JP6481051B2 - 電気刺激を分析し活性化容積を選択又は操作するシステム及び方法 - Google Patents
電気刺激を分析し活性化容積を選択又は操作するシステム及び方法 Download PDFInfo
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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
- A61N1/372—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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- 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
- A61N1/0526—Head electrodes
- A61N1/0529—Electrodes for brain stimulation
- A61N1/0534—Electrodes for deep brain 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
- A61N1/02—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
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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
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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
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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
Description
本出願は、引用によって本明細書に組み込まれる2015年5月26日出願の米国仮特許出願第62/166,569号の「35 U.S.C.§119(e)」の下での利益を主張するものである。
以下に本発明の実施態様を記載する。
(実施態様1)病態又は疾患を処置するための身体の部分の電気刺激が該病態又は疾患の少なくとも1つの症状、刺激効果、又は副作用のうちの少なくとも1つに影響を与える身体の部分を識別するためのシステムであって、
コンピュータプロセッサを含み、このコンピュータプロセッサが、
複数の刺激インスタンスの各々に対して、該刺激インスタンス中に刺激された身体の領域の推定と、前記病態又は疾患の少なくとも1つの症状、刺激効果、又は刺激副作用のうちの各々に対するスコアと、を取得するステップと、
身体の複数の部分の各々に対して、並べ替え試験において前記スコア及び前記推定を使用して、身体の部分の刺激が前記病態又は疾患の少なくとも1つ、刺激効果、又は刺激副作用に影響を与える可能性を決定するステップと、
身体のどの部分が、電気的に刺激された時に、前記病態又は疾患の少なくとも1つの症状、刺激効果、又は刺激副作用のうちの少なくとも1つに影響を与えるかを識別するために、決定された可能性を格納又は表示するステップと、
を含む処理を実行するように構成かつ配置されている、システム。
(実施態様2)前記処理は、前記複数の刺激インスタンスと各刺激インスタンスに対して1組の刺激パラメータとを取得するステップを更に含む、実施態様1に記載のシステム。
(実施態様3)刺激インスタンス中に刺激された身体の領域の推定を取得するステップは、該刺激インスタンス中に使用された刺激パラメータに基づいて該刺激インスタンス中の身体刺激の領域を推定するステップを含む、実施態様1又は2に記載のシステム。
(実施態様4)前記可能性を決定するステップは、身体の選択された部分と選択された病態又は疾患の症状、刺激効果、又は刺激副作用のための複数の行及び列を含むマトリックスを形成するステップを含み、
前記列又は行のうちの1つが、各刺激インスタンスに対応し、
複数の刺激インスタンスの各々に対して、列又は行内の第1のエントリが、身体の選択された部分がその刺激インスタンスにおいて刺激されたか否かを示し、列又は行内の第2のエントリが、その刺激インスタンスに対して選択された病態又は疾患の症状、刺激効果、又は副作用に対する前記スコアに対応する、実施態様1〜3のいずれか1項に記載のシステム。
(実施態様5)前記可能性を決定するステップは、帰無仮説が無効である可能性を決定するステップを更に含み、
前記帰無仮説は、身体の選択された部分が、選択された病態又は疾患の症状、刺激効果、又は副作用に対する前記スコアに影響を与えないということである、実施態様4に記載のシステム。
