JP7387633B2 - 直径方向に対向する感知電極を有する可撓性マルチアームカテーテル - Google Patents
直径方向に対向する感知電極を有する可撓性マルチアームカテーテル Download PDFInfo
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Description
心筋内の電気信号は、診断心臓カテーテル上に配置された感知電極によって記録され得る。このような感知電極は、剛性の骨格構造体を含むカテーテル遠位端、又は剛性アームの上に配置されてもよい。剛性の骨格構造は、例えば、両方のそれらの端部でシャフトに固定され、例えばバスケットカテーテルに組み立てられるスパインで作製されてもよい。あるいは、十分に剛性であるアームは、一方の端部のみに保持され得る。
図1は、本発明の一実施形態による、カテーテルに基づく電気生理学的マッピングシステム20の概略的な絵画図である。システム20はカテーテル21を含み、カテーテルのシャフト22は、シース23を通って患者28の心臓26に挿入される。カテーテル21の近位端は、制御コンソール31に接続されている。本明細書に記載される実施形態では、カテーテル21は、心臓26の組織の電気生理学的マッピング及び/又は電気解剖学的マッピングなど、任意の好適な診断目的で使用され得る。
図2は、本発明の一実施形態による、軟マルチアーム感知カテーテル40の概略的な絵画図である。分かるように、軟マルチアームカテーテル40は、シャフト22の遠位端に適合される。カテーテル40は、シャフト22の遠位端の中心から斜め外側に延在する複数の可撓性スパインで作製される。次いで、スパインは、シャフト22の遠位端の上で、近位方向に内側に屈曲し、それらの他方の端部は自立し、固定されていない。矩形の感知電極24の形態の多数の金属要素は、対向する方向からの信号の検出を可能にするように、可撓性スパイン27の2つのファセットの上にパターン形成される。
(1) 医療用器具であって、
患者の体内に挿入するためのシャフトと、
前記シャフトの遠位端に接続されたそれぞれの第1の端部と、自立しかつ固定されていないそれぞれの第2の端部とを有する、複数の可撓性スパインであって、前記スパインは、前記第2の端部が前記第1の端部よりも近位になるように近位に屈曲され、前記可撓性スパインのそれぞれが、前記可撓性スパインを近位に屈曲させるように構成された引張層を備える、可撓性スパインと、
前記可撓性スパインの上に配置された複数の電極と、を備える、医療用器具。
(2) 前記複数の電極は、前記可撓性スパインの直径方向に対向する表面上に配置されている、実施態様1に記載の医療用器具。
(3) 前記可撓性スパイン及び前記電極が、回路基板、及び前記回路基板上に配置された金属要素をそれぞれ含む、実施態様1に記載の医療用器具。
(4) 前記回路基板は、前記複数の電極が、前記回路基板の直径方向に対向するファセットの上に配置されるように折り畳まれている、実施態様3に記載の医療用器具。
(5) 前記引張層のそれぞれが、前記可撓性スパインを近位に屈曲させるように構成された1つ以上の引張繊維を含む、実施態様1に記載の医療用器具。
(7) 製造方法であって、
複数の電極が配置された複数の可撓性スパインを製造することと、
シャフトの遠位端に前記複数の可撓性スパインを取り付けることであって、前記複数の可撓性スパインが、前記シャフトの遠位端に接続されたそれぞれの第1の端部と、自立しかつ固定されていないそれぞれの第2の端部とを有し、前記スパインは、前記第2の端部が前記第1の端部よりも近位になるように近位に屈曲され、前記可撓性スパインのそれぞれが、前記可撓性スパインを近位に屈曲させるように構成された引張層を備える、取り付けることと、を含む、製造方法。
(8) 前記スパインを製造することが、複数の電極を前記可撓性スパインの直径方向に対向する表面上に配置することを含む、実施態様7に記載の製造方法。
(9) 前記スパインを製造することが、前記電極を回路基板上に配置することを含む、実施態様7に記載の製造方法。
(10) 前記スパインを製造することは、前記複数の電極が前記回路基板の直径方向に対向するファセットの上に配置されるように、前記回路基板を折り畳むことを含む、実施態様9に記載の製造方法。
(12) 前記スパインを製造することが、同じ寸法のニチノール合金層の引張強度よりも大きい引張強度を有する引張層を含むことを含む、実施態様7に記載の製造方法。
(13) 製造方法であって、
複数の可撓性回路基板上に電極及び導電線をパターン形成することと、
可撓性スパインを形成するように、前記可撓性回路基板の対を、引張材料の層が各対の前記回路基板間に挟まれた状態で積層することと、
シャフトの遠位端に複数の前記可撓性スパインを取り付けることであって、前記複数の可撓性スパインが、前記シャフトの遠位端に接続されたそれぞれの第1の端部と、自立しかつ固定されていないそれぞれの第2の端部とを有し、前記スパインは、前記第2の端部が前記第1の端部よりも近位になるように近位に屈曲され、前記可撓性スパインのそれぞれに含まれる引張層は、前記可撓性スパインを近位に屈曲させるように構成されている、取り付けることと、を含む、製造方法。
(14) 製造方法であって、
複数の可撓性回路基板上に電極及び導電線をパターン形成することと、
引張材料で作られた1つ以上の繊維上で、前記回路基板のそれぞれの長手方向軸に沿って前記可撓性回路基板を折り畳んで、前記繊維が、パターン形成された前記可撓性基板の2つの直径方向に対向するファセット間に挟まれるようにし、可撓性スパインを形成することと、
シャフトの遠位端に複数の前記可撓性スパインを取り付けることであって、前記複数の可撓性スパインが、前記シャフトの遠位端に接続されたそれぞれの第1の端部と、自立しかつ固定されていないそれぞれの第2の端部とを有し、前記スパインは、前記第2の端部が前記第1の端部よりも近位になるように近位に屈曲され、前記可撓性スパインのそれぞれに含まれる引張層は、前記可撓性スパインを近位に屈曲させるように構成されている、取り付けることと、を含む、製造方法。
(15) 医療用器具であって、
長手方向軸に沿って近位端から遠位端まで延在する、カテーテルシャフトと、
前記カテーテルシャフトから前記遠位端に向かって延在する複数の可撓性スパインと、を含み、各可撓性スパインは、
