JP6983146B2 - カテーテル - Google Patents
カテーテル Download PDFInfo
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- JP6983146B2 JP6983146B2 JP2018236146A JP2018236146A JP6983146B2 JP 6983146 B2 JP6983146 B2 JP 6983146B2 JP 2018236146 A JP2018236146 A JP 2018236146A JP 2018236146 A JP2018236146 A JP 2018236146A JP 6983146 B2 JP6983146 B2 JP 6983146B2
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3601—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of respiratory organs
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
- A61B5/024—Detecting, measuring or recording pulse rate or heart rate
- A61B5/0245—Detecting, measuring or recording pulse rate or heart rate by using sensing means generating electric signals, i.e. ECG signals
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B5/25—Bioelectric electrodes therefor
- A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
- A61B5/28—Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
- A61B5/283—Invasive
- A61B5/287—Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
- A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
- A61B5/6852—Catheters
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
- A61M25/0026—Multi-lumen catheters with stationary elements
- A61M25/0029—Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
- A61M25/0133—Tip steering devices
- A61M25/0147—Tip steering devices with movable mechanical means, e.g. pull wires
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/0551—Spinal or peripheral nerve electrodes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
- A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
- A61N1/3611—Respiration control
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
- A61N1/36128—Control systems
- A61N1/36146—Control systems specified by the stimulation parameters
- A61N1/36182—Direction of the electrical field, e.g. with sleeve around stimulating electrode
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
- A61N1/36128—Control systems
- A61N1/36146—Control systems specified by the stimulation parameters
- A61N1/36182—Direction of the electrical field, e.g. with sleeve around stimulating electrode
- A61N1/36185—Selection of the electrode configuration
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
- A61B2562/04—Arrangements of multiple sensors of the same type
- A61B2562/043—Arrangements of multiple sensors of the same type in a linear array
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
- A61M25/0026—Multi-lumen catheters with stationary elements
- A61M2025/0034—Multi-lumen catheters with stationary elements characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
