JP2012122187A - 医療器具用の強化された吸収性複層布およびその製造方法 - Google Patents

医療器具用の強化された吸収性複層布およびその製造方法 Download PDF

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Publication number
JP2012122187A
JP2012122187A JP2012052931A JP2012052931A JP2012122187A JP 2012122187 A JP2012122187 A JP 2012122187A JP 2012052931 A JP2012052931 A JP 2012052931A JP 2012052931 A JP2012052931 A JP 2012052931A JP 2012122187 A JP2012122187 A JP 2012122187A
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Prior art keywords
fabric
absorbent
nonwoven
reinforced
woven
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JP2012052931A
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JP5437419B2 (ja
Inventor
Dhanraj S Shetty
シェティー・ドゥハヌラージ・エス
Manohar Pendharkar Sanyog
ペンダカー・サンヨグ・マノハー
Anne Jessica Gorman
ゴーマン・アン・ジェシカ
Saimi Kalirai
カリライ・サイミイ
Moore Jerry
ムーア・ジェリー
Sulidebi Danaraj
ダーナラージ・スリデビー
Heep Dou
ドゥ・ヒープ
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Ethicon Inc
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Ethicon Inc
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    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2307/00—Properties of the layers or laminate
    • B32B2307/70—Other properties
    • B32B2307/726—Permeability to liquids, absorption
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2459/00—Nets, e.g. camouflage nets
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2535/00—Medical equipment, e.g. bandage, prostheses or catheter
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T442/00—Fabric [woven, knitted, or nonwoven textile or cloth, etc.]
    • Y10T442/30—Woven fabric [i.e., woven strand or strip material]
    • Y10T442/3707—Woven fabric including a nonwoven fabric layer other than paper
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T442/00—Fabric [woven, knitted, or nonwoven textile or cloth, etc.]
    • Y10T442/40—Knit fabric [i.e., knit strand or strip material]
    • Y10T442/494—Including a nonwoven fabric layer other than paper

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Abstract

【課題】医療処置に関連し、第２の吸収性織布または編地によって強化された第１の吸収性不織布を有する、強化された吸収性複層布を使用する。
