JP6101405B2 - 閾値以下の変調治療のための電極選択 - Google Patents
閾値以下の変調治療のための電極選択 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
- A61N1/18—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
- A61N1/3615—Intensity
- A61N1/36164—Sub-threshold or non-excitatory signals
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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
- A61N1/36071—Pain
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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
- A61N1/36132—Control systems using patient feedback
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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
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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
- A61N1/36167—Timing, e.g. stimulation onset
- A61N1/36178—Burst or pulse train parameters
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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
-
- 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
- A61N1/37235—Aspects of the external programmer
- A61N1/37247—User interfaces, e.g. input or presentation means
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- Pain & Pain Management (AREA)
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Description
本出願は、2013年6月28日に出願された米国仮特許出願第61/841,216号の合衆国法典第35編第119条(e)に基づく優先権の利益を主張するものであり、この仮特許出願を本明細書に援用する。
Claims (19)
- 患者と共に使用するための神経変調システムであって、
複数の電極セットにそれぞれ結合されるように構成された複数の電気端子と、変調出力回路と、メモリと、制御回路と、を有し、
前記変調出力回路は、閾値以上のアノード電気エネルギ及び閾値以上のカソード電気エネルギを、前記電気端子を介して前記電極セットの各々から患者に個別に送出するように構成され、且つ、閾値以下の電気エネルギを、前記電気端子を介して前記電極セットのうちの1つの有効な電極セットから患者に送出するように構成され、
前記閾値以下の電気エネルギは、患者知覚閾値未満であり、前記閾値以上の電気エネルギは、患者知覚閾値以上であり、患者知覚閾値は、それ未満において患者が前記電気エネルギの送出を感知せず且つそれ以上において患者が前記電気エネルギの送出を感知する境界であり、
前記メモリは、前記電極セットの各々から患者にそれぞれ送出された前記閾値以上のアノード電気エネルギのアノード知覚閾値を記憶するように構成され、且つ、前記電極セットの各々から患者にそれぞれ送出された前記閾値以上のカソード電気エネルギのカソード知覚閾値を記憶するように構成され、
前記制御回路は、前記電極セットの各々の前記アノード知覚閾値と前記カソード知覚閾値の比率を計算するように構成され、且つ、前記計算した比率に基づいて、前記電極セットのうちの1つの電極セットを、前記変調出力回路が前記閾値以下の電気エネルギを患者に送出する前記有効な電極セットとして選択するように構成される、神経変調システム。 - 前記神経変調システムは、脊髄変調(SCM)システムを含み、
前記患者知覚閾値は、それ未満で患者が異常感覚を体験せず、それ以上で患者が異常感覚を体験する境界であり、
前記変調システムは、疼痛を軽減するのに有効な治療電気エネルギを送出するように構成され、前記疼痛を軽減するのに有効な治療電気エネルギは、異常感覚なしに疼痛を軽減するのに有効な閾値以下の電気エネルギを含む、請求項1に記載の神経変調システム。 - 更に、ユーザからの入力を受け取るように構成されたユーザインタフェースを有し、
前記制御回路は、ユーザからの入力に応答して、前記アノード知覚閾値及び前記カソード知覚閾値を記憶するように構成される、請求項1又は2に記載の神経変調システム。 - 更に、モニタ回路を有し、前記モニタ回路は、前記閾値以上のアノード電気エネルギ及び前記閾値以上カソード電気エネルギを前記電極セットの各々から患者に送出することに応答して、患者の誘発複合活動電位(eCAP)を検知するように構成され、
前記制御回路は、前記モニタ回路による誘発複合活動電位(eCAP)の検知に応答して、前記アノード知覚閾値及び前記カソード知覚閾値を記憶するように構成される、請求項1〜3のいずれか1項に記載の神経変調システム。 - 前記制御回路は、ユーザからの入力なしに、前記1つの電極セットを前記有効な電極として自動的に選択するように構成される、請求項1に記載の神経変調システム。
- 前記制御回路は、前記計算した比率に基づいて、複数の候補電極セットを前記複数の電極セットから自動的に選択するように構成され、
前記神経変調システムは、更に、ユーザインタフェースを有し、前記ユーザインタフェースは、前記候補電極セットをユーザに表示して、ユーザからの入力を受け取るように構成され、
