JP2014100580A - 体腔に不連続周縁治療を施す装置 - Google Patents

体腔に不連続周縁治療を施す装置 Download PDF

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JP2014100580A
JP2014100580A JP2013244847A JP2013244847A JP2014100580A JP 2014100580 A JP2014100580 A JP 2014100580A JP 2013244847 A JP2013244847 A JP 2013244847A JP 2013244847 A JP2013244847 A JP 2013244847A JP 2014100580 A JP2014100580 A JP 2014100580A
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treatment
electrode
expandable element
vessel
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Denise Demarais
デニス ディマレイズ
Hanson Gifford Iii
ハンソン ザ サード ギフォード
Zadno Nicolas
ニコラス ザドノ
Mark Deem
マーク ディーム
j clark Benjamin
ベンジャミン ジェイ クラーク
Andrew Wu
アンドリュー ウー
Kenneth J Michlitsch
ケニス ジェイ ミクリッチ
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Medtronic Ardian Luxembourg SARL
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Abstract

【課題】体腔の不連続周縁治療を施す装置を提示する。
【解決手段】装置は患者の体腔内に設置されてから、長手方向および所与の角度の第１位置でエネルギーを伝搬することで、該第１位置に全周に満たない周縁治療域を設けることができる。装置はまた、体腔内の１箇所以上の更に別な長手方向および所与の角度の位置でエネルギーを伝搬することで、第１治療域から長手方向にオフセットされるとともに角度的にもオフセットされたこれら１箇所以上の更に別な位置に、全周に満たない周縁治療域（１箇所または複数個所）を設けるようにしてもよい。第１治療域および１箇所以上の更に別な治療域を互いに重畳することで不連続周縁治療域を規定しながら、尚且つ、連続する周縁損傷帯を形成することが無い。このような不連続周縁治療を達成するための装置の多様な実施例が提示されている。
【選択図】図４

Description

＜関連出願の参照＞
本願は以下に示す（１）〜（３）の同時係属中の各米国特許出願の優先権を主張するものである。
（１）２００６年１１月１４日出願の米国特許出願第１１／５９９，８９０号；
（２）２００５年５月１３日出願の米国特許出願第１１／１２９，７６５号：
後者の（２）の出願は、（ａ）２００４年１０月５日出願の米国特許仮出願第６０／６１６，２５４号および２００４年１１月２日出願の米国特許仮出願第６０／６２４，７９３号の優先権を主張するものであり、また、（ｂ）２００３年４月８日出願の米国特許出願第１０／４０８，６６５号の部分継続出願であり、´６６５号出願は２００２年４月８日出願の米国特許仮出願第６０／３７０，１９０号、２００２年１０月３日出願の米国特許仮出願第６０／４１５，５７５号、および、２００３年１月２９日出願の米国特許仮出願第６０／４４２，９７０号の優先権を主張するものである。
（３）２００５年７月２５日出願の米国特許出願第１１／１８９，５６３号：
この（３）の出願は、（ａ）２００５年５月１３日出願の米国特許出願第１１／１２９，７６５号の部分継続出願であり、´７６５号出願は２００４年１０月５日出願の米国特許仮出願第６０／６１６，２５４号および２００４年１１月２日出願の米国特許仮出願第６０／６２４，７９３号の優先権を主張するものであり、また、（ｂ）２００４年７月２８日出願の米国特許出願第１０／９００，１９９号（現在の米国特許第６，９７８，１７４号）の部分継続出願であり、´１９９号出願は２００３年４月８日出願の米国特許出願第１０／４０８，６６５号の部分継続出願であり、´６６５号出願は２００２年４月８日出願の米国特許仮出願第６０／３７０，１９０号、２００２年１０月３日出願の米国特許仮出願第６０／４１５，５７５号、および、２００３年１月２９日出願の米国特許仮出願第６０／４４２，９７０号の優先権を主張するものである。
前述の出願および特許はいずれも、それぞれの内容全体はここに引例に挙げることにより本件の一部を成すものとする。
＜特許出願の援用＞
本明細書に言及されている公開および特許出願は全て、本件の一部を成すものとして援用されているが、その程度は、公開または特許出願の文書を特定して個別に示すことで、各々の文書を援用することにより本明細書の一部に組込まれているものと分かる範囲での援用である。
＜技術分野＞
本発明は、体腔の内部で不連続周縁治療を施す装置に関するものである。このような装置の実施例は、１つ以上の離散した治療領域においてエネルギーを供与することで１つ以上の損傷部位を設け、これら損傷部位が体腔の長手方向軸線に対して垂直な１断面部の全周に亘って互いに隣接しておらず、すなわち、不連続であるようにする、体腔の周縁治療を対象としている。