【解決手段】本発明は、第２の吸収性織布または編地によって強化された第１の吸収性不織布を含む、強化された吸収性複層布、および、この複層布を製造する方法に向けられている。さらに詳しくは、第１の吸収性不織布は、脂肪族ポリエステルのポリマー、コポリマー、または、それらの混合物を含有する繊維を含み、第２の吸収性織布または編地は、酸化された再生セルロース繊維を含む。
【選択図】なし

Description

本出願は、出願日２００４年１０月２０日の米国仮出願第60/620624号に基づく優先権を主張する。
本発明は、医療器具において有用である、強化された吸収性複層布、および、この複層布を製造する方法に関する。
医療処置に関連し複層布を使用することは、一般に知られている。例えば、複層布は、汎用パッド、創傷被覆材、（ヘルニア修復用メッシュ、癒着防止メッシュ、および、組織強化メッシュを包含する）外科用メッシュ、欠損閉鎖デバイス（defect closure devices）、および、止血材として使用される。
リヒテンシュタイン(Lichtenstein)等への米国特許第5,593,441号明細書は、複合人工器官（composite prosthesis）であって、好ましくは、組織が内方へ成長するのを可能にするポリプロピレンメッシュ（例えば、マーレックス(Marlex)（登録商標）メッシュ）のシートを有する人工器官を記述する。この参考文献は、組織の補強および欠損の閉鎖に適している他の外科用材料であって、ポリグラクチン９１０(バイクリル（Vicryl）)（登録商標）メッシュのような吸収性メッシュを包含する外科用材料を利用することができることを開示する。リヒテンシュタイン等の複合人工器官はまた、癒着障壁（好ましくは、シリコーンエラストマーのシート）を有する。この参考文献は概して、（ニュージャージー州サマービル（Somerville, New Jersey）所在の、エシコン社(Ethicon,Inc.)から市販されている）インターシード(Interceed)（登録商標）（ＴＣ７）吸収性癒着障壁のような酸化された再生セルロースを癒着障壁として使用して、短期的な効用を有する複合人工器官を製造することができることを示唆している。リヒテンシュタイン等の複合人工器官は、弱体化した筋肉壁を強化し修復し、同時に、術後癒着の発生を制限するために使用されると記述されている。
シルダー(Schilder)等への米国特許第5,686,090号明細書には、非吸収性膜または吸収性膜と組み合わされたフリース(fleece)を使用して、隣接組織に対する誤成長(mis-growths)を防ぎ、癒着を軽減することが記述されている。シルダー等は概して、ポリプロピレン、ポリエステル、ポリグラクチン(polyglactin)、ポリジオキサノン（polydioxanone）、または、ポリグレカプロン(poliglecaprone)２５は、フリース材料または膜材料として使用することができることを開示する。この参考文献で使用される用語「フリース（fleece）」は、それの空隙率によって示されている。この空隙率は、２００Ｐａの入口圧力、５０ｃｍ2の試験表面、および、１ｍｍの試験厚さで測定されたガス流量が１００Ｌ／（ｍ2ｓ）〜１０００Ｌ／（ｍ2ｓ）の範囲であると記述されている。シルダー等の複合材料は、概して、複層インプラント(multilayered implant)であると記述されている。
さらに、複層布(multilayered fabrics)は、ヒト組織工学および整形外科用途に有用である。最近、ヒト組織工学が出現したことによって、損傷組織／病変組織を修復し再生するための数多くのアプローチが提案されている。ヒト組織工学の方策は、組織機能を最終的に回復するか、または改善することのできる生体適合材料を使用することを探究してきた。植え込み可能かつ改造可能な足場材料(scaffolding materials)を、組織テンプレート(tissue templates)、導管（conduits）、障壁および貯蔵器(reservoirs)として使用することが、広く研究されてきた。生体組織の再構築／再生を行うためだけでなく、組織の成長を誘発するための走化性物質(chemotactic agents)を送達するために、とりわけ、フォーム（foams）、スポンジ、ゲル、ヒドロゲル、織物(textile)および不織布の形態の、合成材料ならびに天然材料が、生体外および生体内で使用されてきた。様々な形態の足場(scaffolds)を積層して、ヒト組織工学による複層足場（multilayered tissue engineering scaffold）を形成することができる。
しかし、従来技術は、第２の吸収性織布または編地（knitted fabric）によって強化された第１の吸収性不織布を有する、強化された吸収性複層布を記述も示唆もしていない。
