JP6190807B2 - 血液ポンプシステムと方法 - Google Patents
血液ポンプシステムと方法 Download PDFInfo
- Publication number
- JP6190807B2 JP6190807B2 JP2014526181A JP2014526181A JP6190807B2 JP 6190807 B2 JP6190807 B2 JP 6190807B2 JP 2014526181 A JP2014526181 A JP 2014526181A JP 2014526181 A JP2014526181 A JP 2014526181A JP 6190807 B2 JP6190807 B2 JP 6190807B2
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- JP
- Japan
- Prior art keywords
- blood pump
- pump system
- blood
- impeller
- centrifugal blood
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Classifications
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- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
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- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
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- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
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- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/50—Details relating to control
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- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/50—Details relating to control
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- A61M60/80—Constructional details other than related to driving
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- A61M60/80—Constructional details other than related to driving
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- A61M60/818—Bearings
- A61M60/825—Contact bearings, e.g. ball-and-cup or pivot bearings
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- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N11/00—Investigating flow properties of materials, e.g. viscosity, plasticity; Analysing materials by determining flow properties
- G01N11/02—Investigating flow properties of materials, e.g. viscosity, plasticity; Analysing materials by determining flow properties by measuring flow of the material
- G01N11/04—Investigating flow properties of materials, e.g. viscosity, plasticity; Analysing materials by determining flow properties by measuring flow of the material through a restricted passage, e.g. tube, aperture
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- A61M2205/00—General characteristics of the apparatus
