JP6946261B2 - Asicを用いない内部電子機器を有する埋め込み可能神経刺激装置および方法 - Google Patents
Asicを用いない内部電子機器を有する埋め込み可能神経刺激装置および方法 Download PDFInfo
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- A61N1/02—Details
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- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
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- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
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- 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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Description
本願は、米国仮出願第62/191,134号(2015年7月10日出願、名称「IMPLANTABLE NERVE STIMULATOR HAVING INTERNAL ELECTRONICS WITHOUT ASIC AND METHODS OF USE」)の利益を主張し、上記出願の全体は、参照により本明細書に引用される。本願は、以下の出願に関連する:米国仮出願第62/038,122号(2014年8月15日出願、名称「Devices and Methods for Anchoring of Neurostimulation Leads」)、米国仮出願第62/038,131号(2014年8月15日出願、名称「External Pulse Generator Device and Associated Methods for Trial Nerve Stimulation」、代理人事件番号97672−001100US)、米国仮出願第62/041,611号(2014年8月25日出願、名称「Electromyographic Lead Positioning and Stimulation Titration in a Nerve Stimulation System for Treatment of Overactive Bladder,Pain and Other Indicators」、代理人事件番号97672−001200US)、米国仮出願第62/110,274号(2015年1月30日出願、名称「Implantable Lead Affixation Structure for Nerve Stimulation to Alleviate Bladder Dysfunction and Other Indications」、代理人事件番号97672−001010US)、および、米国仮出願第62/101,888号(名称「Electromyographic Lead Positioning and Stimulation Titration in a Nerve Stimulation System for Treatment of Overactive Bladder」、代理人事件番号97672−001210US)、米国仮出願第62,101,899号(名称「Integrated Electromyographic Clinician Programmer For Use With an Implantable Neurostimulator」、代理人事件番号97672−001220US)、米国仮出願第62/101,897号(名称「Systems and Methods for Neurostimulation Electrode Configurations Based on Neural