JP2023502413A - 重ね貼り時に高い光学的透明度を有する医療用テープ - Google Patents
重ね貼り時に高い光学的透明度を有する医療用テープ Download PDFInfo
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Abstract
Description
-CH2CH2(OCH2CH2)nOCH2CH2-などである。
・透過%は、用語が意味するように、透過される光の量、すなわち、光学物体の出射光に対する入射光の比率の尺度である。
・ヘイズは、広角散乱の測定値であり、コントラストの喪失、又は乳白色の外観を引き起こす。
・透明度(clarity)は、狭角散乱の尺度であり、基材を通して見たときに、物体の細部が見えなくなることを引き起こす。透明度はまた、距離依存性であり、これは、物体が基材を通してより遠くで見られると、細部がより見えなくなることを意味する。
各Rは、独立して、約1~12個の炭素原子を有し、かつ例えばトリフルオロアルキル基若しくはビニル基、ビニルラジカル、若しくは式、Rd(CH2)aCH=CH2(式中、Rd基は-(CH2)b-又は-(CH2)cCH=CH-であり、aは1、2又は3であり、bは0、3又は6であり、cは3、4又は5である)によって表される高級アルケニル基で置換されていてもよいアルキル部分;約6~12個の炭素原子を有し、かつアルキル基、フルオロアルキル基、及びビニル基で置換されていてもよいシクロアルキル部分;又は約6~20個の炭素原子を有し、かつ例えばアルキル基、シクロアルキル基、フルオロアルキル基、及びビニル基で置換されていてもよいアリール部分である、部分であるか、あるいはRは、米国特許第5,028,679号に記載されているようなペルフルオロアルキル基、又は米国特許第5,236,997号に記載されているようなフッ素含有基、又は米国特許第4,900,474号及び同第5,118,775号に記載されているようなペルフルオロエーテル含有基であり;典型的には、R部分の少なくとも50%はメチル基であり、残りは、1~12個の炭素原子を有する一価のアルキル若しくは置換アルキル基、アルケニル基、フェニル基、又は置換フェニル基であり、
各Zは、約6~20個の炭素原子を有するアリーレン基又はアラルキレン基、約6~20個の炭素原子を有するアルキレン基又はシクロアルキレン基である、多価の基であり、いくつかの実施形態では、Zは、2,6-トリレン、4,4’-メチレンジフェニレン、3,3’-ジメトキシ-4,4’-ビフェニレン、テトラメチル-m-キシリレン、4,4’-メチレンジシクロヘキシレン、3,5,5-トリメチル-3-メチレンシクロヘキシレン、1,6-ヘキサメチレン、1,4-シクロヘキシレン、2,2,4-トリメチルヘキシレン、及びこれらの混合物であり、
各Yは、独立して、1~10個の炭素原子のアルキレン基、6~20個の炭素原子を有するアラルキレン基又はアリーレン基である、多価の基であり、
各Dは、水素、1~10個の炭素原子のアルキル基、フェニル、及びB又はYを含む環構造を完成させて複素環を形成する基からなる群から選択され、
Bは、アルキレン、アラルキレン、シクロアルキレン、フェニレン、ヘテロアルキレン、例えばポリエチレンオキシド、ポリプロピレンオキシド、ポリテトラメチレンオキシドなど、並びにこれらのコポリマー及び混合物からなる群から選択される、多価の基であり、
mは、0~約1000の数であり、
nは、少なくとも1である数であり、
pは、少なくとも10、いくつかの実施形態では15~約2000又は30~1500である数である]
によって表される。
W-(A)n-Si(R4)3-mQm
式IV
(式中、Wはビニル基であり、Aは二価結合基であり、nは0又は1であり、mは1~3の整数であり、R4は、水素、低級アルキル(例えば、メチル、エチル、又はプロピル)、アリール(例えば、フェニル又は置換フェニル)、又はアルコキシであり、Qは、約500を上回る数平均分子量を有し、共重合条件下で本質的に非反応性である一価のシロキサンポリマー部分である)。
光学特性
