JP2021519668A - 中枢神経系局所的低体温装置および方法 - Google Patents
中枢神経系局所的低体温装置および方法 Download PDFInfo
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Abstract
Description
本出願は、2018年3月22日に出願された「Central Nervous System Localized Hypothermia Apparatus and Methods」と題された米国仮特許出願第62/646,539号に対する米国特許法第119条に基づく優先権を主張し、その内容全体が参照により本明細書に組み込まれる。
Claims (20)
- 脊髄冷却および排出装置であって、
挿入部分および作動端部部分を備える、患者の中への髄腔内挿入のために適合される排出および冷却カテーテルアセンブリであって、前記排出および冷却カテーテルアセンブリの前記挿入部分の最大断面寸法が、約5Frである、排出および冷却カテーテルアセンブリと、
コンソールであって、
排出ポンプと、
前記排出ポンプに動作可能に接続されている排出制御システムであって、患者からの脳脊髄液の排出速度を制御するように構成されている、排出制御システムと、
脳脊髄液収集リザーバであって、前記排出および冷却カテーテルアセンブリに流体的に結合され、かつ前記収集リザーバ内に収集されたある容積の脳脊髄液上に自由に浮遊するようにサイズ決定されたフロートを備える、脳脊髄液収集リザーバと、
冷却液ポンプであって、前記排出および冷却カテーテルアセンブリに結合され、かつ前記排出および冷却カテーテルアセンブリと前記コンソールとの間で冷却液を循環させるように構成されている、冷却液ポンプと、
熱電冷却ユニットを備える冷却機アセンブリと、を備える、コンソールと、を備える装置。 - 前記排出制御システムが、
(a)第1の時点で前記フロートまでの第1の距離を測定して、前記第1の距離および前記第1の時点に対応する第1の信号を生成し、かつ(b)第2の時点で前記フロートまでの第2の距離を測定して、前記第2の距離および前記第2の時点に対応する第2の信号を生成するように適合された、非接触測定システムと、
(a)少なくとも前記第1の信号および前記第2の信号に基づいて流量を計算し、かつ(b)前記計算された流量に基づいて排出ポンプ制御信号を生成するように適合された、コントローラと、を備える、請求項1に記載の装置。 - 前記コンソールが、真空レギュレータをさらに備え、前記排出ポンプが、真空ポンプであり、前記真空ポンプおよび前記真空レギュレータが、前記排出制御システムコントローラに動作可能に接続されている、請求項2に記載の装置。
- 前記真空ポンプが、前記収集リザーバに流体的に接続され、かつ前記真空レギュレータが、前記真空ポンプと前記収集リザーバとの間に装着され、前記真空レギュレータが、前記排出ポンプ制御信号に基づいて、前記収集リザーバに適用される前記真空レベルを調節する、請求項3に記載の装置。
- 前記カテーテルアセンブリが、
近位端部、開放遠位端部、およびそれらの間を通る中央管腔を有する円筒形本体を有する排出カテーテルと、
前記排出カテーテルの前記近位端部を前記収集リザーバに流体的に結合する排出配管セットと、
冷却液入口ラインおよび冷却液出口ラインを備える冷却配管セットと、
近位端部および閉鎖遠位端部を有する冷却カテーテルであって、前記近位端部が、(a)前記冷却液入口ラインを前記冷却カテーテルの第1の内部管腔に、および(b)前記冷却液出口ラインを前記冷却カテーテルの第2の内部管腔に、結合するように適合され、前記第1の内部管腔および前記第2の内部管腔が、前記冷却カテーテルの前記閉鎖遠位端部の近くで流体連通している、冷却カテーテルと、を備え、
前記冷却液入口ラインおよび冷却液出口ラインが、前記冷却カテーテルを前記冷却機アセンブリに流体的に結合する、請求項1に記載の装置。 - 前記排出カテーテルが、前記円筒形本体の外側表面から前記中央管腔まで通る複数の孔をさらに備え、前記複数の孔が、前記排出カテーテルの前記遠位端部に向かって位置付けられる、請求項5に記載のカテーテルアセンブリ。
- 前記排出カテーテルの中央管腔の内壁と前記冷却カテーテルの外壁との間に脳脊髄液の流れを可能にする隙間が存在するように、前記冷却カテーテルが、前記排出カテーテルの前記中央管腔を通過するように構成される、請求項5に記載のカテーテルアセンブリ。
- 前記排出および冷却カテーテルアセンブリが、内部に埋め込まれた強化メッシュ構造を有するポリウレタンからなる、請求項1に記載の装置。
- 前記排出および冷却カテーテルアセンブリが、排出管腔と、冷却液入口管腔と、冷却液出口管腔と、を備える、多管腔カテーテルを備え、前記排出管腔の遠位端部が、患者の髄腔内空洞と流体連通するように適合され、かつ前記入口管腔および出口管腔が、前記多管腔カテーテルの前記遠位端部で互いに流体連通する、請求項1に記載の装置。