Localization」、代理人事件番号97672−001230US)、米国仮出願第62/101,666号(名称「Patient Remote and Associated Methods of Use With aNerve Stimulation System」、代理人事件番号97672−001400US)、米国仮出願第62/101,884号(名称「Attachment Devices and Associated Methods of Use With aNerve Stimulation Charging Device」、代理人事件番号97672−001500US)、米国仮出願第62/101,782号(名称「Improved Antenna and Methods of Use For an Implantable Nerve Stimulator」、代理人事件番号97672− 001600US)(以上の全ては2015年1月9日出願)。
上記出願の各々は、出願人に譲渡され、あらゆる目的のためにその全体が参照により本明細書に引用される。
本発明は、例えば、以下を提供する。
(項目1)
1つ以上の電気パルスを患者の体内の標的領域に送達するための埋め込み可能神経刺激装置システムであって、
複数の電極を備えている埋め込み可能導線であって、前記複数の電極は、前記導線の遠位端上に位置しており、前記電極は、患者の体内の標的領域に近接して位置付け可能であり、電気刺激を前記標的領域に提供する、埋め込み可能導線と、
前記導線の近位端に電気的に結合されている埋め込み可能パルス発生器と
を備え、
前記埋め込み可能パルス発生器は、
密封してシールされた内部容積を画定する生体適合性筐体と、
前記生体適合性筐体の前記密封してシールされた内部容積内に配置されている再充電可能電力供給源と、
前記生体適合性筐体の前記密封してシールされた内部容積内に配置されている回路と
を備え、
前記回路は、前記再充電可能電力供給源に電気的に結合され、1つ以上の電気パルスを生成するように構成され、前記回路は、電流を前記導線に選択的にソースし、電流を前記導線から選択的にシンクするように構成されている第1の差動増幅器を備えている、
埋め込み可能神経刺激装置システム。
(項目2)
前記回路は、電流を前記導線に選択的にソースし、電流を前記導線から選択的にシンクするように構成されている第2の差動増幅器をさらに備えている、項目1に記載の埋め込み可能神経刺激装置システム。
(項目3)
前記第2の差動増幅器は、前記第1の差動増幅器が、電流を前記導線上に位置している前記複数の電極のうちの少なくとも1つにソースするために選択されている場合、電流を前記導線上に位置している前記複数の電極のうちの少なくとも別の1つからシンクするために選択される、項目2に記載の埋め込み可能神経刺激装置システム。
(項目4)
前記第2の差動増幅器は、前記第1の差動増幅器が、電流を前記導線上に位置している前記複数の電極のうちの少なくとも1つからシンクするために選択されている場合、電流を前記導線上に位置している前記複数の電極のうちの少なくとも別の1つにソースするために選択される、項目3に記載の埋め込み可能神経刺激装置システム。
(項目5)
前記第1の差動増幅器は、電流コマンドに結合されている非反転入力を含み、前記電流コマンドは、第1の範囲内の電圧を前記非反転入力に供給するように構成され、前記第1の差動増幅器は、仮想接地に結合されている反転入力を含む、項目4に記載の埋め込み可能神経刺激装置システム。
(項目6)
供給される電圧の前記第1の範囲は、最大電圧および最小電圧を有し、前記第1の範囲の前記最大電圧と前記最小電圧との間の電圧の差異は、少なくとも5ボルトである、項目5に記載の埋め込み可能神経刺激装置システム。
(項目7)
前記仮想接地は、前記供給される電圧の前記最大電圧と前記最小電圧との間の接地電圧を備えている、項目6に記載の埋め込み可能神経刺激装置システム。
(項目8)
前記第1の差動増幅器の反転入力に結合されている仮想接地は、前記回路が定常状態で動作しているときの前記仮想接地の接地電圧と等しい前記反転入力における電圧を有する、項目7に記載の埋め込み可能神経刺激装置システム。
(項目9)
