JP2023033405A - 医療用バルーンのための楔形切開器具 - Google Patents
医療用バルーンのための楔形切開器具 Download PDFInfo
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Abstract
Description
は、楔形切開器具として、血管中のプラークを切り裂くために使用することができる。実施形態において、医療用バルーンカテーテルが開示されており、楔形切開器具及び帯状体は、医療用バルーンカテーテル、あるいは他の膨張可能な部材に取り付けられるように構成することができる。バルーンカテーテルは、次のような部材を任意の数含むことができる。具体的に、内腔を有し、長手方向軸を画定する細条の部材、細条の部材の遠位側において、当該細条の部材と結合された膨張可能なバルーン、各帯状体が、各帯状体の表面に沿って離隔した複数の楔形切開器具を有し、各帯状体がバルーンの外表面に沿って長さ方向に延在している、複数の帯状体などである。楔形切開器具は、各帯状体の表面に直接近接した帯状の切面を有する。また、楔形切開器具の切面は、半径方向外向きの近位縁部と遠位縁部との間の長さに相当する長さを有し、各楔形切開器具の高さを決定する。半径方向外向きの切面は、近位縁部において第1幅を有し、近位縁部と遠位縁部との間において、第1幅よりも小さい幅の第2幅を有し、遠位縁部において、第2幅よりも大きな幅の第3幅を有する。実施形態において、第2幅は、半径方向外向きの切面の長さに沿った単一点に相当する。第2幅は、近位縁部及び遠位縁部間における中心部長さを有する中心部に相当する。各帯状体の長さは、各帯状体の長さ方向と同軸であるバルーンの外表面の長さよりも小さい。各帯状体の長さは、各帯状体の長さ方向と同軸のバルーンの外表面の約3%から約6%の間である。各楔形切開器具の、半径方向外向きの切面全体の長さは、各楔形切開器具の帯状のベース面の全体の長さよりも小さい。半径方向外向きの切面は、例えば、1以上の曲面及び/又は面取り面を有することができる。半径方向外向きの切面は、近位縁部において第1高さを有し、近位縁部と遠位縁部との間において第2高さを有する。第2高さは第1高さよりも大きい。ある場合において、半径方向外向き切面の最大高さを第1の無境界端と、第2の無境界端との中心点とすることができる。ある場合において、無境界表面の最大高さは、その近位縁部及び遠位縁部からずれた位置とすることができる。実施形態において、楔形切開器具の、ベース面から近位縁部までの側面部分は、第1勾配を有する第1部分と、第1勾配と異なる第2勾配を有する第2部分とを有する。帯状体は、繊維状の表面を有することができる。実施形態において、帯状体は、楔形切開器具の反対側にある下面上に複数のタブを有することができる。帯状体上には、複数のレリーフを配設することもできる。ある場合において、帯状体は、細条であって、横方向において第1端部及び第2端部を有することができる。複数の帯状体の第1端部及び第2端部は、接着剤で固定することができる。実施形態において、バルーン、帯状体、楔形切開器具の外表面には、親水性の滑層を配設することができる。実施形態において、バルーン、帯状体、楔形切開器具の外表面には少なくとも1つの高分子保持層を配設することができる。バルーンは、その横方向端部において円錐体を含むことができる。円錐体の最大外径は、バルーンの最大外径より約5%大きい。ある場合において、円錐体は、帯状体の長さ方向に配向した軌条を有する。
細条の部材は、内腔、長手方向軸を画定する細条部材を有することができる。バルーンは、細条部材の遠位縁部において、当該細条部材と接合することができる。ケージは、バルーンを配置するために用いることができる。ケージは、複数の帯状体と複数のリングとを有することができる。複数のリングは、複数の帯状体をバルーンカテーテルに固定するように構成することができる。各帯状体は、遠位縁部で第1リングを有し、近位縁部で第2リングを有することができる。帯状体の遠位縁部と近位縁部との少なくとも中間部分は、リングで被覆されないままとすることができ、リングに接続されないままとすることができる。バルーン及びケージは、初期状態及び膨張状態を有するように構成でき、複数の帯状体は、バルーンが膨張する際には、バルーンとともに移動するように構成することができる。
