JP5362172B2 - 虚血性の再灌流されている心筋層への心臓保護薬の配給用の装置 - Google Patents
虚血性の再灌流されている心筋層への心臓保護薬の配給用の装置 Download PDFInfo
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Description
発明の分野
本発明は脈管の病気の予防および治療のための薬物/薬物の組み合わせ物の局所的な投与に関連しており、特に、脈管の病気の予防および治療のための薬物/薬物の組み合わせ物の局所的な配給のための医療装置に関連している。また、本発明は心筋層ならびに、例えば、脳等の別の器官の虚血性の組織を治療するための薬物、薬剤および/または配合物、ならびに、これらの組み合わせを有する医療装置にも関連している。
心臓は心膜により囲まれており、この心膜は二層の組織(線維性の心膜および漿液性心膜の壁側板)から成る嚢である。この心膜と心臓との間の心膜の腔は、その外側の組織の心臓を安定な浸透性で電解質の環境の中に浸しているいくらかの心膜液を含んでいる。また、心臓組織自体は4つの層、すなわち、漿液性心膜の臓側板と、埋め込まれている動脈および静脈を含む脂肪層と、心臓における主要な筋肉の層である心筋層と、心内膜と呼ばれている内側の上皮層と、により構成されている(「カージオプルモナリー・アナトミー・アンド・フィジオロジー(Cardiopulmonary anatomy and physiology)」,ヒックス(Hicks),WB.サンダース(WB. Saunders),2000年)。
本発明の1種類以上の薬物、薬剤、および/または配合物の治療の投薬との組み合わせにおける医療装置は、前記において簡単に説明されているような、虚血性の組織の治療のために現在において用いられている方法および装置に付随している問題を解消するための手段を提供している。
本発明の薬物/薬物の組み合わせおよび配給装置は、脈管の病気、特に傷害により生じた脈管の病気を効果的に予防および治療するために利用できる。加えて、同一のまたは追加の薬物/薬物の組み合わせが、不十分な血流により生じた虚血症を治療するために、局所的に配給できる。脈管の病気の治療において利用されている種々の医療用の治療装置は、最終的にさらに別の合併症を誘発する可能性がある。例えば、バルーン脈管形成術は動脈の中を通る血流を増加するために利用されている処置であり、冠状動脈の狭窄における主要な治療方法である。しかしながら、前述のように、この処置は脈管壁部に対してある程度の損傷を生じるために、ある程度の時間の経過後に、その問題を潜在的に悪化させる可能性がある。また、別の処置および病気も同様の傷害の原因になる可能性があるが、本発明の例示的な実施形態は、経皮経管冠状動脈脈管形成術およびその他の、類似の動脈、静脈およびこれら以外の流体運搬用の導管を含む、別の類似の動脈/静脈用の処置に続いて生じる再狭窄および関連の合併症の治療に関して説明されている。加えて、被覆型の医療装置の効果的な配給のための種々の方法および装置が説明されている。
実施例1:
それぞれ、F19NMRにより決定された場合に、92/8重量%および91/9重量%のフッ化ビニリデン(vinylidenefluoride)/HFPである、PVDFホモポリマー(テキサス州ヒュートンのソルベイ・アドバンスド・ポリマーズ社(Solvay Advanced Polymers)から入手可能なソレフ(Solef)(登録商標)1008、融点:約175℃)およびポリ(フッ化ビニリデン(vinylidenefluoride)/HFP)のポリフルオロ・コポリマー(それぞれ、例えば、テキサス州ヒュートンのソルベイ・アドバンスド・ポリマーズ社(Solvay Advanced Polymers)から入手可能なソレフ(Solef)(登録商標)11010および11008、融点:約159℃および160℃)をステント用の可能性のある被膜として調べた。これらのポリマーはDMAc、N,N−ジメチルホルムアミド(N,N-dimethylformamide)(DMF)、ジメチル・スルホキシド(dimethyl sulfoxide)(DMSO)、N−メチルピロリドン(N-methylpyrrolidone)(NMP)、テドラヒドロフラン(tetrahydrofuran)(THF)およびアセトンを含むが、これらに限定されない、溶媒の中において溶ける。これらのポリマーをプライマーとしてアセトン中に5重量%で溶解させるか、そのポリマーを上部被膜として50/50のDMAc/アセトン中に30重量%で溶解させることにより、それぞれのポリマー被膜を調製した。