本件出願人らは、例えば、腎機能に一助を成している神経線維を含有している組織を除神経処置に付すといったように、腎機能に一助をなしている神経線維に神経信号変調を起こさせることにより、心不全、腎臓疾患、腎不全、高血圧、造影剤腎症、心房細動、心筋梗塞などのような多様な腎疾患および心腎疾患を治療する方法および装置を既に開示している。このような処置は、身体から水およびナトリウムを除去さする作用を増幅させる、腎交感神経活動を緩和することを期待してのことである。正常な腎分泌物により、腎臓に血液供給を行っている血管が安定したレベルの拡張および収縮を示すが、これが適切な腎臓血流を促す。例えば、本件出願人らの以下に列挙する同時係属中の米国特許出願（ａ）〜（ｅ）および米国特許を参照されたい。（ａ）２００３年４月８日出願の第１０／４０８，６６５号、（ｂ）２００５年５月１３日出願の第１１／１２９，７６５号、（ｃ）２００５年７月２５日出願の第１１／１８９，５６３号、（ｄ）２００６年２月２７日出願の第１１／３６３，８６７号、（ｅ）２００６年８月１４日出願の第１１／５０４，１１７号、および、米国特許第６，９７８，１７４号。これら出願および特許はいずれも、それぞれの内容全体はここに援用することにより本件の一部を成すものとする。
本件出願人らが既に開示している方法および装置としてはまた、患者身体の神経叢が分布している血管または血管の近位にある標的神経線維を血管内誘導式神経信号変調処置または除神経処置に付すことで、例えば、神経疾患やそれ以外の医学的症状を治療することを目的とした方法および装置がある。血管の近位の神経叢は効果器または効果器組織に分布している。血管内誘導式神経信号変調処置または除神経処置を利用して、各種神経疾患またはそれ以外の医学的諸症状の宿主を治療することができ、そのような疾患および症状の具体例として、心不全および高血圧などのような上述の諸症状のほかに、疼痛ならびに末梢動脈閉塞性疾患（例えば、鎮痛処置による治療）が挙げられるが、これらに限定されるものではない。このような方法および装置を使って、求心性神経信号または遠心性神経信号を変調させるとともに、求心性神経信号と遠心性神経信号の両方の組合せを変調させることもできる。例えば、本件出願人らの同時係属中の、２００６年１１月１４日出願の「血管内誘導式神経信号変調処置または除神経処置の方法および装置（Ｍｅｔｈｏｄｓ ａｎｄ Ａｐｐａｒａｔｕｓ ｆｏｒ Ｉｎｔｒａｖａｓｃｕｌａｒｌｙ−Ｉｎｄｕｃｅｄ Ｎｅｕｒｏｍｏｄｕｌａｔｉｏｎ ｏｒ Ｄｅｎｅｒｖａｔｉｏｎ）」という名称の米国特許出願第１１／５９９，６４９号（弁護士事件登録番号５７８５６．８０１８．ＵＳ）を参照するとよいが、かかる出願の内容全体は、ここに援用することにより本件の一部を成すものとする。
米国特許出願第１０／４０８，６６５号 米国特許出願第１１／１２９，７６５号 米国特許出願第１１／１８９，５６３号 米国特許出願第１１／３６３，８６７号 米国特許出願第１１／５０４，１１７号 米国特許第６，９７８，１７４号 米国特許出願第１１／５９９，６４９号
前述の方法は、それら自体が有用であるが、血管内神経信号変調処置、除神経処置、または、その両方の処置の難題解決の取組みの１つは、血管内から神経組織に十分な作用を与えることである。例えば、血管内神経信号変調処置では、急性狭窄症、遅発性狭窄症、または、その両方の危険を増大させることを回避しなければならない。よって、このような難題に一層の対処を行っている方法および装置を提供するのが望ましい。
動脈の近位にある神経線維の共通部位を例示した概略等角詳細図である。 体腔の不連続周縁帯を治療する方法および装置の一例を例示した部分断面概略側面図である。 図２Ａの実施例を例示した部分断面概略側面図である。 図２Ａの実施例を例示した部分断面概略側面図である。 図２Ａの実施例を例示した部分断面概略側面図である。 図２Ａの実施例を例示した部分断面概略側面図である。 図２Ａの実施例を例示した部分断面概略側面図である。 図２Ａの実施例を例示した部分断面概略側面図である。 図２Ａの実施例を例示した部分断面概略側面図である。 図２Ａの実施例を例示した部分断面概略側面図である。 図２Ａの実施例を例示した部分断面概略側面図である。 図２の方法および装置の代替の実施例を例示した部分断面概略側面図である。 不連続周縁帯を治療する更に別な実施例を例示した部分断面概略側面図である。 不連続周縁帯を治療する更にまた別な実施例を例示した部分断面概略側面図である。 不連続周縁帯を治療するもう１つ別な実施例を例示した部分断面概略側面図である。
本発明の幾つかの実施例は、後段の詳細な説明を添付の図面と関連づけて理解しながら思量すれば明瞭となるが、添付図面は各図を通して、同一構成部材は同一参照番号で示してある。
＜Ａ． 概観＞
本件出願人らが発見したところによると、体腔に周縁治療を施して或る医学的症状に積極的に作用を与える手段として、体腔壁に対して垂直な放射方向の１断面部の全周に添って不連続である複数の離散区域にエネルギーを供与する方法を採るのが望ましい場合がある。例えば、心房細動を治療するにあたり、周縁治療は、肺静脈の放射方向の１断面部の全周を巡る途切れの無い連続周縁損傷帯を形成することで異常電気信号を途絶させることにより達成される。心不全の治療では、周縁治療は、腎動脈の放射方向１断面部の全周を巡る途切れの無い、上記と同様の連続周縁損傷帯を形成して腎交感神経活動を緩和することにより達成される。しかしながら、体腔に対して、または、体腔の近隣組織に対して垂直である放射方向の１断面部の周囲３６０度の全周を囲んで途切れ無く延在している連続周縁損傷帯は、血管内の急性狭窄形成、遅延性狭窄形成、または、その両方の狭窄形成の危険を増大させることがある。よって、後段で説明する実施例の大半は、複数の互いに離散した不連続損傷部を体腔内側に形成しながらも、血管に悪影響を及ぼすことがないようにすることを目標としている。