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- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Heart & Thoracic Surgery (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Radiology & Medical Imaging (AREA)
- Cardiology (AREA)
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- Neurology (AREA)
- Neurosurgery (AREA)
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- Hematology (AREA)
- Anesthesiology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Signal Processing (AREA)
- Mechanical Engineering (AREA)
- Electrotherapy Devices (AREA)
- Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)
Description
・筋萎縮性側索硬化症(ALS)
・昼間または夜間の換気駆動の減少(例えば、中枢性睡眠時無呼吸、オンディーヌの呪い)
・麻酔薬および/または機械的な換気の影響下にあるときの換気駆動の減少
これらの症状は、多くの人々に影響を与えている。
・使われない横隔膜筋の急速な萎縮を引き起こす(人工呼吸器誘発横隔膜機能不全(VIDD))。
・食べることおよび話すことに支障をきたす。
・患者が正常な呼吸を取り戻すことができずに人工呼吸に依存するようになると、死亡リスクが高くなる。
本開示の実施形態は、患者の神経を電気的に刺激するための医療器具および方法に概して関する。一実施形態においては、患者の神経を刺激することにより、横隔膜が動いて呼吸が回復または制御される。
図1〜6Bを参照して、医療器具の例示的実施形態および使用方法の概要を以下に説明する。それ以降の図面は、様々な医療器具部品の追加的または代替的な実施形態の説明において参照される。
図7A〜13Kに、本明細書に記載する各カテーテルとともに使用できる電極および電極アセンブリの追加的または代替的な実施形態を示す。以下に記載する実施形態は、上記の電極アセンブリおよび電極の変更例である。したがって、言及されない特徴については変更されていないか、上記の実施形態に対して適宜変更が加えられている。参照を容易にするために、各実施形態の基端側電極36、基端側電極アセンブリ32、先端側電極38および先端側電極アセンブリ34には、その特徴のいくつかが下記の実施形態において変更されている場合でも、上記と同じ符号が付されている。
図7A〜7Dに示すように、リード44の一部から非導電性材料46の層を除去し、下側の導電部材45を露出させてもよい。図7Aはカテーテル10を示し、図7Bは基端側電極アセンブリ32を示す。リード44の露出した導電部材45(直線状または表面積を増やすためにコイル状になっている)はカテーテル10の窓16,18内に配置され、いくつかの実施形態においては、窓16,18から径方向外側に延びている。別の実施形態においては、図7Cに示すように、導電部材45はカテーテル外壁の開口部からカテーテル10の管腔を出て基端側−先端側方向に移動して、カテーテル10の別の開口部から管腔内に戻っている。電極36,38を形成している導電部材45の部分は、リード44の先端であってもよい。追加的または代替的に、絶縁リード44はカテーテル10に縫い込まれ、露出した導電部材45はカテーテル10の外側に配置され、残りの絶縁リード44はカテーテル管腔内に配置される。図7Dは、カテーテル10の、露出した導電部材45を有する一対の基端側電極36を通る断面図である。
図8Aに、カテーテル10の外側に直接プリントされた電極およびリードを有するカテーテルを示す。図8Bは、カテーテル10の先端側電極38の分解図であり、図8Cはカテーテル10の基端側電極36の分解図であり、図8Dは図8CのVIIID−VIIID面に沿った基端側電極対36の横断面図である。電極36,38は導電性インク(ポリマー内に懸濁する銀フレークまたは炭素フレーク)により形成される。これらの導電性インクは、カテーテル10に直接載置されて接着され、露出した電極36,38を除いて、外側ポリウレタンフィルムまたは他の可撓性および絶縁性を有するフィルムによって封止される。露出した電極36,38も、導電性や表面積等の電気的特性の向上、耐食性の付与、有毒となりえる銀酸化物形成の可能性の低減等の目的のいくつかを満たすために被覆される(例えば窒化チタンで被覆される)。図8Cに示すように、先端側電極38の導電性インクトレースは、カテーテル10に沿って基端側電極36を越えて基端側に延びる。
図9A〜9Eに、カテーテル10の管腔内に配置されたカテーテル94,96に支持された電極36,38を示す。この実施形態においては、基端側電極36は電極カテーテル94に接合され、先端側電極38は電極カテーテル96に接合されている。カテーテル94,96は、非導電性材料を含む長尺状の管状部材である。電極36,38はカテーテル94,96に圧着されて、電極カテーテル94,96の壁を介してリード44の導電部材45に電気的に接続されている。カテーテル94,96の断面積は、カテーテル10の対応する管腔の断面積よりも小さく、カテーテル10の管腔にカテーテル94,96を挿入できるようになっている。カテーテル94,96がカテーテル10に挿入されると、他の実施形態と同様に、電極36,38がカテーテル10の窓16,18と整合されてその位置に固定される。図9Eには示されていないが、リード44は電極カテーテル94,96内を基端側−先端側方向に移動する。
図10A〜10Eは、カテーテル10の外側に配置された電極36,38を示す。図10A〜10Eの実施形態においては、電極36,38はリード44に接続(マイクロ溶接等)されてカテーテル10の外側に固定(圧着、接着等)される。リード44はカテーテル10の壁を通って(例えば窓16,18を通って)挿入され、カテーテル10の管腔内に入る。
