JP2008080143A - 医療装置 - Google Patents
医療装置 Download PDFInfo
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Abstract
【解決手段】本発明によれば、医療装置へ適用(塗布)された薬剤(対生物作用材料)の品質劣化は、対生物作用材料を溶剤,触媒,加熱あるいは化学的な手を用いずにポリマーの多孔質層でもってカバーすることにより回避できる。このような生物適合性のあるポリマーは、好ましくは蒸着あるいはプラズマ堆積により形成され、これを重合化する。本発明の一実施例によれば、本発明の医療装置は、患者の体内(食道,気管,結腸,胆汁管,泌尿器管等)内に導入するのに適した構造体を有する。この構造体は、ベース材料とこの構造体上の少なくとも一部上に形成された生物適合材料をその構造体の表面の溝,孔,スロット等内に含む、そしてこの対生物作用材料上に少なくとも1つの多孔質層と対生物作用材料のない表面とを有する。この多孔質材料は、ポリマーと対生物作用材料がそこを介して制御しながら放出できるような充分な厚さを有する。
【選択図】図1
Description
ステンレス(stainless steel),タンタル(tantalum),チタン(titanium),ニチノール(Nitinol),金,プラチナ,インコネル(inconel),イリジウム(iridium),銀,タングステン(tungsten),あるいは他の生物適応金属あるいはこれらの合金,カーボン,炭素または炭素繊維,セルロースアセテート(cellulose acetate),セルロースニチレート(cellulose nitrate),シリコン,ポリエチレン,テラフタレート(teraphtalate),ポリウレタン,ポリアミド,ポリエステル,ポリオルトエステル(polyorthoester),ポリアンヒドライド(polyanhydride),ポリエーテルスルフォン(polyether sulfone),ポリカーボネート(polycarbonate),ポリプロピレン(plypropylene),高分子重量ポリエチレン,ポリテトラフルオロエチレン(polytetrafluoroethylene),あるいは他の生物適合ポリマー材料,あるいはこれらの混合物あるいはコポリマー(copolymer),ポリラクティック酸(polylactic acid),ポリグリコリック酸(polyglycolic acid)あるいはそのコポリマー,ポリアンヒドライド(polyanhydride), ポリカプロラクトン(polycaprolactone),ポリハイドロキシブチレート(polyhydroxy-butyrate)バレレート(valerate)あるいは他の生物劣化型ポリマー,あるいはこれらの混合物あるいはコポリマー,タンパク質,エクストラセルラマトリックス成分(extracellular matrix component),コラーゲン,ヒブリンあるいは他のバイオロジック剤,あるいはそれらの混合物の少なくとも1つを含む。ステンレスは、構造体12が脈管ステントとして構成される場合にはベース材料14の材料として最も好ましいものである。
ヘパリン(heparin),共役ヘパリン(covalent heparin),あるいは他のスロビンインヒビタ(thrombin inhibitor),ヒルディン(hirudin),ヒルログ(hirulog),アルガトロバン(argatroban),D−フェニルララニル−L−ポリ−L−アルジニルクロロメチルケトン(D-phenylalanyl-L-poly-L-arginylchloromethyl ketone,あるいは他のアンチスロンボジェニック剤(antithrombogenic agent),あるいはそれらの混合物,ウロキネーゼ(urokinase),ステレプトキネーゼ(streptokinase),ティッシュプラズミノゲンアクティビエータ(tissueplasminogen activator),あるいは他のスロンボリティック剤(thrombolytic agent),あるいはそれらの混合物,ヒブリノリティック剤(fibrionolytic agent),バソスパズムインヒビタ(vasospasm inhibitor),カルシウムチャネルブロッカー(calcium channel blocker),ニトレート(nitrate),ニトリック酸化物(nitric oxide),ニトリック酸化物プロモータ(nitric oxide promoter)あるいは他のバソディレータ(vasodilator),アンティミクロビアル剤(antimicrobial agent)あるいは他のアンティバイオティック(antibiotic),アスピリン(aspirin),ティクロピダイン(ticlopidine),グリコプロテインIIb/IIIaインヒビタ(glycoprotein 11b/111a inhibitor)あるいは他の表面グリコプロテインレセプタ(surface glycoprotein reseptors)のインヒビタ,あるいは他のアンティプレイトレット剤(antiplatelet agent),コルキシン(colchicine)あるいは他のアンティミトティック(antimitotic),あるいは他のミクロチューブールインヒビタ(microtubule inhibitor),ディメチルサルフォキシデ(DMSO),レティノイド(retinoid)あるいは他のアンティセクレタリー剤(anti secretory agent),シトカラシン(cytochalasin)あるいは他のアクティンインヒビタ(actin inhibitor),あるいはリモデリングインヒビタ(remodeling