JP7191977B2 - 電気用量を設定するための装置および方法 - Google Patents
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- 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
- A61N1/02—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
- A61N1/0556—Cuff 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
- 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
- A61N1/36153—Voltage
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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
- A61N1/361—Phantom sensations, e.g. tinnitus
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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
- A61N1/36146—Control systems specified by the stimulation parameters
- A61N1/3615—Intensity
-
- 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
- A61N1/36171—Frequency
-
- 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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Description
本特許は、2018年4月9日に出願された(APPARATUSES AND METHODS FOR SETTING AN ELECTRICAL DOSE」)という名称の米国仮特許出願第62/655,122号に基づく優先権を主張する。
参照による組込み
Vp = √(Tp x Vs) = √(Tp x Ts x Rs) (1)
Vp= 4 * √Vs (2)
一例では、各神経の最大耐容治療電圧は、上述の方法を使用して決定された。埋め込まれた装置は、図1および図2に示す装置と同様であった。埋込み式神経変調装置が埋め込まれた患者は、回復することができ、次いで変調によって誘起された感覚を報告するよう訓練された。
最初に感じられた - 「今治療を感じ始めた」
弱い - 「注意すると気づくにすぎない」
強い - 「強い感覚だが苦にならない」
非常に強い - 「15~20分間耐えることができる最も強い感覚」
強すぎる - 「この感覚に数分より長く耐えることができない」
103 リード
105 波形発生器
107 切断患者
131 コントローラ
303 ランプアップ期間
305 持続ピーク変調時間
309 例
311 第2のプロファイル
Claims (23)
- 患者に埋め込まれた神経変調装置の治療量を設定するための神経変調装置の作動方法であって、前記治療量が、ピーク変調電圧に達するための治療ランプアップ時間と、電圧が前記ピーク変調電圧で持続される持続ピーク変調時間とを含む、治療量継続期間を含み、前記作動方法が、
前記神経変調装置が、テスト電圧ランプから、前記患者に固有の目標感覚強度変調電圧を決定するステップと、
前記神経変調装置が、前記治療ランプアップ時間と前記目標感覚強度変調電圧との積の平方根として推定ピーク変調電圧を計算するステップであって、前記治療ランプアップ時間は、前記治療量継続期間の設定された割合の時間である、ステップと、
前記神経変調装置が、前記推定ピーク変調電圧を使用して、前記治療量を設定するステップと
を含む、神経変調装置の作動方法。 - 前記ピーク変調電圧までの前記治療ランプアップ時間が、前記治療量継続期間の半分となるように設定される、請求項1に記載の作動方法。
- 前記治療量継続期間が、30分となるように設定される、請求項1に記載の作動方法。
- 前記目標感覚強度変調電圧を決定するステップが、治療量に対して前記患者が耐えることができる最も強い感覚を示す患者報告フィードバックが、前記テスト電圧ランプの適用中に受け取られるとき、適用されている前記テスト電圧ランプの電圧を決定するステップを含む、請求項1に記載の作動方法。
- 前記神経変調装置が、前記テスト電圧ランプから前記患者に固有の、患者が感知できる最小変調電圧を決定するステップをさらに含み、さらに前記治療量を設定するステップが、前記患者が感知できる最小変調電圧を、前記治療量のための開始電圧として使用するステップを含む、請求項1に記載の作動方法。
- 前記患者が感知できる最小変調電圧を決定するステップが、前記テスト電圧ランプの適用中に患者報告フィードバックを受け取るステップを含む、請求項5に記載の作動方法。
- 前記治療量を設定するステップが、前記埋め込まれた神経変調装置または前記埋め込まれた神経変調装置と通信しているコントローラにおいて前記治療量を設定するステップを含む、請求項1に記載の作動方法。
- 前記推定ピーク変調電圧を使用して前記治療量を設定する前に、前記神経変調装置が、前記治療量継続期間、前記ピーク変調電圧に達するための前記治療ランプアップ時間、および前記持続ピーク変調時間のうちの1つ以上を設定するステップをさらに含む、請求項1に記載の作動方法。
- 前記神経変調装置が、適用される前記テスト電圧ランプの高周波成分を設定し、前記治療量の高周波成分を、適用される前記テスト電圧ランプの前記高周波成分に設定するステップをさらに含む、請求項1に記載の作動方法。
- 適用される前記テスト電圧ランプの前記高周波成分が、1kHz~100kHzである、請求項9に記載の作動方法。
- 前記神経変調装置が、患者に埋め込まれた前記神経変調装置の代替治療量を設定するステップをさらに含み、代替治療量が、前記ピーク変調電圧の60%~95%である代替ピーク変調電圧を含む、請求項1に記載の作動方法。
- 患者に埋め込まれた神経変調装置の治療量を設定するための神経変調装置の作動方法であって、前記治療量が、ピーク変調電圧に達するための治療ランプアップ時間と、電圧が前記ピーク変調電圧で持続される持続ピーク変調時間とを含む、治療量継続期間を含み、前記作動方法が、
前記神経変調装置が、テスト電圧ランプから、前記患者に固有の患者が感知できる最小変調電圧を決定するステップと、
前記神経変調装置が、前記テスト電圧ランプから、前記患者に固有の目標感覚強度変調電圧を決定するステップと、
前記神経変調装置が、前記目標感覚強度変調電圧の平方根と前記ピーク変調電圧に達するための前記治療ランプアップ時間の関数との積として推定ピーク変調電圧を計算するステップであって、前記治療ランプアップ時間は、前記治療量継続期間の設定された割合の時間である、ステップと、
前記神経変調装置が、前記推定ピーク変調電圧を使用し、かつ前記患者が感知できる最小変調電圧を前記治療量のための開始電圧として使用して、前記治療量を設定するステップと
