JP6159888B2 - 腎神経変調バルーンへの接着性を向上させたフレキシブル回路 - Google Patents
腎神経変調バルーンへの接着性を向上させたフレキシブル回路 Download PDFInfo
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Description
高血圧とは、血圧が上昇しているという慢性的な医学的状態をいう。持続的な高血圧は、心臓発作、心不全、動脈瘤、及び脳卒中等の様々な医学的状態に関連した重要なリスク要因である。持続的な高血圧は、慢性腎不全の主原因でもある。腎交感神経の機能亢進は、高血圧やその進行に関連する。腎動脈神経除去を介した腎神経の不活性化は、血圧を低下させることができ、従来の薬では効果のなかった高血圧患者に対する治療の選択肢となり得る。
腎交感神経の治療のための具体的な方法として、腎交感神経を破壊するための高周波エネルギーを用いた経皮的なカテーテルベースの治療がある。この方法では拡張可能な医療用バルーンが用いられるが、このバルーンは治療部位まで前進されて拡張され、バルーンの外側に配置されたフレキシブル回路を介し、バルーンを通してエネルギーが送達される。
バルーンの挿入、折り畳み、及び除去の間にフレキシブル回路の剥離が生じることは、問題となり得る。そこで、腎動脈神経除去のための高いロバスト性を有する改良されたバルーンのための技術が、依然として必要とされている。
本願に係る装置及び方法は、恒久的に神経機能を変調させるため、腎神経に高周波エネルギーを送達することを含む。
図1は、その遠位端に配置された腎神経変調バルーン20を有するカテーテル又はカテーテルアセンブリ10の側面図である。カテーテル10は、膨張流体のためのポート32を有するマニホールド31、フレキシブル回路22上の電極から電極プラグ36、さらに発電機(図示なし)へ延在するワイヤが通るポート33、及びガイドワイヤ管腔34を含む。
図2はカテーテル10の外側シャフト24、外側シャフト24内に配置された電極26、膨張管腔28、及びガイドワイヤ管腔30を示し、図1の2−2線に沿った断面図である。電極26は外側シャフト24内に配置されて示されているが、別の実施形態において、電極26は外側シャフト24の外面に沿って配置されてもよい。
本実施形態において、各フレキシブル回路はポリマー基材50から形成される。ポリマー基材50は、デュポン社(デラウェア州ウィルミントン)から入手可能なKAPTON(登録商標)等のポリイミド材料を含んでもよい。
本実施形態において、複数の電極は、バルーンの周りにオフセットして長手方向に離間し、円周360°の被覆率で空間的に配置され、その結果として健康的な腎組織を損傷させ、血管の外傷や狭窄を生じさせ得る単一の環状リングの切除を回避するような動脈被覆率となる。従って、個々のフレキシブル回路22によって実現される個々の治療位置は、健康な血管に与える負の影響を最小限にするとともに、神経除去のため、血管の円周を完全に覆うように空間的に配置される。
柔軟性バルーンは、比較的柔軟な、可撓性を有するポリマー材料から生成される。これらの材料の例には、熱可塑性ポリマー、熱可塑性エラストマー、(高密度、低密度、中間密度、線状低密度の)ポリエチレン、ポリエチレンの様々な共重合体及び混合物、アイオノマー、ポリエステル、ポリウレタン、ポリカーボネート、ポリアミド、ポリ塩化ビニルやアクリロニトリル−ブタジエン−スチレン共重合体が挙げられる。適切な共重合体材料やポリオレフィン材料は、SURLYN(登録商標)という商品名のアイオノマーとして、イー・アイ・デュポン・ドゥ・ヌムール社(デラウェア州ウィルミントン)から入手可能である。
非柔軟性バルーンは、比較的硬い、剛性を有するポリマー材料から生成される。これらの材料は、熱可塑性ポリマー及び熱硬化性ポリマー材料である。このような材料のいくつかの例には、ポリ(エチレンテレフタレート)、ポリイミド、熱可塑性ポリイミド、ポリアミド、ポリエステル、ポリカーボネート、ポリフェニレンスルフィド、ポリプロピレン、及び硬質ポリウレタンが挙げられる。ポリ(エチレンテレフタレート)から生成された非柔軟性バルーンは一般に、PETバルーンと呼ばれる。
フレキシブル回路22は、バルーン20の外面上に配置される。フレキシブル回路22は、接着剤を介してバルーン20の表面上に配置されることが望ましい。
図7は、遠位パッド60及び近位パッド62の各々が、その上に選択的に配置される接着剤70を含む一実施形態を示す。パッド60、62の互いに対する相対位置を維持することで、二つの電極間の間隔が固定され、最適なアブレーション間隔が維持されることがわかっている。
図9は、遠位パッド60及び近位パッド62の各々に、カテーテルアセンブリの長手方向軸線に対して斜めに延びるストライプ状に接着剤70が適用された代替実施形態を示す。
図10では、接着剤70のドットが、遠位パッド60及び近位パッド62の各々、並びに、遠位スプライン64及び近位スプライン66の両方の上に均一なパターンで適用される。
いくつかの実施形態において、接着剤は熱硬化性接着剤である。
一実施形態において、接着剤はウレタンアクリル系接着剤である。
市販の医療用ウレタンアクリル系接着剤の一例として、Dymax(商標)社(コネチカット州トリントン)から入手可能なDymax(商標)204CTHが挙げられる。
Claims (13)
- 腎神経変調のためのバルーンであって、前記バルーンは、
ポリマー材料で形成されたバルーン壁を含み、
前記バルーン壁は内面、外面、及び一つ以上のフレキシブル回路を有しており、前記フレキシブル回路はポリマー材料で形成されたベースを含み、前記フレキシブル回路は前記バルーン壁の外面に接着剤で選択的に接着され、前記フレキシブル回路の一部は前記バルーンの外面に対して自由に移動し、前記フレキシブル回路、前記バルーン、又はその両方は、フレキシブル回路エッジ上の揚力に垂直なレーザー励起微細パターンを含むバルーン。 - 請求項1に記載のバルーンにおいて、前記フレキシブル回路の各々の前記ベースは少なくとも二つのパッドと、少なくとも二つの前記パッドを接続する遠位スプラインとを含み、
