとたび吸収膨潤されたならば、PVAは、Izardに発行され本書に参考として内含されている米国特許第2,169,250号(U.S. Patent No. 2,169,250)の教示に従って、トリカルボン酸であるクエン酸と化学的に架橋された。
この例は、例26に従ったPVAを吸収膨潤させた材料とアスパラギン酸の架橋について記述している。例26に従ったウェブ材料内にPVAがひとたび吸収膨潤されたならば、PVAは、ジカルボンアミノ酸であるアスパラギン酸と化学的に架橋された。
この例は、例26に従ったPVAを吸収膨潤させた材料とカルボキシメチルセルロース(CMC)の架橋について記述している。例26に従ったウェブ材料内にPVAがひとたび吸収膨潤されたならば、PVAは、ポリカルボン酸であるCMCと化学的に架橋された。
この例は、PBS中の例28〜31の構造のヒドロゲル構成要素の膨潤について記述している。PBS溶液中にこれらの構造の各々を浸漬した時点で、PVAは膨潤して、本発明のヒドロゲルで充填されたウェブ材料を生産した。さらに2日間浸漬した時点で、PVAは、上述の化学的架橋の存在に起因して全てのウェブ材料の内部で無傷であった。各々のヒドロゲル充填されたウェブ材料がウェブ材料を横断したPBSの移動を防止することが観察された。
この例は、例5に従ったウェブ材料のすきま空間内でのPLURONIC(登録商標)界面活性剤の吸収膨潤について記述している。PLURONIC(登録商標)界面活性剤は、BASF(FlorhamPark, NJ)から入手可能なポリエチレングリコール及びポリプロピレングリコールの共重合体である。PLURONIC(登録商標)界面活性剤の一部のグレードは、Herryに発行され本書に参考として内含されている米国特許第5,366,735号(U.S. Patent No.5,366,735)で教示された通りのグレードF−127といったような温かい生体液の中に浸漬された場合、ゲルを形成する。グレードF−127のPLURONIC(登録商標)界面活性剤を、5mlあたり5gの濃度でジクロロメタン中に溶解させた。
この例は、例21に従ったウェブ材料のヒドロゲル材料中への生物活性種の取込みについて記述している(図9A)。脱イオン水中に、10mg/100mlの濃度でデキサメタゾン(Sigma、St.Louis)を溶解させた。工業用配合機を用いて、溶液に対し4グラムの高粘度CMCを添加した。閉じ込められた空気を遠心分離により除去した。ローラーを用いて、完成ウェブ内にCMC/デキサメタゾン溶液を吸収膨潤させ、16時間室温で空気乾燥させた。PBS内に浸漬させた時点で、CMCは膨潤し、デキサメタゾンがハイドロゲルから溶出するのが観察された。
この例は、例21に従ったウェブ材料のヒドロゲル材料中への生物活性種の、物理的架橋を伴う取込みについて記述している。リン酸デキサメタゾン(Sigma、St.Louis)を、脱イオン水中で10mg/100mlの濃度で溶解させた。工業用配合機を用いて溶液に対し4グラムの高粘度CMCを添加した。遠心分離により、閉じ込められた空気を除去した。ローラーを用いて完成ウェブ内にCMC/リン酸デキサメタゾン溶液を吸収膨潤させ、16時間室温で空気乾燥させた。PBS中への浸漬時点で、CMCは膨潤L、リン酸デキサメタゾンは、塩基性リン酸デキサメタゾンと酸性CMCの間の物理的酸/塩基錆化に起因して例34の場合よりも低速でヒドロゲルから溶出することが観察された。
この例は、例24に従ったウェブ材料のヒドロゲル材料中への生物活性種の、物理的架橋を伴う取込みについて記述している。デキサメタゾン(Sigma、St.Louis)を、脱イオン水中で10mg/100mlの濃度で溶解させた。工業用配合機を用いて溶液に対し4グラムのCMCを添加した。37パーセント(37%)のHClを滴下により添加して、デキサメタゾン/CMC溶液のpHをpH4に調整した。デキサメタゾン/CMC溶液を例20に従ってひとたび吸収膨潤させ空気乾燥させた時点で、複合材を1時間、摂氏100度(100℃)に設定されたオーブンの中に入れて、CMC化学主鎖上に存在するアルコール基とカルボン酸基の間及びデキサメタゾン上に存在するアルコール基とCMC上に存在するカルボン酸基の間のエステル架橋を誘発した。PBS中への浸漬時点で、CMCは膨潤し、デキサメタゾンは、それとCMCとの間の化学的エステル結合の形成に起因して、例35の場合よりも低速でヒドロゲルから溶出することが観察された。
