JP2007533371A - ナノ構造表面の医療装置応用 - Google Patents
ナノ構造表面の医療装置応用 Download PDFInfo
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Abstract
Description
本願は米国仮特許出願第60/549,711号(出願日2004年3月2日)及び米国特許出願第10/902,700号(出願日2004年7月29日)の優先権を主張する。本願は更に各々その開示内容全体を参考資料として本明細書に組込む米国特許出願第10/828,100号(出願日2004年4月19日)の一部継続出願、米国特許出願第10/833,944号(出願日2004年4月27日)の一部継続出願、及び米国特許出願第10/792,402号(出願日2004年3月2日)の一部継続出願である米国特許出願第10/840,794号(出願日2004年5月5日)の一部継続出願としての優先権も主張する。
(発明の技術分野)
I)静菌性疎水性抗血栓性カテーテル内腔としてのナノファイバー表面
II)使い捨て外科用リトラクター、歯科用リトラクター及び配置装置におけるナノファイバー増大表面
III)ナノファイバー増大表面の使用による腹腔鏡クリップにおける牽引増加
IV)創外固定具インプラント静菌性表面材
V)バタフライ型皮膚バンデージ/パッチ
VI)心臓外科用高牽引クランプ装置
VII)接着性疎水性耳栓
VIII)外科用癒着防止材
IX)内視鏡及びカテーテル
X)腔内カメラ
XI)心臓機械弁
XII)小径血管グラフト
XIII)美容用充填剤
XIV)高流動性低血栓形成性心臓機械弁
XV)埋込型センサー及びペーシングリードの高持続性機能
XVI)血管ステント及び次世代薬剤溶出冠動脈ステント
XVII)小径血管グラフト
XVIII)時限放出ナノワイヤーボール
XIX)外科用針
XX)創傷包帯
XXI)腹部(又は胸部)大動脈瘤(AAA)医療処置
・(1)Ancure(登録商標)Endograft(登録商標)System(Guidant Corporation)。1999年に認可されたこのシステムでは、エンドグラフトを大動脈内に配置し、バルーンを膨らまして拡げる。グラフトは無縫合フックを使用して上端と下端を血管壁に固定する。2001年3月16日にGuidantはこのシステムの生産を中止し、全在庫のリコールを発表した。同社は多数の装置故障と有害イベント(装置の配置の問題に伴う重症血管損傷を含む)の報告を怠ったことをFDAに報告した。FDAに正しく報告されていない製造変更もあった。FDAはこの装置とAneuRx装置に関して「公衆衛生通知:腹部大動脈瘤の治療用血管内グラフトの問題(Public Health Notification:Problems with Endovascular Grafts for Treatment of Abdominal Aortic Aneurysm(AAA))」を発表した。
・(2)Ancure(登録商標)Aortoiliac System(Guidant Corporation)。この新バージョンは2002年に認可され、大動脈回腸動脈用Ancure(登録商標)グラフトでは上下アタッチメントシステムに縫合ループを設けたが、それ以外は先のGuidant Endovascular Grafting Systemと同じである。この装置は解剖学的に単管又は二股エンドグラフト装置の使用に適さない患者での使用を目的としている。