(実施態様6)前記可能性を決定するステップは、身体の事前選択部分が刺激される場合のスコアと身体の該事前選択部分が刺激されない場合のスコアとの間の差を決定するステップを更に含む、実施態様4に記載のシステム。
(実施態様7)前記可能性を決定するステップは、前記第1のエントリについて前記第2のエントリをランダムに割り当てて複数の追加マトリックスを形成するステップを更に含み、
前記可能性を決定するステップは、任意的に、前記マトリックス及び前記複数の追加マトリックスに基づいて分布を生成するステップを更に含む、実施態様6に記載のシステム。
(実施態様8)病態又は疾患を処置するための身体の部分の電気刺激が該病態又は疾患の少なくとも1つの疾患、刺激効果、又は刺激副作用のうちの少なくとも1つに影響を与える身体の部分を識別するためのシステムであって、
コンピュータプロセッサを含み、このコンピュータプロセッサが、
Nが1よりも大きい整数であるN個の刺激インスタンスと、各刺激インスタンスに対して、前記病態又は疾患の少なくとも1つの症状、刺激効果、又は刺激副作用のうちの各々に対する結果スコアと、を取得するステップと、
Mが1よりも大きい整数である身体のM個の部分を選択するステップと、
N個の刺激インスタンスの各々に対してかつ身体のM個の部分の各々に対して、身体の部分が刺激インスタンス中に刺激されたか否かを推定するステップと、
a)エントリaijを有するN×Mマトリックス、又はb)エントリajiを有するM×Nマトリックスのいずれかであるマトリックスを生成するステップであって、iが1からNに及ぶ整数でありi番目の刺激インスタンスに対応し、jが1からMに及ぶ整数であり身体のj番目の部分に対応し、aij又はajiが、それぞれ、身体のj番目の部分がi番目の刺激インスタンス中に刺激されない場合は0であり、身体のj番目の部分がi番目の刺激インスタンス中に刺激される場合は非ゼロ値である、マトリックスを生成するステップと、
前記マトリックスの疑似逆マトリックスを決定して、前記N個の刺激インスタンスに対する結果スコアにおいて身体の前記M個の部分の各々の影響を推定する、前記マトリックスの疑似逆マトリックスを決定するステップと、
推定された影響を格納又は表示して、身体のどの部分が、電気的に刺激された時に、前記病態又は疾患の少なくとも1つの症状、刺激効果、又は刺激副作用のうちの少なくとも1つに影響を与えるかを識別する、前記推定された影響を格納又は表示するステップと、を含む処理を実行するように構成かつ配置されている、システム。
(実施態様9)前記N個の刺激インスタンスの各々に対してかつ身体のM個の部分の各々に対して、身体の部分が刺激インスタンス中に刺激されたか否かを推定するステップは、前記N個の刺激インスタンスの各々に対してかつ身体の前記M個の部分の各々に対して、身体の部分が刺激インスタンス中に刺激されたか否かを該刺激インスタンス中に使用された刺激パラメータに基づいて推定するステップを含む、実施態様8に記載のシステム。
(実施態様10)N個の刺激インスタンスを取得するステップは、複数の患者から該N個の刺激インスタンスを取得するステップを含む、実施態様8又は9に記載のシステム。
(実施態様11)前記処理は、前記N個の刺激インスタンスに対する結果スコアを含むスコアベクトルを生成するステップを更に含む、実施態様8〜10のいずれか1項に記載のシステム。
(実施態様12)前記マトリックスの疑似逆マトリックスを決定するステップは、該疑似逆マトリックスとスコアベクトルとを使用して影響ベクトル決定するステップを含み、
前記影響ベクトル内の各エントリが、身体の異なる部分に対応し、
前記影響ベクトルのエントリは、前記病態又は疾患の少なくとも1つの症状、刺激効果、又は刺激副作用に対する対応する身体の部分の相対的な影響を示す、実施態様11に記載のシステム。
(実施態様13)電気刺激のための活性化容積を選択又は操作するためのシステムであって、
コンピュータプロセッサを含み、このコンピュータプロセッサが、
和集合ボタン、共通集合ボタン、及び差集合ボタンから選択された少なくとも1つのユーザ起動可能ボタンを含むグラフィカルユーザインタフェースを提示するステップと、 少なくとも2つの活性化容積を表示するステップと、
前記少なくとも1つのユーザ起動可能ボタンのユーザ起動に応答して、前記少なくとも2つの活性化容積のうちの少なくとも2つの和集合、共通集合、又は差集合を表示するステップと、を含む処理を実行するように構成かつ配置されている、システム。
(実施態様14)前記グラフィカルユーザインタフェースは、和集合ボタン、共通集合ボタン、及び差集合ボタンを含む、実施態様13に記載のシステム。
(実施態様15)前記活性化容積は、該活性化容積に関連付けられたメタデータを更に含有し、前記グラフィカルユーザインタフェースは、検索ボタンを更に含み、
前記処理は、
前記検索ボタンのユーザ起動に応答して、該ユーザが1又は2以上の検索語を示すことを可能にするステップと、
