JP2018158129A - 微粒子が配置された弾性基質を有する挿入可能な医療機器、および薬物送達方法 - Google Patents
微粒子が配置された弾性基質を有する挿入可能な医療機器、および薬物送達方法 Download PDFInfo
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Abstract
【解決手段】膨張可能な弾性部と、弾性部の外側の表面上の、特定のポリマーからなる可撓性の生体安定性ヒドロゲルマトリックスと、生体安定性ヒドロゲルマトリックスが脱水された状態である場合に、生体安定性ヒドロゲルマトリックスの外側の表面に配置された微粒子と、を含み、微粒子は、非水溶性の生物活性を有する薬剤を含み、微粒子の20%を超える部分は、生体安定性ヒドロゲルマトリックスが水和し、弾性部が膨張したときに、生体安定性ヒドロゲルマトリックスから分離して、水和した生体安定性ヒドロゲルマトリックス及び微粒子と被検体の血管とが接触する医療機器。
【選択図】図12b
Description
本発明は、出願人を同じくする仮出願61/072,234(出願日:2008年3月28日)の利益を享受する本出願である(発明の名称:微粒子が配置された弾性基質を有する挿入可能な医療機器、および薬物送達方法)。
本発明は、挿入可能な医療器具から薬物を送達する分野に関する。
移植された医療機器からの薬剤の放出は、機器の機能および様々な医療条件での治療にとって有益であることが示されている。例えば、装置の表面から薬剤を送達することにより、移植可能な装置の存在によって生じる細胞応答を避けることができる。また、装置から放出される薬剤は、移植に伴う装置の機能寿命を短縮させる条件を回避することができる。装置から放出された薬剤で、身体の罹患部の治療を行ってもよい。
本発明は、生物活性を有する薬剤を含む微粒子が配置された挿入可能な医療機器に関する。微粒子は、装置から放出され得るものであり、被検体に対して生物活性を有する薬剤を与え、標的部位に治療効果をもたらす。本発明に係る装置は、被覆材料を介して微粒子が配置された膨張可能な弾性表面を有している。
図1a〜図1cは、埋め込まれた微粒子を備えた可撓性ヒドロゲル被膜に覆われた弾性基質を有する機器の一部と、弾性基質の膨張直後の、ヒドロゲル被膜から組織への微粒子の送達とを示す。
本願に記載された本発明に係る実施形態は、包括的なものではなく、本発明を以下の詳細な説明に開示された形態に限定するものではない。むしろ、実施形態は、当業者が本発明の原理および実施を認識および理解できるように、選択および記載されている。
[-R1-Q1-R4-Q2-]x-[R2-Q3-R4-Q4-]y-[R3-Q5-R4-Q6-]z- (1)
[-R1-R2-R 1-Q1-R4-Q2-]x-[R3-Q2-R4-Q1]z- (2)
[-R2-R1-R 2-Q1-R4-Q2-]x-[R3-Q2-R4-Q1]zB- (3)
これらの化学式では、R1およびR2は、非晶性ポリエステル、非非晶性ポリエーテルエステル、または非晶性ポリカーボネート;あるいは混合エステル、エーテルおよび/またはカーボネート基から得られる非晶性プレポリマーである。R1およびR2は、ポリエステル基を含んでいてもよい。これは、重合開始剤としてこれらの化合物を使用する結果起こり、ポリエーテルは、室温において非晶性または結晶性である。しかし、そうして導入されるポリエーテルは、生理学的条件下において非晶性となる。R1およびR2は、非晶性プレポリマーまたはブロックAおよびBからそれぞれ抽出され、R1およびR2は、同一ではない。R1およびR2は、同時にポリエーテル基を含んでいてもよいが、好適には、それらのうちの1つのみがポリエーテル基を含む。zは、ゼロまたは正の整数である。R3は、ポリ(エチレングリコール)などのポリエーテルであり、(z ≠ 0)、すなわち(z=0)ではない場合に存在する。R3は、生理学的条件下において非晶性となる。R4は、脂肪族C2-C8アルキレン基である。このアルキレン基は、任意にC1-C10 アルキレンによって置換されていてもよく、脂肪族基は、線形または環状であり、R4は、好適にはブチレン(CH2)4−基であり、C1-C10 アルキレン側基は、保護されたS、N、PまたはO成分を含んでいてもよい。Xおよびyは、正の整数であり、好適には少なくとも1であり、xおよびyの合計(x+y)は好適には最大2000、より好適には最大500、最も好適には最大200である。Q1〜Q6は、プレポリマーと多機能連鎖延長剤との反応によって得られる結合ユニットである。Q1〜Q6は、それぞれアミン、ウレタン、アミド、カーボネート、エステルまたは無水物である。
バルーンカテーテルのバルーンの弾性表面に、パクリタキセル微粒子に覆われた可撓性ヒドロゲル被膜を設けた。被覆工程に使用したバルーンカテーテルは、Minnesota Medtec (Maple Grove, MN)から入手した。バルーンの弾性部は、ナイロン製であり、バルーン壁の厚さは5〜10μmである。
実施例1に記載の被覆工程を繰り返した。ただし、ヒドロゲル被覆層を形成するために異なる被膜組成物を用いた点が実施例1とは異なる。
バルーンカテーテルのバルーンの弾性表面に可撓性ヒドロゲル被膜を設け、ヒドロゲル表面上にパクリタキセル微粒子を形成させた。
シリコンチューブモデルにおいて、ヒドロゲル被膜を有するパクリタキセル微粒子被膜バルーンからの微粒子の送達を検査した。
シリコンチューブに送達されるパクリタキセルの量を表1に表す。