・(3)AneuRx(登録商標)Stent Graft System(Medtronic AVE)。AneuRxシステムは1999に認可され、ポリエステル織布内面と自己拡張型Nitinol外骨格から構成される。拡張中のステントの径方向力により外骨格が動脈瘤壁に埋込まれ、アタッチメントメカニズムを構成する。この装置も上記FDA公衆衛生通知の対象となった。2003年12月にFDAは上市前調査からの長期追跡データの分析に基づき、AneuRx(登録商標)Stent Graft Systemに伴う死亡危険に関する更新情報を発表した。調査結果に基づき、FDAは「妥当なリスク便益プロフィルを満たし、使用上の注意に従って治療できる患者のみに」AneuRx(登録商標)Stent Graftを使用するように通告した。
・(4)EXCLUDER(登録商標)Bifurcated Endoprosthesis(W.L.Gore and Associates,Inc.)。この装置は2002年に認可され、大動脈の内側で大動脈及び腸骨動脈の直径まで自己拡張し、動脈瘤を密閉し、動脈壁を再び覆う。
・(5)Zenith(登録商標)AAA Endovascular Graft and H&L−B One−Shot(登録商標)Introduction System(Cook,Inc.)。この装置は2003年に認可され、自己拡張型であり、突起を介して血管壁に付着する。
XXII)脳及び他の身体臓器における血管閉塞
XXIII)無縫合グラフトプロテーゼ
XXIV)整形外科用インプラント
XXV)バイオエンジニアド神経スカフォールド
XXVI)ナノファイバー表面基板の特徴
XVII)ナノファイバー及びナノファイバー作製
A)ナノファイバー
B)機能化
C)密度及び関連事項
D)ナノファイバー作製
E)生体材料とナノファイバー増大表面積基板の相互作用
i)医療装置の細菌汚染の現行防止手段
ii)ナノファイバー増大表面積によるバイオフィルム形成の防止
iii)ナノファイバー表面への細胞外蛋白質の付着
XVIII)キット/システム
Claims (82)
- 複数のナノ構造コンポーネントを結合した1個以上の表面をもつ本体構造を含む医療装置。
- 医療装置が体内もしくは体外装置、一時的もしくは永久的インプラント、ステント、血管グラフト、吻合装置、動脈瘤修復装置、塞栓装置、又は埋込型装置である請求項1に記載の装置。
- 複数の複数のナノ構造コンポーネントが複数のナノファイバーを含む請求項1に記載の装置。
- 複数のナノファイバーが平均長約1ミクロン〜少なくとも約500ミクロン、約5ミクロン〜少なくとも約150ミクロン、約10ミクロン〜少なくとも約125ミクロン、又は約50ミクロン〜少なくとも約100ミクロンである請求項3に記載の装置。
- 複数のナノファイバーが平均直径約5nm〜少なくとも約1ミクロン、約5nm〜少なくとも約500nm、約20nm〜少なくとも約250nm、約20nm〜少なくとも約200nm、約40nm〜少なくとも約200nm、約50nm〜少なくとも約150nm、又は約75nm〜少なくとも約100nmである請求項3に記載の装置。
- 複数のナノファイバーが平均密度約0.11本/平方ミクロン〜少なくとも約1000本/平方ミクロン、約1本/平方ミクロン〜少なくとも約500本/平方ミクロン、約10本/平方ミクロン〜少なくとも約250本/平方ミクロン、又は約50本/平方ミクロン〜少なくとも約100本/平方ミクロンである請求項3に記載の装置。
- 複数のナノファイバーがシリコン、ガラス、石英、プラスチック、金属及び金属合金、ポリマー、TiO、ZnO、ZnS、ZnSe、ZnTe、CdS、CdSe、CdTe、HgS、HgSe、HgTe、MgS、MgSe、MgTe、CaS、CaSe、CaTe、SrS、SrSe、SrTe、BaS、BaSe、BaTe、GaN、GaP、GaAs、GaSb、InN、InP、InAs、InSb、PbS、PbSe、PbTe、AlS、AlP、AlSb、SiO1、SiO2、炭化ケイ素、窒化ケイ素、ポリアクリロニトリル(PAN)、ポリエーテルケトン、ポリイミド、芳香族ポリマー、並びに脂肪族ポリマーから構成される群から独立して選択される材料を含む請求項3に記載の装置。
