JP2019195674A - 動脈壁を支配する機能的神経を位置決し、識別するためのシステムおよび方法ならびにそのカテーテル - Google Patents
動脈壁を支配する機能的神経を位置決し、識別するためのシステムおよび方法ならびにそのカテーテル Download PDFInfo
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Abstract
Description
高血圧の発生と持続性に寄与する腎交感神経活動亢進が系統的に研究されている。その理由は主に次の事実に起因している、現在、患者の生活スタイルを改善するための薬品、併用薬品と資源がたくさんあるにもかかわらず、高血圧の治癒率が驚くほど低いままである。特に、高血圧患者の約三分の一は最適化された薬物療法に対して完全に応答しない。そのような患者の中の測定した血圧の範囲が異常のままである。この症状は薬剤抵抗性高血圧と呼ばれている。高血圧患者の約半数において、血圧は一般的に認められた治療目標レベルよりも高いままである。これらの患者のうち、「必須」高血圧(即ち、特定の原因が発見されていない持続的かつ病理学的な高血圧)患者は、現在の治療レジメンに応答しない潜在的な病理生理学的メカニズムを備える可能性が存在している。また、このような患者において、遠心性腎臓の交感神経流出はレニン放出を刺激し、管状ナトリウム再吸収を増加させ、腎血流量を減少させることができ、腎臓からの求心性神経信号は中央交感神経流出を調節することができる、それによって、ナトリウムおよび水の代謝、血管に寄与しながら、血管トーン(tone)/抵抗および血圧を調節することが注目されている。
腎交感神経活動亢進はインスリン感受性およびグルコース代謝に重要な影響を与えると断定され、特に、ノルアドレナリン放出の増加に伴い、腎神経活動亢進の結果による血流の低下はグルコースの取込みを減少した。これは膜を横切ってグルコースを輸送する細胞の能力障害を示している。腎神経活動亢進はオープン毛細血管数の神経調節性の低下に関連し、インスリンが血管内コンパートメントから細胞膜に到達するために移動しなければならない距離の増加があるようになっている。筋肉灌流でのインスリン媒介性の増加はインスリン抵抗性の状態で約30%低減される。結果的に、筋肉交感神経活動とインスリン抵抗性との間に直接的な関係があり、インスリン抵抗性とオープン毛細血管数との間に逆の関係を持っている(Mahfound,et al.,2011)。腎交感神経活動亢進はこのように糖尿病および/またはメタボリックシンドロームの特定の態様に関連している;交感神経活動亢進はインスリン抵抗性および高インスリン血症を誘発し、次いで、追加の交感神経活性を生成する。研究は糖尿病の基準に基づき、腎除神経の影響についての評価を行ってきた。
Krumらの研究は、カテーテル手段を介入して腎神経切除を行うための特定の方法論を受け入れ、確立された後、方法論に幾つかのバリエーションを含むことが特徴となっている。一般的には、腎神経アブレーションはカテーテルに基づいた方法を包含し、当該方法においては、無線周波数(RF)が自動化され、低消費電力であり、安全性アルゴリズムが内蔵されたRF発生器によって生成され、無線周波数(RF)は、腎動脈当たりの治療に4〜6分間施される。5mm以上の離間単位で無線周波数を印加しながら、大動脈の遠位端から大動脈の近位端へのカテーテルの移動をさせることにより、カテーテルによって通常5〜8Wの無線周波数を腎動脈に施す。
解剖学的に、腎臓の中で繊維を運ぶ神経が腹腔神経叢(a/k/a 太陽神経叢)とその下位区分神経、腰椎内臓神経、および腸間膜動脈間神経叢に由来している(DiBona and Kopp, 1997, p. 79)。腹腔神経叢は副腎神経節(即ち、大動脈腎動脈神経節)、腹腔神経節、および主要な内臓神経で構成されている。腹腔神経節は胸部交感神経幹(胸内臓神経)および迷走神経からの寄与を受ける(DiBona and Kopp, 1997, p. 79)。
