JP2014054549A - 心臓支援デバイス、システム、および方法 - Google Patents
心臓支援デバイス、システム、および方法 Download PDFInfo
- Publication number
- JP2014054549A JP2014054549A JP2013216383A JP2013216383A JP2014054549A JP 2014054549 A JP2014054549 A JP 2014054549A JP 2013216383 A JP2013216383 A JP 2013216383A JP 2013216383 A JP2013216383 A JP 2013216383A JP 2014054549 A JP2014054549 A JP 2014054549A
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- JP
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- Prior art keywords
- heart
- energy
- force
- cardiac
- patient
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
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Abstract
【解決手段】心臓接触器官は、埋込み可能なデバイスがヒト患者内に埋込まれた後においては、心臓に作用する前記力の位置を変更するように動かせるように適合される。本発明はさらに、前記デバイスを使用する方法に関する。
【選択図】 図25
Description
そのプレートは、埋込み可能なデバイスがヒト患者内に埋込まれた後であれば、ヒト患者の心臓に作用する力の位置の変更のために、動かせように適合されている。そのプレートは、動作デバイスを使用して動かせるように適合することができ、動作デバイスには、電気、液圧、または空気圧で動力供給することができる。
体内制御ユニットと、
心臓の生理学的な電気パルスまたは筋肉収縮を感知するセンサとを備え、
前記制御ユニットが、感知された情報に従って前記心臓補助デバイスを制御することが好ましい。
− 針または管状の計器を患者の身体の胸部内に挿入するステップと、
− 針または管状の計器を使用して胸部に気体を充填し、それによって胸腔を膨張させるステップと、
− 少なくとも2つの腹腔鏡トロカールを患者の体内に配置するステップと、
− 腹腔鏡トロカールの1つを通して胸部内にカメラを挿入するステップと、
− 前記少なくとも2つの腹腔鏡トロカールの1つを通して少なくとも1つの切開器具を挿入し、患者の心臓の所期の配置領域を切開するステップと、
− 胸部内の配置領域内に心臓補助デバイスを1つまたは複数の部分として配置するステップとを含み、このステップが、
− 血流に影響を及ぼす心臓接触器官を配置するステップと、
− 心臓接触器官によって使用される動力学的運動を生じさせる駆動ユニットを配置するステップと、
− 固定デバイスを人骨に安定した位置で取り付けて、前記駆動ユニットおよび動力学的運動が必要な抗力を得られるようにするステップと、
− 安定した骨の位置に対して心臓の呼吸運動を補償する呼吸運動補償器を配置するステップと、
− 心臓補助デバイスに動力供給する埋込まれたエネルギー受信器または体内エネルギー源を配置して接続し、それによって、
心臓を少なくとも部分的に圧迫する方法ステップ、および心臓補助デバイスを少なくとも部分的に弛緩させる方法ステップの少なくとも1つを実行して、心臓のポンプ機構をその外側から支持するステップとを含む。
− 患者の皮膚を切るステップと、
− 胸腔を開くステップと、
− 心臓に対して内側に心臓補助デバイスを配置する配置領域を切開するステップと、
− 胸部内の配置領域内に心臓補助デバイスを1つまたは複数の部分として配置するステップとを含み、このステップが、
− 血流に影響を及ぼす心臓接触器官を配置するステップと、
− 心臓接触器官によって使用される動力学的運動を生じさせる駆動ユニットを配置するステップと、
− 固定デバイスを人骨に安定した位置で取り付けて、前記駆動ユニットおよび動力学的運動が必要な抗力を得られるようにするステップと、
− 安定した骨の位置に対して心臓の呼吸運動を補償する呼吸運動補償器を配置するステップと、
− 心臓補助デバイスに動力供給する埋込まれたエネルギー受信器または体内エネルギー源を配置して接続し、それによって、
心臓を少なくとも部分的に圧迫する方法ステップ、および心臓補助デバイスを少なくとも部分的に弛緩させる方法ステップの少なくとも1つを実行して、心臓のポンプ機構をその外側から支持するステップとを含む。
