JP5185128B2 - 埋め込み型充電式神経刺激装置 - Google Patents
埋め込み型充電式神経刺激装置 Download PDFInfo
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- 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
- A61N1/36114—Cardiac control, e.g. by vagal stimulation
- A61N1/36117—Cardiac control, e.g. by vagal stimulation for treating hypertension
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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
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/37211—Means for communicating with stimulators
- A61N1/37217—Means for communicating with stimulators characterised by the communication link, e.g. acoustic or tactile
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- A—HUMAN NECESSITIES
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- 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
- 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
- A61N1/18—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
- A61N1/37205—Microstimulators, e.g. implantable through a cannula
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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
- A61N1/37211—Means for communicating with stimulators
- A61N1/37252—Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
- A61N1/37288—Communication to several implantable medical devices within one patient
Description
2005年10月24日出願の米国特許出願整理番号11/256,907に対する優先権の利益をここに主張し、この出願は参照により本明細書に組み込まれる。
本出願は、一般に埋め込み型医療装置に関し、より詳細には、埋め込み型充電式神経刺激装置に関する。
と、皮下注射針を用いて皮下移植されるように構成された構造からなる構造群から選択される。
神経刺激は、高血圧のような様々な全身性異常に治療を施すために利用できる。高血圧は、心臓病とその他の関連する心臓併存疾患の原因である。高血圧は血管が収縮する際に起こる。結果として、心臓は高い血圧で血流を維持するためにより盛んにはたらき、それが心不全の一因となり得る。一般人口の大部分、さらにペースメーカーや除細動器を移植した患者の大部分が、高血圧に苦しんでいる。血圧を下げて高血圧を軽減させることができれば、これらの人々の長期死亡率、さらに生活の質を改善することができる。高血圧に苦しむ多くの患者は、ライフスタイルの変化に関する処置や高血圧薬などの処置では効果がない。高血圧は一般に、心臓血管の損傷や他の悪影響を引き起こしやすいレベルへの、全身動脈血圧の一時的もしくは持続的な上昇などの、高い血圧に関連する。高血圧は、140 mmHgよりも高い最高血圧、もしくは90 mmHgよりも高い最低血圧として任意に定義されてきた。高血圧は血管が収縮する際に起こる。結果として、心臓は高い血圧で血流を維持するためにより盛んにはたらく。管理不良高血圧の結果は、網膜血管病と卒中、左心室肥大と左心室不全、心筋梗塞、解離性動脈瘤、および腎血管性疾患を含むが、限定はされない。
善が可能となる。プロセスにおいて心拍出量を損なうことなく血圧が低下し、その結果望ましくない患者症状を避けることができる。心筋梗塞治療に関しては、増加した圧反射刺激は、迅速な血管拡張と付随する全身血圧の低下を通して、低下した圧反射感受性を補い、心筋梗塞後の患者の臨床転帰を改善する。
図1は長期移植装置の一実施形態のブロック図である。この実施形態に従うと、長期移植装置100は、血管内神経刺激装置と、電力/通信回路102、制御回路104、神経刺激回路106、検出回路108を含むセンサーを形成する。長期移植装置100の構成要素は下記により詳細に記載される。神経刺激回路106は、高血圧を処置するための神経刺激治療や、痛みを軽減するための神経刺激治療など、所望の治療を施すように作動する治療供給回路としてはたらく。一実施形態では、検出回路108は圧力を感知するように作動する。