配設することもできるし、膨張後の位置に配設することもできるが、バルーンが膨張するにつれて、第1リング及び第2リングは互いに近接するようになり、帯状体の間隔は広がる。
出する。この位置において、薬剤が血管内に疾患組織と接触するように配置される。
中央部が最も抵抗が少ないことに起因する。これによって、疾患の形態やバルーン20が膨張したことによる動脈の形態とは無関係にバルーン20のドッグボーンを防止し、抑制することができる。
複数のスパイクあるいは楔形切開器具26を有して形成されている。実施形態においては、図4A及び図4Bの未完成のケージをもとに、管にスリットを形成して互いに近接した帯状体を形成することができる。楔形切開器具26は、延在したチップ及び基材を有するテント状あるいは斧頭状に形成することができる。これらのチップ及び基材は、管の長さ方向に沿って、長さ方向に延在している。楔形切開器具26は、血管形成施術の前あるいはその最中において、プラークを切断し、及び/又はプラークに孔を開けるようにアシストする。楔形切開器具26間の間隔は、機械加工や材料の除去によって形成することができ、帯状体の柔軟性を増大させることができる。楔形切開器具26の間隔は、楔形切開器具26の長さの2倍としているが、他の間隔に設定することもできる。代表的な間隔は、当該間隔と長さが4:1~3:1の範囲であり、より一般的には、3:1~1:1の範囲である。
ーンの周囲に組み立てることもできる。例えば、1以上の帯状体をリングと結合させる以前に、当該帯状体をバルーンの表面に配設することができる。ケージ10は、バルーン20の一端あるいは両端に永久的に固定することもできるし、バルーンカテーテルに永久的に固定することもできる。実施形態において、リング12,14は、バルーンの一部あるいはバルーンカテーテルの一部に対して帯状体を固定しておくことができる。帯状体16は、バルーン20を配置する以前において、当該バルーンを圧縮状態に保つことができ、膨張後にバルーンを収縮した状態にしておくことができる。
えば、摩擦力によって帯状体16と機械的に接合させることもできるし、超音波溶接、接着剤などによって結合させることもできる。図8において、リング12,14は、2つの部分からなり、当該リングを反対方向(例えば、時計回り及び反時計回り)に回転させることによって、ケージ10の複数の帯状体16に結合する。リング12,14は、孔部32を有し、当該孔部を通じて帯状体16を挿入し、リングと結合する。特に、非対称の孔部32は、図6Bに示したような、周期的に離隔した楔形切開器具26を有する帯状体を収容するように構成することができる。
ンされている。
致するようにして形成することができる。例えば、リングを構成する材料に切れ目29を形成して、熱収縮材料からなるリングがバルーンの形状に沿って収縮するようにすることができる。
、帯状体の端と端とを引張ることによって、あるいは放射状に圧力を負荷することによって、バルーンを収縮させる力を生成するようにデザインすることができるが、リングは、帯状体の動きを制限することによって、帯状体を支持するようにデザインすることができ、楔形切開器具の配向性を促進し、帯状体がバルーンから離隔するのを防止することができる。これらの機能的な特性に寄与するデザイン的な特徴は、楔形切開器具の配向性を安定化させることができる平坦な底面を有し、バルーンに接して存在するように十分に薄い、すなわち折りたたまれたバルーン中に含まれるような十分に薄い帯状体を有することである。楔形切開器具間にスペースを設けることは、リングを当該スペースに配設することができる。帯状体の楔形切開器具を有しない部分は最も薄くなっている。当該箇所は、リングを帯状体に結合させるために大きくすることができる。帯状体は、バルーンの端部で最も柔軟にすることができる。この部分は、カテーテルが移動する際に、最も力が大きくなる箇所である。その他の利益及び利点についても提供することができる。
