JP5199118B2 - 血管内冷却システム及び方法 - Google Patents
血管内冷却システム及び方法 Download PDFInfo
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- JP5199118B2 JP5199118B2 JP2008547246A JP2008547246A JP5199118B2 JP 5199118 B2 JP5199118 B2 JP 5199118B2 JP 2008547246 A JP2008547246 A JP 2008547246A JP 2008547246 A JP2008547246 A JP 2008547246A JP 5199118 B2 JP5199118 B2 JP 5199118B2
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- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3368—Temperature
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/36—General characteristics of the apparatus related to heating or cooling
- A61M2205/3606—General characteristics of the apparatus related to heating or cooling cooled
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Description
ΔQB+ΔQI=mBcBΔTB+mIcIΔTI
となる。式中、下付文字Bは血液を示し、Iは注入液を示す。これらの流体が水と同様の熱容量を有するという前提で、血液及び注入液の熱容量を1に設定し、及び周辺システムから混合物内への熱の漏れがない、すなわちエネルギーが保存されているという前提で、ΔQI=−ΔQBに設定し、上記方程式を0=vBΔTB+vIΔTIに変換することができる。式中、vBは血液の量であり、TAは混合物温度であり(均一な混合物温度と仮定する)、ΔTB=TA−TBは血液温度の変化を示し、ΔTI=TA−TIは注入液の温度変化を示す。例えばカテーテル2(図1A)の関連パラメータをそれぞれTA、TB及びTIに対するT1(血液及び注入液混合物の温度)、T4(全身血液温度)、及びT2(注入液温度)を含む、方程式0=vBΔTB+vIΔTI内に代入し、vBを時間(t)で掛けた自然血液貢献(X)で置換することにより、以下の方程式が得られる。
0=X・t・(T4−T1)+IR・t・(T1−T2)
自然血液貢献(X)の値を求め、時間(t)で割ることにより以下の式が得られる。
P1=混合物(meq/L)の[Na+]
P2=注入液(meq/L)の[Na+]
P3=潅流[Na+](meq/L)
P4=全血[Na+](meq/L)
IR=注入速度(cc/秒)
X=自然血液寄与(cc/秒)
血管内の流れ=(注入液初期速度)+((注入液速度増加)/間隔)*(間隔の数)
式中、間隔の数はT3<T4である場合、すなわち冷たい注入液の還流がある場合の間隔の数に等しい。
X=IR*(T1−T2)/(T4−T1)=0.5mL/秒(308K−282K)/(310K−308K)
を算出し、これにより、4mL/秒の自由流貢献が生じる。コントローラ22はまた、希釈係数、dF=IR/(IR+X)=0.5mL/秒/(0.5mL+4mL/秒)を算出し、これにより0.11の希釈係数が生じる。コントローラ22はまた、血液及び注入液混合物のヘマトクリット値、amHct=基準htc*(1−dF)=45*(1−0.11)を算出し、これにより40.05のヘマトクリット値が生じる。amHctはCAH以上であり、T3はT4以上であり(還流は検出されない)、T1は目標温度以上であり、T1は目標温度プラス0.2以下であるので、現在の注入速度はコントローラ22によって維持することができる。次に、T1からT4はもう一度評価又は測定され、自由流貢献、希釈係数、及び混合物ヘマトクリット値が再算出される。この過程はその後、図11に示すのと一致するように繰り返すことができる。別の方法では、注入速度は、所定の期間だけコントローラ22によって維持することができ、注入速度は、amHct、T1及びT4に関する上記条件が満たされているかどうかに関わらず、期間が終了すると減少する可能性がある。
4 管状部材
6 遠位カテーテル部
8 近接カテーテル部
10a センサ
10b センサ
10c センサ
10d センサ
12 外側表面
14 ワイヤ
16 プラグ
18 マニホールド
20 内側表面
22 コントローラ
23 遠位カテーテル先端
24 注入ポンプ
24a ポンプ
24b ポンプ
26 ワイヤ
30 冷却器
31 加熱器
32 入口
34 出口
36 矢印
38 管腔
40 注入液出口部位又は領域
42 遠位部
44 挿入装置
46 遠位開口
48 温度センサ
49 温度センサ
50 頚動脈
51 大腿動脈
52 矢印
52’ 矢印
54 混合物
58 矢印
58’ 矢印
60 カテーテル
62 外壁
64 内壁
66 管腔
