JP2009500051A - 副鼻腔炎を治療する装置及びシステム - Google Patents
副鼻腔炎を治療する装置及びシステム Download PDFInfo
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Abstract
Description
通常、用語「副鼻腔炎」は、バクテリア、ウィルス、菌類(カビ)、アレルギーや、これらの組み合わせに起因する副鼻腔の炎症や感染を意味する。慢性副鼻腔炎(例、3ヶ月以上続く)により、米国において、年間1,800万人乃至2,200万人の患者が内科医の診療所を訪れていると概算されている。
−頭痛や顔面痛
−鼻づまりやその後の鼻水
−片方か両方の鼻の穴による呼吸の困難
−口臭
−上の歯の痛み
従って、副鼻腔炎の治療法の一つとして、粘液の流れを回復させることである。初期治療としては、炎症部位を減少させるための消炎剤及び感染部位を治療するための抗生物質を使用した薬物療法が挙げられる。多数の患者は、薬物療法に反応しない。現在において、薬物療法に反応しない慢性副鼻炎の患者に対する最も基準となる処置は、機能的内視鏡下副鼻腔手術(Functional Endoscopic Sinus Surgery:FESS)と呼ばれる矯正手術である。
FESSにおいて、内視鏡が鼻内に挿入され、同内視鏡により可視化された下で、外科的処置により患部である、或いは、肥大した組織や骨を取り除き、副鼻腔の通常の排出を回復させるように鼻腔の開口部を拡張する。通常、FESSの処置は、全身麻酔を施した患者に対して行われる。
特許文献1(Robinson)及び特許文献2(Becker)は、副鼻腔に関与する部位において膨張するバルーンを使用する方法及び器具を開示する。例えば、特許文献1(Robinson)は、副鼻腔の手術後に同副鼻腔内に挿入されて膨張させることができる膨張可能な圧力装置を開示する。同特許文献は、複雑な解剖上の鼻を通過して、副鼻腔の未処置の開口部に接触するよう柔軟に案内する装置の設計及び方法を開示するものではない。バルーン材料の検討も、副鼻腔の骨の開口部を膨張させることには略不十分であるゴムのような薄い可撓性を有する材料に帰着する。
本発明に従った別の態様において、副鼻腔の開口部(例、自然の小口、外科的に、或いは、治療により変形させた小口、外科的に形成した、又は人工の開口部、洞フィステル形成術による開口部、截骨術による開口部、穿孔、バーによる孔、ドリルによる孔、篩骨洞手術による開口部、組織上の通路、自然の又は人工の通路等を含む副鼻腔や頭蓋の顔面の気泡内の経鼻的に接触可能な開口部であるが、これらに限定されるものではない)や、人の、或いは、動物の体内のその他の組織上の部位に、これらの開口部や部位が直接又は内視鏡によっても全体的或いは部分的に隠れた状態においても、接触する(例、カテーテル、案内部やその他の装置を前進させることにより)方法が提供される。
鼻腔NC、鼻咽腔NP、前頭洞FS、篩骨洞ES、篩骨蜂巣EAC、ちょう形骨洞SS、ちょう形骨洞口SSO、上顎洞MS、粘液嚢胞MC。
上述した処置の別例が可能である。実施例において、案内ワイヤ910が、予め案内装置900内に装填される。案内ワイヤ910及び案内装置900が、同案内装置900の末端の先端部が組織の目的の部位の近傍に位置するように、共に組織内に案内される。別例において、バルーンカテーテル934が、案内ワイヤ910上に予め載置される。次にバルーンカテーテル934及び案内ワイヤ910の組み合わせが、案内装置900内に予め装填される。このようなバルーンカテーテル934、案内ワイヤ910、及び、案内装置900の組み合わせが、同組み合わせの末端部が所望の目的の部位の近傍に位置するように、鼻腔内に案内されてもよい。その後、案内ワイヤ910が副鼻腔のような所望の目的の部位内に前進される。その後、バルーンカテーテル934は、案内ワイヤ910上を前進される。バルーン938は、組織の領域を拡張するために膨張される。
発明の例や実施例を参照して発明を上述したが、これらの例や実施例は、本発明の趣旨及び範囲の範囲を超えるものでなければ様々な、追加、削除、変更、修正をされてもよいといえる。例えば、実施例における、要素や特性は、意図した使用において不適なものとならない限り、別例に組み込んだり、別例において使用してもよい。また、開示し、一覧にし、或いは請求した方法や処置の工程の順番は、実施例が当該技術において通常の知識を有する者に対して新規性を失ったり、自明なものとならない限り、或いは、意図した使用において不適なものとならない限り、その他の順番により実施してもよい。全ての妥当な追加、削除、修正、及び、変更が、開示した実施例の均等物とみなされ、特許請求の範囲内に包含される。
Claims (200)
- 副鼻腔の開口部内へ、或いは、開口部を通過して案内ワイヤ、カテーテルやその他の装置を容易に前進させる管状案内装置であって、同案内装置は、
管腔及び末端部を有する管状の基端部と、
先の基端部の管腔と略同軸上にある管腔と末端部を有する管状の末端部から構成されることと、同管状の末端部は該基端部の末端部から延びることと、同管状の末端部は基端部より柔軟であり、経鼻的に挿入すること、及び同管状の末端部の末端部が副鼻腔の開口部内、或いは、開口部に隣接して配置されるように装置を配置することが容易にできるように構成されていることを特徴とする管状案内装置。 - 30°以下の湾曲部が前記末端部に形成されることを特徴とする請求項1に記載の装置。
- 約30°の湾曲部が前記末端部に形成されることを特徴とする請求項1に記載の装置。
- 約70°の湾曲部が前記末端部に形成されることを特徴とする請求項1に記載の装置。
- 約90°の湾曲部が前記末端部に形成されることを特徴とする請求項1に記載の装置。
- 約110°の湾曲部が前記末端部に形成されることを特徴とする請求項1に記載の装置。
- 前記末端部は、角度(A)の湾曲部及び末端の先端部を有することと、同末端部は、幅(W)と、湾曲部上の最も基端側の地点から末端の先端部までの第1の長さ(L1)を有することを特徴とする請求項1に記載の装置。
