JP7411643B2 - 自己潤滑性医療用物品 - Google Patents
自己潤滑性医療用物品 Download PDFInfo
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- JP7411643B2 JP7411643B2 JP2021516599A JP2021516599A JP7411643B2 JP 7411643 B2 JP7411643 B2 JP 7411643B2 JP 2021516599 A JP2021516599 A JP 2021516599A JP 2021516599 A JP2021516599 A JP 2021516599A JP 7411643 B2 JP7411643 B2 JP 7411643B2
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Description
ポリウレタン
HO(CH2CH2O)pCH2CF2O(CF2CF2O)q(CF2O)rCF2CH2(OCH2CH2)pOH
本明細書で議論したポリウレタンを、パイロットスケールのポリウレタン(PU)プロセッサーを用いた1段階共重合プロセスによって調製した。合計約7.5kgのポリグリコール、変性オリゴマーおよび鎖延長剤を、タンク攪拌器および材料リサイクルループを通して適切に混合しながらPUプロセッサーのBタンク(リサイクルループを備えた2.5ガロンのフルタンク収容能力)に充填した。ジイソシアネート(Bタンクのポリオール混合物と反応する計算量)を、PUプロセッサーのAタンク(リサイクルループを備えた2.5ガロンのフルタンク収容能力)に充填した;反応中に、BタンクおよびAタンク材料の両方を、制御された供給速度でそれぞれの供給ラインを通してポンピングして、1.0から1.1のイソシアネート指数を達成した;1つ以上の実施態様では、イソシアネート指数は、1.02である;BおよびAストリームの両方を、適切な混合のために、それぞれのインジェクターを通して、高速ローター速度で8cc混合ヘッドに連続的に注入し、シリコーンパンに注いだ;A/Bタンク、充填/供給/リサイクル/排水ライン、インジェクター、および混合ヘッドを含むPUプロセッサーシステム全体を、50~90℃の温度(種々のゾーン温度制御)に維持し、タンクを、動作中、100mmHg未満の真空下で引いた;PU反応物混合物で満たされたシリコーンパンを、完全な反応を達成するために、10~20分の硬化時間で150°Fのコンベアオーブンに通過させた;得られた白色PUスラブは、7.7インチ×3.5インチ×0.3インチの寸法を有する。その後、PUスラブを、下流の配合および押出/共押出プロセスのために顆粒状に粉砕した。
医療用物品は、下記成分:ジイソシアネート;ジオール鎖延長剤;ポリグリコール;および;ジオール含有ペルフルオロポリエーテル及び/又は単官能性ポリシロキサンを含む変性オリゴマーの反応生成物であるポリウレタン系樹脂から形成され、ジオール含有ペルフルオロポリエーテルが、ジイソシアネートと、ポリグリコールと、ジオール鎖延長剤によって形成されるポリウレタン系樹脂の主鎖に組み込まれており、単官能性ポリシロキサンが、側鎖として組み込まれている。1つ以上の実施形態において、ポリグリコールは、ポリテトラメチレンエーテルグリコールおよびポリエチレングリコールの一方または両方を含み得る、1つ以上のポリアルキレングリコールである。得られるポリウレタン系樹脂は、成分に基づくランダム共重合体である。硬質セグメントの含有量は25重量%~75重量%の範囲であり、樹脂の軟質セグメントの含有量は75重量%~25重量%の範囲である。
医療用物品は、流体通路の任意のプラスチック部分であり得る。本明細書に開示されるポリウレタンによって形成され得る例示的な医療用物品は、カテーテル;ニードル/ニードルレスコネクタ;またはチューブの構成要素であり得る。例示的なデバイスは、中心静脈カテーテル、末梢挿入中心カテーテル、および末梢静脈内カテーテルである。カテーテルチューブは、配合および押出/共押出プロセスによって形成することができる。配合中に、本明細書に記載される合成されたベースのポリウレタンの粒状物、および任意の放射線不透過性充填剤が、2軸式配合機に同時に添加される。混合比は重量測定マルチフィーダシステムによって制御および調整できる。混合ポリウレタン溶融物(複数の加熱ゾーンを介した搬送)は、ダイ、急冷タンクを連続的に通過し、続いて、プラーペレタイザーによってレギュラーサイズのペレットに切断される。収集されたペレットは、チューブの特定の形状に応じて、押出機/共押出機に供給され、カテーテルチューブを形成するために使用される。
様々な実施形態を以下に列挙する。理解されるように、以下に列挙される実施形態は、本発明の範囲に従って、全ての態様および他の実施形態と組み合わせることができる。