68 断熱環状空間
70 遠位部
80 ガイドカテーテル
82 遠位端
84 頚動脈
86 マイクロカテーテル
88 遠位端
92 ワイヤ
94 遠位部
96 センサ
98 センサ
100 センサ
102 センサ
104 センサ
106 マーカ
108 マーカ
110 遠位部
112 カテーテル
114 内側環状センサ
115 管腔
116 穿孔
120 矢印
122 遠位環状センサ
124 環状センサ
126 近接環状センサ
136 マイクロカテーテル
138 カテーテル
140 遠位端
142 遠位端
144 センサ
146 センサ
148 センサ
150 センサ
184 制御/表示パネル
T1 温度
T2 温度
T3 温度
T4 温度
Claims (22)
- 注入液源に流体連通するように構成されている挿入装置と、
少なくとも、挿入装置の注入液出口位置に対して血流方向下流側において前記挿入装置に位置決めされ、前記挿入装置が注入液の注入のために患者の血管内に定置されているときに、注入液と血液との混合物の温度(T 1 )を測定する第1の温度センサと、
前記センサのうちの少なくとも1つのセンサから信号を受信し、血液と前記注入液との混合物の温度(T 1 )及び患者の血管内の自然血管流量に基づいて、前記挿入装置を通過する前記注入液の温度、流量、及び量のうちの少なくとも1つを制御するように構成されているコントローラと、
を備えた装置。 - ガイドカテーテルであって、前記挿入装置の外面と前記ガイドカテーテルの内面との間の断熱環状空間の形成及び寸法増大のうちの少なくとも一方を行うように、第1の小さい外形から第2のより大きい外形まで拡大するように構成されたガイドカテーテルを備えることを特徴とする請求項1に記載の装置。
- 前記コントローラはさらに、患者の基準全身ヘマトクリット値(Hct)及び血液の希釈度(dF)を使用して、前記注入液出口位置の下流側の混合ヘマトクリット値を算出するとともに、前記混合ヘマトクリット値に基づいて前記挿入装置を通過する前記注入液の温度、流量、及び量のうちの少なくとも1つを制御するように構成されていることを特徴とする請求項1に記載の装置。
- 前記コントローラは、方程式(Hct)*(1−dF)を使用して前記注入液出口位置の下流側の混合ヘマトクリット値を算出するように構成されており、ここで、dF=(注入速度)/(注入速度+X)であり、Xは血液と注入液との混合物中での深部体温での血液量/単位時間であって方程式X=(注入速度×(T1−T2)/(T4−T1))で示され、T 2は、前記注入液出口位置において、及びその隣接位置においてのうちの少なくとも1方において第2の温度センサによって測定された注入液の温度であり、T3は前記注入液出口位置に上流側で隣接した位置において第3の温度センサによって測定された温度であり、T4は患者の深部体温であることを特徴とする請求項3に記載の装置。
- 複数の温度センサを備え、該複数のセンサは、
前記注入液出口位置及び該注入液出口位置に隣接した位置のうちの少なくとも一方で注入液の温度(T 2 )を測定するように構成された第2の温度センサと、
前記出口位置の上流側で前記注入液出口位置に隣接してカテーテルの外側の温度(T 3 )を測定するように構成された第3の温度センサと、
患者の深部体温(T 4 )を測定するように構成された第4の温度センサと、
をさらに含んでいることを特徴とする請求項1に記載の装置。 - 前記コントローラは、前記注入液出口位置及び前記注入液出口位置に隣接した位置のうちの少なくとも一方で前記注入液の温度を算出するように設けられていることを特徴とする請求項1に記載の装置。
- 前記コントローラは、血管内の自然血管流量の安定状態に基づいて、前記挿入装置を通過する前記注入液の流量又は量を制御するように構成されていることを特徴とする請求項1に記載の装置。
- 第1の方向に流れる流体で満たされたシステムの中に挿入されるように構成されている細長いセンサ支持装置であって、その長さに沿って前記支持装置に連結された1つ以上のセンサを有する細長いセンサ支持装置と、
前記1つ以上のセンサから信号を受信し、挿入装置の注入液出口位置に対して下流側の注入液混合物の温度、流量、及び量のうちの少なくとも1つを、前記挿入装置が患者の血管内に定置されている間に、患者の血管内の自然血管流量に基づいて制御するように構成されているコントローラと、
を備えた装置。 - 注入液源と流体連通するとともに、前記システム内に位置決めされるように構成された、前記細長いセンサ支持装置以外の挿入装置と、
前記挿入装置の内部管腔の外側に配置され、前記第1の方向と反対の第2の方向に沿って前記挿入装置の注入液出口位置から所定の距離を離隔して配置されたセンサと、
を備え、前記コントローラは、
前記流体の少なくとも1つのパラメータを示すセンサからの信号を受信し、前記センサからの前記信号に基づいて、
(a)前記注入液の少なくとも1つのパラメータ、
(b)前記挿入装置を通る前記注入液の注入速度、及び
(c)前記挿入装置を通過する前記注入液の量、
