JP4965556B2 - 経脈管神経刺激デバイス - Google Patents
経脈管神経刺激デバイス Download PDFInfo
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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
- A61N1/056—Transvascular endocardial electrode systems
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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
- A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
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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
- A61N1/0558—Anchoring or fixation means therefor
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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
- A61N1/36053—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for vagal stimulation
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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
- A61N1/3606—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
- A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
- A61N1/36114—Cardiac control, e.g. by vagal stimulation
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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
- A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
- A61N1/36114—Cardiac control, e.g. by vagal stimulation
- A61N1/36117—Cardiac control, e.g. by vagal stimulation for treating hypertension
-
- 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
- A61N1/362—Heart stimulators
- A61N1/3627—Heart stimulators for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
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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
- A61N1/362—Heart stimulators
- A61N1/3629—Heart stimulators in combination with non-electric therapy
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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
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/37211—Means for communicating with stimulators
- A61N1/37217—Means for communicating with stimulators characterised by the communication link, e.g. acoustic or tactile
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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
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/37211—Means for communicating with stimulators
- A61N1/37252—Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
- A61N1/37288—Communication to several implantable medical devices within one patient
Description
優先権の利益が、2005年4月11日に提出された米国特許出願整理番号第11/103,245号に対して、請求され、この出願が参照によって本明細書に組み込まれる。
図1Aをここで参照すると、埋込み可能な心臓デバイス100の実施形態が、心臓に向かって延びている導線200とともに、患者の胸の中に皮下または筋肉下で配置されている。少なくとも1つの導線200が、血管内に配置されかつ血管の脈管外表面上のまたはその近くの神経を経脈管刺激するように位置調整された電極295と結合されている。経脈管刺激は、刺激中の神経との直接の接触を回避し、かつ直接刺激によって誘発される神経の炎症または損傷に付随する問題を減少させる。導線は、胸郭との一体性を維持するために、脈管構造を通って埋め込まれる。脈管内供給される導線を使用した経脈管刺激は、カフ電極と比較して、神経支配の解剖学的目標や点への比較的非侵襲性のアクセスを提供する。
図3Aは、血管310内に埋め込まれた例示的な膨張可能な電極305の断面図を示している。ある例では、膨張可能な電極が、その少なくとも一部分が導電性であるメッシュを備える。ある例では、膨張可能な電極が、プラチナまたはプラチナ・イリジウムから形成されている。ある実施形態では、膨張可能な電極305は、ステントに類似している。
電極は、交感または副交感神経系の幹または分枝の近くの様々な位置を含む、体内の様々な位置に埋め込まれてもよい。
図1Aに示されている例を再び参照すると、埋込み可能なデバイス100が、血管内に挿入されかつ電極295と結合された導線200と結合されている。電気的信号が導線200を通して電極295へ送られ、血管の脈管外表面上の神経を経脈管刺激する。デバイス100は、心臓内に血管内螺合された1つまたは複数のCRT導線を通して、オプションで、心臓の再同調治療(CRT)を行うことができる。CRT導線は、デバイス100を、心房および/または心室の感知またはペーシングのために使用される電極300と接続する。経脈管刺激電極296が、CRT導線と結合されている。いくつかの実施形態は、固有心臓電気信号を処理し、かつ電極295、296のうちの1つを通して応答性神経刺激治療を行う。オプションで、サテライトユニット110が、神経刺激のための電極を備え、かつ無線リンクまたは体を通る伝導を介してデバイス100と通信する通信回路を備える。サテライトユニット110電極が、血管の壁を通して迷走神経などの神経を経脈管刺激するために、内頚動脈などの血管内に埋め込まれている。
神経刺激治療は、不整脈、心不全、高血圧、失神、または起立不耐症を含むがそれに限定されない、様々な状態のうちの1つまたは複数を治療するために使用される。ある例では、遠心性末梢神経が、埋め込まれた膨張可能な電極によって経脈管刺激される。別の例では、求心性末梢神経が刺激される。
図5をここで参照すると、経脈管神経刺激を与えるための例示的な方法は、505で、医療デバイスを埋め込むステップを含む。510で、電極が、心臓末梢神経幹などの神経幹の近くの血管内に長期的に埋め込まれる。ある例では、電極は、ステントなどの膨張可能な電極である。ある例では、膨張可能な電極が、摩擦力によって電極を定位置に固定するような寸法にされている膨張した直径を有する。ある例では、膨張可能な電極が、閉塞を防止する、または電極から電気的刺激を受ける脈管壁または神経の炎症を防止する薬剤溶出被覆を備える。ある例では、電極が、神経幹が血管の脈管外表面に沿って延びている位置で血管内に埋め込まれる。ある例では、電極が、末梢神経幹の近くの血管内に埋め込まれる。ある例では、末梢神経幹が、交感または副交感神経を含む。ある例では、電極が、SVC、冠状静脈洞、または奇静脈などの血管内の迷走心臓神経の近くに埋め込まれる。別の例では、電極が、内頸静脈内に埋め込まれる。
