JP6876363B2 - 埋込可能な神経刺激器の充電を最適化する周波数調製のための方法およびシステム - Google Patents
埋込可能な神経刺激器の充電を最適化する周波数調製のための方法およびシステム 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
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/378—Electrical supply
- A61N1/3787—Electrical supply from an external energy source
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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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- H—ELECTRICITY
- H02—GENERATION; CONVERSION OR DISTRIBUTION OF ELECTRIC POWER
- H02J—CIRCUIT ARRANGEMENTS OR SYSTEMS FOR SUPPLYING OR DISTRIBUTING ELECTRIC POWER; SYSTEMS FOR STORING ELECTRIC ENERGY
- H02J50/00—Circuit arrangements or systems for wireless supply or distribution of electric power
- H02J50/10—Circuit arrangements or systems for wireless supply or distribution of electric power using inductive coupling
- H02J50/12—Circuit arrangements or systems for wireless supply or distribution of electric power using inductive coupling of the resonant type
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- H—ELECTRICITY
- H02—GENERATION; CONVERSION OR DISTRIBUTION OF ELECTRIC POWER
- H02J—CIRCUIT ARRANGEMENTS OR SYSTEMS FOR SUPPLYING OR DISTRIBUTING ELECTRIC POWER; SYSTEMS FOR STORING ELECTRIC ENERGY
- H02J50/00—Circuit arrangements or systems for wireless supply or distribution of electric power
- H02J50/80—Circuit arrangements or systems for wireless supply or distribution of electric power involving the exchange of data, concerning supply or distribution of electric power, between transmitting devices and receiving devices
-
- H—ELECTRICITY
- H02—GENERATION; CONVERSION OR DISTRIBUTION OF ELECTRIC POWER
- H02J—CIRCUIT ARRANGEMENTS OR SYSTEMS FOR SUPPLYING OR DISTRIBUTING ELECTRIC POWER; SYSTEMS FOR STORING ELECTRIC ENERGY
- H02J7/00—Circuit arrangements for charging or depolarising batteries or for supplying loads from batteries
- H02J7/007—Regulation of charging or discharging current or voltage
- H02J7/0071—Regulation of charging or discharging current or voltage with a programmable schedule
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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
- A61N1/36007—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of urogenital or gastrointestinal organs, e.g. for incontinence control
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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
- A61N1/36107—Sexual dysfunction
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- H—ELECTRICITY
- H02—GENERATION; CONVERSION OR DISTRIBUTION OF ELECTRIC POWER