- Aは約30°未満であり、Wは約0.034インチ(約0.08636cm)未満であり、L1は約0.046インチ(約0.1168cm)未満であることを特徴とする請求項7に記載の装置。
- 末端部は、基端部の末端部から末端部の湾曲部における最も基端側の地点までの第2の長さL2を有し、同第2の長さL2は、約2インチ(約5.08cm)未満であることを特徴とする請求項8に記載の装置。
- Aは約30°であり、Wは約0.34インチ(約0.8636cm)であり、L1は約0.46インチ(約1.168cm)であることを特徴とする請求項7に記載の装置。
- 末端部は、基端部の末端部から末端部の湾曲部における最も基端側の地点までの第2の長さL2を有し、同第2の長さL2は、約2インチ(約5.08cm)未満であることを特徴とする請求項10に記載の装置。
- Aは約70°であり、Wは約0.48インチ(約1.219cm)であり、L1は約0.32インチ(約0.8128cm)であることを特徴とする請求項7に記載の装置。
- 末端部は、基端部の末端部から末端部の湾曲部における最も基端側の地点までの第2の長さL2を有し、同第2の長さL2は、約2インチ(約5.08cm)未満であることを特徴とする請求項12に記載の装置。
- Aは約90°であり、Wは約0.39インチ(約0.9906cm)であり、L1は約0.25インチ(約0.635cm)であることを特徴とする請求項7に記載の装置。
- 末端部は、基端部の末端部から末端部の湾曲部における最も基端側の地点までの第2の長さL2を有し、同第2の長さL2は、約2インチ(約5.08cm)未満であることを特徴とする請求項8に記載の装置。
- Aは約110°であり、Wは約0.25インチ(約0.635cm)未満であることを特徴とする請求項7に記載の装置。
- 末端部は、基端部の末端部から末端部の湾曲部における最も基端側の地点までの第2の長さL2を有し、同第2の長さL2は、約2インチ(約5.08cm)未満であることを特徴とする請求項16に記載の装置。
- 前記末端部は、外表面及び末端部の外表面上の最も末端側の地点から末端の先端部上の最も基端側の地点までの長さL3を有し、同長さL3は、約0.18インチ(約0.4572cm)であることを特徴とする請求項16又は17に記載の装置。
- 前記基端部は、第1の管を備えることと、第2の管が第1の管の管腔を通過して延びて第1の管の末端部から外方にかつ末端部上に突出することと、装置の末端部は少なくとも部分的に、第1の管の末端部の外方にかつ末端部上に突出する第2の管の一部により構成されていることを特徴とする請求項1に記載の装置。
- 前記第1の管は、略金属により形成されることと、前記第2の管は、略ポリマー材料から形成されることを特徴とする請求項19に記載の装置。
- 第2の管の管腔は、装置の全長にわたって延びる貫通管腔を形成することを特徴とする請求項19に記載の装置。
- 前記ポリマー材料は、ナイロン、ナイロン11、ナイロン12、登録商標名Pebax、Pebax72D、ポリイミド、ポリ(エーテルエーテルケトン)(PEEK)、ポリ(ブチレンテレフタレート)(PBT)、及びこれらの組み合わせや混合物から必要不可欠に構成される一群から選択されることを特徴とする請求項20に記載の装置。
- 前記第1の管はハイポチューブであることを特徴とする請求項20に記載の装置。
- 貫通管腔の少なくとも一部を覆うライナーを更に備えることを特徴とする請求項21に記載の装置。
- 前記ライナーは、第2の管に取り付けられることを特徴とする請求項24に記載の装置。
- 前記ライナーは、ポリテトラフルオロエチレン、ポリ(フッ化ビリニデン)(PVDF)及び高密度ポリエチレン(HDPE)から構成される一群から選択される材料によって形成されることを特徴とする請求項24に記載の装置。
- 前記装置の末端部は、第1の材料から形成される本体と、同第1の材料より柔軟な第2の材料から形成される末端の先端部を備えることを特徴とする請求項1に記載の装置。
- 前記本体は約70R乃至約110Rのロックウェル硬さを有することと、末端の先端部は約35D乃至約72Dのショアデュロメータ硬さを有することを特徴とする請求項27に記載の装置。
- 前記末端部の本体はナイロンから構成されることと、前記末端の先端部は弾性ポリエーテルブロックアミドから構成されることとを特徴とする請求項28に記載の装置。
- 装置の少なくとも一部は略透明であることを特徴とする請求項1に記載の装置。
- 装置の末端部は、少なくとも一部が略透明なポリマー材料から形成されることを特徴とする請求項30に記載の装置。
- 装置の末端部に、或いは、近傍に設けられる放射線不透過性のマーカー又は放射線不透過性の材料を更に備えることを特徴とする請求項1に記載の装置。
- 管腔及び末端部を有する金属管と、
管腔及び末端部を有する合成樹脂の管と、同合成樹脂の管は金属管より長いことと、
合成樹脂の管の末端部上の末端の先端部と、同末端の先端部は合成樹脂の管より柔軟であることと、合成樹脂の管は、合成樹脂の末端部及び末端の先端部が金属管の末端部から外側に突出するように、金属管の管腔を通過して延びることを特徴とする請求項1に記載の装置。 - 前記装置の基端部は金属管の末端部に向かって基端方向に延びる部分であり、前記装置の末端部は金属管の末端部に向かって末端方向に延びる部分であることを特徴とする請求項33に記載の装置。
- 合成樹脂の管の管腔を通過して延びるライナーを更に備えることを特徴とする請求項33に記載の装置。
- 金属管の外表面及び金属管の末端部上を突出する合成樹脂の管の一部の外表面を略包囲する外側カバーを更に備えることを特徴とする請求項33に記載の装置。
- 外側カバーは、略ナイロンやその他の熱可塑性材料から形成されることを特徴とする請求項34に記載の装置。
- 前記外側のカバーは、滑りがよい円滑な表面を装置上に形成することを特徴とする請求項34に記載の装置。
- 前記外側のカバーは、金属管及び合成樹脂の管の間の連結部からの漏出を抑止することを特徴とする請求項34に記載の装置。