Claims (14)
- 心不全の治療を行うために内頸静脈(IJV)から頸部領域の迷走神経幹を経脈管刺激するための埋込み可能な装置であって、
内頸静脈(IJV)内に長期的に埋込み可能な膨張可能な電極を備え、前記膨張可能な電極は、迷走神経幹の近傍の内頸静脈(IJV)の脈管内表面と当接するように構成されており、
さらに、前記膨張可能な電極と結合された電気導線と、
前記導線と結合され、かつ前記導線を通して前記電極へ電気的刺激信号を送るように構成された埋込み可能なパルス発生器とを備え、
前記装置は、内頸静脈(IJV)から迷走神経幹を経脈管刺激するように構成されており、
さらに、前記埋込み可能なパルス発生器と通信するように構成されたコントローラを備え、前記コントローラは、プログラム可能な電気パルス治療を送るようにプログラムされて、心不全のリモデリングを阻害するように構成されており、前記心不全を阻害するための電気パルス治療は、内頸静脈(IJV)内の前記膨張可能な電極から迷走神経幹に送るようになっている、
ことを特徴とする装置。 - 前記膨張可能な電極は、内頸静脈(IJV)の所定の長さに沿って、内頸静脈(IJV)の所定の血管内の表面領域と当接するように構成されていることを特徴とする、請求項1に記載の装置。
- 前記所定の血管内の表面領域は、0.25平方センチメートルから5平方センチメートルであることを特徴とする、請求項2に記載の装置。
- 前記所定の長さは、0.5センチメートルから2.0センチメートルであることを特徴とする、請求項2に記載の装置。
- 前記膨張可能な電極はメッシュを備え、前記メッシュの少なくとも一部分が導電性であることを特徴とする、請求項1に記載の装置。
- 前記膨張可能な電極は、内頸静脈(IJV)の内側に埋め込まれるように構成された、薬剤溶出構成要素を備えており、前記薬剤溶出構成要素は、炎症を低下させる薬剤を溶出させ、或いは、閉塞を防止する薬剤を溶出させるようになっていることを特徴とする、請求項1に記載の装置。
- 前記膨張可能な電極はステントを備えることを特徴とする、請求項1に記載の装置。
- 前記コントローラは、さらに、心筋梗塞の後の抗不整脈治療を施すように、内頸静脈(IJV)内の前記電極を使用して、迷走神経幹を経脈管刺激するようにプログラムされていることを特徴とする、請求項1に記載の装置。
- 前記埋込み可能なパルス発生器は、20ヘルツのパルス列を電極へ送るように構成されていることを特徴とする、請求項1に記載の装置。
- 生理学的特性を感知し、前記感知された生理学的特性に応答して神経刺激を経脈管で送るために、電極へ電気信号を送る手段をさらに備えることを特徴とする、請求項1に記載の装置。
- 前記膨張可能な電極は、膨張されたときに直径が0.5センチメートルから1.5センチメートルであることを特徴とする、請求項1に記載の装置。
- 前記膨張可能な電極は、内頸静脈(IJV)の壁に接触するための電極表面領域を有しており、前記電極表面領域の全てが導電性であることを特徴とする、請求項1に記載の装置。
- 前記膨張可能な電極は、内頸静脈(IJV)の壁に接触するための電極表面領域を有しており、前記電極表面領域の一部が非導電性であることを特徴とする、請求項1に記載の装置。
- さらに、右心室導線と、左心室導線とを有しており、前記装置は、前記右心室導線と前記左心室導線とを使用して、心筋組織を捕捉するようになっており、前記装置は、前記右心室導線と前記左心室導線とを使用して、心臓の再同調治療を行うようになっていることを特徴とする、請求項1に記載の装置。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US11/103,245 US7499748B2 (en) | 2005-04-11 | 2005-04-11 | Transvascular neural stimulation device |
US11/103,245 | 2005-04-11 | ||
PCT/US2006/011882 WO2006110338A1 (en) | 2005-04-11 | 2006-03-28 | Transvascular neural stimulation device |
Publications (3)
Publication Number | Publication Date |
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JP2008535624A JP2008535624A (ja) | 2008-09-04 |
JP2008535624A5 JP2008535624A5 (ja) | 2009-05-14 |
JP4965556B2 true JP4965556B2 (ja) | 2012-07-04 |
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JP2008506496A Expired - Fee Related JP4965556B2 (ja) | 2005-04-11 | 2006-03-28 | 経脈管神経刺激デバイス |
Country Status (4)
Country | Link |
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US (4) | US7499748B2 (ja) |
EP (3) | EP2277583A3 (ja) |
JP (1) | JP4965556B2 (ja) |
WO (1) | WO2006110338A1 (ja) |
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-
2005
- 2005-04-11 US US11/103,245 patent/US7499748B2/en active Active
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2006
- 2006-03-28 EP EP20100181314 patent/EP2277583A3/en not_active Withdrawn
- 2006-03-28 JP JP2008506496A patent/JP4965556B2/ja not_active Expired - Fee Related
- 2006-03-28 EP EP20100181222 patent/EP2301623A3/en not_active Withdrawn
- 2006-03-28 WO PCT/US2006/011882 patent/WO2006110338A1/en active Application Filing
- 2006-03-28 EP EP20060740184 patent/EP1871460A1/en not_active Withdrawn
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2009
- 2009-02-13 US US12/371,153 patent/US20090149900A1/en not_active Abandoned
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- 2010-12-15 US US12/968,831 patent/US8929990B2/en active Active
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EP2277583A2 (en) | 2011-01-26 |
US7499748B2 (en) | 2009-03-03 |
WO2006110338A1 (en) | 2006-10-19 |
EP2277583A3 (en) | 2011-06-29 |
US20110082537A1 (en) | 2011-04-07 |
US8929990B2 (en) | 2015-01-06 |
JP2008535624A (ja) | 2008-09-04 |
EP2301623A2 (en) | 2011-03-30 |
EP2301623A3 (en) | 2011-06-22 |
EP1871460A1 (en) | 2008-01-02 |
US20090149900A1 (en) | 2009-06-11 |
US20060229677A1 (en) | 2006-10-12 |
US20150119790A1 (en) | 2015-04-30 |
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