を含む、作動方法。 - システムであって、
埋込み式の神経変調装置と、
前記神経変調装置による治療量の適用を制御するためのコントローラであって、前記治療量が、ピーク変調電圧に達するための治療ランプアップ時間と、電圧が前記ピーク変調電圧で持続される持続ピーク変調時間とを含む、治療量継続期間を含み、前記コントローラが、1つ以上のプロセッサを含む、コントローラと、
1つ以上の前記プロセッサに結合されたメモリであって、前記メモリは、コンピュータプログラム命令を記憶するように構成され、前記コンピュータプログラム命令は、1つ以上の前記プロセッサによって実行される場合にコンピュータ実装方法を実施する、メモリと、
を備え、
前記コンピュータ実装方法が、
患者に埋め込まれた前記神経変調装置がテスト電圧ランプを適用するステップと、
前記神経変調装置が、前記テスト電圧ランプから、前記患者に固有の目標感覚強度変調電圧を決定するステップであって、前記目標感覚強度変調電圧が、前記テスト電圧ランプの適用中に患者が耐えることができる最大電圧である、ステップと、
前記神経変調装置が、前記治療ランプアップ時間と前記目標感覚強度変調電圧との積の平方根として推定ピーク変調電圧を計算するステップであって、前記治療ランプアップ時間は、前記治療量継続期間の設定された割合の時間である、ステップと、
前記神経変調装置が、前記推定ピーク変調電圧を使用して、前記治療量を設定するステップと
を含むシステム。 - 前記ピーク変調電圧までの前記治療ランプアップ時間が、前記治療量継続期間の半分となるように設定される、請求項13に記載のシステム。
- 前記治療量継続期間が、30分となるように設定される、請求項13に記載のシステム。
- 前記目標感覚強度変調電圧を決定するステップが、治療量に対して前記患者が耐えることができる最も強い感覚を示す患者報告フィードバックが、前記テスト電圧ランプの前記適用中に受け取られるとき、適用されている前記テスト電圧ランプの電圧を決定するステップを含む、請求項13に記載のシステム。
- 前記コンピュータ実装方法が、前記テスト電圧ランプから前記患者に固有の、患者が感知できる最小変調電圧を決定するステップをさらに含み、さらに前記治療量を設定するステップが、前記患者が感知できる最小変調電圧を、前記治療量のための開始電圧として使用するステップを含む、請求項13に記載のシステム。
- 前記患者が感知できる最小変調電圧を決定するステップが、前記テスト電圧ランプの前記適用中に患者報告フィードバックを受け取るステップを含む、請求項17に記載のシステム。
- 前記治療量を設定するステップが、前記埋め込まれた神経変調装置または前記埋め込まれた神経変調装置と通信しているコントローラにおいて前記治療量を設定するステップを含む、請求項13に記載のシステム。
- 前記コンピュータ実装方法が、前記推定ピーク変調電圧を使用して前記治療量を設定する前に、前記治療量継続期間、前記ピーク変調電圧に達するための前記治療ランプアップ時間、および前記持続ピーク変調時間のうちの1つ以上を設定するステップをさらに含む、請求項13に記載のシステム。
- 前記コンピュータ実装方法が、適用される前記テスト電圧ランプの高周波成分を設定し、前記治療量の高周波成分を、適用される前記テスト電圧ランプの前記高周波成分に設定するステップをさらに含む、請求項13に記載のシステム。
- 適用される前記テスト電圧ランプの高周波成分が、1kHz~100kHzである、請求項21に記載のシステム。
- 前記コンピュータ実装方法が、患者に埋め込まれた前記神経変調装置の代替治療量を設定するステップをさらに含み、前記代替治療量が、前記ピーク変調電圧の60%~95%である代替ピーク変調電圧を含む、請求項13に記載のシステム。
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US201862655122P | 2018-04-09 | 2018-04-09 | |
US62/655,122 | 2018-04-09 | ||
PCT/US2019/025707 WO2019199558A1 (en) | 2018-04-09 | 2019-04-04 | Apparatuses and methods for setting an electrical dose |
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KR (1) | KR102505594B1 (ja) |
CN (1) | CN112188915A (ja) |
AU (1) | AU2019253298A1 (ja) |
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US11413458B2 (en) | 2011-05-19 | 2022-08-16 | Neuros Medical, Inc. | Nerve cuff electrode for neuromodulation in large human nerve trunks |
AU2018385603B2 (en) | 2017-12-13 | 2024-05-02 | Neuros Medical Inc | Nerve cuff deployment devices |
JP7191977B2 (ja) | 2018-04-09 | 2022-12-19 | ニューロス・メディカル・インコーポレイティッド | 電気用量を設定するための装置および方法 |
WO2021163308A1 (en) | 2020-02-11 | 2021-08-19 | Neuros Medical, Inc. | System and method for quantifying qualitative patient-reported data sets |
WO2023215884A1 (en) * | 2022-05-05 | 2023-11-09 | Pyles Stephen T | Neural dose calculation |
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JP2021520872A (ja) | 2021-08-26 |
WO2019199558A1 (en) | 2019-10-17 |
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US20220072310A1 (en) | 2022-03-10 |
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CA3096599A1 (en) | 2019-10-17 |
US11730963B2 (en) | 2023-08-22 |
US20240001122A1 (en) | 2024-01-04 |
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US20190308020A1 (en) | 2019-10-10 |
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