Extracorporeal circulation blood system and use method of extracorporeal circulation blood system

By introducing a blood flow regulation mechanism with heart rate synchronization in the peripheral circulatory blood system, the problem of cardiac-assisted treatment of central muscle burden and blood flow reduction in multivascular organs is solved, and more effective cardiac-assisted and blood circulation management is achieved.

JP2025059330APending Publication Date: 2025-04-10TERUMO KK
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Patent Information

Application Number
JP2023169369
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Filing Date
2023-09-29
Publication Date
2025-04-10

AI Technical Summary

Technical Problem

When using the peripheral circulating blood system for cardiac assisted treatment, the blood is sent to the artery, and the pressure of the heart is reversed, causing the myocardium to need to rest, but the pumping pressure of the peripheral circulating blood system may be too high, delaying myocardium recovery. In addition, blood circulation under fixed pressure may lead to a decrease in blood flow to multivascular organs such as the brain, intestine, and kidneys.

Method used

A peripheral circulating blood system is designed that includes a blood delivery circuit with branching and regulatory mechanisms. The system uses control unit to drive regulation mechanisms to adjust blood flow in arterial and venous circuits to simulate the systolic and diastolic cycles of the heart.

Benefits of technology

By adjusting blood flow, reducing the burden on the heart during the systolic period and increasing blood supply during the diastolic period, simulating normal pressure fluctuations in the heart, thereby improving blood flow to multivascular organs, reducing myocardial burden and risk of reduced blood flow.

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Abstract

To provide: an extracorporeal circulation blood system capable of suppressing burden imposed on a heart and suppressing reduction in blood flow to an organ with many capillary vessels when performing extracorporeal circulation; and a use method of the extracorporeal circulation blood system.SOLUTION: An extracorporeal circulation blood system 1 includes: a branch part 44 where an artery circuit 24 and a vein circuit 25 are branched in a blood sending circuit 22; an adjustment mechanism 45 arranged in the branch part and adjusting a flow rate of blood to the artery circuit and the vein circuit; and a control unit 90 controlling the adjustment mechanism. The control unit drives the adjustment mechanism to adjust the flow rate of blood to the artery circuit and the vein circuit in accordance with a pulsation cycle of a heart of a patient.SELECTED DRAWING: Figure 1
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Description

[Technical field]

[0001] The present invention relates to an extracorporeal blood circulation system and a method of using the extracorporeal blood circulation system. [Background technology]

[0002] Conventionally, percutaneous cardiopulmonary support (PCPS) has been used to perform cardiopulmonary resuscitation, circulatory support, and respiratory support in emergency treatment. PCPS is a method that temporarily supports or substitutes for cardiopulmonary function using an extracorporeal membrane oxygenation (ECMO).

[0003] An extracorporeal blood circulation system such as an extracorporeal membrane oxygenator includes a blood circuit consisting of a circulation pump, an oxygenator, a blood removal line, and a blood delivery line, and performs gas exchange on the removed blood and delivers it to the blood delivery line, as shown in Patent Document 1 below, for example. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Special Publication No. 2014-504906 Summary of the Invention [Problem to be solved by the invention]

[0005] In an extracorporeal blood circulation system, veno-arterial ECMO (VA-ECMO) may be performed on patients who are expected to recover from the primary disease that is causing the deterioration of their cardiac function by performing treatment. In VA-ECMO, blood drawn from the vein is oxygenated using an artificial lung and then sent to the artery. However, in VA-ECMO, when blood is sent to the artery during the systole of the heart, counter pressure is generated against the heart's pumping, and although the myocardium should be rested, the pressure from the circulation pump of the extracorporeal blood circulation system becomes a high load, which may delay the recovery of the myocardium.

[0006] In addition, in an extracorporeal blood circulation system, blood is circulated at a constant pressure by a circulation pump, and since red blood cells in the blood are larger than the inner diameter of the capillaries, there is a risk of reduced blood flow to organs with many capillaries (such as the brain, intestines, and kidneys).

