JP2006519672A - 結晶度が選択的に変性された重合物質を有する管腔内プロテーゼ及びその製法 - Google Patents
結晶度が選択的に変性された重合物質を有する管腔内プロテーゼ及びその製法 Download PDFInfo
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Abstract
Description
本発明は、一般的に医療機器、さらに詳細には管腔内プロテーゼに関する。
Claims (77)
- 重合物質の外面を有し、被検者身体の管腔内に配備されると、収縮形状から拡張し得る管腔内プロテーゼを製造する方法であって、
その結晶度を選択的に変性させるに充分な温度で、配備前のある期間、重合物質をアニールするステップを含む、製法。 - アニーリングは、重合物質の結晶度を選択的に増加させるのに充分な期間、重合物質のガラス転移温度と融点の間の温度まで、重合物質を加熱するステップを含む、請求項1に記載の方法。
- アニーリングは、重合物質の融点より高い第一温度まで、第一期間の間、重合物質を加熱し、次いで、重合物質の結晶度を選択的にコントロールするのに充分な第二の期間の間、融点より低い第二温度まで重合物質を急冷するステップを含む、請求項1に記載の方法。
- 第二温度は、重合物質のガラス転移温度と融点の間にある、請求項3に記載の方法。
- 第二温度は、重合物質のガラス転移温度より低い、請求項3に記載の方法。
- アニーリングは、重合物質のモジュラスを選択的に増加又は減少させるのに充分な期間、重合物質のガラス転移温度と融点の間の温度まで、重合物質を加熱するステップを含む、請求項1に記載の方法。
- アニーリングは、管腔内プロテーゼの円周強度を選択的に増加又は減少させるのに充分な期間、重合物質のガラス転移温度と融点の間の温度まで、重合物質を加熱するステップを含む、請求項1に記載の方法。
- アニーリングは、引き続いての溶出が可能であるように重合物質内に捕捉された薬剤の溶出速度を選択的に変更するのに充分な期間、重合物質のガラス転移温度と融点の間の温度まで、重合物質を加熱するステップを含む、請求項1に記載の方法。
- アニーリングは、重合物質内の感熱性薬剤に選択的に影響するのに充分な期間、重合物質のガラス転移温度と融点の間の温度まで、重合物質を加熱するステップを含む、請求項1に記載の方法。
- 溶出速度が増加される、請求項8に記載の方法。
- 溶出速度が減じられる、請求項8に記載の方法。
- アニーリングは、管腔内プロテーゼ内の応力を選択的に減じるのに充分な期間、重合物質のガラス転移温度と融点の間の温度まで、重合物質を加熱するステップを含む、請求項1に記載の方法。
- アニーリングは、管腔内プロテーゼ内の応力を選択的に増加させるのに充分な期間、重合物質のガラス転移温度と融点の間の温度まで、重合物質を加熱するステップを含む、請求項1に記載の方法。
- 重合物質は、被検者身体の管腔内に配備されると、第一の速度で浸食されるように構成され、またアニーリングは、被検者身体の管腔内に配備されると、第一の速度より大きい第二の速度で浸食されるように、重合物質を選択的に変性させるのに充分な期間、重合物質のガラス転移温度と融点との間の温度まで、重合物質を加熱するステップを含む、請求項1に記載の方法。
- 重合物質は、被検者身体の管腔内に配備されると、第一の速度で浸食されるように構成され、またアニーリングは、被検者身体の管腔内に配置されると、第一の速度より小さい第三の速度で浸食されるように、重合物質を選択的に変性させるのに充分な期間、重合物質のガラス転移温度と融点の間の温度まで、重合物質を加熱するステップを含む、請求項1に記載の方法。
- アニーリングは、二酸化炭素の存在下に実施される、請求項1に記載の方法。
- アニーリングに先行して、重合物質は二酸化炭素中に浸漬される、請求項1に記載の方法。
- アニーリングは、重合物質上又は内に設けられた核化剤の存在下に実施される、請求項1に記載の方法。