のうちの少なくとも1つを制御するように構成されていることを特徴とする請求項8に記載の装置。 - 前記システムは血液で満たされた患者の脈管構造であり、前記コントローラは、還流を検出し、還流が起こったときの決定に基づいて、(i)前記挿入装置が挿入される血管の自然血管流量、(ii)前記血管内の血液の希釈係数、(iii)前記血管内の前記血液及び注入液の混合物のヘマトクリット値、及び(iv)前記血管内の前記血液及び注入液の混合物の温度、のうちの少なくとも1つを算出するように構成されていることを特徴とする請求項9に記載の装置。
- 前記システムは血液で満たされた患者の脈管構造であり、前記コントローラは、前記挿入装置が挿入される血管の自然血管流量を算出し、前記自然血管流量の安定状態を監視するように構成されていることを特徴とする請求項8に記載の装置。
- 前記コントローラは、前記自然血管流量の安定状態を検出した際に、前記患者内への前記注入液の注入を停止する、維持する、及び減少させる、のうちの少なくとも1つを行うように構成されていることを特徴とする請求項8に記載の装置。
- 前記システムは血液で満たされた患者の脈管構造であり、前記コントローラは前記挿入装置が挿入される血管内の自然血管流量を計算するように構成され、前記コントローラは、自然血管流量又は混合ヘマトクリット値に基づいて、患者内への前記注入液の温度、量、及び流量のうちの少なくとも1つを制御するように構成されていることを特徴とする請求項8に記載の装置。
- 注入液源と流体連通するとともに、血管内に配置されるように構成された挿入装置と、
血管内へ下流側方向に前記挿入装置を通過する前記注入液の温度、流量、及び量のうちの少なくとも1つを、血管中の自然血管流量に基づいて制御するように構成されたコントローラと、
を備える装置。 - 前記コントローラは、患者の基準全身ヘマトクリット値(Hct)を入力として受け取り、患者体内へと前記挿入装置を通過する注入液の量と、患者による液体出力量とに基づいてHctを更新することを特徴とする請求項1、8、又は14に記載の装置。
- 患者の体内で測定された少なくとも1つの他の温度は、(a)前記注入液出口位置、及び前記注入液出口位置に隣接する位置のうちの少なくとも一方における前記注入液の温度、(b)前記注入液出口位置の上流の隣接する位置の温度、及び(c)患者の深部体温であることを特徴とする請求項8又は14に記載の装置。
- 前記コントローラは、前記挿入装置の前記注入液出口位置の下流において混合ヘマトクリットを計算するとともに、前記挿入装置を通過する注入液の温度、流量、及び量のうちの少なくとも1つを前記混合ヘマトクリットに基づいて制御することを特徴とする請求項14に記載の装置。
- 前記コントローラは、前記1つ以上のセンサから信号を受信し、前記注入液の温度、流量、及び量のうちの少なくとも1つを、前記挿入装置が患者の血管中に定置されている間に、前記挿入装置の注入液出口位置に対して下流における血液と注入液との混合液の少なくとも1つのパラメータに基づいて、注入液の注入に対する血液の下流への流れを制御するように構成されている請求項8に記載の装置。
- 第1の方向に流れる流体で満たされたシステムの中に挿入されるように構成されている細長いセンサ支持装置であって、その長さに沿って前記支持装置に連結された1つ以上のセンサを有する細長いセンサ支持装置と、
前記センサから信号を受信し、挿入装置を通じて患者に注入される注入液の温度、流量、及び量のうちの少なくとも1つを、前記挿入装置の注入液出口位置に対して下流の血液と注入液との混合物の少なくとも1つのパラメータ、及び血管内の自然血管流量に基づいて制御するように構成されているコントローラと、
を備えた装置。 - 前記コントローラは、前記注入液の温度を、
(1)前記挿入装置の前記注入液出口位置に対して下流の血液と注入液との混合物の温度と、
(2)(a)前記注入液出口位置における注入液の温度及び前記注入液出口位置に隣接する位置における注入液の温度のうちの少なくとも1つ、
(b)前記注入液出口位置の上流の隣接した注入液の温度、及び
(c)前記患者の中核体温
のうちの少なくとも1つと、
に基づいて制御するように構成されていることを特徴とする請求項19に記載の装置。 - 患者の体内に挿入されるように構成されている細長いセンサ支持装置であって、その長さに沿って前記支持装置に連結された1つ以上のセンサを有する細長いセンサ支持装置と、
前記センサから信号を受信し、第1の位置における血液と注入液との混合物の少なくとも1つのパラメータであって、前記第1の位置は、前記挿入装置の前記注入液出口位置に隣接するとともに前記注入液出口位置から前記第1の方向とは反対の第2の方向に沿って所定の距離を離間している、パラメータと、前記血管中の自然血管流量と、に基づいて、
(a)第1の方向に挿入装置を通じて患者の体内に注入される注入液の少なくとも1つのパラメータ、
(b)前記注入液の注入速度、及び
(c)前記注入液の量、
のうちの少なくとも1つを制御するように構成されたコントローラと、
を備える装置。 - 前記センサは温度センサであり、前記コントローラは、前記センサから温度信号を受信し、
(a)前記患者の体内に、前記第1の方向に前記挿入装置を通じて注入される注入液の温度、
(b)前記注入液の注入速度、及び
(c)前記注入液の量、
のうちの少なくとも1つを、前記第1の位置における血液と注入液との混合物の温度に基づいて制御するように構成されていることを特徴とする請求項21に記載の装置。
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