JP5048656B2 - 埋め込み型神経刺激装置用安全管理システム - Google Patents
埋め込み型神経刺激装置用安全管理システム Download PDFInfo
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- JP5048656B2 JP5048656B2 JP2008513543A JP2008513543A JP5048656B2 JP 5048656 B2 JP5048656 B2 JP 5048656B2 JP 2008513543 A JP2008513543 A JP 2008513543A JP 2008513543 A JP2008513543 A JP 2008513543A JP 5048656 B2 JP5048656 B2 JP 5048656B2
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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
- A61N1/36142—Control systems for improving safety
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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
- A61N1/36128—Control systems
- A61N1/36135—Control systems using physiological parameters
- A61N1/36139—Control systems using physiological parameters with automatic adjustment
-
- 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
- A61N1/37—Monitoring; Protecting
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- Heart & Thoracic Surgery (AREA)
- Physiology (AREA)
- Biophysics (AREA)
- Electrotherapy Devices (AREA)
Description
参照により本明細書に組み込まれている、2005年5月24日に出願された米国特許出願第11/135、883号への優先権の利益をここに主張する。
Claims (17)
- 神経刺激パルスを伝送するための少なくとも1つの刺激チャネルを含む刺激出力回路と、
前記刺激出力回路に結合され、複数の刺激パラメータを用いて前記神経刺激パルスの伝送を制御するための刺激コントローラと、
前記刺激コントローラに結合された安全コントローラと
を備え、前記安全コントローラが、
前記1つ又は複数の神経刺激パルスのエネルギーである刺激エネルギーを検出するようにされたエネルギー検出モジュールと、各々が前記複数の刺激パラメータの値である1つ又は複数のパラメータ値を検出するようにされた刺激パラメータ検出モジュールとを含む安全管理イベント検出モジュールを有し、この安全管理イベント検出モジュールは、前記刺激エネルギーが所定のエネルギーしきい値を超え、また前記複数の刺激パラメータのうちの第1のパラメータの値である少なくとも第1のパラメータが前記第1のパラメータの第1のしきい値を超えると、安全管理イベントの検出を表示するようにされており、
前記安全コントローラが、前記安全管理イベントの検出に応答して、前記複数の刺激パラメータの1つ又は複数のパラメータを調整するようにされた安全応答モジュールを更に有する、神経刺激システム。 - 前記安全応答モジュールは、前記複数の刺激パラメータのパラメータの値が前記パラメータのしきい値を超えると前記パラメータの値を前記パラメータのしきい値に設定するようにされたパラメータ制限モジュールを備える請求項1に記載の神経刺激システム。
- 前記安全応答モジュールは、前記安全管理イベントが検出されると前記少なくとも1つの刺激チャネルを経て前記神経刺激パルスの伝送を一時停止するための刺激切り換えモジュールを備える請求項1に記載の神経刺激システム。
- 前記エネルギー検出モジュールは、前記少なくとも1つの刺激チャネルを経て伝送される前記神経刺激パルスのうちの1つの神経刺激パルスのエネルギーである前記刺激エネルギーを検出するようにされ、前記安全管理イベント検出モジュールは、前記刺激エネルギーが所定のしきい値エネルギーを超えると、前記安全管理イベントの検出を表示するようにされている請求項1から3のいずれかに記載の神経刺激システム。
- 前記エネルギー検出モジュールは、所定期間にわたり前記少なくとも1つの刺激チャネルを経て伝送される前記神経刺激パルスの全エネルギーである前記刺激エネルギーを検出するようにされ、前記安全管理イベント検出モジュールは、前記刺激エネルギーが所定のしきい値エネルギーを超えると、前記安全管理イベントの検出を表示するようにされた請求項1から4のいずれか1項に記載の神経刺激システム。
- 前記刺激出力回路と、前記刺激コントローラと、前記安全コントローラとを含む神経刺激回路を収容するように構成された埋め込み型ハウジングをさらに備える請求項1から5のいずれか1項に記載の神経刺激システム。