前記第1の差動増幅器は、前記第1の差動増幅器の非反転入力に印加される前記供給される電圧が前記仮想接地の接地電圧を上回る場合、電流をソースするために構成可能である、項目8に記載の埋め込み可能神経刺激装置システム。
(項目10)
前記第1の差動増幅器は、前記第1の差動増幅器の非反転入力に印加される前記供給される電圧が前記仮想接地の接地電圧未満である場合、電流をシンクするために構成可能である、項目9に記載の埋め込み可能神経刺激装置システム。
(項目11)
複数の電極を備えている埋め込み可能導線を用いて1つ以上の電気パルスを患者の体内の標的領域に送達するための埋め込み可能神経刺激装置であって、前記複数の電極は、前記標的領域に近接して位置付け可能であり、前記標的領域に電気的に統合可能であり、
前記埋め込み可能神経刺激装置は、
患者の体内に埋め込まれるように構成されている密封してシールされた内部容積を画定する生体適合性筐体と、
前記生体適合性筐体の前記密封してシールされた内部容積内に配置されている再充電可能バッテリと、
前記生体適合性筐体の前記密封してシールされた内部容積内に配置されている回路と
を備え、
前記回路は、前記再充電可能電力供給源に電気的に結合され、1つ以上の電気パルスを生成するように構成され、
前記回路は、
第1の電流制御モジュールと、
第2の電流制御モジュールと
を備え、
前記第1の電流制御モジュールおよび前記第2の電流制御モジュールの各々は、
非反転入力、反転入力、および出力を有する電流駆動差動増幅器と、
前記非反転入力に結合されている電流制御であって、前記電流制御は、第1の範囲内の電圧を前記非反転入力に供給するように構成され、前記第1の範囲は、最小電圧と最大電圧との間である、電流制御と、
前記反転入力に結合されている仮想接地であって、前記仮想接地は、前記最小電圧と前記最大電圧との間の接地電圧を有する、仮想接地と、
前記電流駆動差動増幅器の出力を前記導線に選択的に結合している負荷経路であって、前記負荷経路は、前記電流駆動差動増幅器の出力と前記導線との間に位置する感知抵抗器を備えている、負荷経路と
を備えている、埋め込み可能神経刺激装置。
(項目12)
前記第1および第2の電流制御モジュールのうちの少なくとも1つは、感知非反転入力、感知反転入力、および感知出力を備えている電流感知差動増幅器を備えている、項目11に記載の埋め込み可能神経刺激装置。
(項目13)
前記感知非反転入力は、第1の抵抗を有する第1の抵抗器を介して、前記感知抵抗器と前記電流駆動差動増幅器の出力との間で前記負荷経路に接続され、前記感知反転入力は、前記第1の抵抗を有する第2の抵抗器を介して、前記感知抵抗器と前記導線との間で前記負荷経路に接続されている、項目12に記載の埋め込み可能神経刺激装置。
(項目14)
前記感知非反転入力は、第2の抵抗を有する第3の抵抗器を介して、前記仮想接地に接続され、前記感知反転入力は、前記第2の抵抗を有する第4の抵抗器を介して、前記感知出力に接続されている、項目13に記載の埋め込み可能神経刺激装置。
(項目15)
前記第2の抵抗は、前記第1の抵抗の少なくとも2倍である、項目14に記載の埋め込み可能神経刺激装置。
(項目16)
前記第2の抵抗は、前記第1の抵抗の少なくとも10倍である、項目15に記載の埋め込み可能神経刺激装置。
(項目17)
前記感知抵抗器を横断する電圧降下を測定するように構成されている電圧センサをさらに備えている、項目14に記載の埋め込み可能神経刺激装置。
(項目18)
前記感知抵抗器を横断する電圧降下は、前記接地電圧と前記電流感知差動増幅器の出力との間の差異を決定することによって測定される、項目17に記載の埋め込み可能神経刺激装置。
(項目19)
前記第1の制御モジュールは、電流を前記導線に選択的にソースし、電流を前記導線から選択的にシンクするように構成されている、項目18に記載の埋め込み可能神経刺激装置。
(項目20)
前記第2の制御モジュールは、電流を前記導線に選択的にソースし、電流を前記導線から選択的にシンクするように構成されている、項目19に記載の埋め込み可能神経刺激装置。
(項目21)