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- A61M2205/3334—Measuring or controlling the flow rate
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- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
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- A61M2205/3344—Measuring or controlling pressure at the body treatment site
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- A61M2205/00—General characteristics of the apparatus
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- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/10—Location thereof with respect to the patient's body
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- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/10—Location thereof with respect to the patient's body
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- A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
- A61M60/148—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
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- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/20—Type thereof
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- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/80—Constructional details other than related to driving
- A61M60/802—Constructional details other than related to driving of non-positive displacement blood pumps
- A61M60/818—Bearings
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- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/80—Constructional details other than related to driving
- A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
- A61M60/857—Implantable blood tubes
Description
によって流出導管30に取り付けられていてもよい。
WSS(Pa)=4Qμ/πR3 [式1]
ここで、
Q=流速(m3/s)
μ=血液の粘度(Pa*s)
R=血管半径(m)
である。
壁剪断応力の制御方法#1:手動方法
壁剪断応力の制御方法#2:血液粘度の間接測定と血流と標的血管直径の直接測定を用いる自動的方法
壁剪断応力の制御方法#3:血液粘度と血流と標的血管直径の間接測定と静脈圧力の直接測定を用いる自動的方法
壁剪断応力の制御方法#4:血液粘度と血流とポンプ圧力水頭と標的血管直径の間接測定を用いる自動的方法
血液ポンプシステム流速と圧力水頭のセンサなしでの決定:
Q=a+b・ln(Pin)+c・ω0.5 [式2]
ここで、
Q=流速(L/min)
Pin=モータへの投入電力(W)
ω=ポンプ速度(rpm)
モータへの投入電力は、測定されたモータ電流と電圧から導かれる。a、b、cに対する値は、モータ速度と投入電力の関数としてのポンプ流速のグラフをカーブフィッティングすることで求められる。
Hp=d+e・ln(Pin)+f・ω2.5 [式3]、
ここで、d、e、fの値は、ポンプ速度とモータの投入電力の関数としてのポンプの圧力水頭のグラフをカーブフィッティングすることで求められる。ここでHpは流入導管20とポンプ25と流出導管30を横断して測定される。