囲に等間隔で配設することができる。帯状体は最初に長さ方向に延在することができ、例えば、2~6列の列状に連続的に配設することができる。各列は、2~6の帯状体を有する。帯状体は、バルーンに対して接着剤で永久的に接合することもできるし、一時的に接合することもできる。熱収縮材料は、リングとして、帯状体の端部周囲に配設することができる。熱収縮材料からなるリングは、バルーンの周囲に配設された多層の帯状体の端部に結合することもできるし、覆うようにすることもできる。熱収縮材料からなるリングは、連続的に列をなすように配設された、隣接する帯状体の端部に結合することもできるし、覆うようにすることもできる。熱が負荷されると、熱収縮材料は収縮する。バルーンは収縮させて、使用前の準備として殺菌することができる。
切開器具200は、帯状に対向する基面202(ここでは境界面と呼ぶ)を有する。楔形切開器具200の基面202は、楔形切開器具200が外方に突出しており、楔形切開器具とバルーンとの間の界面で、帯状体の表面と直接的に連続した基面として定義できる。帯状体は、スプライン300あるいはその他の帯状体構造とすることができる。実施形態において、基面202は、鋭角な端部を保持できるような固い材料からなり、その幅は相対的に狭小である。実施形態において、好ましい材料は、ロックウェルCスケール硬さが52から64のマルテンサイトステンレスであるが、ポリオレフィン、(フッ素化エチレンプロピレン(FEP)、ポリテトラフルオロエチレン(PTFE)、フッ化ポリビニリデン(PVDF)(例えばKYNAR)を含む)フッ素ポリマー、ポリ塩化ビニル(PVC)、ネオプレン、シリコーン、エラストマー、合成ゴム、フッ素ポリマーエラストマー(例えば、VITON)あるいはこれらの組み合わせなどの、高分子あるいは共重合体から製造することができる。なお、高分子あるいは共重合体は、上記材料に限定されるものではない。帯状体の幅は、0.008インチ以下、0.010インチ以下、0.012インチ以下とすることができる。ある場合において、その幅は、0.006から0.020インチの間、あるいは0.004から0.030インチの間とすることができる。帯状体300は、バルーンの長さ方向に沿って位置するが、バルーンの長手方向軸から立ち上がって90°になるように位置することもでき、さらには、異なるピッチでらせん状に位置することもできる。実施形態において、帯状体300の高さは、0.004から0.010インチの間とすることができ、0.004から0.010インチ、さらには0.002から0.020インチの間とすることができる。
の境界面202の幅は、固定あるいは一定、又は可変とすることができる。
08で所定の曲率半径を有して丸みを帯びている。ここでは、ベース面202から測った場合に高さ24H1が小さい方の端部206の曲率半径は大きく、ベース面202から測った場合に高さ24H2が大きい方の端部208の曲率半径は小さい。
わせからなる孔形状、スリット形状のレリーフを有する(図25及び図26参照)。帯状体は、支持ベースインフラを提供し、楔形切開器具を正確に配向させるために柔軟であり、かつバルーンの動きに追従する。
300の製造工程を示す図である。タブ580は、原料581をレーザカットすることによって形成でき、原料581の近接領域においてその一端が結合されている。また、他端は、例えば、帯状体300の下面のはめ込みレリーフ502にはめ込まれている。はめ込みレリーフ502は、例えば図25A-25Kで説明したような、任意の形状のパターンとすることができる。実施形態において、はめ込みレリーフ502は、楔形切開器具200の下方に示されている。図25Mにおいては、原料581に対して帯状体300を固定しておく必要がない場合、続く製造工程において、セグメント588及び589に切断されたタブ580が示されている。帯状体300は、バルーンその他の装置に取り付けるために分離することができる。はめ込みを形成することによってタブを除去することができ、バルーンやその他の膨張装置と帯状体とを接合する際に邪魔になる帯状体の下方に存在する材料の量を最小化することができる。