このような不連続治療は、例えば、血管内部位または管腔内部位から遂行され、具体例として、血管内部位から血管外部位まで通された各種部材を利用する治療、すなわち、血管内外導通治療がある。しかしながら、本発明による血管外治療装置およびその方法も施すことができると理解するべきである。
これらの治療は神経に対して適用されるが、例えば、脳内神経組織、それ以外の、血管内または体腔内にあるか、もしくは、血管の近隣または体腔の近隣にあって、血管または体腔の長さ寸法に少なくとも概ね平行に延びているか、もしくは、そのような長さ寸法に沿って延びる標的構造体の神経組織などが挙げられる。これに加えて、または、これに代わるものとして、標的構造体は血管（体腔）に相関的な回転配向を示していることもある。不連続周縁治療の既に開示されている実施例の幾つかは、血管（体腔）の長さ寸法に沿って互いから離隔されている多数の放射方向平面の周縁または多数の断面の周縁沿いの各部で神経物質を治療することにより、急性狭窄形成、遅延性狭窄形成、または、その両方の危険を低減することができる。
個々の放射方向平面または断面部の周縁治療領域は、血管（体腔）の全周に沿って完全には連続していない治療域を規定し、すなわち、治療域を規定しながらも途切れなく連続する周縁損傷帯を設けることが無いようにしている。しかしながら、多数の治療域が多数の放射方向平面または断面部の周縁に沿って重畳しているところは、不連続な互いに重なり合った周縁治療域を血管（体腔）の長さ方向セグメント沿いに規定することになる。或る実施例においては、このような互いに重なり合った治療域は不連続的ではあるが、実質的には全周縁治療を施して、尚且つ、連続する周縁損傷帯を形成することがないように作用する。他の実施例では、互いに重なり合う治療域が不連続な部分周縁治療の作用をする。
このようにして、不連続周縁治療は血管（体腔）の長さ方向セグメントのあちこちで施されるが、長さ寸法沿いに断面部または放射方向の平面が１つだけの場合の連続周縁治療とは対照を成す。従って、血管（体腔）の長さ寸法に沿って実質的な距離に亘って連続する標的構造体は、不連続の態様で周縁に作用して、尚且つ、血管（体腔）の断面部または放射方向の平面のどの１つに沿っても連続する周縁損傷帯を形成することが無い。これで、血管（体腔）内部に急性狭窄形成または遅延性狭窄形成を生じる危険を緩和することができる。従って、不連続周縁治療では、体腔の長さ寸法周縁の多数部位で治療が遂行され、長さ寸法沿いのどの１部位の治療域も放射方向の１平面の全周を巡る連続周縁損傷帯を含むことは無いが、長さ寸法沿いの全部位または幾つかの部位において複数の治療域の重畳部で、互いに重なり合った周縁治療域を規定する。
不連続周縁治療は、任意で、体腔内の標的神経線維の近位に設置されて標的神経線維にエネルギーを供与する装置によって達成されてもよい。この治療を誘導する方法として、例えば、電気エネルギー投入法、磁気エネルギー投入法、電磁エネルギー投入法、熱エネルギー投入法（加温法または冷却法のいずれか）、機械エネルギー投入法、化学エネルギー投入法、核エネルギーまたは放射線エネルギー投入法、流体エネルギー投入法などが挙げられる。このような治療を達成する方法として、例えば、熱電界法、非熱電界法、連続電界法、パルス電界法、刺激電界法、局所薬物搬送法、高強度集束超音波法、熱技術、非熱技術、これらの各種組合せのいずれか等が挙げられる。このような治療は、例えば、標的神経線維において不可逆電気穿孔、不可逆電気融解、壊死、アポトーシス誘導、活動電位遮断、染色体発現変性、活動電位減衰、サイトカインの上限調節の変動、融除、それ以外の各種条件を実施することができる。これら装置の全部または一部が、任意で、体腔の壁を貫通して体腔外部位に通されることで、治療を容易にすることができる。体腔とは、具体例として、血管が挙げられるが、装置は周知の各種経皮技術によって血管内に設置される。
治療を達成する手段として、標的構造体（例えば、標的神経構造体）を直接変性させるか、または、血管、もしくは、それ以外の、標的構造体またはその周辺組織を維持している構造体であって、例えば、動脈、細動脈、毛細血管、静脈、細静脈などのような構造体を少なくとも部分的に変性させるか、いずれかの方法がある。或る実施例では、治療は標的構造体または維持構造体にエネルギーを直接供与することにより達成される。また別な実施例では、電界供与または高強度集束超音波供与のようなエネルギーの間接生成、間接投入、または、間接生成投入によって達成されるが、電界または高強度集束超音波は抵抗を誘起して標的構造体または維持構造体において加温作用する。これらに代わる熱技術を利用してもよい。
或る実施例においては、治療を実時間監視するとともに、標的構造体または維持構造体、標的になっていない組織、もしくは、その両方の構造体および組織に及ぼされる治療効果をも実時間監視するための方法および装置が提示されている。同様に、エネルギー伝搬装置の実時間監視も提示されている。これに加えて、または、これに代わる例として、標的組織または標的ではない組織に伝搬される、または、装置に伝搬される動力もしくは総エネルギー量、インピーダンス、温度、または、これらの各種組合せが監視されるようにしてもよい。
所望の周縁治療を達成するのに電界を利用する場合、電界パラメータは、所望に応じて、変動させてもよいし、どのような組合せで連携させてもよい。このようなパラメータとしては、電圧、電力、電界強度、パルス幅、パルス持続時間、パルスの形状、パルスの個数、１パルスから次のパルスまでの間隔（例えば、デューティーサイクル）、または、これらの各種組合せが挙げられるが、これらに限定されるものではない。例えば、好適な電界強度は約１０，０００ Ｖ／ｃｍまで高くしてもよいし、電界は連続式でもパルス式でもいずれであってもよい。電気波形の好適な形状としては、例えば、交流波形、正弦波形、余弦波形、正弦波と余弦波の各種組合せ、直流波形、直流成分を移相した交流波形、高周波波形、方形波、台形波、指数関数的減衰波、または、これらの各種組合せ波形が挙げられる。