- 請求項1に記載の管状案内装置と、同管状案内装置を通過して前進するような寸法に形成され構成され、副鼻腔の開口部を膨張させることに適用可能なバルーンカテーテルを組み合わせて備えることを特徴とするシステム。
- 請求項1に記載の管状案内装置と、管状案内装置を通過して、副鼻腔内や副鼻腔の開口部内に前進可能な案内ワイヤを組み合わせて備えることを特徴とするシステム。
- 請求項1に記載の管状案内装置と、管状案内装置を通過して、副鼻腔内や副鼻腔の開口部内に前進可能な管状シースを組み合わせて備えることを特徴とするシステム。
- 案内ワイヤ上を管状案内装置を通過して前進するような寸法に形成され構成され、副鼻腔の開口部を膨張させることに適用可能なバルーンカテーテルを更に備えることを特徴とする請求項41に記載のシステム。
- 案内ワイヤに沿って管状案内装置を通過して前進するような寸法に形成され構成され、少なくとも物質の注入に適用可能な管状シースを更に備えることを特徴とする請求項41に記載のシステム。
- 前記管状案内部は、約5インチ乃至約6インチ(約12.7cm乃至約15.24cm)の長さを有することと、バルーンカテーテルは、約8インチ乃至約20インチ(約20.32cm乃至約50.8cm)の長さを有することを特徴とする請求項40及び43のうちいずれか一方に記載のシステム。
- 前記バルーンカテーテルは、カテーテルシャフトと、膨張可能なバルーンと、目的の部位内に挿入された後のバルーンの位置を示す少なくとも1つのマーカーを備えることを特徴とする請求項40及び43のうちいずれか一方に記載のシステム。
- 前記少なくとも1つのマーカーはバルーンカテーテルシャフト上の少なくとも1つのマーカーから構成されることと、同マーカーは、直接、又は内視鏡により操作者に認識可能であることを特徴とする請求項46に記載のシステム。
- 前記バルーンカテーテルは末端部を有することと、前記少なくとも1つのマーカーは、管状案内部の末端部に対するバルーンカテーテルの末端部の位置を決定することに適用可能であることを特徴とする請求項46に記載のシステム。
- 前記少なくとも1つのマーカーが、管状案内部の末端部に対するバルーンの位置を示すことを特徴とする請求項46に記載のシステム。
- 前記少なくとも1つのマーカーは、
管状案内部の末端部に対するバルーンカテーテルの末端部の位置を示す第1のマーカーと、
管状案内装置の末端部に対するバルーンの位置を示す第2のマーカーから構成されることを特徴とする請求項47、48、49のいずれか一項に記載のシステム。 - 前記バルーンは基端部及び末端部を備えることと、第2のマーカーは、a)管状案内装置の末端部に対するバルーンの末端部の位置と、b)管状案内装置の末端部に対するバルーンの基端部の位置とを示すことを特徴とする請求項50に記載のシステム。
- 第2のマーカーは、バルーンの長さと略同じ長さを有する認識可能なマークから構成されることを特徴とする請求項51に記載のシステム。
- 前記バルーンカテーテルは、略非柔軟なバルーンから構成されることを特徴とする請求項40及び43のうちいずれか一方に記載のシステム。
- 前記バルーンカテーテルは、ポリエチレンテレフタレート、ナイロン、及びポリアミドから構成される一群から選択される材料から形成されるバルーンを備えることを特徴とする請求項53に記載のシステム。
- 前記バルーンカテーテルは、破裂することなく22気圧以上の圧力に耐久可能なバルーンから構成されることを特徴とする請求項40及び43のうちいずれか一方に記載のシステム。
- 前記バルーンカテーテルは、副鼻腔の開口部を膨張することに適用可能なバルーンを備えることを特徴とする請求項40又は43に記載のシステム。
- 前記バルーンは、副鼻腔の開口部周辺に位置する骨を骨折させることが可能であることを特徴とする請求項56に記載のシステム。
- 前記バルーンカテーテルは、少なくとも1つのX線撮影により認識可能な要素を更に備えることと、同要素は、X線撮像装置と組み合わせてバルーンがいつ副鼻腔の開口部内に位置するかを決定することに適用可能であることとを特徴とする請求項56に記載のシステム。
- バルーンがいつ副鼻腔の開口部内に位置するかを決定するためにX線撮影により認識可能な要素を撮像することに適用可能な蛍光透視鏡を更に備えることを特徴とする請求項56に記載のシステム。
- 前記蛍光透視鏡は、Cアーム型蛍光透視鏡から構成されることを特徴とする請求項59に記載のシステム。
- 前記バルーンカテーテルは、少なくとも1つの内視鏡により認識可能な要素を更に備えることと、同要素は、内視鏡と組み合わせてバルーンがいつ副鼻腔の開口部内に位置するかを決定することに適用可能であることとを特徴とする請求項56に記載のシステム。
- 内視鏡により認識可能な要素を観察することに適用可能な内視鏡を更に備えることを特徴とする請求項61に記載のシステム。
- 前記バルーンカテーテルは、最初に収縮した状態で配置され、次に膨張した状態に膨張可能であるバルーンを備えることを特徴とする請求項40及び43のうちいずれか一方に記載のシステム。
- 前記バルーンは、収縮した状態であるときに折りたたまれ、複数の翼部を形成することを特徴とする請求項63に記載のシステム。
- 前記バルーンは、3乃至8の翼部を形成するよう折りたたまれることを特徴とする請求項64に記載のシステム。
- 前記バルーンは、ポリマーコーティングによりコーティングされることを特徴とする請求項40及び43のうちいずれか一方に記載のシステム。
- 前記コーティングは、ポリウレタンコーティングから構成されることを特徴とする請求項66に記載のシステム。
- 前記コーティングは、浸漬により適用されることを特徴とする請求項66に記載のシステム。
- 前記バルーンカテーテルは、バルーンが収縮した状態においてバルーンを覆う、退去可能なシースを更に備えることを特徴とする請求項63に記載のシステム。
- 前記バルーンカテーテルはバルーンを備えることと、同バルーンは、約0.002インチ(約0.00508cm)の厚みを有するポリエチレンテレフタレートから形成されることと、同ポリエチレンテレフタレートはポリウレタンのコーティングを載置することと、同コーティングは約2インチ(約0.00508cm)の厚みを有することとを特徴とする請求項40及び43のうちいずれか一方に記載のシステム。