光透過率(luminous transmission)、透明度、及びヘイズを、Gardner Haze-Guard Plus model 4725(BYK-Gardner,Columbia,MDより入手可能)を用い、ASTM D1003-00に従って測定した。報告された値は、特に明記しない限り、3回の繰り返しの平均である。スイスガラスであるスライドガラス(Swiss glass microscope slide)を試験中のブランクとして使用した。テープの1つ、2つ、及び4つの層を試験した。(ガラススライドへの又はテープ同士の)各積層は、4ポンドローラーの2回の通過を使用して実施した。
破断点引張強度及び破断点極限伸度を、PSTC-31、ASTM D882、及びD3759試験方法から変更された方法に従って、並びにクランプ型ジョーを備えたZ005引張試験機(Zwick Roell Group,Kennesaw,Georgia,USA)を用いて、25.4cm/分の一定速度で実施した。
試料を、2.54センチメートル×12.7センチメートルの寸法に切断した。ライナーを試料から取り外し、試料を、#320ステンレス鋼又はポリエチレン試験パネル上に接着剤側を下にして配置した。試料を、2.0kgの鋼ローラーの2回の通過を使用して試験パネルに固定した。50kgロードセルを装備したZ005引張試験機(Zwick Roell Group,Kennesaw,Georgia,USA)を使用して、30.5センチメートル/分の分離速度で、室温において剥離試験を実施した。平均剥離力を記録して、オンス/インチ単位の平均剥離接着強度を算出するために使用した。報告された値は、特に明記しない限り、5回の繰り返しの平均である。オンス/インチの接着強度をニュートン/デシメートル(N/dm)に変換した。
試験試料を、バルクフィルムから3.8cmの直径を有するディスクを切断することによって調製した。各ディスクを楕円形開口部を有する2つのホイルリング間に配置し、したがって、5.1cm2の試料表面積を露出させ、ホイル/ドレッシング/ホイルアセンブリ(「組立品」)を形成した。報告された値は、特に明記しない限り、5回の繰り返しの平均である。
W1は、試験期間前の瓶の質量であり、
W2は、試験期間後の瓶の質量であり、
Tは、時間単位の試験期間である。
2つの市販の医療用テープを対照として使用した。参照テープ1(BLENDERM)及び参照テープ2(TRANSPORE)は、両方とも3M Company(St.Paul,MN)から入手可能である。本発明の2つの実施例のテープ試料を、光学的に透明であるように設計した。これらの比較テープについての光学測定値を表2に示す。
フィルム2(CLAF SS 1601)は、JXNipponANCI,Inc.(Kennesaw,GA)から入手可能なクロスラミネートポリオレフィンオープンメッシュ不織布材料である。使用された接着剤は、米国特許第6,294,249号(Hamerら)に記載されているように調製した、イソオクチルアクリレート及びアクリル酸のホットメルト加工可能な(メタ)アクリレートPSA(約96/4モノマー比)であった。接着剤を剥離ライナー上に押し出し、次いでフィルム2の不織布材料を接着剤に適用した。接着剤を、5.6グラム/24インチ2のコーティング重量を提供する速度で適用した。次いで、TEGADERMで使用したポリウレタンフィルムを接着剤/フィルム3の構築物に積層した。このテープについての光学測定値を表2に示す。
医療グレードのアクリル感圧接着剤を、約6グラム/24インチ2のコーティング重量を提供する速度で剥離ライナー上にコーティングした。接着剤は、米国特許第5,637,646号(Ellis)に記載されているように調製された、2-エチルヘキシルアクリレート、n-ブチルアクリレート、アクリル酸、及びABPの架橋性(メタ)アクリレートPSAであった。ABPは、米国特許第4,737,559号(Kellenら)に従って調製された4-アクリルオキシベンゾフェノンの共重合性光開始剤を指す。その後、接着剤層を52mJ/cm2~55mJ/cm2のUV線量でのUV硬化させた。
