JP2023501446A - 閉ループ神経調節のための方法、システム、および装置 - Google Patents
閉ループ神経調節のための方法、システム、および装置 Download PDFInfo
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- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
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- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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Abstract
Description
Claims (55)
- 被験者の体内に埋め込まれた第1の血管内担体に結合される第1の電極アレイを使用して、前記被験者の電気生理学的信号を検知するステップと、
前記被験者の体内に移植されるとともに前記第1の電極アレイに電気的に結合された神経調節部を使用して、前記電気生理学的信号を解析するステップと、
前記被験者の頭蓋底よりも上方に移植された第2の血管内担体に結合されるとともに前記神経調節部に電気的に結合された第2の電極アレイを使用して、検知された前記電気生理学的信号に応答して前記被験者の体内の目的の部位を刺激するステップと、
を含む、てんかんを処置する方法。 - 前記体内の目的の部位を刺激するステップは、前記神経調節部のパルス発生器を使用して電気的インパルスを生成するステップをさらに含む、請求項1に記載の方法。
- 前記体内の目的の部位が、前記被験者の迷走神経の一部である、請求項1に記載の方法。
- 前記体内の目的の部位が前記迷走神経の上神経節である、請求項3に記載の方法。
- 前記第2の血管内担体が内頸静脈の一部内に移植され、前記第2の血管内担体の少なくとも一部が、前記被験者の頸静脈孔よりも上方に移植される、請求項3に記載の方法。
- 前記第2の血管内担体が内頸動脈の一部内に移植され、前記第2の血管内担体の少なくとも一部が前記被験者の前記頭蓋底よりも上方に移植される、請求項3に記載の方法。
- 前記体内の目的の部位が前記被験者の小脳である、請求項1に記載の方法。
- 前記第2の血管内担体が、前記被験者のS字状静脈洞および直静脈洞のうちの少なくとも1つの中に移植される、請求項7に記載の方法。
- 前記体内の目的の部位が前記被験者の運動皮質である、請求項1に記載の方法。
- 前記第2の血管内担体が、下矢状静脈洞、中央溝静脈、後中央溝静脈、および前中央溝静脈のうちの少なくとも1つの中に移植される、請求項9に記載の方法。
- 前記第2の血管内担体が浅大脳静脈内に移植される、請求項1に記載の方法。
- 前記第2の血管内担体が、ラベ静脈、トロラード静脈、シルビウス静脈、およびローランディック静脈のうちの少なくとも1つの中に移植される、請求項11に記載の方法。
- 前記第2の血管内担体は、深大脳静脈内に移植される、請求項1に記載の方法。
- 前記第2の血管内担体が、ローゼンタール静脈、ガレン静脈、上視床線条体静脈、および内大脳静脈のうちの少なくとも1つの中に移植される、請求項13に記載の方法。
- 前記第1の血管内担体が、前記被験者の上矢状静脈洞、下矢状静脈洞、S字状静脈洞、横静脈洞、および直静脈洞のうちの少なくとも1つの中に移植される、請求項1に記載の方法。
- 前記第1の血管内担体が、ラベ静脈、トロラード静脈、シルビウス静脈、およびローランディック静脈のうちの少なくとも1つの中に移植される、請求項1に記載の方法。
- 前記第1の血管内担体が、ローゼンタール静脈、ガレン静脈、上視床線条体静脈、および内大脳静脈のうちの少なくとも1つの中に移植される、請求項1に記載の方法。
- 前記第1の血管内担体が、中央溝静脈、後中央溝静脈、および前中央溝静脈のうちの少なくとも1つの中に移植される、請求項1に記載の方法。
- 前記第1の血管内担体および前記第2の血管内担体のうちの少なくとも一方が、前記被験者の海馬を通って延びる血管内に移植される、請求項1に記載の方法。
- 前記第1の血管内担体および前記第2の血管内担体のうちの少なくとも一方が、前記被験者の扁桃体を通って延びる血管内に移植される、請求項1に記載の方法。
- 前記神経調節部が、前記被験者の前腕内に移植される、請求項1に記載の方法。
- 前記第1の電極アレイは、第1のリード直径を有する第1の伝送リードを介して前記神経調節部に電気的に結合され、前記第1の伝送リードは、前記被験者の首部を通って延び、前記第1のリード直径は、約0.5mm乃至1.5mmである、請求項1に記載の方法。