本明細書で使用される用語「不織布(nonwoven fabric)」は、紡糸(spinning)、製織(weaving)、または、編成(knitting)以外のプロセスによって製造される、接着布(bonded fabrics)、形成布(formed fabrics)、または、加工布(engineered fabrics)を包含するが、それらに限定されない。さらに詳しくは、用語「不織布」は、一般にフラットシート形態である多孔質の織物様の材料であって、主としてまたは完全に、ウェブ(web)、シート、または、バット(batt)の状態に組み立てられたステープルファイバー(staple fibers)で構成された材料をいう。不織布の構造は、例えば、典型的には、大体無作為に配列されているステープルファイバーの配列に基づいている。不織布の引張特性、応力−歪特性(stress-strain properties)および触知性(tactile properties)は通常、（例えば、ステープルファイバーの）からみ合い(entanglement)および強化(reinforcement)によって作り出される繊維−繊維の摩擦に由来し、および／または、接着、化学結合あるいは物理結合に由来する。それにもかかわらず、不織布を製造するのに使用される素材は、紡糸、製織、または、編成を包含するプロセスによって製造されたヤーン、スクリム(scrims)、ネット(netting)、または、フィラメントとすることができる。
課題を解決する手段
本発明は、第２の吸収性織布または編地によって強化された第１の吸収性不織布を有する、強化された吸収性複層布、および、その複層布を製造する方法に向けられている。さらに詳しくは、第１の吸収性不織布は、脂肪族ポリエステルのポリマー、コポリマー、または、それらの混合物を含む繊維を含み、第２の吸収性織布または編地は、酸化された再生セルロース繊維を含む。
本発明によれば、医療器具において有用な、強化された吸収性複層布が提供される。
強化された吸収性複層布は概して、不織布および強化布（reinforcement fabric）を含む。強化布は、不織布が直接的または間接的に取り付けられる場合がある、裏地(backing)を提供する。
不織布は、本明細書に記述される強化された吸収性複層布の第１の吸収性不織布として機能する。第１の吸収性不織布は、脂肪族ポリエステルのポリマー、コポリマー、または、それらの混合物を含む繊維で構成される。それらの脂肪族ポリエステルは典型的には、乳酸、（Ｌ−ラクチド、Ｄ−ラクチド、メソラクチド、および、Ｄ−ラクチドとＬ−ラクチドとの混合物を包含する）ラクチド、グリコール酸、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）（p-dioxanone (l,4-dioxan-2-one)）、および、トリメチレンカーボネート（１，３−ジオキサン−２−オン）（trimethylene carbonate (1,3-dioxan- 2-one)）を包含するが、それらに限定されないモノマーの開環重合によって合成される。
第１の吸収性不織布は、好ましくは、グリコリドとラクチドとのコポリマーを含み、かかるコポリマーにおいては、グリコリドがモル基準で約７０％〜９５％の範囲の量にあり、残部がラクチドである。
代替の実施形態では、第１の吸収性不織布は、脂肪族ポリエステルのポリマー、コポリマー、または、それらの混合物で構成された繊維を、酸化多糖類繊維（oxidized polysaccharide fibers）と組み合わせて含む。
この不織布は、紡糸、製織、または、編成とは異なるプロセスによって製造されることが好ましい。例えば、この不織布は、紡糸、製織、または、編成を包含するプロセスによって製造されたヤーン、スクリム(scrims)、ネット(netting)、または、フィラメントで作ることができる。ヤーン、スクリム、ネット、および／または、フィラメントは、捲縮されて(crimped)、相互のからみ合い、および、第２の吸収性織布(woven fabric)または編地(knitted fabric)への取付けが改善される。このような捲縮されたヤーン、スクリム、ネット、および／または、フィラメントは、次いで、からみ合うのに十分な長さのステープルに切断することができる。ステープルは、長さが約０．２５ｃｍ〜７．６２ｃｍ（約０．１ｉｎ〜３．０ｉｎ）の間、好ましくは約１．９１ｃｍ〜６．３５ｃｍ（約０．７５ｉｎ〜２．５ｉｎ）の間、最も好ましくは約３．８１ｃｍ〜５．０８ｃｍ（約１．５ｉｎ〜２．０ｉｎ）の間である場合がある。ステープルは、カーディングを行って(carded)、不織布バット(nonwoven batt)を作り出すことができる。不織布バットは、次いで、ニードルパンチングを行うか（needlepunched）、またはカレンダリングを行って（calendared）、第１の吸収性不織布にすることができる。さらに、ステープルは、ねじる(kinked)か、または、パイルをつける(piled)ことができる。
