JP6816121B2 - 尿管ステント、方法およびその使用 - Google Patents
尿管ステント、方法およびその使用 Download PDFInfo
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- JP6816121B2 JP6816121B2 JP2018511541A JP2018511541A JP6816121B2 JP 6816121 B2 JP6816121 B2 JP 6816121B2 JP 2018511541 A JP2018511541 A JP 2018511541A JP 2018511541 A JP2018511541 A JP 2018511541A JP 6816121 B2 JP6816121 B2 JP 6816121B2
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- Prior art keywords
- stent
- stent according
- agent
- ureteral
- gelatin
- Prior art date
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- 238000000034 method Methods 0.000 title claims description 21
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- 239000008273 gelatin Substances 0.000 claims description 38
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- 235000010443 alginic acid Nutrition 0.000 claims description 37
- 229920000615 alginic acid Polymers 0.000 claims description 37
- 235000019322 gelatine Nutrition 0.000 claims description 37
- 235000011852 gelatine desserts Nutrition 0.000 claims description 37
- FHVDTGUDJYJELY-UHFFFAOYSA-N 6-{[2-carboxy-4,5-dihydroxy-6-(phosphanyloxy)oxan-3-yl]oxy}-4,5-dihydroxy-3-phosphanyloxane-2-carboxylic acid Chemical compound O1C(C(O)=O)C(P)C(O)C(O)C1OC1C(C(O)=O)OC(OP)C(O)C1O FHVDTGUDJYJELY-UHFFFAOYSA-N 0.000 claims description 35
- 229940072056 alginate Drugs 0.000 claims description 34
- 229920000642 polymer Polymers 0.000 claims description 24
- 239000003431 cross linking reagent Substances 0.000 claims description 23
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 21
- 238000000576 coating method Methods 0.000 claims description 20
- 239000011248 coating agent Substances 0.000 claims description 18
- CURLTUGMZLYLDI-UHFFFAOYSA-N Carbon dioxide Chemical compound O=C=O CURLTUGMZLYLDI-UHFFFAOYSA-N 0.000 claims description 16
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- GMZOPRQQINFLPQ-UHFFFAOYSA-H dibismuth;tricarbonate Chemical compound [Bi+3].[Bi+3].[O-]C([O-])=O.[O-]C([O-])=O.[O-]C([O-])=O GMZOPRQQINFLPQ-UHFFFAOYSA-H 0.000 claims description 6
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- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 claims description 3
- AZKVWQKMDGGDSV-BCMRRPTOSA-N Genipin Chemical compound COC(=O)C1=CO[C@@H](O)[C@@H]2C(CO)=CC[C@H]12 AZKVWQKMDGGDSV-BCMRRPTOSA-N 0.000 claims description 3
