JP5058808B2 - 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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- JP5058808B2 JP5058808B2 JP2007537973A JP2007537973A JP5058808B2 JP 5058808 B2 JP5058808 B2 JP 5058808B2 JP 2007537973 A JP2007537973 A JP 2007537973A JP 2007537973 A JP2007537973 A JP 2007537973A JP 5058808 B2 JP5058808 B2 JP 5058808B2
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- fabric
- absorbent
- multilayer
- nonwoven
- knitted
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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
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 (26)
- 複層布を組織に縫合することを伴う、組織の修復または組織の再生における使用のための当該複層布において、
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、酸化多糖類を含む、
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、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1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3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3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6に記載の複層布において、
前記第1の吸収性不織布は、1.91cm〜6.35cm(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7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6に記載の複層布において、
前記第1の吸収性不織布は、3.81cm〜5.08cm(1.5in〜2in)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6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9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1〜4デニールの繊維から得られる、複層布。 - 請求項12に記載の複層布において、
前記第1の吸収性不織布は、0.002g/cm2〜0.031g/cm2(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、0.001g/cm2〜0.031g/cm2(0.001g/in2〜0.2g/in2)の坪量を有している、
複層布。 - 複層布を組織に縫合することを伴う、組織の修復または組織の再生における使用のための当該複層布において、
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、
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、酸化多糖類を含む、
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、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、0.25cm〜6.35cm(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、室温で40%〜60%に制御する工程と、
を含む、方法。 - 請求項15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15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17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17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15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20に記載の方法において、
前記第1の吸収性不織布は、1.91cm〜6.35cm(0.75in〜2.5in)の長さを有するステープルを含む、方法。 - 請求項21に記載の方法において、
前記第1の吸収性不織布は、3.81cm〜5.08cm(1.5in〜2.0in)の長さを有するステープルを含む、方法。 - 請求項20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23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24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1〜4デニールの範囲である、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、0.002g/cm2〜0.031g/cm2(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、0.001g/cm2〜0.031g/cm2(0.001g/in2〜0.2g/in2)の坪量を有する、
方法。
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