不織布を製造するための他の既知の方法を利用することができ、それらの方法には、空気集積(air laying)、ウェットフォーミング(wet forming)、および、スティッチボンディング(stitch bonding)のようなプロセスが包含される。そのような方法は、「高分子科学工学百科事典(Encyclopedia of Polymer Science and Engineering)」、第１０巻、２０４頁〜２５３頁（１９８７）、および、アルビン・ターバンク(Albin Turbank)著、「不織布の序論(Introduction to Nonwovens)」（ジョージア州アトランタ、タッピ・プレス(Tappi Press)、１９９９年）に、概して解説されている。両刊行物は、参照することによって、全体を本明細書に組み入れられる。
不織布の厚さは、約０．２５ｍｍ〜２ｍｍの範囲である場合がある。この不織布の坪量は、約０．００２ｇ／ｃｍ2〜０．０３１ｇ／ｃｍ2（約０．０１ｇ／ｉｎ2〜０．２ｇ／ｉｎ2）、好ましくは約０．００５ｇ／ｃｍ2〜０．０１６ｇ／ｃｍ2（約０．０３ｇ／ｉｎ2〜０．１ｇ／ｉｎ2）、最も好ましくは約０．００６ｇ／ｃｍ2〜０．０１２ｇ／ｃｍ2（約０．０４ｇ／ｉｎ2〜０．０８ｇ／ｉｎ2）の範囲である。第１の吸収性不織布の重量百分率は、強化された吸収性複層布の全重量に基づき、約１０％〜８０％の範囲である場合がある。
第２の吸収性織布、または、編地は、強化布として機能し、また、酸化された多糖類を含み、特には、酸化セルロース、および酸化セルロースの中和された誘導体を含む。例えば、セルロースは、カルボン酸−酸化セルロース、または、アルデヒド−酸化セルロースである場合がある。さらに好ましくは、酸化された再生多糖類(regenerated polysaccharides)を使用して、第２の吸収性織布、または、編地を作ることができる。酸化された再生多糖類は、酸化された再生セルロース(oxidized regenerated polysaccharides)を包含するが、それに限定されない。再生セルロースは、再生されなかったセルロースと比べてより高い均一度を有するため、好ましい。再生セルロース、および、酸化された再生セルロースを製造する方法に関する詳細な記述とは、米国特許第3,364,200号、米国特許第5,180,398号、および、米国特許第4,626,253号明細書に説明されている。それら米国特許明細書のそれぞれの内容は、参照することによって、全体を説明されるかのように、本明細書に組み入れられる。
強化布として利用することのできる繊維の例は、インターシード(Interceed)（登録商標）吸収性癒着障壁、サージセル(Surgicel)（登録商標）吸収性止血材、サージセル・ヌ−ニット(Surgicel Nu-Knit)（登録商標）吸収性止血材、および、サージセル(Surgicel)（登録商標）細繊維吸収性止血材(Fibrillar absorbable hemostat)を包含するが、それらに限定されない（これらの繊維は、それぞれ、ジョンソン・エンド・ジョンソン・ウーンド・マネージメント・ワールドワイド社(Johnson & Johnson Wound Management Worldwide)、または、ガインケア・ワールドワイド社(Gynecare Worldwide)から市販されている。それらの会社は、いずれも、ニュージャージー州サマービル所在の、エシコン社(Ethicon, Inc.)の一部門である）。
本発明において利用される強化布が、意図された用途で使用されるのに必要な物理特性を有するという条件で、この強化布は、織られている(woven)か、または、編まれている(knitted)場合がある。このような布は、例えば、米国特許第4,626,253号、米国特許第5,002,551号、および、米国特許第5,007,916号明細書に記述されており、これらの米国特許明細書の内容は、参照することによって、全体を説明されるかのように、本明細書に組み入れられる。好ましい実施形態では、強化布は、ブライトレーヨン(bright rayon)のヤーンを材料として作られた、たて編トリコット布(warp knitted tricot fabric)であって、その後、カルボキシル部分またはアルデヒド部分を、強化布に生分解性を提供するのに有効な量で含有するように酸化される、たて編トリコット生地である。
別の実施形態において、第２の吸収性織布または編地は、脂肪族ポリエステルのポリマー、コポリマー、または、それらの混合物で構成された繊維と組み合わされた酸化多糖類繊維を含有する。