- 前記バルーンカテーテルは、約20cm未満の長さを有することを特徴とする請求項40又は43に記載のシステム。
- 前記バルーンカテーテルは、約15cm未満の長さを有することを特徴とする請求項40又は43に記載のシステム。
- 前記バルーンカテーテルは、約10cm未満の長さを有することを特徴とする請求項40又は43に記載のシステム。
- 前記案内ワイヤは、異なる可撓性を備える少なくとも2つの領域を有することを特徴とする請求項41に記載のシステム。
- 前記案内ワイヤは、第1の可撓性を有する基端部と、第2の可撓性を有する中間部と、第3の可撓性を有する末端部とを有することを特徴とする請求項74に記載のシステム。
- 前記基端部は約18インチ乃至約21インチ(約45.72cm乃至約53.34cm)の長さを有し、前記中間部は約7インチ乃至約10インチ(約17.78cm乃至約25.4cm)の長さを有し、前記末端部は約0.5インチ乃至約1.5インチ(約1.27cm乃至約3.81cm)の長さを有することを特徴とする請求項75に記載のシステム。
- 前記基端部は約35インチ乃至約39インチ(約88.9cm乃至約99.06cm)の長さを有し、前記中間部は約7インチ乃至約10インチ(約17.78cm乃至約25.4cm)の長さを有し、前記末端部は約0.5インチ乃至約1.5インチ(約1.27cm乃至約3.81cm)の長さを有することを特徴とする請求項75に記載のシステム。
- 前記案内ワイヤは、約120cmを超える長さを有することを特徴とする請求項77に記載のシステム。
- 前記案内ワイヤの少なくとも一部は放射線不透過性であることと、案内ワイヤは、副鼻腔内に前進され、副鼻腔内において巻き付けられ、これにより、副鼻腔のX線撮影による試験のためにX線撮影の対比をなすよう構成されることを特徴とする請求項41に記載のシステム。
- 前記管状案内部の末端部は湾曲していることと、前記管状シースはよじれることなく管状案内部の湾曲した末端部を通過して前進可能となるように構成されていることを特徴とする請求項42に記載のシステム。
- 前記管状案内部は、約70°を超える角度の湾曲部を有することを特徴とする請求項80に記載のシステム。
- 前記シースは、側壁及び同側壁内の刃を有する管を備えることと、同刃は、シースが管状案内装置の湾曲した末端部を通過して前進される場合にシースのよじれの発生を抑止するよう構成されていることとを特徴とする請求項80に記載のシステム。
- 前記シースは、側壁を有する管を備えることと、同側壁は少なくともその一部が、シースが管状案内装置の湾曲した末端部を通過して前進される場合にシースのよじれの発生を抑止する特性を有するポリマー材料から形成されることとを特徴とする請求項80に記載のシステム。
- 前記側壁は少なくともその一部が、相互連結されたポリマーから形成されることと、ポリマーの相互連結により、ポリマーは、シースが管状案内装置の湾曲した末端部を通過して前進される場合に同シースのよじれの発生を抑止するのに十分な剛性を付与されることを特徴とする請求項80に記載のシステム。
- 前記ポリマーは、前記相互連結を発生させるように、電子ビームの放射にさらされたポリエチレンから構成されることを特徴とする請求項84に記載のシステム。
- 前記ポリマーは、高密度のポリエチレン及び低密度のポリエチレンの混合体から構成されることを特徴とする請求項85に記載のシステム。
- 約0.100インチ+−0.060インチ(約0.254cm+−0.1524cm)の内径を有する管腔が装置を通過して延びることを特徴とする請求項1に記載の管状案内装置。
- 前記末端部は、約0.134インチ+−0.080インチ(約0.3404cm+−0.2032cm)の外径を有することを特徴とする請求項87に記載の管状案内装置。
- 前記基端部は、約0.150インチ+−0.080インチ(約0.381cm+−0.2032cm)の外径を有することを特徴とする請求項87に記載の管状案内装置。
- 目的の部位に挿入されることを意図される、装置の一部は、約2インチ乃至約6インチ(約5.08cm乃至約15.24cm)の長さを有することを特徴とする請求項1に記載の管状案内装置。
- 前記末端部に湾曲部が形成されることと、装置は同装置の基端部上にハブ部材を備えることと、同ハブ部材は、湾曲部の方向を示す、少なくとも1つの湾曲方向指示要素を有することとを特徴とする請求項1に記載の管状案内装置。
- 前記湾曲方向表示要素は、ハブ上に1つ以上の翼部を備えることと、同1つ以上の翼部は、湾曲の方向を示すために湾曲部に沿って配置されることを特徴とする請求項91に記載の管状案内装置。
- 請求項1に記載の複数の管状案内装置から構成されることと、各管状案内装置は異なる形状を有することとを特徴とするシステム。
- 管腔が前記案内装置のそれぞれを通過して延びることと、このような管腔は略同じ長さを有することを特徴とする請求項93に記載のシステム。
- カテーテルシャフト、バルーン、及び同シャフト上に設けられる少なくとも1つのバルーン位置決めマーカーを備えるバルーンカテーテルと更に組み合わされることと、同バルーン位置決めマーカーは、システム内の管状案内装置の管腔の共通の長さと相関し、バルーンが管状案内装置のいずれか1つの管腔から外側に充分前進されたときを示すことを特徴とする請求項94に記載のシステム。
- 前記基端部の少なくとも一部は、柔軟であり、これにより、様々な形状に変形可能であることを特徴とする請求項1に記載の管状案内装置。
- 人、或いは、動物の副鼻腔の開口部を膨張させるためのバルーンカテーテル装置であって、同バルーンカテーテル装置は、
カテーテルシャフトと、
同カテーテルシャフト上に設けられる非柔軟なバルーンと、同バルーンは、非膨張状態において副鼻腔の開口部内に配置可能であり、その後同副鼻腔の開口部を膨張させることができるように少なくとも約3mmの直径を有する膨張状態に膨張可能であることと、同バルーンは、ポリマー材料から構成されるを載置する外表面を有することと、