- 前記第2の電極アレイは、第2のリード直径を有する第2の伝送リードを介して前記神経調節部に電気的に結合され、前記第2の伝送リードは、前記被験者の首部を通って延び、前記第2のリード直径は、約0.5mm乃至1.5mmである、請求項1に記載の方法。
- 前記第1の電極アレイおよび前記第2の電極アレイは、リード直径を有する1本の伝送リードを介して前記神経調節部に結合され、前記1本の伝送リードは、前記被験者の首部を通って延び、前記リード直径は、約0.5mm乃至1.5mmである、請求項1に記載の方法。
- 前記パルス発生器は、体外装置によって電力を供給されて、作動される、請求項2に記載の方法。
- 前記パルス発生器が第1の磁気構成要素からなり、前記体外装置が前記第1の磁気構成要素に磁気的に結合されるように構成された第2の磁気構成要素からなり、前記体外装置が前記パルス発生器の近傍に配置されたときに電磁誘導を介して前記体外装置によって前記パルス発生器が充電されるように構成されている、請求項25に記載の方法。
- 前記体外装置がアームバンドの一部として設けられる、請求項25に記載の方法。
- 前記第1の血管内担体および前記第2の血管内担体のうちの少なくとも一方が、電極アレイを含む拡張可能なステントまたは血管内スキャフォールドであり、前記電極アレイは、前記拡張可能なステントまたは血管内スキャフォールドに結合される、請求項1に記載の方法。
- 前記第1の血管内担体および前記第2の血管内担体のうちの少なくとも一方が、自己拡張型ステントまたは自己拡張型血管内スキャフォールドである、請求項28に記載の方法。
- 前記第1の血管内担体および前記第2の血管内担体のうちの少なくとも一方が、電極アレイを含むとともに巻かれたまたはコイル状に構成されたワイヤーまたはケーブルであり、前記電極アレイはワイヤーまたはケーブルに結合される、請求項1に記載の方法。
- 前記第1の血管内担体および前記第2の血管内担体のうちの少なくとも一方が、内腔または血管壁を貫通するための鋭い遠位端からなるワイヤーまたはケーブルである、請求項1に記載の方法。
- 前記第1の血管内担体および前記第2の血管内担体のうちの少なくとも一方が、アンカーを含むワイヤーまたはケーブルであり、前記アンカーが、さかとげ付きアンカーおよび半径方向に拡張可能なアンカーのうちの少なくとも一方である、請求項1に記載の方法。
- 前記神経調節部は、遠隔測定部をさらに備え、同遠隔測定部は、前記電気生理学的信号を1つ以上の信号閾値またはパターンと比較することによって検知された前記電気生理学的信号を解析するように構成されている、請求項1に記載の方法。
- 前記電気生理学的信号が、前記被験者の脳内で測定された局所電位(LFP)および頭蓋内脳波(EEG)のうちの少なくとも一方である、請求項1に記載の方法。
- 前記電気生理学的信号が皮質脳波信号である、請求項1に記載の方法。
- 前記第1の血管内担体および前記第2の血管内担体が、白金タングステン、金、アルミニウム、ニチノール・ワイヤー、ロジウム、イリジウム、ニッケル、ニッケル-クロム合金、金-パラジウム-ロジウム合金、クロム-ニッケル-モリブデン合金およびステンレス鋼のうちの少なくとも1つで部分的に形成される、請求項1に記載の方法。
- 前記電気的インパルスを生成するステップが、前記電気的インパルスの電流振幅を0.1mAずつ0mAから最大10mAまで増加させるステップと、前記電気的インパルスの電圧を0.25Vずつ0Vから最大10Vまで増加させるステップと、をさらに含み、前記電気的インパルスのパルス幅が25μS乃至約600μSであり、前記電気的インパルスの周波数が1Hz乃至400Hzである、請求項2に記載の方法。
- 前記被験者の前記電気生理学的信号を検知するに先だって、1本の送達カテーテルを介して前記第1の血管内担体および前記第2の血管内担体を送達するステップをさらに含む、請求項1に記載の方法。
- 前記被験者の前記電気生理学的信号を検知するに先だって、前記第1の血管内担体を第1の送達カテーテルを通して送達し、前記第2の血管内担体を第2の送達カテーテルを通して送達するステップをさらに含む、請求項1に記載の方法。
- 被験者の体内に移植されるように構成された第1の血管内担体に結合された第1の電極アレイであって、前記被験者の電気生理学的信号を検知するように構成された第1の電極アレイと、
前記被験者の頭蓋底よりも上方に移植されるように構成された第2の血管内担体に結合された第2の電極アレイであって、前記被験者の体内の目的の部位を刺激するように構成された第2の電極アレイと、