血管抵抗の決定と血管半径の推定:
Rv=(Pv−CVP)/Q [式4]
ここで、
Hv=血液の心臓への復路上の末梢血管で損失する圧力水頭(mmHg)
Pv=吻合における静脈圧力(mmHg)
CVP=中心静脈圧(mmHg)
Rv=血管抵抗((mmHg・min)/L)
である。通常CVPは2〜8mmHgの間の範囲であり、PvとQの動作範囲は相対的にはるかに大きいので、上式においてはこれを無視することができる。図36Eに示すように、血管抵抗はPv−Q曲線660の勾配としてグラフ上に表すことができる。曲線660は非線形なので、傾斜はQの関数である。次式で表されるように、一時的に速度を数百rpm(Δω)だけ上昇させて、それによる静脈圧力の変化(ΔPv)を測定し、結果としてのポンプ流の変化(ΔQ)を推定することによって、血管抵抗を求めてもよい。
RV(Q)=ΔPV/ΔQ [式5]
血管抵抗は血管直径又は半径に強く依存する関数であって、静脈が小さいほど血管抵抗が高いことに留意されたい。血管抵抗は様々な単位で定量化可能であり、例えばウッド単位((mmHg・min)/L)であれば、8倍すればSI単位((Pa・s)/m3)に変換できる。
Hv=Hp [式6]
末梢血管の半径は、Qに対するHvの比である血管抵抗(Rv)に逆比例する。円形断面の血管内のハーゲンーポアズイユ血液流を仮定すると、血管抵抗は次の式を用いて表現できる。
RV(Pa・s/m3)=Pv/Q=8・μ・L/π・R4 [式7]
ここで、
PvはPa単位で表され、
Qは(m3/s)の単位で表され、
μ=血液の粘度(Pa*s)、
R=血管半径(m)、
L=血管長さ(m)
である。実際には、直径が既知の特定の静脈における圧力低下を生体内測定することで、式7の精度が上げられる。こうして次の経験式が得られる。
Rv(Pa・s/m3)=K・μ/R4 [式8]
ここで、Kは標的静脈に関する実験定数(m)である。
壁剪断応力の決定:
Q=Pv/Rv [式9]
式8より、血管半径は次式で表される。
R=(K・μ/Rv)0.25 [式10]
式1、9、10より、壁剪断応力は次式で表される。
WSS(Pa)=((4・Pv)/(π・K0.75))・(μ/Rv)0.25 [式11]
安全機能と警報:
Claims (35)
- 少なくとも7日間、50mL/min〜1500mL/minの間の速度で血液を抹消静脈にポンプ輸送する遠心血液ポンプシステムであって、前記遠心血液ポンプシステムが作動する時、前記抹消静脈内の平均壁剪断応力は2.5Pa〜10.0Paの範囲の中にありかつ前記抹消静脈内の脈圧は供与ベゼルの脈圧より低く、
前記遠心血液ポンプシステムは、遠心血液ポンプ、流入導管、流出導管、及び制御装置を備え、
a)前記遠心血液ポンプは、
血液を受けて血液をインペラ上に振り向けると共に、筐体の頂部から入口の内部に向かって延伸する頂部ピボットベアリングを支持する頂部ベゼルと、前記筐体の底部から前記筐体の内部に向かって延伸する底部ベゼルと底部ピボットベアリングとを有する流入ディフューザを備える入口及び出口と、
前記筐体の中の前記入口と前記出口との間に配置されると共に、前記頂部ピボットベアリングと前記底部ピボットベアリングとに機械的に係合するように構成されたインペラピボットシャフトを備えたインペラと、
前記インペラの頂部表面の上に位置しかつ前記インペラの中心から放射状に離れる方向に延伸し、前記入口で受け取った血液を、前記筐体を介して前記出口に向かわせる複数のブレードと、
前記インペラと機械的に係合した少なくとも1つの磁石と、
前記少なくとも1つの磁石と磁力によって係合し、前記少なくとも1つの磁石と前記インペラとを回転させる電気モータと、
を備え、
b)前記流入導管は、4〜6mmの内径であり、第1の端、第2の端、及び前記流入導管の中の流体経路への制御されたアクセスを提供する少なくとも1つの側部ポートを備え、
前記第1の端は、前記入口に流体接続され、
前記第2の端は、前記抹消静脈の内腔の中に挿入されるように構成され、
c)前記流出導管は、4〜6mmの内径であり、第1の端、第2の端、及び前記流出導管の中の流体経路への制御されたアクセスを提供する少なくとも1つの側部ポートを備え、
前記第1の端は、前記出口に流体接続され、
前記第2の端は、前記抹消静脈への外科的吻合を形成するように構成され、
d)前記制御装置は、前記インペラの速度を制御するプロセッサ、メモリ、バッテリ、及び前記制御装置と前記遠心血液ポンプとを電気的に接続するケーブルを備え、
前記制御装置は、粘度計、流速センサ、及び半径測定手段を備え、
a)前記粘度計は、血液粘度を測定し、
b)前記流速センサは、血液ポンプシステム又は血管内の血流速度を測定し、
c)前記半径測定手段は、血管の半径を測定し、
d)前記制御装置は、前記測定した血液粘度と前記測定した流速と前記血管の半径から、前記血管内の壁剪断応力を決定し、
e)前記制御装置は、前記決定された壁剪断応力を所定の参照値と比較し、
f)前記制御装置は、前記決定された壁剪断応力が前記所定の参照値に近くない場合に血液ポンプ速度を調節し、