所望に応じて膨張させるために、いつバルーンが副鼻腔の開口部内に位置するかを決定することに適用可能な少なくとも1つの位置表示要素を備えることを特徴とする、人、或いは、動物の副鼻腔の開口部を膨張させるためのバルーンカテーテル装置。 - 前記少なくとも1つの位置表示要素はバルーンカテーテルシャフト上の少なくとも1つのマーカーから構成される少なくとも1つのマーカーを備えることと、同マーカーは、直接、又は内視鏡により操作者に認識可能であることを特徴とする請求項97に記載のバルーンカテーテル装置。
- 前記バルーンカテーテルは末端部を有することと、前記少なくとも1つのマーカーは、バルーンカテーテル装置が挿入される管状案内部の末端部に対するバルーンカテーテルの末端部の位置を示すことを特徴とする請求項97に記載のバルーンカテーテル装置。
- 前記少なくとも1つのマーカーは、
管状案内部の末端部に対するバルーンカテーテルの末端部の位置を示す第1のマーカーと、
管状案内装置の末端部に対するバルーンの位置を示す第2のマーカーとを備えることを特徴とする請求項97に記載のバルーンカテーテル装置。 - 前記バルーンは基端部及び末端部を備えることと、第2のマーカーは、a)管状案内装置の末端部に対するバルーンの末端部の位置と、b)管状案内装置の末端部に対するバルーンの基端部の位置とを示すことを特徴とする請求項100に記載のバルーンカテーテル装置。
- 前記第2のマーカーは、バルーンの長さと略同じ長さを有する認識可能なマークから構成されることを特徴とする請求項100に記載のバルーンカテーテル装置。
- 前記バルーンは略非柔軟であることを特徴とする請求項97に記載のバルーンカテーテル装置。
- 前記バルーンは、ポリエチレンテレフタレート、ナイロン、及びポリアミドから構成される一群から選択される材料から形成されることを特徴とする請求項97に記載のバルーンカテーテル装置。
- 前記バルーンは、破裂することなく22気圧以上の圧力に耐久可能であることを特徴とする請求項97に記載のバルーンカテーテル装置。
- 前記バルーンは、副鼻腔の開口部周辺に位置する骨を骨折させることが可能であることを特徴とする請求項97に記載のバルーンカテーテル装置。
- 前記少なくとも1つの位置表示要素は、X線撮影法により認識可能な要素を備えることと、同X線撮影法により認識可能な要素は、開口部を膨張させるためにバルーンがいつ副鼻腔の開口部内に位置するかを決定することにX線撮像装置と組み合わせて適用可能であることを特徴とする請求項97に記載のバルーンカテーテル装置。
- バルーンがいつ副鼻腔の開口部内に位置するかを決定するためにX線撮影により認識可能な要素を撮像することに適用可能な蛍光透視鏡と組み合わせた請求項97に記載のバルーンカテーテル装置を備えることを特徴とするシステム。
- 前記蛍光透視鏡は、Cアーム型蛍光透視鏡から構成されることを特徴とする請求項108に記載のシステム。
- 前記バルーンは、最初に収縮した状態で配置され、続いて膨張した状態に膨張可能であることを特徴とする請求項97に記載のバルーンカテーテル装置。
- 前記バルーンは、収縮した状態であるときに折りたたまれ、複数の翼部を形成することを特徴とする請求項110に記載のバルーンカテーテル装置。
- 前記バルーンは、3乃至8の翼部を形成するよう折りたたまれることを特徴とする請求項111に記載のバルーンカテーテル装置。
- 前記バルーンはポリマーコーティングによりコーティングされることを特徴とする請求項97に記載のバルーンカテーテル装置。
- 前記コーティングはポリウレタンコーティングから構成されることを特徴とする請求項113に記載のバルーンカテーテル装置。
- 前記コーティングは、浸漬により適用されることを特徴とする請求項113に記載のバルーンカテーテル装置。
- バルーンが収縮した状態においてバルーンを覆う、退去可能なシースを更に備えることを特徴とする請求項110に記載のバルーンカテーテル装置。
- 前記バルーンは、約0.002インチ(約0.00508cm)の厚みを有するポリエチレンテレフタレートから形成されることと、同ポリエチレンテレフタレートはポリウレタンのコーティングを載置することと、同コーティングは約2インチ(約0.00508cm)の厚みを有することとを特徴とする請求項97に記載のバルーンカテーテル装置。
- 前記バルーンは、約0.002インチ(約0.00508cm)の厚みを有するポリエチレンテレフタレートから略形成されることと、同ポリエチレンテレフタレートはポリウレタンのコーティングを載置することと、同コーティングは約2インチ(約0.00508cm)の厚みを有することとを特徴とする請求項97に記載のバルーンカテーテル。
- 約20cm未満の長さを有することを特徴とする請求項97に記載のバルーンカテーテル。
- 約15cm未満の長さを有することを特徴とする請求項97に記載のバルーンカテーテル。
- 約10cm未満の長さを有することを特徴とする請求項97に記載のバルーンカテーテル。
- バルーンカテーテルに取り付けられ、バルーンカテーテルの末端部から延びる案内部材を更に備えることを特徴とする請求項97に記載のバルーンカテーテル。
- 前記案内部材は、固定された案内ワイヤを備えることを特徴とする請求項122に記載のバルーンカテーテル。
- 人や動物の副鼻腔の開口部を膨張させる方法であって、同方法は、
a)案内装置を提供する工程と、
b)前記案内装置を通過、或いは案内装置に沿って前進可能であるバルーンカテーテルを提供する工程と、同バルーンカテーテルはカテーテルシャフトと同カテーテルシャフト上に設けられるバルーンを備えることと、
c)同案内装置を副鼻腔の開口部内、開口部を通過して、或いは、開口部の近傍に挿入する工程と、
d)バルーンカテーテルを案内装置を通過、或いは案内装置に沿って、バルーンが副鼻腔の開口部内に位置する地点に前進させる工程と、
e)バルーンを膨張させて副鼻腔の開口部を膨張させる工程とから構成されることを特徴とする人や動物の副鼻腔の開口部を膨張させる方法。 - 前記案内装置は案内ワイヤから構成されることと、バルーンカテーテルは、同案内ワイヤに沿って前進されることを特徴とする請求項124に記載の方法。