前記1又は2以上の検索語を使用して1組の活性化容積のメタデータを検索し、1又は2以上の活性化容積を該1又は2以上の検索語に対応するメタデータに従って分類するステップと、
を更に含む、実施態様13又は14に記載のシステム。
S1 スコア
S2 スコア
S3 スコア
S4 スコア
Claims (14)
- 病態又は疾患を処置するための身体の部分の電気刺激が該病態又は疾患の少なくとも1つの症状、刺激効果、又は副作用のうちの少なくとも1つに影響を与える身体の部分を識別するためのシステムであって、
コンピュータプロセッサを含み、このコンピュータプロセッサが、
複数の刺激インスタンスの各々に対して、該刺激インスタンス中に刺激された身体の領域の推定と、前記病態又は疾患の少なくとも1つの症状、刺激効果、又は刺激副作用のうちの各々に対するスコアと、を取得するステップと、
身体の複数の部分の各々に対して、並べ替え試験において前記スコア及び前記推定を使用して、身体の部分の刺激が前記病態又は疾患の少なくとも1つ、刺激効果、又は刺激副作用に影響を与える可能性を決定するステップと、
身体のどの部分が、電気的に刺激された時に、前記病態又は疾患の少なくとも1つの症状、刺激効果、又は刺激副作用のうちの少なくとも1つに影響を与えるかを識別するために、決定された可能性を格納又は表示するステップと、
を含む処理を実行するように構成かつ配置されている、システム。 - 前記処理は、前記複数の刺激インスタンスと各刺激インスタンスに対して1組の刺激パラメータとを取得するステップを更に含む、請求項1に記載のシステム。
- 刺激インスタンス中に刺激された身体の領域の推定を取得するステップは、該刺激インスタンス中に使用された刺激パラメータに基づいて該刺激インスタンス中の身体刺激の領域を推定するステップを含む、請求項1又は2に記載のシステム。
- 前記可能性を決定するステップは、身体の選択された部分と選択された病態又は疾患の症状、刺激効果、又は刺激副作用のための複数の行及び列を含むマトリックスを形成するステップを含み、
前記列又は行のうちの1つが、各刺激インスタンスに対応し、
複数の刺激インスタンスの各々に対して、列又は行内の第1のエントリが、身体の選択された部分がその刺激インスタンスにおいて刺激されたか否かを示し、列又は行内の第2のエントリが、その刺激インスタンスに対して選択された病態又は疾患の症状、刺激効果、又は副作用に対する前記スコアに対応する、請求項1〜3のいずれか1項に記載のシステム。 - 前記可能性を決定するステップは、帰無仮説が無効である可能性を決定するステップを更に含み、
前記帰無仮説は、身体の選択された部分が、選択された病態又は疾患の症状、刺激効果、又は副作用に対する前記スコアに影響を与えないということである、請求項4に記載のシステム。 - 前記可能性を決定するステップは、身体の事前選択部分が刺激される場合のスコアと身体の該事前選択部分が刺激されない場合のスコアとの間の差を決定するステップを更に含む、請求項4に記載のシステム。
- 前記可能性を決定するステップは、前記第1のエントリについて前記第2のエントリをランダムに割り当てて複数の追加マトリックスを形成するステップを更に含み、
前記可能性を決定するステップは、任意的に、前記マトリックス及び前記複数の追加マトリックスに基づいて分布を生成するステップを更に含む、請求項6に記載のシステム。 - 病態又は疾患を処置するための身体の部分の電気刺激が該病態又は疾患の少なくとも1つの疾患、刺激効果、又は刺激副作用のうちの少なくとも1つに影響を与える身体の部分を識別するためのシステムであって、
コンピュータプロセッサを含み、このコンピュータプロセッサが、
Nが1よりも大きい整数であるN個の刺激インスタンスと、各刺激インスタンスに対して、前記病態又は疾患の少なくとも1つの症状、刺激効果、又は刺激副作用のうちの各々に対する結果スコアと、を取得するステップと、
Mが1よりも大きい整数である身体のM個の部分を選択するステップと、
N個の刺激インスタンスの各々に対してかつ身体のM個の部分の各々に対して、身体の部分が刺激インスタンス中に刺激されたか否かを推定するステップと、
a)エントリaijを有するN×Mマトリックス、又はb)エントリajiを有するM×Nマトリックスのいずれかであるマトリックスを生成するステップであって、iが1からNに及ぶ整数でありi番目の刺激インスタンスに対応し、jが1からMに及ぶ整数であり身体のj番目の部分に対応し、aij又はajiが、それぞれ、身体のj番目の部分がi番目の刺激インスタンス中に刺激されない場合は0であり、身体のj番目の部分がi番目の刺激インスタンス中に刺激される場合は非ゼロ値である、マトリックスを生成するステップと、
前記マトリックスの疑似逆マトリックスを決定して、前記N個の刺激インスタンスに対する結果スコアにおいて身体の前記M個の部分の各々の影響を推定する、前記マトリックスの疑似逆マトリックスを決定するステップと、