この例は、例28に従ったウェブ材料のヒドロゲル材料中への生物活性種の、化学的架橋を伴う取込みについて記述している。脱イオン水中で10mg/100mlの濃度でデキサメタゾン(Sigma、St.Louis)を溶解させた。
この例は、伸長された生体吸収性ウェブと組合せた形で添加された材料を内含するための本発明の物品の形成について記述している(図12)。
この例は、綿撤糸材料と組合せた形で本発明の材料を構成する複合材料の構築物について記述している(図10)。本発明の材料は、外科的処置の間ステープル器具上の所定の位置に綿撤糸材料を保持する上で一助となる(図10A及び10B)。
この例は、非生体吸収性材料と組合せた形で本発明の材料を構成する複合材料の構築物について記述している(図15)。この実施形態においては、生体吸収性材料は、複合材の非生体吸収性材料とは全く異なる部域を専有している。特に本発明のこの複合材料は、生体吸収性部分が予測可能な時限で被移植者の体から消滅する一方でデバイスの非生体吸収性部分は被移植者の体内に残り得る移植可能な歯科用デバイスとして有用である。この実施形態においては、第2の移植可能な歯科用デバイスを、当初該発明の生体吸収性部分が占めていた本発明の部域の中に設置することができる。
この例は、生体吸収性構成要素と組合わされた非生体吸収性構成要素を有する本発明の複合材料の構築物について記述している(図21)。この例では、例1で記述されているような完成6:1の生体吸収性ウェブ材料が多孔性延伸ポリテトラフルオロエチレン材料に接着されて、移植可能なシートを形成する。該シートは、さまざまな解剖学的膜の交換物又は代用品として使用可能である。特に、これらの膜は、硬膜及び神経系のその他の膜の代用品として有用である。
この例は、解剖学的構造又は器官のための外部支持ラップとしての本発明の多孔性自己密着伸長ウェブ材料の使用について記述している(図11)。このラップは、漏出及び組織接着性を最小限におさえるため解剖学的部位においても使用可能である。
この例は、即時に出血を止め且つ出血箇所での止血性を提供するのに十分な血栓形成性を有する複合材の形態である本発明の実施態様の構成について記述している。
この例は、対象の恒温動物の出血箇所で止血をもたらす本発明の使用について記述している。上記の例43で記載された本発明の実施態様を得て、深刻な出血をしている外傷を受けた豚の肝臓に置いた。本発明の生体吸収性のウェブ材料を出血組織に置き、人手による圧力を本発明の非生体吸収性の部分にかけて、ウェブ材料を出血組織に接触させたままにした。数分後(例えば10分未満)、人手でかけた圧力を開放し、出血が止まったことを観察した。止血に続いて、本発明の非生体吸収性構成要素を出血箇所にある期間残し、短期間の治療およびさらに生体吸収性ウェブ材料の結合を可能にした。一度或る程度の治療が起きると、非生体活性構成要素は生体吸収性ウェブ材料から簡単かつ傷をつけることなく分離され、対象動物の体から取り外される。
Claims (30)
- 多孔性ウェブを形成するべく混ぜ合わされている溶融成形された連続生体吸収性フィラメントと溶融成形された非連続生体吸収性フィラメント;及び前記溶融成形されたフィラメントの集団に放出可能に付着させられた非生体吸収性材料を含む移植可能物品であって、前記フィラメントが多数の接触点で互いに自己密着し、前記フィラメントが、少なくとも1つの非晶質重合体構成成分に共有結合した又はこの構成成分と配合された少なくとも1つの半結晶性重合体構成成分を含んで成り、該フィラメントが、結晶状態にある時に部分的乃至は完全な重合体構成成分相非混和性を有し、前記多孔性ウェブは、付加的な構成成分が不在である場合に90超の多孔性百分率を有し、該多孔性ウェブは、一軸伸長されたウェブであり、そして該フィラメントは、カーディング手順によって摩耗させられて、該ウェブの該フィラメントの少なくとも幾つかが、係合され、かつ互いから分離される、移植可能物品。
