JP2020521604A - 心不全患者の体液過剰を軽減するための直接ナトリウム除去方法、溶液、及び装置 - Google Patents
心不全患者の体液過剰を軽減するための直接ナトリウム除去方法、溶液、及び装置 Download PDFInfo
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Abstract
Description
本出願は、引用により全容が本明細書に組み込まれる、2017年5月24日に出願された米国仮出願第62/510,652号の優先権の利益を請求するものである。
本発明は、一般に、患者の腹腔に投与してナトリウムを直接除去し、これにより体から体液を除去して残存腎機能を有する心不全患者の体液過剰を緩和する無又は低ナトリウム注入液(以降、DSR注入液と呼ぶ)の使用に関する。この方法、DSR注入液、及び装置は、ナトリウムの除去により過剰な体液を除去するように機能する。ナトリウムは、(1)限外濾過及び/又は(2)急な濃度勾配での拡散の一方又は両方によって腹腔に移動され、その後、そこから除去される。液体は、(1)浸透圧限外濾過(osmotic ultrafiltration)を誘導して体液を患者の体から腹腔に移動させ、そこから除去すること、及び/又は(2)排尿による腎臓を介した過剰な体液の排出を促進すること、の一方又は両方によって、比較的安定した血清ナトリウム濃度を維持するために体から除去される。
いくつかの形態の心不全のいずれかに罹患している患者は、体組織に追加のナトリウムが蓄積しやすく、その結果、体内の体液が増加する。例えば、うっ血性心不全では、心臓の左側又は右側、又は両方の機能不全により、体が正常な効率で血液を送り出すことができず、ナトリウムの貯留及び肺若しくは肝臓における血液若しくは体液の滞留若しくは貯留をもたらし得る体循環の低下、浮腫、並びに/又は心肥大に至る。
eGFR=141×min(SCr /κ、l)α×max(SCr /κ、l)-1.209×0.993Age×1.018[女性の場合]×1.159[黒人の場合]
式中:
eGFR(推定糸球体濾過率)= mL /分/ 1.73 m2
SCr(標準化血清クレアチニン)= mg / dL
κ=0.7(女性)又は0.9(男性)
α=-0.329(女性)又は-0.411(男性)
min=SCr /κ又は1の最小値を示す
max=SCr /κ又は1の最大値を示す
age=年齢
上記の式は、National Kidney FoundationのWebサイトhttps://www.kidney.org/content/ckd-epi-creatinine-equation-2009で入手可能である。
本発明は、腹腔に投与される無又は低ナトリウムDSR注入液を使用してナトリウムを除去し、これにより患者の体から体液を除去して体液過剰を軽減する、残存腎機能を有する心不全患者の体液過剰を処置する方法に関する。ナトリウムは、(1)限外濾過及び/又は(2)急な濃度勾配での拡散の一方又は両方によって腹腔に移動され、その後、そこから除去される。液体は、(1)浸透圧限外濾過を誘導して体液(浸透限外濾過液(osmotic ulfiltrate))を患者の体から腹腔に移動させ、そこから除去すること、及び/又は(2)排尿による腎臓を介した過剰な体液の排出を促進すること、の一方又は両方によって、比較的安定した血清ナトリウム濃度を維持するために体から除去される。従って、本発明は、体からナトリウムを除去し、これにより低ナトリウム血症を防止すると共に、液体が比較的安定した血清ナトリウム濃度を維持し、体液過剰及び浮腫を軽減する。
