JP2006522635A - 体内通信用音響遠隔測定装置 - Google Patents
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Abstract
Description
本発明は、一般的に外科的にまたはその他の方法で体内に配置して、一またはそれ以上の生理的パラメータをモニタし、及び/又は、一またはそれ以上の治療機能を実行することができるインプラントに関する。特に、本発明は、例えば、身体内の一のインプラントを用いて身体内に配置した別のインプラントを活性化、不活性化、及び/又は制御する音響遠隔測定を用いて患者の身体内のインプラント間の通信を行うシステムに関する。一または両方のインプラントが、生理的状態をモニタし、及び/又は、治療機能を提供することができる。本発明のインプラントは、例えば、心室除細動、ペーシング、痛除去刺激、神経刺激、薬剤投与、光ダイナミック治療用光源の活性化、イオン化を含む放射線投与のモニタリング、磁気又は音響発光、バイパス移植における流れのモニタ、細胞酸素処理およびメンブレイン電解搬送、心室圧、インフラクション温度、頭蓋内圧、電気的インピーダンス、位置、整形インプラントの歪/ずれ、あるいはpHなどを含む様々な生理的パラメータの測定など、様々な診療及び/又は治療機能用に用いることができる。
図面を参照すると、図1は、患者の身体(図示せず)内にインプラントした2又はそれ以上のインプラント間の体内通信用システム10の実施例を示す。一般的に、システム10は第1のインプラント12(いわゆる、制御インプラントあるいはマスターインプラント)と第2のインプラント32(いわゆる休眠インプラントあるいはスレーブインプラント)を具える。選択的に、システム10は、例えば一またはそれ以上の追加の休眠またはスレーブインプラントなどの第2インプラント32と同様であり、以下に述べるように、制御インプラントが通信可能な追加インプラント(図示せず)を具えていてもよい。
制御インプラント12は、例えば電気回路14、音響トランスデューサ16、及び/又はエネルギィ源18などの複数のコンポネントを具えており、これらはボックス又はケーシング20内に設けられている。ケーシング20は、例えばチタンなどでできており、実質的に封入されており、好ましくはケーシング20の外側から制御インプラント12の部品を実質的に隔離するよう密封されている。ケーシング20は、例えば一又はそれ以上のサイドパネルなどの、一またはそれ以上の領域を具えており、音響エネルギィがケーシング20を通る、すなわち、音響トランスデューサ16へ及び/又は音響トランスデューサ16からの音響エネルギィの通過を容易なものにしている。例えば、音響トランスデューサの上にあるパネル20aは、チタンまたはその他の材料でできた、例えば約0.5mmの厚さの比較的薄い壁であり、音波が実質的に通過するようになっている。ここに述べる全インプラントを構成できる方法の更なる情報は、2001年6月21日に出願された米国特許出願第09/888,272号に見ることができる。
以下の記載は、エネルギィ消費パラメータに関するものであり、結果的に、図1、2Aおよび2Bに示す制御インプラント12などの制御インプラント用に、バッテリなどのエネルギィ源として、具体的には電力を必要とする。音響エネルギィ交換器またはトランスデューサは、現在は、約2V/kPaの感度を達成することができる。インプラントの活性化に使用できる音響スイッチは、シリコン圧電素子の場合約0.5Vを必要とするMOSFETを閉じることによって動作する。したがって音響スイッチを閉じるのに必要な最小音響レベルは、約250から500パスカル(250−500Pa)である。トランスミッタとレシーバ間の距離が約10cmである(すなわち、制御用の音響トランスデューサと患者の体内にインプラントした休眠インプラントとの間の距離)と仮定すると、500パスカル(500Pa@10cm)を生む音響パワーは:
である。
ここで、“ρ”と“c”は、それぞれ、水中の密度及び音速であり、“R”は距離、“p”は所望の音圧である。電気−音響変換効率を20%とすると、この式は約100mWの必要瞬間電力を提供する。
E=250×10−6×0.1=25μJ (2)
である。
P=25×10−6×4/3600=0.028μW (3)
となる。