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- SDUQYLNIPVEERB-QPPQHZFASA-N gemcitabine Chemical compound O=C1N=C(N)C=CN1[C@H]1C(F)(F)[C@H](O)[C@@H](CO)O1 SDUQYLNIPVEERB-QPPQHZFASA-N 0.000 claims description 3
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- AOJJSUZBOXZQNB-VTZDEGQISA-N 4'-epidoxorubicin Chemical compound O([C@H]1C[C@@](O)(CC=2C(O)=C3C(=O)C=4C=CC=C(C=4C(=O)C3=C(O)C=21)OC)C(=O)CO)[C@H]1C[C@H](N)[C@@H](O)[C@H](C)O1 AOJJSUZBOXZQNB-VTZDEGQISA-N 0.000 claims description 2
- GSDSWSVVBLHKDQ-UHFFFAOYSA-N 9-fluoro-3-methyl-10-(4-methylpiperazin-1-yl)-7-oxo-2,3-dihydro-7H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic acid Chemical compound FC1=CC(C(C(C(O)=O)=C2)=O)=C3N2C(C)COC3=C1N1CCN(C)CC1 GSDSWSVVBLHKDQ-UHFFFAOYSA-N 0.000 claims description 2
- MBUVEWMHONZEQD-UHFFFAOYSA-N Azeptin Chemical compound C1CN(C)CCCC1N1C(=O)C2=CC=CC=C2C(CC=2C=CC(Cl)=CC=2)=N1 MBUVEWMHONZEQD-UHFFFAOYSA-N 0.000 claims description 2
- ZOXJGFHDIHLPTG-UHFFFAOYSA-N Boron Chemical compound [B] ZOXJGFHDIHLPTG-UHFFFAOYSA-N 0.000 claims description 2
- GAGWJHPBXLXJQN-UORFTKCHSA-N Capecitabine Chemical compound C1=C(F)C(NC(=O)OCCCCC)=NC(=O)N1[C@H]1[C@H](O)[C@H](O)[C@@H](C)O1 GAGWJHPBXLXJQN-UORFTKCHSA-N 0.000 claims description 2
- GAGWJHPBXLXJQN-UHFFFAOYSA-N Capecitabine Natural products C1=C(F)C(NC(=O)OCCCCC)=NC(=O)N1C1C(O)C(O)C(C)O1 GAGWJHPBXLXJQN-UHFFFAOYSA-N 0.000 claims description 2
- 229930186147 Cephalosporin Natural products 0.000 claims description 2
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- HTIJFSOGRVMCQR-UHFFFAOYSA-N Epirubicin Natural products COc1cccc2C(=O)c3c(O)c4CC(O)(CC(OC5CC(N)C(=O)C(C)O5)c4c(O)c3C(=O)c12)C(=O)CO HTIJFSOGRVMCQR-UHFFFAOYSA-N 0.000 claims description 2
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- CEAZRRDELHUEMR-URQXQFDESA-N Gentamicin Chemical compound O1[C@H](C(C)NC)CC[C@@H](N)[C@H]1O[C@H]1[C@H](O)[C@@H](O[C@@H]2[C@@H]([C@@H](NC)[C@@](C)(O)CO2)O)[C@H](N)C[C@@H]1N CEAZRRDELHUEMR-URQXQFDESA-N 0.000 claims description 2
- 229930182566 Gentamicin Natural products 0.000 claims description 2
- SXRSQZLOMIGNAQ-UHFFFAOYSA-N Glutaraldehyde Chemical compound O=CCCCC=O SXRSQZLOMIGNAQ-UHFFFAOYSA-N 0.000 claims description 2
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- HEFNNWSXXWATRW-UHFFFAOYSA-N Ibuprofen Chemical compound CC(C)CC1=CC=C(C(C)C(O)=O)C=C1 HEFNNWSXXWATRW-UHFFFAOYSA-N 0.000 claims description 2
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- FBOZXECLQNJBKD-ZDUSSCGKSA-N L-methotrexate Chemical compound C=1N=C2N=C(N)N=C(N)C2=NC=1CN(C)C1=CC=C(C(=O)N[C@@H](CCC(O)=O)C(O)=O)C=C1 FBOZXECLQNJBKD-ZDUSSCGKSA-N 0.000 claims description 2