パルス電界を利用する場合、好適なパルス幅は所望の間隔であればよく、例えば、最長１秒までの間隔であるとよい。電界は少なくとも１個のパルスを含んでおり、大半の応用例で、電界は複数のパルスを含んでいるか、または、連続的に電界印加され、例えば、最長数分間まで継続する。好適なパルス間隔としては、例えば、約１０秒を越えない間隔が挙げられる。これらのパラメータは好適な具体例として提示されているのであって、限定するものであると解釈するべきではない。
熱メカニズムを利用して所望の治療を達成する場合、熱誘導式不連続周縁治療の期間中に、平滑筋細胞などのような、標的ではない組織を熱損傷から保護するために、保護部材が任意で設けられてもよい。例えば、標的神経または維持構造体を加温する場合、対流冷却部材などのような保護冷却部材を利用して、標的ではない組織を保護するとよい。同様に、標的神経または維持構造体を冷却する場合、対流式加温部材などのような保護加温部材を利用して、標的ではない組織を保護すると良い。熱エネルギーを短期間または或る持続期間に亘り直接的または間接的のいずれかの態様で供与することで、例えば、所望の神経信号変調または除神経を達成することができる。標的組織または標的ではない組織に沿った検知温度、もしくは、装置に沿った検知温度などのフィードバックを利用して、熱エネルギーの伝搬を制御および監視するようにしてもよい。
任意で、例えば、神経信号変調処置期間中または除神経処置期間中に、標的ではない組織を保護する手段として、過剰な熱エネルギー（高温または低温）を奪う伝導式吸放熱器、対流式吸放熱器、または、その両方の機能を果たすものとして血管を利用することができる。例えば、血流が遮断されていなければ、循環する血液が比較的一定温度の媒体として作用することで、処置期間中に標的ではない組織から過剰な熱エネルギーを取り除くことができる。これに加えて、または、これに代わるものとして、標的ではない組織を保護する手段として、標的構造体または維持構造体に熱エネルギー（または、それ以外のエネルギー）を集束させて、エネルギー強度が標的構造体または維持構造体から遠隔にある、標的ではない組織に熱損傷を誘発するには不十分となるようにする方法が採られてもよい。
これとは別な方法および装置、ならびに、これに代わる方法および装置を利用して不連続周縁治療を施し、後段で説明するように、連続周縁損傷帯を形成しないで済むようにすることができる。本発明の各種装置の構造と、そのような各種装置を利用して不連続周縁治療を施す方法とをより良好に理解するために、人体に共通する神経血管の解剖学的構造を吟味するのが有益である。
＜Ｂ． 神経血管の解剖学的構造の概要＞
図１は、体腔または血管構造体（通例は動脈）に相関的な神経構造体のありふれた解剖学的配置を例示している。神経線維Ｎは、概ね、長手方向に動脈Ａの長さ寸法Ｌに沿って延びており、半径寸法ｒが放射状に延びた複数点からなる比較的狭い範囲に散在し、動脈血管外膜の内側に位置していることが多い。動脈Ａは平滑筋細胞ＳＭＣを含んでおり、このような細胞は動脈周縁を取巻いて、動脈の角度範囲θの範囲で概ね螺旋状を描いており、これもまた、半径寸法ｒが放射状に延びた複数点からなる比較的狭い範囲内に散在している。従って、動脈の平滑筋細胞はその長手方向軸線すなわち長さ寸法が概ね、血管の長さ寸法を横断して（すなわち、血管の長さ寸法に対して平行ではない方向に）延びている。神経線維の長さ寸法と平滑筋細胞の長さ寸法とが不整列であることは、「細胞不整列」と定義される。
神経叢Ｎと平滑筋細胞ＳＭＣとの細胞不整列を活用して、平滑筋細胞に及ぼされる影響を低減しながら、神経細胞に選択的に作用するようにすることができる。より詳細に説明すると、不連続周縁治療を達成する手段として、放射方向の１平面すなわち１断面部のみについて連続周縁治療を施す方法を採るのではなく、むしろ、動脈の長さ寸法Ｌに沿って互いから離隔している、動脈Ａの多数の放射方向の平面すなわち多数の断面部に沿って重畳治療を執り行っている。このように、細胞不整列のおかげで、長手方向に配向された神経線維は十分かつ不連続な周縁治療を受けることがででき、角度を設けて配向された平滑筋細胞は周縁治療を部分的にしか受けることがない。任意で、身体構成要素監視を利用して、神経に誘導された治療、平滑筋に誘導された治療、または、その両方に誘導された治療の程度を査定することができるようになるうえに、所望の効果を達成するように治療パラメータも調節することができるようになる。
＜Ｃ． 体腔の不連続周縁治療の装置および方法の実施例＞
図２から図５は、不連続周縁治療を実施する血管内システムおよびその方法の実施例を例示している。本件出願人らは、神経信号変調処置または除神経処置を施す血管内システムおよび血管内外導通システムを既に開示しており、例えば、同時係属中の、２００５年５月１３日出願の米国特許出願第１１／１２９，７６５号および２００６年２月２７日出願の米国特許出願第１１／３６３，８６７号に記載されているが、かかる出願はいずれも、ここに援用することにより本件の一部を成すものとする。本件出願人らはまた、神経信号変調処置または除神経処置を施す血管外システムを開示しており（例えば、２００５年７月２５日出願の米国特許出願第１１／１８９，５６３号を参照するとよいが、かかる出願は、ここに援用することにより、本件の一部を成すものとする）、また、血管内システム（管腔内システム）または血管内外導通システム（管腔内外導通システム）に加えて、血管外システム（または、管腔外システム）を利用して、不連続周縁治療を実施することができるものと理解するべきである。本件出願人はまた、神経信号変調処置または除神経変調処置を施すための熱システムを既に開示しているが、例えば、２００６年８月１４日出願の、同時係属中の米国特許出願第１１／５０４，１１７号に記載されている。