[0007] The present invention has been made to solve the above problems, and aims to provide an extracorporeal blood circulation system and a method for using the extracorporeal blood circulation system that can reduce the burden on the heart and prevent a decrease in blood flow to organs with many capillaries when performing extracorporeal circulation. [Means for solving the problem]

[0008] The above object of the present invention can be achieved by the following means.

[0009] (1) An artificial lung that exchanges gases with the blood; a blood removal circuit for sending the blood drawn from a patient to the oxygenator, and a blood sending circuit for sending the blood from the oxygenator to the patient; A circulation pump for pumping the blood in the circuit, The blood supply circuit includes: an arterial circuit delivering the blood to an artery of the patient; a venous circuit for delivering the blood to a vein of the patient; a branching portion in the blood supply circuit where the arterial circuit and the venous circuit are branched; an adjustment mechanism provided at the branching portion for adjusting the flow rate of the blood into the arterial circuit and the venous circuit; A control unit that controls the adjustment mechanism, The control unit drives the adjustment mechanism to adjust the flow rate of blood to the arterial circuit and the venous circuit in accordance with the heartbeat period of the patient.

[0010] (2) The extracorporeal blood circulation system according to (1), further comprising a detection unit for detecting the pulsation of the patient's heart.

[0011] (3) The adjustment mechanism includes: a fin provided at the branching portion and arranged so that an opening degree of the arterial circuit and the venous circuit can be adjusted; and a drive unit that drives the fins to adjust the opening degree of the arterial circuit and the venous circuit.

[0012] (4) The control unit drives the fins via the drive unit based on the pulsation information of the patient detected by the detection unit, and adjusts the opening degree of the arterial circuit and the venous circuit.

[0013] (5) The extracorporeal blood circulation system according to any one of (1) to (4), wherein the control unit determines the timing to increase blood supply to the arterial circuit and the timing to increase blood supply to the venous circuit based on the patient's pulsation information.

[0014] (6) The extracorporeal blood circulation system according to any one of (1) to (5), wherein the control unit determines a ratio of blood sent to the arterial circuit and the venous circuit based on pulsation information of the patient.

[0015] (7) The extracorporeal blood circulation system according to any one of (4) to (6), wherein the pulsation information includes an electrocardiogram length from an electrocardiogram and a pressure in the blood transfer circuit.

[0016] (8) The adjustment mechanism includes: a first clamp for clamping an arterial circuit connector connected to the arterial circuit; and a second clamp that clamps a venous circuit connector that is connected to the venous circuit, The control unit controls the opening and closing ratios of the first clamp and the second clamp in accordance with the heartbeat period of the patient to adjust the flow rate of the blood to the arterial circuit and the venous circuit.

[0017] (9) An artificial lung that exchanges gases with the blood; a blood removal circuit for sending the blood drawn from a patient to the oxygenator, and a blood sending circuit for sending the blood from the oxygenator to the patient; a circulation pump for pumping the blood in the circuit, The blood supply circuit includes: an arterial circuit delivering the blood to an artery of the patient; a venous circuit for delivering the blood to a vein of the patient; a branching portion in the blood supply circuit where the arterial circuit and the venous circuit are branched; A method of using an extracorporeal blood circulation system having an adjustment mechanism provided at the branching portion for adjusting the flow rate of the blood to the arterial circuit and the venous circuit, and a control unit for controlling the adjustment mechanism, comprising: A method of using an extracorporeal blood circulation system, in which the control unit drives the adjustment mechanism in accordance with the pulsation cycle of the patient's heart to adjust the flow rate of blood to the arterial circuit and the venous circuit. Effect of the Invention

[0018] According to the extracorporeal blood circulation system configured as above, during the systole of the heart, the amount of blood sent to the artery can be reduced and more blood can be sent to the venous side. Therefore, it is possible to prevent back pressure from occurring against the pumping of the heart, and to reduce the burden on the heart. Also, during the diastole of the heart, the aortic valve is closed, and even if more blood is sent to the artery, the burden on the heart can be reduced. Therefore, during the diastole of the heart, the amount of blood sent to the vein can be reduced and more blood can be sent to the artery. By changing the flow rate of blood sent to the aorta for each heartbeat in this way, the internal pressure of the aorta fluctuates, and the same behavior as pulsation can be obtained. Therefore, the fluctuation in the internal pressure of the aorta causes the pressure of the capillaries to fluctuate, which promotes the deformation of red blood cells and improves the blood flow to organs with many capillaries. From the above, when performing extracorporeal circulation, the burden on the heart can be reduced and the reduction in blood flow to organs with many capillaries can be suppressed. [Brief description of the drawings]