- 多孔性百分率が91超である、請求項1に記載の移植可能物品。
- 少なくとも1つの半結晶性重合体構成成分が少なくとも1つの非晶質重合体構成成分に共有結合されている、請求項1に記載の移植可能物品。
- 少なくとも1つの半結晶性重合体構成成分が少なくとも1つの非晶質重合体構成成分と配合されている、請求項1に記載の移植可能物品。
- 構成成分の少なくとも1つがブロック共重合体を含んで成る、請求項3又は4に記載の移植可能物品。
- 少なくとも1つの半結晶性重合体構成成分は摂氏80度(80℃)超の融点を有する、請求項1に記載の移植可能物品。
- 前記溶融成形されたフィラメントの集団に付着させられた生体吸収性材料をさらに含んで成る、請求項1に記載の移植可能物品。
- 該生体吸収性材料が、多孔性ウェブを形成するべく混ぜ合わされた溶融成形された連続フィラメントの形態であり、前記フィラメントが多数の接触点で互いに自己密着し、前記フィラメントが、少なくとも1つの非晶質重合体構成成分に共有結合した又はこの構成成分と配合された少なくとも1つの半結晶性重合体構成成分を含み、該フィラメントが、結晶状態にある時に部分的乃至は完全な重合体構成成分相非混和性を有する、請求項7に記載の移植可能物品。
- 実質的に平面のシートの形をしている、請求項1に記載の移植可能物品。
- 2以上の平面のシートの形をしている、請求項1に記載の移植可能物品。
- 前記シートが一緒に付着されて積層を形成する、請求項10に記載の移植可能物品。
- 非生体吸収性材料は、シートの形をしている、請求項1、10又は11に記載の移植可能物品。
- 前記非生体吸収性材料のシートがフッ素重合体材料を含んで成る、請求項12に記載の移植可能物品。
- 前記フッ素重合体材料がポリテトラフルオロエチレンである、請求項13に記載の移植可能物品。
- 非生体吸収性材料は、シートの形をしており、そして前記非生体吸収性材料のシートが、細胞の内側への成長に対する障壁である辺を有する、請求項11に記載の移植可能物品。
- 非生体吸収性材料は、シートの形をしており、そして前記非生体吸収性材料のシートが、細胞の内側への成長に対する障壁である第二の辺を有する、請求項11に記載の移植可能物品。
- 前記フィラメントの集団が、細胞の内側への成長に対する障壁である前記非生体吸収性材料のシートの前記辺に付着される、請求項15に記載の移植可能物品。
- 前記フィラメントの集団が、細胞の内側への成長に対する障壁である前記非生体吸収性材料のシートの前記第二の辺に付着される、請求項16に記載の移植可能物品。
- 多孔性ウェブを形成するべく混ぜ合わされている溶融成形された連続生体吸収性フィラメントと溶融成形された非連続生体吸収性フィラメント;及び前記溶融成形されたフィラメントの集団に放出可能に付着させられた非生体吸収性材料を含む移植可能物品であって、前記フィラメントが多数の接触点で互いに自己密着し、前記フィラメントが、少なくとも1つの付加的な半結晶性重合体構成成分に共有結合した又はこの構成成分と配合された少なくとも1つの半結晶性重合体構成成分を含み、該フィラメントが、結晶状態にある時に部分的乃至は完全な重合体構成成分相非混和性を有し、前記多孔性ウェブは、付加的な構成成分が不在である場合に90超の多孔性百分率を有し、該多孔性ウェブは、一軸伸長されたウェブであり、そして該フィラメントは、カーディング手順によって摩耗させられて、該ウェブの該フィラメントの少なくとも幾つかが、係合され、かつ互いから分離される、移植可能物品。
- 多孔性百分率が、付加的な構成成分が不在である場合に91超である、請求項19に記載の移植可能物品。