生体外Cモデルにおいて、ヒドロゲル被膜を有するパクリタキセル微粒子被覆バルーンからの微粒子の送達を検査した。
豚の動脈に送達されるパクリタキセルの量を表2に表す。
Claims (5)
- 被検体の血管に生物活性を有する薬剤を送達することができる、挿入可能な医療機器であって、
膨張可能な弾性部と、
上記膨張可能な弾性部の外側の表面上の、ポリ(アクリルアミド)、ポリ(メタクリルアミド)、ポリ(ビニルピロリドン)、ポリ(アクリル酸)、ポリ(エチレングリコール)、ポリ(ビニルアルコール)、ポリ(HEMA)、メチルビニルエーテル/無水マレイン酸共重合体、およびビニルピロリドン/(メタ)アクリルアミド共重合体からなる群から選択される可撓性の生体安定性ヒドロゲルマトリックスと、
上記可撓性の生体安定性ヒドロゲルマトリックスが脱水された状態である場合に、当該可撓性の生体安定性ヒドロゲルマトリックスの外側の表面に配置された微粒子と、を含み、
上記微粒子は、非水溶性の生物活性を有する薬剤を含み、
上記可撓性の生体安定性ヒドロゲルマトリックスの外側の表面に配置された微粒子の20%を超える部分は、上記可撓性の生体安定性ヒドロゲルマトリックスが水和し、上記弾性部が膨張したときに、上記可撓性の生体安定性ヒドロゲルマトリックスから分離して、水和した上記可撓性の生体安定性ヒドロゲルマトリックスおよび上記微粒子と上記被検体の血管とが接触する、医療機器。 - 上記可撓性の生体安定性ヒドロゲルマトリックスが、ペンデント反応性フォト基を有するポリマーをさらに含み、
上記ペンデント反応性フォト基は、上記可撓性の生体安定性ヒドロゲルマトリックス内にある他のポリマーから選択された標的および上記膨張可能な弾性部の外側の表面に対して上記ポリマーを共有結合させるものであることを特徴とする請求項1に記載の医療機器。 - 上記生物活性を有する薬剤が、抗増殖性物質、抗炎症薬、および抗血小板化合物からなる群から選択されることを特徴とする請求項1に記載の医療機器。
- 上記生物活性を有する薬剤が、パクリタキセルであることを特徴とする請求項1に記載の医療機器。
- 被検体に生物活性を有する薬剤を送達することができる血管形成術用バルーンを備えた、挿入可能な医療機器であって、
膨張可能な弾性バルーン部と、
上記膨張可能な弾性バルーン部の外側の表面上を被覆する、ポリ(アクリルアミド)、ポリ(メタクリルアミド)、ポリ(ビニルピロリドン)、ポリ(アクリル酸)、ポリ(エチレングリコール)、ポリ(ビニルアルコール)、ポリ(HEMA)、メチルビニルエーテル/無水マレイン酸共重合体、およびビニルピロリドン/(メタ)アクリルアミド共重合体からなる群から選択される可撓性の生体安定性ヒドロゲルマトリックスであって、さらに、ペンデント反応性アリルケトンフォト基を有するポリマーを含み、上記ペンデント反応性アリルケトンフォト基は、上記可撓性の生体安定性ヒドロゲルマトリックス内にある他のポリマーから選択された標的および上記膨張可能な弾性バルーン部の被膜に対して上記ポリマーを共有結合させるものであるマトリックスと、
上記可撓性の生体安定性ヒドロゲルマトリックスに配置された微粒子と、を含み、
上記微粒子は、生物活性を有する薬剤を含み、
上記可撓性の生体安定性ヒドロゲルマトリックスに配置された微粒子の20%を超える部分は、上記弾性バルーン部が膨張すると上記弾性バルーン部から分離し、
上記生体安定性ヒドロゲルマトリックスは、水中に上記微粒子を含んだ懸濁液を、上記可撓性の生体安定性ヒドロゲルマトリックス上に配置する工程を含む方法によって形成されたものであり、上記膨張可能な弾性バルーン部の表面上の懸濁液を乾燥させることによって上記微粒子を上記生体安定性ヒドロゲルマトリックスに配置させることができる、医療機器。
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CA2719222A1 (en) | 2009-10-01 |
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EP2271379A2 (en) | 2011-01-12 |
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WO2009120361A2 (en) | 2009-10-01 |
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JP6714043B2 (ja) | 2020-06-24 |
US11020513B2 (en) | 2021-06-01 |
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EP2271379B1 (en) | 2015-11-25 |
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JP2011517589A (ja) | 2011-06-16 |
US20150165094A1 (en) | 2015-06-18 |
US20160339214A1 (en) | 2016-11-24 |
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US20180126128A1 (en) | 2018-05-10 |
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