- ナノ構造コンポーネントが中空ナノチューブ構造を含む請求項1に記載の装置。
- ナノ構造コンポーネントがナノワイヤーを含む請求項1に記載の装置。
- ナノファイバーが本体構造の1個以上の表面にナノファイバーを直接成長させることにより前記1個以上の表面に付着している請求項3に記載の装置。
- ナノファイバーが本体構造の1個以上の表面にナノファイバーを共有結合することにより前記1個以上の表面に付着又は他の方法で結合している請求項3に記載の装置。
- 本体構造が少なくとも第1の材料から構成され、複数のナノ構造コンポーネントが少なくとも第1の材料に組込まれている請求項1に記載の装置。
- ナノ構造コンポーネントが本体構造の1個以上の表面に付着しており、医療装置が更に1個以上のナノ構造表面に付設された1個以上の生体適合性又は生体活性コーティングを含む請求項1に記載の装置。
- 複数のナノ構造コンポーネントが患者の身体の1個以上の組織表面に対する装置の接着性、非接着性、摩擦性、開存性、又は生物汚染防止の1種以上を強化する請求項1に記載の装置。
- ステントの1個以上の表面と結合した複数のナノ構造コンポーネントを含む血管ステント。
- 複数のナノ構造コンポーネントが複数のナノファイバーを含む請求項15に記載のステント。
- 複数のナノファイバーがシリコン、ガラス、石英、プラスチック、金属及び金属合金、ポリマー、TiO、ZnO、ZnS、ZnSe、ZnTe、CdS、CdSe、CdTe、HgS、HgSe、HgTe、MgS、MgSe、MgTe、CaS、CaSe、CaTe、SrS、SrSe、SrTe、BaS、BaSe、BaTe、GaN、GaP、GaAs、GaSb、InN、InP、InAs、InSb、PbS、PbSe、PbTe、AlS、AlP、AlSb、SiO1、SiO2、炭化ケイ素、窒化ケイ素、ポリアクリロニトリル(PAN)、ポリエーテルケトン、ポリイミド、芳香族ポリマー、並びに脂肪族ポリマーから構成される群から独立して選択される材料を含む請求項16に記載のステント。
- ナノ構造コンポーネントが中空ナノチューブ構造を含む請求項15に記載のステント。
- ナノ構造コンポーネントがナノワイヤーを含む請求項15に記載のステント。
- ナノファイバーがステントの1個以上の表面にナノファイバーを直接成長させることにより前記1個以上の表面に付着している請求項16に記載のステント。
- ナノファイバーがステントの1個以上の表面にナノファイバーを別個に共有結合することにより前記1個以上の表面に付着している請求項16に記載のステント。
- ステントがNitinol、ニッケル合金、錫合金、ステンレス鋼、コバルト、クロム、金、ポリマー、又はセラミックから選択される1種以上の材料から作製される請求項15に記載のステント。
- ステントがナノ構造表面に直接吸着させるか又は1個以上のシラン基の使用により結合した薬剤化合物を含む請求項15に記載のステント。
- ステントがナノ構造表面に吸着させるか又は1個以上のリンカー分子の使用により結合した薬剤化合物を含む請求項15に記載のステント。
- 患者の体内で動脈瘤の領域に配置されるように構成されたグラフト部材を含み、前記グラフト部材がグラフト部材の1個以上の表面と結合した複数のナノ構造コンポーネントを含む動脈瘤修復装置。
- 複数のナノ構造コンポーネントが複数のナノファイバーを含む請求項25に記載の装置。
- 複数のナノファイバーがシリコン、ガラス、石英、プラスチック、金属又は金属合金、ポリマー、TiO、ZnO、ZnS、ZnSe、ZnTe、CdS、CdSe、CdTe、HgS、HgSe、HgTe、MgS、MgSe、MgTe、CaS、CaSe、CaTe、SrS、SrSe、SrTe、BaS、BaSe、BaTe、GaN、GaP、GaAs、GaSb、InN、InP、InAs、InSb、PbS、PbSe、PbTe、AlS、AlP、AlSb、SiO1、SiO2、炭化ケイ素、窒化ケイ素、ポリアクリロニトリル(PAN)、ポリエーテルケトン、ポリイミド、芳香族ポリマー、及び脂肪族ポリマーから構成される群から独立して選択される材料を含む請求項26に記載の装置。
