JP7241405B2 - 患者の血管及び体液状態をモニタリングするための無線共振回路ならびに可変インダクタンス血管インプラント、ならびにそれを利用するシステム及び方法 - Google Patents
患者の血管及び体液状態をモニタリングするための無線共振回路ならびに可変インダクタンス血管インプラント、ならびにそれを利用するシステム及び方法 Download PDFInfo
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Description
IVCの特殊な生理機能は、患者の体液状態の変化から生じる、その寸法の変化を検出かつ解釈することを試みる際、いくつかの特有の課題を提示する。例えば、通常のモニタリング領域(すなわち、肝静脈と腎静脈の間)のIVC壁は、他の血管と比べて比較的柔軟であり、それは、血管容積の変化が、横方向の中間壁と比較して、前後の壁の間に異なる相対的な距離変化をもたらし得ることを意味する。したがって、体液量の変化が、血管の形状及び動きの奇異的変化をもたらすことは、実に典型的である。すなわち、血液量が減少するにつれて、IVCはより小さくなって、呼吸によってしぼむ傾向があり、血液量が増加するにつれて、IVCはより大きくなる傾向があり、呼吸によるしぼみが低減する。本明細書に開示されるシステム及びインプラントは、このような奇異的変化を補いかつ解釈するように、独自に構成される。
例示のシステム全体10の1つの可能な実施形態の詳細は、図2~図8Cを参照して、以下に述べられる。その後で、システム構成要素の更なる代替的実施形態の詳細を記載する。しかし、例示のシステムが、図2~図7及び図9A~図9Cで示す特定の要素または部品の使用に限定されず、その後に記載される任意の代替の構成要素が、特に指摘される場合を除いて、システム全体での変化がなくても置換され得ることを理解すべきである。例えば、RC-WVMインプラント12、または代替のRC-WVMインプラント12c~12k、12m、12n及び12pのいずれかは、最初に以下で説明するようにインプラント12aまたは12bと置換されることができる。同様に、制御システム14は、図4、図24A、図24B、図26A、図26B、図26C、図28A、図28B、図29A及び図29Bのいずれかに示すように提供されることができ、及び/またはアンテナモジュール16は、例えば、パッドまたはベルトアンテナ(例えば、単スイッチ型アンテナコイル、もしくは別個の分離した送信及び受信コイルを備えたパッドアンテナ16a、またはベルトアンテナ16b、16c、16d、16eもしくは16f)として提供されることができる。
の相互作用に関して概略的に示す。アンテナベルト16b及びインプラント12は、通常、軸(A)の周囲に配置される。ベルト型アンテナで最良の結果を得るために、それぞれが配置される軸は、実質的に平行の配向にあって、図3Eに示すように、実行可能な範囲で一致する状態にある。互いに対して適切に配向されているとき、アンテナベルト16bのコアワイヤ82の電流(I)は、磁場
を生成し、それは、インプラント12のコイルを励起して、刺激時のその寸法/形状に対応するその共振周波数で、それを共振させる。図3Eで示すアンテナベルト16bとインプラント12の間の配向は、インプラントコイルを励起して、読み込み可能な共振周波数応答信号を生成するのに必要なパワーを最小限にする。
本明細書に記載されるシステムは、RC-WVMインプラント12a(図2のような)、アンテナベルト16b(図3のような)と類似のアンテナベルト及び制御システム14a(図4のような)を使用して、前臨床試験で評価された。インプラントは、標準的なインターベンション技術を使用する送達システム130(図9Bのような)を用いて、ヒツジのIVC内に配置された。配置は、血管内超音波を使用して及びアンテナベルトを使用して、血管造影的に確認された。