前記カテーテルシャフトの前記遠位端に接続されたそれぞれの第1の端部と、自立しかつ固定されていないそれぞれの第2の端部と、
前記長手方向軸に面する前記スパインの表面上に配置された第1の複数の電極と、
前記長手方向軸から離れる方向に面する前記スパインの表面上に配置された第2の複数の電極と、
895MPaを超える引張強度を有する前記第1の複数の電極と前記第2の複数の電極との間に配置された引張部材と、を備える、医療用器具。
Claims (8)
- 医療用器具であって、
患者の体内に挿入するためのシャフトと、
前記シャフトの遠位端に接続されたそれぞれの第1の端部と、自立しかつ固定されていないそれぞれの第2の端部とを有する、複数の可撓性スパインであって、前記可撓性スパインは、前記第2の端部が前記第1の端部よりも近位になるように近位に屈曲され、前記可撓性スパインのそれぞれが、前記可撓性スパインを近位に屈曲させるように構成された引張層を備える、可撓性スパインと、
前記可撓性スパインの上に配置された複数の電極と、を備え、
前記可撓性スパイン及び前記電極が、回路基板、及び前記回路基板上に配置された金属要素をそれぞれ含み、
前記回路基板は、前記複数の電極が前記回路基板の直径方向に対向する面の上に配置され、前記対向する面によって前記引張層が挟み込まれるように折り畳まれている、医療用器具。 - 前記引張層のそれぞれが、前記可撓性スパインを近位に屈曲させるように構成された1つ以上の引張繊維を含む、請求項1に記載の医療用器具。
- 前記引張層の引張強度が、同じ寸法のニチノール合金層の引張強度よりも大きい、請求項1に記載の医療用器具。
- 製造方法であって、
複数の電極が配置された複数の可撓性スパインを製造することと、
シャフトの遠位端に前記複数の可撓性スパインを取り付けることであって、前記複数の可撓性スパインが、前記シャフトの遠位端に接続されたそれぞれの第1の端部と、自立しかつ固定されていないそれぞれの第2の端部とを有し、前記可撓性スパインは、前記第2の端部が前記第1の端部よりも近位になるように近位に屈曲され、前記可撓性スパインのそれぞれが、前記可撓性スパインを近位に屈曲させるように構成された引張層を備える、取り付けることと、を含み、
前記可撓性スパインを製造することが、前記電極を回路基板上に配置することを含み、
前記可撓性スパインを製造することは、前記回路基板を、前記複数の電極が前記回路基板の直径方向に対向する面の上に配置され、前記対向する面によって前記引張層が挟み込まれるように折り畳むことを含む、製造方法。 - 前記可撓性スパインを製造することが、前記可撓性スパインを近位に屈曲させるように、前記スパインのそれぞれに1つ以上の引張繊維を適合させることを含む、請求項4に記載の製造方法。
- 前記可撓性スパインを製造することが、同じ寸法のニチノール合金層の引張強度よりも大きい引張強度を有する引張層を含むことを含む、請求項4に記載の製造方法。
- 製造方法であって、
複数の可撓性回路基板上に電極及び導電線をパターン形成することと、
引張材料で作られた1つ以上の繊維上で、前記可撓性回路基板のそれぞれの長手方向軸に沿って前記可撓性回路基板を折り畳んで、前記繊維が、パターン形成された前記可撓性回路基板の2つの直径方向に対向するファセット間に挟まれるようにし、可撓性スパインを形成することと、
シャフトの遠位端に複数の前記可撓性スパインを取り付けることであって、前記複数の可撓性スパインが、前記シャフトの遠位端に接続されたそれぞれの第1の端部と、自立しかつ固定されていないそれぞれの第2の端部とを有し、前記可撓性スパインは、前記第2の端部が前記第1の端部よりも近位になるように近位に屈曲され、前記可撓性スパインのそれぞれに含まれる引張層は、前記可撓性スパインを近位に屈曲させるように構成されている、取り付けることと、を含み、
前記可撓性スパインを形成することが、前記電極を前記可撓性回路基板上に配置することを含み、
前記可撓性スパインを形成することは、前記可撓性回路基板を、複数の前記電極が前記可撓性回路基板の直径方向に対向する面の上に配置されるように折り畳むことを含む、製造方法。 - 前記複数の電極が、
前記シャフトの長手方向軸に面する前記可撓性スパインの表面上に配置された第1の複数の電極と、
前記長手方向軸から離れる方向に面する前記可撓性スパインの表面上に配置された第2の複数の電極と、を備え、
895MPaを超える引張強度を有する前記第1の複数の電極と前記第2の複数の電極との間に配置された引張部材を備える、請求項1に記載の医療用器具。
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US20210127999A1 (en) | 2019-11-05 | 2021-05-06 | Biosense Webster (Israel) Ltd. | Using Statistical Characteristics of Multiple Grouped ECG Signals to Detect Inconsistent Signals |
US11931182B2 (en) | 2019-12-09 | 2024-03-19 | Biosense Webster (Israel) Ltd. | Catheter with plurality of sensing electrodes used as ablation electrode |
US20210169567A1 (en) | 2019-12-09 | 2021-06-10 | Biosense Webster (Israel) Ltd. | Irreversible-electroporation (ire) balloon catheter with membrane-insulated high-voltage balloon wires |
US20210169568A1 (en) | 2019-12-09 | 2021-06-10 | Biosense Webster (Israel) Ltd. | Oriented irreversible-electroporation (ire) pulses to compensate for cell size and orientation |