- 重合物質に化学処理を施すことにより重合物質の分子架橋を変性するステップを更に含む、請求項1に記載の方法。
- 重合物質に化学処理を施すステップは、重合物質に1つ以上の多官能性架橋剤を施すステップを含む、請求項19に記載の方法。
- 1つ以上の多官能性架橋剤は、ホルムアルデヒド、二官能性ジアルデヒド及びジイソシアナートからなる群から選択される、請求項20に記載の方法。
- 重合物質に化学処理を施すステップは、重合物質に1つ以上の酵素的架橋剤を施すステップを含む、請求項21に記載の方法。
- 1つ以上の酵素的架橋剤は、自然組織酵素を用いて、グルタミンアミドとリジン含有ポリペプチドとで官能性にされたポリエチレングリコール(PEG)及びトランスグルタミナーゼからなる群から選択される、請求項22に記載の方法。
- 重合物質は、アニーリングの間、化学処理を施される、請求項19に記載の方法。
- 重合物質は、アニーリングの後、化学処理を施される、請求項19に記載の方法。
- 重合物質を照射することにより重合物質の分子架橋を変性するステップを更に含む、請求項1に記載の方法。
- 重合物質を照射することにより重合物質を殺菌するステップを更に含む、請求項1に記載の方法。
- 分子架橋を変性するのに利用される放射線は、イオン化放射線及びUV/可視光線からなる群から選択される、請求項26に記載の方法。
- イオン化照射は、電子ビーム照射又はガンマ照射を含む、請求項27に記載の方法。
- 分子架橋を変性するために利用される放射線は、光酸発生剤の存在下でのUV/可視光線を含む、請求項26に記載の方法。
- 光酸発生剤は、ジニトロベンジルトシラート、スルホニウム塩、ヨードニウム塩、ジアゾジスルホン誘導体及びスルホナートからなる群から選択される、請求項30に記載の方法。
- 重合物質は、アニーリングの間に、照射される、請求項26に記載の方法。
- 重合物質は、アニーリング後に、照射される、請求項26に記載の方法。
- 管腔内プロテーゼはステントである、請求項1に記載の方法。
- 重合物質は浸食性である、請求項1に記載の方法。
- 重合物質は非浸食性である、請求項1に記載の方法。
- 重合物質は、管腔内プロテーゼ上のコーティングである、請求項1に記載の方法。
- 浸食性重合物質は、外科用縫糸、絹、木綿、ポリ(ヒドロキシ酪酸)、ポリカルボナート、ポリアクリラート、ポリ酸無水物、ポリ(オルトエステル)、ポリ(ホスホエステル)、ポリエステル、ポリアミド、ポリホスファゼン、ポリ(p−ジオキサン)、ポリ(アミノ酸)、ポリグラクチン、浸食性ヒドロゲル、コラーゲン、キトサン、ポリ(乳酸)、ポリ(L−乳酸)、ポリ(D,L−乳酸)、ポリ(グリコール酸)、ポリ(D−乳酸/グリコール酸)、ポリ(L−乳酸/グリコール酸)、ポリ(D,L−乳酸/グリコール酸)、ポリ(ε−カプロラクトン)、ポリ(バレロラクトン)、ポリ(ヒドロ吉草酸)、ポリジオキサノン、ポリ(プロピレンフマル酸)、ポリ(エチレンオキシド)−ポリ(ブチレンテトラフタラート)、ポリ(乳酸/リジン)、ポリ(乳酸/トリメチレンカルボナート)、ポリ(L−乳酸)及びポリ(ε−カプロラクトン)コポリマーからなる群から選択される、請求項36に記載の方法。
- 浸食性重合物質は、外科用縫糸、絹、木綿、ポリ(ヒドロキシ酪酸)、ポリカルボナート、ポリアクリラート、ポリ酸無水物、ポリ(オルトエステル)、ポリ(ホスホエステル)、ポリエステル、ポリアミド、ポリホスファゼン、ポリ(p−ジオキサン)、ポリ(アミノ酸)、ポリグラクチン、浸食性ヒドロゲル、コラーゲン、キトサン、ポリ(乳酸)、ポリ(L−乳酸)、ポリ(D,L−乳酸)、ポリ(グリコール酸)、ポリ(D−乳酸/グリコール酸)、ポリ(L−乳酸/グリコール酸)、ポリ(D,L−乳酸/グリコール酸)、ポリ(ε−カプロラクトン)、ポリ(バレロラクトン)、ポリ(ヒドロ吉草酸)、ポリジオキサノン、ポリ(プロピレンフマル酸)、ポリ(エチレンオキシド)−ポリ(ブチレンテトラフタラート)、ポリ(乳酸/リジン)、ポリ(乳酸/トリメチレンカルボナート)、ポリ(L−乳酸)及びポリ(ε−カプロラクトン)コポリマーからなる群から選択される重合物質のブレンドを含む、請求項36に記載の方法。