本発明は、左心機能障害又は右心機能障害などの様々な形態の心不全における体液過剰を処置する方法に関する。本発明の原理に従って、体液過剰に苦しんでいる残存腎機能を有する心不全患者は、腹腔に投与される無又は低ナトリウムDSR注入液で処置される。DSR注入液のナトリウム濃度が低いと、ナトリウム及び体液(浸透限外濾過液)が患者の体から腹腔に移動する。DSR注入液は、除去されるまでの所定の期間、取り出されたナトリウム及び浸透限外濾過液と共に、腹腔内に残留又は滞留させることができる。ナトリウムを含んだDSR注入液及び浸透限外濾過液の腹腔からの除去は、Sequana Medical AG, Zurich, Switzerlandが販売するAlfapumpなどの植え込みシステムを用いて行うことができる。
図1Aを参照すると、本発明の方法の実施に使用するための例示的なシステム10の選択された構成要素の概要が示されている。図1Aでは、システムの構成要素は、相対的にも絶対的にも縮尺通りには示されていない。システム10は、植え込み装置20、外部充電及び通信システム30、ソフトウェアをベースとした監視及び制御システム40、並びに任意にDSR注入液リザーバ45を含む。例示されている実施態様では、監視及び制御システム40は、担当医が使用することができる従来のラップトップコンピュータ、タブレット、又はスマートフォンにインストールされ、これらで実行される。患者の診察中に、植え込み装置20に保存された検査データをダウンロードするため、又は該植え込み装置の動作パラメータを調整するために、充電及び通信システム30を、無線又は有線で監視及び制御システム40に接続することができる。監視及び制御システム40は、充電及び通信システム30から回収されたデータを、医師又は該充電及び通信システム30が後にアクセスする遠隔サーバーにアップロードして保存するように構成することもできる。
図2A及び図2Bを参照すると、腹膜カテーテル50は、Medionics International Inc.の腹膜透析カテーテル(モデル番号PSNA-100)又は類似の構造と機能を有するカテーテルであり得る。腹膜カテーテル50は、図1A〜図1Cの腹膜カテーテル23に対応し、複数の壁貫通孔53を有する入口(遠位)端部52及び出口(近位)端部54を備える医療用シリコーンからなるチューブ51を備えることができる。孔53は、図2Bに示されているように、約90度だけ円周方向にオフセットして配置することができる。腹膜カテーテル50は、該カテーテルの周囲組織への付着を促進し、これにより該カテーテルを所定の位置に固定するために、孔53から離れた部分にポリエステルカフ(不図示)も備えることもできる。別法では、腹膜カテーテル50の入口端部52は、螺旋構造及び非外傷性先端部を有することができ、孔53が、閉塞のリスクを低減するためにチューブの全長にわたって分布している。
ここで図4を参照すると、本発明の方法の実施に使用するのに適した植え込み装置20の機能ブロックを表現する略図が描かれている。植え込み装置20は、不揮発性メモリ71、例えば、フラッシュメモリ又は電気的消去・書き込み可能読出し専用メモリ、及び揮発性メモリ72にデータバスによって接続された制御回路、例示的にプロセッサ70を備える。プロセッサ70は、電気モータ73、バッテリ74、誘導回路75、無線送受信機76、UVランプ85、並びに湿度センサ77、複数の温度センサ78、加速度計79、複数の圧力センサ80、及び呼吸数センサ81を含む複数のセンサに電気的に接続されている。誘導回路75は、充電及び通信システム30から送信されるエネルギーを受信するためにコイル84に電気的に接続される一方、送受信機76は、アンテナ82に接続され、かつ同様に、以下に説明するように該充電及び通信システム30の送受信機と通信するように構成されている。任意に、誘導回路75はまた、赤外線発光ダイオード83に接続することができる。モータ73は、専用制御装置を備えることができ、該制御装置は、プロセッサ70からのコマンドを理解し、該コマンドに応答して該モータ73を作動させる。任意に、プロセッサ70は、弁制御装置86とさらに通信する。図4に描かれている構成要素のすべては、図5Aに示されているように、小型の密封生体適合性ハウジング内に収容されている。