- 前記安全管理イベント検出モジュールは、前記複数の刺激パラメータのうちの第1のパラメータの値である少なくとも第1のパラメータが前記第1のパラメータの第1のしきい値を超えると、前記安全管理イベントの検出を表示するようにされた請求項1から6のいずれか1項に記載の神経刺激システム。
- 前記安全管理イベント検出モジュールは、前記複数の刺激パラメータのうちの第2のパラメータの少なくとも第2のパラメータ値に基づいて、前記第1のパラメータの値を動的に調整するようにされたしきい値調整モジュールをさらに備える請求項7に記載の神経刺激システム。
- 前記安全管理イベント検出モジュールは、前記第1のしきい値を前記複数の刺激パラメータのうちの第2のパラメータの少なくとも第2のパラメータの値と関連付ける参照テーブルをさらに備える請求項7に記載の神経刺激システム。
- 前記刺激コントローラは、
前記神経刺激パルスのパルス振幅であるパルス振幅、
前記神経刺激パルスのパルス幅であるパルス幅、
前記神経刺激パルスがパルス・バーストのバースト伝送中に伝送される周波数である刺激周波数、
前記パルス・バーストのバーストがその間に伝送されるバースト持続時間、
前記神経刺激パルスのバーストがその間に伝送されるバースト間隔、
前記バースト持続時間と前記バースト間隔との比率である刺激デューティ・サイクル
から選択される刺激パラメータを用いて前記神経刺激パルスのパルス・バーストの伝送を制御するようにされた請求項1から9のいずれか1項に記載の神経刺激システム。 - 前記安全管理イベント検出モジュールはさらに、前記神経刺激パルスの伝送に関連する非意図的影響を検出する非意図的影響検出器を備える請求項1から10のいずれか1項に記載の神経刺激システム。
- 前記非意図的影響検出器は、生理学的パラメータの値を検知し、前記検知された値を1つ又は複数のしきい値を含む正常値範囲と比較し、前記検知された値が前記正常値範囲から外れると前記非意図的影響の検出を表示するようにされた生理学的パラメータ検出モジュールを備える請求項11に記載の神経刺激システム。
- 前記非意図的影響検出器は前記非意図的影響の検出を示す信号を受信するようにされた請求項11に記載の神経刺激システム。
- 前記非意図的影響検出器は前記非意図的影響を示す信号を検知し、前記信号から前記非意図的影響を検出するようにされた請求項11に記載の神経刺激システム。
- 前記非意図的影響検出器は非意図的な心臓イベントを検出するための非意図的心臓イベント検出器を備える請求項11から14のいずれか1項に記載の神経刺激システム。
- 前記非意図的影響検出器はさらに、非意図的な肺イベントを検出するための非意図的肺イベント検出器を備える請求項11から15のいずれか1項に記載の神経刺激システム。
- 前記安全応答モジュールは、安全管理イベントが検出されているとき、少なくとも2つの刺激チャネルを経て、神経刺激パルスを伝送の強度を低減するようになったパラメータ制限モジュールを有する請求項1に記載の神経刺激システム。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US11/135,883 | 2005-05-24 | ||
US11/135,883 US7551958B2 (en) | 2005-05-24 | 2005-05-24 | Safety control system for implantable neural stimulator |
PCT/US2006/019142 WO2006127366A1 (en) | 2005-05-24 | 2006-05-17 | Safety control system for implantable neural stimulator |
Publications (3)
Publication Number | Publication Date |
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JP2008541850A JP2008541850A (ja) | 2008-11-27 |
JP2008541850A5 JP2008541850A5 (ja) | 2009-07-02 |
JP5048656B2 true JP5048656B2 (ja) | 2012-10-17 |
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Application Number | Title | Priority Date | Filing Date |
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JP2008513543A Expired - Fee Related JP5048656B2 (ja) | 2005-05-24 | 2006-05-17 | 埋め込み型神経刺激装置用安全管理システム |
Country Status (4)
Country | Link |
---|---|
US (5) | US7551958B2 (ja) |
EP (3) | EP1919553B1 (ja) |
JP (1) | JP5048656B2 (ja) |
WO (1) | WO2006127366A1 (ja) |
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