- アニーリング後に重合物質に所定量の薬剤を含浸させるステップを更に含む、請求項1に記載の方法。
- 重合物質に所定量の薬剤を含浸させるステップは、
担体流体と薬剤との混合物に、管腔内プロテーゼを浸漬し、
重合物質を膨潤させて、担体流体と薬剤を少なくとも部分的に膨潤重合物質中に浸透させるのに充分な時間、前記混合物を加圧し、
担体流体が膨潤重合物質の外へ拡散し、かつ所定量の薬剤が重合物質内に溶出可能なように捕捉されて残存するように圧を除くこと、
を含む、請求項40に記載の方法。 - 担体流体は、二酸化炭素であり、薬剤は疎水性である、請求項40に記載の方法。
- 薬剤は、抗腫瘍薬、抗有糸分裂剤、抗炎症剤、抗血小板薬、抗凝血薬、抗線維素剤、抗トロンビン剤、抗増殖剤、抗生物質、抗酸化剤、免疫抑制剤、抗アレルギー物質及びこれらの組み合わせからなる群から選択される、請求項42に記載の方法。
- 担体流体は、水であり、薬剤は親水性である、請求項40に記載の方法。
- 担体流体と薬剤との混合物への加圧は、担体流体と薬剤との混合物に加圧二酸化炭素を施すことを含む、請求項44に記載の方法。
- 二酸化炭素は超臨界状態で存在する、請求項42に記載の方法。
- 二酸化炭素は補助溶媒を含有する、請求項46に記載の方法。
- 補助溶媒は、エタノール及びメタノールからなる群から選択される、請求項47に記載の方法。
- 重合物質をアニーリングするステップは、結晶度を重合物質の一部のみ選択的に変性することを含む、請求項1に記載の方法。
- 結晶度を重合物質の一部のみ選択的に変性するステップは、
重合物質の1つ以上の部分のマスキングステップと、
重合物質の露出部分に二酸化炭素を施すステップと、
を含む、請求項49に記載の方法。 - 結晶度を重合物質の一部のみ選択的に変性するステップは、重合物質のガラス転移温度と融点の間の温度まで、重合物質の一部を加熱することを含む、請求項49に記載の方法。
- 結晶度を重合物質の一部のみ選択的に変性するステップは、重合物質の一部に化学処理を施すことを含む、請求項49に記載の方法。
- 結晶度を重合物質の一部のみ選択的に変性するステップは、重合物質の一部に照射することを含む、請求項49に記載の方法。
- 重合物質の外面を有する管状本体部を含む管腔内プロテーゼであって、
管腔内プロテーゼが被検者身体の管腔内に配備されると、管状本体は、その収縮形状から拡張し、かつ重合物質は、配備前に、その結晶度を選択的に変性するのに充分な温度と期間アニールされる、プロテーゼ。 - 重合物質の結晶度を選択的に増加させるのに充分な期間、重合物質のガラス転移温度と融点の間の温度まで、重合物質が加熱される、請求項54に記載の管腔内プロテーゼ。
- 重合物質は、重合物質の融点より高い第一温度まで、第一期間の間、加熱され、次いで、重合物質の結晶度を選択的にコントロールするのに充分な第二の期間の間、融点より低い第二温度まで急冷される、請求項54に記載の管腔内プロテーゼ。
- 第二温度は、重合物質のガラス転移温度と融点の間である、請求項56に記載の管腔内プロテーゼ。
- 第二温度は、重合物質のガラス転移温度より低い、請求項56に記載の管腔内プロテーゼ。
- 重合物質のモジュラスを選択的に増加又は減少させるに充分な期間、重合物質のガラス転移温度と融点の間の温度まで、重合物質が加熱される、請求項54に記載の管腔内プロテーゼ。
- 管腔内プロテーゼの円周強度を選択的に増加又は減少させるに充分な期間、重合物質のガラス転移温度と融点の間の温度まで、重合物質が加熱される、請求項54に記載の管腔内プロテーゼ。
- 薬剤は、アニールされた重合物質内に溶出可能なように捕捉されている、請求項54に記載の管腔内プロテーゼ。