− 針または管状の計器を患者の身体の腹部内に挿入するステップと、
− 針または管状の計器を使用して腹部に気体を充填し、それによって腹腔を膨張させるステップと、
− 少なくとも2つの腹腔鏡トロカールを患者の腹部内に配置するステップと、
− 腹腔鏡トロカールの1つを通して腹部内にカメラを挿入するステップと、
− 前記少なくとも2つの腹腔鏡トロカールの1つを通して少なくとも1つの切開器具を挿入するステップと、
− 隔膜筋内を切開して開口を生じさせるステップと、
− 前記開口を通して患者の心臓の所期の配置領域を切開するステップと、
− 胸部内の配置領域内に心臓補助デバイスを1つまたは複数の部分として配置するステップとを含み、このステップが、
− 血流に影響を及ぼす心臓接触器官を配置するステップと、
− 心臓接触器官によって使用される動力学的運動を生じさせる駆動ユニットを配置するステップと、
− 固定デバイスを人骨に安定した位置で取り付けて、前記駆動ユニットおよび動力学的運動が必要な抗力を得られるようにするステップと、
− 安定した骨の位置に対して心臓の呼吸運動を補償する呼吸運動補償器を配置するステップと、
− 心臓補助デバイスに動力供給する埋込まれたエネルギー受信器または体内エネルギー源を配置して接続し、それによって、
心臓を少なくとも部分的に圧迫する方法ステップ、および心臓補助デバイスを少なくとも部分的に弛緩させる方法ステップの少なくとも1つを実行して、心臓のポンプ機構をその外側から支持するステップとを含む。
− 患者の皮膚を切るステップと、
− 腹腔を開くステップと、
− 隔膜筋内を切開して開口を生じさせるステップと、
− 前記開口を通して心臓補助デバイスを配置する配置領域を切開するステップと、
− 胸部内の配置領域内に心臓補助デバイスを1つまたは複数の部分として配置するステップとを含み、このステップが、
− 血流に影響を及ぼす心臓接触器官を配置するステップと、
− 心臓接触器官によって使用される動力学的運動を生じさせる駆動ユニットを配置するステップと、
− 固定デバイスを人骨に安定した位置で取り付けて、前記駆動ユニットおよび動力学的運動が必要な抗力を得られるようにするステップと、
− 安定した骨の位置に対して心臓の呼吸運動を補償する呼吸運動補償器を配置するステップと、
− 心臓補助デバイスに動力供給する埋込まれたエネルギー受信器または体内エネルギー源を配置して接続し、それによって、
心臓を少なくとも部分的に圧迫する方法ステップ、および心臓補助デバイスを少なくとも部分的に弛緩させる方法ステップの少なくとも1つを実行して、心臓のポンプ機構をその外側から支持するステップとを含む。
− 前記駆動ユニットから前記心臓補助デバイスへ運動力を供給し、前記心臓接触器官の運動を引き起こすステップをさらに含むことができる。
− 駆動ユニットを、前記駆動ユニットに動力供給する埋込み可能なエネルギー受信器または体内エネルギー源と接続するステップをさらに含むことができる。
− 前記固定子および回転子を腹部または胸部内に配置するステップであって、前記回転子が前記心臓補助デバイスに接続する、ステップと、
− 前記固定子へエネルギーを供給して前記回転子を回転させ、それによって前記心臓補助デバイスへ運動エネルギーを輸送するステップとをさらに含む。
− 心臓補助デバイスまたは駆動ユニットに接続された電線を、心臓の右心房内へ、さらに静脈血管システム内をさかのぼって切開して配置するステップと、
− 鎖骨下静脈、頚静脈、または上腕静脈内など、皮下領域内または皮下領域のより近くで血管システムから出るステップと、
− 皮下領域内もしくはその付近に、または胸部もしくは腹部内に体内エネルギー源を配置するステップと、
− 患者の皮膚を貫通しないで、体外エネルギー源からエネルギーを非侵襲的に供給し、体内エネルギー源に動力供給して心臓補助デバイスまたは駆動ユニットに間接的または直接的に動力供給するステップとをさらに含む。
− 心臓の右心房または右心室内に電極を配置するステップと、
− 心臓の右心房を介して電極へ、さらに静脈血管システム内をさかのぼって電線を配置するステップと、
− 鎖骨下静脈、頚静脈、または上腕静脈内など、皮下領域内または皮下領域のより近くで血管システムから出るステップと、
− 皮下領域内もしくはその付近に、または胸部もしくは腹部内に体内制御ユニットを配置するステップとをさらに含むことができ、この方法が、
− 心臓収縮を制御する前記電極からのエネルギー・パルスを伝送するステップ、および − 心臓補助デバイスまたは駆動ユニットを連係して働かせるステップの少なくとも1つをさらに含む。
− 心臓の右心房または右心室内に電極を配置するステップと、
− 心臓の右心房を介して電極へ、さらに静脈血管システム内をさかのぼって電線を配置するステップと、
− 鎖骨下静脈、頚静脈、または上腕静脈内など、皮下領域内または皮下領域のより近くで血管システムから出るステップと、