図11A〜11Fに、電極アセンブリ32,34の製造工程に射出成形が含まれる実施形態を示す。電極を図11Bおよび11Cに示すように構成するために、電極36,38が射出成形によってリード44に個別に装着される。電極36,38は、導電部材45と電気的に接触している。この成形工程において、各リード44の周囲に被覆部98が形成される。被覆部98はプラスチック等の非導電性材料を含んでいる。電極36,38は平坦状、半円状、または他の好適な形状を有している。同様に、被覆部98は、リード44の周囲において、例えば図11Fに示す形状のような、いかなる形状を有していてもよい。
図12A〜12Kに、電極アセンブリ32,34のさらに別の実施形態を示す。この実施形態においては、管状部材100がリード44の先端102を支持し、電極36,38の近傍において先端102を保持している。
図13A〜13Kに、図12A〜12Kに示す実施形態に類似した実施形態を示す。図12A〜12Kの実施形態と類似する特徴については説明を省略する。図13A〜13Kの実施形態と図12A〜12Kの実施形態の主な相違点は、図13A〜13Kの各電極36,38は円弧状であるため、リード44の先端102(露出した導電部材45を含む)を保持して接触できるようになっている点である。図13A〜13Kの基端側および先端側のアセンブリ32,34は管状部材100を有していても有していなくてもよい。
図14に、2つのECG電極106および関連する部材を示す。本明細書における他の全特徴と同様に、ECG電極106は本明細書に記載する他の実施形態と共に用いることができる。ECG電極106はカテーテル10の先端に配置される(図12A)。一実施形態においてはカテーテル10が2つのECG電極106を有しているが、いくつかの実施形態のカテーテル10は1つの電極106または2つよりも多い電極106を有している。各電極106は、絶縁された導電部材104によって患者の体外に配置されたECGシステムに接続されている。ECG導電部材104はまとめて編組または撚合されており、非導電性層105(図12Jおよび12Kにも示されている)に覆われている。
血管内においてカテーテルの窓16,18および電極36,38の位置決め制御を補助するために、様々な操縦機構を医療器具50に配置することができる。操縦機構はカテーテル10の中心管腔30またはカテーテル10の他の管腔内に配置される。少なくともいくつかの電極36,38を各標的神経のすぐ近くに配置することが好ましい。神経の近くに電極を置くことによって、血液を介して分流する電流が減り、神経の活性化に要する電流を低減できる。
図15A〜15Cに示すように、操縦機構112は、カテーテル10を操縦するワイヤまたはチューブ(例えばステンレス鋼皮下チューブやニチノール皮下チューブ)等の、予備成形された単一の長尺状部材114を有している。長尺状部材114はハンドル120と、ハンドル120に連結された基端部116と、基端部116に対して屈曲している先端部118とを有している。基端部116がハンドル120を介して回されると、先端部118がこれに応じて様々な位置に回転され、カテーテル10の先端を位置決めするよう機能する。
図16A〜16Eに、1つまたは複数の制御部材122を含む他の実施形態の操縦機構112を示す。一実施形態において、制御部材122はカテーテル10の一部を屈曲また湾曲させるために引いたり押したりされる。制御部材122は、皮下チューブまたは圧縮コイル等の1つまたは複数の管状部材124によって包囲され、管状部材124に対して長手方向にスライドする。管状部材124は可撓性を有している。本実施形態の操縦機構112は、管状部材124に装着(溶接、接着等)されたチューブやロッド等の補強要素126をさらに有している。
(カテーテル窓構成)
図20A〜20Cを参照して、カテーテル10の窓16,18については様々な代替配置が可能である。例えば、図1に示すように整列しているのではなく、カテーテル10の外面の基端−先端線136またはカテーテル10の外周上の周方向線138を基準として、窓16は別の窓16からずらして配置されていてもよく、窓18は別の窓18からずらして配置されていてもよい。例えば、より基端側の窓16が、最も先端側の窓16の中心を通って延びる一本の基端−先端線136上に位置していないときは、窓16は互いにずらして配置されている。図20Bおよび20Cの各窓18は、窓18の中心を通って延びる周方向線138を基準にして、他の窓18からずらして配置されている。カテーテル10の実施形態においては、窓16,18はずらされた窓およびずらされていない窓をいかなる組み合わせにて構成することができる。前述したように、一組の窓16または窓16の列は、基端−先端線136を基準として、一組の窓18または窓18の列からずらされていてもよい。
図21に、本明細書に開示された実施形態による電極36,38を有する、予備成形されたカテーテル10を備える医療器具50を示す。予備成形されたカテーテル10は、円弧状、コイル状、S字状、U字状または他の予備成形された部分を有している。予備成形されたカテーテル10は、右横隔神経の経路が通常よりも前方または後方に位置している患者であっても、電極36,38が血管壁に密接して横隔神経または他の神経の近くに確実に配置されるように機能する。
図22A〜24Bを参照して、追加的または代替的な実施形態においては、カテーテル10の外側に沿って長尺状間隙140が形成される。長尺状間隙140はカテーテル10の外側と内腔とを接続し、スリットまたは経路とも称される。図22Aおよび22Bに示すように、長尺状間隙140はカテーテル10の全長にわたって延びていてもよい。追加的または代替的に、図23Aおよび23Bに示すように、長尺状間隙140はカテーテル10の全長の一部のみにわたって延びていてもよい。図24Aおよび24Bに示すように、長尺状間隙140は追加的または代替的にスリーブ142によって覆われていてもよい。
