JP2008516819A - 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 PDFInfo
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- JP2008516819A JP2008516819A JP2007537973A JP2007537973A JP2008516819A JP 2008516819 A JP2008516819 A JP 2008516819A JP 2007537973 A JP2007537973 A JP 2007537973A JP 2007537973 A JP2007537973 A JP 2007537973A JP 2008516819 A JP2008516819 A JP 2008516819A
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- fabric
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- nonwoven
- woven
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- 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
Abstract
【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。
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。
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。
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。
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。
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。
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。
(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)。
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。
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。
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。
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。
(1)複層布において、
第1の吸収性不織布と、
第2の吸収性織布または編地と、
を含む、複層布。
(2)実施態様1に記載の複層布において、
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む、複層布。
(3)実施態様2に記載の複層布において、
前記第1の吸収性不織布は、グリコリド/ラクチドのコポリマーを含有している、複層布。
(4)実施態様2に記載の複層布において、
前記第2の吸収性織布または編地は、酸化多糖類を含有している、複層布。
(5)実施態様4に記載の複層布において、
前記第2の吸収性織布または編地は、酸化セルロースを含有している、複層布。
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有している、複層布。
(7)実施態様5に記載の複層布において、
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有する吸収性編地である、複層布。
(8)実施態様1に記載の複層布において、
前記第1の吸収性不織布は、グリコリド/ラクチドのコポリマーを含有し、
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有している、
複層布。
(9)実施態様8に記載の複層布において、
前記第1の吸収性不織布は、約1.91cm〜6.35cm(約0.75in〜2.5in)の長さを有するステープルを含む、複層布。
(10)実施態様9に記載の複層布において、
前記ステープルは、捲縮されている、複層布。
前記第1の吸収性不織布は、約3.81cm〜5.08cm(約1.5in〜2in)の長さを有するステープルを含む、複層布。
(12)実施態様11に記載の複層布において、
前記ステープルは、捲縮されている、複層布。
(13)実施態様8に記載の複層布において、
前記第1の吸収性不織布は、ポリグリコリドをモル基準で約70%〜95%含有し、残部がポリラクチドであり、
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有している、
複層布。
(14)実施態様11に記載の複層布において、
前記ステープルは、フィラメント1本当り約1〜4デニールの繊維から得られる、複層布。
(15)実施態様14に記載の複層布において、
前記第1の吸収性不織布は、約0.002g/cm2〜0.031g/cm2(約0.01g/in2〜0.2g/in2)の坪量を有し、
前記第2の吸収性織布または編地は、約0.001g/cm2〜0.031g/cm2(約0.001g/in2〜0.2g/in2)の坪量を有している、
複層布。
第1の吸収性不織布と、
第2の吸収性織布または編地と、
抗菌性物質(antibacterial agent)、抗菌剤(antimicrobial agent)、成長因子、鎮痛薬、および、麻酔薬からなる群から選択された、少なくとも1種類の薬剤と、
を含む、複層布。
(17)実施態様1に記載の複層布を製造する方法において、