冠動脈システム用に設計されたある種のカテーテルシステムは、腎神経アブレーションにおいて使用することができるものと同様であり、特に、頻脈を改善するように調整されている冠状動脈の使用のために設計されたアブレーションカテーテルシステムは、腎神経アブレーション処置のために使用することができる。このように、これらのシステムは、典型的なカテーテル電極を通して、心臓組織における既存の電流を評価するために設計された電極を含む。対照的に、腎除神経のための理想的なカテーテルシステムは、最適には二重の機能を用いて操作される:電気刺激および腎除神経の結果として生じるリアルタイムの患者の生理学的変化における評価を内科医が行うことができるように、電気刺激を与えることによって、腎神経分布をマッピングし、腎交感神経活動を刺激する。しかし、そのようなカテーテルは、以前に開発されていない。
Symplicity(登録商標)カテーテルシステム、即ち、アブレーションカテーテルおよび無線周波数発生器の両方を含む腎切除のために利用される現在のカテーテルシステムは、Ardian社(マウンテンビュー、CA、USA)によって設計されている。しかしながら、Symplicity(登録商標)カテーテルはマッピング機能を有していない。アブレーションがその唯一の機能である。また、このようなカテーテルシステム(だけでなく、血管形成のための血管形成術および遠位保護デバイス)は、冠動脈および頸動脈システム用に設計された‐それゆえ、これらのシステムは、高血圧、心不全、腎不全および糖尿病を治療するための腎神経アブレーションと除神経に使用されることは「適応外」となっている。
1995)。
動脈壁神経支配の位置決め
動脈壁を支配する神経の位置決めする方法は、適切な用量のエネルギーの送達後に生理的パラメータの変化の検討をして、急性のブタの実験で設計され、実行された。この実験の目的は以下の通りである。
1.腎神経マッピングとアブレーションの目的のために、既存の心臓アブレーションカテーテル(7F、Bタイプ、2‐5‐2mm間隔、CELSIUS(登録商標) RMT診断/アブレーション操作可能なカテーテル、バイオセンスウェブスター、ダイアモンドバー、カリフォルニア州91765、米国)と高周波発生器(STOCKERT70、RF発生器、モデルStockert GmbHは、EP‐SHUTTLE ST‐3205、STOCKERT社、フライブルク、ドイツ)をテストする。
2.左右の腎動脈のルーメン内の異なる部位での電気刺激印加時の血圧および心拍数の変化の検査を介して、腎神経マッピングをテストする。
3.腎動脈壁および組織の視覚的変化の検討を通じて、腎神経切除のために腎動脈に放出される高周波エネルギーの安全な範囲を決定する。
4.腎切除中の腎神経の効率的な切除の指標として、血圧および心拍数の変化を使用する。
生理的パラメータと動脈壁を支配する神経との関係
動脈壁上の別の場所に送達されるエネルギーは、血圧および心拍数のような生理学的パラメータ、およびそのような特性に異なる効果をもたらし得ることを実証するために、神経支配する動脈壁の種類を識別するために活用することができ、電気エネルギーはいくつかの方法に従ってブタモデルの腎動脈壁上の神経支配領域に送達された。ブタ#1、ブタ#2、ブタ#3に送達される電気エネルギーについての詳細なパラメータは、それぞれ表1、表2および表3に示す。
[実施例3]
確実にエネルギーが切除中の標的神経に向けられる
[実施例4]
慢性腎神経アブレーションの実験結果
[実施例5]
腎マッピングカテーテルデザイン
[参考文献]
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Claims (19)
- 機能的な神経の位置を特定または識別するための方法において使用されるように適合されたカテーテルに被験体における血管壁を支配するシャフトを含み、前記シャフトの近位端はエネルギー源に接続するように構成され、遠位端(カテーテルチップ)は単一螺旋、二重螺旋または1つ以上の電極を有する複数のプロングの形態であることを特徴とするカテーテル。
- 1つまたは複数の電極が、前記血管に神経を刺激するか、または切除するのに十分なエネルギーを放出するように構成されていることを特徴とする請求項1に記載されるカテーテル。
- 電極は、互いに独立して作動させることができることを特徴とする請求項1、2のいずれかに記載されるカテーテル。