制御インプラントの音響トランスデューサ(呼びかけ型トランスデューサ)は、様々な方法で構築することができる。一例は、音響トランスデューサ116として図3に記載されている圧電セラミックシリンダである。この製品は、ドイツ国、カールスルー所在の、Physik Instrumente (PI)GmbH & Co. KG社によってPIC181 PZTとして販売されている。このシリンダは、印加した交流電圧の影響下で膨張したり緊縮したりする。これはこのシリンダの体積を変化させ、単一の(すなわち、モノポール)ソースとして周囲のすべての液体に音響信号を送信する。
である。
ここで、“λ”は音波長であり、“V”は素子の体積である。40kHzで500Pa@10cmの必要な音響レベルを得るには、約2.5×10−6m3/secの体積変化か、あるいは約10−11m3の体積変化幅が必要である。
で与えられる。
ここで、“S”は歪である。10−11m3の体積変化を得るには、約4×10−6の歪が必要である。PI社のPIC181 PZT は、圧電歪定数が120×10−12m/m/V/mである。したがって、4×10−6の歪を得るには、約33,000V/mの電界を与えなければならず、さもなければ、約1mmの壁厚に対して約33Vの振幅が必要である。
図1に戻ると、第2のあるいは休眠インプラント32の例示的な実施例が示されている。一般的に、制御インプラント12と同様に、休眠インプラント32は、例えば、電気回路34、音響スイッチ42、及び/又はエネルギィ源38などの複数部品を具えており、これらはケーシング40の中に収納されている。ケーシング40は、例えば、チタンなどでできており、密封あるいは他の方法で封印され、休眠インプラント312の部品をケーシング40の外部から実質的に隔離している。ケーシング40は音響エネルギィをケーシング40を通過しやすくする一又はそれ以上の領域を具える。例えば、音響トランスデューサ36の上のパネル40aは比較的薄いチタンでできたメンブレインであるか、あるいは厚さ約50μmもしくはそれ未満の他の材料であってもよく、この部分を音波が通過する。
A.生理的圧力の測定
一の実施例では、図1に示すインプラント32などの休眠インプラントを用いて、休眠インプラントがインプラントされている患者の身体内の位置における生理的圧力をモニタすることができる。このようなアプリケーション用に、休眠インプラント32は電気回路34に接続した圧力センサ(図示せず)を具えていてもよい。この圧力センサは、インプラント32内に収納されている、すなわち、患者の体内の圧力がかかった活性センサプローブを伴っているが、代替的に圧力センサを例えば一またはそれ以上のリード線でインプラント32に接続するようにしてもよい(いずれの場合も、ここでは圧力センサを「内部圧力センサ」と言う)。
別の実施例では、本発明のシステムを心室の圧力及び/又は患者の心臓内の大きな脈管の圧力をモニタリングするのに用いることができる。得られたデータは、デバイスの性能を最適にするために、例えば、ペースメーカや、両心室性ペーサなどの、ペーシングインプラントなどのデバイスに生理的なフィードバックを提供するのに使用することができる。例えば、両心室性ペースメーカ(図示せず)は、患者の心臓の異なる心室の収縮間の遅れを制御して、心臓のポンピング効率を最適化することができる。休眠トランスデューサは、遠隔制御圧力センサとして働き、ペースメーカへのフィードバックを提供するために、例えば肺動脈、左心房、あるいは左心室といった脈管から両心室性ペースメーカへ圧力データを送信する。休眠インプラントは、除細動器の性能を改善するために圧力を測定して圧力データを送信するのにも使用することができる。
糖尿病は米国においては6つの主要な死因であり、罹患率が急速に増えている。自分で食事療法を変えて対処することができない何百万人もの糖尿病患者にとって、これらの疾患の継続的なコントロールは、血糖値レベルを適宜モニタしてインシュリンで治療することによっている。これを行うためには、糖尿病患者は、繰り返し指を針でさして血液サンプルを血糖またはグルコーステストを行わなければならない。結果によっては、彼らはインシュリンの投薬を自身で注射して行い、許容レベルにグルコースを戻さなくてはならない。適宜の血糖レベルが維持できないと、複数の身体器官を含む重い合併症を引き起こし、心臓血管と腎臓の疾患が進行し、視力が落ち、及び/又は周辺脈管の疾患を引き起こす。
Claims (16)
- 患者の体内に通信を提供するシステムにおいて:
a)音響信号を送信する第1の音響トランスデューサを具える第1のインプラントと;
b)第2のインプラントであって、
i)前記インプラントが活性化したときに一またはそれ以上のコマンドを実行するように構成された電気回路と;
ii)前記電気回路に接続されたスイッチと;