− 皮下領域内もしくはその付近に、または胸部もしくは腹部内に体内制御ユニットを配置するステップとをさらに含み、この方法が、
− 心臓の電気パルスまたは筋肉収縮に関連するセンサ入力を受け取るステップ、および − 前記センサ入力に基づいて心臓補助デバイスまたは駆動ユニットを連係して働かせるステップの少なくとも1つをさらに含む。
第1、第2、および第3の部分は互いに対して移動可能であり、回転運動するように適合される。第2のプレート12はコイル14を備え、第1および第3のプレートは磁石15を備える。コイルは、制御ユニット176から制御して連続して付勢することができ、それによってコイル14と磁石15の間の磁気的接続により第1および第3のプレートの運動を生じさせる。第1のプレート11および第2のプレート12の表面は互いに当接し、実質上一定の運動状態にあり、それによって動作デバイス57の機能を妨害しうる瘢痕組織のあらゆる成長を妨げる。当接する表面の一定の運動が生じさせる摩耗に動作デバイスが耐えることができるように、プレート11、12、13、または別法としてこれらの表面は、耐久性の高い材料から作る必要がある。そのような材料は、セラミック材料、炭素ベースの材料、またはチタンもしくはステンレス鋼などの金属材料とすることができる。
プレートまたは表面は、フッ素重合体などの自己潤滑性材料から作られることがさらに考えられ、別法としてこれらの表面は、埋込み可能な潤滑システムを用いて潤滑されるように適合することができる。埋込み可能な潤滑システムは、プレート11、12、13または表面をヒアルロン酸などの生体親和性の潤滑流体で潤滑するように適合することができる。記載の材料の組合せがさらに考えられる。図7の実施形態によれば、動作デバイス57は回転運動するように適合されるが、動作デバイスを往復運動するように適合させることも可能である。
第1、第2、および第3の部分は互いに対して移動可能であり、回転運動するように適合される。第2のプレート12はコイル14を備え、第1および第3のプレートは磁石15を備える。コイルは、制御ユニット176から制御して連続して付勢することができ、それによってコイル14と磁石15の間の磁気的接続により第1および第3のプレートの運動を生じさせる。動作デバイスは、動作デバイス57の回転運動を案内する中心軸17をさらに備える。
図9では、埋込み可能なデバイスは第2のポンプ・デバイス53をさらに備え、第1および第2のポンプ・デバイスは、それぞれ人間の心臓Hの左側および右側で動作するように適合されるが、他の実施形態では、第1のポンプ・デバイス3および第2のポンプ・デバイス53は、ヒト患者の心臓Hの腹側および背側で動作するように適合することができる。埋込み可能なデバイス1は、前記埋込み可能なデバイス1を人体構成骨240の構造に固定させるように適合された第1の固定部材241aおよび第2の固定部材241bをさらに備える。これらの固定部材は、ねじを使用して互いに固定される第1のプレート242aおよび第2のプレート242bを備える。当接する表面の一定の運動が生じさせる摩耗にポンプ・デバイスが耐えることができるように、影響を受ける部分または表面は、耐久性の高い材料から作る必要がある。そのような材料は、セラミック材料、炭素ベースの材料、またはチタンもしくはステンレス鋼などの金属材料とすることができる。これらの部分または表面は、フルオポリマーなどの自己潤滑性材料から作られることがさらに考えられ、別法としてこれらの表面は、埋込み可能な潤滑システムを用いて潤滑されるように適合することができる。埋込み可能な潤滑システムは、これらの部分または表面をヒアルロン酸などの生体親和性の潤滑流体で潤滑するように適合することができる。記載の材料の組合せがさらに考えられる。このデバイスは実質上一定の運動状態にあり、それによってデバイスの機能を妨害しうる瘢痕組織のあらゆる成長を妨げる。
動作デバイス57は、偏心運動を生じさせるように適合された駆動部材91に取り付けられた回転中心を有する回転部材93を動作させる。この駆動部材は、ヒンジ101で留められたピボット100と接触している。ピボットは、機械的力伝送器として働くことができ、またはヒト患者の心臓Hに力を作用させるように適合された心臓接触器官2として働くことができる。動作デバイスは、接続部材906を通して動作デバイスに接続された制御ユニット176を使用して制御される。動作デバイスは、電気、磁気、液圧、または空気圧モータとすることができる。液圧が使用される任意の実施形態では、液圧システム内で流体の較正を可能にするように、注入ポート97を設けることができる。制御ユニット176は、デバイスまたは患者の変量を感知する少なくとも1つのセンサ98をさらに備えることができる。さらに、制御ユニット176は、無線エネルギーおよび/または情報を伝達する無線伝達ユニット99を備えることができる。制御ユニット内には、少なくとも1つの電池106を設けることができる。