- H02J—CIRCUIT ARRANGEMENTS OR SYSTEMS FOR SUPPLYING OR DISTRIBUTING ELECTRIC POWER; SYSTEMS FOR STORING ELECTRIC ENERGY
- H02J2310/00—The network for supplying or distributing electric power characterised by its spatial reach or by the load
- H02J2310/10—The network having a local or delimited stationary reach
- H02J2310/20—The network being internal to a load
- H02J2310/23—The load being a medical device, a medical implant, or a life supporting device
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- H—ELECTRICITY
- H02—GENERATION; CONVERSION OR DISTRIBUTION OF ELECTRIC POWER
- H02J—CIRCUIT ARRANGEMENTS OR SYSTEMS FOR SUPPLYING OR DISTRIBUTING ELECTRIC POWER; SYSTEMS FOR STORING ELECTRIC ENERGY
- H02J7/00—Circuit arrangements for charging or depolarising batteries or for supplying loads from batteries
- H02J7/00032—Circuit arrangements for charging or depolarising batteries or for supplying loads from batteries characterised by data exchange
- H02J7/00034—Charger exchanging data with an electronic device, i.e. telephone, whose internal battery is under charge
Description
本出願は、2016年1月29日に出願された“Methods and Systems for Frequency Adjustment to Optimize Charging of Implantable Neurostimulator”と題する米国仮出願番号第62/289,073号に基づく優先権の利益を主張しており、その全体は、本明細書によって参考として本明細書中に援用される。
本発明は、神経刺激処置システムおよび関連デバイス、ならびにそのような処置システムの処置、埋込、および構成の方法に関する。
埋込可能神経刺激システムを用いた処置は、近年、ますます一般的になっている。そのようなシステムは、いくつかの状態を処置する際に有望性を示しているが、処置の有効性は、患者間で著しく変動し得る。いくつかの要因は、患者が経験する非常に異なる転帰につながり得、処置の実行可能性は、埋込の前に判定することが困難であり得る。例えば、刺激システムは、多くの場合、1つまたはそれを上回る標的神経構造を処置するために、電極のアレイを利用する。電極は、多くの場合、多電極導線上にともに搭載され、導線は、標的神経構造への電極の電気結合をもたらすことを意図している位置において患者の組織に埋め込まれ、典型的には、結合の少なくとも一部は、中間組織を介して提供される。他のアプローチもまた、例えば、標的神経構造を覆う皮膚に取り付けられる、標的神経の周囲でカフに埋め込まれる、もしくは同等物である、1つまたはそれを上回る電極とともに、採用されてもよい。それにもかかわらず、医師は、典型的には、電極に印加される電気刺激を変動させることによって、適切な処置プロトコルの確立を模索する。
本開示の一側面は、1つまたはそれを上回る電気パルスを患者の身体内の標的領域に送達するための埋込可能神経刺激装置と結合するための充電器に関する。充電器は、電気エネルギーを貯蔵するための電源と、複数の自然(固有)周波数を有するように構成され得る、共振回路と、電源および共振回路に結合される、ドライバであって、共振回路を給電し得る、ドライバと、共振回路に結合され、共振回路の自然周波数を制御するためのプロセッサとを含む。いくつかの実施形態では、プロセッサは、埋込可能神経刺激装置と関連付けられた記憶されたデータに従って、共振回路の自然周波数を制御することができる。
本発明は、神経刺激処置システムおよび関連デバイス、ならびにそのような処置システムの処置、埋込/留置、および構成の方法に関する。1つの特定の実施形態では、本発明は、過活動膀胱(「OAB」)を処置し、膀胱関連機能不全の症状を緩和するように構成される、仙骨神経刺激処置システムに関する。しかしながら、本発明はまた、当業者によって理解されるであろうように、排便機能不全等の任意の種々の神経調節用途、運動または情動障害等の疼痛もしくは他の適応症の処置にも利用され得ることが理解され得る。
I.神経刺激適応症
II.仙骨神経調節
A.仙骨神経調節システムの埋込
B.EMGとともに神経刺激導線を位置付ける
C.例示的実施形態
Claims (38)
- 1つまたはそれを上回る電気パルスを患者の身体内の標的領域に送達するための埋込可能神経刺激装置と結合するための充電器であって、
電気エネルギーを貯蔵するための電源と、
共振回路であって、複数の自然周波数に構成可能である、共振回路と、
