JP5362828B2 - 音響的にイネーブルされる埋め込み型医療デバイス用のインプラント補助装置 - Google Patents
音響的にイネーブルされる埋め込み型医療デバイス用のインプラント補助装置 Download PDFInfo
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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
- A61N1/372—Arrangements in connection with the implantation of stimulators
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- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
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- A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
- A61B5/28—Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
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- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
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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
- A61N1/372—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
- A61N1/378—Electrical supply
- A61N1/3787—Electrical supply from an external energy source
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Description
り、IMD12とインプラント補助デバイス18との間で、あるいは、IMD12とIMD12と通信する別の内部または外部デバイスとの間で音響通信の信号強度および品質を増加させる。送出カテーテル16は、近位部分38、遠位部分40、および、送出中に内部にIMD12を保持することが可能な内部管腔42を有する細長い軸36を含む。
および継続時間から著しく変わる可能性がある。
に埋め込まれるように構成される。たとえば、IMD12が、ペースメーカまたは徐細動器などのインプラントと音響通信するように構成される実施形態では、インプラント補助デバイス18は、インプラントを、通常、支持する体腔内にまたはその近くに一時的に留置されてもよい。インプラント補助デバイス18のこうした留置は、IMD12が身体内に埋め込まれ、インプラントと通信状態に置かれるとたどられる経路と同様の経路を、IMD12によって送信され、かつ、デバイス18によって受信される音響信号がたどることを保証する。一部の実施形態では、インプラント補助デバイス18は、ペースメーカまたは徐細動器などの別のインプラントに一体化されてもよい。
フィードバックを提供してもよい。
開されたIMD12を示す。IMD12が身体内に埋め込まれると、インプラント補助デバイス18はまた、所望である場合、埋め込まれたIMD12からの音響送信の信号強度および品質を検証するために使用され得る。一部の実施形態では、たとえば、IMD12は、内部管腔42から引抜かれると、カテーテル16の外側の位置からインプラント補助デバイス18に音響信号を送信してもよい。音響送信の強度および/または品質が、埋め込み後、低いかまたは許容可能でない場合、IMD12は、埋め込み部位における線維性内部成長が起こる前に、必要に応じて取出され、再展開され得る。一旦埋め込まれると,IMD12は、その後、指定された機能を実施するために起動され得る。IMD12の埋め込みに続いて、インプラント補助デバイス18はまた、身体内で徐々に起こった可能性がある任意の生理的変化を考慮して、IMD12がセンサデータおよびデバイス状態情報を正確に送信し続け得るかどうかを判定するために、音響通信を定期的に評価するために利用され得る。
かどうかを臨床医が迅速に判定することを可能にするために、赤と緑の両方であり得る。受信される音響信号の強度および品質が、許容可能なレベルに達すると、たとえば、スクリーンまたはディスプレイパネルは、通信リンクが適切であることを示す、全て緑であるいくつかのバーを表示してもよい。別の実施形態によれば、たとえば、ユーザフィードバックデバイス72は、IMD12によって送信される音響信号の強度および品質が許容可能な性能レベルに達すると、シンボル(たとえば、緑の光)を表示するだけであってもよい。臨床医に視覚、聴覚、および/または触覚フィードバックを提供する他の手段も可能である。
最初に、IMD12は、所定の振幅レベルを有する音響ウェークアップコマンドに応答して、ウェークアップされ、アクティブ動作モードに移行するようにプログラムされる。一部の実施形態では、IMD12は、たとえば、50%送信電力レベルなどの低減された電力レベルでインプラント補助デバイス18によって送信された音響ウェークアップコマンドに応答してアクティブ動作モードに移行するようにプログラムされる。初期の低減電力のウェークアップコマンドが、IMD12をウェークアップさせるのに十分な振幅である場合、IMD12内の制御/処理回路52は、受信された音響ウェークアップコマンドの電力レベルに整合するようにIMD12の送信電力レベルを調整し(ブロック104)、その後、調整された電力レベルの音響信号を、インプラント補助デバイス18に返送する(ブロック106)。たとえば、IMD12によって受信される音響ウェークアップコマンドが、50%送信電力レベルを有し、IMD12をウェークアップさせるのに十分である場合、IMD12内の制御/処理回路52は、IMD12の送信電力レベルを50%に調整し、その後、50%電力レベルで音響信号を、インプラント補助デバイス18に返送し得る。
ンプラント補助デバイス18はまた、IMD12からインプラント補助デバイス18への音響通信に関連する種々の通信パラメータをIMD12に調整するよう促す他のコマンドをIMD12に送出してもよい。IMD12からインプラント補助デバイス18への音響
通信に関連する例示的なパラメータは、パルスカウント(たとえば、1送信当たりのパスル数)およびデータレート(たとえば、ビット間の時間または継続時間)を含んでもよい。インプラント補助デバイス18はまた、インプラント補助デバイス18へのアップリンク送信中にIMD12のクロック周波数を調整するコマンドを送信してもよい。