前記電流駆動差動増幅器の反転入力に結合されている前記仮想接地は、前記第1の制御モジュールおよび前記第2の制御モジュールのうちの少なくとも1つが定常状態で動作しているとき、前記仮想接地の接地電圧と等しい前記反転入力における電圧を有する、項目20に記載の埋め込み可能神経刺激装置。
(項目22)
前記電流駆動差動増幅器は、前記電流駆動差動増幅器の非反転入力に印加される供給される電圧が前記仮想接地の接地電圧を上回る場合、電流をソースするために構成可能である、項目21に記載の埋め込み可能神経刺激装置。
(項目23)
前記電流駆動差動増幅器は、前記電流駆動差動増幅器の非反転入力に印加される前記供給される電圧が前記仮想接地の接地電圧未満である場合、電流をシンクするために構成可能である、項目22に記載の埋め込み可能神経刺激装置。
(項目24)
埋め込み可能導線に対して電流を選択的にソースまたはシンクするように埋め込み可能神経刺激装置の回路の作動方法であって、前記埋め込み可能導線は、前記回路に電気的に結合され、前記埋め込み可能導線は、電気刺激を前記標的領域に送達するために患者の体内の標的領域に近接して位置付け可能である複数の電極を備え、
前記方法は、
第1の差動増幅器の所望の動作を識別することであって、前記第1の差動増幅器は、生体適合性筐体の密封してシールされた内部容積内に位置し、前記第1の差動増幅器は、電流を導線に選択的にソースし、電流を前記導線から選択的にシンクするように構成されている、ことと、
第1の制御信号を生成することであって、前記第1の制御信号は、前記第1の差動増幅器に、電流を前記導線にソースすることまたは電流を前記導線からシンクすることのいずれかを行わせるように構成されている、ことと
前記第1の制御信号を前記第1の差動増幅器に提供することと
を含む、方法。
(項目25)
前記第1の制御信号を生成することは、前記第1の差動増幅器の所望の動作が電流を前記導線にソースすることであるか、または電流を前記導線からシンクすることであるかを決定することを含む、項目24に記載の方法。
(項目26)
前記第1の制御信号を生成することは、電流を前記第1の差動増幅器からソースすべきか、または電流を前記第1の差動増幅器に選択的にシンクすべきかを決定することを含む、項目25に記載の方法。
(項目27)
前記第1の制御信号を生成することは、電流を前記第1の差動増幅器からソースすべきことが決定された場合、仮想接地電圧を上回る電圧を有する前記第1の制御信号を生成することをさらに含む、項目26に記載の方法。
(項目28)
前記制御信号を生成することは、電流を前記第1の差動増幅器にシンクすべきことが決定された場合、仮想接地電圧未満の電圧を有する前記第1の制御信号を生成することをさらに含む、項目26に記載の方法。
(項目29)
第2の差動増幅器の所望の動作を識別することであって、前記第2の差動増幅器は、生体適合性筐体の密封してシールされた内部容積内に位置し、前記第2の差動増幅器は、電流を前記導線に選択的にソースし、電流を前記導線から選択的にシンクするように構成されている、ことと、
第2の制御信号を生成することであって、前記第2の制御信号は、前記第2の差動増幅器に、電流を前記導線にソースするか、または電流を前記導線からシンクするかのいずれかを行わせるように構成されている、ことと、
前記第2の制御信号を前記第2の差動増幅器に提供することと
をさらに含む、
項目24に記載の方法。
(項目30)
前記第1の制御信号が前記第1の差動増幅器に電流を前記導線にソースさせる場合、前記第2の信号は、前記第2の差動増幅器に電流を前記導線からシンクさせるために生成される、項目29に記載の方法。
(項目31)
前記第1の制御信号が前記第1の差動増幅器に電流を前記導線からシンクさせる場合、前記第2の信号は、前記第2の差動増幅器に電流を前記導線にソースさせるために生成される、項目29に記載の方法。
(項目32)
前記第1の差動増幅器は、電流を前記導線の前記複数の電極のうちの第1の少なくとも1つに選択的にソースし、電流を前記導線の前記複数の電極のうちの前記第1の少なくとも1つから選択的にシンクするように構成され、前記第2の差動増幅器は、電流を前記導線の前記複数の電極のうちの第2の少なくとも1つに選択的にソースし、電流を前記導線の前記複数の電極のうちの前記第2の少なくとも1つから選択的にシンクするように構成されている、項目29に記載の方法。