ここで図２Ａから図２Ｊを参照すると、装置３００の実施例はカテーテル３０２を備えており、カテーテルには、任意の設置部材３０４（例えば、バルーン、拡張自在ワイヤ籠、それ以外の機械的拡張装置など）と、カテーテル３０２のシャフトに沿って設置されているとともに図では設置部材３０４の上を覆って配置されている拡張自在電極素子３０６とが設けられている。電極素子３０６は、電界発生器５０に電気接続されて標的神経線維に電界を伝搬する１個以上の電極３０７を備えている。代替の実施例では、電極素子３０６の１個以上の電極３０７はペルティエ電極を備えており、標的神経線維を加温または冷却することにより神経線維の信号変調を実施するようにしてもよい。任意で、電極３０７は個別に割当てを行うことができ、バイポーラ形式で利用することができ、患者の体外に装着された体外接地パッドとモノポーラ形式で利用することができ、または、これら各種組合せの形態を取ることができる。
電界発生器５０も、本件に記載されている電極の各実施例も、所望の電界パラメータの電界を伝搬する目的で、本発明のいずれの実施例と併用されてもよい。電界発生器５０は患者の体外に配置することができる。後段に記載されている各実施例の電極は電界発生器と電気接続することができるが、但し、各実施例に関しては電界発生器が明確には図示も説明もなされていないものと理解するべきである。更に、任意で、電界発生器は患者の体内に設置されてもよく、電極、電界発生器、または、その両方ともが一時的または恒久的に患者の体内に移植されるようにしてもよい。
設置部材３０４は、任意で、電極（１個または複数個）３０７を血管壁と接触させて設置してもよいし、または、それとは別な態様で駆動するようにしてもよい。設置部材３０４はまた、インピーダンス変動部材を備えており、この部材が治療中に血管内のインピーダンスを変動させることで血管壁を横断する向きに電界を当てることができる。これで、所望の神経信号変調処置または除神経処置を達成するのに必要なエネルギーを低減することができるとともに、標的ではない組織を損傷してしまう危険を緩和することができる。本件出願人らはインピーダンス変動部材の用途を既に開示しており、例えば、２００５年１１月４日出願の同時係属中の米国特許出願連続番号第１１／２６６，９９３号に記載されているが、かかる出願の内容全体はここに引例に挙げることにより本件の一部を成すものとする。設置部材３０４が膨張自在バルーンを備えている場合、図２Ａから図２Ｊに例示されているように、バルーンは拡張自在電極素子３０６の中心設置部材、拡張部材、または、その両方の部材として機能することができ、更に、インピーダンス変動電気絶縁装置として作用して、電極（１個または複数個）３０７を介して伝搬された電界を血管壁の内部または血管壁を横断する向きに当て、標的神経線維の信号変調を行うこともできる。設置部材３０４によって施される電気絶縁は、標的神経線維に所望の信号変調を達成するのに必要な供給エネルギーの大きさまたは必要な電界の他のパラメータを、標的神経線維を含んでいる組織の除神経を十分に実施する程度まで低減するとともに、それ以外の効果をも達成する程度に低減することができる。
更に、任意で、設置部材３０４は吸放熱部材としても利用することができる。例えば、設置部材３０４は冷却液で膨張させることで吸熱器として作用し、前記部材に接触した組織から熱を除去することができる。これとは逆に、設置部材３０４は加温液で膨張させることで放熱作用し、該部材に接触した組織を加温する。設置部材３０４の内部の吸放熱液は、任意で、該部材の中を循環させられ該部材の内部で熱交換されることで、より有効な伝導性熱伝達、対流性熱伝達、または、その両方を容易に行えるようにしてもよい。吸放熱液を利用することで、熱冷却メカニズムまたは熱加温メカニズムにより熱による神経信号変調を達成することもできるが、これは後段でより詳細に説明される。
電極（１個または複数個）３０７は個別電極（すなわち、複数の独立接点が設けられている）であってもよいし、複数の共通接続接点が設けられた１個の分割電極であってもよいし、または、１個の連続電極であってもよい。更に、電極（１個または複数個）３０７がバイポーラ信号を供与する構成であってもよいし、または、電極（１個または複数個）３０７がモノポーラ用途に適するように別個の患者用接地パッドと連携して一緒にまたは個別に使用するようにしてもよい。拡張自在電極素子３０６に沿って電極（１個または複数個）３０７を配置する代わりに、または、これに加えて、図２に例示されているように、電極（１個または複数個）３０７は設置部材３０４に取付けられて、設置部材３０４の拡張時に動脈の壁に接触することができるようにしてもよい。このような変形例では、電極（１個または複数個）３０７は、例えば、設置部材３０４の壁内面または壁外面に付着され、或いは、該壁に少なくとも一部が埋設されるようにするとよい（図５Ａおよび図５Ｂを参照のこと）。もう１つ別の実施例においては、電極（１個または複数個）は血管壁には接触せずに、血管の内側のどこであれ所望の部位に設置されるとよい。