- 薬剤は、抗腫瘍薬、抗有糸分裂剤、抗炎症剤、抗血小板薬、抗凝血薬、抗線維素剤、抗トロンビン剤、抗増殖剤、抗生物質、抗酸化剤、免疫抑制剤、抗アレルギー物質及びこれらの組み合わせからなる群から選択される、請求項61に記載の管腔内プロテーゼ。
- 管腔内プロテーゼ内の応力を選択的に増加又は減少させるのに充分な期間、重合物質のガラス転移温度と融点の間の温度まで、重合物質が加熱される、請求項54に記載の管腔内プロテーゼ。
- 重合物質は、被検者身体の管腔内に配備されると、第一の速度で浸食されるように構成され、かつ被検者身体の管腔内に配備されると、第一の速度より大きい第二の速度で浸食されるように、重合物質を選択的に変性させるのに充分な期間、重合物質のガラス転移温度と融点の間の温度まで、重合物質が加熱される、請求項54に記載の管腔内プロテーゼ。
- 重合物質は、被検者身体の管腔内に配備されると、第一の速度で浸食されるように構成され、かつ被検者身体の管腔内に配置されると、第一の速度より小さい第三の速度で浸食されるように、重合物質を選択的に変性させるのに充分な期間、重合物質のガラス転移温度と融点の間の温度まで、重合物質が加熱される、請求項54に記載の管腔内プロテーゼ。
- 重合物質は、二酸化炭素の存在下に加熱される、請求項54に記載の管腔内プロテーゼ。
- 重合物質は、加熱前に二酸化炭素中に浸漬される、請求項54に記載の管腔内プロテーゼ。
- 重合物質は、重合物質の上又は内部に設けられた核化剤の存在下に加熱される、請求項54に記載の管腔内プロテーゼ。
- 管腔内プロテーゼはステントである、請求項54に記載の管腔内プロテーゼ。
- 重合物質は浸食性である、請求項54に記載の管腔内プロテーゼ。
- 重合物質は非浸食性である、請求項54に記載の管腔内プロテーゼ。
- 重合物質は、管状本体上のコーティングである、請求項54に記載の管腔内プロテーゼ。
- 浸食性重合物質は、外科用縫糸、絹、木綿、ポリ(ヒドロキシ酪酸)、ポリカルボナート、ポリアクリラート、ポリ酸無水物、ポリ(オルトエステル)、ポリ(ホスホエステル)、ポリエステル、ポリアミド、ポリホスファゼン、ポリ(p−ジオキサン)、ポリ(アミノ酸)、ポリグラクチン、浸食性ヒドロゲル、コラーゲン、キトサン、ポリ(乳酸)、ポリ(L−乳酸)、ポリ(D,L−乳酸)、ポリ(グリコール酸)、ポリ(D−乳酸/グリコール酸)、ポリ(L−乳酸/グリコール酸)、ポリ(D,L−乳酸/グリコール酸)、ポリ(ε−カプロラクトン)、ポリ(バレロラクトン)、ポリ(ヒドロ吉草酸)、ポリジオキサノン、ポリ(プロピレンフマル酸)、ポリ(エチレンオキシド)−ポリ(ブチレンテトラフタラート)、ポリ(乳酸/リジン)、ポリ(乳酸/トリメチレンカルボナート)、ポリ(L−乳酸)及びポリ(ε−カプロラクトン)コポリマーからなる群から選択される、請求項71に記載の管腔内プロテーゼ。
- 浸食性重合物質は、外科用縫糸、絹、木綿、ポリ(ヒドロキシ酪酸)、ポリカルボナート、ポリアクリラート、ポリ酸無水物、ポリ(オルトエステル)、ポリ(ホスホエステル)、ポリエステル、ポリアミド、ポリホスファゼン、ポリ(p−ジオキサン)、ポリ(アミノ酸)、ポリグラクチン、浸食性ヒドロゲル、コラーゲン、キトサン、ポリ(乳酸)、ポリ(L−乳酸)、ポリ(D,L−乳酸)、ポリ(グリコール酸)、ポリ(D−乳酸/グリコール酸)、ポリ(L−乳酸/グリコール酸)、ポリ(D,L−乳酸/グリコール酸)、ポリ(ε−カプロラクトン)、ポリ(バレロラクトン)、ポリ(ヒドロ吉草酸)、ポリジオキサノン、ポリ(プロピレンフマル酸)、ポリ(エチレンオキシド)−ポリ(ブチレンテトラフタラート)、ポリ(乳酸/リジン)、ポリ(乳酸/トリメチレンカルボナート)、ポリ(L−乳酸)及びポリ(ε−カプロラクトン)コポリマーからなる群から選択される重合物質のブレンドを含む、請求項71に記載の管腔内プロテーゼ。
- 重合物質は、配向ポリマーを含む、請求項54に記載の管腔内プロテーゼ。