(項目33)
前記導線の前記複数の電極のうちの前記第1の少なくとも1つおよび前記導線の前記複数の電極のうちの前記第2の少なくとも1つは、前記患者の体内の標的領域を通して回路を完成するように選択される、項目32に記載の方法。
(項目34)
前記患者の身体の標的領域は、仙骨組織を備えている、項目33に記載の方法。
(項目35)
前記第1の差動増幅器および前記第2の差動増幅器は、電流をソースまたは電流をシンクし、1つまたはいくつかの電気パルスを生成するように構成されている、項目29に記載の方法。
(項目36)
前記1つまたはいくつかの電気パルスは、前記電気パルスのパラメータを規定するパルスプログラムに従って生成される、項目35に記載の方法。
(項目37)
前記1つまたはいくつかの電気パルスは、単極であることができる、項目36に記載の方法。
(項目38)
前記1つまたはいくつかの電気パルスは、双極であることができる、項目36に記載の方法。
(項目39)
埋め込み可能導線を用いて1つ以上の電気パルスを患者の体内の標的領域に送達するための埋め込み可能神経刺激装置であって、前記埋め込み可能導線は、前記標的領域に近接して位置付け可能であり、前記標的領域に電気的に統合可能な複数の電極を備え、
前記埋め込み可能導線は、
無ASIC電流ソース/シンク発生器であって、前記発生器は、
電流を前記導線に選択的にソースし、電流を前記導線から選択的にシンクするように構成されている第1の差動増幅器と、
電流を前記導線に選択的にソースし、電流を前記導線から選択的にシンクするように構成されている第2の差動増幅器と
を備えている、無ASIC電流ソース/シンク発生器と、
刺激コントローラと
を備え、
前記刺激コントローラは、
前記第1の差動増幅器のために、電流をソースすることまたはシンクすることのうちの一方を選択するための第1の電気信号を生成することと、
前記第2の差動増幅器のために、電流をソースすることまたはシンクすることのうちの他方を選択するための第2の電気信号を生成することと
を行うように構成されている、埋め込み可能神経刺激装置。
(項目40)
前記第1の差動増幅器は、仮想接地に接続されている反転入力および第1の電流コマンドに接続されている非反転入力を備え、前記第2の差動増幅器は、前記仮想接地に接続されている反転入力および第2の電流コマンドに接続されている非反転入力を備えている、項目39に記載の埋め込み可能神経刺激装置。
(項目41)
前記仮想接地は、第1の電圧を前記第1の差動増幅器の反転入力に供給し、前記第1の電圧を前記第2の差動増幅器の反転入力に供給する、項目40に記載の埋め込み可能神経刺激装置。
(項目42)
前記第1の電流コマンドは、電流をソースするために前記第1の差動増幅器を選択する場合、前記供給される第1の電圧を上回る第2の電圧を供給し、前記第1の電流コマンドは、電流をシンクするために前記第1の差動増幅器を選択する場合、前記供給される第1の電圧未満の第2の電圧を供給する、項目41に記載の埋め込み可能神経刺激装置。
(項目43)
前記第2の電流コマンドは、電流をソースするために前記第2の差動増幅器を選択する場合、前記供給される第1の電圧を上回る第3の電圧を供給し、前記第2の電流コマンドは、電流をシンクするために前記第2の差動増幅器を選択する場合、前記供給される第1の電圧未満の第3の電圧を供給する、項目42に記載の埋め込み可能神経刺激装置。