図25A〜26Hに示すように、追加的または代替的な実施形態においては、1つまたはすべての電極リード44が可撓性リボンケーブル144内に埋め込まれる。リボンケーブル144は、長さ方向に沿って互いに接続して単一の面構造を形成している複数の絶縁リード44を有している。面構造は可撓性を有し、他の形状に成形できる。本明細書に記載する他のリード44と同様に、リボンケーブル144のリード44は、絶縁材等の非導電性材料46の層によって包囲された長尺状の導電部材45を有している。
医療器具50は、高度の異なる場所で動作できるように気圧に対する調整機能を有していてもよい。横隔膜に対して電気刺激による横隔神経ペーシングを受ける患者は、一定の酸素供給量を吸気する必要があるが、空気の密度は高度に応じて異なる。自然な修正法としては、患者がより深くおよび/または速く呼吸することによって対処される。医療器具50またはカテーテル10は、高度変化の影響を補うために大気圧を測定する測定器(気圧計等)を有していてもよい。高度の高い場所で動作できることは、軍隊や、怪我人を搬送する他の機関(スキーリゾート、登山者)、そしてより一般的には、ペーシングを必要とする患者が飛行機で移動する際に特に有益である。
医療器具50またはカテーテル10は、カテーテル10および/またはその使用方法についての情報を記憶している電子チップを備えていてもよい。例えば、チップはカテーテル10のハブに配置される。一実施形態においては、カテーテル10が制御装置に接続されると、制御装置がチップを読み取り、チップの暗号化および/または応答が正しい場合にのみ電極36,38に信号を送る。チップは、カテーテルシリアル番号、サイズ(長さおよび/または直径)、ロット番号、バッチ番号、製造日、電極構成、電極相互接続情報(カテーテルにおいて導体によって電極に接続されたコネクタ用のピン配列)等のうちの1つまたは複数の情報を含む。制御装置は、チップに記録された情報によって識別された特定のシリアル番号またはカテーテル種類のみに適応されるアルゴリズムアップグレードを確定してもよい。
前述したように、本明細書に開示されたすべての実施形態の部品および特徴は、開示された他の部品および特徴と適宜組み合わせることができる。しかし、例示を目的として、本明細書に記載する例示的実施形態の変更例を以下に挙げる。
・電極構成の変更
・電極固定の変更(圧着、接着剤、マイクロ溶接等)
・電極形状の変更(球形、楕円形、円形、長方形等)
・電極材料の変更
・電極表面積の変更
・電極間隔の変更
・管腔の数または形状の変更
・窓の形状/寸法の変更
・カテーテルの太さの変更(例えば、3mm(9Fr)以上/以下)
・カテーテルの長さの変更
・操縦機構の変更
本明細書および特許請求の範囲において、内容が明らかに異なることを示していない限り、以下の通りとする。
・「接続された」、「連結された」およびこれらの変形は、2つ以上の要素間の直接的または間接的なあらゆる接続および連結を指す。要素間の連結または接続は物理的、論理的またはこれらの組み合わせが可能である。
本明細書および添付の特許請求の範囲において使用される「縦」、「横」、「水平」、「上方」、「下方」、「前方」、「後方」、「内向き」、「外向き」、「左」および「右」等の方向を示す言葉は、記載および表示される装置の特定の配向によって決定される。本明細書に記載する主題は、多くの代替的配向が可能である。したがって、これらの方向を表す単語は厳密に定義されているものでなく、狭義に解釈されない。
Claims (7)
- カテーテルであって、
長尺状部材と、
前記長尺状部材の第1長手方向部分に沿って配置されている基端側の組の電極と、
前記長尺状部材の第2長手方向部分に沿って配置されている先端側の組の電極と、
管腔であって、その内側からカテーテルの外側へ流体を搬送するように構成されている管腔と、を備えており、
前記基端側および先端側の組の電極が、前記基端側の組の電極が患者の左横隔神経を刺激するように構成され、かつ、前記先端側の組の電極が患者の右横隔神経を刺激するように構成されるように配置されており、
前記基端側および先端側の組の電極のそれぞれの電極が、リードに対して固定されており、かつ、リードに接触するとともに内壁および外壁を有している円弧状部材を備えており、
前記リードが前記円弧状部材の内壁および外壁に挟まれており、
前記長尺状部材の第3長手方向部分が、前記第1長手方向部分と前記第2長手方向部分との間に延在している、カテーテル。 - 前記基端側および先端側の組の電極の各電極が、該電極から基端側に延びている長尺状の導電部材の先端に電気的に連結されている、請求項1に記載のカテーテル。
- 前記カテーテルの長尺状部材が第1管腔、第2管腔、第3管腔および第4管腔を有しており、第1の複数の基端側の組の電極が前記第1管腔内において第1の長尺状の管状部材によって支持されており、第2の複数の基端側の組の電極が前記第2管腔内において第2の長尺状の管状部材によって支持されており、第1の複数の先端側の組の電極が前記第3管腔内において第3の長尺状の管状部材によって支持されており、第2の複数の先端側の組の電極が前記第4管腔内において第4の長尺状の管状部材によって支持されている、請求項1に記載のカテーテル。
- 前記長尺状部材の先端を湾曲させるように構成されている操縦機構をさらに備えている、請求項1に記載のカテーテル。
- 前記カテーテルの基端部が第1断面形状を有しており、前記カテーテルの先端部が、前記第1断面形状とは異なる第2断面形状を有している、請求項1に記載のカテーテル。
- 前記カテーテルが、その1つまたは複数の電極アセンブリ管腔内に2つの基端側電極アセンブリおよび2つの先端側電極アセンブリを有している、請求項1に記載のカテーテル。
- 前記基端側の組の電極の各電極が、前記第1長手方向部分の外周の一部分のみに沿って、前記長尺状部材の外側に電気エネルギーを発することと、前記長尺状部材の外側から電気エネルギーを受け取ることとの少なくとも一方を行うように構成されており、前記先端側の組の電極の各電極が、前記第2長手方向部分の外周の一部分のみに沿って、前記長尺状部材の外側に電気エネルギーを発することと、前記長尺状部材の外側から電気エネルギーを受け取ることとの少なくとも一方を行うように構成されている、請求項1に記載のカテーテル。
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