- ナノ構造コンポーネントが中空ナノチューブ構造を含む請求項25に記載の装置。
- ナノ構造コンポーネントがナノワイヤーを含む請求項25に記載の装置。
- ナノファイバーがグラフト部材の1個以上の表面にナノファイバーを直接成長させることにより前記1個以上の表面に付着している請求項26に記載の装置。
- ナノファイバーがグラフト部材の1個以上の表面にナノファイバーを結合することにより前記1個以上の表面に付着している請求項26に記載の装置。
- グラフト部材が処理済み天然組織、実験室で作製した組織、及び合成ポリマー繊維の1種以上から作製される請求項25に記載の装置。
- グラフト部材がDacron、Teflon、金属もしくは合金メッシュ、セラミック又はガラス繊維から選択される合成ポリマーから作製される請求項25に記載の装置。
- グラフト部材がグラフト部材の1個以上のナノ構造表面に付設された1個以上の生体適合性コーティングを含む請求項25に記載の装置。
- グラフト部材が患者の大動脈内の動脈瘤の領域に配置されるように構成されている請求項25に記載の装置。
- グラフト部材が脳の動脈瘤の領域に血液を供給するか又は前記領域から血液を供給する血管の側壁に近接して配置されるように構成されている請求項25に記載の装置。
- 端端又は端側吻合で第1の血管を第2の血管と結合することにより患者に吻合を形成するための装置であって、管状部材の1個以上の表面と結合した複数のナノ構造コンポーネントを含む管状部材を含む前記装置。
- 複数のナノ構造コンポーネントが複数のナノファイバーを含む請求項37に記載の装置。
- 複数のナノファイバーがシリコン、ガラス、石英、プラスチック、金属、ポリマー、TiO、ZnO、ZnS、ZnSe、ZnTe、CdS、CdSe、CdTe、HgS、HgSe、HgTe、MgS、MgSe、MgTe、CaS、CaSe、CaTe、SrS、SrSe、SrTe、BaS、BaSe、BaTe、GaN、GaP、GaAs、GaSb、InN、InP、InAs、InSb、PbS、PbSe、PbTe、AlS、AlP、AlSb、SiO1、SiO2、炭化ケイ素、窒化ケイ素、ポリアクリロニトリル(PAN)、ポリエーテルケトン、ポリイミド、芳香族ポリマー、及び脂肪族ポリマーから構成される群から独立して選択される材料を含む請求項38に記載の装置。
- ナノ構造コンポーネントが中空ナノチューブ構造を含む請求項37に記載の装置。
- ナノ構造コンポーネントがナノワイヤーを含む請求項37に記載の装置。
- ナノファイバーが管状部材の1個以上の表面にナノファイバーを直接成長させることにより前記1個以上の表面に付着している請求項38に記載の装置。
- ナノファイバーが管状部材の1個以上の表面にナノファイバーを結合することにより前記1個以上の表面に付着している請求項38に記載の装置。
- 管状部材が処理済み天然組織、実験室で作製した組織、変性動物組織、ステンレス鋼、金属、合金、セラミック又はガラス繊維、ポリマー、プラスチック、シリコーン、及び合成ポリマー繊維の1種以上から作製される請求項37に記載の装置。
- 管状部材が端側吻合を実施するためのTチューブを含む請求項37に記載の装置。
- 管状部材が管状部材の1個以上のナノ構造表面に付設された1個以上の生体適合性又は生体活性コーティングを含む請求項37に記載の装置。
- 管状部材が円形、半円形、楕円形、及び多角形から選択される横断面形状をもつ請求項37に記載の装置。
- 第1の血管と第2の血管の一方が合成バイパスグラフト血管を含む請求項37に記載の装置。