推定された影響を格納又は表示して、身体のどの部分が、電気的に刺激された時に、前記病態又は疾患の少なくとも1つの症状、刺激効果、又は刺激副作用のうちの少なくとも1つに影響を与えるかを識別する、前記推定された影響を格納又は表示するステップと、
を含む処理を実行するように構成かつ配置されている、システム。 - 前記N個の刺激インスタンスの各々に対してかつ身体のM個の部分の各々に対して、身体の部分が刺激インスタンス中に刺激されたか否かを推定するステップは、前記N個の刺激インスタンスの各々に対してかつ身体の前記M個の部分の各々に対して、身体の部分が刺激インスタンス中に刺激されたか否かを該刺激インスタンス中に使用された刺激パラメータに基づいて推定するステップを含む、請求項8に記載のシステム。
- N個の刺激インスタンスを取得するステップは、複数の患者から該N個の刺激インスタンスを取得するステップを含む、請求項8又は9に記載のシステム。
- 前記処理は、前記N個の刺激インスタンスに対する結果スコアを含むスコアベクトルを生成するステップを更に含む、請求項8〜10のいずれか1項に記載のシステム。
- 前記マトリックスの疑似逆マトリックスを決定するステップは、該疑似逆マトリックスとスコアベクトルとを使用して影響ベクトル決定するステップを含み、
前記影響ベクトル内の各エントリが、身体の異なる部分に対応し、
前記影響ベクトルのエントリは、前記病態又は疾患の少なくとも1つの症状、刺激効果、又は刺激副作用に対する対応する身体の部分の相対的な影響を示す、請求項11に記載のシステム。 - 病態又は疾患を処置するための身体の部分の電気刺激が該病態又は疾患の少なくとも1つの症状、刺激効果、又は副作用のうちの少なくとも1つに影響を与える身体の部分を識別するためのプロセッサ実行可能命令を有する非一時的コンピュータ可読媒体であって、
前記プロセッサ実行可能命令は、デバイス上にインストールされたときに前記デバイスがアクションを実行することを可能にし、前記アクションは、
複数の刺激インスタンスの各々に対して、該刺激インスタンス中に刺激された身体の領域の推定と、前記病態又は疾患の少なくとも1つの症状、刺激効果、又は刺激副作用のうちの各々に対するスコアと、を取得するステップと、
身体の複数の部分の各々に対して、並べ替え試験において前記スコア及び前記推定を使用して、身体の部分の刺激が前記病態又は疾患の少なくとも1つ、刺激効果、又は刺激副作用に影響を与える可能性を決定するステップと、
身体のどの部分が、電気的に刺激された時に、前記病態又は疾患の少なくとも1つの症状、刺激効果、又は刺激副作用のうちの少なくとも1つに影響を与えるかを識別するために、決定された可能性を格納又は表示するステップと、
を含む、非一時的コンピュータ可読媒体。 - 病態又は疾患を処置するための身体の部分の電気刺激が該病態又は疾患の少なくとも1つの症状、刺激効果、又は刺激副作用のうちの少なくとも1つに影響を与える身体の部分を識別するためのプロセッサ実行可能命令を有する非一時的コンピュータ可読媒体であって、
前記プロセッサ実行可能命令は、デバイス上にインストールされたときに前記デバイスがアクションを実行することを可能にし、前記アクションは、
Nが1よりも大きい整数であるN個の刺激インスタンスと、各刺激インスタンスに対して、前記病態又は疾患の少なくとも1つの症状、刺激効果、又は刺激副作用のうちの各々に対する結果スコアと、を取得するステップと、
Mが1よりも大きい整数である身体のM個の部分を選択するステップと、
N個の刺激インスタンスの各々に対してかつ身体のM個の部分の各々に対して、身体の部分が刺激インスタンス中に刺激されたか否かを推定するステップと、
a)エントリa ij を有するN×Mマトリックス、又はb)エントリa ji を有するM×Nマトリックスのいずれかであるマトリックスを生成するステップであって、iが1からNに及ぶ整数でありi番目の刺激インスタンスに対応し、jが1からMに及ぶ整数であり身体のj番目の部分に対応し、a ij 又はa ji が、それぞれ、身体のj番目の部分がi番目の刺激インスタンス中に刺激されない場合は0であり、身体のj番目の部分がi番目の刺激インスタンス中に刺激される場合は非ゼロ値である、マトリックスを生成するステップと、
前記マトリックスの疑似逆マトリックスを決定して、前記N個の刺激インスタンスに対する結果スコアにおいて身体の前記M個の部分の各々の影響を推定する、前記マトリックスの疑似逆マトリックスを決定するステップと、
推定された影響を格納又は表示して、身体のどの部分が、電気的に刺激された時に、前記病態又は疾患の少なくとも1つの症状、刺激効果、又は刺激副作用のうちの少なくとも1つに影響を与えるかを識別する、前記推定された影響を格納又は表示するステップと、
を含む、非一時的コンピュータ可読媒体。
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