第２の吸収性織布または編地は、酸化された再生セルロースを含有することが好ましく、約０．００１ｇ／ｃｍ2〜０．０３１ｇ／ｃｍ2（約０．００１ｇ／ｉｎ2〜０．２ｇ／ｉｎ2）の範囲、好ましくは約０．００２ｇ／ｃｍ2〜０．０１６ｇ／ｃｍ2（約０．０１ｇ／ｉｎ2〜０．１ｇ／ｉｎ2）の範囲、最も好ましくは約０．００６ｇ／ｃｍ2〜０．０１１ｇ／ｃｍ2（約０．０４ｇ／ｉｎ2〜０．０７ｇ／ｉｎ2）の範囲の坪量を有することができる。
第１の吸収性不織布は、第２の吸収性織布または編地に直接的または間接的に取り付けられる。例えば、この不織布は、ニードルパンチング、カレンダリング、エンボス加工(embossing)、あるいは、ハイドロエンタングルメント(hydroentanglement)、または、化学結合あるいは熱結合(thermal bonding)によって、第２の吸収性織布または編地の中に組み入れることができる。第１の吸収性不織布のステープルは、互いにからみ合わされて、第２の吸収性織布または編地の中に埋め込むことができる。さらに詳しくは、化学結合あるいは熱結合以外の方法について、第１の吸収性不織布のステープルの少なくとも約１％、好ましくは約１０％〜２０％、好ましくは約５０％以下が第２の吸収性織布または編地の他方の側に露出するように、第１の吸収性不織布は第２の吸収性織布または編地に取り付けることができる。このことによって、第１の吸収性不織布と第２の吸収性織布または編地とは、確実に結合されたままとなり、通常の取り扱い条件の下では層間剥離しない。実質的にいかなる第２の吸収性織布または編地も、第１の吸収性不織布による被覆(coverage)の視覚的な欠けがないように、強化された吸収性複層布は均一である。
本明細書に記述される複層布を製造する１つの方法は、次のプロセスによる。繊維１本当り約１〜４のデニールを有する吸収性ポリマー繊維を、約８０〜１２０デニールのマルチフィラメントヤーン(multifilament yarn)にまとめ、次いで、約８００〜１２００デニールのヤーンにまとめ、熱的に捲縮し、次いで、約１．９１ｃｍ〜３．８１ｃｍ（約０．７５ｉｎ〜１．５ｉｎ）の間の長さを有するステープルに切断する。このステープルは、マルチローラー乾式レイ・カーディング機(multiroller dry lay carding machine)の中に１回以上供給し、カーディングを行って均一な不織布バットにすることができ、同時に、湿度は、６０℃〜７５℃の室温で約４０％〜６０％の間に制御する。例えば、均一な不織布バットは、互い違いに配置されたローラーとストリップロール(stripper rolls)とで覆われたメインシリンダ(main cylinder)を有する、単シリンダ・ローラートップ・カード(single cylinder roller-top card)を用いて作ることができる。その場合、不織布バットは、ドッファーローラー(doffer roller)によってシリンダの表面から外し、次いで、コレクターロール(collector roll)上に置く。不織布バットは、ニードルパンチング、または、カレンダリング等の任意の他の方法によってさらに処理することができる。その後、第１の吸収性不織布は、ニードルパンチング等の様々な技術によって、第２の吸収性織布または編地に取り付けることができる。強化された吸収性複層布は、次いで、適切な溶媒で洗浄することによって洗い上げ、次いで、穏やかな条件の下、約３０分間乾燥させることができる。
ステープル長さ、ステープルの開き度（opening）、ステープルの供給速度（feed rate）、相対湿度、等の処理パラメータを制御することが望ましい。例えば、まとめられたヤーンは、約５捲縮数／ｉｎ〜５０捲縮数／ｉｎ（about 5 to 50 crimps per inch）、好ましくは約１０捲縮数／ｉｎ〜３０捲縮数／ｉｎ（about 10 to 30 crimps per inch）を有することができる。長くかつ不完全に切断されたステープルはいかなるものも、カーディング機(carding machine)上に張り付き、ピリング(pilling)を生じる傾向があるため、捲縮ヤーン(crimped yarns)を効果的に切断することが望ましい。ステープル長さの好ましい範囲は、約１．９１ｃｍ〜６．３５ｃｍ（約０．７５ｉｎ〜２．５ｉｎ）、好ましくは約３．８１ｃｍ〜５．０８ｃｍ（約１．５ｉｎ〜２．０ｉｎ）である。
均一性を最適化し、静電気の蓄積を最小限に抑えるため、バット処理(batt processing)を行う間、好ましくは、均一な不織布バットを形成するためのカーディングを行う間、相対湿度を制御することができる。不織布バットは、約６０℃〜７５℃の室温で少なくとも約４０％の相対湿度で、乾式レイ・カーディング処理(dry lay carding process)を用いて処理することが好ましい。不織布バットは、約５０％〜６０％の相対湿度で処理することがさらに好ましい。
複層布は、あらゆる紡糸仕上げ剤(spin finish)を溶解するのに適した溶媒を用いて洗い上げる。溶媒は、イソプロピルアルコール、ヘキサン、酢酸エチル、および、塩化メチレンを包含するが、それらに限定されない。次いで、複層布は、十分な乾燥を提供し、同時に、収縮を最小限に抑える条件の下で、乾燥させる。