- ポリマー配向は、一軸配向である、請求項75に記載の管腔内プロテーゼ。
- ポリマー配向は、二軸配向である、請求項75に記載の管腔内プロテーゼ。
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JP2009504899A (ja) * | 2005-08-22 | 2009-02-05 | ザ ジェネラル ホスピタル コーポレイション ディー ビー エイ マサチューセッツ ジェネラル ホスピタル | 耐酸化性の均質化した重合体状材料 |
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US9339568B2 (en) | 2006-07-13 | 2016-05-17 | Abbott Cardiovascular Systems, Inc. | Reduced temperature sterilization of stents |
JP2012120850A (ja) * | 2006-10-25 | 2012-06-28 | Biosensors Internatl Group Ltd | 一時的な管腔内ステント、並びにそれを作製及び使用する方法 |
US8961862B2 (en) | 2008-08-11 | 2015-02-24 | Abbott Cardiovascular Systems Inc. | Method of improving fracture toughness of implantable medical devices through annealing |
US9205575B2 (en) | 2008-08-11 | 2015-12-08 | Abbott Cardiovascular Systems Inc. | Medical device fabrication process including strain induced crystallization with enhanced crystallization |
JP2012526622A (ja) * | 2009-05-13 | 2012-11-01 | アボット カルディオバスキュラー システムズ インコーポレーテッド | 非晶質のポリマーまたは結晶度が非常に低いポリマーのコンストラクトからの埋込式医療機器(デバイス)の製造方法 |
Also Published As
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US8906286B2 (en) | 2014-12-09 |
US7919162B2 (en) | 2011-04-05 |
US20050228492A1 (en) | 2005-10-13 |
WO2004080332A3 (en) | 2005-04-07 |
CA2516799C (en) | 2014-04-08 |
US20110169198A1 (en) | 2011-07-14 |
WO2004080332A2 (en) | 2004-09-23 |
EP1601524A4 (en) | 2010-09-22 |
AU2004220631B2 (en) | 2009-06-04 |
CA2516799A1 (en) | 2004-09-23 |
US6932930B2 (en) | 2005-08-23 |
EP1601524B1 (en) | 2014-11-19 |
AU2004220631A1 (en) | 2004-09-23 |
US20040181271A1 (en) | 2004-09-16 |
JP4836779B2 (ja) | 2011-12-14 |
EP1601524A2 (en) | 2005-12-07 |
US20150066133A1 (en) | 2015-03-05 |
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