実施例1
種々のポリウレタン樹脂を、上記の例示的配合物I-Cに従って、前述したようなパイロットスケールのポリウレタン(PU)プロセッサーを使用する1段階共重合プロセス(無触媒および無溶媒)によって、表1に従って製造した。例示的配合物は、芳香族ジイソシアネートとしてのMDI、ポリグリコール混合物としてのポリテトラメチレンエーテルグリコール(平均等価分子量500~1000DaのPTMEG)および場合によりポリエチレングリコール4000(PEG-4000)の組み合わせ、鎖延長剤としての1,4-ブタンジオール、および表1による変性オリゴマーを有する。変性オリゴマーを有しない参考例ポリウレタンも同様に製造した。
試験
表1の各例について、ポリウレタン(PU)スラブ(約7.7インチ×3.5インチ×0.3インチの寸法)は、上述のパイロットスケールPUプロセッサーおよびコンベヤーオーブン硬化システムから製造され、その後、粒状に粉砕され、材料の物理的特性評価のためにリボンシートに押出成形された。リボンシートの厚さは、0.004インチから0.008インチであった。
表1のいくつかの組成物(本発明のPU1-B-I、1-C、1-F-I、および参考例PU1-L)について、ポリウレタン顆粒物/チップを、さらなるチューブ特性試験のために、22GA標準単層カテーテルチューブに押し出し成形した。押出後、チューブを90~95℃で1時間アニールした。前掲のリボンの発見と同様に、本発明のPUチューブサンプル1-B-I、1-Cおよび1-F-Iは、参考例PUチューブサンプル1-Lと比較して透明性が低い(濁っている)。前述のように、これはおそらく、Fluorolink(登録商標)E10-HまたはMCR-C62の導入による本発明のPFPE-およびPDMS-変性PU内のコポリマー相分離の増加によるものであり、結果的に光散乱に影響を及ぼし得る。しかしながら、本発明のPFPE-およびPDMS-変性PUチューブ試料1-B-I、1-Cおよび1-F-Iは、カテーテルチューブ用途に使用された場合に、依然として、血液フラッシュバック識別のために透視するのに十分な透明性を示した。
Claims (18)
- ポリウレタン系樹脂から形成される医療用物品であって、前記ポリウレタン系樹脂は、以下の成分:
ジイソシアネート;
ジオール鎖延長剤;
ポリグリコール;および
ジオール含有ペルフルオロポリエーテルを含む変性オリゴマー;
の反応生成物のランダム共重合体であり、
前記ジオール含有ペルフルオロポリエーテルが、前記ジイソシアネート、前記ポリグリコールおよび前記ジオール鎖延長剤によって形成される前記ポリウレタン系樹脂の主鎖に組み込まれており、
前記ジオール含有ペルフルオロポリエーテルが、
HO(CH 2 CH 2 O) p CH 2 CF 2 O(CF 2 CF 2 O) q (CF 2 O) r CF 2 CH 2 (OCH 2 CH 2 ) p OH
(式中、p+q+rは、55重量%~60重量%の範囲内のオリゴマーのフッ素含有量、および1500~2200g/molの範囲内の変性オリゴマーの平均分子量を提供する)の構造を有し、
前記樹脂の硬質セグメントの含有量が、25重量%~75重量%の範囲であり、前記樹脂の軟質セグメントの含有量が、75重量%~25重量%の範囲であり、前記ペルフルオロポリエーテルが、樹脂組成物全体の0.1~10重量%の範囲の量で軟質セグメント中に存在し、
前記医療用物品は、自己潤滑性および/または自己防汚性の医療用物品として効果的である、医療用物品。 - 前記医療用物品の表面における前記ペルフルオロポリエーテルの濃度が、前記成分の均一な分布に基づく前記ペルフルオロポリエーテルの理論濃度よりも高い、請求項1に記載の医療用物品。
- 前記ジオール含有ペルフルオロポリエーテルが、55重量%~60重量%の範囲のフッ素含有量、および1500~2200g/molの範囲の平均分子量を有する、請求項1に記載の医療用物品。
- 前記変性オリゴマーが、モノジアルコール末端ポリジメチルシロキサンを更に含み、前記モノジアルコール末端ポリジメチルシロキサンは前記ポリウレタン系樹脂に側鎖として組み込まれている、請求項1に記載の医療用物品。
- 前記モノジアルコール末端ポリジメチルシロキサンが、ポリウレタン系樹脂の軟質セグメント中に側鎖として0.1~9.9重量%の範囲の量で存在し、前記ペルフルオロポリエーテルが、樹脂組成物全体の0.1~9.9重量%の範囲の量で存在する、請求項4に記載の医療用物品。
- 前記ポリグリコールが、ポリテトラメチレンエーテルグリコールおよびポリエチレングリコール4000を含み、前記ポリエチレングリコール4000が、前記ポリウレタン系樹脂の軟質セグメント中に、樹脂組成物全体で0~10重量%の範囲の量で存在する、請求項1に記載の医療用物品。