[0019] [Figure 1] 1 is a system diagram showing an extracorporeal blood circulation system according to an embodiment of the present invention. [Diagram 2] 2 is a perspective view showing a connecting member and a base of the extracorporeal blood circulation system according to the present embodiment. FIG. [Diagram 3] 2 is a perspective view showing a connecting member of the extracorporeal blood circulation system according to the present embodiment. FIG. [Figure 4] 2 is a plan view showing a connecting member of the extracorporeal blood circulation system according to the present embodiment. FIG. [Diagram 5] FIG. 2 is a perspective view showing a connecting member of the extracorporeal blood circulation system according to the present embodiment, with the upper half cut away. [Figure 6] FIG. 2 is a plan view showing a connecting member of the extracorporeal blood circulation system according to the present embodiment, with the upper half cut away. [Figure 7] 2 is a plan view showing a base of the extracorporeal blood circulation system according to the present embodiment. FIG. [Figure 8] 1 is a graph showing systole and diastole of the heart. [Figure 9]FIG. 7 is a diagram corresponding to FIG. 6 when there is a large amount of blood flow toward the arterial circuit side. [Figure 10] FIG. 7 is a diagram corresponding to FIG. 6 when there is a large amount of blood flow toward the venous circuit side. [Figure 11] FIG. 7 is a view corresponding to FIG. 6 when blood flows only through the arterial circuit. [Figure 12] FIG. 7 is a diagram corresponding to FIG. 6 when blood flows only into the venous circuit. [Figure 13] 13 is a perspective view showing a connecting member and a base of an extracorporeal blood circulation system according to a modified example. FIG. [Figure 14] 13 is a front view showing a connecting member and a base of an extracorporeal blood circulating system according to a modified example. FIG. [Figure 15] FIG. 15 corresponds to FIG. 14 when there is a large amount of blood flow toward the venous circuit. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0020] Hereinafter, an embodiment of the present invention will be described with reference to Fig. 1 to Fig. 12. Note that the following description does not limit the technical scope or the meaning of terms described in the claims. Also, the dimensional ratios in the drawings are exaggerated for the convenience of explanation and may differ from the actual ratios.

[0021] FIG. 1 is a system diagram showing an extracorporeal blood circulation system 1 used as a percutaneous cardiopulmonary support (PCPS) that temporarily supports and substitutes for the functions of the heart and lungs when the patient's heart is weak until the heart function recovers. FIG. 2 is a perspective view showing a connecting member 40 and a base 50 of the extracorporeal blood circulation system 1 according to this embodiment. FIG. 3 is a perspective view showing the connecting member 40 of the extracorporeal blood circulation system 1 according to this embodiment. FIG. 4 is a plan view showing the connecting member 40 of the extracorporeal blood circulation system 1 according to this embodiment. FIG. 5 is a perspective view showing the connecting member 40 of the extracorporeal blood circulation system 1 according to this embodiment, with the upper half cut away. FIG. 6 is a plan view showing the connecting member 40 of the extracorporeal blood circulation system 1 according to this embodiment, with the upper half cut away. FIG. 7 is a plan view showing the base 50 of the extracorporeal blood circulation system 1 according to this embodiment. FIG. 8 is a graph showing the systole and diastole of the heart. FIG. 9 is a view corresponding to FIG. 6 when there is a large amount of blood flow toward the arterial circuit side 24. Fig. 10 is a diagram corresponding to Fig. 6 in the case where there is a large amount of blood flowing toward the venous circuit 25. Fig. 11 is a diagram corresponding to Fig. 6 in the case where blood flows only toward the arterial circuit 24. Fig. 12 is a diagram corresponding to Fig. 6 in the case where blood flows only toward the venous circuit 25.