US11950930B2 (en) | 2019-12-12 | 2024-04-09 | Biosense Webster (Israel) Ltd. | Multi-dimensional acquisition of bipolar signals from a catheter |
US11684302B2 (en) | 2019-12-13 | 2023-06-27 | Biosense Webster (Israel) Ltd. | Automated graphical presentation of electrophysiological parameters |
US11040208B1 (en) | 2019-12-17 | 2021-06-22 | Biosense Webster (Israel) Ltd. | Distributed cardiac pacing system |
US11517218B2 (en) | 2019-12-20 | 2022-12-06 | Biosense Webster (Israel) Ltd. | Selective graphical presentation of electrophysiological parameters |
US11006902B1 (en) | 2019-12-23 | 2021-05-18 | Biosense Webster (Israel) Ltd. | GUI for selective operation of multi-electrode catheters |
US11484367B2 (en) | 2019-12-27 | 2022-11-01 | Biosense Webster (Israel) Ltd. | Device and method of determining location of sheath using electromagnetic sensors on sheath |
US20210196372A1 (en) | 2019-12-31 | 2021-07-01 | Biosense Webster (Israel) Ltd. | Using irrigation on irreversible-electroporation (ire) electrodes to prevent arcing |
US11730414B2 (en) | 2020-01-21 | 2023-08-22 | Biosense Webster (Israel) Ltd. | Automatic pattern acquisition |
US20210278936A1 (en) | 2020-03-09 | 2021-09-09 | Biosense Webster (Israel) Ltd. | Electrophysiological user interface |
US11497427B2 (en) | 2020-03-12 | 2022-11-15 | Biosense Webster (Israel) Ltd. | Adjusting annotation points in real time |
US20210307815A1 (en) | 2020-04-07 | 2021-10-07 | Biosense Webster (Israel) Ltd. | Basket Catheter with Solid Conducting Spines as Electrodes for IRE |
US11553961B2 (en) | 2020-04-30 | 2023-01-17 | Biosense Webster (Israel) Ltd. | Catheter with stretchable irrigation tube |
-
2018
- 2018-04-11 US US15/950,994 patent/US20190314083A1/en not_active Abandoned
-
2019
- 2019-04-09 EP EP19724919.6A patent/EP3773188A1/en active Pending
- 2019-04-09 JP JP2020555334A patent/JP7387633B2/ja active Active
- 2019-04-09 WO PCT/IB2019/052928 patent/WO2019197996A1/en unknown
- 2019-04-09 CN CN201980024994.1A patent/CN112020324A/zh active Pending
-
2020
- 2020-10-07 IL IL277850A patent/IL277850A/en unknown
- 2020-12-11 US US17/119,949 patent/US11992259B2/en active Active
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JP2017516588A (ja) | 2014-06-04 | 2017-06-22 | ボストン サイエンティフィック サイムド,インコーポレイテッドBoston Scientific Scimed,Inc. | 電極組立体 |
JP2017124159A (ja) | 2015-12-09 | 2017-07-20 | バイオセンス・ウエブスター・(イスラエル)・リミテッドBiosense Webster (Israel), Ltd. | 二重ノードマルチレイ電極カテーテル |
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JP2021520880A (ja) | 2021-08-26 |
EP3773188A1 (en) | 2021-02-17 |
US20190314083A1 (en) | 2019-10-17 |
US11992259B2 (en) | 2024-05-28 |
US20210093377A1 (en) | 2021-04-01 |
CN112020324A (zh) | 2020-12-01 |
WO2019197996A1 (en) | 2019-10-17 |
IL277850A (en) | 2020-11-30 |
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