図11Aは、本明細書の他の箇所で記載されるように、IVCのモニタリング位置に置かれるRC-WVMインプラント12を使用した、体液状態モニタリングに基づいて、患者ケアを提供するように構成される、代替のシステム10aを概略的に示す。RC-WVMインプラント12を使用することによって、インプラント12によるIVCの直径または面積の測定は、1つ以上の呼吸サイクルを通じて連続的に行われて、このサイクルにわたる患者の体液量の変化を測定できる。更に、これらの測定は、予め選択された期間で及び/または医療供給者/患者から遠隔で提供されるプロンプトに応答して、連続的にとられることが可能である。
IVCの寸法変化の測定値が、IVCの固有の解剖学的特徴から生じる、固有の検討事項及び要件を示すことは理解されるであろう。例えば、IVCは、比較的低い圧力の薄肉の血管であり、それは、血液量及び圧力変化に対応して、単にその直径でなく、その全体の形状(断面の形状)を変える。その周囲で対称的に膨張かつ収縮する代わりに、IVCは、高容積の比較的円形な断面から、低容積の平坦な卵型断面へ進んで、主に前後の方向に拡張し、かつつぶれる。したがって、RC-WVMインプラント12の実施形態は、過剰な半径方向の圧迫のない、A-P方向のこの非対称で低圧のつぶれ及び膨張を監視しなければならないが、更に、確実にインプラントを固定して、移動を防ぐために、血管壁も十分な力で係合しなければならない。したがって、RC-WVMインプラント12は、一般的な円形断面から、血管の自然の形状の過剰な歪みのない卵円形または平坦な断面へ、A-P方向に血管をしぼませることができなければならない。RC-WVMインプラント12のコイル測定部分が、その歪みを生じさせ得る過度の半径方向の圧力なしで、IVC壁に対する接触を維持するように、これらの要件は、材料のコンプライアンス及び構成の適切な選択によって、本明細書に記載の種々の実施形態により、成し遂げられる。例えば、本明細書に記載の実施形態によるRC-WVMインプラント12は、圧縮50%で約0.05N~0.3Nの範囲の半径方向力を行使できる。別の代替例で、測定値に影響を及ぼさないように、測定断面から十分な間隔を置いて固定することに起因する、血管壁の可能な歪みを移動させるように、固定部分及び測定部分を物理的に切り離すことによって、測定応答を弱めることなく、位置決めの潜在的に増加する信頼度を得ることができる。
アンテナモジュール16の代替的実施形態16c及び16dを、それぞれ図22A及び図22Bに示す。示すように、図22Aで、制御システム14は、本明細書の他の箇所で述べられるように、入力波形を生成して、RC-WVMインプラント12から戻る信号を受信する。特に、制御システム14内の信号発生モジュールは、数字の8型の送信コイル258を駆動して、それはRC-WVMインプラント12にエネルギーを加える。RC-WVMインプラント12のワイヤにより形成されるLC回路に起因して、インプラントは次に、共振して、誘導電流の結果としてそれ自身の磁場を生じる。それから、RC-WVMインプラント12により生じる磁場は、受信コイル260を使用して測定されることができ、それは、制御システム14内の増幅器-受信器モジュールを介して監視されて、それから、それはデータを遠隔システム18に送達できる。代替のアンテナの実施形態16cで、受信コイル260は、磁場がインプラントによって発生するときに電流を発生させるために適切に配向されるように、送信コイルとして、同じ主平面に置かれる1つの正方形のコイルを含む。周知の右手の法則の下で、電流が送信コイルを介して流れるとき、磁場は、各コイルの平面に垂直な方向に発生する。電流を各送信コイル周囲の反対方向へ流れさせることにより、磁場は、インプラントの誘導コイルにより、1つの送信コイルから患者の身体内に流れ、他の送信コイルにより患者から戻る、環状体形状を形成する。この配置は、図25Bに関連して以下で更に詳細に記載されるように、送信及び受信コイルの幾何学的減結合を生じる。また、更に他の箇所で詳細に述べられるように、送信コイルにより生じる領域が、インプラントの誘導コイルの中心を通過するように、インプラントが配向されなければならない点に留意する。