(a)吸収性ポリマーの繊維またはヤーンを、約10捲縮数/in〜30捲縮数/inの範囲で捲縮する工程と、
(b)前記の捲縮された繊維またはヤーンを、約0.25cm〜6.35cm(約0.1in〜2.5in)の間のステープルの長さに切断する工程と、
(c)前記ステープルのカーディングを行って、前記第1の吸収性不織布を形成する工程と、
(d)前記第1の吸収性不織布を第2の吸収性織布または編地に取り付ける工程と、
(e)工程(c)のための環境の湿度を、約60℃〜75℃の室温で約40%〜60%に制御する工程と、
を含む、方法。
(18)実施態様17に記載の方法において、
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る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む、方法。
(19)実施態様18に記載の方法において、
前記第1の吸収性不織布は、グリコリド/ラクチドのコポリマーを含有する、方法。
(20)実施態様18に記載の方法において、
前記第2の吸収性織布または編地は、酸化多糖類を含有する、方法。
前記第2の吸収性織布または編地は、酸化セルロースを含有する、方法。
(22)実施態様21に記載の方法において、
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有する、方法。
(23)実施態様21に記載の方法において、
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有する吸収性編地である、方法。
(24)実施態様17に記載の方法において、
前記第1の吸収性不織布は、グリコリド/ラクチドのコポリマーを含有し、
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有する、
方法。
(25)実施態様24に記載の方法において、
前記第1の吸収性不織布は、約1.91cm〜6.35cm(約0.75in〜2.5in)の長さを有するステープルを含む、方法。
前記第1の吸収性不織布は、約3.81cm〜5.08cm(約1.5in〜2.0in)の長さを有するステープルを含む、方法。
(27)実施態様24に記載の方法において、
前記第1の吸収性不織布は、グリコリドとラクチドとのコポリマーを含み、前記グリコリドとラクチドとのコポリマーにおいて、グリコリドがモル基準で約70%〜95%の範囲の量にあり、残部がポリラクチドであり、
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有する、
方法。
(28)実施態様27に記載の方法において、
前記第1の吸収性不織布は、ニードルパンチングによって、前記第2の吸収性織布または編地に取り付けられている、方法。
(29)実施態様28に記載の方法において、
前記吸収性ポリマーの繊維は、フィラメント1本当り約1〜4デニールの範囲である、方法。
(30)実施態様29に記載の方法において、
前記第1の吸収性不織布は、約0.002g/cm2〜0.031g/cm2(約0.01g/in2〜0.2g/in2)の坪量を有し、
前記第2の吸収性織布または編地は、約0.001g/cm2〜0.031g/cm2(約0.001g/in2〜0.2g/in2)の坪量を有する、
方法。
Claims (30)
- 複層布において、
第1の吸収性不織布と、
第2の吸収性織布または編地と、
を含む、複層布。 - 請求項1に記載の複層布において、
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む、複層布。 - 請求項2に記載の複層布において、
前記第1の吸収性不織布は、グリコリド/ラクチドのコポリマーを含有している、複層布。 - 請求項2に記載の複層布において、
前記第2の吸収性織布または編地は、酸化多糖類を含有している、複層布。 - 請求項4に記載の複層布において、
前記第2の吸収性織布または編地は、酸化セルロースを含有している、複層布。 - 請求項5に記載の複層布において、
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有している、複層布。 - 請求項5に記載の複層布において、
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有する吸収性編地である、複層布。 - 請求項1に記載の複層布において、
前記第1の吸収性不織布は、グリコリド/ラクチドのコポリマーを含有し、
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有している、
複層布。 - 請求項8に記載の複層布において、
前記第1の吸収性不織布は、約1.91cm〜6.35cm(約0.75in〜2.5in)の長さを有するステープルを含む、複層布。 - 請求項9に記載の複層布において、
前記ステープルは、捲縮されている、複層布。 - 請求項8に記載の複層布において、
前記第1の吸収性不織布は、約3.81cm〜5.08cm(約1.5in〜2in)の長さを有するステープルを含む、複層布。 - 請求項11に記載の複層布において、
前記ステープルは、捲縮されている、複層布。 - 請求項8に記載の複層布において、
前記第1の吸収性不織布は、ポリグリコリドをモル基準で約70%〜95%含有し、残部がポリラクチドであり、
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有している、
複層布。 - 請求項11に記載の複層布において、
前記ステープルは、フィラメント1本当り約1〜4デニールの繊維から得られる、複層布。 - 請求項14に記載の複層布において、
前記第1の吸収性不織布は、約0.002g/cm2〜0.031g/cm2(約0.01g/in2〜0.2g/in2)の坪量を有し、
