JP2020171791A - 脳および脊髄に局所冷却を提供するシステム - Google Patents
脳および脊髄に局所冷却を提供するシステム Download PDFInfo
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Abstract
Description
図1は、対象101、処置部位102、チューブ104、処置ユニット106およびポート108を含む生物流体または生物系を処置するシステム100の実施形態を示す。
特定の実施形態において、カテーテル130は1つ以上の管腔を備え得る。カテーテル130はまた、1つ以上の管腔を処置部位102の流体144と流体接続させるポートも備えてもよいが、備えなくてもよい。カテーテル130は、一般に、可撓性であり、操縦可能であり、かつ非外傷性であるように構成され得る。カテーテル130は、温度、頭蓋内圧、および/または他のパラメータの感知を可能にし得る。カテーテル130の大きさは、遠隔のチューブ(例えばチューブ104)、コンソール(例えば処置ユニット106)または他のユニットへの取り付けを可能にするために、約6フレンチ(約2.0mm)以上であり、かつ約20〜約120cmであり得るが、他の大きさを用いてもよい。いくつかの実施形態では、カテーテルの大きさは約5フレンチ(約1.7mm)であってもよい。
図11〜図14は、温度制御バルーンを備えた実施形態を示す。温度制御バルーンは、側脳室の壁に接触して配置されるように構成され得る。温度制御バルーンは、脳実質、脊髄または他の目標を冷却するために、処置部位102付近の組織に触れている拡張可能部分において伝熱流体を循環させることにより、温度を修正し得る。脳室において用いられる場合、バルーンの膨張は脳室内のCSFを退去させ得る。
センサー
様々な実施形態は、温度、頭蓋内圧および他の測定値を監視するためのセンサーを備え得る。
本願に記載するシステムおよび方法は、対象101の安全な処置を促進するために様々な安全装置を備え得る。
体外温度制御。図15は、処置ユニットを生物流体の処置に用いる方法300を示しており、前記方法は、開始ステップ302と、一定体積の流体を採取するステップ304と、前記一定体積の流体を処置するステップ306と、特性を測定するステップ308と、前記一定体積の流体を返還するステップ310と、判定するステップ312と、パラメータを更新するステップ314と、終了するステップ316とを含む。方法300はシステム100を含む様々な実施形態に用いられ得る。
処置部位の温度制御。図16は、処置部位102における温度制御のための方法320を示す。具体的には、方法320は、処置部位102における直接温度制御に関する図15の方法300の修正版であり得る。方法320は、開始するステップ322と、処置を施すステップ324と、特性を測定するステップ326と、判定するステップ328と、パラメータを更新するステップ330と、終了するステップ322とを含み得る。上記方法はシステム100を含む特定の実施形態に用いられ得る。
図17および図18は、処置を制御し、パラメータを更新する方法の例を示す。具体的には、図17は、温度を制御する方法400の例を示す。温度を制御する方法は、図15および図16に記載した方法とともに、またはそれらの方法の代わりに用いられ得る。該方法は、処置を開始するステップ402と、センサーを読み取るステップ404と、目標に到達しているかを判定するステップ406と、健康チェックを実施するステップ408と、処置を継続するステップ410と、処置を終了するかどうかを判定するステップ412と、処置を停止するステップ414とを含み得る。
目標冷却パターン。図17の方法に図18の目標冷却パターンを適用する実施形態において、時間t0は0分であり、初期の温度Tiは約37℃であり、目標温度Ttは約30℃であり、目標時間t1は約60分であり、時間t2は約120分(t2−t1=約60分)であり、最終温度Tfは約37℃であり、t3は約180分(t3−t2=約60分)である。いくつかの実施形態において、システム100は、軽度の低体温、中程度の低体温、または超低体温を開始するため、温度を維持するため、システムが適切に機能していることを保証するために圧力、流量および温度の変化を監視するため、および対象101の冷却およびドレナージ状態を管理するための所定モードを有し得る。いくつかの実施形態において、目標温度は測定の位置に基づいて変化してもよい。例えば、低体温法の間、コア脳温度は低温塩水注入速度に従って約28〜約31℃に維持され得る。冷却が開始した後、深部脳温度は約28℃に低下し、皮質下脳温度はほぼ31℃に達し得る。脳表面と脳深部との間のこの温度勾配は、血液供給に基づいて変化し得る。いくつかの実施形態において、(例えば、カテーテル上に位置した)複数の温度センサーが用いられてもよく、また平均脳温度は個々の温度プローブに基づいて用いられてもよい。いくつかの実施形態において、臨床医が対象において超低体温(例えば約25〜約30℃)を誘発させようとしている場合には、次にシステムは実質温度を測定し、測定した温度に基づいて冷却を継続するか、または温度を維持するかのいずれかを行い得る。臨床医が患者を回復させようとしている場合には、次に再度加温アルゴリズムが関与し得る。
