JP2021142162A - 人工肺およびその製造方法 - Google Patents
人工肺およびその製造方法 Download PDFInfo
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- JP2021142162A JP2021142162A JP2020043496A JP2020043496A JP2021142162A JP 2021142162 A JP2021142162 A JP 2021142162A JP 2020043496 A JP2020043496 A JP 2020043496A JP 2020043496 A JP2020043496 A JP 2020043496A JP 2021142162 A JP2021142162 A JP 2021142162A
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- Prior art keywords
- hollow fiber
- fiber membrane
- artificial lung
- antithrombotic agent
- polymer layer
- Prior art date
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- SINFYWWJOCXYFD-UHFFFAOYSA-N methoxymethyl prop-2-enoate Chemical compound COCOC(=O)C=C SINFYWWJOCXYFD-UHFFFAOYSA-N 0.000 description 1
- 125000001570 methylene group Chemical group [H]C([H])([*:1])[*:2] 0.000 description 1
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- QYZFTMMPKCOTAN-UHFFFAOYSA-N n-[2-(2-hydroxyethylamino)ethyl]-2-[[1-[2-(2-hydroxyethylamino)ethylamino]-2-methyl-1-oxopropan-2-yl]diazenyl]-2-methylpropanamide Chemical compound OCCNCCNC(=O)C(C)(C)N=NC(C)(C)C(=O)NCCNCCO QYZFTMMPKCOTAN-UHFFFAOYSA-N 0.000 description 1
- 230000007935 neutral effect Effects 0.000 description 1
- 239000003002 pH adjusting agent Substances 0.000 description 1
- PNJWIWWMYCMZRO-UHFFFAOYSA-N pent‐4‐en‐2‐one Natural products CC(=O)CC=C PNJWIWWMYCMZRO-UHFFFAOYSA-N 0.000 description 1
- 230000002093 peripheral effect Effects 0.000 description 1
- JRKICGRDRMAZLK-UHFFFAOYSA-L peroxydisulfate Chemical compound [O-]S(=O)(=O)OOS([O-])(=O)=O JRKICGRDRMAZLK-UHFFFAOYSA-L 0.000 description 1
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Abstract
Description
本発明の一形態に係る人工肺は、少なくとも一部がポリメチルペンテンで形成される複数のガス交換用多孔質中空糸膜を有する人工肺であって、前記中空糸膜は、内腔を形成する内表面と、外表面とを有しており、前記内表面および外表面の少なくとも一方に、重合体層および抗血栓剤層をこの順番で(即ち、中空糸膜、重合体層および抗血栓剤層の順で)配置される。そのため、本発明に係る人工肺は、高い抗血栓剤による効果(例えば、抗血栓性)を発揮できる。よって、例えば1か月以上の長期にわたる使用にあっても抗血栓性を維持できる(すなわち、抗血栓性および抗血栓維持性に優れる)。ゆえに、本発明に係る人工肺は、肺炎、重症呼吸不全、急性心筋梗塞、急性心筋炎等の循環不全にある患者に対して、呼吸・循環をサポートする目的で、ECMO(Extra Corporeal Membrane Oxygenation)やPCPS(Percutaneous Cardio Pulmonary Support)等の体外循環装置として特に好適に使用できる。
重合体層は、中空糸膜上に形成される抗血栓剤層の耐久性を向上させる機能を有する。これにより、十分な抗血栓性を長期間維持できる人工肺を提供することが可能となる。重合体層は、中空糸膜の内表面または外表面のいずれか一方の直上に設けられても、別の層を介して設けられても構わないが、直上に設けられることが好ましい。
抗血栓剤層は、血液接触部である中空糸膜表面(例えば、中空糸膜の外表面)に形成された重合体層上に形成され、人工肺に抗血栓性を付与する機能を有する。
次に、本発明の人工肺の製造方法について詳細に説明する。当該製造方法は、上記人工肺の製造方法であって、中空糸膜の内表面または外表面に重合体層形成化合物を含むコート液を接触させて、前記内表面または外表面に前記化合物の重合体を含む重合体層を形成し((1)重合体層形成工程)、前記重合体層上に抗血栓剤を有する抗血栓剤層を形成する((2)抗血栓剤層形成工程)ことを有することを特徴とする。以下、各工程について説明する。