前記第2の吸収性織布または編地は、約0.001g/cm2〜0.031g/cm2(約0.001g/in2〜0.2g/in2)の坪量を有している、
複層布。 - 複層布において、
第1の吸収性不織布と、
第2の吸収性織布または編地と、
抗菌性物質、抗菌剤、成長因子、鎮痛薬、および、麻酔薬からなる群から選択された、少なくとも1種類の薬剤と、
を含む、複層布。 - 請求項1に記載の複層布を製造する方法において、
(a)吸収性ポリマーの繊維またはヤーンを、約10捲縮数/in〜30捲縮数/inの範囲で捲縮する工程と、
(b)前記の捲縮された繊維またはヤーンを、約0.25cm〜6.35cm(約0.1in〜2.5in)の間のステープル長さに切断する工程と、
(c)前記ステープルのカーディングを行って、前記第1の吸収性不織布を形成する工程と、
(d)前記第1の吸収性不織布を第2の吸収性織布または編地に取り付ける工程と、
(e)工程(c)のための環境の湿度を、約60℃〜75℃の室温で約40%〜60%に制御する工程と、
を含む、方法。 - 請求項17に記載の方法において、
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る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む、方法。 - 請求項18に記載の方法において、
前記第1の吸収性不織布は、グリコリド/ラクチドのコポリマーを含有する、方法。 - 請求項18に記載の方法において、
前記第2の吸収性織布または編地は、酸化多糖類を含有する、方法。 - 請求項20に記載の方法において、
前記第2の吸収性織布または編地は、酸化セルロースを含有する、方法。 - 請求項21に記載の方法において、
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有する、方法。 - 請求項21に記載の方法において、
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有する吸収性編地である、方法。 - 請求項17に記載の方法において、
前記第1の吸収性不織布は、グリコリド/ラクチドのコポリマーを含有し、
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有する、
方法。 - 請求項24に記載の方法において、
前記第1の吸収性不織布は、約1.91cm〜6.35cm(約0.75in〜2.5in)の長さを有するステープルを含む、方法。 - 請求項25に記載の方法において、
前記第1の吸収性不織布は、約3.81cm〜5.08cm(約1.5in〜2.0in)の長さを有するステープルを含む、方法。 - 請求項24に記載の方法において、
前記第1の吸収性不織布は、グリコリドとラクチドとのコポリマーを含み、前記グリコリドとラクチドとのコポリマーにおいて、グリコリドがモル基準で約70%〜95%の範囲の量にあり、残部がポリラクチドであり、
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有する、
方法。 - 請求項27に記載の方法において、
前記第1の吸収性不織布は、ニードルパンチングによって、前記第2の吸収性織布または編地に取り付けられている、方法。 - 請求項28に記載の方法において、
前記吸収性ポリマーの繊維は、フィラメント1本当り約1〜4デニールの範囲である、方法。 - 請求項29に記載の方法において、
前記第1の吸収性不織布は、約0.002g/cm2〜0.031g/cm2(約0.01g/in2〜0.2g/in2)の坪量を有し、
前記第2の吸収性織布または編地は、約0.001g/cm2〜0.031g/cm2(約0.001g/in2〜0.2g/in2)の坪量を有する、
方法。
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JP2009533568A (ja) * | 2006-04-10 | 2009-09-17 | エシコン・インコーポレイテッド | 医療器具に使用するための吸収性強化複層布および製造方法 |
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JP2012513848A (ja) * | 2008-12-31 | 2012-06-21 | ケーシーアイ ライセンシング インコーポレイテッド | 組織のロール型足場 |
JP2013505109A (ja) * | 2009-09-22 | 2013-02-14 | エシコン・インコーポレイテッド | 層状の複合体止血用装置 |
JP2013526369A (ja) * | 2010-05-17 | 2013-06-24 | エシコン・インコーポレイテッド | 止血用途のための強化された吸収性多層布 |
JP2013526368A (ja) * | 2010-05-17 | 2013-06-24 | エシコン・インコーポレイテッド | 止血用途のための強化された吸収性合成マトリックス |
JP2012205720A (ja) * | 2011-03-29 | 2012-10-25 | Gunze Ltd | 腱板及び肩関節内構成体再生材料 |
JP2015503368A (ja) * | 2011-12-21 | 2015-02-02 | エシコン・インコーポレイテッドEthicon, Inc. | ガルバーニ微粒子を含む止血材料及び装置 |
JP2015516838A (ja) * | 2012-03-28 | 2015-06-18 | エシコン・エンド−サージェリィ・インコーポレイテッドEthicon Endo−Surgery,Inc. | 複数の材料で構成された組織厚さコンペンセーター |
WO2023249065A1 (ja) * | 2022-06-22 | 2023-12-28 | 学校法人藤田学園 | 組織再生促進シート |
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