これは、回路のキャパシタに起因して、コイルのサイズ及び形状に基づく特定の周波数で共振する、誘導コイルを通過する電流を発生させる。それにより、この電流は、誘導コイルの平面と垂直なインプラントから出て、外部の受信コイルを通過して、その内部に電流を発生させる領域を生成する。この電流の周波数は、測定されることができて、血管の直径と相関し得る。代替のアンテナの実施形態16dで、送信コイル262は2つの正方形コイルも含むが、この場合、受信コイル264は2つの円形コイルを含み、それぞれ各1つが送信コイル内に配置される。また、送信及び受信コイルは、上述のとおり、同じ平面に配置される。
本明細書に記載されるようにシステムは、図12Aに示すようにRC-WVMインプラント12c、及び図22Bに概略的に示すようにアンテナモジュール16dを使用して、前臨床試験で評価された。インプラントは、大腿部のアクセス及び標準的なインターベンション技術を使用して、ブタのIVC内に配置された。配置は、血管造影的にかつ血管内超音波を使用して、確認された。外部アンテナモジュール16dは動物の下に配置されて、リングバック信号を得た。
場合によっては、外部送信及び受信アンテナの必要性を取り除いて、RC-WVMインプラントの通信距離を増加させて、及び/または別の埋入したモニター/装置と通信することが望ましい場合がある。図30A及び図30Bは、2つの代替の内蔵型エレクトロニクスシステムを示す、ブロック図である。図31A及び図31Bは、エレクトロニクスモジュールを含む、代替の無線インプラント12q及び12rを示し、それは、例えば図30A及び図30Bで示すように、内蔵型エレクトロニクスシステムを含むことができる。
本明細書に記載の態様及び実施形態(例えば、通信、モニタリング、制御または信号処理に関連する)のうちの任意の1つ以上は、当業者には明らかなように、本明細書の教示にしたがってプログラムされた1つ以上の機械(例えば、電子文書用のユーザーの計算装置、1つ以上のサーバ装置(例えば、文書サーバ)として利用される、1つ以上の計算装置)を使用して、都合よく実施できる点に留意する必要がある。適切なソフトウェアのコーディングは、ソフトウェア技術の当業者にとっては明らかであるように、本開示の教示に基づいて、熟練したプログラマによって直ちに作成されることができる。ソフトウェア及び/またはソフトウェアモジュールを使用する、上述の態様及び実施態様は、ソフトウェア及び/またはソフトウェアモジュールの機械実行可能な命令の実施を補助するための、適切なハードウェアも含むことができる。一般に、本明細書で使用する場合「モジュール」という用語は、上述したモジュール機能、及び特に明記しない限り、命令セットを含有する非一時的記憶もしくは格納装置を実行するための一連の命令を実施する、ソフトウェアまたはファームウェアを含む構造を指す。記憶または格納は、関連するプロセッサに関して、ローカルでも遠隔でもよい。したがってモジュールは、命令セットを実行して、モジュールの上述した機能を実行するのに必要であると記載され得る、プロセッサ及び/または他のハードウェア装置も含むことができる。
本開示は、その内部にセンサーが挿入される、体内管腔の寸法の変化を検出するように構成される、埋入れ型無線モニタリングセンサー、ならびにこのようなセンサーを使用するシステム及び方法の、複数の実施形態を記載する。開示されたセンサー、システム及び方法の態様は、以下の1つ以上を含み、それは、本明細書に記載の複数の異なる組み合わせに組み込まれることができる。
・ 弾性センサー構造物
・ 弾性金属フレーム
・ 成形したワイヤ
・ レーザー切断
・ ニチノール
・ コイル
・ フレームに巻いた複数のワイヤのストランド
・ リッツ線
・ 裸のワイヤ
・ 絶縁したフレーム
・ フレーム周囲の1回巻き
・ フレーム周囲の複数回巻き
・ コイル形状
・ 回転対称形状
・ 応答性に影響を及ぼさずに、任意の回転の配向での配置を可能にするA-P及びM-L方向のIVCの収縮の変化に対応する非対称形
・ A-Pの管腔寸法対M-Lの管腔寸法の変化の間の識別を可能にする