動作デバイス57は、偏心運動を生じさせるように適合された駆動部材91に取り付けられた回転中心を有する回転部材93を動作させる。駆動部材は、一方の端部で、ヒンジ101で留められたピボット100と接触しており、他の端部は、他の端部107でヒンジで留められる別のピボット103と接触している。第1のピボット100および第2のピボット103を機械的力伝送器として使用できるピボット・システム、または前記第1もしくは第2のピボットは、心臓Hに力を作用させるように適合された心臓接触器官2を備えることができる。
動作デバイス57は、偏心運動を生じさせるように適合された駆動部材91に取り付けられた回転中心を有する回転部材93を動作させる。駆動部材は、2つの案内部材105a、bによって案内される往復運動部材104と接触している。往復運動部材104は、機械的力伝送器として使用することができ、または心臓Hに力を作用させるように適合された心臓接触器官2を備えることができる。
遠隔位置は制御ユニットを備え、制御ユニットは、動作デバイス146aと、注入ポート146bと、電池146cと、埋込み可能なシステムまたは患者の変量を感知する少なくとも1つのセンサ146dとを備えることができる。
しかし、接続アーム244は、それぞれ、点170aおよび170bの1つにヒンジで留められ、他方の170a、bに固定して取り付けられることが考えられる。接続アーム244は、手動または動力供給で動作できるように適合することができる。接続アームは、動作デバイス172を用いて動作できるようにすることができる。動作デバイス172は、電気、機械、液圧、または空気圧式の動作デバイス172とすることができる。動作デバイス172は、固定部材241と接続して配置することができ、遠隔制御装置を使用して体外から遠隔で制御されるように適合することができる。接続アームは、手術または腹腔鏡による手順中に手動で調整できることも考えられ、その場合、埋込み可能なデバイス1には調整部材(図示せず)を設けることができる。調整部材は、手術または腹腔鏡による手順で使用される手術器具を用いて調整可能なものとすることができる。
代替実施形態では、人体構成骨240の構造の腹側Aから配置されたねじを備えることができ、その場合これらのナットは、構造構成骨240の背側Pに配置される。第1の固定部材241aおよび第2の固定部材241bは、人体構成骨240の構造を締め付ける。
固定部材241aは接続アーム244と接触することができ、接続アーム244は心臓のポンプ・デバイスと接触することができる。
第1の固定部材241aおよび第2の固定部材241bは、人体構成骨240の構造を締め付ける。固定部材241aは接続アーム244と接触することができ、接続アーム244は心臓のポンプ・デバイスと接触することができる。
このシステムは埋込み可能アキュムレータをさらに含むことができ、第2の形のエネルギーは、アキュムレータを充電するために少なくとも部分的に使用される。
したがって、装置10の調節は、皮下スイッチを手動で押すことによって非侵襲的に実行され、それによって装置10の動作のオンとオフが切り換えられる。図示の実施形態は簡略化したものであること、そして体内制御ユニットまたは本出願に開示のあらゆる他の部分などの追加の構成要素をシステムに追加できることが理解されよう。2つの皮下スイッチを使用することもできる。好ましい実施形態では、1つの埋込まれたスイッチが体内制御ユニットへ情報を送って特定の所定の実行を行い、患者が再びスイッチを押すと、その実行が反転される。
しかし、本発明は一般に、いかなる特定のエネルギー伝達技法、TETデバイス、またはエネルギー源にも限定されるものではなく、あらゆる種類の無線エネルギーを使用することができる。
概略的な図64には受信コイルL1を含み、システムの伝送部は除いた。
この特定の場合、埋込まれた構成要素へのエネルギーは、25kHzの周波数で伝送される。エネルギー・バランス出力信号は、試験点Y1に現れる。
偏心回転部材891は駆動部材であり、回転中心803を有する動作デバイスの一部である。動作デバイスは、図7および8を参照して記載の磁気モータなど、コイル804と、前記コイル804と磁気的に接続される磁石とを備える磁気モータの一実施形態をさらに備える。コイル804は第1のプレート812上に配置され、第1のプレート812は、磁石を備える第2のプレート891と接続される。図89aに示す実施形態では、第2のプレート891は偏心回転部材891を備える。第1のプレート812および第2のプレート891は、互いに対して回転的に移動できるように適合されており、磁石と磁気的に接続されたコイル804を連続して付勢することによって力が生じ、それによって第2のプレート891に対して第1のプレート812の回転運動を生じさせ、第2のプレート891は偏心回転部材891に影響を及ぼす。さらに、図89aの実施形態によれば、第1のプレート812および第2のプレート891は、この実施形態によれば摩耗に耐えるセラミック材料を含む接触表面で、使用の際には互いと接触するように適合される。