- 前記案内装置は管状案内部から構成されることと、バルーンカテーテルは、同管状案内部を通過して前進されることを特徴とする請求項124に記載の方法。
- 前記案内装置は、管状案内部、及び同管状案内部を通過して前進可能な案内ワイヤを備えることと、前記バルーンカテーテルは、案内ワイヤに沿って、及び管状案内部を通過して前進されることを特徴とする請求項124に記載の方法。
- 前記案内部は、湾曲部を有することと、工程cは、案内部の湾曲部を既存の組織の部位の周囲に前進させる工程から構成されることとを請求項124に記載の方法。
- 前記案内部は、約70°乃至約135°の湾曲部を有することと、工程cは、案内部の末端部が上顎洞口内、或いは、隣接した部位に位置するように、案内部の湾曲部を鉤状突起の周囲に前進させる工程から構成されることとを特徴とする請求項128に記載の方法。
- 前記案内部は、30°乃至約100°の湾曲部を有することと、工程cは、案内部の末端部が前頭洞口内、或いは、隣接した部位に位置するように、案内部を前頭洞の周囲に前進させる工程から構成されることとを特徴とする請求項128に記載の方法。
- 前記案内部は、約0°乃至約45°の湾曲部を有することと、工程cは、案内部の末端部がちょう形骨洞口内、或いは、隣接した部位に位置するように、案内部を前進させる工程から構成されることとを特徴とする請求項128に記載の方法。
- 前記方法は、成人の自然の上顎洞口を膨張させるために実施されることと、バルーンは、約4mm乃至約10mmの膨張後の径、及び約8mm乃至約16mmの長さを有することを特徴とする請求項124に記載の方法。
- 前記案内部は、約70°乃至約135°の湾曲部を有することを特徴とする請求項132に記載の方法。
- 前記方法は、治療により、或いは、外科的処置により以前に変形された、成人の上顎洞口を膨張させるために実施されることと、バルーンは、約7mm乃至約30mmの膨張後の径、及び約8mm乃至約16mmの長さを有することを特徴とする請求項124に記載の方法。
- 前記案内部は、約0°乃至約135°の湾曲部を有することを特徴とする請求項134に記載の方法。
- 前記方法は、成人の自然の前頭洞口を膨張させるために実施されることと、バルーンは、約3mm乃至約10mmの膨張後の径、及び約8mm乃至約50mmの長さを有することを特徴とする請求項124に記載の方法。
- 前記案内部は、約30°乃至約90°の湾曲部を有することを特徴とする請求項136に記載の方法。
- 前記方法は、治療により、或いは、外科的処置により以前に変形された、成人の前頭洞口を膨張させるために実施されることと、バルーンは、約5mm乃至約30mmの膨張後の径、及び約8mm乃至約50mmの長さを有することを特徴とする請求項124に記載の方法。
- 前記案内部は、約0°乃至約90°の湾曲部を有することを特徴とする請求項138に記載の方法。
- 前記方法は、成人の自然のちょう形骨洞口を膨張させるために実施されることと、バルーンは、約3mm乃至約10mmの膨張後の径、及び約8mm乃至約16mmの長さを有することを特徴とする請求項124に記載の方法。
- 前記案内部は、約0°乃至約30°の湾曲部を有することを特徴とする請求項140に記載の方法。
- 前記方法は、治療により、或いは、外科的処置により以前に変形された、成人のちょう形骨洞口を膨張させるために実施されることと、バルーンは、約5mm乃至約30mmの膨張後の径、及び約8mm乃至約16mmの長さを有することを特徴とする請求項124に記載の方法。
- 前記案内部は、約0°乃至約30°の湾曲部を有することを特徴とする請求項142に記載の方法。
- 前記方法は、成人の自然の篩骨洞口を膨張させるために実施されることと、バルーンは、約1mm乃至6mmの膨張後の径、及び約3mm乃至約12mmの長さを有することを特徴とする請求項124に記載の方法。
- 前記案内部は、約0°乃至約30°の湾曲部を有することを特徴とする請求項144に記載の方法。
- 前記方法は、治療により、或いは、外科的処置により以前に変形された、成人の篩骨洞口を膨張させるために実施されることと、バルーンは、約3mm乃至20mmの膨張後の径、及び約3mm乃至約12mmの長さを有することを特徴とする請求項124に記載の方法。
- 前記案内部は、約0°乃至約30°の湾曲部を有することを特徴とする請求項146に記載の方法。
- 前記案内装置は案内ワイヤを備えることと、工程dは、バルーンカテーテルを案内ワイヤに沿って前進させる工程から構成されることを特徴とする請求項124に記載の方法。
- 案内ワイヤの少なくとも一部は放射線不透過性であることと、前記方法は、
案内ワイヤの放射線不透過性を有する部分を鼻腔内で湾曲し、巻き込まれ、或いは、巻き付かれるように副鼻腔内に前進させる工程と、
副鼻腔内で湾曲し、巻き込まれ、或いは、巻き付かれた、案内ワイヤの放射線不透過性を有する部分のX線撮影による像を得る工程とから更に構成されることを特徴とする請求項148に記載の方法。 - X線撮像装置を提供する工程と、
同X線撮像装置を使用して副鼻腔内で湾曲し、巻き込まれ、或いは、巻き付かれた、案内ワイヤの放射線不透過性を有する部分を撮像する工程とから更に構成されることを特徴とする請求項149に記載の方法。 - 前記X線撮像装置は、Cアーム型蛍光透視鏡を備えることと、X線撮像装置を使用して副鼻腔内で湾曲し、巻き込まれ、或いは、巻き付かれた、案内ワイヤの放射線不透過性を有する部分を撮像する工程は、
Cアームを移動して、所望の視点から副鼻腔の像を得られるように蛍光透視鏡を位置決めする工程と、
その後、蛍光透視鏡を使用して、副鼻腔内で湾曲し、巻き込まれ、或いは、巻き付かれた、案内ワイヤの放射線不透過性の部分を撮像する工程とから構成されることとを特徴とする請求項150に記載の方法。 - 前記案内装置は管状案内部を備えることと、工程dは、バルーンカテーテルを管状案内部を通過して前進させる工程から構成されることを特徴とする請求項124に記載の方法。