Claims (20)
- テープであって、
第1の主面及び第2の主面を有する光学的に透明なテープバッキングと、
第1の主面及び第2の主面を有する光学的に透明な感圧接着剤層と、
を含み、
前記光学的に透明な接着剤層の前記第2の主面の少なくとも一部分は、前記光学的に透明なテープバッキングの前記第1の主面の少なくとも一部分に隣接しており、
前記テープは、光学的に透明であり、倒立カップ法を使用して、少なくとも250g/m2/24時間/37℃/100%~10%RHの水蒸気透過率(MVTR)を有し、
前記テープは、少なくとも2層のテープ層を含む光学的に透明な多層テープスタックを形成することができる、テープ。 - 前記テープが、85%の可視光の透過%、40%未満のヘイズ、及び少なくとも50%の透明度を有する、請求項1に記載のテープ。
- 前記少なくとも2層のテープ層を含む多層テープスタックが、80%の可視光の透過%、70%未満のヘイズ、及び少なくとも30%の透明度を有する、請求項1に記載のテープ。
- 前記透明なテープバッキングが、ポリエステル、ポリオレフィン、又はポリウレタンを含む、請求項1に記載のテープ。
- 前記光学的に透明な接着剤層が、(メタ)アクリレート系感圧接着剤、シリコーン感圧接着剤、(メタ)アクリレート-シリコーン感圧接着剤、又はシリコーンゲル接着剤を含む、請求項1に記載のテープ。
- 第1の主面及び第2の主面を有する透明な補強材料層を更に含み、前記透明な補強材料層が、前記透明なテープバッキングと前記光学的に透明な接着剤層との間に位置し、それにより、前記光学的に透明な接着剤層の前記第2の主面の少なくとも一部分が前記透明な材料層の前記第1の主面と接触し、かつ前記透明な材料層の前記第2の主面が前記透明なテープバッキングの前記第1の主面の少なくとも一部分と接触している、請求項1に記載のテープ。
- 前記補強材料層が、ポリエステル又はポリオレフィンを含む、ポリマー材料のウェブ又は不連続層を含む、請求項6に記載のテープ。
- 前記補強材料層が格子状であり、前記補強材料の最大70%が開放領域である、請求項6に記載のテープ。
- 前記補強材料層が、100マイクロメートル~300マイクロメートルの厚さを有する、請求項6に記載のテープ。
- 多層物品であって、
基材表面と、
前記基材表面上に配置された多層テープスタックと、
を含み、前記多層テープスタックは、少なくとも2層の光学的に透明なテープの層を含み、前記光学的に透明なテープの層は、
光学的に透明なテープの第1の層であって、
第1の主面及び第2の主面を有する光学的に透明なテープバッキングと、
第1の主面及び第2の主面を有する光学的に透明な接着剤層と、
を含み、前記光学的に透明な接着剤層の前記第2の主面の少なくとも一部分は、前記光学的に透明なテープバッキングの前記第1の主面の少なくとも一部分に隣接しており、
前記テープは、光学的に透明であり、倒立カップ法を使用して少なくとも250g/m2/24時間/37℃/100~10%RHの水蒸気透過率(MVTR)を有し、
前記光学的に透明な接着剤層の前記第1の主面は、前記基材表面と接触している、光学的に透明なテープの第1の層と、
光学的に透明なテープの第2の層であって、
前記光学的に透明なテープの第1の層に接着されており、それにより、前記光学的に透明なテープの第2の層の光学的に透明な接着剤層の第1の主面は、前記第1の光学的に透明なテープの光学的に透明なテープバッキングの第2の主面上に配置されている、光学的に透明なテープの第2の層と、
を含み、前記多層テープスタックは光学的に透明である、多層物品。 - 前記基材表面が、哺乳類の皮膚を含む、請求項10に記載の多層物品。
- 前記多層テープスタックが、光学的に透明なテープの第3の層を更に含み、前記光学的に透明なテープの第3の層は、前記光学的に透明なテープの第2の層に接着されており、それにより、前記光学的に透明なテープの第3の層の光学的に透明な接着剤層の第1の主面が、前記第2の光学的に透明なテープの光学的に透明なテープバッキングの第2の主面上に配置されており、前記多層テープスタックが光学的に透明である、請求項10に記載の多層物品。