iii)前記スイッチに接続された第2の音響トランスデューサであって、前記第2のインプラントを活性化するべく前記スイッチを閉じるために前記第1の音響トランスデューサから一またはそれ以上の音響信号を受信するように構成された第2の音響トランスデューサと;
を具える第2のインプラントと;
を具えることを特徴とするシステム。 - 請求項1に記載のシステムにおいて、前記スイッチが前記第2の音響トランスデューサが第1の音響励起信号を受信して、第2の音響励起信号がそれに続くときにのみ閉じられ、前記第1及び第2の音響励起信号が所定の遅れ分だけ離れていることを特徴とするシステム。
- 請求項1又は2に記載のシステムにおいて、前記第2の音響トランスデューサが前記第1の音響励起信号と第2の音響励起信号を受信するように構成されており、前記スイッチが前記第1の音響励起信号が前記第2の音響トランスデューサによって受信されるときに閉じ、前記第2のインプラントを不活性化するべく前記第2の音響励起信号が前記第2の音響トランスデューサによって受信されるときに前記スイッチが開くことを特徴とするシステム。
- 請求項1乃至3のいずれかに記載のシステムにおいて、前記第2のインプラントが前記スイッチに接続されたエネルギィ保存デバイスを具え、前記スイッチが閉じたときに前記エネルギィ保存デバイスから前記電気回路に電流が流れることを特徴とするシステム。
- 請求項4に記載のシステムにおいて、前記エネルギィ保存デバイスがバッテリを具えることを特徴とするシステム。
- 請求項4に記載のシステムにおいて、前記エネルギィ保存デバイスが再チャージ可能なデバイスを具え、当該再チャージ可能なデバイスが前記第2の音響トランスデューサによって受信された音響エネルギィによって再チャージされることを特徴とするシステム。
- 請求項1又は2に記載のシステムにおいて、前記第2のインプラントが前記電気回路に接続されたセンサを具え、当該センサが前記第2のインプラントが活性化されたときに前記身体内の生理的パラメータを測定するように構成されていることを特徴とするシステム。
- 請求項7に記載のシステムにおいて、前記第1の音響トランスデューサが音響信号を受信するように構成されており、前記第2の音響トランスデューサが前記測定した生理的パラメータに関連する生理的データを具える信号を前記第1の音響トランスデューサに送信するように構成されていることを特徴とするシステム。
- 請求項1に記載のシステムが更に、前記電気回路に接続された治療デバイスを具え、前記電気回路が前記第1の音響トランスデューサから受信した音響信号に応じて前記治療デバイスを制御するように構成されていることを特徴とするシステム。
- 請求項1に記載のシステムにおいて、前記一またはそれ以上のコマンドが、前記電気回路に接続されたアクチュエータの活性化コマンドを具え、当該アクチュエータがアクチュエータに接続されている治療デバイスを制御するように構成されていることを特徴とするシステム。
- 請求項1に記載のシステムにおいて、前記第2の音響トランスデューサが第1の音響励起信号とそれに続く第2の音響励起信号を受信するように構成されており、前記電気回路が所定のコマンドセットの一つとして前記第2の音響励起信号を翻訳処理するように構成されており、前記第1の音響トランスデューサが前記第1の音響励起信号とそれに続く第2の音響励起信号を送信するように構成されていることを特徴とするシステム。
- 請求項1又は11に記載のシステムにおいて、前記第2のインプラントが更に、前記スイッチに接続されたタイマを具え、当該タイマが前記スイッチが最初に閉じた後、所定の時間が過ぎた後に前記スイッチを開くように構成されていることを特徴とするシステム。
- 請求項1に記載のシステムにおいて、前記第1のインプラントがペースメーカに接続されたコントローラを具え、前記第2のインプラントが患者の心臓内の圧力を測定する圧力センサを具え、前記第2のインプラントが音響信号を前記第1のインプラントに送信するように構成されており、前記音響信号が患者の心臓内で測定された圧力を具え、前記コントローラが前記音響信号から前記測定した圧力を抽出して、少なくとも部分的に前記測定した圧力に基づいて、前記ペースメーカを制御するように構成されていることを特徴とするシステム。
- 請求項1に記載のシステムにおいて、前記第1のインプラントがインシュリンポンプに接続されたコントローラを具え、前記第2のインプラントが患者の体内における血糖値濃度を測定するグルコースセンサを具え、前記第2のインプラントが前記第1のインプラントに音響信号を送信するように構成されており、前記音響信号が前記患者の体内の測定した血糖値濃度を具え、前記コントローラが前記音響信号から前記測定した血糖値濃度を抽出して少なくとも部分的に前記測定した血糖値濃度に基づいて前記インシュリンポンプを制御するように構成されていることを特徴とするシステム。