- 管状案内部を介して吸引する工程を更に含むことを特徴とする請求項152に記載の方法。
- 管状案内部を介して物質を注入する工程を更に含むことを特徴とする請求項152に記載の方法。
- 管状案内部を介して別の装置を案内する工程を更に含むことを特徴とする請求項152に記載の方法。
- 前記別の装置は、バルーンカテーテル、切断するバルーン、カッター、歯、回転カッター、回転ドリル、回転刃、連続する膨張具、先細の膨張具、パンチ、解剖用器具、バー、非膨張の機械的に拡張可能な部材、高周波の機械的バイブレータ、拡張ステント、及び高周波切断装置、マイクロ波切断装置、レーザー装置、シュリンゲ、生検器具、スコープ、及び診断のための、或いは、治療のための薬剤を案内する装置から構成される一群から選択されることを特徴とする請求項155に記載の方法。
- 管状案内部を通過するような寸法及び形状に形成された管状シースを提供する工程と、
同管状シースを管状案内部を通過してi)副鼻腔の開口部内、或いは開口部に隣接する位置、及びii)副鼻腔内のうちいずれか一方の位置に前進させる工程とから更に構成されることを特徴とする請求項152に記載の方法。 - 前記案内装置は管状案内部と組み合わせた案内ワイヤを備えることと、工程dは、バルーンカテーテルを案内ワイヤに沿って管状案内部を通過して前進させる工程から構成されることを特徴とする請求項124に記載の方法。
- 工程cは、管状案内部を挿入し、その後、案内ワイヤを管状案内部を通過して前進させる工程から構成されることを特徴とする請求項158に記載の方法。
- 工程cは、案内ワイヤを挿入し、その後、管状案内部を案内ワイヤに沿って前進させる工程から構成されることを特徴とする請求項158に記載の方法。
- 工程cは、管状案内部内に案内ワイヤを挿入し、その後、管状案内部及び案内ワイヤを同時に挿入する工程から構成されることを特徴とする請求項158に記載の方法。
- 工程の実施に先立って、前記方法は、バルーンの膨張により開口部が膨張されるようにバルーンが開口部内に位置することを確認する工程から更に構成されることを特徴とする請求項124に記載の方法。
- 前記バルーンカテーテルは、バルーンの位置を決定するためにX線撮影により撮像される、1つ以上の放射線不透過性を有するマーカーを有することと、バルーンの膨張により開口部が膨張されるようにバルーンが開口部内に位置することを確認することとを特徴とする請求項162に記載の方法。
- X線撮像装置を提供する工程と、
同X線撮像装置を使用してバルーンの位置を決定するためにX線撮影により撮像される1つ以上の放射線不透過性を有するマーカーを撮像する工程から更に構成されることを特徴とする請求項163に記載の方法。 - 前記X線撮像装置は、Cアーム型蛍光透視鏡を備えることと、バルーンの位置を決定するためにX線撮影により撮像される、1つ以上の放射線不透過性のマーカーを撮像する工程は、
Cアームを移動して、膨張される副鼻腔の開口部の像を得られるように蛍光透視鏡を位置決めする工程と、
その後、蛍光透視鏡を使用して、開口部に対するバルーンの位置を決定するために副鼻腔の開口部とバルーンカテーテル上の1つ以上のマーカーとを撮像する工程とから構成されることを特徴とする請求項164に記載の方法。 - 骨は開口部に隣接して位置することと、工程dは、開口部に隣接した骨を折る工程から構成されることを特徴とする請求項124に記載の方法。
- バルーンカテーテルの少なくとも一部は可撓性を備えることと、少なくとも1つの組織上の部位は、剛性を備えた長尺状をなす装置が開口部内に経鼻的に前進されることを抑止するように配置されることと、
工程cは、組織上の部位を切断したり寸法や形状を変化させることなく同組織上の部位の周囲の案内装置を副鼻腔の開口部内、或いは、近傍に前進させる工程から構成されることを特徴とする請求項124に記載の方法。 - バルーンカテーテルの少なくとも一部は可撓性を備えることと、工程dは、バルーンカテーテルの可撓性を備えた部分を案内装置に沿って、或いは、案内装置を通過して組織上の部位の周囲に前進させる工程から構成されることとを特徴とする請求項167に記載の方法。
- 像を見ることに適用可能であるスコープを提供する工程と、
同スコープを経鼻的に挿入する工程と、
同スコープを使用して組織、及び方法の少なくとも一部を見る工程とから更に構成されることを特徴とする請求項124に記載の方法。 - 前記スコープは、案内装置及びバルーンカテーテルとは分離していることを特徴とする請求項169に記載の方法。
- 前記スコープは、案内装置に取り付けられるか、一体的に構成されることを特徴とする請求項169に記載の方法。
- 前記案内装置は管腔を備えるスコープから構成されることと、工程dは、バルーンカテーテルをスコープの管腔を通過して前進させる工程から構成されることを特徴とする請求項171に記載の方法。
- 前記スコープは、鼻内や鼻腔内に位置し、少なくとも方法の一部を可視化することに適用可能であることを特徴とする請求項169に記載の方法。
- 前記案内装置は、案内ワイヤを備えることと、同案内ワイヤは末端部を有し、同末端部は案内ワイヤのどの部分よりも可撓性を備えることを特徴とする請求項124に記載の方法。
- 前記方法は、成人の上顎洞や前頭洞の開口部を膨張させるために実施されることと、案内ワイヤの末端部は約1mm乃至20mmの長さ、及び約0.02インチ乃至約0.04インチ(約0.0508cm乃至約0.1016cm)の径を有することを特徴とする請求項124に記載の方法。
- 前記方法は、成人のちょう形骨洞の開口部を膨張させるために実施されることと、案内ワイヤの末端部は約1mm乃至10mmの長さ、及び約0.02インチ乃至約0.02インチ(約0.0508cm乃至約0.0508cm)の径を有することを特徴とする請求項124に記載の方法。
- 前記方法は、成人の篩骨洞の開口部を膨張させるために実施されることと、案内ワイヤの末端部は約0.5mm乃至約5.0mmの長さ、及び約0.02インチ乃至約0.04インチ(約0.0508cm乃至約0.1016cm)の径を有することを特徴とする請求項124に記載の方法。