図38はウシ対象におけるCSF冷却の検討中に測定された脳実質温度を示す。脳実質の温度は、一定期間にわたって、脳室から3mm、脳室から8mm、および脳室から13mmの距離において測定された。本検討において、ウシ対象のCSFは二重管腔カテーテルを用いて採取され、冷却器によって冷却され、カテーテルを用いて対象に返還された。本検討は、3−オン−1温度センサーの使用を含んでいた。
この開示内において、接続の言及(例えば、取り付けられた、結合された、接続された、接合された)は、一群の構成要素間の中間部材および構成要素間の相対運動を含み得る。そのような言及は、2つの構成要素が直接接続されており、互いに固定関係にあることを必ずしも意味しない。例示的な図面は例証のみを目的としており、本願に添付された図面に反映された寸法、位置、順番および相対的な大きさは変化してもよい。
Claims (15)
- 処置部位の局所冷却を提供するためのシステムであって、前記システムは、
CSF(脳脊髄液)含有空間を含む前記処置部位にアクセスするように構成されたカテーテルと、
前記カテーテルに結合され、前記処置部位と流体連通するポートを含む処置ユニットと、
を備え、
前記処置ユニットは、前記CSF含有空間から受けた所定量のCSFを冷却するように構成された温度制御ユニットを含み、かつ、
前記処置ユニットは、温度制御の速度を温度制御の目標速度と比較し、前記温度制御の速度が前記温度制御の目標速度と異なる場合には処置のパラメータを更新するように構成される、システム。 - 前記CSF含有空間から前記所定量のCSFを除去するように構成される、請求項1に記載のシステム。
- 冷却されたCSFの少なくとも一部を前記処置部位に返還するように構成される、請求項2に記載のシステム。
- 前記カテーテルは、多管腔カテーテルである、請求項1に記載のシステム。
- 前記多管腔カテーテルは、第1のポートまたは第1の複数のポートを含むとともに、前記多管腔カテーテルは、第2のポートまたは複数の第2のポートを含む、請求項4に記載のシステム。
- 第1の量のCSFが、前記第1のポートまたは前記第1の複数のポートを通って前記多管腔カテーテルに入るように構成される、請求項5に記載のシステム。
- 前記第1の量のCSFが、前記処置ユニットのポートに接続されたチューブを介して通るように構成される、請求項6に記載のシステム。
- 第2の量のCSFが、前記チューブから通って、前記第2のポートまたは前記複数の第2のポートから出るように構成される、請求項7に記載のシステム。
- 前記処置部位は、前記CSF含有空間内の第1位置を含み、本システムは、本システムに連結されるとともに前記第1位置とは異なる前記CSF含有空間内の第2位置に配置される、第2のカテーテルをさらに備える、請求項1に記載のシステム。
- 前記処置ユニットと前記カテーテルとの間に配置されるチューブをさらに備える、請求項1に記載のシステム。
- 前記処置ユニットは、ポンプを含む、請求項1に記載のシステム。
- 前記処置ユニットは、前記所定量のCSFを濾過するように構成されたフィルタを含む、請求項1に記載のシステム。
- 前記フィルタは、前記CSFからサイトカインを除去するように構成される、請求項12に記載のシステム。
- 前記処置ユニットは、センサーを含む、請求項1に記載のシステム。
- 前記センサーは、温度と、圧力と、前記処置部位への流体流量と、前記処置部位からの流体流量と、前記CSF中の汚染物質の量と、前記CSF中の汚染物質の種類と、流体の他の測定項目とのうち、少なくともいずれか1つ以上の組み合わせを感知するように構成される、請求項14に記載のシステム。
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CN116458983B (zh) * | 2023-04-07 | 2024-02-13 | 心诺普医疗技术(北京)有限公司 | 降温速率可控的冷冻消融系统及方法 |
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EP3359071A1 (en) | 2018-08-15 |
CN108289702A (zh) | 2018-07-17 |
AU2016333997A1 (en) | 2018-04-19 |
JP2023009077A (ja) | 2023-01-19 |
JP2018529473A (ja) | 2018-10-11 |
AU2019226194A1 (en) | 2019-09-26 |
CA3000747A1 (en) | 2017-04-13 |
EP3359071A4 (en) | 2019-06-05 |
AU2016333997B2 (en) | 2019-06-06 |
AU2019226194B2 (en) | 2020-07-09 |
CA3000747C (en) | 2022-11-01 |
US20200188646A1 (en) | 2020-06-18 |
WO2017062606A1 (en) | 2017-04-13 |
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