図7A、図7B、及び図8を参照して、充電及び通信システム150(図1Aのシステム30に対応する)を詳細に説明する。好ましい一実施態様では、充電及び通信システム150は、ハンドピース151及びベース31を備えている(図1Aを参照)。ベース31は、ハンドピース151を再充電するためのクレードルを備え、好ましくは、該ハンドピース151が該ベースに装着されたときに該ハンドピースを充電するために通常の120/220/240 Vの電力を適切な直流電流に変換するための変換器及び回路を備える。別法では、ハンドピース151は、該ハンドピースのバッテリを充電するための回路、及び着脱式電源コードを備えることができる。この実施態様では、ハンドピース151は、充電のためにコンセントに直接差し込むことができ、電源コードは、該ハンドピースを使用して植え込み装置を再充電するときには取り外される。
ここで、図9を参照して、図1Aの監視及び制御システムを実行するソフトウェアを説明する。ソフトウェア180は、図9に模式的に示されているいくつかの機能ブロックを含み、該機能ブロックは、主ブロック184、イベントログブロック182、データダウンロードブロック183、構成セットアップブロック184、ユーザーインターフェイスブロック185、健康状態監視ブロック191及び感染予測ブロック192を含むアラーム検出ブロック186、センサ校正ブロック187、ファームウェアアップグレードブロック188、装置識別子ブロック189、及び状態情報ブロック190を含む。一実施態様では、このソフトウェアは、C++でコードされ、かつオブジェクト指向形式を利用するが、他のソフトウェア言語及び環境を使用することもできる。一実施態様では、このソフトウェアは、通常はデスクトップ及びラップトップコンピュータで使用される、Microsoft Windows. RTM(Microsoft社、Redmond, Wash.の登録商標)又はユニックスベースのオペレーティングシステム上で動作するように構成されるが、他のオペレーティングシステムも利用することができる。
本発明のDSR注入液及び方法の初期試験はブタモデルで行われており、これは、本発明のシステム、方法、及びDSR注入液がヒトでどのように挙動するかについての有効な洞察を提供すると期待される。以下にさらに詳細に説明するように、その初期試験は、予想をはるかに超える極めて上出来で有益な結果をもたらした。
Claims (47)
- 体液過剰の心不全患者を処置するために無又は低ナトリウムDSR注入液を使用する方法であって、該患者が、15 ml /分/ 1.73 m2よりも高い推定糸球体濾過率を有し:
無又は低ナトリウムDSR注入液を該患者の腹腔内に導入するステップ;
滞留期間中に、ナトリウム及び浸透限外濾過液を該腹腔内で該DSR注入液を用いて蓄積させるステップ;
低ナトリウム血症を防止すると共に体液過剰を緩和するために、該DSR注入液、ナトリウム、及び浸透限外濾過液を該患者の腹腔から除去するステップを含む、前記方法。 - 腎機能によって引き起こされる排尿を介して液体を前記患者から除去するステップをさらに含む、請求項1記載の方法。
- 無又は低ナトリウムDSR注入液を前記心不全患者の腹腔内に導入するステップが、120 meq / L未満のナトリウム濃度を有するDSR注入液を導入するステップを含む、請求項1記載の方法。
- 無又は低ナトリウムDSR注入液を導入するステップが、デキストロース又はイコデキストリン、又はそれらの組み合わせを有するDSR注入液を導入するステップを含む、請求項1記載の方法。
- 無又は低ナトリウムDSR注入液を前記患者の腹腔内に導入するステップが、植え込みポンプを使用して該DSR注入液をリザーバから該患者の腹腔内に移送するステップを含む、請求項1記載の方法。
- 無又は低ナトリウムDSR注入液を前記患者の腹腔内に導入するステップが、リザーバから該DSR注入液を送達するために重力を利用して該DSR注入液を該患者の腹腔内に注入するステップを含む、請求項1記載の方法。