- 案内装置の少なくとも一部は柔軟であることと、前記方法は、案内装置の柔軟な部分の形状を形成する工程から更に構成されることを特徴とする請求項124に記載の方法。
- バルーンカテーテルの少なくとも一部は柔軟であることと、前記方法は、案内装置の柔軟な部分の形状を形成する工程から更に構成されることを特徴とする請求項124に記載の方法。
- 前記案内装置及びバルーンカテーテルは、案内ワイヤが取り付けられたバルーンカテーテルを備える固定した案内ワイヤバルーンカテーテルから構成されることと、同案内ワイヤの突出部はバルーンカテーテルの末端部から延びることと、工程c及びdは、案内ワイヤの突出部が副鼻腔の開口部を介して、バルーンが副鼻腔の開口部内に位置する地点に前進するように、固定した案内ワイヤバルーンカテーテルを鼻を介して前進させる工程から構成されることを特徴とする請求項124に記載の方法。
- 前記案内装置は管状案内部から構成されることと、前記バルーンカテーテルは、案内ワイヤを取り付けられた、固定された案内ワイヤバルーンカテーテルから構成されることと、これにより、案内ワイヤの突出部は、バルーンカテーテルの末端部上を延びることと、工程dは、案内ワイヤの突出部が副鼻腔の開口部を通過して、バルーンが副鼻腔の開口部内に位置する地点に前進するように、固定した案内ワイヤバルーンカテーテルを管状案内部を通過して前進させる工程から構成されることを特徴とする請求項180に記載の方法。
- 副鼻腔の開口部、或いは、人や動物の頭部内において粘膜により覆われる骨から構成されるその他の組織の通路を膨張させる方法であって、同方法は、
a)少なくとも1つの可撓性を備えた領域及び少なくとも1つの剛性を備えた領域を有する長尺状をなすシャフトから構成される膨張装置を提供する工程と、
b)開口部や組織の通路内に膨張装置を挿入する工程と、
c)膨張装置により開口部や組織の通路を膨張させる工程と、
d)膨張装置を退去させる工程とから構成されることを特徴とする副鼻腔の開口部、或いは、人や動物の頭部内において粘膜により覆われる骨から構成されるその他の組織の通路を膨張させる方法。 - 工程cは、骨を骨折させる工程から構成されることを特徴とする請求項182に記載の方法。
- 膨張装置の少なくとも1つの可撓性を備えた領域と、同可撓性を備えた領域のうち少なくとも1つの剛性を備えた領域と、同剛性を備えた領域のうち少なくとも1つは、互いに内部に入れ子構造であり、同軸上を相互に連動して移動可能である管状構造体を構成することを特徴とする請求項182に記載の方法。
- 前記少なくとも1つの可撓性を備えた領域は、膨張装置の長尺状をなすシャフトの末端部から延びる、可撓性を備えた案内ワイヤから構成されることを特徴とする請求項182に記載の方法。
- 膨張装置の基端部は剛性を備え、膨張装置の末端部は可撓性を備えることを特徴とする請求項182に記載の方法。
- 膨張装置の可撓性を備えた領域、及び膨張装置の剛性を備えた領域は、相互に固定された位置にあることを特徴とする請求項182に記載の方法。
- i)膨張装置の可撓性を備えた領域、及びii)膨張装置の剛性を備えた領域のうち少なくとも1つは他方に連動して作動されることを特徴とする請求項182に記載の方法。
- 膨張装置の一部は柔軟であることと、前記方法は、膨張装置の柔軟な部分の形状を形成する工程から更に構成されることを特徴とする請求項182に記載の方法。
- 人や動物の頭部内に位置する、粘液により覆われる骨構造体から構成される目的の部位に進入する方法であって、同方法は、
a)第1の器具を挿入する工程と、同器具は、第1の組織上の領域を骨構造体に対して係合させることができる少なくとも1つの末端の部分を有することと、
b)第1の器具の末端の部分の指向方向を評価し、第1の組織上の領域と同第1の組織上の領域内に案内される第2の器具の目的の位置との間における予想される軌跡と第1の器具の指向方向とを相関させる工程と、
c)第2の器具を第1の組織上の領域内に挿入し、目的の部位内に前進させる工程とから構成されることを特徴とする人や動物の頭部内に位置する、粘液により覆われる骨構造体から構成される目的の部位に進入する方法。 - 前記第1の工具は少なくとも1つの管腔を有することと、前記第2の器具は第1の器具の管腔内に挿入されることを特徴とする請求項190に記載の方法。
- 第1の器具は少なくとも部分的に剛性を備えることと、第2の器具は少なくとも部分的に可撓性を備えることを特徴とする請求項190に記載の方法。
- 第2の器具の挿入に先立って、第1の器具を取り外す工程から更に構成されることを特徴とする請求項190に記載の方法。
- 前記第2の器具は、案内ワイヤから構成されることを特徴とする請求項190に記載の方法。
- 前記第1の器具は、ステンレス鋼の器具から構成されることを特徴とする請求項190に記載の方法。
- 人や動物の副鼻腔に外科的処置を施す方法であって、同方法は、
a)少なくとも1つの内視鏡を挿入する工程と、
b)内視鏡の視野において操作可能である少なくとも1つの剛性を備えた器具を挿入する工程と、
c)内視鏡の視野外において操作可能である少なくとも1つの可撓性を備えた領域を有する少なくとも1つの管状装置を挿入する工程と、
d)同剛性を備えた器具を使用して内視鏡の視野内において操作する工程と、
e)前記少なくとも1つの管状装置を使用して内視鏡の視野外において操作する工程とから構成されることを特徴とする人や動物の副鼻腔に外科的処置を施す方法。 - 前記堅固な器具は、組織を切断したり取り除くことに使用されることを特徴とする請求項196に記載の方法。
- 前記管状装置は、膨張装置を備えることと、工程eは、副鼻腔の開口部を膨張させるために管状装置を使用する工程から構成されることを特徴とする請求項196に記載の方法。
- 前記管状装置は案内ワイヤを備えることを特徴とする請求項196に記載の方法。
- 前記剛性を備えた器具は、吸引器であることを特徴とする請求項196に記載の方法。
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