これに加えて、または、これに代わる例として、電極（１個または複数個）３０７、または、装置３００のそれ以外の何らかの部分であって、例えば、カテーテル３０２または設置部材３０４などは、熱電対３１０などのような１個以上のセンサーを備えており、温度やそれ以外の各種パラメータを監視するにあたり、標的組織、標的ではない組織、電極、設置部材、装置３００の上記以外の各部、患者の解剖学的構造部の上記以外の部位、または、これらの各種組合せの温度やそれ以外の各種パラメータを監視することができるようにしている。治療管理形態は、測定されたパラメータ（１種類または複数種類）をフィードバックとして利用しながら制御される。このフィードバックを利用して、例えば、所望の閾レベルより低くパラメータ（１種類または複数種類）を維持することができるが、具体的には、標的ではない組織に損傷を引起す原因となる閾レベルよりも低く維持するとよい。これとは逆に、フィードバックを利用して、所望の閾レベルまたはそれより上にパラメータ（１種類または複数種類）を維持することができるが、具体的には、標的神経線維の神経信号変調または標的神経線維が分布している組織の除神経などのような所望の効果を標的組織に誘導することができる閾レベルまたはそれより上に維持するとよい。更に、フィードバックを利用して、標的組織に所望の効果を誘導して尚且つ標的ではない組織を損傷することがない範囲にパラメータ（１種類または複数種類）を維持することができる。任意で、多数パラメータ（または、多数部位の同一種類パラメータまたは多数種類パラメータ）を制御フィードバックとして利用して、所望の効果を確保しながら同時に望ましくない効果を緩和することができる。
図２Ａで分かるように、カテーテル３０２は動脈Ａの内側（または、標的神経線維の近位の静脈またはそれ以外の血管の内側）の治療部位に搬送されるが、このときの搬送形状は低姿勢で行われ、例えば、ガイドカテーテルまたは鞘部材３０３の中を通される。これに代わる例として、カテーテルは多数血管に設置され、例えば、動脈と静脈の両方の内側に設置されるとよい。電界神経信号変調を施すための多数血管技術は既に開示されており、例えば、本件出願人らの同時係属中の、２００６年７月１２日出願の米国特許出願第１１／４５１，７２８号に記載されており、その内容全体は、ここに援用することにより本件の一部を成すものとする。
任意の設置部材３０４は、所望に応じて血管内に設置されてしまうと拡張状態となって、図２Ｂで分かるように、電極素子３０６を拡張させるとともに電極３０７を血管の内壁に接触させることができる。次に、電界発生器５０によって電界が発生させられて、カテーテル３０２の中を通して電極素子３０６および電極３０７に伝達され、更に、電極３０７により動脈の壁を横断するように伝搬される。電界は動脈の壁の内部または動脈の近位の神経線維に沿って活動電位を変調させ、例えば、神経線維が分布している組織または器官（１種類または２種類）を少なくとも部分的に除神経処置に付す。これは、例えば、標的神経線維または維持構造体を融除または壊死させることにより、もしくは、融除によるものではない損傷またはそれ以外の各種変性を生じさせることによって達成することができる。電界はまた、神経線維に電気穿孔を誘導することもできる。
図２Ｂの放射方向の平面Ｉ―Ｉに沿って破断された図２Ｃの断面図で分かるように、装置３００には、電極素子３０６および設置部材３０４の周縁部を巡って４個の電極３０７が互いから均等に離隔されて設けられているのを例示している。図２Ｄで分かるように、体外接地（本質的に周知であるため、図示せず）と組合せたモノポーラ形式で利用される場合、各電極によって治療を施される周縁帯区分は各々が重なり合って、血管壁に対して垂直である放射方向の平面位置で動脈の周縁の全周に亘って連続してはいない複数の離散治療域ＴＺＩを形成する。その結果、動脈の周縁を巡る不連続の治療を受けない区域ＵＺＩ
が存在するようになる。
図２Ｅで分かるように、電極素子３０６は動脈の半径寸法ｒの中心に向けて収縮状態となり、例えば、設置部材３０４を収縮させることにより電極３０７が血管壁と接触していない状態になるようにすることができる。電極素子３０６を動脈の角度範囲θについて回転させ、電極３０７を角度的に設置し直すことができる（図２Ｇで最もよく分かる）。このような回転動作は、例えば、カテーテル３０２を所与の角度分だけ回転させることにより達成される。図２Ｅでは、電極素子は動脈の角度範囲について約４５度だけ既に回転させたところを例示している。図２Ａから図２Ｄに例示されている装置３００の実施例においては、複数の電極が装置の周縁を巡って互いから均等に離隔され、４５度だけ角回転させることで電極を設置し直すにあたり、図２Ｄに例示されている電極相互の初期位置のほぼ中間点に再設置される。
電極を所与の角度分だけ設置し直すのに加えて、電極は動脈の長さ寸法Ｌに沿っても再設置され、これもまた図２Ｅに、電極３０７と放射方向の平面であるＩ−Ｉ破断面との間の長手方向の片寄せとして例示されている。このような長手方向再設置は、電極の角度的再設置の前後または同時のいずれの時機に行われてもよい。図２Ｆで分かるように、長手方向の範囲と角度範囲の両方に再設置が行われると、電極素子３０６は半径方向に中心から拡張し直した状態となり、電極３０７を血管壁と接触させることができる。次に、角度的にも長手方向にも設置し直された電極３０７により、電界が伝搬される。
図２Ｇでは、図２Ｆの放射方向の平面であるＩＩ−ＩＩ破断面に対応する周縁帯沿いの治療により、治療域ＴＺＩＩおよび治療を施されない区域ＵＺＩＩが設けられている。図２Ｄの治療域ＴＺＩについてと同様、図２Ｇの治療域ＴＺＩＩは動脈の全周に亘って連続しているわけではない。図２Ｈおよび図２Ｉにより、治療域ＴＺＩと治療域ＴＺＩＩの比較を行うことができる。装置３００は図２Ｈおよび図２Ｉには例示されておらず、例えば、装置は患者から既に取外されて処置を完了していることが推察される。