・ 適切な配置を容易にするための、異なる方向の異なる半径方向力
・ 可変インダクタンス
・ 共振回路
・ 固定した静電容量を備える可変インダクタンス
・ 回路に加えた別個のキャパシタ
・ 構造固有のキャパシタンス
・ アンカー要素
・ 逆とげまたはワイヤ
・ 頭側に配向
・ 尾側に配向
・ 双方向に配向
・ アンカーとしてのコイル
・ 検知態様からアンカー態様を分離して、検知位置の管腔壁の歪みを防ぐためのアンカー分離構造
・ インプラントまたは弾性センサー構造物の構成の電気特性
・ 高いQ値を備える選択されたキャパシタンス
・ 周波数
・ 1MHzの範囲の周波数
・ Q値を最大化するために選択された周波数
・ リングバック信号の長さに対する信号の品質計数
・ 高周波数
・ 小型のアンテナを許可
・ より絶縁を要する
・ 図2及び図2Aで示す、回転対称の正弦波または連結した「Z形状」構成
・ 図12A、図19A及び図19Bのいずれかで示す、「イヌ用の骨」形状の構成
・ 図12B及び図12Cのいずれかで示す、「クロスポウ」形状の構成
・ 図13A、図13B及び図13Cのいずれかで示す、別個のコイル構成
・ 図12C、図14A、図14B、図15A、図15B、図16A、図16B、図17A、図17B、図19A、図19Bのいずれかで示す、減結合した固定及び検知機能による構成
・ 固定及び検知のための別個のコイルを使用する構成であり、固定コイルは、図16B及び図18Aのいずれかで示すようにアンテナとしても機能できる
・ アンテナ
・ ベルトアンテナシステム
・ 送信と受信の間を切り替える単一のコイル
・ ダイオード切り替え
・ 一定の長さのアンテナ線を含有する伸縮性ベルト
・ センサーコイルの軸と一直線に並ぶ、またはそれと並行なアンテナコイルの軸の配向
・ 平面的なアンテナシステム
・ 別個の送信及び受信コイル
・ 干渉を防ぐための送信及び受信コイルの減結合
・ 幾何学的減結合
・ 配置
・ 送達カテーテル
・ 送達シース
・ シース内の押出要素
・ 部分的にシース内に含有される共に、部分的に管腔壁に接触させるための、インプラントへの段階的な展開
・ 再配置を可能にするための、部分的に展開したインプラントの引き戻し
Claims (16)
- 患者の血管構造に展開かつ挿入されて、管腔壁と接触する血管腔のモニタリング位置に配置されるように適合される、無線の血管モニタリングインプラントであって、前記無線の血管モニタリングインプラントが、前記患者の前記血管構造における体液量の変化によって前記管腔壁の伸縮に連動して寸法的に伸縮するように構成される、弾性センサー構造物を含み、
前記弾性センサー構造物は、インダクタンスを有する共振回路を含み、
前記インダクタンスは、前記弾性センサー構造物の伸縮による寸法の変化に基づいて変化し、
前記共振回路は、遠隔でエネルギーを加えられたとき、前記インダクタンスを示す共振周波数を生成するように適合され、
前記血管腔の外側にて無線で前記共振周波数を読み込み可能であり、前記血管腔の寸法を測定する、
無線の血管モニタリングインプラント。 - 前記弾性センサー構造物は、意図的に除去されるまでは前記管腔壁上または前記管腔壁の中に埋入されたままになるように構成される、
請求項1に記載の無線の血管モニタリングインプラント。 - 前記弾性センサー構造物は、前記血管腔を横切る方向に沿って前記管腔壁によって伸縮するように構成される、
請求項1または2に記載の無線の血管モニタリングインプラント。 - 前記弾性センサー構造物は、フレームとコイルとをさらに含み、
前記フレームは、少なくとも1つの弾性部分を有し、
前記少なくとも1つの弾性部分は、前記弾性センサー構造物が前記管腔壁と接触する前記モニタリング位置に配置されるとき、前記管腔壁の対向面を係合するように互いの反対側に配置されるように構成される少なくとも2つの点で形成され、
前記コイルは、前記管腔壁の少なくとも2つの対抗する点を係合するように構成され、
前記コイルは、前記コイルの前記2つの対抗する点の間の距離に基づいて変化するインダクタンスを有し、