この場合に、浸漬によりステントに供給されて、数時間にわたり空気中において60℃で乾燥された後に、100mmHg(1.33×104 パスカル)よりも低い真空中において3時間にわたり60℃で乾燥された被膜は白色の発泡体状のフィルムを結果として得た。さらに、供給時に、これらのフィルムはステントに対する接着性が欠けており、剥がれ落ちて、過度に脆いことが分かった。さらに、前記の様式で被覆されたステントは175℃を超える温度、すなわち、そのポリマーの溶融温度を超える温度に加熱されると、透明で付着性のフィルムが形成された。それゆえ、高品質のフィルムを達成するために、被膜は高い温度、例えば、ポリマーの溶融温度を超える温度、を必要とする。前述のように、このような高温の熱処理は大部分の薬剤配合物において、これらの熱に対する影響の受けやすさにより、許容不可能である。
次に、F19NMRにより決定された場合に、14.5重量%のHFPと共重合されている85.5重量%のフッ化ビニリデン(vinylidenefluoride)を含有しているポリフルオロ・コポリマー(例えば、ソレフ(Solef)(登録商標)21508)を評価した。このコポリマーは前記実施例1において記載されているポリフルオロ・ホモポリマーおよびコポリマーよりも結晶性が低い。さらに、このコポリマーは約133℃であると報告されている低い融点も有している。この場合も同様に、約20重量%の前記ポリフルオロ・コポリマーを含む被膜が50/50のDMAc/MEK中におけるポリマー溶液により供給されている。その後、数時間にわたり60℃で(空気中において)乾燥した後に、100mmHg(1.33×104 パスカル)よりも低い真空中において3時間にわたり60℃で乾燥したことにより、透明な付着性のフィルムが得られた。この方法は高品質のフィルムを達成するための高温の熱処理の必要性を排除している。このようにして得られた被膜は前記実施例1の被膜よりも滑らかであり且つ付着性が高かった。また、拡張された一部の被覆型ステントは、前記フィルムが金属から分離するのに従って、ある程度の付着性の低下と「テント状化」を示した。そこで、必要である場合には、前記の各コポリマーを含有している被膜の改質を、例えば、可塑剤等をその被膜配合物に添加する等により、行なうことができる。このような被膜により調製されたフィルムは、特に、その装置がステントの程度までの膨張に対して影響を受けにくい場合に、それぞれのステントおよびその他の医療装置を被覆するために使用できる。
その後、前記よりもさらに高いHFP含有量のポリフルオロ・コポリマーを試験した。この系列のポリマーは半結晶質ではなく、むしろ、エラストマーとして市販されている。一例のこのようなコポリマーはフルオレル(Fluorel)(商標)FC2261Q(ミネソタ州オークデールの、3M−ホエスト・エンタープライズ(3M-Hoechst Enterprise)の1社である、ダイニオン社(Dyneon)による)、すなわち、フッ化ビニリデン(vinylidenefluoride)/HFPの60.6/39.4(重量/重量)のコポリマーである。このコポリマーは室温よりも十分に低いTg(ガラス転移点)(このTgは約−20℃)を有しているが、室温または60℃でも粘着性にならない。このポリマーは示差走査熱量計(DSC)または広角X線回折法により測定された場合に、検出可能な結晶化度を持たない。前述のようなステント上に形成されるフィルムは非粘着性で、透明であり、ステントが拡張される時に問題を生じることなく拡張される。
図3は85.5/14.5のフッ化ビニリデン(vinylidenefluoride)/HFPのポリフルオロ・コポリマーに関するデータをプロットしたグラフ図であり、上部被膜の無い場合における時間の関数として放出される薬剤のフラクションを示している。また、図4は上部被膜が配置されている同一のポリフルオロ・コポリマーについてのデータをプロットしたグラフ図であり、放出速度における最も大きな影響が透明な上部被膜を伴う場合に生じていることを示している。図示のように、例えば、TC150は150マイクログラムの上部被膜を有する装置を示しており、TC235は235マイクログラムの上部被膜を示している。上部被膜を備える前の各ステントは30%のラパマイシン(rapamycin)を含有している平均で750マイクログラムの被膜を有していた。さらに、図5は60.6/39.4のフッ化ビニリデン(vinylidenefluoride)/HFPのポリフルオロ・コポリマーについてのデータをプロットしたグラフ図であり、時間の関数としての放出される薬剤のフラクションを示しており、上部被膜を伴わない場合の被膜からの放出速度の著しい調整を示している。すなわち、この放出は薬剤をフィルム中に装填することにより調整されている。