[0022] The extracorporeal blood circulation system 1 according to the present embodiment can be used by appropriately switching between the veno-arterial (VA) and veno-venous (VV) techniques. The veno-arterial (VA) technique refers to a technique in which a pump is operated to draw blood from a patient's vein (e.g., the vena cava), the blood is oxygenated by gas exchange in the blood using the artificial lung 10, and the blood is then returned to the patient's artery (e.g., the aorta). On the other hand, the veno-venous (VV) technique refers to a technique in which a pump is operated to draw blood from a patient's vein (e.g., the vena cava), the blood is oxygenated by gas exchange in the blood using the artificial lung 10, and the blood is then returned to the patient's vein (e.g., the vena cava). In this way, the extracorporeal blood circulation system 1 can be used as a device that assists the patient's heart and lungs. Hereinafter, the technique of drawing blood from a patient, performing a predetermined treatment outside the body, and then sending the blood back into the patient's body is referred to as "extracorporeal circulation".

[0023] As shown in Figures 1 to 7, the extracorporeal blood circulation system 1 comprises an artificial lung 10, a circuit 20 consisting of a blood removal circuit 21 and a blood supply circuit 22, a circulation pump 30, a drive motor 31 that drives the circulation pump 30, a detection unit 33 that detects the heartbeat of the patient, a connecting member 40 that connects the main circuit 23 of the blood supply circuit 22 and the arterial circuit 24 and venous circuit 25, and a control unit 90 that drives the drive motor 31 and drives a drive unit 55 of the connecting member 40 described later.

[0024] The oxygenator 10 is disposed between the circulation pump 30 and the main circuit 23. The oxygenator 10 performs gas exchange (addition of oxygen and / or removal of carbon dioxide) with respect to the blood. The oxygenator 10 is, for example, a membrane type oxygenator, and is particularly preferably a hollow fiber membrane type oxygenator.

[0025] 1, the circuit 20 has a blood removal circuit 21 and a blood feed circuit 22. One end of the blood removal circuit 21 is inserted into the femoral vein and passes through the inferior vena cava until its tip is placed in the right atrium. The other end of the blood removal circuit 21 is connected to a circulating pump 30.

[0026] As shown in FIG. 1, the blood supply circuit 22 has a main circuit 23 disposed between the oxygenator 10 and the connecting member 40, an arterial circuit 24 inserted into the femoral artery, and a venous circuit 25 inserted into the right internal jugular vein.

[0027] The main circuit 23 is a flow path through which blood to which oxygen has been added in the artificial lung 10 moves to the connecting member 40. A first flow meter 81 is disposed on the main circuit 23, as shown in Fig. 1. With reference to the flow rate of blood flowing through the first flow meter 81, a control unit 90, which will be described later, controls the rotation amount of the drive motor 31 of the circulation pump 30 so as to achieve a desired flow rate for the patient P. Note that any known flow meter can be used.

[0028] 1, a pressure sensor 83 is disposed in the main circuit 23. When the extracorporeal blood circulation system 1 is performing extracorporeal circulation for the patient P, the pressure sensor 83 can measure the pressure in the main circuit 23. The mounting position of the pressure sensor 83 is not limited to the above mounting position, and the pressure sensor 83 can be mounted at any position in the circuit 20. A known sensor can be used as the pressure sensor 83.

[0029] One end of the arterial circuit 24 is inserted into the femoral artery. The other end of the arterial circuit 24 is connected to the connecting member 40. As shown in Fig. 1, a second flow meter 82 is disposed on the arterial circuit 24. The method of using the second flow meter 82 will be described later.

[0030] One end of the venous circuit 25 is inserted into the right internal jugular vein. The other end of the venous circuit 25 is connected to a connecting member 40.

[0031] The tubes constituting the circuit 20 may be made of, for example, a highly transparent, elastically deformable, flexible synthetic resin pipe such as polyvinyl chloride resin or silicone rubber.

[0032] When the drive motor 31 operates the circulation pump 30 in response to a command from the control unit 90, the circulation pump 30 can draw blood from the blood removal circuit 21, pass the blood through the artificial lung 10, and then return the blood to the patient P via the blood delivery circuit 22.