前記コイルは、前記フレーム周辺に複数の隣接するワイヤのストランドを形成するように前記フレーム周辺に配置される少なくとも1つのワイヤによって前記フレーム上に形成される、
請求項1から3のいずれか1項に記載の無線の血管モニタリングインプラント。 - 前記コイルは、前記患者の身体の外側から前記コイルに向けられる磁場によりエネルギーを加えられるように構成される、
請求項4に記載の無線の血管モニタリングインプラント。 - 前記コイルは、少なくとも1つのキャパシタ要素を含む、
請求項4または5に記載の無線の血管モニタリングインプラント。 - 前記コイルは、ワイヤの複数のストランドを撚り合わせた束を有し、
前記束は、前記フレームの周囲に複数回巻きつけられる、
請求項4または5に記載の無線の血管モニタリングインプラント。 - 前記共振回路の静電容量は、隣接するワイヤの束の間の間隙によって作成される前記コイルの固有の静電容量からなる、
請求項7に記載の無線の血管モニタリングインプラント。 - 前記弾性センサー構造物は、ループ状のジグザグ型である、
請求項1から8のいずれか1項に記載の無線の血管モニタリングインプラント。 - 前記弾性センサー構造物は、鋭角を形成する丸みをおびた頂部によりその両端で接合したまっすぐな支柱を含む、
請求項9に記載の無線の血管モニタリングインプラント。 - 前記弾性センサー構造物は、送達カテーテルによる送達のために折り畳み可能である、
請求項1から10のいずれか1項に記載の無線の血管モニタリングインプラント。 - 前記無線の血管モニタリングインプラントは、埋入した後、前記患者の身体の外側の位置への物理的な接続を必要としない、
請求項1から11のいずれか1項に記載の無線の血管モニタリングインプラント。 - 請求項1から12のいずれか1項に記載の無線の血管モニタリングインプラントを含む、無線の血管検出システムであって、
励起に相関して一度に前記血管腔の寸法を示す共振周波数応答信号を生成する、前記弾性センサー構造物の前記励起のための手段と、
前記患者の身体の外側において前記無線の血管モニタリングインプラントからの前記共振周波数応答信号を受信するように構成されるアンテナモジュールと、
を更に含む、
無線の血管検出システム。 - 前記アンテナモジュールは、前記モニタリング位置の前記無線の血管モニタリングインプラントに隣接する位置で前記患者を囲むように構成される、少なくとも1つのアンテナ線を含む、
請求項13に記載の無線の血管検出システム。 - 前記アンテナモジュールは、前記患者の腰部または胴体の周囲を包むように構成されるベルトを更に含む、
請求項13または14に記載の無線の血管検出システム。 - 前記アンテナモジュールは、送信及び受信モード間で切り替え可能な単一コイルアンテナを含む、
請求項13から15のいずれか1項に記載の無線の血管検出システム。
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CA3043228A1 (en) | 2018-06-07 |
CN110300546B (zh) | 2023-03-31 |
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CN110300546A (zh) | 2019-10-01 |
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EP3463082B1 (en) | 2020-07-29 |
KR20190086476A (ko) | 2019-07-22 |
KR102518920B1 (ko) | 2023-04-06 |
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EP3705031A1 (en) | 2020-09-09 |
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