- 少なくとも1つの半結晶性重合体構成成分が少なくとも1つの付加的な半結晶性重合体構成成分に共有結合されている、請求項19に記載の移植可能物品。
- 少なくとも1つの半結晶性重合体構成成分が少なくとも1つの付加的な半結晶性重合体構成成分と配合されている、請求項19に記載の移植可能物品。
- 構成成分のうちの少なくとも1つがブロック共重合体である、請求項21又は22に記載の移植可能物品。
- 少なくとも1つの半結晶性重合体構成成分は摂氏80度(80℃)超の融点を有する、請求項19に記載の移植可能物品。
- フッ素重合体構成成分をさらに含んで成る、請求項19に記載の移植可能物品。
- 前記フッ素重合体構成成分がポリテトラフルオロエチレンを含んで成る、請求項25に記載の移植可能物品。
- 多孔性ウェブを形成するべく混ぜ合わされた溶融成形された連続フィラメントの形態で生体吸収性材料をさらに含む移植可能物品であって、前記フィラメントが多数の接触点で互いに自己密着し、前記フィラメントが、少なくとも1つの付加的な半結晶性重合体構成成分に共有結合した又はこの構成成分と配合された少なくとも1つの半結晶性重合体構成成分を含み、該フィラメントが、結晶状態にある時に部分的乃至は完全な重合体構成成分相非混和性を有する、請求項19に記載の移植可能物品。
- 摩擦電気材料が配置された貯蔵容器をさらに含んで成る、請求項1、7、10、11及び19のいずれか1項に記載の移植可能物品。
- 以下の工程:
混ぜ合わされている溶融成形された連続生体吸収性フィラメントと溶融成形された非連続生体吸収性フィラメントを含む多孔性前駆体ウェブ材料を提供する工程において、前記フィラメントが多数の接触点で互いに自己密着し、前記フィラメントが、少なくとも1つの非晶質重合体構成成分に共有結合した又はこの構成成分と配合された少なくとも1つの半結晶性重合体構成成分を含んで成り、かつ該フィラメントが、結晶状態にある時に部分的乃至は完全な重合体構成成分相非混和性を有する工程;
前記前駆体ウェブ材料を一軸の方向で伸長する工程;
前記伸長された前駆体ウェブ材料をアニールする工程;
該ウェブ材料の該フィラメントをカーディング手順によって摩耗させることにより、該ウェブの該フィラメントの少なくとも幾つかを係合させ、かつ互いから分離させる工程;及び
非生体吸収性材料を該ウェブ材料に放出可能に付着させる工程
を含む、請求項1に記載の移植可能物品の製造方法。 - 以下の工程:
混ぜ合わされている溶融成形された連続生体吸収性フィラメントと溶融成形された非連続生体吸収性フィラメントを含む多孔性前駆体ウェブ材料を提供する工程において、前記フィラメントが多数の接触点で互いに自己密着し、前記フィラメントが、少なくとも1つの付加的な半結晶性重合体構成成分に共有結合した又はこの構成成分と配合された少なくとも1つの半結晶性重合体構成成分を含んで成り、かつ該フィラメントが、結晶状態にある時に部分的乃至は完全な重合体構成成分相非混和性を有する工程;
前記前駆体ウェブ材料を一軸の方向で伸長する工程;
前記伸長された前駆体ウェブ材料をアニールする工程;
該ウェブ材料の該フィラメントをカーディング手順によって摩耗させることにより、該ウェブの該フィラメントの少なくとも幾つかを係合させ、かつ互いから分離させる工程;及び
非生体吸収性材料を該ウェブ材料に放出可能に付着させる工程
を含む、請求項19に記載の移植可能物品の製造方法。
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US7659219B2 (en) | 2010-02-09 |
US20070027553A1 (en) | 2007-02-01 |
US7655584B2 (en) | 2010-02-02 |
ES2537193T3 (es) | 2015-06-03 |
US20070027554A1 (en) | 2007-02-01 |
JP2009502330A (ja) | 2009-01-29 |
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