ム構成要素の間の電流を制御することにより、システムの電力を制御するために用いられる。コントローラーは任意のシステム構成要素の操作を制御することができ、電子計時(electronics timing)と機能性のためにシステムに時計を提供することができる。一実施形態に従えば、コントローラーは状態機械である。図示された装置は制御回路104とメモリ118を含む。制御回路は、ハードウェア、ソフトウェア、およびハードウェアとソフトウェアの組み合わせを用いて実装することができる。例えば、様々な実施形態に従えば、制御回路は、AHT治療などのNS治療に関連する機能を発揮するためにメモリ内に内蔵された命令を実行するプロセッサを含む。図示されたIMDは神経刺激機能を実行するように構成される。図示されたIMDのいくつかの実施形態は、抗高血圧(AHT)機能を果たす。
でき、それにより、埋め込み型NS装置は患者の高血圧のレベルを決定し、適切なレベルの治療を施すことによって応答することが可能となる。
一実施形態に従えば、血管内装置によって提供される電気刺激機能は、マルチサイトペーシングのためにいくつかの電極が配置されたときにおいても、低侵襲手術のみを必要とする。マルチサイトペーシングを組み込む方法は、治療上の利点をもたらすと考えられる。
に形成され得る。これらのステントは、冠状動脈ステント、血管ステント、気管気管支ステント、結腸/十二指腸ステント、食道ステント、胆管ステント、泌尿器ステント、神経血管ステント、腹部大動脈瘤ステント、腎臓ステント、および頸動脈ステントを含むが、限定されない。
長期移植装置は電力回路を含む。様々な実施形態に従って、例えば電力回路は図1の電力/通信回路102の一部を形成する。図8にあらわすように、長期移植装置のいくつかの実施形態は超音波電源838からの超音波836を用いて再充電されるように構成された小さな充電式バッテリーによって電力供給される。超音波を使用する事で装置を遠隔的に充電することができる。図示された装置800は、超音波信号を電気信号に変換する、超音波変換器840、もしくは変換器の配列を含む。超音波変換器の例は、音響装置、圧電装置、静電装置、および磁歪装置を含む。充電回路842は、変換器から電気信号を受け取り、この信号を電荷に変換処理してバッテリー 834 に与えるように接続される。
長期移植装置は外部装置と通信するために使用される通信回路を含む。様々な実施形態に従って、例えば通信回路は図1の電力/通信回路102の一部を形成する。実施形態は、例えば超音波を用いた長期移植装置と外部装置との間の通信を提供する。図9に示すように、二つの埋め込み型神経刺激装置900Aと900Bが相互に通信するように構成される。各装置は超音波信号の受信と発生のための超音波変換器946を備える通信回路944を持つ。通信回路は装置が理解可能な情報に信号を処理するように構成される。
一実施形態に従って、神経刺激装置は、パルス幅、周波数、負荷サイクル、バースト継続時間、振幅、刺激モード(例えば双極もしくは単極)、および複数の場所が利用可能な場合は刺激場所などの、調節可能な刺激変数を持つ。一実施形態に従って、神経刺激回路はコントローラーからその変数を受信する。
は下大静脈と左心房の付近にある。上大静脈、大動脈、心静脈、下大静脈、もしくは冠状静脈洞に移植された電極は、様々な心臓の脂肪体を刺激するために使用できる。
一実施形態に従えば、装置によって提供される検出機能は、血圧、血流、および血管の大きさなど、血管内の連続測定を提供することができる。一実施形態に従えば、長期移植装置、もしくは装置のシステムは、埋め込み型装置などの中心ユニットと通信し、血流、血圧、および血管の内径を監視する。
電気的機能と機械的機能が相互に一致しない、もしくは同調しない状態を識別する。
図10は、本主題の様々な実施形態に従って、埋め込み型医療装置(IMD)1052とプログラマー1054を含むシステム1050をあらわす。IMD1052の様々な実施形態は、神経刺激装置機能のみを含み、また様々な実施形態は、NSとCRM機能の組み合わせを含む。プログラマー1054とIMD1052は無線でデータと命令を通信することができる。様々な実施形態では、例えばプログラマーとIMDは無線でデータと命令を通信するためにテレメトリコイルを用いる。いくつかの実施形態は通信のために超音波変換器を使用し、またいくつかの実施形態はIMDを再充電するために超音波変換器を使用する。従って、プログラマーはIMDによって供給されたプログラムされた治療を調節するために使用でき、またIMDは装置データ(バッテリーデータとリード抵抗など)と治療データ(検出データと刺激データなど)を、例えば無線テレメトリを用いてプログラマーに通信できる。様々な実施形態に従って、IMDは圧受容器を刺激してAHT治療などのNS治療を施す。IMDの様々な実施形態は、血管系を通して送り込まれたリードを用いて神経標的を刺激する。IMDの様々な実施形態は、皮下注射針を通した皮下移植に適した形状因子を持つ。様々な実施形態に従って、IMDはANS活動を感知するセンサーを含む。そのようなセンサーは閉ループ制御系でフィードバックを実行するために利用できる。例えば、様々な実施形態は、ANS活動の指標となる、呼吸や血圧などの代替指標を感知する。従って、様々な実施形態は圧力を感知する圧力センサーを提供する。様々な実施形態に従って、IMDはペーシングや除細動機能などの心刺激機能をさらに含み、その上圧受容器の刺激機能および/またはANS活動検出機能をさらに含む。
様々な実施形態に従って、治療は心筋梗塞後の処置、痛みを和らげるための処置、高血圧のための治療の内の一つ以上を含む。
Claims (17)
- 血管内に長期移植されるように構成された、血管内装置である、埋め込み型医療装置であって、
超音波信号を通して充電されるように構成された充電式電源と、
前記充電式電源に接続され、電極を通して神経刺激を標的に伝達するための神経刺激信号を作り出すように構成された神経刺激装置と、