本明細書に説明されるもののうちのいずれか等の神経刺激(または以降で同義的に使用され得るような神経調節)治療システムは、急性疼痛障害、運動障害、情動障害、ならびに膀胱関連機能不全等の種々の病気および関連症状を治療するために使用されることができる。神経刺激によって治療され得る疼痛障害の例は、脊椎手術後疼痛症候群、反射性交感神経性ジストロフィまたは複合性局所疼痛症候群、灼熱痛、クモ膜炎、および末梢神経障害を含む。運動障害は、筋麻痺、振戦、ジストニア、およびパーキンソン病を含む。情動障害は、うつ病、強迫性障害、群発頭痛、トゥレット障害、およびあるタイプの慢性疼痛を含む。膀胱関連機能不全は、OAB、切迫尿失禁、切迫頻尿、および尿閉を含むが、それらに限定されない。OABは、単独で、または組み合わせて、切迫尿失禁および切迫頻尿を含むことができる。切迫尿失禁は、突然の強い尿意(切迫性)に関連付けられる失禁である。切迫頻尿は、多くの場合、非常に少量の排尿をもたらす(頻尿)、頻繁で多くの場合は制御不能な尿意切迫感(切迫性)である。尿閉は、膀胱を空にすることができない状態である。神経刺激治療は、その状態もしくは関連症状に関連付けられる感覚および/または運動制御に関する標的神経組織の神経刺激を達成することによって、特定の状態に対処するように構成されることができる。
SNMは、切迫尿失禁、切迫頻尿、および非閉塞性尿閉の管理のための安全、効果的、可逆的、かつ長期継続的な治療選択肢を提供する確立された療法である。SNM療法は、下背に位置する仙骨神経を刺激するために、弱電気パルスの使用を伴う。電極は、電極導線を仙骨の対応する孔の中に挿入することによって、仙骨神経に隣接して、通常、S3レベルに設置される。電極は、皮下に挿入され、後に、本明細書では「埋め込み可能神経刺激装置」または「神経刺激装置」とも称される、埋め込み可能パルス発生器(IPG)に取り付けられる。切迫尿失禁および切迫頻尿の両方の患者のために、5年の耐久性を含む、OABの治療のためのSNMの安全性ならびに有効性が、複数の研究によって支持され、十分に証明されている。SNMは、より保守的治療に失敗した患者、またはその候補ではない患者における慢性便失禁を治療するためにも是認されている。
現在、SNM資格は、試験段階を油脂、成功した場合、恒久的埋め込みが続く。試験段階は、療法が効果的であるかどうかを患者が評価することを可能にされる試験刺激期間である。典型的には、試験刺激を行うために利用される、2つの技法がある。第1は、経皮的神経評価(PNE)と称される通院ベースの手技であり、他方は、段階的試験である。
従来のアプローチは、膀胱関連機能不全の治療において有効性を示しているが、神経刺激導線の位置付けおよび導線の試験的位置と恒久的埋め込み位置との間の一貫性を向上させる必要が存在する。神経刺激は、1つ以上の神経刺激電極を介して、パルス発生器から特定の神経もしくは標的領域に治療用刺激を一貫して送達することに依拠する。神経刺激電極は、患者組織内に形成されるトンネルを通して前進させられることができる、埋め込み可能導線の遠位端上に提供される。埋め込み可能神経刺激システムは、患者に大幅な自由度および移動性を提供するが、そのようなシステムの神経刺激電極が外科的に埋め込まれる前に、それらを調節することがより容易であり得る。医師は、IPGを埋め込む前に、患者が所望の運動および/または感覚反応を有することを確認することが望ましい。少なくともいくつかの治療(少なくともいくつかの形態の排尿および/または排便機能不全の治療を含む)に対して、適切な運動反応の実証は、感覚反応が要求されないことも、利用可能でないこともあるが(例えば、患者が全身麻酔下にある)、正確かつ客観的な導線設置のために高度に有益であり得る。
図1は、本発明の側面による、試験的神経刺激システム200および恒久的埋め込み式神経刺激システム100の両方を含む、例示的神経刺激システムを概略的に図示する。EPG80およびIPG10の各々は、臨床医用プログラム装置(CP)60および患者遠隔装置70との適合性があり、無線で通信し、臨床医用プログラム装置60および患者遠隔装置70は、試験的神経刺激システム200および/または試験成功後の恒久的埋め込み式システム100を位置付けることおよび/またはプログラムすることにおいて使用される。上で議論されるように、臨床医用プログラム装置は、導線設置、プログラミング、再プログラミング、刺激制御、および/またはパラメータ設定に役立つように、特殊ソフトウェア、特殊ハードウェア、ならびに/もしくは両方を含むことができる。加えて、IPGおよびEPGの各々は、患者が、患者遠隔装置を用いて、刺激の少なくとも一部を制御し(例えば、事前に設定されたプログラムを開始すること、刺激を増加または減少させること)、および/またはバッテリステータスを監視することを可能にする。このアプローチは、試験的システムと恒久的システムとの間のほぼシームレスな遷移も可能にする。