- 前記変性オリゴマーが、前記ポリウレタン系樹脂の全組成物の約0.1~約10重量%の範囲の量で前記ポリウレタン系樹脂中に存在する、請求項1に記載の医療用物品。
- 前記ポリウレタン系樹脂が、少なくとも6000psiの破断点引張、および/または150%以上の破断点伸びを有する、請求項1に記載の医療用物品。
- ポリウレタン系樹脂から形成される医療用物品であって、以下の成分:
ジイソシアネート;
ジオール鎖延長剤;
ポリグリコール;および
モノジアルコール末端ポリジメチルシロキサンを含む変性オリゴマー;
の反応生成物であり、
前記ポリグリコールは、1000g/モル未満の平均分子量を有するポリテトラメチレンエーテルグリコールを含み、
前記モノジアルコール末端ポリジメチルシロキサンが、前記ジイソシアネートと、前記ポリグリコールと、前記ジオール鎖延長剤によって形成されるポリウレタン系樹脂の側鎖として組み込まれており、
前記ポリウレタン系樹脂は、1.0~1.1のイソシアネート指数を有し、
前記樹脂の硬質セグメントの含有量が、25重量%~75重量%の範囲であり、前記樹脂の軟質セグメントの含有量が、75重量%~25重量%の範囲であり、
前記医療用物品は、自己潤滑性および/または自己防汚性の医療用物品として効果的である、医療用物品。 - 前記医療用物品の表面における前記モノジアルコール末端ポリジメチルシロキサンの濃度が、前記成分の均一な分布に基づくモノジアルコール末端ポリジメチルシロキサンの理論濃度より高い、請求項9に記載の医療用物品。
- 前記モノジアルコール末端ポリジメチルシロキサンは、ポリウレタン系樹脂の軟質セグメントに、側鎖として、樹脂組成物全体の0.1~10重量%の範囲の量で存在する、請求項9に記載の医療用物品。
- 前記ポリグリコールは、ポリテトラメチレンエーテルグリコールおよびポリエチレングリコール4000を含み、前記ポリエチレングリコール4000が、前記ポリウレタン系樹脂の軟質セグメント中に、樹脂組成物全体の0~10重量%の範囲の量で存在し、および/または、前記ジイソシアネートが、脂肪族ジイソシアネート、脂環式ジイソシアネートおよび芳香族ジイソシアネートからなる群から選択され、および/または前記鎖延長剤が、エチレングリコール、1,3-プロピレングリコール、1,4-ブタンジオール、ネオペンチルグリコール、および10個までの炭素原子を有する脂環式グリコールからなる群から選択され、および/または、前記ポリグリコールが、ポリアルキレングリコール、ポリエステルグリコール、ポリカーボネートグリコール、およびそれらの組み合わせからなる群から選択される、請求項9に記載の医療用物品。
- 前記モノジアルコール末端ポリジメチルシロキサンは、前記ポリウレタン系樹脂の全組成物の約0.1~約10重量%の範囲の量で前記ポリウレタン系樹脂中に存在する、請求項9に記載の医療用物品。
- 前記ポリウレタン系樹脂は、少なくとも6000psiの破断点引張を有し、および/または、150%以上の破断点伸びを有する、請求項9に記載の医療用物品。
- 下記の(A)および(B)、場合により(C)、ならびに(D)および(E)の一方または両方の鎖セグメントを含むランダム共重合体であるポリウレタン系樹脂を含む医療用物品:
- 前記ランダム共重合体が、(A)、(B)、および(D)、または(A)、(B)、(C)、および(D)の鎖セグメントを含む、請求項15に記載の医療用物品。
- 前記ランダム共重合体が、(A)、(B)、および(E)、または(A)、(B)、(D)、および(E)の鎖セグメントを含む、請求項15に記載の医療用物品。
- 前記ランダム共重合体が、(A)、(B)、(C)、および(E)、または(A)、(B)、(C)、(D)、および(E)の鎖セグメントを含む、請求項15に記載の医療用物品。
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JP2022502140A (ja) | 2022-01-11 |
AU2019346381A1 (en) | 2021-04-01 |
WO2020068619A1 (en) | 2020-04-02 |
CN113164657A (zh) | 2021-07-23 |
EP3856268A1 (en) | 2021-08-04 |
AU2019346381B2 (en) | 2022-04-14 |
KR20210065143A (ko) | 2021-06-03 |
AU2022202529A1 (en) | 2022-05-12 |
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CA3112818A1 (en) | 2020-04-02 |
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