inhibitor),デオキシリボヌクレリック酸(deoxyribonucleic acid),アンティセンスヌクレオタイド(antisense nucleotide)あるいは他のモリキュラジェネティックインタベーション剤(agent for molecular genetic intervention),メトトレキサ(methotrexate)あるいは他のアンティメタボライト(antimetrabolite)あるいはアンティプロリファラティブ剤(antiproliferative agent),タモキセフィンシトレート(tamoxifen citrate),タクスノール(taxol)(登録商標)あるいはその派生物,あるいは他のアンティキャンサーセモセラニューティック剤(anti-cancer chemotherapeutic agents),デキサメサソン(dexamethasone),デキサメサソンソディウムホスファート(dexamethasone sodium phosphate),デキサメサソンアセテート(dexamethasone acetate)あるいは他のデキサメサソン派生物(dexamethasone derivative),あるいは他のアンティインフラメトリーステロイド(anti-inflammatory steroid)あるいは非ステロイドアンティインフラメトリー剤(non-steroidal antiinflammatory agent),サイクロスピン(cyclosporin)あるいは他のイムノサプレッシブ剤(immunosuppressive agent),トラピラル(PDCFアンタゴニスト),
グロースファクタ(growth factor)あるいはアンティグロースファクタ抗体(anti-growth factor antibody),あるいは他のグロースファクタアンタゴニスト(growth factor antagonist),ドパミン(dopamine),ブロムクリプティンメシレート(bromocriptine mesylate),ペルゴライドメシレート(pergolide mesylate)あるいは他のドパミンアゴニスト(depamine agonist),60Co,192Ir,32P,111In,90Y,99Tc あるいは他のラディオセラピューティック剤(radiotherapeutic agent),イオデン含有化合物,バリウム含有化合物,金,タンタル,プラチナ,タングステンあるいは他の放射線不透過剤として機能する他の重金属,ペプタイド(peptite),プロテイン,エンジミ(enzyme),エクストラセルラマトリックスコンポーネント(extracellulate matrix component),セルラーコンポーネント(cellular component)あるいは他の生物ロジック剤,カプトプリ(captopril),エナラプリ(enalapril)あるいは他のアンジオテンシン変換エジム(angiotensin converting enzyme)(ACE)インヒビタ(inhibitor),アスコビック酸(ascorbic acid),アルファトコフェロール(alpha tocopherol),スーパーオキサイドジスムターゼ(superoxide dismutase),ディフェロキサミン(deferoxamine),21−アミノステロイド(ラサロイド)(21-amino steroid(lasaroid))あるいは他の自由ラディカル14C−,3H−,131I−,32P−あるいは36S−放射線同位元素形態あるいは前述の他の放射線同位元素,エストロゲンあるいは他のセックスホルモン,AZTあるいは他のアンティポリマーラーゼ(antipolymerases),アシクリバー(acyclovir),ファミシリクロバー(famciclovir),リマンタダインハイドロクロライド(rimantadine hydrochloride),ガンシクロヴィアナトリウム(ganciclovir sodium)あるいは他のアンティヴィラル剤(antiviral agents),5−アミノレボリック酸(5-aminolevulinic acid),メタ−テトラヒドロキシフェニルクロリン(meta-tetrahydroxyphenylchlorin),ヘキサデカフルオロ鉛フタロシナニン(hexadecafluoro zinc phthalocyanine),テトラメチルヘマトロフィリン(tetramethyl hematoporphyrin),ロダミン(rhodamine)123あるいは他のフォトダイナミックセラピー剤(photodynamic therapy),シュードモナスアウルゲジノサエキシトンA(Pseudomonas aeruginosa exotoxin A)に対するIgG2カッパ抗体およびA431エピデモイドカルシノマセル(epidermoid carcinoma cells)との反応するIgG2カッパ抗体,サポリンと共役ノラドレネジックエンジミドパミンベータ−ハイドロキシラーゼ(noradrenergic enzyme dopamine beta-hydroxylase)に対するモノクロナル抗体あるいは他の抗体ターゲットセラピー剤,ジェンセラピー剤(gene therapy agents),エナラピル(enalapril)と他のプルドラグ(prodrugs),あるいはこれらのいずれかの混合物の少なくとも1つを含む
12 構造体
14 ベース材料
16 付加コーティング層
18 対生物作用材料層
20 多孔質層
22 第2の対生物作用材料層
24 第2の多孔質材料層
26 コネクタ
28 ホール
Claims (6)
- (A) ベース材料層(14)を表面に有する構造体(12)を用意するステップと、