Claims (23)
- 1つ以上の電気パルスを患者の体内の標的領域に送達するための埋め込み可能神経刺激装置システムであって、
複数の電極を備えている埋め込み可能導線であって、前記複数の電極は、前記導線の遠位端上に位置しており、前記電極は、患者の体内の標的領域に近接して位置付け可能であり、電気刺激を前記標的領域に提供する、埋め込み可能導線と、
前記導線の近位端に電気的に結合されている埋め込み可能パルス発生器と
を備え、
前記埋め込み可能パルス発生器は、
密封してシールされた内部容積を画定する生体適合性筐体と、
前記生体適合性筐体の前記密封してシールされた内部容積内に配置されている再充電可能電力供給源と、
前記生体適合性筐体の前記密封してシールされた内部容積内に配置されている回路と
を備え、
前記回路は、前記再充電可能電力供給源に電気的に結合され、1つ以上の電気パルスを生成するように構成され、前記回路は、電流コマンドおよび一定電圧源に結合される入力を有する第1の差動増幅器であって、電流を前記導線に選択的にソースし、電流を前記導線から選択的にシンクするように構成されている第1の差動増幅器を備えており、
前記第1の差動増幅器の前記入力は、前記電流コマンドに結合されている非反転入力を含み、前記電流コマンドは、第1の範囲内の電圧を前記非反転入力に供給するように構成され、前記第1の差動増幅器の前記入力は、前記一定電圧源に結合されている反転入力を含む、
埋め込み可能神経刺激装置システム。 - 前記回路は、電流を前記導線に選択的にソースし、電流を前記導線から選択的にシンクするように構成されている第2の差動増幅器をさらに備えている、請求項1に記載の埋め込み可能神経刺激装置システム。
- 前記第2の差動増幅器は、前記第1の差動増幅器が、電流を前記導線上に位置している前記複数の電極のうちの少なくとも1つにソースするために選択されている場合、電流を前記導線上に位置している前記複数の電極のうちの少なくとも別の1つからシンクするために選択される、請求項2に記載の埋め込み可能神経刺激装置システム。
- 前記第2の差動増幅器は、前記第1の差動増幅器が、電流を前記導線上に位置している前記複数の電極のうちの少なくとも1つからシンクするために選択されている場合、電流を前記導線上に位置している前記複数の電極のうちの少なくとも別の1つにソースするために選択される、請求項2に記載の埋め込み可能神経刺激装置システム。
- 供給される電圧の前記第1の範囲は、最大電圧および最小電圧を有し、前記第1の範囲の前記最大電圧と前記最小電圧との間の電圧の差異は、少なくとも5ボルトである、請求項1に記載の埋め込み可能神経刺激装置システム。
- 前記一定電圧源は、前記供給される電圧の前記最大電圧と前記最小電圧との間の電圧を備えている、請求項5に記載の埋め込み可能神経刺激装置システム。
- 前記第1の差動増幅器の反転入力に結合されている前記一定電圧源は、前記回路が定常状態で動作しているときの前記一定電圧源の電圧と等しい前記反転入力における電圧を有する、請求項6に記載の埋め込み可能神経刺激装置システム。
- 前記第1の差動増幅器は、前記第1の差動増幅器の非反転入力に印加される前記供給される電圧が前記一定電圧源の電圧を上回る場合、電流をソースするために構成可能である、請求項7に記載の埋め込み可能神経刺激装置システム。
- 前記第1の差動増幅器は、前記第1の差動増幅器の非反転入力に印加される前記供給される電圧が前記一定電圧源の電圧未満である場合、電流をシンクするために構成可能である、請求項8に記載の埋め込み可能神経刺激装置システム。
- 埋め込み可能導線に対して電流を選択的にソースまたはシンクするための埋め込み可能神経刺激装置の回路の作動方法であって、前記埋め込み可能導線は、前記回路に電気的に結合され、前記埋め込み可能導線は、電気刺激を標的領域に送達するために患者の体内の前記標的領域に近接して位置付け可能である複数の電極を備え、
前記方法は、