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- FQISKWAFAHGMGT-SGJOWKDISA-M Methylprednisolone sodium succinate Chemical compound [Na+].C([C@@]12C)=CC(=O)C=C1[C@@H](C)C[C@@H]1[C@@H]2[C@@H](O)C[C@]2(C)[C@@](O)(C(=O)COC(=O)CCC([O-])=O)CC[C@H]21 FQISKWAFAHGMGT-SGJOWKDISA-M 0.000 claims description 2
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Description
ステント除去のための第2の手術の必要性を回避する;
外科的処置にかけられた患者の罹患率を低下させる;
尿管ステントの移植後の感染の危険性を低下させるまたは排除する。
哺乳動物の身体によって拒絶されず、
このステントは、改善された機械的特性を有し、in vivoでの器具の移植を哺乳動物モデルにおいて可能にし、
外科的処置にかけられた哺乳動物患者によって除去され、および
実施された外科的処置から回復するのに十分な時間生物体内にある。
2〜5%(w/w)の造影剤、好ましくは5%(w/w)の造影剤、すなわち炭酸ビスマス(III);
ポリマー基材は、20〜40%(w/w)のアルギン酸塩および55〜70%(w/w)のゼラチンを含んでもよく、好ましくはポリマー基材は、30%(w/w)のアルギン酸塩および65%(w/w)のゼラチンを含んでもよい。
アルギン酸塩、ゼラチンを、40〜90℃、好ましくは70℃の水に溶解させる工程;
300〜1500rpmで30分間〜3時間、好ましくは600rpmで1時間撹拌し、ポリマー基材を得る工程;
任意に、化学架橋剤をポリマー基材に添加する工程;
ポリマー基材を鋳型に注入し、ステントを得る工程;
ステントをアルコール溶液に30分〜3時間、好ましくは1時間浸す工程;
ステントを0.05〜2Mの架橋剤溶液に、1〜24時間、好ましくは2時間、20〜25℃で絶え間なく撹拌しながら浸す工程;
ステントをアルコール溶液に入れる工程;
超臨界流体、特に二酸化炭素の高圧容器内で、35〜60℃、71〜200バールで60〜360分間、連続モードでステントを乾燥させる工程;
ステントを15〜90分間、好ましくは30分間水に浸漬させる工程;
ステントをエタノールに1〜5時間、好ましくは1時間浸漬させる工程;
ステントを20〜25℃で1日乾燥させる工程;
ステントを5〜20%の樹脂、好ましくは10%のポリカプロラクトンの溶液に5〜30秒間、好ましくは10秒間浸漬させる工程;
15〜35℃、好ましくは20℃で12〜24時間、好ましくは15時間乾燥させる工程。
前記組成物が生分解性ステントに施され、
前記ステントが、10〜50%(w/w)のアルギン酸塩と45〜85%(w/w)のゼラチンとを基材として含み、ポリマー生分解性樹脂を基材コーティングとして含む組成物に関する。
原料 - 一実施形態では、アルギン酸ナトリウム塩、ゼラチン、尿素、カナバリア・エンシホルミス(タチナタマメ)由来ウレアーゼIX型、塩化カルシウム、クロロホルム、エタノール、塩基性炭酸ビスマス(III)、二塩基性リン酸ナトリウムおよびアジ化ナトリウムは、Sigma-Aldrich(ドイツ)から購入した。オルトリン酸二水素カリウムおよび塩化マグネシウム六水和物は、Riedel-de Haen(ドイツ)から入手した。
%重量損失 = (Wf-Wi)/Wi* 100 (1)
ここで、Wfは試料(浸漬後に乾燥させた)の最終重量であり、Wiは試料の初期重量である。各配合物を三重に試験した。
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Claims (30)
- 以下を含むステント:
ポリマー基材であって、10〜50%(w/w)のアルギン酸塩および45〜85%(w/w)のゼラチンを含む該ポリマー基材と;
前記ポリマー基材をコーティングするためのポリマー生分解性樹脂。 - 該ポリマー基材が、20〜40%(w/w)のアルギン酸塩および55〜70%(w/w)のゼラチンを含む、請求項1に記載のステント。
- 3〜50%(w/v)のポリマー生分解性樹脂の溶液が前記ステントに添加される、請求項1〜2のいずれか一項に記載のステント。
- 5〜20%(w/v)のポリマー生分解性樹脂の溶液が前記ステントに添加される、請求項1〜3のいずれか一項に記載のステント。
- 5〜10%(w/v)のポリマー生分解性樹脂の溶液が前記ステントに添加される、請求項1〜4のいずれか一項に記載のステント。
- 造影剤をさらに含む、請求項1〜5のいずれか一項に記載のステント。
- 以下を含む、請求項1〜6のいずれか一項に記載のステント:
2〜5%(w/w)の造影剤;
20〜40%(w/w)のアルギン酸塩および55〜70%(w/w)のゼラチン。 - 以下を含む、請求項1〜7のいずれか一項に記載のステント:
5%(w/w)の造影剤、;