図示のように、放射方向の平面であるＩ−Ｉ破断面に沿った治療を受けていない区域ＵＺＩおよびＩＩ−ＩＩ破断面に沿った治療を受けていない区域ＵＺＩＩは互いから角度的に片寄せされている。図２Ｊで分かるように、動脈Ａの互いに異なる複数の断面すなわち放射方向の互いに異なる複数平面に沿って配置されている治療域ＴＺＩおよび治療域ＴＺＩＩを互いに重畳することにより、複合治療域ＴＺＩ−ＩＩが形成されるが、これにより、不連続でありながら、尚且つ、動脈の長手方向の１区分を占める実質的に全周に亘る治療を施すように作用する。このような重畳治療域は動脈に対して垂直な個々の放射方向の平面または縦断面の全周に亘る連続周縁損傷帯を設けることがない点で有利であり、連続周縁損傷帯を設ける先行技術の周縁治療と比較して、急性狭窄形成または遅延性狭窄形成の危険を低減することができる。
前述のように、多数の長手方向の部位に沿って互いに異なる角度配向で複数の電極を設置することで実施される不連続周縁治療は、動脈の長さ寸法に沿って実質的に増殖している各種解剖学的構造体に対して優先的に作用することができる。このような解剖学的構造体としては、神経線維、神経線維を維持する構造体、または、その両方がある。更に、このような不連続周縁治療は、動脈の角度範囲に亘って増殖している平滑筋細胞などのような構造体において誘導される、潜在的に好ましからざる各種効果を緩和または低減することができる。平滑筋細胞の動脈に対する角度配向または周方向配向は、連続周縁損傷帯が急性狭窄症または遅延性狭窄症の危険を増大させる恐れがある理由について、少なくとも部分的に解明している。
図２Ａから図２Ｊには、電極素子３０６が設置部材３０４により拡張されているが、これに加えて、または、その代替例として、拡張自在電極素子または拡張自在電極は自己拡張して血管壁に接触する構成にしてもよいものと理解するべきである。例えば、電極の搬送時形状をより小さく拘束する鞘部材またはガイドカテーテル３０３を除去した後で、電極が自己拡張するとよい。電極または電極素子は、例えば、自己拡張する構成の形状記憶部材から製造されている（または、そのような形状記憶部材に接続されている）ようにしてもよい。自己拡張式の実施例は、任意で、自己拡張部材の上を覆う拘束用の鞘部材またはカテーテルを設置し直すことにより、収縮状態にして患者体内から回収するようにしてもよい。
図３は、自己拡張式電極素子３０６´が設けられた装置３００の代替の実施例を例示している。設置部材３０４は既に装置から取外されている。使用時には、装置３００は鞘部材またはガイドカテーテル３０３の内部に入ったまま治療部位まで進入させられる。鞘部材が取出されてから、電極素子３０６´が自己拡張して、電極３０７を血管壁に接触させる。治療域ＴＺＩを形成している間、血液は継続して動脈Ａを通って流動し続けるのが有利である。次に、電極素子３０６´は一部または全部が収縮状態にされ（例えば、鞘部材３０３の内部で）、血管に相対的に所与の角度だけ回転させられ、血管に相対的に水平方向に設置し直されてから、再度、拡張状態にされることで、さっきとは異なる放射方向の平面または断面の周縁沿いの血管壁に接触することができる。新たな部位で新たな角度配向で、血流が存在する状態で治療を進行させ、例えば、治療域ＴＺＩと重畳させると不連続周縁治療域ＴＺＩ−ＩＩを設けることができる、重なり合う治療域ＴＺＩＩを形成する。次に、再度、電極素子３０６´を収縮させてから、装置３００を患者体内から取出すことで、処置を完了することができる。
ここで図４を参照すると、電極またはそれ以外のエネルギー伝搬素子を角度的、長手方向、または、その両方について設置し直すこと無しに不連続周縁治療を達成するのが望ましい。このために、また別な実施例において、装置４００は能動的に拡張自在なワイヤ籠すなわち自己拡張式のワイヤ籠４０４が設けられているカテーテル４０２を備えており、ワイヤ籠には近位電極４０６および遠位電極４０８が互いから長手方向に離隔されて設けられている。近位電極４０６および遠位電極４０８はまた、ワイヤ籠の周囲で放射方向にも互いから離隔されており、電界発生器５０（図２Ａを参照のこと）に電気接続されている。近位電極４０６は、ワイヤ籠において遠位電極４０８が設置されているワイヤとは異なるワイヤに沿って設置されている。従って、近位電極および遠位電極は角度的にも水平方向にも互いから片寄せされている。
近位電極は遠位電極とは無関係に作動するようにしてもよいし、近位電極と遠位電極が全て同一極性で作動し、例えば、体外接地と組合わされた能動電極としてモノポーラ形式で作動されてもよいし、または、その両方の態様で作動するようにしてもよい。これに代わる例として、または、これに加えて、近位電極を互いにバイポーラ形式で利用してもよいし、遠位電極を互いにバイポーラ形式で利用してもよいし、または、その両方の態様で利用してもよい。近位電極および遠位電極が取混ぜて一緒にバイポーラ形式で利用されることがないようにするのが好ましい。遠位電極４０８を用いて治療することにより、図２Ｈの治療域ＴＺＩを動脈の周囲の方々に形成させることができる。近位電極４０６を用いて治療することにより、図２Ｉの治療域ＴＺＩＩを設けることができるが、治療域ＴＺＩＩは治療域ＴＺＩに対して角度的に片寄せされている。治療域ＴＺＩおよび治療域ＴＺＩＩを互いに重畳させることで、動脈の長手方向の１区分に亘って不連続周縁治療域ＴＺＩ−ＩＩを設けている。
任意で、近位電極および遠位電極を同時に利用して、治療域ＴＺＩおよび治療域ＴＺＩＩを同時に形成することができる。これに代わる例として、電極を所望の順序で連続して作動させることにより、複数の治療域を連続して形成するようにしてもよい。また別な代替例として、治療域の一部は同時治療により形成され、別な一部は連続治療により形成されるようにしてもよい。