前記電源および前記共振回路に結合される、ドライバであって、前記共振回路を給電するように構成される、ドライバと、
前記共振回路に結合され、前記共振回路の自然周波数を制御するためのプロセッサであって、前記共振回路の自然振動数が前記埋込可能神経刺激装置の自然振動数に対応するように前記埋込可能神経刺激装置と関連付けられた記憶されたデータに従って、前記共振回路の自然周波数を制御するように構成される、プロセッサと、
を備える、充電器。 - 前記埋込可能神経刺激装置と関連付けられた記憶されたデータに従って、前記共振回路の自然周波数を制御することは、
前記埋込可能神経刺激装置を識別する識別データを前記埋込可能神経刺激装置から受信することと、
特性評価データを読み出すことであって、前記特性評価データは、前記埋込可能神経刺激装置の共振回路の自然周波数を識別する、ことと、
を含む、請求項1に記載の充電器。 - 前記埋込可能神経刺激装置と関連付けられた記憶されたデータに従って、前記共振回路の自然周波数を制御することは、
前記充電器の共振回路の第1の自然周波数を検出することと、
前記充電器の共振回路の第1の自然周波数と前記特性評価データを比較することと、
前記充電器の共振回路の自然周波数を前記第1の自然周波数から第2の自然周波数に変化させることと、
を含む、請求項2に記載の充電器。 - 前記充電器の共振回路の第1の自然周波数を検出することは、前記ドライバの駆動周波数の判定または前記共振回路のリンギングの検出のうちの少なくとも1つを含む、請求項3に記載の充電器。
- 前記第2の自然周波数は、前記特性評価データに対応する、請求項3または4のいずれかに記載の充電器。
- 前記共振回路は、
インダクタと、
前記インダクタに直列に結合される、第1のコンデンサと、
前記インダクタに切替可能に結合可能な複数のコンデンサであって、それぞれ、前記インダクタに切替可能に結合されると、前記第1のコンデンサと並列であるように構成される、複数のコンデンサと、
を備える、請求項3から5のいずれかに記載の充電器。 - 前記複数のコンデンサは、3つのコンデンサを備える、請求項6に記載の充電器。
- 前記複数のコンデンサはそれぞれ、トランジスタを介して、前記インダクタに切替可能に結合可能である、請求項6または7のいずれかに記載の充電器。
- 前記トランジスタは、電界効果トランジスタである、請求項8に記載の充電器。
- 前記充電器の共振回路の自然周波数を前記第1の自然周波数から第2の自然周波数に変化させることは、
前記第1の自然周波数をもたらす前記共振回路の第1のスイッチ構成を識別することと、
前記第2の自然周波数をもたらす前記共振回路の第2のスイッチ構成を識別することと、
前記インダクタからの前記複数のコンデンサのうちの少なくとも1つを接続解除するための前記共振回路内の少なくとも1つのスイッチの開放または前記インダクタからの前記複数のコンデンサのうちの少なくとも1つを接続するための前記共振回路内の少なくとも1つのスイッチの閉鎖のうちの少なくとも1つを制御するための制御信号を発生させることと、
を含む、請求項6から9のいずれかに記載の充電器。 - 前記充電器の共振回路の自然周波数を前記第1の自然周波数から前記第2の自然周波数に変化させることは、
前記第1の自然周波数をもたらす前記共振回路内のインダクタの第1のインダクタンスを識別することと、
前記第2の自然周波数をもたらす前記共振回路内のインダクタの第2のインダクタンスを識別することと、
前記インダクタのインダクタンスを前記第1のインダクタンスから前記第2のインダクタンスに変化させるための制御信号を発生させることと、
を含む、請求項3から5のいずれかに記載の充電器。 - 前記インダクタのインダクタンスを前記第1のインダクタンスから前記第2のインダクタンスに変化させることは、前記インダクタのコアの飽和レベルを第1の飽和レベルから第2の飽和レベルに変化させることを含む、請求項11に記載の充電器。
- 前記インダクタのコアの飽和レベルを前記第1の飽和レベルから前記第2の飽和レベルに変化させることは、前記インダクタのコアに印加される電圧を第1の電圧から第2の電圧に変化させることを含む、請求項12に記載の充電器。
- 前記第1の自然周波数は、繰り返し検出される、請求項3から5のいずれかに記載の充電器。
- 前記第1の自然周波数は、周期的に検出される、請求項3から5のいずれかに記載の充電器。
- 前記共振回路の自然周波数は、20Hzの範囲内で調節されることができる、請求項3から5のいずれかに記載の充電器。
- 前記共振回路の自然周波数は、10Hzの範囲内で調節されることができる、請求項3から5のいずれかに記載の充電器。
- 前記共振回路の自然周波数は、約119Hz〜130Hzで調節されることができる、請求項3から5のいずれかに記載の充電器。
- 前記ドライバは、クラス−Eドライバを備える、請求項1から18のいずれかに記載の充電器。
- 前記埋込可能神経刺激装置と関連付けられた記憶されたデータは、前記埋込可能神経刺激装置を識別し、前記埋込可能神経刺激装置の自然周波数を識別する、請求項1から18のいずれかに記載の充電器。
- 1つまたはそれを上回る電気パルスを患者の身体内の標的領域に送達するための神経刺激システムであって、
埋込可能神経刺激装置であって、
患者の身体内に埋め込まれるように構成される外部表面を有する、密閉筐体であって、セラミック伝送領域を備える、筐体と、
前記密閉筐体のセラミック領域を通して電力を受信するように構成される、充電回路と、
を備える、埋込可能神経刺激装置と、
埋込可能神経刺激装置と結合するための充電器であって、
共振回路であって、複数の自然周波数に構成可能である、共振回路と、
前記共振回路の自然振動数が前記埋込可能神経刺激装置の自然振動数に対応するように前記埋込可能神経刺激装置の充電回路の自然周波数を識別する記憶されたデータに従って、前記共振回路に結合され、前記共振回路の自然周波数を制御するためのプロセッサと、