通常の餌を与えられている9匹のニュージーランド種の白色ラビット(2.5kg〜3.0kg)に、手術の24時間前と、手術の直前と、調査の残りの部分と、においてアスピリン(aspirin)を与えた。手術時に、各動物体にアセプロマジン(acepromazine)(0.1〜0.2mg/kg)をあらかじめ投薬して、ケタミン(ketamine)/キシラジン(xylazine)の混合物(それぞれ40mg/kgおよび5mg/kg)により麻酔をかけた。さらに、各動物体にヘパリン(heparin)の1回分の処置間投与量(150IU/kg、(静脈内(i.v.))を与えた。
前記のフルオレル(Fluorel)(商標)FC2261Qコポリマーを約10重量%でMEK中に溶解して、14:1のエタノール/水とMEK溶液との溶液比率においてエタノール/水の50/50の混合物中において洗浄した。その後、このポリマーを沈澱させて、遠心処理により溶媒相から分離した。さらに、そのポリマーを再びMEK中に溶解して、洗浄処理を繰り返し行なった。その後、このポリマーを各洗浄工程の後に一晩にわたり真空オーブン(200ミリトル(0.266×102 パスカル)よりも低い)内において60℃で乾燥させた。
クロスフレックス(CrossFlex)(登録商標)ステント(コーディス(Cordis)、ジョンソン・アンド・ジョンソン・カンパニー社(Johnson & Johnson Company)の1社、から入手可能)を、前記の「受け入れられた」フルオレル(Fluorel)(商標)FC2261Q PVDFコポリマーおよび前記実施例6において浄化したポリフルオロ・コポリマーにより、浸漬処理および拭き取り法を用いて被覆した。その後、これらの被覆されたステントをエチレン・オキシドおよび標準的な処理工程により滅菌処理した。さらに、これらの被覆されたステントおよび被覆されていない金属ステント(対照品)をブタの各冠状動脈に植え込み、これらを28日間にわたりその状態に維持した。
細胞増殖を阻止するクラドリビン(cladribine)の能力を評価するために、人間の平滑筋または内皮細胞(クロネテイクス社(Clonetics)、ウォーカースビル、メリーランド州)を2000個の細胞/cm2 の密度(約3600個の細胞/ウェル)で接種して12個ウェル型のプレートのそれぞれの中に入れた後に、5%のウシ胎児血清(FCS)を含有している1.5mlの増殖培地により培養した。24時間後に、前記の増殖培地を変えて、10ng/mlの血小板由来型増殖因子AB(PDGF・AB、ライフ・テクノロジー社(LIFE Technologies))ならびに種々の濃度のクラドリビン(cladribine)(0.001〜10,000nM)を含有している新鮮な培地を3回にわたり各ウェルに加えた。その後、培地を3日後に新鮮なクラドリビン(cladribine)を含有している培地に交換した。さらに、6日目において、細胞をトリプシン処理することにより分離して細胞懸濁液を得て、軽く遠心処理することによりペレットにして、ノイバウアー(Neubauer)血球計システムを用いて手動により計数した。その後、細胞の生活能力をトリパン・ブルー除外処理により評価した。
H>(OM(r)−IM(r))−WT
(1)治療部位の近くの脈管の中に位置決め可能な、経皮的に配給される装置であって、
医療装置と、
虚血性の組織を治療するための、治療の投薬量における、1種類以上の薬剤と、
配給機構であって、前記1種類以上の薬剤を含み、前記医療装置に作用可能に付随していて、所定の時間の期間にわたり下流側の虚血性の組織に少なくとも1種類の薬剤を配給するように構成されている配給機構と、を備えている、装置。
(2)実施態様1に記載の経皮的に配給される装置であって、
前記医療装置が内腔内装置を含む、装置。
(3)実施態様2に記載の経皮的に配給される装置であって、
前記内腔内装置がステントを含む、装置。
(4)実施態様3に記載の経皮的に配給される装置であって、
前記内腔内装置がステント移植片を含む、装置。
(5)実施態様3に記載の経皮的に配給される装置であって、
前記内腔内装置が吻合装置を含む、装置。
前記1種類以上の薬剤がカルシウム拮抗薬(calcium antagonists)を含む、装置。
(7)実施態様1に記載の経皮的に配給される装置であって、
前記1種類以上の薬剤が有機硝酸塩(organic nitrate)を含む、装置。
(8)実施態様1に記載の経皮的に配給される装置であって、
前記1種類以上の薬剤がベータアドレナリン受容体遮断薬(beta-adrenoceptor blocking agents)を含む、装置。
(9)実施態様1に記載の経皮的に配給される装置であって、
前記1種類以上の薬剤がホルモンを含む、装置。