- 前記少なくとも2層のテープ層を含む多層テープスタックが、80%の可視光の透過%、70%未満のヘイズ、及び少なくとも30%の透明度を有する、請求項10に記載の多層物品。
- 前記基材表面の一部分と接触し、また前記多層テープスタックの少なくとも一部分と接触した医療デバイスを更に含む、請求項10に記載の多層物品。
- 前記医療デバイスが、ドレープ、チューブ、カテーテル、オストミー器具、及びセンサーを含む、請求項14に記載の多層物品。
- 医療デバイスを哺乳類の皮膚に接着する方法であって、前記方法は、
哺乳類の皮膚を含む基材表面を提供することと、
前記哺乳類の皮膚に接着される医療デバイスを提供することと、
前記医療デバイスを基材表面に隣接して配置することと、
光学的に透明なテープを提供することと、
前記光学的に透明なテープの第1の部分を前記医療デバイス及び前記基材表面の一部分に接触させることと、
前記光学的に透明なテープの第2の部分を、光学的に透明なテープの前記第1の部分に接触させて、光学的に透明なテープのテープスタックを形成することを含み、前記テープスタックは、光学的に透明である、方法。 - 前記医療デバイスが、ドレープ、チューブ、カテーテル、オストミー器具、及びセンサーを含む、請求項16に記載の方法。
- 前記少なくとも2層のテープ層を含む多層テープスタックが、80%の可視光の透過%、70%未満のヘイズ、及び少なくとも30%の透明度を有する、請求項16に記載の方法。
- 前記光学的に透明なテープが、
第1の主面及び第2の主面を有する光学的に透明なテープバッキングと、
第1の主面及び第2の主面を有する光学的に透明な接着剤層と、
を含み、前記光学的に透明な接着剤層の前記第2の主面の少なくとも一部分が、前記光学的に透明なテープバッキングの前記第1の主面の少なくとも一部分に隣接しており、
前記テープが、光学的に透明であり、倒立カップ法を使用して、少なくとも250g/m2/24時間/37℃/100%~10%RHの水蒸気透過率(MVTR)を有し、
前記テープが、少なくとも2層のテープ層を含む光学的に透明な多層テープスタックを形成することができる、請求項16に記載の方法。 - 前記テープが、第1の主面及び第2の主面を有する透明な補強材料層を更に含み、前記透明な補強材料層が、前記透明なテープバッキングと前記光学的に透明な接着剤層との間に位置し、それにより、前記光学的に透明な接着剤層の前記第2の主面の少なくとも一部分が前記透明な材料層の前記第1の主面と接触し、かつ前記透明な材料層の前記第2の主面が前記透明なテープバッキングの前記第1の主面の少なくとも一部分と接触している、請求項19に記載の方法。
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-
2020
- 2020-11-19 JP JP2022529299A patent/JP2023502413A/ja active Pending
- 2020-11-19 US US17/770,375 patent/US20220387226A1/en active Pending
- 2020-11-19 CN CN202080075628.1A patent/CN114616302A/zh active Pending
- 2020-11-19 EP EP20816620.7A patent/EP4061901A1/en active Pending
- 2020-11-19 WO PCT/IB2020/060937 patent/WO2021099997A1/en unknown
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CN114616302A (zh) | 2022-06-10 |
US20220387226A1 (en) | 2022-12-08 |
EP4061901A1 (en) | 2022-09-28 |
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