前記充電式電源に接続され、前記神経刺激装置を神経刺激プロトコルに従って制御するために前記神経刺激装置に接続されたコントローラーと、
前記血管内の圧力を感知するために、前記コントローラーに電気的に接続された圧力センサーと、を含み、
前記血管内装置の前記電源、前記神経刺激装置、前記コントローラー、及び前記圧力センサーは、血管内に長期移植されるように構成されている、
埋め込み型医療装置。 - 前記電極と前記圧力センサーの少なくとも一方が、前記埋め込み型医療装置のハウジングに一体化されている、請求項1に記載の装置。
- 前記電極と前記圧力センサーの両方が前記埋め込み型医療装置のハウジングに一体化されている、請求項2に記載の装置。
- 前記コントローラーが、感知された血管内の圧力に応じて神経刺激プロセスを制御するように構成された、請求項1から3のいずれか1項に記載の装置。
- 前記コントローラーが、感知された血管内の圧力に応じて圧受容器刺激プロセスを制御するように構成された、請求項1から3のいずれか1項に記載の装置。
- 前記コントローラーが、前記感知された血管内の圧力に応じて迷走神経刺激プロセスを制御するように構成された、請求項5に記載の装置。
- 前記コントローラーが、前記感知された血管内の圧力に応じて心臓神経の神経刺激を制御するように構成された、請求項5に記載の装置。
- 前記装置が、拡張して前記装置を血管内に固定するように構成されたステント状の構造を有し、前記ステント状の構造は、血管内で再狭窄を防止するように構成される、請求項1から7のいずれか1項に記載の装置。
- 前記コントローラーに接続され、超音波通信信号を送受信するように構成された通信モジュールをさらに含む、請求項1から8のいずれか1項に記載の装置。
- 前記装置が、超音波通信信号を用いて少なくとも一つの他の埋め込み型装置と通信するように構成された、請求項9に記載の装置。
- 前記装置が、超音波通信信号を用いて外部装置と通信するように構成された、請求項9に記載の装置。
- 前記神経刺激装置が、前記電極へリードを介して前記神経刺激信号を伝達するように構成された、請求項1から11のいずれか1項に記載の装置。
- 前記神経刺激装置が、前記電極へ前記神経刺激信号を無線で伝達するように構成された、請求項1から11のいずれか1項に記載の装置。
- 前記コントローラーは、前記圧力センサーからのフィードバックを用いて神経刺激治療を供給するために、神経刺激装置を制御するように構成されており、前記神経刺激治療は、心筋梗塞後の処置を含む、請求項1から13のいずれか1項に記載の装置。
- 前記コントローラーは、前記圧力センサーからのフィードバックを用いて神経刺激治療を供給するために、神経刺激装置を制御するように構成されており、前記神経刺激治療は、痛みを軽減する処置を含む、請求項1から14のいずれか1項に記載の装置。
- 前記コントローラーは、前記圧力センサーからのフィードバックを用いて神経刺激治療を供給するために、神経刺激装置を制御するように構成されており、前記神経刺激治療は、高血圧治療を含む、請求項1から15のいずれか1項に記載の装置。
- 請求項1から16のいずれか1項に記載の第2の埋め込み型医療装置を含むシステム内に組み込まれ、
各装置は、別の埋め込み型医療装置に超音波通信信号を受信するように構成された通信モジュールを含む、請求項1から16のいずれか1項に記載の装置。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US11/256,907 US7616990B2 (en) | 2005-10-24 | 2005-10-24 | Implantable and rechargeable neural stimulator |
US11/256,907 | 2005-10-24 | ||
PCT/US2006/041569 WO2007050657A1 (en) | 2005-10-24 | 2006-10-23 | Implantable and rechargeable neural stimulator |
Publications (3)
Publication Number | Publication Date |
---|---|
JP2009512505A JP2009512505A (ja) | 2009-03-26 |
JP2009512505A5 JP2009512505A5 (ja) | 2009-12-03 |
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2006
- 2006-10-23 JP JP2008536619A patent/JP5185128B2/ja not_active Expired - Fee Related
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US20100049275A1 (en) | 2010-02-25 |
WO2007050657A1 (en) | 2007-05-03 |
US8126561B2 (en) | 2012-02-28 |
EP1940509A1 (en) | 2008-07-09 |
US20130073000A1 (en) | 2013-03-21 |
US20070093875A1 (en) | 2007-04-26 |
US20120158090A1 (en) | 2012-06-21 |
US8660648B2 (en) | 2014-02-25 |
JP2009512505A (ja) | 2009-03-26 |
US7616990B2 (en) | 2009-11-10 |
US8634921B2 (en) | 2014-01-21 |
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