- 前記カテーテル全体は、長さが1〜2mの間であり、カテーテル先端部は、長さが2〜8cmの間で、直径が0.5mm〜10mmの間であることを特徴とする請求項1〜3のいずれかに記載するカテーテル。
- 前記螺旋またはプロングコイルが円形または平坦状であり、電極が前記コイルまたはプロングの長手方向に沿って配置され、その電極がコイルまたはプロングに埋め込まれている、または当該コイルやプロングの表面上にあることを特徴とする請求項1〜4のいずれかに記載するカテーテル。
- 電極は均等に互いに90度または120度で前記コイルの長手方向に沿って離間されることを特徴とする請求項1〜5のいずれかに記載するカテーテル。
- カテーテル先端が前記螺旋又はプロングのコイル内の空間を埋めるために、バルーン膨張可能に保持するように構成されていることを特徴とする請求項1〜6のいずれかに記載するカテーテル。
- プロングは、遠位端で再結合されることを特徴とする請求項1〜7のいずれかに記載するカテーテル。
- 対象における血管壁を支配する場所または機能的神経を識別するための下記工程を含むことを特徴とする請求項1〜8のいずれかに記載するカテーテルであって、
a)前記血管内に前記カテーテルを挿入し、前記血管の1つ以上の場所に十分なエネルギーを送達するためにカテーテル上の電極を活性化し、交感神経または副交感神経によって、前記血管の神経支配に関連する1つ以上の生理学的パラメータを変更する。及び、
b)各エネルギー送達後の1つ以上の生理学的パラメータを測定し、対応するパラメータの変化は前記血管に前記エネルギーを送達せずに得られたことを決定する。
工程bにおいて、前記生理学的パラメータにおける変化の欠如は、エネルギー送達の場所における機能の神経が存在しないことを示す、工程bにおいて、前記生理学的パラメータの有意な変化は、エネルギー送達の場所における機能の神経の存在を示す、前記工程bにおいて、前記生理学的パラメータの変化の方向は、エネルギー送達の場所における神経が交感神経または副交感神経であると判断することを特徴とする、カテーテル。 - 血管は腎動脈を含む動脈であることを特徴とする請求項9に記載するカテーテルの使用。
- 圧反射が機能的神経に関連していることを特徴とする請求項9〜10のいずれかに記載するカテーテルの使用。
- 前記位置は、神経が切除された領域であり、前記工程bにおいて、前記生理学的パラメータにおける変化の欠如は神経切除を確認された領域も含むことを特徴とする請求項9〜11のいずれかに記載するカテーテルの使用。
- 前記被験体が人間または人間以外の動物であることを特徴とする請求項9〜12のいずれかに記載するカテーテルの使用。
- 前記生理学的パラメータは、血圧、心拍数、心臓の電気的活動、筋肉活動、骨格神経活動、細胞の活動電位、瞳孔反応、筋電図、血管収縮、及びエピネフリン、ノルエピネフリン、レニン〜アンジオテンシンIIとバソプレシンから選択される生化学物質のレベルから選択されることを特徴とする請求項9〜13のいずれかに記載するカテーテルの使用。
- 前記エネルギーが調整可能であり、電気的、機械的、超音波、放射線、光及び熱エネルギーの1つ以上から成ることを特徴とする請求項9〜14のいずれかに記載するカテーテルの使用。
- 前記エネルギーは、神経刺激または神経切除を引き起こすことができることを特徴とする請求項9〜15のいずれかに記載するカテーテルの使用。
- 前記神経は交感神経や副交感神経であることを特徴とする請求項9〜16のいずれかに記載するカテーテルの使用。
- カテーテル先端は、次の順序で血管内に移動されることを特徴とする請求項9〜17のいずれかに記載するカテーテルの使用であって、
a.動脈の前壁から後壁へ90度以下回し、
b.動脈の後壁から上壁へ90度以下回し、
c.動脈の上壁から下壁へ90度以下回す、カテーテルの使用。 - 送達されるエネルギーが以下の範囲内にあることを特徴とする請求項9〜18のいずれかに記載する方法であって、
a.電圧が2〜30Vの間にあり、
b.抵抗が100〜1000オームの間にあり、
c.電流が5〜40mAの間にあり、
d.印加時間が0.1〜20ミリ秒の間にある、方法。
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