- 管状部材がストレートチューブを含む請求項37に記載の装置。
- 本体構造の1個以上の表面と結合した複数のナノ構造コンポーネントを含む本体構造を含む埋込型整形外科用装置。
- 複数のナノ構造コンポーネントが複数のナノファイバーを含む請求項50に記載の装置。
- 複数のナノファイバーがシリコン、ガラス、石英、プラスチック、金属、ポリマー、TiO、ZnO、ZnS、ZnSe、ZnTe、CdS、CdSe、CdTe、HgS、HgSe、HgTe、MgS、MgSe、MgTe、CaS、CaSe、CaTe、SrS、SrSe、SrTe、BaS、BaSe、BaTe、GaN、GaP、GaAs、GaSb、InN、InP、InAs、InSb、PbS、PbSe、PbTe、AlS、AlP、AlSb、SiO1、SiO2、炭化ケイ素、窒化ケイ素、ポリアクリロニトリル(PAN)、ポリエーテルケトン、ポリイミド、芳香族ポリマー、及び脂肪族ポリマーから構成される群から独立して選択される材料を含む請求項51に記載の装置。
- ナノ構造コンポーネントが中空ナノチューブ構造を含む請求項50に記載の装置。
- ナノ構造コンポーネントがナノワイヤーを含む請求項50に記載の装置。
- ナノファイバーが本体構造の1個以上の表面にナノファイバーを直接成長させることにより前記1個以上の表面に付着している請求項51に記載の装置。
- ナノファイバーが本体構造の1個以上の表面にナノファイバーを結合することにより前記1個以上の表面に付着している請求項51に記載の装置。
- 本体構造が処理済み天然組織、実験室で作製した組織、変性動物組織、ステンレス鋼、金属、合金、セラミック又はガラス繊維、ポリマー、プラスチック、シリコーン、及び合成ポリマー繊維の1種以上から作製される請求項50に記載の装置。
- 本体構造が本体構造の1個以上のナノ構造表面に付設された1個以上の生体適合性又は生体活性コーティングを含む請求項50に記載の装置。
- 埋込型整形外科用装置が人工膝関節、人工股関節、軟骨を置換又は補強するものを含む足関節、肘関節、手関節、及び肩関節インプラント、脛骨、腓骨、大腿骨、橈骨、及び尺骨の骨折修復及び外部固定用等の長骨インプラント、固定装置を含む脊髄インプラント、頭蓋骨固定装置を含む顎顔面インプラント、人工骨置換、歯科用インプラント、ポリマー、樹脂、金属、合金、プラスチック及びその組合せから構成される整形外科用セメント及び接着剤、釘、ネジ、プレート、固定装置、ワイヤー及びピンの少なくとも1種から選択される請求項50に記載の装置。
- 複数のナノ構造コンポーネントを結合したベースメンブレン又はマトリックスを含む神経再生用スカフォールドを提供するためのバイオエンジニアドスカフォールド装置。
- メンブレン又はマトリックスが天然もしくは合成ポリマー、導電性ポリマー、金属、合金、セラミック、グラスファイバー、又はシリコーンの1種以上から作製される請求項60に記載のスカフォールド装置。
- メンブレン又はマトリックスが導電性ポリマーから作製される請求項61に記載のスカフォールド装置。
- 複数のナノ構造コンポーネントが複数のナノファイバー又はナノワイヤーを含む請求項60に記載の装置。
- メンブレン又はマトリックスのナノ構造表面が軸索伸長と機能的神経活動を助長するために1種以上の薬剤、細胞、繊維芽細胞、神経増殖因子(NGF)、細胞播種用化合物、神経栄養増殖因子もしくは前記因子を産生する遺伝子組換え細胞、VEGF、又はラミニンを含浸させるか又は結合している請求項60に記載の装置。
- 複数のナノ構造コンポーネントが生体適合性ポリマーに埋込まれている請求項60に記載の装置。
- 表面と前記表面に結合した複数のナノファイバーを含む子宮又は卵管内植込み用医療装置。
- 1個以上の表面が体液の結晶化を防ぐように構成された医療装置であって、表面と前記表面に結合した複数のナノファイバーを含む前記装置。