強化された吸収性複層布は、約０．７５ｍｍ〜３．０ｍｍの間、好ましくは約１．００ｍｍ〜２．５ｍｍの間、最も好ましくは約１．２ｍｍ〜２．０ｍｍの間の平均厚さを有することができる。強化された吸収性複層布の坪量は、約０．００８ｇ／ｃｍ2〜０．０３９ｇ／ｃｍ2（約０．０５ｇ／ｉｎ2〜０．２５ｇ／ｉｎ2）の間、好ましくは約０．０１２ｇ／ｃｍ2〜０．０３１ｇ／ｃｍ2（約０．０８ｇ／ｉｎ2〜０．２ｇ／ｉｎ2）の間、最も好ましくは約０．０１６ｇ／ｃｍ2〜０．０２８ｇ／ｃｍ2（約０．１ｇ／ｉｎ2〜０．１８ｇ／ｉｎ2）の間である。強化された吸収性複層布は、坪量、または、各平方インチをわたる厚さ（thickness across each square inch）が約１０％以下の変動(variation)（平均の相対標準偏差）を有するように、均一である。
さらに、不織布は、止血剤等の生理活性剤を含有することができる。使用することのできる止血剤は、天然に存在するか、組換え体であるか、または、合成物である、凝血促進酵素(procoagulant enzymes)、タンパク質、および、ペプチドを包含するが、それらに限定されない。さらに具体的には、プロトロンビン、トロンビン、フィブリノーゲン、フィブリン、フィブロネクチン、第Ｘ／Ｘａ因子（Factor X/Xa）、第VII／VIIａ因子（Factor VII/VIIa）、第IX／IXａ因子（Factor IX/IXa）、第XI／XIａ因子（Factor XI/XIa）、第XII／XIIａ因子（Factor XII/XIIa）、組織因子、フォン・ウィルブランド因子(von Willebrand Factor)、コラーゲン、エラスチン(elastin)、止血活性度を有する合成ペプチド、前述のものの誘導体、および、それらのいずれかの組合せを利用することができる。好ましい止血剤は、トロンビン、フィブリノーゲン、および、フィブリンである。
加えて、不織布は、薬理学的かつ生物学的に活性な薬剤を含有することができる。それらの薬剤は、創傷治癒薬、抗菌性物質（antibacterial agent）、抗菌剤（antimicrobial agent）、成長因子、鎮痛薬、および、麻酔薬を包含するが、それらに限定されない。強化された吸収性複層布が組織足場として使用される場合、標的組織(targeted tissue)に植え込みを行う前、この複層布に適切な細胞型を接種するか、または、培養することができる。
実施例１ ＯＲＣ布を有するＰＧＬ不織布
ポリ（グリコリド−コ−ラクチド）（Poly (glycolide-co-lactide)）（ＰＧＬ、９０／１０ｍｏｌ／ｍｏｌ）を繊維になるように溶融紡糸した。マルチフィラメントヤーンは、まとめて、捲縮し、次いで、４．４５ｃｍ（１．７５ｉｎ）の長さを有するステープルに切断した。このステープルは、不織布バット(nonwoven batt)を作り出すためにカーディングを行い、次いで、約１．２５ｍｍの厚さおよび約９８．１ｍｇ／ｃｃの密度に圧縮した。次いで、不織布は、エシコン社(Ethicon, Inc.)から商品名「インターシード(Interceed)（登録商標）」で入手可能な、編成カルボン酸−酸化再生セルロース（ＯＲＣ）布（knitted carboxylic-oxidized regenerated cellulose (ORC) fabric）の中にニードルパンチングを行って、不織布をこのＯＲＣ布（ORC fabric）に固定した。最終の複層布は、不織布を約６０重量％含有した。
実施例２ ＯＲＣ布を有するＰＧＬ不織布
ポリ（グリコリド−コ−ラクチド）（ＰＧＬ、９０／１０ｍｏｌ／ｍｏｌ）を繊維になるように溶融紡糸した。マルチフィラメントヤーンは、まとめて、捲縮し、次いで、４．４５ｃｍ（１．７５ｉｎ）の長さを有するステープルに切断した。このステープルは、不織布バットを作り出すためにカーディングを行い、次いで、約１．２２ｍｍの厚さおよび約１０３．４ｍｇ／ｃｃの密度に圧縮した。次いで、不織布は、エシコン社から商品名「サージセル・ヌニット(Surgicel NuKnit)（登録商標）」で入手可能な、編成カルボン酸−酸化再生セルロース布（ＯＲＣ）の中にニードルパンチングを行って、不織布をこのＯＲＣ布に固定した。最終の複層布は、不織布を約２５重量％含有した。
実施例３ ＯＲＣ布を有するＰＧＬ不織布
ポリ（グリコリド−コ−ラクチド）（ＰＧＬ、９０／１０ｍｏｌ／ｍｏｌ）を繊維になるように溶融紡糸した。マルチフィラメントヤーンは、まとめて、捲縮し、次いで、４．４５ｃｍ（１．７５ｉｎ）の長さを有するステープルに切断した。このステープルは、不織布バットを作り出すためにカーディングを行い、次いで、約１．１ｍｍの厚さおよび約１０２．８ｍｇ／ｃｃの密度を有するフェルト(felt)に圧縮した。次いで、不織布は、エシコン社から商品名「サージセル(Surgicel)（登録商標）」で入手可能な、編成カルボン酸−酸化再生セルロース布（ＯＲＣ）の中にニードルパンチングを行って、不織布をこのＯＲＣ布に固定した。最終の複層布は、該不織布を約６０重量％含有した。