(10)実施態様1に記載の経皮的に配給される装置であって、
前記1種類以上の薬剤がカリウム・チャネル活性薬(potassium channel activators)を含む、装置。
前記1種類以上の薬剤がアンジオテンシン変換酵素阻害薬(ACE inhibitors)を含む、装置。
(12)実施態様1に記載の経皮的に配給される装置であって、
前記1種類以上の薬剤が抗炎症薬を含む、装置。
(13)実施態様1に記載の経皮的に配給される装置であって、
前記1種類以上の薬剤がスタチン(statins)を含む、装置。
(14)実施態様1に記載の経皮的に配給される装置であって、
前記1種類以上の薬剤が抗不整脈薬を含む、装置。
(15)実施態様3に記載の経皮的に配給される装置であって、
前記配給機構が前記ステントの中の溝または開口部を含む、装置。
前記配給機構は高分子の基材を含み、
前記1種類以上の薬剤は、その高分子の基材の中に組み込まれていて、前記ステントに固定されている、装置。
(17)治療部位の近くの脈管の中に位置決めされる経皮的に配給される装置であって、
医療装置と、
虚血性の組織を治療するための、治療の投薬量における、1種類以上の第1の薬剤と、
組織の治癒を促進するための、治療の投薬量における、1種類以上の第2の薬剤と、
配給機構であって、前記1種類以上の第1の薬剤および前記1種類以上の第2の薬剤を含み、前記医療装置に作用可能に付随していて、所定の期間にわたり下流側の虚血性の組織に前記少なくとも1種類の第1の薬剤および前記少なくとも1種類の第2の薬剤を配給するように構成されている配給機構と、を備えている、装置。
Claims (1)
- 治療部位の近くの脈管の中に位置決めされる経皮的に配給される装置であって、
治療されるべき器官の上流側に位置決めでき、器官を再灌流して治療薬を脈管と器官に配給するように構成された医療装置と、
カルシウム拮抗薬(calcium antagonists)、有機硝酸塩(organic nitrate)、ベータアドレナリン受容体遮断薬(beta-adrenoceptor blocking agents)、ホルモン(hormones)、カリウム・チャネル活性薬(potassium channel activators)、アンジオテンシン変換酵素阻害薬(ACE inhibitors)、アンギオテンシン・レセプター拮抗薬(angiotensin receptor antagonists)、非ステロイド性抗炎症薬(non-steroidal anti-inflammatory agents)、ステロイド性抗炎症薬(steroidal anti-inflammatory agents)、スタチン(statins)を1以上含み、虚血性の組織を治療するための、治療の投薬量における、1種類以上の第1の薬剤と、
再狭窄を治療するための、治療の投薬量における、1種類以上の第2の薬剤と、
前記医療装置と作用的に関連して、所定の時間の期間にわたり下流側の虚血性の組織に前記第1及び第2の薬剤を局所的に配給するように構成され、第1の層及び第2の層を含むポリマー基材を含み、前記第1の層が、前記第2の層に対して相対的に高い水の取り込み量を有する材料を含んでいて虚血性の患部を治療し且つ器官を再灌流するために24時間よりも短い持続時間の間に高濃度の前記第1の薬剤を配給するように構成され、前記第2の層が、前記第1の層に対して相対的に低い水の取り込み量を有する材料を含んでいて再狭窄の治療のために前記持続時間よりも長い時間の間に前記第2の薬剤を配給するように構成される、配給機構と、
を備えていることを特徴とする装置。
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2005
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- 2005-12-12 EP EP05257611A patent/EP1671605A1/en not_active Withdrawn
- 2005-12-14 JP JP2005360877A patent/JP5362172B2/ja not_active Expired - Fee Related
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CA2529812A1 (en) | 2006-06-15 |
US20060129225A1 (en) | 2006-06-15 |
JP2006167466A (ja) | 2006-06-29 |
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