本工程では、中空糸膜の内表面または外表面(以下、単に「中空糸膜表面」とも称する)に、ドーパミンならびにその塩およびオリゴマーからなる群より選択される少なくとも一種の化合物を含む重合体層を形成する。一実施形態によると、ドーパミンならびにその塩およびオリゴマーからなる群より選択される少なくとも一種の化合物を含むコート液を調製し、当該コート液を中空糸膜表面に接触させることにより中空糸膜表面に重合体層形成化合物の重合体層を形成する。
本工程では、重合体層上に抗血栓剤を含む被膜(抗血栓剤層)を形成する。一実施形態では、抗血栓剤を含む水性コート液を調製し、前記水性コート液を、上記(1)にて中空糸膜の外表面又は内表面に形成された重合体層に塗布する。
ポリメチルペンテン(PMP)の板(長さ×幅×厚み=20mm×5mm×1mm)を準備した。ドーパミン塩酸塩(dopamine hydrochloride)(シグマアルドリッチジャパン合同会社製)を、PBS溶液(組成:8g/L NaCl、0.2g/L KCl、1.15g/L Na2HPO4、0.2g/L KH2PO4、pH 7.4)に2mg/mLの濃度となるように溶解させ、DA/PBS溶液(pH 7.4)を得た。この混合溶液(DA/PBS溶液)にPMP板を浸漬させて、37℃で24時間保持した。これにより、ドーパミンを酸化・重合して、PMP板の表面にドーパミン重合体を吸着させた。このPMP板をDA/PBS溶液から取り出し、RO水で洗浄し、室温(25℃)で自然乾燥させ、表面に重合体層(厚み200nm、重合体の含有量2μg/cm2)を有するPMP板を得た。
重合体層を形成しなかったこと以外は、実施例1と同様の操作を行い、表面に抗血栓剤層のみが形成されたPMP板(比較PMP板1)を得た。
重合体層を形成しなかったこと、および、コロナ処理を行った後に抗血栓剤層を形成したこと以外は、実施例1と同様の操作を行い、コロナ処理後の表面に抗血栓剤層のみが形成されたPMP板(比較PMP板2)を得た。なお、コロナ処理は、TANTEC HTX1−13sp−02装置を用いて、出力50Wにて、5秒間処理することで行った。
PMP板1および比較PMP板1〜2について、抗血栓剤層の耐久性を評価した。PMP板をポリ塩化ビニル製の回路(図8、内径0.6cm)中に、ピン留めして固定した。回路内を2mMのドデシル硫酸ナトリウム(Sodium dodecyl sulfate;SDS)水溶液で満たし、回路内の溶液を3L/分の流速で48時間循環させた。その後、PMP板をRO水で洗浄し、室温(25℃)で自然乾燥させ、表面に残存するPMEAをATR FT−IRで確認した。測定結果を図9A〜図9Cに示す。なお、図9A〜図9Cに示す各スペクトルは、上記操作をそれぞれ3連で行い、各測定結果を重ね合わせたものである。FT−IRにおいて、PMEA中のカルボルニル基は1750cm−1近傍に特有の吸収スペクトルを有する。
2、23 ハウジング、
3、50 ガス交換用多孔質中空糸膜、
3a スキン層、
3a’ 外表面、
3b 多孔質層、
3c 内面層、
3c’ 内表面、
3d 通路(内腔)、
3f 内表面側の開口部、
4,5 隔壁、
6、17a、28 血液流入口、
7、29a、29b 血液流出口、
8,24 ガス流入口、
9,27 ガス流出口、
10 ガス流入側ヘッダー、
11 ガス流出側ヘッダー、
12、17 血液室、
13 ガス流入室、
14 ガス流出室、
16 重合体層、
17b 第1の血液室、
17c 第1の血液室、
18 抗血栓剤層、
22 筒状中空糸膜束、
25 第1の隔壁、
26 第2の隔壁、
31 内側筒状部材、
32 血液流通用開口、
33 外部筒状部材、
35 内筒体、
35a 上端、
41 ガス流入用部材、
42 ガス流出用部材。
Claims (6)
- 少なくとも一部がポリメチルペンテンで形成される複数のガス交換用多孔質中空糸膜を有する人工肺であって、
前記中空糸膜は、内腔を形成する内表面と、外表面とを有しており、
前記内表面または前記外表面のいずれか一方に、
ドーパミンならびにその塩およびオリゴマーからなる群より選択される少なくとも一種の化合物の重合体を含む重合体層と、抗血栓剤を含む抗血栓剤層と、が順次形成される、人工肺。 - 前記重合体層は、10〜200nmの厚み(乾燥膜厚)を有する、請求項1に記載の人工肺。
- 前記重合体層は、前記重合体を1〜20μg/cm2の量で含む、請求項1または2に記載の人工肺。
- 前記化合物は、ドーパミンまたはドーパミン塩である、請求項1〜3のいずれか1項に記載の人工肺。
- 請求項1〜5のいずれか1項に記載の人工肺の製造方法であって、
前記中空糸膜の内表面または外表面に前記化合物を含むコート液を接触させて、前記内表面または外表面に前記化合物の重合体を含む重合体層を形成し、
前記重合体層上に抗血栓剤を有する抗血栓剤層を形成することを有する、方法。
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JP5130446B2 (ja) * | 2009-05-11 | 2013-01-30 | 独立行政法人科学技術振興機構 | 表面修飾基材およびポリマー被覆基材 |
JP2014147639A (ja) * | 2013-02-04 | 2014-08-21 | Terumo Corp | 医療用具 |
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JP5130446B2 (ja) * | 2009-05-11 | 2013-01-30 | 独立行政法人科学技術振興機構 | 表面修飾基材およびポリマー被覆基材 |
JP2014147639A (ja) * | 2013-02-04 | 2014-08-21 | Terumo Corp | 医療用具 |
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