前記接着剤が少なくとも二つの前記パッドの少なくとも一部の上に、あるいは、少なくとも二つの前記パッドの少なくとも一部と前記遠位スプラインの一部との上に選択的に堆積されるように、前記接着剤が前記バルーンの外面、前記フレキシブル回路、又はその両方に選択的に適用され、
少なくとも二つの前記パッドの一部、あるいは、少なくとも二つの前記パッドの一部と前記遠位スプラインの一部とは、前記バルーンの外面に接着され、前記フレキシブル回路の残りの部分は、前記バルーンの外面に対して自由に移動するバルーン。 - 請求項2に記載のバルーンにおいて、前記フレキシブル回路は近位スプラインを含み、前記接着剤は前記近位スプラインの一部に適用されるバルーン。
- 請求項2に記載のバルーンにおいて、前記接着剤は、少なくとも二つの前記パッドの少なくとも一部にのみ適用されるバルーン。
- 請求項4に記載のバルーンにおいて、前記接着剤は、少なくとも二つの前記パッドの全面に適用されるバルーン。
- 請求項2に記載のバルーンにおいて、前記接着剤は、前記バルーンの長手方向軸線に垂直に延びるストライプ状に、あるいは、前記バルーンの長手方向軸線に斜めに延びるストライプ状に適用されるバルーン。
- 請求項2に記載のバルーンにおいて、前記接着剤は、ドットの均一なパターンで適用されるバルーン。
- 請求項1〜7の何れか一項に記載のバルーンにおいて、前記バルーン壁を形成するポリマー材料は、非柔軟性ポリマー材料であるバルーン。
- 請求項1〜8の何れか一項に記載のバルーンにおいて、前記フレキシブル回路は、前記バルーン壁を形成するポリマー材料よりも剛性の高い複合材料であるバルーン。
- 請求項1〜9の何れか一項に記載のバルーンにおいて、前記フレキシブル回路の内面は第一レーザー励起微細パターンを含み、前記バルーンの外面は第二レーザー励起微細パターンを含み、前記第一レーザー励起微細パターン及び前記第二レーザー励起微細パターンは、微細ラッチ機構を形成するように適合するバルーン。
- 腎神経変調のためのバルーンであって、前記バルーンは、
ポリマー材料で形成されたバルーン壁を含み、前記バルーン壁は内面、外面、及び複数のフレキシブル回路を有しており、前記フレキシブル回路はポリマー材料で形成されたベースを含み、前記フレキシブル回路は前記バルーン壁の外面に接着剤で接着され、
前記フレキシブル回路、前記バルーン、又はその両方は、フレキシブル回路エッジ上の揚力に垂直なレーザー励起微細パターンを含むバルーン。 - 請求項11に記載のバルーンにおいて、前記フレキシブル回路の各々の前記ベースは少なくとも二つのパッドと、少なくとも二つの前記パッドを接続する遠位スプラインとを含み、前記接着剤が少なくとも二つの前記パッドの少なくとも一部の上に、あるいは、少なくとも二つの前記パッドの少なくとも一部と前記遠位スプラインの一部との上に選択的に堆積されるように、前記接着剤が前記バルーンの外面、前記フレキシブル回路、又はその両方に選択的に適用され、
少なくとも二つの前記パッドの一部、あるいは、少なくとも二つの前記パッドの一部と前記遠位スプラインの一部とは、前記バルーンの外面に接着され、前記フレキシブル回路の残りの部分は、前記バルーンの外面に対して自由に移動するバルーン。 - 請求項11又は12に記載のバルーンにおいて、前記フレキシブル回路の内面は第一レーザー励起微細パターンを含み、前記バルーンの外面は第二レーザー励起微細パターンを含み、前記第一レーザー励起微細パターン及び前記第二レーザー励起微細パターンは、微細ラッチ機構を形成するように適合するバルーン。
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PCT/US2014/052154 WO2015027096A1 (en) | 2013-08-22 | 2014-08-21 | Flexible circuit having improved adhesion to a renal nerve modulation balloon |
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US8347891B2 (en) | 2002-04-08 | 2013-01-08 | Medtronic Ardian Luxembourg S.A.R.L. | Methods and apparatus for performing a non-continuous circumferential treatment of a body lumen |
US7756583B2 (en) | 2002-04-08 | 2010-07-13 | Ardian, Inc. | Methods and apparatus for intravascularly-induced neuromodulation |
US20120259269A1 (en) | 2011-04-08 | 2012-10-11 | Tyco Healthcare Group Lp | Iontophoresis drug delivery system and method for denervation of the renal sympathetic nerve and iontophoretic drug delivery |
WO2012148969A2 (en) | 2011-04-25 | 2012-11-01 | Brian Kelly | Apparatus and methods related to constrained deployment of cryogenic balloons for limited cryogenic ablation of vessel walls |
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US10722300B2 (en) | 2020-07-28 |
US11350990B2 (en) | 2022-06-07 |
JP2016532506A (ja) | 2016-10-20 |
CN105473093A (zh) | 2016-04-06 |
CN105473093B (zh) | 2019-02-05 |
US20150057656A1 (en) | 2015-02-26 |
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