うな深さとする。
インドメタシンナトリウム、インドプロフェン、インドクソール、イントラゾル、イソフルプレドンアセテート、イソキセパック、イソキシカム、ケトプロフェン、塩酸ロフェミゾル、ロモキシカム、ロテプレドノールエタボン酸エステル、メクロフェナム酸ナトリウム、メクロフェナム酸、メクロリゾーンジブチラート、メファナム酸、メサラミン、メサクラゾン、メチルプレドニゾロンスルプタネート、モニフルメート、ナブメトン、ナプロキセン、ナプロキセンナトリウム、ナプロキソール、ミマゾン、オルサラジンナトリウム、オルゴテイン、オルパノキシン、オキサプロジン、オキシフェンブタゾン、塩酸パラニライン、ペントサンポリ硫酸ナトリウム、フェンブタゾングリセリン酸ナトリウム、ピルフェニドン、ピロキシカム、ピロキシカム桂皮酸、ピロキシカムオラミン、ピルプロフェン、プレドナザート、ピルフェロン、プロドリック酸、プロクアゾン、プロキサゾル、クエン酸ピロキサゾール、ロメキソロン、サルコレックス、サルナサジン、塩化サングイナリウム、セクラゾーン、セルメタシン、スドキシカム、スリンダック、スプロフェン、タルメタシン、タルニフルメート、タロサレート、テブフェロン、テニダップ、テニダップナトリウム、テノキシカム、テシカム、テシミド、テトリダミン、ティオピナック、チクソコルトールピバル酸エステル、トルメチン、トルメチンナトリウム、トリコロニド、トリフルミデート、ジドメタシン、ゾメピラックナトリウム、アスピリン(アセチルサリチル酸)、サリチル酸、副腎皮質ステロイド、グルココルチコイド、タクロリムス、ピメクロリムスなどを挙げることができるが、これらに限定されるものではない。
ザ化学蒸着、セルフアセンブリ技術、高分子/金属3D印刷、選択的レーザ焼結、粉体印刷、その他のリソグラフィ技術を挙げることができるが、その他の方法を用いてもよい。また、減算的な方法としては、エッチング、CNCミリング、レーザ切断、ウォータージェト、放電加工を挙げることができるが、その他の方法を用いてもよい。
、バルーンを楔形切開器具から保護する。実施形態において、上記コート層は、制御された浸漬工程を経て帯状体にコーティングを行ったのと同様の方法で行うことができ、これによって、ウレタンあるいはポリウレタンからなる1以上の均一な層を形成することができる。上記保持層を硬化した後は、親水性あるいはその他のコーティングを行って、バルーンの摩擦を低減し、バルーンの輸送性及び回収性を増大させることができる。外周面のスリップコーティングによって、装置の挿脱の際における力を低減することができるので、バルーンの機能性を増大させることができる。
する、あるいは身体に残存したインプラントの鋭利な端部や、血管内のひどく石灰化した疾患部の鋭利な端部に対する耐性を増大させることができる。実施形態においては、バルーン及び/又は楔形切開器具を覆う保持層上に、滑層270Dが形成されている。種々の親水性コーティングが利用でき、これによって、摩擦を低減することができるとともに、曲がりくねった狭い解剖学的な特徴部分の中におけるバルーンの案内性を向上させることができる。バルーンの表面は、親水性コーティングでその全体を覆うようにすることもできるが、バルーンが収縮してひだ状となった後にコーティングすることができる。したがって、輸送中に露出した表面のみが親水性コーティングで覆われることになる。代表的な親水性コートの厚さは、数ミクロンであり、約10オングストロームと薄くすることもできる。
ングなどのように、バルーンと接触するのを制限し、バルーンと垂直に配向するなどのように、装置の輸送中に血管の内膜に引掻き傷を付けてしまうことを制限する。そのようなスパイクの配向は、図28に示すように、バルーン表面に対する接線方向である。
Claims (20)
- 内腔を有し、長手方向軸を画定する細条の部材と、
前記細条の部材の遠位側において、当該細条の部材に接続された膨張可能なバルーンと、
複数の帯状体と、
を備え、