実施例４ ＯＲＣ布を有するＰＧＬ不織布
ポリ（グリコリド−コ−ラクチド）（ＰＧＬ、９０／１０ｍｏｌ／ｍｏｌ）を繊維になるように溶融紡糸した。８０デニールのマルチフィラメントヤーンをまとめて、まとめられた８００デニールのヤーンにした。それらのまとめられたヤーンは、約１１０℃で捲縮した。捲縮ヤーンは、３．１８ｃｍ（約１．２５ｉｎ）の長さを有するステープルに切断した。捲縮ステープル（crimped staple）２０ｇを精確に秤量し、次いで、マルチローラー・カーディング機(multi-roller carding machine)の供給コンベヤーベルトの上に均一に広げた。環境条件（温度：２１．１℃（７０°Ｆ）／相対湿度：５５％）を制御した。次いで、ステープルにカーディングを行い、不織布バットを作り出した。このバットを、ピックアップローラー(pick-up roller)から取り外し、４つの均等な部分に切断した。これらは、回収方向に垂直なカーダー(carder)の中に再び供給した。この第２の試み(pass)の後、バットは、秤量し（１９．８ｇ：布収率９９％）、次いで、フェルトになるよう圧縮した。この圧縮フェルトは、ＯＲＣ布上に正確に敷かれ、次いで、ニードルパンチング機（needlepunching equipment）に２回通すことによって固着させた。複層布は、トリミングして(trimmed)、３台の別個のイソプロピルアルコール槽で洗い上げ、紡糸仕上げ剤およびあらゆる機械油を取り除いた。洗い上げられた複層布は、７０℃のオーブンで３０分間乾燥させ、冷却し、秤量した。
複層布の「厚さ（"thickness"）」は、本明細書に記述されるように測定した。測定用具は、次の通りである：
（１）ミツトヨ製絶対ゲージ(Mitutoyo Absolute gauge)型式番号ＩＤ−Ｃ１２５ＥＢ（コード番号：５４３−４５２Ｂ）。このゲージ上で直径１ｉｎのフット（foot）を使用した。
（２）所定の位置でロックし、キャリパーをダイ定盤(die platen)にセットするために、磁気ホルダー(magnetic holder)を使用した。
（３）２枚の金属板：約６．９９ｃｍ×５．０８ｃｍ×１．５２ｃｍ（約２．７５ｉｎ×２ｉｎ×０．６０ｉｎ）、４０．８ｇ〜４１．５ｇの間の重さ（組合せ合計は約８２．１８ｇ）。
滑らかな機械仕上げ面である定盤表面の上に、複層布を配置した。複層布上の互いの上面（top）に２枚の金属板を配置し、次いで、複層布が確実に平らになるように、それら金属板の角で丁寧に加圧した。それら金属板の上面にゲージフットを配置し、次いで、このゲージフットを再び持ち上げて再び配置し、この時、読み取りを行った。
洗い上げた複層布から、１２枚の２．５４ｃｍ×２．５４ｃｍ（１ｉｎ×１ｉｎ）断片をダイで打ち抜き、精確に秤量した。各２．５４ｃｍ×２．５４ｃｍ（１ｉｎ×１ｉｎ）断片の厚さは、信頼性の高い平均を得るために、金属プレートの異なる領域で４〜５回測定した。表１に、各断片の重量および厚さを示す。それらの値は、両方の層の被覆度(coverage)が、あらゆる方向で類似していることを示している。
Figure 2012122187
実施例５ ポリグラクチン９１０ステープルの処理に及ぼす湿度の影響
８０デニールのポリグラクチン(polyglactin)９１０のまとめられたヤーンを捲縮し、次いで、４．４５ｃｍ（１．７５ｉｎ）のステープルに切断した。室温は、２０．５℃〜２１．１℃（６９°Ｆ〜７０°Ｆ）の間に維持され、相対湿度は、室内湿度調節装置で制御され、３６％から６０％まで変動した。捲縮ステープルは、約８１．２８ｃｍ×２０．３２ｃｍ（約３２ｉｎ×８ｉｎ）のバットになるようにカーディングを行った。カーディング機(carding machine)を２回通した後、バットの中に組み込まれたステープルの百分率、すなわち、収率は、湿度の増加と共に増加し、かつ、このバットの品質は収率と共に改善された。
Figure 2012122187
実施例６ ポリグラクチン９１０ステープルの処理に及ぼすステープル長さの影響
８０デニールのポリグラクチン９１０のまとめられたヤーンを捲縮し、次いで、長さ３．１８ｃｍ（１．２５ｉｎ）、３．８１ｃｍ（１．５ｉｎ）、および、４．４５ｃｍ（１．７５ｉｎ）のステープルに切断した。室温は２０．５℃〜２１．７℃（６９°Ｆ〜７１°Ｆ）の間に維持され、相対湿度は室内湿度調節装置で〜５５％に制御された。捲縮ステープルは、約８１．２８ｃｍ×２０．３２ｃｍ（約３２ｉｎ×８ｉｎ）のバットになるようにカーディングを行った。
Figure 2012122187