Claims (14)
- 患者の身体内の目標場所に埋め込み型デバイスを送出し配置するシステムであって、
バイオセンサおよび音響信号を送信するように構成された少なくとも1つの音響変換器を含む埋め込み型デバイスを送出するようになっているカテーテルと、
音響通信リンクを介して前記埋め込み型デバイスと音響通信するインプラント補助デバイスとを備え、前記インプラント補助デバイスは、前記埋め込み型デバイスから前記音響信号を受信するようになっている少なくとも1つの音響変換器および前記音響通信リンクの性能を評価するように構成された回路を含んでなり、前記音響通信リンクは前記埋め込み型デバイスが送信した前記音響信号に関連する複数のパラメータであって所定の組の信号基準に対する複数のパラメータを重み付けることによって加算した重み付き加算を比較することによって評価される、システム。 - 前記インプラント補助デバイスは、前記埋め込み型デバイスが、前記カテーテルの内部管腔内に少なくとも部分的に配設されている間に、前記埋め込み型デバイスから前記音響信号を受信するように構成される請求項1に記載のシステム。
- 前記インプラント補助デバイスは前記音響通信リンクの性能を示す情報をユーザに提供するように構成されたユーザインタフェースを備える、請求項1に記載のシステム。
- 前記インプラント補助デバイスは外部デバイスである請求項1に記載のシステム。
- 前記インプラント補助デバイスは埋め込み型デバイスである請求項1に記載のシステム。
- インプラント補助デバイスの作動方法において、
埋め込み型デバイスと前記インプラント補助デバイスとの間で音響通信リンクを確立する工程であって、前記インプラント補助デバイスは、前記埋め込み型デバイスによって送信される音響信号を受信するように構成された音響変換器および前記音響通信リンクの性能を評価するように構成された回路を含む、前記埋め込み型デバイスと前記インプラント補助デバイスとの間で音響通信リンクを確立する工程と、
少なくとも、所定の組の信号基準に対する前記音響信号に関連する複数のパラメータの重み付き加算を比較することによって、前記インプラント補助デバイスと前記埋め込み型デバイスとの間の前記音響通信リンクの性能を評価する工程と、
埋め込み型デバイスとインプラント補助デバイスとの間の音響通信リンクを評価することを前記ユーザに可能にさせるべく前記音響通信リンクの性能を示す情報をユーザインタフェースに提供する工程とを備える、方法。 - 前記複数のパラメータには、前記インプラント補助デバイスによって受信された前記音響信号の信号強度および品質が含まれる、請求項6に記載の方法。
- 前記複数のパラメータには、ノイズフロアレベルパラメータ、搬送波周波数パラメータ、信号タイミングパラメータ、信号継続時間パラメータ、信号形態パラメータ、受信機利得パラメータ、受信機閾値パラメータ、デコードレシオパラメータ、ビットエラーレートパラメータ、ビット訂正レートパラメータ、音響減衰パラメータ、およびウェークアップ閾値余裕パラメータが含まれる、請求項6に記載の方法。
- 前記複数のパラメータは、信号振幅を含み、前記音響通信リンクの性能を評価する工程において、前記音響信号の振幅を閾値振幅値と比較する、請求項6に記載の方法。
- 前記複数のパラメータは、複数の重み付きパラメータを含む請求項6に記載の方法。
- 前記埋め込み型デバイスによって送信される前記音響信号のパルスカウントまたはパルス継続時間を前記インプラント補助デバイスが調整する工程をさらに備え、前記音響通信リンクの性能を評価する工程において、前記調整されたパルスカウントまたはパルス継続時間に対する前記音響信号の応答を評価する、請求項6に記載の方法。
- 前記音響信号のクロックスキューを調整する工程をさらに備え、前記音響通信リンクの性能を評価する工程において、前記調整されたクロックスキューに対する前記音響信号の応答を評価する、請求項6に記載の方法。
- 音響通信リンクを確立する工程は、前記インプラント補助デバイスが前記インプラント補助デバイスから前記埋め込み型デバイスへ第1の音響信号を送信する工程、および、前記インプラント補助デバイスが前記埋め込み型デバイスから第2の音響信号を受信する工程を含み、前記埋め込み型デバイスから受信される前記第2の音響信号は、前記第1の音響信号に振幅が比例する、請求項6に記載の方法。
- 前記音響通信リンクを評価する工程は、前記インプラント補助デバイスが前記インプラント補助デバイスから前記埋め込み型デバイスへ第1の音響信号を送信する工程と、前記インプラント補助デバイスが前記埋め込み型デバイスから第2の音響信号を受信する工程とを含み、前記埋め込み型デバイスから受信される前記第2の音響信号は、前記第1の音響信号に振幅が比例する、請求項6に記載の方法。
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PCT/US2009/049409 WO2010008936A1 (en) | 2008-07-15 | 2009-07-01 | Implant assist apparatus for acoustically enabled implantable medical device |
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-
2009
- 2009-07-01 JP JP2011516852A patent/JP5362828B2/ja not_active Expired - Fee Related
- 2009-07-01 US US12/496,332 patent/US8934987B2/en active Active
- 2009-07-01 EP EP09790027A patent/EP2296536A1/en not_active Withdrawn
- 2009-07-01 WO PCT/US2009/049409 patent/WO2010008936A1/en active Application Filing
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EP2296536A1 (en) | 2011-03-23 |
JP2011526195A (ja) | 2011-10-06 |
US8934987B2 (en) | 2015-01-13 |
US20100016840A1 (en) | 2010-01-21 |
WO2010008936A1 (en) | 2010-01-21 |
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