前記複数の帯状体の各々の帯状体は、当該各々の帯状体の表面に沿って離隔した複数の楔形切開器具を有し、前記各々の帯状体は、前記バルーンの外表面に沿って長さ方向に延在し、
前記楔形切開器具は、前記各々の帯状体の表面に直接近接した帯状のベース面と、半径方向外向きの近位縁部と遠位縁部置との間の長さに相当する長さを有し、かつ前記楔形切開器具の高さを決定する、半径方向外向きの切面と、前記ベース面と前記切面との間に位置する側面と、を有し、
前記切面は、前記近位縁部において第1幅を有し、前記近位縁部と前記遠位縁部との間において、前記第1幅よりも小さい幅の第2幅を有し、前記遠位縁部において、前記第2幅よりも大きな幅の第3幅を有することを特徴とする、医療用バルーンカテーテル。 - 前記第2幅は、前記半径方向外向きの切面の長さに沿った単一点に相当することを特徴とする、請求項1に記載の医療用バルーンカテーテル。
- 前記第2幅は、前記近位縁部及び前記遠位縁部間における中心部長さを有する中心部に相当することを特徴とする、請求項1に記載の医療用バルーンカテーテル。
- 各帯状体の長さは、前記各々の帯状体の長さ方向と同軸である前記バルーンの外表面の長さよりも小さいことを特徴とする、請求項1に記載の医療用バルーンカテーテル。
- 各帯状体の長さは、前記各々の帯状体の長さ方向と同軸の前記バルーンの外表面の約3%から約6%の間であることを特徴とする、請求項1に記載の医療用バルーンカテーテル。
- 各楔形切開器具の、前記半径方向外向き切面の全体の長さは、前記楔形切開器具の帯状の前記ベース面の全体の長さよりも小さいことを特徴とする、請求項1に記載の医療用バルーンカテーテル。
- 前記半径方向外向きの切面は、曲面を有することを特徴とする、請求項1に記載の医療用バルーンカテーテル。
- 前記半径方向外向きの切面は、少なくとも1つの面取り面を有することを特徴とする、請求項1に記載の医療用バルーンカテーテル。
- 前記半径方向外向きの切面は、前記近位縁部において第1高さを有し、前記近位縁部と前記遠位縁部との間において第2高さを有し、前記第2高さは前記第1高さよりも大きいことを特徴とする、請求項1に記載の医療用バルーンカテーテル。
- 前記半径方向外向きの切面の最大高さが、第1の無境界端と、第2の無境界端との中心点であることを特徴とする、請求項1に記載の医療用バルーンカテーテル。
- 無境界表面の最大高さは、前記近位縁部及び前記遠位縁部からずれた位置にあることを特徴とする、請求項1に記載の医療用バルーンカテーテル。
- 前記楔形切開器具の、前記ベース面から前記近位縁部までの側面部分は、第1勾配を有する第1部分と、前記第1勾配と異なる第2勾配を有する第2部分と、を有することを特徴とする、請求項1に記載の医療用バルーンカテーテル。
- 前記帯状体は、繊維状の表面を有することを特徴とする、請求項1に記載の医療用バルーンカテーテル。
- 前記帯状体の、前記楔形切開器具の反対側の下面上に、複数のタブを有することを特徴とする、請求項1に記載の医療用バルーンカテーテル。
- 前記帯状体上に複数のレリーフを有することを特徴とする、請求項1に記載の医療用バルーンカテーテル。
- 前記複数の帯状体は、細条であって、横方向において第1端部及び第2端部を有し、前記第1端部及び前記第2端部は、接着剤で固定されていることを特徴とする、請求項13に記載の医療用バルーンカテーテル。
- 前記バルーン、前記帯状体及び前記楔形切開器具の外表面に親水性の滑層を有することを特徴とする、請求項1に記載の医療用バルーンカテーテル。
- 前記バルーン、前記帯状体及び前記楔形切開器具の外表面に少なくとも1つの高分子保持層を有することを特徴とする、請求項1に記載の医療用バルーンカテーテル。
- 前記バルーンは、横方向端部において円錐体を含み、当該円錐体の最大外径は、前記バルーンの最大外径の約5%よりも大きいことを特徴とする、請求項1に記載の医療用バルーンカテーテル。
- 円錐体は、前記帯状体の長手方向軸方向に配向した軌条を有することを特徴とする、請求項1に記載の医療用バルーンカテーテル。
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