- 無又は低ナトリウムDSR注入液を前記患者の腹腔内に導入するステップが、体外ポンプ、加圧容器、又は重力に基づく供給システムを使用して該DSR注入液を送達するステップを含む、請求項1記載の方法。
- ナトリウム及び浸透限外濾過液を含むDSR注入液を前記患者の腹腔から除去するステップが、滞留期間の終了時に、植え込みポンプを使用して該DSR注入液、ナトリウム、及び浸透限外濾過液を該患者の腹腔から膀胱に移送するステップを含む、請求項1記載の方法。
- 前記植込みポンプを所定の時間に作動させて、所定量のDSR注入液、ナトリウム、及び浸透限外濾過液を前記患者の腹腔から前記膀胱に移送するステップをさらに含む、請求項8記載の方法。
- 1つ又は複数のセンサで前記患者の腹腔内圧を監視するステップをさらに含む、請求項1記載の方法。
- 前記腹腔内の液体蓄積速度を監視するステップをさらに含む、請求項10記載の方法。
- 前記腹腔内の前記液体蓄積速度の増加又は腹腔内圧の増加を示す医師への警告を生成するステップをさらに含む、請求項11記載の方法。
- 体液過剰の心不全患者を処置するために無又は低ナトリウム溶液を使用する方法であって、該患者が、正常からCKD病期4までの腎機能を有し;
無又は低ナトリウムのDSR注入液を該患者の腹腔内に導入するステップ;
滞留期間中に、ナトリウム及び浸透限外濾過液を該腹腔内で該DSR注入液を用いて蓄積させるステップ;
前記体液過剰を緩和するために、該DSR注入液、ナトリウム、及び浸透限外濾過液を該腹腔から除去するステップ;及び
低ナトリウム血症を防止すると共に血清ナトリウム濃度を回復させるために、排尿により液体を患者から除去するステップを含む、前記方法。 - 無又は低ナトリウムDSR注入液を前記患者の腹腔内に導入するステップが、120 meq / L未満のナトリウム濃度を有するDSR注入溶液を導入するステップを含む、請求項13記載の方法。
- 無又は低ナトリウムDSR注入液を前記患者の腹腔内に導入するステップが、水溶液100ml当たり5〜50gmの範囲の濃度のデキストロース、水溶液100ml当たり5〜50gmの範囲のイコデキストリン、又はそれらの組み合わせを含むDSR注入液を導入するステップを含む、請求項14記載の方法。
- 無又は低ナトリウムDSR注入液を前記患者の腹腔内に導入するステップが、植え込みポンプを使用して該DSR注入液をリザーバから該患者の腹腔内に移送するステップを含む、請求項13記載の方法。
- 無又は低ナトリウムDSR注入液を前記患者の腹腔内に導入するステップが、リザーバから該DSR注入液を送達するために重力を利用して該DSR注入液を該患者の腹腔内に注入するステップを含む、請求項13記載の方法。
- 無又は低ナトリウムDSR注入液を前記患者の腹腔内に導入するステップが、体外ポンプ、加圧容器、又は重力に基づく供給システムを使用して該DSR注入液を送達するステップを含む、請求項13記載の方法。
- 前記DSR注入液、ナトリウム、及び浸透限外濾過液を前記患者の腹腔から除去するステップが、滞留期間の終了時に、植え込みポンプを使用して該DSR注入液、ナトリウム、及び浸透限外濾過液を該患者の腹腔から膀胱に移送するステップを含む、請求項13記載の方法。
- 前記植込みポンプを所定の時間に作動させて、一定量のDSR注入液、ナトリウム、及び浸透限外濾過液を前記患者の腹腔から前記膀胱に移送するステップをさらに含む、請求項19記載の方法。
- 1つ又は複数のセンサで前記患者の腹腔内圧を監視するステップをさらに含む、請求項13記載の方法。
- 前記腹腔内の液体蓄積速度を監視するステップをさらに含む、請求項21記載の方法。
- 前記腹腔内の前記液体蓄積速度の増加又は腹腔内圧の増加を示す医師への警告を生成するステップをさらに含む、請求項23記載の方法。