- 請求項1に記載のシステムにおいて、前記第2のインプラントは患者の身体内の生理的パラメータを測定するセンサを具え、前記第2のインプラントが音響信号を前記第1のインプラントに送信するように構成されており、前記音響信号が前記測定した生理的パラメータに関連するデータを具え、前記第1のインプラントが前記測定した生理的パラメータに関連するデータを保存するメモリを具え、前記患者の身体外に位置するデバイスにデータを送信するトランスミッタを備えることを特徴とするシステム。
- 請求項5に記載のシステムにおいて、前記トランスミッタが患者の身体外に位置するデバイスから音響信号を受信する音響トランスデューサを具え、当該音響トランスデューサが前記生理パラメータに関連したデータを含む音響信号を送信するように構成されていることを特徴とするシステム。
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2013
- 2013-09-11 US US14/024,620 patent/US20140012342A1/en not_active Abandoned
Cited By (7)
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KR101374679B1 (ko) | 2007-01-26 | 2014-03-17 | 엘렉트리씨트 드 프랑스 | 하우징에서 가스의 압력 및/또는 몰 질량의 측정방법, 및 이에 대응하는 측정 어셈블리 |
JP2011526195A (ja) * | 2008-07-15 | 2011-10-06 | カーディアック ペースメイカーズ, インコーポレイテッド | 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 |
JP2017192733A (ja) * | 2011-06-30 | 2017-10-26 | エンドトロニックス インコーポレイテッド | ワイヤレス回路 |
US10433764B2 (en) | 2011-06-30 | 2019-10-08 | Endotronix, Inc. | Implantable sensor enclosure with thin sidewalls |
US11547320B2 (en) | 2011-06-30 | 2023-01-10 | Endotronix, Inc. | Implantable sensor enclosure with thin sidewalls |
US12029546B2 (en) | 2011-06-30 | 2024-07-09 | Endotronix, Inc. | Implantable sensor enclosure with thin sidewalls |
JP2016533802A (ja) * | 2013-10-25 | 2016-11-04 | シンテフ ティーティーオー エーエス | 生体内圧力モニタリングシステム |
Also Published As
Publication number | Publication date |
---|---|
EP1613396A1 (en) | 2006-01-11 |
US7198603B2 (en) | 2007-04-03 |
WO2004089465A1 (en) | 2004-10-21 |
US20070142728A1 (en) | 2007-06-21 |
EP1613396B1 (en) | 2009-01-07 |
DE602004018911D1 (de) | 2009-02-26 |
ATE419899T1 (de) | 2009-01-15 |
US20140012342A1 (en) | 2014-01-09 |
US8540631B2 (en) | 2013-09-24 |
EP2036588B1 (en) | 2012-05-16 |
US20040204744A1 (en) | 2004-10-14 |
EP2036588A1 (en) | 2009-03-18 |
JP4429310B2 (ja) | 2010-03-10 |
CA2521637A1 (en) | 2004-10-21 |
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