- 脊髄冷却および排出システムであって、
冷却カテーテルを備えるカテーテルアセンブリと、
配管セットと、
コンソールであって、
熱電冷却ユニットおよび冷却液を備える、冷却システムと、
循環システムと、
制御システムと、を備える、コンソールと、を備え、
前記配管セットが、前記冷却システムを前記カテーテルアセンブリに流体的に接続し、かつ前記冷却システムと前記冷却カテーテルとの間の前記冷却液の循環を可能にするように構成され、
前記循環システムが、前記冷却システムと前記カテーテルアセンブリとの間の前記冷却液の流れを制御するように構成される、脊髄冷却および排出システム。 - 前記冷却カテーテルが、近位端部および遠位端部を有し、かつ前記冷却カテーテル内の入口管腔および出口管腔を通した前記冷却液の循環を可能にするように構成され、前記入口管腔および出口管腔が、前記冷却カテーテルの前記遠位端部の近くで互いに流体的に接続され、かつ各々が前記冷却カテーテルの前記近位端部で前記配管セットに流体的に接続される、請求項10に記載の脊髄冷却システム。
- 前記カテーテルアセンブリの遠位部分が、患者の中への挿入のために構成され、かつ約5Frの最大外形寸法を有する、請求項10に記載の脊髄冷却システム。
- 前記カテーテルアセンブリの遠位部分が、患者の中への挿入のために構成され、かつ約4Frの最大外形寸法を有する、請求項10に記載の脊髄冷却システム。
- 排出システムをさらに備え、前記排出システムが、排出カテーテルと、排出配管セットと、収集リザーバと、排出制御装置と、を備え、前記排出配管セットが、前記排出カテーテルを前記収集リザーバに流体的に接続し、前記冷却カテーテルが、前記排出カテーテルの中央管腔を通って取り外し可能に同軸に挿入されるように構成される、請求項10に記載の脊髄冷却システム。
- 前記排出カテーテルが、近位端部および遠位端部を備え、前記排出カテーテルの前記遠位端部が、患者の中への挿入のために構成され、前記排出カテーテルの前記近位端部が、前記排出配管セットへの接続のために構成される、請求項14に記載の脊髄冷却システム。
- 前記排出制御装置が、前記収集リザーバに流体的に接続されている真空源と、前記制御システムに動作可能に接続されているフィードバックシステムと、を備える、請求項14に記載の脊髄冷却システム。
- 前記フィードバックシステムが、非接触測定システムと、前記収集リザーバ内に収集されたある容積の流体上に浮遊するように構成されているフロートと、を備え、前記フィードバックシステムが、前記非接触測定システムからの読み取りに基づいてフィードバックデータを生成するように構成される、請求項16に記載の脊髄冷却システム。
- 前記排出制御システムが、前記排出カテーテルを通るCSF流量を調節するように、前記フィードバックデータに基づいて前記真空源を制御するように構成される、請求項17に記載の脊髄冷却システム。
- 前記コンソールが、熱交換器を備える冷却液回路をさらに備え、前記冷却液回路が、前記流体冷却システム、前記配管セット、および前記カテーテルシステムを流体的に接続し、前記冷却液を前記循環システムによって閉ループ内で循環することを可能にし、前記熱交換器が、前記循環冷却液から熱を除去するように、前記熱電冷却ユニットと相互作用するように適合される、請求項10に記載の脊髄冷却システム。
- 前記熱交換器が、前記熱電冷却システムへ取り外し可能に挿入されるように構成される可撓性ポーチを備える、請求項19に記載の脊髄冷却システム。
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- 2019-03-22 US US16/361,566 patent/US11672695B2/en active Active
- 2019-03-22 JP JP2021500502A patent/JP2021519668A/ja active Pending
- 2019-03-22 EP EP19772187.1A patent/EP3768204A4/en active Pending
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US11672695B2 (en) | 2023-06-13 |
WO2019183464A1 (en) | 2019-09-26 |
EP3768204A4 (en) | 2022-01-12 |
CA3094812A1 (en) | 2019-09-26 |
US20190290481A1 (en) | 2019-09-26 |
EP3768204A1 (en) | 2021-01-27 |
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