実施例７ 強化された吸収性複層布を用いた回旋腱板の修復
回旋腱板(rotator cuff)に問題がある場合、外科医はまず、関節鏡を用いて損傷の程度を診る。次いで、患者は、全身麻酔下で、裂傷を修復するための開放手術を受ける。
麻酔薬を投与し、肩の準備ができた後、肩の頂部前面の角(top front corner of the shoulder)の上に美容整形的切開部(cosmetic incision)が形成される。この切開によって、三角筋の前部と中間部との間の継ぎ目へアクセスすることが可能になる。この継ぎ目を分離することによって、肩の力(shoulder’s power)のかなりの部分を担っている重要な三角筋を分離させることも、損傷させることもなく、回旋腱板へアクセスすることが可能になる。全ての瘢痕組織は、三角筋および肩峰(三角筋が付着している肩甲骨の部分)の下の空間から除去される。肥厚化した嚢(bursa)、および、回旋腱板と上腕骨（上腕の骨）との粗い縁(edge)もまた、滑らかになり、この嚢および縁は、肩峰および三角筋の下を円滑に、確実に通過する。
腱板の腱の縁を識別し、腱板組織の質および量を測定する。修復の目標は、上腕骨上の位置であってその位置から腱が裂傷を負った位置に、良質の腱を再び取り付けることである。溝(groove)またはトラフ(trough)を、腱板の正常な取付け部位に作る。腱を支持し回復を補助するため、外科医は、強化された吸収性複層布のパッチ(patch)を所定の位置に、腱の全面にわたって縫合する。縫合糸（多数本の手術用の糸）は、溝であって、腱がその溝まで回復する溝の中に、この腱の縁を固定するように引き込む。
外科医は次いで、三角筋と皮膚の切開部とを閉鎖することによって、手術を完了する。時間が経つと、身体は、前記領域内に、周囲の組織と調和する新しい組織を作り出す。身体はまた、２〜４ヶ月で植え込まれたパッチを吸収する。
実施例８ 強化された吸収性複層布を用いた膝軟骨の修復
外科医はまず、関節鏡によって膝を診察する。関節鏡は、医師が膝関節を調べるのを可能にする小さな装置である。損傷が発見されると、外科的処置が行われる。
麻酔薬が投与され、膝の準備ができた後、膝蓋骨の頂部前面の角の上の皮膚を通して美容整形的切開部が形成される。まず、損傷した軟骨を除去する。次いで、強化された吸収性複層布をこの損傷の中に植え込む。この複層布は、縫合糸、留め鋲(tack)、または、多種の生体適合性接着剤のうちのいずれかを用いて、損傷部位へ取り付けることができる。
外科医は次いで、皮膚の切開部を閉鎖することによって、手術を完了する。軟骨細胞は、植え込まれた複層布の中に移動し、次いで、この植え込まれた複層布の中で増殖し、次いで、この細胞／複層布インプラントは、周囲の軟骨と一体化する。時間と共に、それら細胞は、成熟し、損傷部にヒアリン軟骨(hyaline cartilage)を充填する。
諸実施例は、本発明のいくつかの実施形態を実証するが、これらの実施例は、本発明の範囲を限定するものと解釈されるべきではなく、本発明の完全な記述に寄与するものと解釈されるべきである。これらの実施例に記載の全ての強化布は、それらの商品名で呼ばれる、対応する市販製品の非殺菌材料（nonsterile materials）である。
なお、本発明の好ましい実施態様は以下の通りである。
（１） 組織の修復または組織の再生における使用のための複層布において、
第１の吸収性不織布と、
ニードルパンチングによって、前記第１の吸収性不織布に取り付けられた、強化用の第２の吸収性織布または編地と、
を含み、
前記第１の吸収性不織布は、乳酸、（Ｌ−、Ｄ−、メソ、および、Ｄ、Ｌの混合物を包含する）ラクチド、グリコール酸、グリコリド、ε−カプロラクトン、ｐ−ジオキサノン、ならびに、トリメチレンカーボネートからなる群から選択された１種類以上のモノマーの、脂肪族ポリエステルのポリマーまたはコポリマーで構成される繊維を含み、
前記第２の吸収性織布または編地は、酸化された再生セルロースを含む、
複層布。

Claims (1)

  1. 組織の修復または組織の再生における使用のための複層布において、
    第１の吸収性不織布と、
    ニードルパンチングによって、前記第１の吸収性不織布に取り付けられた、強化用の第２の吸収性織布または編地と、
    を含み、
    前記第１の吸収性不織布は、乳酸、（Ｌ−、Ｄ−、メソ、および、Ｄ、Ｌの混合物を包含する）ラクチド、グリコール酸、グリコリド、ε−カプロラクトン、ｐ−ジオキサノン、ならびに、トリメチレンカーボネートからなる群から選択された１種類以上のモノマーの、脂肪族ポリエステルのポリマーまたはコポリマーで構成される繊維を含み、
    前記第２の吸収性織布または編地は、酸化された再生セルロースを含む、
    複層布。
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