第1の差動増幅器の所望の動作を識別することであって、前記第1の差動増幅器は、一定電圧源に結合される入力を有し、前記第1の差動増幅器は、生体適合性筐体の密封してシールされた内部容積内に位置し、前記第1の差動増幅器は、電流を導線に選択的にソースし、電流を前記導線から選択的にシンクするように構成されている、ことと、
第1の制御信号を生成することであって、前記第1の制御信号は、前記第1の差動増幅器に、電流を前記導線にソースすることまたは電流を前記導線からシンクすることのいずれかを行わせるように構成されており、前記第1の制御信号を生成することは、電流を前記第1の差動増幅器からソースすべきことが決定された場合、前記一定電圧源の電圧を上回る電圧を有する前記第1の制御信号を生成することを含む、ことと、
前記第1の制御信号を前記第1の差動増幅器に提供することと
を含む、方法。 - 前記第1の制御信号を生成することは、前記第1の差動増幅器の所望の動作が電流を前記導線にソースすることであるか、または電流を前記導線からシンクすることであるかを決定することを含む、請求項10に記載の方法。
- 前記第1の制御信号を生成することは、電流を前記第1の差動増幅器からソースすべきか、または電流を前記第1の差動増幅器に選択的にシンクすべきかを決定することを含む、請求項11に記載の方法。
- 前記制御信号を生成することは、電流を前記第1の差動増幅器にシンクすべきことが決定された場合、前記一定電圧源の電圧未満の電圧を有する前記第1の制御信号を生成することをさらに含む、請求項12に記載の方法。
- 第2の差動増幅器の所望の動作を識別することであって、前記第2の差動増幅器は、生体適合性筐体の密封してシールされた内部容積内に位置し、前記第2の差動増幅器は、電流を前記導線に選択的にソースし、電流を前記導線から選択的にシンクするように構成されている、ことと、
第2の制御信号を生成することであって、前記第2の制御信号は、前記第2の差動増幅器に、電流を前記導線にソースするか、または電流を前記導線からシンクするかのいずれかを行わせるように構成されている、ことと、
前記第2の制御信号を前記第2の差動増幅器に提供することと
をさらに含む、
請求項10に記載の方法。 - 前記第1の制御信号が前記第1の差動増幅器に電流を前記導線にソースさせる場合、前記第2の信号は、前記第2の差動増幅器に電流を前記導線からシンクさせるために生成される、請求項14に記載の方法。
- 前記第1の制御信号が前記第1の差動増幅器に電流を前記導線からシンクさせる場合、前記第2の信号は、前記第2の差動増幅器に電流を前記導線にソースさせるために生成される、請求項14に記載の方法。
- 前記第1の差動増幅器は、電流を前記導線の前記複数の電極のうちの第1の少なくとも1つに選択的にソースし、電流を前記導線の前記複数の電極のうちの前記第1の少なくとも1つから選択的にシンクするように構成され、前記第2の差動増幅器は、電流を前記導線の前記複数の電極のうちの第2の少なくとも1つに選択的にソースし、電流を前記導線の前記複数の電極のうちの前記第2の少なくとも1つから選択的にシンクするように構成されている、請求項14に記載の方法。
- 前記導線の前記複数の電極のうちの前記第1の少なくとも1つおよび前記導線の前記複数の電極のうちの前記第2の少なくとも1つは、前記患者の体内の前記標的領域を通して回路を完成するように選択される、請求項17に記載の方法。
- 前記患者の身体の前記標的領域は、仙骨組織を備えている、請求項18に記載の方法。
- 前記第1の差動増幅器および前記第2の差動増幅器は、電流をソースまたは電流をシンクし、1つまたはいくつかの電気パルスを生成するように構成されている、請求項14に記載の方法。
- 前記1つまたはいくつかの電気パルスは、前記電気パルスのパラメータを規定するパルスプログラムに従って生成される、請求項20に記載の方法。
- 前記1つまたはいくつかの電気パルスは、単極であることができる、請求項21に記載の方法。
- 前記1つまたはいくつかの電気パルスは、双極であることができる、請求項21に記載の方法。
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