- 1個以上の表面が血栓形成を防ぐように構成された医療装置であって、表面と前記表面に結合した複数のナノファイバーを含む前記装置。
- 1個以上の表面が組織浸潤を防ぐように構成された医療装置であって、表面と前記表面に結合した複数のナノファイバーを含み、前記ナノファイバーが疎水性に構成されている前記装置。
- 表面と前記表面に結合した複数のナノファイバーを含む医療装置と患者を接触させる段階を含む患者の治療方法。
- 患者の身体に薬剤化合物を投与する方法であって、
少なくとも1個の表面と、複前記表面に結合した複数のナノファイバーと、前記複数のナノファイバーに結合した薬剤化合物を含む薬剤溶出装置を提供する段階と;
前記薬剤溶出装置を患者の体内に導入する段階と;
患者の体内に薬剤化合物を送達する段階を含む前記方法。 - 薬剤溶出装置が冠動脈ステントを含む請求項71に記載の方法。
- 薬剤化合物がパクリタキセル又はシロリムスを含む請求項72に記載の方法。
- 薬剤化合物が薬剤溶出装置のナノファイバー表面に吸着されている請求項71に記載の方法。
- 薬剤化合物が1個以上のシラン基の使用によりナノファイバー表面に結合している請求項71に記載の方法。
- 薬剤化合物が1個以上のリンカー分子の使用によりナノファイバー表面に結合している請求項71に記載の方法。
- 薬剤化合物が薬剤溶出装置のナノファイバー表面に共有又はイオン結合している請求項71に記載の方法。
- 薬剤溶出装置が冠動脈ステントを含み、薬剤化合物の送達が冠動脈内の病変部位で薬剤化合物を溶出させることを含む請求項71に記載の方法。
- 薬剤化合物が冠動脈ステントの拡張後に病変部位で冠動脈内に溶出する請求項78に記載の方法。
- 薬剤化合物が時間をかけてゆっくりと溶出するようにナノファイバー表面が構成されている請求項79に記載の方法。
- ナノファイバーの耐久性を強化するように複数のナノファイバーがポリマーコーティングに埋込まれている請求項71に記載の方法。
- 薬剤化合物がデキサメタゾン、M−プレドニソロン、インターフェロン、レフルノミド、タクロリムス、ミゾリビン、スタチン、シクロスポリン、トラニラスト、及びバイオレスト等の抗炎症性免疫調節剤;タキソール、メトトレキセート、アクチノマイシン、アンギオペプチン、ビンクリスチン、マイトマイシン、RestenASE、及びPCNAリボザイム等の抗増殖性化合物;バチマスタット、プロリルヒドロキシラーゼ阻害剤、ハロフギノン、C−プロテイナーゼ阻害剤、及びプロブコール等の遊走抑制剤;並びにVEGF、エストラジオール、抗体、NO供与剤、及びBCP671等の治癒と再内皮細胞化を促進する化合物の1種以上から選択される請求項71に記載の方法。
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Also Published As
Publication number | Publication date |
---|---|
EP1725189A4 (en) | 2011-03-09 |
WO2005084582A1 (en) | 2005-09-15 |
CA2557757A1 (en) | 2005-09-15 |
EP1725189A1 (en) | 2006-11-29 |
US20090162643A1 (en) | 2009-06-25 |
JP5039539B2 (ja) | 2012-10-03 |
AU2005218592A1 (en) | 2005-09-15 |
US20050038498A1 (en) | 2005-02-17 |
CA2557757C (en) | 2013-01-22 |
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