JP2017504401A - 耐引き裂き性フレックス回路アセンブリ - Google Patents
耐引き裂き性フレックス回路アセンブリ Download PDFInfo
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Abstract
Description
したがって、1つの例示的な実施形態は、交感神経アブレーション用の医療デバイスである。医療デバイスは、長手方向軸を有するカテーテルシャフト、および、カテーテルシャフトに配置される拡張可能なバルーンを有する。バルーンは、未拡張形態と拡張形態との間でシフト可能である。医療デバイスは、複数の層を有するフレキシブル回路として構成される長尺状の電極アセンブリをさらに有する。電極アセンブリは、バルーンの外面に取り付けられる。フレキシブル回路は、ASTM規格D−1004−09に従って7.5N(1.7lbf)超の初期引き裂き強度を有する第1の層を有する。いくつかの場合、第1の層は、ASTM規格D−1922−09に従って0.15N(0.03lbf)超の引き裂き伝播強度を有する。
本明細書において、全ての数値は、明示的に示されているか否かにかかわらず、「約」という用語によって修飾されるとみなされる。「約」という用語は、数値との関連では、概して、記載されている値と同等である(すなわち、同じ機能または結果を有する)と当業者が考えるある範囲の数字を指す。多くの場合、「約」という用語は、最も近い有効数字に四捨五入される数字を含むことができる。「約」という用語の他の使用は(すなわち、数値以外との関連では)、別途明記されない限り、明細書の文脈から、明細書の文脈と一致して理解されるような、それらの通常の常用される定義を有するものとみなされ得る。
「1つの」および「前記」という単数形は、本明細書および添付の特許請求の範囲において用いられる場合、文脈によって別途はっきりと指示されない限り、複数の指示対象を含む。「または」という用語は、本明細書および添付の特許請求の範囲において用いられる場合、概して、文脈によって別途はっきりと指示されない限り、「および/または」を含む意味で用いられる。
そのような実施形態では、温度センサ226は、ベース層202と絶縁層206との間に埋め込むことができ、温度センサ226が、フレキシブル回路および電極アセンブリ200、あるいはフレキシブル回路または電極アセンブリ200内で流体密にされるようにする。換言すると、いくつかの実施形態では、温度センサ226は、電極アセンブリ200の外面には位置決めされないものとすることができ、一方で、図4〜図6に示されている温度センサ226(サーミスタ)は、電極アセンブリ200の外面に位置決めされるかまたは電極アセンブリ200の外面から外方に延びる。いくつかの実施形態では、温度センサ226において電極アセンブリ200の底面に突起は形成されないものとすることができる。例えば、平らになった形態では、拡張可能な部材130の外面に面する電極アセンブリ200の底面は、中断されない表面を形成することができる。いくつかの実施形態では、平らになった形態では、電極アセンブリの底面は、電極アセンブリ200上/内の適所の温度センサ226と本質的に連続的に平面的な表面を有することができる(それに加えて、または、中断されない表面は、電極アセンブリ200上/内の適所の温度センサ226と本質的に連続的に平面的な表面を形成することができる)。換言すると、温度センサ226は、ベース層202を通って突出しないかまたはベース層202から外方に延びないものとすることができる。
好適な金属および金属合金のいくつかの例としては、304V、304Lおよび316LVステンレス鋼等のステンレス鋼;軟鋼;線形弾性および超弾性ニチノール、あるいは線形弾性または超弾性ニチノール等のニッケル−チタン合金;ニッケル−クロム−モリブデン合金(例えば、INCONEL(登録商標)625等のUNS:N06625、HASTELLOY C−22(登録商標)等のUNS:N06022、HASTELLOY(登録商標)C276等のUNS:N10276、他のHASTELLOY(登録商標)合金等)、ニッケル−銅合金(例えば、MONEL(登録商標)400、NICKELVAC(登録商標)400、NICORROS(登録商標)400等のUNS:N04400)、ニッケル−コバルト−クロム−モリブデン合金(例えば、MP35−N(登録商標)等のUNS:R30035等)、ニッケル−モリブデン合金(例えば、HASTELLOY(登録商標)ALLOY B2等のUNS:N10665)、他のニッケル−クロム合金、他のニッケル−モリブデン合金、他のニッケル−コバルト合金、他のニッケル−鉄合金、他のニッケル−銅合金、他のニッケル−タングステンまたはタングステン合金等の他のニッケル合金;コバルト−クロム合金;コバルト−クロム−モリブデン合金(例えば、ELGILOY(登録商標)、PHYNOX(登録商標)等のUNS:R30003等);白金富化ステンレス鋼;チタン;それらの組み合わせ等;または、任意の他の好適な材料が挙げられる。