g)前記粘度計、前記流速センサ、前記半径測定手段、及び前記制御装置は、前記決定された壁剪断応力が前記所定の参照値に近づくまでa〜fのステップを繰り返す、
遠心血液ポンプシステム。 - 少なくとも7日間、50mL/min〜1500mL/minの間の速度で血液を抹消静脈にポンプ輸送する遠心血液ポンプシステムであって、前記遠心血液ポンプシステムが作動する時、前記抹消静脈内の平均壁剪断応力は2.5Pa〜10.0Paの範囲の中にありかつ前記抹消静脈内の脈圧は供与ベゼルの脈圧より低く、
前記遠心血液ポンプシステムは、遠心血液ポンプ、流入導管、流出導管、及び制御装置を備え、
a)前記遠心血液ポンプは、
血液を受けて血液をインペラ上に振り向けると共に、筐体の頂部から入口の内部に向かって延伸する頂部ピボットベアリングを支持する頂部ベゼルと、前記筐体の底部から前記筐体の内部に向かって延伸する底部ベゼルと底部ピボットベアリングとを有する流入ディフューザを備える入口及び出口と、
前記筐体の中の前記入口と前記出口との間に配置されると共に、前記頂部ピボットベアリングと前記底部ピボットベアリングとに機械的に係合するように構成されたインペラピボットシャフトを備えたインペラと、
前記インペラの頂部表面の上に位置しかつ前記インペラの中心から放射状に離れる方向に延伸し、前記入口で受け取った血液を、前記筐体を介して前記出口に向かわせる複数のブレードと、
前記インペラと機械的に係合した少なくとも1つの磁石と、
前記少なくとも1つの磁石と磁力によって係合し、前記少なくとも1つの磁石と前記インペラとを回転させる電気モータと、
を備え、
b)前記流入導管は、4〜6mmの内径であり、第1の端、第2の端、及び前記流入導管の中の流体経路への制御されたアクセスを提供する少なくとも1つの側部ポートを備え、
前記第1の端は、前記入口に流体接続され、
前記第2の端は、前記抹消静脈の内腔の中に挿入されるように構成され、
c)前記流出導管は、4〜6mmの内径であり、第1の端、第2の端、及び前記流出導管の中の流体経路への制御されたアクセスを提供する少なくとも1つの側部ポートを備え、
前記第1の端は、前記出口に流体接続され、
前記第2の端は、前記抹消静脈への外科的吻合を形成するように構成され、
d)前記制御装置は、前記インペラの速度を制御するプロセッサ、メモリ、バッテリ、及び前記制御装置と前記遠心血液ポンプとを電気的に接続するケーブルを備え、
前記制御装置は、
a)血液粘度を間接測定することと、
b)血液ポンプシステム又は血管内の血流速度を間接測定することと、
c)血管の半径を間接測定することと、
d)前記間接測定した血液粘度と前記間接測定した流速と前記血管の半径から、前記血管内の壁剪断応力を決定することと、
e)前記決定された壁剪断応力を所定の参照値と比較することと、
f)前記決定された壁剪断応力が前記所定の参照値に近くない場合に血液ポンプ速度を調節することと、
g)前記決定された壁剪断応力が前記所定の参照値に近づくまでa〜fのステップを繰り返すことと、
を行う、
遠心血液ポンプシステム。 - 前記制御装置は、粘度計、流速センサ、及び半径測定手段の少なくとも1つを備え、
前記制御装置は、
前記間接測定された前記血液粘度を、前記粘度計により直接測定された値で較正すること、
前記間接測定された前記血流速度を、前記流速センサにより直接測定された値で較正すること、
前記間接測定された前記半径を、前記半径測定手段により直接測定された値で較正すること、
の少なくとも1つを行う、
請求項2に記載の遠心血液ポンプシステム。 - 前記遠心血液ポンプシステムが作動する時、前記遠心血液ポンプシステムは、前記流出導管に流体接続された静脈内の平均壁剪断応力を0.76Pa〜23Paの範囲に維持する、ように構成されている、請求項1〜請求項3の何れか1項に記載の遠心血液ポンプシステム。
- 前記流入導管と前記流出導管の少なくとも1つは、ポリウレタンで構成されている、請求項1〜請求項4の何れか1項に記載の遠心血液ポンプシステム。
- 前記流入導管又は前記流出導管は、ePTFEで構成されている、請求項1〜請求項5の何れか1項に記載の遠心血液ポンプシステム。
- 前記流入導管又は前記流出導管は、ポリウレタンとePTFEの接合したセグメントを備えている、請求項6に記載の遠心血液ポンプシステム。
- 前記流入導管と前記流出導管との1つの少なくとも1部分は、形状記憶又は自己拡張性の材料を備える支持構造又はステンレススチールを備える、請求項1〜請求項7の何れか1項に記載の遠心血液ポンプシステム。
- 前記形状記憶又は前記自己拡張性の材料はニチノールである、請求項8に記載の遠心血液ポンプシステム。
- 前記ニチノール又は前記ステンレススチールの少なくとも1部は、編み状又はコイル状に形成されている、請求項9に記載の遠心血液ポンプシステム。
- 前記流入導管と前記流出導管の少なくとも1つは、半径方向に圧縮性のコネクタを用いて前記遠心血液ポンプ又は側部ポートに接続されている、請求項1〜請求項10の何れか1項に記載の遠心血液ポンプシステム。