前記制御回路は、ユーザからの入力に応答して、前記候補電極セットのうちの1つの候補電極セットを前記有効な電極セットとして選択するように更に構成される、請求項1に記載の神経変調システム。 - 前記制御回路は、前記アノード知覚閾値と前記カソード知覚閾値との間の比率が1に最も近い電極セットを前記有効な電極セットとして選択するように構成される、請求項1〜6のいずれか1項に記載の神経変調システム。
- 前記制御回路は、前記閾値以上の電気エネルギを前記電極セットの各々から送出することに起因して異常感覚が知覚された身体領域を含む異常感覚マップを作成するように構成され、且つ、前記異常感覚マップに基づいて、前記1つの電極セットを前記有効な電極セットとして選択するように構成される、請求項1に記載の神経変調システム。
- 前記制御回路は、疼痛のある身体領域に一致する異常感覚が知覚された身体領域に対応する電極セットを前記有効な電極セットとして選択するように構成される、請求項8に記載の神経変調システム。
- 前記制御回路は、異常感覚が知覚された各身体領域と疼痛のある身体領域との間の相対的一致のカバレージスコアを計算するように構成され、且つ、前記カバレージスコアに基づいて、前記1つの電極セットを前記有効な電極セットとして選択するように構成される、請求項9に記載の神経変調システム。
- 前記制御回路は、前記電極セットの各々について、前記比率及び前記カバレージスコアから合計スコアを計算するように構成され、且つ、最高合計スコアを有する前記1つの電極セットを前記有効な電極セットとして選択するように構成される、請求項10に記載の神経変調システム。
- 前記送出される閾値以下の電気エネルギは、1500Hzよりも高い周波数を有し、又は、前記送出される閾値以下の電気エネルギは、200μsよりも短いパルス持続期間を有する、請求項1〜11のいずれか1項に記載の神経変調システム。
- 前記送出される閾値以下の電気エネルギは、電気パルス列を含む、請求項1〜12のいずれか1項に記載の神経変調システム。
- 前記電気パルス列は、2相パルス列である、請求項13に記載の神経変調システム。
- 前記2相パルス列は、能動的アノード相を有する、請求項14に記載の神経変調システム。
- 前記2相パルス列は、受動的カソード充電相を有する、請求項14に記載の神経変調システム。
- 前記電極セットの各々は、単一の電極を含む、請求項1〜16のいずれか1項に記載の神経変調システム。
- 前記制御回路は、前記比率に基づいて、前記電極セットのうちの別の電極セットを、別の有効な電極セットとして選択するように構成され、
前記変調出力回路は、閾値以下の電気エネルギを前記別の有効な電極セットから患者に送出するように構成される、請求項1〜17のいずれか1項に記載の神経変調システム。 - 前記制御回路は、前記有効な電極セットのアノード知覚閾値及び/又はカソード知覚閾値の間の比率に基づいて、前記有効な電極セットにおける前記閾値以下の電気エネルギの配分を計算するように構成される、請求項18に記載の神経変調システム。
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US201361841216P | 2013-06-28 | 2013-06-28 | |
US61/841,216 | 2013-06-28 | ||
PCT/US2014/044430 WO2014210373A1 (en) | 2013-06-28 | 2014-06-26 | Electrode selection for sub-threshold modulation therapy |
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JP2016523175A JP2016523175A (ja) | 2016-08-08 |
JP6101405B2 true JP6101405B2 (ja) | 2017-03-22 |
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US (3) | US9623250B2 (ja) |
EP (1) | EP3013413B1 (ja) |
JP (1) | JP6101405B2 (ja) |
CN (1) | CN105358214B (ja) |
AU (1) | AU2014302297B2 (ja) |
WO (1) | WO2014210373A1 (ja) |
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
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US10398900B2 (en) | 2013-06-28 | 2019-09-03 | Boston Scientific Neuromodulation Corporation | Electrode selection for sub-threshold modulation therapy |
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CN105358214A (zh) | 2016-02-24 |
CN105358214B (zh) | 2017-05-17 |
EP3013413A1 (en) | 2016-05-04 |
US20180369591A1 (en) | 2018-12-27 |
AU2014302297B2 (en) | 2017-04-13 |
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WO2014210373A1 (en) | 2014-12-31 |
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AU2014302297A1 (en) | 2015-12-24 |
EP3013413B1 (en) | 2017-05-10 |
US20150005842A1 (en) | 2015-01-01 |
US10398900B2 (en) | 2019-09-03 |
JP2016523175A (ja) | 2016-08-08 |
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