30%(w/w)のアルギン酸塩および65%(w/w)のゼラチン。 - 前記樹脂が、以下のリストから選択される、請求項1〜8のいずれか一項に記載のステント:ポリカプロラクトン樹脂、ポリグリコリドおよびその共重合体: ポリ(乳酸-グリコール酸共重合体と乳酸)、ポリ(グリコリド-カプロラクトン共重合体とε-カプロラクトン)、およびポリ(グリコリド-トリメチレンカーボネート共重合体とトリメチレンカーボネート)、またはそれらの混合物。
- 該造影剤が以下のリストから選択される、請求項1〜9のいずれか一項に記載のステント:バリウム塩、ビスマス塩、スピネル顔料、またはそれらの混合物、特に炭酸ビスマス(III)。
- 架橋剤をさらに含む、請求項1〜10のいずれか一項に記載のステント。
- 該架橋剤が、ゼラチンアミンと反応することができる官能基を含む化学架橋剤である、請求項11に記載のステント。
- 前記架橋剤が以下のリストから選択される、請求項11〜12に記載のステント:イオン性架橋剤は、一価または二価のイオンを含み、そのカチオンはカルシウム、マグネシウム、バリウム、ストロンチウム、ホウ素、ベリリウム、アルミニウム、鉄、銅、コバルト、鉛または銀であり; そのアニオンは、塩化物、硝酸塩、リン酸塩、クエン酸塩、ホウ酸塩、コハク酸塩、マレイン酸塩もしくはシュウ酸塩、またはそれらの混合物からなる群より選択される。
- 該架橋剤が、塩化カルシウム、ゲニピン、グルタルアルデヒド、カルボジイミド、およびそれらの混合物からなる群より選択される、請求項11〜13に記載のステント。
- 治療剤、すなわち、抗炎症剤、抗菌剤、抗がん剤、抗ウイルス剤、またはそれらの混合物をさらに含む、請求項1〜14のいずれか一項に記載のステント。
- 該抗炎症剤が以下のリストから選択される、請求項15記載のステント:プレドニゾロン、メチルプレドニゾロン、フルオロメトロン、デキサメタゾン、ベタメタゾン、ヒドロコルチゾン、メドリゾン、ロテプレドノール、リメキソロン、トリアムシノロン、ジクロフェナク、ケトロラク、フルルビプロフェン、インドメタシン、スプロフェン、イブプロフェン、ケトロラクトロメタミン、エメダスチン、レボカバスチン、アゼラスチン、オロパタジン、ケトチフェン、ケトプロフェン、クロモリン、ヨードキサミドまたはそれらの混合物。
- 該抗菌剤が以下のリストから選択される、請求項15に記載のステント:アモキシシリン、ジクロキサシリン、オーグメンチン、セファロスポリン、ゲンタマイシン、トブラマイシン、ネオマイシン、エリスロマイシン、アジスロマイシン、クラリスロマイシン、オフロキサシン、シプロフロキサシン、ノルフロキサシン、レボフロキサシンまたはそれらの混合物。
- 該抗がん剤が以下のリストから選択される、請求項15に記載のステント:メトトレキサート、ビンブラスチン、ドキソルビシン、シスプラチン、顆粒球コロニー刺激因子、ゲムシタビン、カルボプラチン、5-フルオロウラシル、イホスファミド、ペメトレキセド、パクリタキセル、エピルビシン、マイトマイシンC、カペシタビン、カルメット・ゲラン桿菌(BCG)またはそれらの混合物。
- 該抗ウイルス剤が以下のリストから選択される、請求項15に記載のステント: アシクロビル、バラシクロビル、ファムシクロビルまたはそれらの混合物。
- 該治療剤が該ポリマー基材に組み込まれている、請求項15〜19 のいずれか一項に記載のステント。
- 該治療剤が該ポリマー基材のコーティング中にある、請求項15〜20のいずれか一項に記載のステント。
- ヒトまたは獣医学における使用のための、請求項1〜21のいずれか一項に記載のステント。
- 再生医療または組織工学における使用のための、請求項1〜22のいずれか一項に記載のステント。
- 泌尿器科疾患の予防または治療における使用のための、請求項1〜23のいずれか一項に記載のステント。
- 該ステントが尿管ステントである、請求項1〜24のいずれか一項に記載のステント。
- 以下の工程を含む、ステントの製造方法:
アルギン酸塩、ゼラチンを、40〜90℃、好ましくは70℃の水に溶解させる工程;
300〜1500rpmで30分間〜3時間、好ましくは600rpmで1時間撹拌し、ポリマー基材を得る工程;
任意に、化学架橋剤を該ポリマー基材に添加する工程;
該ポリマー基材を鋳型に注入し、ステントを得る工程;
該ステントをアルコール溶液に30分〜3時間、好ましくは1時間浸す工程;
該ステントを0.05〜2Mの架橋剤溶液に、1〜24時間、好ましくは2時間、20〜25℃で絶え間なく撹拌しながら浸す工程;
該ステントをアルコール溶液に入れる工程;
超臨界流体、特に二酸化炭素の高圧容器内で、35〜60℃、71〜200バールで60〜360分間、連続モードでステントを乾燥させる工程;
ステントを15〜90分間、好ましくは30分間水に浸漬させる工程;
ステントをエタノールに1〜5時間、好ましくは1時間浸漬させる工程;
ステントを20〜25℃で1日乾燥させる工程;
ステントを5〜20%の樹脂、好ましくは10%のポリカプロラクトンの溶液に5〜30秒間、好ましくは10秒間浸漬させる工程;
15〜35℃、好ましくは20℃で12〜24時間、好ましくは15時間乾燥させる工程。 - アルギン酸塩およびゼラチンを溶解させる工程が、炭酸ビスマス(III)を溶解させる工程をさらに含む、請求項26に記載の方法。
- 連続モードでステントを乾燥させる工程が、35〜50℃、100バールで2時間の超臨界流体含浸によって行われる、請求項26〜27に記載の方法。
- 該架橋剤溶液の濃度が、0.24M、0.48M、1Mである、請求項26〜28に記載の方法。
- 二酸化炭素の高圧容器内での乾燥工程が、40℃、100バールで90分間実施される、請求項26〜29に記載の方法。
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