- 前記遠心血液ポンプシステムが作動する時、前記遠心血液ポンプシステムは、前記流出導管に流体接続された静脈内の上昇した平均壁剪断応力を、少なくとも14日、28日、56日、又は112日の間維持する、ように構成されている、請求項1〜請求項4の何れか1項に記載の遠心血液ポンプシステム。
- 前記遠心血液ポンプシステムが作動する時、前記遠心血液ポンプシステムは、前記流出導管に流体接続された静脈内の平均血液速度を10cm/s〜120cm/s又は25cm/s〜100cm/sの範囲に維持する、ように構成されている、請求項1〜請求項12の何れか1項に記載の遠心血液ポンプシステム。
- 前記流入導管及び前記流出導管は、合わせた長さが4cm〜220cmである、請求項1〜請求項13の何れか1項に記載の遠心血液ポンプシステム。
- 前記流入導管又は前記流出導管は切り取られてもよい、請求項1〜請求項14の何れか1項に記載の遠心血液ポンプシステム。
- 前記複数のブレードの少なくとも1つは弓型である、請求項1〜請求項15の何れか1項に記載の遠心血液ポンプシステム。
- 前記少なくとも1つの磁石は、リング又は円盤を形成する、請求項1〜請求項16の何れか1項に記載の遠心血液ポンプシステム。
- 前記1つ以上のベアリングは、アルミナ、アルミナ及びジルコニア、又は、アルミナ及びシリコンカーバイドを備える、請求項1〜請求項17の何れか1項に記載の遠心血液ポンプシステム。
- 前記インペラピボットシャフトの端は、凸型であり、前記頂部ピボットベアリング及び前記底部ピボットベアリングは、凹型であり、
又は、
前記インペラピボットシャフトの端は、凹型であり、前記頂部ピボットベアリング及び前記底部ピボットベアリングは、凸型である、請求項1〜請求項18の何れか1項に記載の遠心血液ポンプシステム。 - 前記入口は、前記流入ディフューザの領域において一般的に円形の内腔から長方形の内腔に変化する、請求項1〜請求項19の何れか1項に記載の遠心血液ポンプシステム。
- 前記流入ディフューザは、弓型である、請求項1〜請求項20の何れか1項に記載の遠心血液ポンプシステム。
- 前記流入ディフューザの長手軸と前記インペラピボットシャフトの長手軸との間の角度は、5度より大きい、請求項1〜請求項21の何れか1項に記載の遠心血液ポンプシステム。
- 前記遠心血液ポンプが作動しているとき、前記インペラピボットシャフトの部分と前記頂部ピボットベアリングの部分とは、前記入口に延伸しかつ流れる血液により浄化される、請求項1〜請求項22の何れか1項に記載の遠心血液ポンプシステム。
- 前記遠心血液ポンプが作動しているとき、前記インペラピボットシャフトの部分と前記底部ピボットベアリングの部分とは、低部ベアリングギャップに延伸しかつ流れる血液により洗われる、請求項1〜請求項23の何れか1項に記載の遠心血液ポンプシステム。
- 頂部ベアリングギャップに延伸する前記頂部ピボットベアリングの部分は、前記供与ベゼルによって支持されている、請求項24に記載の遠心血液ポンプシステム。
- 前記インペラは、前記インペラの中心軸に平行に底面から前記インペラを通って頂部面に延伸する複数の孔を備える、請求項1〜請求項25の何れか1項に記載の遠心血液ポンプシステム。
- 前記遠心血液ポンプが作動しているとき、前記インペラのまわり及び下に流れかつ前記孔を介して頂部へ流れる血液が、前記インペラの下面と下部ベアリング面の部分とを浄化する、請求項26に記載の遠心血液ポンプシステム。
- 前記遠心血液ポンプが作動しているとき、前記インペラのまわり及び下を流れかつ前記孔を介して頂部へ流れる血液が、上部ベアリング面の部分を浄化する、請求項26に記載の遠心血液ポンプシステム。
- 頂部ベアリングギャップに延伸する頂部ベアリングピンの部分は、ベゼル血液によって支持されると共に、前記遠心血液ポンプが作動しているとき、前記インペラのまわり及び下を流れかつ前記孔を介して頂部へ流れる血液が、ベゼルの背面領域を浄化する、請求項26に記載の遠心血液ポンプシステム。
- 少なくとも1つの血液接触面は、PEEKにより作られる、請求項1〜請求項29の何れか1項に記載の遠心血液ポンプシステム。
- 前記遠心血液ポンプ、前記流入導管、前記流出導管、及び前記側部ポートの面を含む少なくとも1つの血液接触面は、抗血栓コーティングにより被覆されている、請求項1〜請求項30の何れか1項に記載の遠心血液ポンプシステム。
- 前記抗血栓コーティングは、ヘパリンを備える、請求項31に記載の遠心血液ポンプシステム。
- 前記流出導管は、外科的吻合を用いて、1mm〜6mmの直径を有する末梢静脈への接続が可能なように構成されている、請求項1〜請求項32の何れか1項に記載の遠心血液ポンプシステム。
- 抗菌カフが、前記流入導管又は前記流出導管の外面に取り付けられている、請求項1〜請求項33の何れか1項に記載の遠心血液ポンプシステム。
- 側部ポートが、血液透析器と流体接続可能なように構成されると共に、遠心血液ポンプシステムが、血液透析の間、導管へのアクセルを提供するように構成されている、請求項1〜請求項34の何れか1項に記載の遠心血液ポンプシステム。
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