を備える、充電器と、
を備える、神経刺激システム。 - 前記プロセッサは、前記埋込可能神経刺激装置の充電回路の自然周波数を識別する特性評価データに従って、前記共振回路の自然周波数を制御するように構成される、請求項21に記載の神経刺激システム。
- 前記特性評価データは、前記埋込可能神経刺激装置と一意に関連付けられ、前記特性評価データは、前記充電器におけるメモリ内のデータベースに記憶される、請求項22に記載の神経刺激システム。
- 前記特性評価データは、前記充電器が前記埋込可能神経刺激装置と結合されると、前記充電器において前記埋込可能神経刺激装置から受信される、請求項22および23のいずれかに記載の神経刺激システム。
- 前記特性評価データは、前記データベースが前記埋込可能神経刺激装置のための特性評価データを含有しないとき、前記充電器によって生成される、請求項23のいずれかに記載の神経刺激システム。
- 前記特性評価データを生成することは、
前記共振回路の自然周波数を制御し、前記共振回路の複数の自然周波数を反復的に循環させることと、
前記埋込可能神経刺激装置から、前記共振回路の複数の自然周波数と前記埋込可能神経刺激装置の充電回路の自然周波数との間の整合のレベルを示すデータを反復的に受信することと、
前記複数の自然周波数のうちの1つを前記埋込可能神経刺激装置の充電回路の自然周波数として識別することと、
を含む、請求項25に記載の神経刺激システム。 - 前記識別された前記複数の自然周波数のうちの1つは、前記埋込可能神経刺激装置の充電回路の自然周波数に最良に整合する、前記複数の自然周波数のうちの1つである、請求項26に記載の神経刺激システム。
- 前記識別された前記複数の自然周波数のうちの1つは、デフォルト自然周波数である、請求項26から27のいずれかに記載の神経刺激システム。
- 充電器と1つまたはそれを上回る電気パルスを患者の身体内の標的領域に送達するための埋込可能神経刺激装置を結合するための方法であって、
電源に結合されるドライバを用いて、充電器の共振回路を給電するステップであって、前記共振回路は、複数の自然周波数に構成可能である、ステップと、
前記共振回路の第1の自然周波数を判定するステップと、
記憶された特性評価データを読み出すステップであって、前記特性評価データは、前記埋込可能神経刺激装置の共振回路の自然周波数を識別する、ステップと、
前記特性評価データに従って、プロセッサによって発生される制御信号を用いて、前記共振回路の自然周波数を前記第1の自然周波数から第2の自然周波数に変化させるステップであって、前記第2の自然振動数が前記埋込可能神経刺激装置の自然振動数に対応する、ステップと、
を含む、方法。 - 前記充電器の共振回路の自然周波数を判定するステップは、前記ドライバの駆動周波数の判定または前記共振回路のリンギングの検出のうちの少なくとも1つを含む、請求項29に記載の方法。
- 前記共振回路は、
インダクタと、
前記インダクタに直列に結合される、第1のコンデンサと、
前記インダクタに切替可能に結合可能な複数のコンデンサであって、それぞれ、前記インダクタに切替可能に結合されると、前記第1のコンデンサと並列であるように構成される、複数のコンデンサと、
を備える、請求項29および30のいずれかに記載の方法。 - 前記複数のコンデンサは、3つのコンデンサを備える、請求項31に記載の方法。
- 前記複数のコンデンサはそれぞれ、トランジスタを介して、前記インダクタに切替可能に結合可能である、請求項31および32のいずれかに記載の方法。
- 前記充電器の共振回路の自然周波数を前記第1の自然周波数から第2の自然周波数に変化させるステップは、
前記第1の自然周波数をもたらす前記共振回路の第1のスイッチ構成を識別することと、
前記第2の自然周波数をもたらす前記共振回路の第2のスイッチ構成を識別することと、
前記インダクタからの前記複数のコンデンサのうちの少なくとも1つを接続解除するための前記共振回路内の少なくとも1つのスイッチの開放または前記インダクタからの前記複数のコンデンサのうちの少なくとも1つを接続するための前記共振回路内の少なくとも1つのスイッチの閉鎖のうちの少なくとも1つを制御するための制御信号を発生させることと、
を含む、請求項33に記載の方法。 - 前記充電器の共振回路の自然周波数を前記第1の自然周波数から第2の自然周波数に変化させることは、
前記第1の自然周波数をもたらす前記共振回路内のインダクタの第1のインダクタンスを識別することと、
前記第2の自然周波数をもたらす前記共振回路内のインダクタの第2のインダクタンスを識別することと、
前記インダクタのインダクタンスを前記第1のインダクタンスから前記第2のインダクタンスに変化させるための制御信号を発生させることと、
を含む、請求項30に記載の方法。 - 前記特性評価データは、前記充電器におけるメモリ内のデータベースから読み出される、請求項29に記載の方法。
- 前記特性評価データは、前記充電器によって生成される、請求項29に記載の方法。
- 前記特性評価データを生成することは、
前記共振回路の自然周波数を制御し、前記共振回路の複数の自然周波数を反復的に循環させることと、
前記埋込可能神経刺激装置から、前記共振回路の複数の自然周波数と前記埋込可能神経刺激装置の充電回路の自然周波数との間の整合のレベルを示すデータを反復的に受信することと、
前記複数の自然周波数のうちの1つを前記埋込可能神経刺激装置の充電回路の自然周波数として識別することと、
を含む、請求項37に記載の方法。
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AU2017212551A1 (en) | 2018-08-02 |
EP3407965A4 (en) | 2019-12-18 |
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