(B) 前記ベース材料層(14)上に対生物作用材料層(18)を、気相堆積、プラズマ蒸着、前記装置の表面への化学的結合、接着媒体としての界面活性剤の使用のいずれかにより、形成するステップと、
(C) 前記対生物作用材料層(18)上に多孔質材料層(20)を形成するステップと
を有する
ことを特徴とする注入用医療装置を製造する方法 - 前記ステップ(B)は、前記対生物作用材料(18)を、粉末、マイクロカプセル化した粒子あるいはマトリクスの組み込まれた材料の形態で用意する
ことを特徴とする請求項1記載の方法。 - 前記ステップ(C)は、前記多孔質材料層(20)が、ジ−p−キシリレン(di-p-xylylene)あるいはその派生物を昇華させひびを入れるステップにより、形成され、モノマーp−キシリレンあるいはその派生物を生成し、
前記モノマーp−キシリレンあるいはその派生物が、前記対生物作用材料層(18)上で凝縮およびポリマー化し、
前記昇華/ひびを入れるステップは、ジクロロ−ジ−p−キシリレンで実行される
ことを特徴とする請求項1に記載の方法。 - 前記ステップ(B)は、前記ベース材料層(14)上に前記対生物作用材料(18)と流体との混合物を塗布し、前記ステップ(C)の前に、除去するステップを有する
ことを特徴とする請求項1記載の方法。 - 前記流体は、揮発性であり、
前記流体を除去するステップは、前記流体の蒸発により行う
ことを特徴とする請求項4記載の方法。 - 前記ベース材料層(14)は、その外側表面内に開口(28)を有し、
前記開口は、穴、スロット、溝、ウエルの形態で、エッチングで形成され、
前記対生物作用材料(18)は、前記開口内に配置される
ことを特徴とする請求項1−5のいずれかに記載の方法。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/484,532 US5609629A (en) | 1995-06-07 | 1995-06-07 | Coated implantable medical device |
US484532 | 1995-06-07 |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP16821896A Division JP4684375B2 (ja) | 1995-06-07 | 1996-06-07 | 医療装置 |
Publications (2)
Publication Number | Publication Date |
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JP2008080143A true JP2008080143A (ja) | 2008-04-10 |
JP5090130B2 JP5090130B2 (ja) | 2012-12-05 |
Family
ID=23924541
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP16821896A Expired - Lifetime JP4684375B2 (ja) | 1995-06-07 | 1996-06-07 | 医療装置 |
JP2007284885A Expired - Lifetime JP5090130B2 (ja) | 1995-06-07 | 2007-11-01 | 医療装置 |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP16821896A Expired - Lifetime JP4684375B2 (ja) | 1995-06-07 | 1996-06-07 | 医療装置 |
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US (2) | US5609629A (ja) |
EP (1) | EP0747069B1 (ja) |
JP (2) | JP4684375B2 (ja) |
KR (1) | KR100478074B1 (ja) |
DE (1) | DE69623855T2 (ja) |
DK (1) | DK0747069T3 (ja) |
ES (1) | ES2184838T3 (ja) |
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Also Published As
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EP0747069A3 (en) | 1998-01-07 |
JP5090130B2 (ja) | 2012-12-05 |
JP4684375B2 (ja) | 2011-05-18 |
DE69623855T2 (de) | 2003-05-28 |
KR100478074B1 (ko) | 2005-09-15 |
KR970000275A (ko) | 1997-01-21 |
JPH0999056A (ja) | 1997-04-15 |
DE69623855D1 (de) | 2002-10-31 |
EP0747069B1 (en) | 2002-09-25 |
US5609629A (en) | 1997-03-11 |
DK0747069T3 (da) | 2002-12-09 |
ES2184838T3 (es) | 2003-04-16 |
EP0747069A2 (en) | 1996-12-11 |
US6096070A (en) | 2000-08-01 |
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