埋込み可能なデバイスは、患者の胸骨250に固定されたプレート242に心臓接触器官2を接続する接続アーム244を備える。他の実施形態によれば、プレート242または固定アーム244は、患者の少なくとも1本の肋骨または少なくとも1つの脊椎骨に固定することができる。図90の実施形態によれば、心臓支援デバイスは、心臓Hの外側の部分に力を作用させることによって心臓を圧迫するように適合されたデバイスであるが、他の実施形態では、心臓支援デバイスは、人体構成骨の一部に同じように固定された人工心臓またはLVADデバイスとすることができる。
このシステムは、システムを補充または較正する注入ポート917をさらに備える。注入ポート917は、皮下に埋込まれ、身体918の組織に固定され、導管916によって低圧チャンバ910に接続される。
封止は、接触点513で生じる。接触点513の表面は、隔膜接触部501と力伝達部材502の間の一定の接触によって生じる摩耗に耐えるために、セラミック材料などの摩耗に耐える耐久性の高い材料から作ることができる。
いくつかの実施形態によれば、心臓接触器官602a、bは液圧または空気圧クッションであり、これらの機能については、本明細書の他の図を参照して説明している。第1のアーム616aが、動作デバイス600を備える部分をヒンジ604で留めた第2のアーム616bへ接続し、それによって第1のアーム616aに対する第2のアーム616bの運動を可能にする。第1の心臓接触器官602aは、心臓に作用する力の位置を変更するために第1の心臓接触器官602aの運動を可能にするように適合されたプレート615に動作可能に取り付けられる。このプレートは、プレート615とプレート615を動作させるように適合されたモータ612との間のギア接続614、613によって動作可能である。心臓に力を作用させることは、動作デバイス600が駆動部材と接続され、駆動ワイア621が固定された固定点609の偏心回転運動を実行し、それによって第2のヒンジで留めたアーム616を引くことによって実行され、それによって心臓に力を作用させる運動を生じさせる。心臓支援デバイスは、この構造によって、心臓収縮に続いて心臓の筋肉に力を周期的に作用させて心臓の筋肉に力をかける。
第1、第2、および第3の表面は、少なくとも部分的に互いに当接するように適合される。第1の部分は、駆動ワイア621との接続によって、心臓の外側の部分に力を間接的に作用させる。第1、第2、および第3の表面は、実質上平行である。第2の部分は磁石15を備え、第1および第3の部分はコイル14を備え、コイル14に連続して付勢することによって、第2の部分の移動が生じる。この移動からの力は、駆動ワイア621が固定された偏心回転固定部材609を備える偏心駆動部材と接続されたギア・システム643、644を通して、ダイブ(dive)・ワイアへ伝達される。
埋込み可能な心臓支援デバイスのポンプ・デバイスは、デバイス706に接続されたアーム705にヒンジで留められ、それによって、固定プレート708に沿って心臓ポンプ・デバイスの運動を可能にする。固定プレート708は、固定プレート708を人体構成骨の一部に固定させる2つの固定部材704を備える。システム全体は、例えば遠隔制御装置を用いて、体外から非侵襲的に制御されるように適合することができる。このときシステムは、例えば無線伝達を用いて、デバイスの位置および動作に関するフィードバックを体外へ送るセンサ機能を有することができる。
Claims (1)
- 心臓の筋肉に外力をかけることによってヒト患者の心臓のポンプ機能を改善する埋込み可能なデバイスであって、
心臓収縮に続いて周期的に心臓の筋肉に力を作用させて心臓の筋肉に力をかける少なくとも1つの心臓接触器官を備え、
前記埋込み可能なデバイスは、前記接触器官によって心臓に作用する力の位置を変更するために前記心臓接触器官の位置への物質的変更を適合し、
前記埋込み可能なデバイスは、前記接触器官によって心臓に作用する力の位置を変更できるように適合され、患者に埋込まれた後においては力の作用する領域を心臓の第1の領域から心臓の第2の領域へと変更することが可能となり、
前記心臓の第1の領域と前記心臓の第2の領域は、前記心臓の同じチャンバの外側に異なる物質的配置であることを特徴とする埋込み可能なデバイス。
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Free format text: JAPANESE INTERMEDIATE CODE: R250 |