いくつかの実施形態では、アブレーションデバイス120に、ある程度の磁気共鳴画像法(MRI)適合性を与えることができる。例えば、デバイスの部分は、画像を実質的に歪めず実質的なアーチファクト(すなわち、画像における空隙)をもたらすことがない材料から作製することができる。例えば、特定の強磁性材料は、MRI画像においてアーチファクトをもたらす可能性があるため、好適ではない場合がある。これらおよび他の実施形態のいくつかでは、アブレーションデバイス120の部分は、MRIマシンが撮像することができる材料から作製することもできる。これらの特性を示すいくつかの材料としては、例えば、タングステン、コバルト−クロム−モリブデン合金(例えば、ELGILOY(登録商標)、PHYNOX(登録商標)等のUNS:R30003)、ニッケル−コバルト−クロム−モリブデン合金(例えば、MP35−N(登録商標)等のUNS:R30035等)、ニチノール等および他のものが挙げられる。
Claims (15)
- 交感神経アブレーション用の医療デバイスであって、
長手方向軸を有するカテーテルシャフトと、
前記カテーテルシャフトに配置される拡張可能なバルーンであって、未拡張形態と拡張形態との間でシフト可能である、拡張可能なバルーンと、
複数の層を有するフレキシブル回路として構成される長尺状の電極アセンブリであって、前記バルーンの外面に取り付けられる、長尺状の電極アセンブリと、
を備え、
前記フレキシブル回路の前記複数の層のうちの第1の層は、ASTM規格D−1004−09に従って7.5N超の初期引き裂き強度を有する、医療デバイス。 - 前記フレキシブル回路の前記複数の層のうちの前記第1の層は、ASTM規格D−1922−09に従って0.15N超の引き裂き伝播強度を有する、請求項1に記載の医療デバイス。
- 前記フレキシブル回路の前記複数の層のうちの前記第1の層は、ASTM規格D−1922−09に従って0.2N超の引き裂き伝播強度を有する、請求項1に記載の医療デバイス。
- 前記フレキシブル回路の前記複数の層のうちの前記第1の層は、ASTM規格D−1004−09に従って8.0N超の初期引き裂き強度を有する、請求項1〜3のいずれか一項に記載の医療デバイス。
- 前記第1の層は、強化ポリマー材料からなる第1の絶縁層であり、前記フレキシブル回路は、前記第1の絶縁層と、ポリマー材料からなる第2の絶縁層との間に介装される複数の導電トレースを有する、請求項1〜4のいずれか一項に記載の医療デバイス。
- 前記強化ポリマー材料は、前記カテーテルシャフトの前記長手方向軸に対してほぼ垂直な向きである複数の繊維を有する、請求項5に記載の医療デバイス。
- 前記強化ポリマー材料は、前記カテーテルシャフトの前記長手方向軸に対してほぼ垂直な向きであるポリマー鎖を有する、請求項5に記載の医療デバイス。
- 前記第2の絶縁層の前記ポリマー材料は、前記カテーテルシャフトの前記長手方向軸に対してほぼ平行な向きであるポリマー鎖を有する、請求項7に記載の医療デバイス。
- 前記強化ポリマー材料は複数の繊維を有し、該複数の繊維はテーパ状の外径を有する、請求項5に記載の医療デバイス。
- 前記第1の層は微細生地層である、請求項1に記載の医療デバイス。
- 前記微細生地層は第1の開口および第2の開口を有し、
前記電極アセンブリは、前記フレキシブル回路の第1の導電トレースに電気的に接触して前記第1の開口を通って延びる第1の電極、および、前記フレキシブル回路の第2の導電トレースに電気的に接触して前記第2の開口を通って延びる第2の電極を有する、請求項10に記載の医療デバイス。 - 前記微細生地層は、前記フレキシブル回路の第1の絶縁ポリマー層と第2の絶縁ポリマー層との間に位置決めされる、請求項10または11に記載の医療デバイス。
- 組織アブレーション用の医療デバイスを形成する方法であって、
強化ポリマー材料からなる第1の絶縁層と、ポリマー材料からなる第2の絶縁層との間に介装される複数の導電トレースを有するフレキシブル回路として構成される電極アセンブリを準備する工程と、
前記フレキシブル回路を、バルーンカテーテルの膨張可能なバルーンの外面に取り付ける工程と、
を備える、方法。 - 前記フレキシブル回路を、前記強化ポリマー材料の繊維が前記膨張可能なバルーンの中心の長手方向軸に対してほぼ垂直な向きである状態で前記膨張可能なバルーンの前記外面に取り付ける、請求項13に記載の方法。
- 前記フレキシブル回路を、前記強化ポリマー材料のポリマー鎖が前記膨張可能なバルーンの中心の長手方向軸に対してほぼ垂直な向きである状態で前記膨張可能なバルーンの前記外面に取り付ける、請求項13に記載の方法。
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EP3091922B1 (en) | 2018-10-17 |
US11202671B2 (en) | 2021-12-21 |
JP6382989B2 (ja) | 2018-08-29 |
CN105899157B (zh) | 2019-08-09 |
EP3091922A1 (en) | 2016-11-16 |
WO2015103617A1 (en) | 2015-07-09 |
US20150190195A1 (en) | 2015-07-09 |
CN105899157A (zh) | 2016-08-24 |
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