- 過剰なナトリウムを除去することによって心不全の処置に使用するための注入液であって、少なくとも残留腎機能を有する患者の腹腔への注入によって投与され、そして該腹腔から排出される、120 meq / L以下のナトリウム濃度を有する、前記注入液。
- 過剰なナトリウムを除去することにより、安定した血清ナトリウムレベルを維持したまま、前記患者の体液過剰を軽減する、請求項24記載の注入液。
- 少なくとも2時間の滞留期間中に、限外濾過液を、前記腹腔に注入された注入液の量の半分以上の量に該腹腔で拡散させるように選択された浸透圧を有する、請求項24記載の注入液。
- ごく微量のナトリウムを含む、請求項24記載の注入液。
- うっ血性心不全を処置するために製剤化される、請求項24記載の注入液。
- 前記残存腎機能を有する患者が、15ml /分/1.73m2を超える推定糸球体濾過速度を有する患者である、請求項24記載の注入液。
- 前記残存腎機能を有する患者が、正常からCKD病期4までの範囲の腎機能を有する患者である、請求項24記載の注入液。
- 過剰なナトリウムを除去することにより、排尿を促進して血清ナトリウム濃度を回復させることによって体液過剰を軽減する、請求項24記載の注入液。
- 穿刺によって排液を行うことができるように製剤化される、請求項24記載の注入液。
- 注入液、過剰なナトリウム、及び限外濾過液を前記患者の膀胱にポンプ輸送することによって排液を可能にするように製剤化される、請求項24記載の注入液。
- 重力による供給を介してリザーバから前記腹腔に注入されるように製剤化される、請求項24記載の注入液。
- 体外ポンプ又は加圧容器を介してリザーバから前記腹腔に注入されるように製剤化される、請求項24記載の注入液。
- 植え込みポンプ又は加圧容器を介してリザーバから前記腹腔に注入されるように製剤化される、請求項24記載の注入液。
- 植え込みポンプを使用して、前記患者の腹腔から膀胱にポンプ輸送されるように製剤化される、請求項33記載の注入液。
- 過剰なナトリウムを除去することによる心不全の処置に使用するための注入液であって、少なくとも正常からCKD病期4までの範囲の残存腎機能を有する患者の腹腔への注入によって投与され、そして該腹腔から排出される、ごく微量のナトリウムを含む、前記注入液。
- 過剰なナトリウムを除去することにより、安定した血清ナトリウムレベルを維持したまま、前記患者の体液過剰を軽減する、請求項38記載の注入液。
- 少なくとも2時間の滞留期間中に、限外濾過液を、前記腹腔に注入された注入液の量の半分以上の量に該腹腔で拡散させるように選択された浸透圧を有する、請求項38記載の注入液。
- 水溶液100 ml当たり5g〜50gの範囲の量のデキストロースを含む、請求項38記載の注入液。
- 水溶液100 ml当たり5g〜50gの範囲の量のイコデキストリンを含む、請求項38記載の注入液。
- 前記残存腎機能を有する患者が、15ml /分/1.73m2を超える推定糸球体濾過速度を有する患者である、請求項38記載の注入液。
- 過剰なナトリウムを除去することにより、排尿を促進して血清ナトリウム濃度を回復させることによって体液過剰を軽減するように製剤化される、請求項38記載の注入液。
- 抗菌特性、抗真菌特性、又は前記注入液のpHを調整するための緩衝物質をさらに含む、請求項38記載の注入液。
- 重力による供給、体外ポンプ、又は加圧容器を介してリザーバから前記腹腔に注入されるように製剤化される、請求項38記載の注入液。
- 植え込みポンプを使用して、前記患者の腹腔から膀胱にポンプ輸送されるように製剤化される、請求項38記載の注入液。
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AU2018273105B2 (en) | 2023-08-10 |
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