図５Ａおよび図５Ｂは、電極またはそれ以外のエネルギー伝搬素子を設置し直す必要無しに不連続周縁治療を施す、また別な装置および方法を例示している。図５Ａおよび図５Ｂで分かるように、装置３００の電極素子３０６´には撓曲回路が設けられており、この回路は設置部材３０４に接続されていてもよいし、または、設置回路３０４の周辺に設置されていてもよい。撓曲回路は、カテーテル３０２の中を通って延びているワイヤ、カテーテル３０２に沿って延在しているワイヤ、または、無線によって電界発生器５０に電気接続されている。図５Ａにおいて、撓曲回路は設置部材３０４の周囲に設置された収縮自在円筒部材を備えている。図５Ｂにおいては、撓曲回路には、個々の電極３０７ごとの個別の電気接続部が設けられており、これにより搬送および回収に好適なように撓曲回路を容易に収縮させることができる。図４の装置４００の電極についてと同様に、図５の複数の電極３０７は、設置部材および血管に相関的な多数の長手方向の位置に置かれて互いに離隔されている。電極３０７は前述のように作動させられて、不連続周縁治療を達成することができる。電極３０７は３つの互いに異なる長手方向の点に設置されているのが例示されているが、不連続周縁治療は、例えば、３つの治療域（血管内の長手方向の１つの位置ごとに１治療域がある）を互いに重畳することにより形成されるとよい。
図２から図５は、周縁治療を施して、尚且つ、周縁損傷帯を形成することの無い電気的な方法および装置を具体的に例示している。しかしながら、磁気エネルギー、熱エネルギー、化学エネルギー、核エネルギー、放射線エネルギー、流体エネルギーなどのような代替エネルギー様式を利用して所望の周縁治療を達成し、尚且つ、周縁損傷帯を設けることが無いようにすることができる。さらに、図２から図５は装置を十分に血管内に設置することを具体的に示しているが、装置の全体または一部は、任意で、血管内外導通アプローチにより血管外に設置されてもよいものと理解するべきである。
電界の伝搬中（または、それ以外のエネルギーの伝搬中）、血管内の血液は吸放熱器（放熱・吸熱のいずれであれ）として作用して、伝導式熱伝達、対流式熱伝達、または、その両方を実施して、標的ではない組織（例えば、血管の内壁など）から過剰な熱エネルギーを奪うことにより、標的ではない組織を保護することができる。このような効果は、図３および図４の実施例で分かるように、エネルギー伝搬中に血流が遮断されていない場合に向上させることができる。患者の血液を吸放熱器として利用することで、より長時間の治療またはより高エネルギーの施療を容易にして、尚且つ、標的ではない組織に損傷を与える危険を低減するものと期待されるが、これにより、例えば、標的神経線維などの標的組織の治療の効果を向上させることができる。
患者の血液を吸放熱器として利用することに加えて、または、これに代わるものとして、吸放熱液（高温または低温）を、例えば、電極またはそれ以外のエネルギー伝搬素子の上流側などの部位で血管に注入し、過剰な熱エネルギーを除去して、標的ではない組織を保護するようにしてもよい。吸放熱液は、例えば、カテーテル装置を通して注入されてもよいし、または、ガイドカテーテルを通して注入されてもよい。更に、注入された吸放熱液を利用して過剰な熱エネルギーを標的ではない組織から除去して標的組織の熱治療中に標的ではない組織を熱損傷から保護する方法は、血管以外の体腔においても利用することができる。
本発明の好ましい具体的な変形例を前段までに説明してきたが、本発明から逸脱せずに、これら実施例に多様な変更および修正を行うことができることが当業者には明らかである。例えば、図２から図４に開示されている実施例では、不連続周縁治療は治療を２箇所で重畳することにより達成されているが、図５Ａおよび図５Ｂに関連して説明したように、２箇所を超える部位における治療を重畳して周縁治療を達成するようにしてもよいものと理解するべきである。更に、前述の実施例においては、本発明の方法は血管内において遂行されているが、これに代わる例として治療は他の体腔において遂行されてもよいものと理解するべきである。添付の特許請求の範囲においては、本発明の真髄および範囲に入る上述のような変更および修正を全て包含するものと解釈するべきである。

Claims (4)

  1. 患者の腎臓血管に不連続周縁治療を施す装置であって、
    前記装置は、カテーテルを備え、前記カテーテルは、シャフトと、収縮された輪郭の搬送状態と拡張された治療状態の間を変動するように構成された拡張自在素子とを有しており、前記装置は、収縮された輪郭の搬送状態にあるときに、腎臓血管内に搬送することができるように構成され、該拡張自在素子は、複数の可撓性ストラット（ｆｌｅｘｉｂｌｅ ｓｔｒｕｔ）であって、各々が少なくとも一つの電極を備える複数の可撓性ストラットを含み、
    前記拡張自在素子が拡張された治療状態にあるときに、血液が該拡張自在素子を通って流れることができ、前記電極は、前記腎臓血管の長手方向軸線に沿って、互いに長手方向に離隔され、かつ、互いに角度的にオフセットされ、
    前記電極は、エネルギーを伝搬して、前記腎臓血管の長手方向部分に沿って不連続な周縁治療域を形成する構成であり、
    前記周縁治療域は、血管壁に垂直な放射方向の平面に形成され、前記腎臓血管の周囲のまわりに完全に連続的でない、
    ことを特徴とする装置。
  2. 前記拡張自在素子は、４本の可撓性ストラットとしての４本の可撓性ワイヤを含むワイヤ籠である
    ことを特徴とする請求項１に記載の装置。
  3. 前記拡張自在素子は、エネルギーが伝搬される前に、腎臓血管の壁と接する状態になるように構成されている
    ことを特徴とする請求項１又は２に記載の装置。
  4. 前記電極は、周縁治療域を順次形成できるように構成されている
    ことを特徴とする請求項１〜３のいずれか１項に記載の装置。
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