前記第1の電極アレイおよび前記第2の電極アレイに電気的に結合された移植可能な神経調節部であって、前記神経調節部は、前記第1の電極アレイによって検知された前記電気生理学的信号を解析し、検知された前記電気生理学的信号に応答して前記体内の目的の部位を刺激するために前記第2の電極アレイに伝達する電気的インパルスをパルス発生器を介して生成するように構成される、神経調節部と、
を備える、神経調節システム。 - 前記電気的インパルスを生成するように構成されたパルス発生器をさらに備え、前記パルス発生器は、前記第2の電極アレイに電気的に結合される、請求項40に記載の神経調節システム。
- 前記神経調節部および前記パルス発生器のうちの少なくとも一方は、体外装置によって電力が供給され、作動される、請求項41に記載の神経調節システム。
- 前記パルス発生器が第1の磁気構成要素からなり、前記体外装置が前記第1の磁気構成要素に磁気的に結合されるように構成された第2の磁気構成要素からなり、前記体外装置が前記パルス発生器の近傍に配置されたときに電磁誘導を介して前記体外装置によって前記パルス発生器が充電されるように構成されている、請求項42に記載の神経調節システム。
- 前記神経調節部は、前記被験者の前腕内に移植されるように構成され、前記体外装置は、アームバンドの一部として設けられる、請求項42に記載の神経調節システム。
- 前記第1の血管内担体および前記第2の血管内担体のうちの少なくとも一方が、電極アレイを含む拡張可能なステントまたは血管内スキャフォールドであり、前記電極アレイは前記拡張可能なステントまたは前記血管内スキャフォールドに結合される、請求項40に記載の神経調節システム。
- 前記第1の血管内担体および前記第2の血管内担体のうちの少なくとも一方は、自己拡張型ステントまたは自己拡張型血管内スキャフォールドである、請求項45に記載の神経調節システム。
- 前記第1の血管内担体および前記第2の血管内担体のうちの少なくとも一方が、電極アレイを含むとともに巻かれるかまたはコイル状にされるように構成されたワイヤーまたはケーブルであり、前記電極アレイは前記ワイヤーまたは前記ケーブルに結合される、請求項40に記載の神経調節システム。
- 前記第1の血管内担体および前記第2の血管内担体のうちの少なくとも一方が、内腔または血管壁を貫通するための鋭い遠位端を含むワイヤーまたはケーブルである、請求項40に記載の神経調節システム。
- 前記第1の血管内担体および前記第2の血管内担体のうちの少なくとも一方が、アンカーを構成するワイヤーまたはケーブルである、請求項40に記載の神経調節システム。
- 前記神経調節部は、遠隔測定部をさらに備え、同遠隔測定部は、前記電気生理学的信号を1つ以上の信号閾値またはパターンと比較することによって検知された前記電気生理学的信号を解析するように構成されている、請求項40に記載の神経調節システム。
- 前記電気生理学的信号が、前記被験者の脳内で測定された局所電位(LFP)および頭蓋内脳波(EEG)のうちの少なくとも一方である、請求項40に記載の神経調節システム。
- 前記電気生理学的信号は、皮質脳波信号である、請求項40に記載の神経調節システム。
- 前記第1の電極アレイおよび前記第2の電極アレイは、共有伝送ワイヤーを介して前記神経調節部に結合される、請求項40に記載の神経調節システム。
- 前記パルス発生器が、前記電気的インパルスの電流振幅を0.1mAずつ0mAから最大10mAまで増加させ、前記電気的インパルスの電圧を0.25Vずつ0Vから最大10Vまで増加させることにより前記電気的インパルスを生成するように構成され、生成された前記電気的インパルスのパルス幅が25μS乃至約600μSであるように構成され、生成された前記電気的インパルスの周波数が1Hz乃至400Hzであるように構成される、請求項41に記載の神経調節システム。
- 被験者の頭蓋底よりも上方に移植された血管内担体に結合された第1の電極アレイを使用して、前記被験者の電気生理学的信号を検知するステップと、
前記第1の電極アレイに電気的に結合された神経調節部を使用して、前記電気生理学的信号を解析するステップと、
同じ血管内担体に結合されるとともに前記神経調節部に電気的に結合された第2の電極アレイであって、その電極が前記第1の電極アレイの電極とは別体である、第2の電極アレイを使用して、検知された前記電気生理学的信号に応答して前記被験者の体内の目的の部位を刺激するステップと、
を含む、てんかんを処置する方法。
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