[0033] The detection unit 33 can detect the beating of the patient's heart. In this embodiment, the detection unit 33 is an electrocardiograph. The electrocardiograph has electrodes fixed at predetermined positions on the patient, and can detect the beating of the patient's heart based on an electrocardiogram acquired by the electrodes. Specifically, as shown in FIG. 8, a certain period L1 after the detection of an R wave of the electrocardiogram is determined as the systole of the heart. Alternatively, a period L2 from a heart sound S synchronized with the R wave of the electrocardiogram to the next heart sound is determined as the systole of the heart. Then, the detection unit 33 determines the period from the end of the systole to the start of the next systole as the diastole of the heart.

[0034] As shown in FIG. 1, the detector 33 is electrically connected to the controller 90 and transmits information about the patient's heartbeat detected by the detector 33 to the controller 90.

[0035] 1, the connecting member 40 connects the main circuit 23, the arterial circuit 24, and the venous circuit 25 so that blood flowing from the main circuit 23 branches into the arterial circuit 24 and the venous circuit 25. The connecting member 40 is disposed on a base 50 as shown in FIG.

[0036] As shown in Figures 2 to 6, the connecting member 40 has a main circuit connecting portion 41 connected to the main circuit 23, an arterial circuit connecting portion 42 connected to the arterial circuit 24, a venous circuit connecting portion 43 connected to the venous circuit 25, a branching portion 44 branching from the main circuit connecting portion 41 to the arterial circuit connecting portion 42 and the venous circuit connecting portion 43, and an adjustment mechanism 45 that adjusts the flow rate of blood to the arterial circuit 24 and the venous circuit 25.

[0037] The main circuit connecting portion 41, the arterial circuit connecting portion 42, and the venous circuit connecting portion 43 are substantially linear flow paths. The material constituting the main circuit connecting portion 41 is not particularly limited, but may be the same material as the tube constituting the circuit 20, or a hard material such as polypropylene.

[0038] The branched portion 44 is configured to branch into a substantially Y-shape. The material constituting the branched portion 44 is not particularly limited, but may be the same material as the tube constituting the circuit 20, or a soft material such as silicone or polyvinyl alcohol.

[0039] The adjustment mechanism 45 has fins 46 provided on the branching portion 44 and a drive portion 55 that drives the fins 46 .

[0040] As shown in FIGS. 3 to 6, the fin 46 is provided outside the branching portion 44 and has a clamped portion 47 clamped by the clamping portion 54 of the base 50, and a valve body 48 provided inside the branching portion 44.

[0041] With the clamped portion 47 being clamped by the clamping portion 54 of the base 50, the clamping portion 54 is rotated clockwise or counterclockwise by the driving portion 55, whereby the valve body 48 is rotated clockwise or counterclockwise.

[0042] As shown in Figure 9, by rotating the clamped portion 47 clockwise, the valve body 48 rotates clockwise, thereby reducing the opening on the venous circuit 25 side and increasing the opening on the arterial circuit 24 side, thereby increasing the blood flow toward the arterial circuit 24 side.

[0043] On the other hand, as shown in FIG. 10, by rotating the clamped portion 47 counterclockwise, the valve body 48 rotates counterclockwise, thereby increasing the opening degree on the venous circuit 25 side and decreasing the opening degree on the arterial circuit 24 side, thereby increasing the blood flow toward the venous circuit 25 side.

[0044] 5 and 6, the valve element 48 has a circular shape with approximately the same outer shape as the lumen of the branching portion 44. Therefore, the valve element 48 can completely block the flow path on the venous circuit 25 side at the branching portion 44 as shown in Fig. 11, or the valve element 48 can completely block the flow path on the arterial circuit 24 side at the branching portion 44 as shown in Fig. 12.

[0045] The material constituting the clamped portion 47 may be a hard material such as metal or polypropylene. The material constituting the valve body 48 may be the same as that constituting the clamped portion 47, but the surface layer may be coated with a soft material such as silicon or polyvinyl alcohol. From the viewpoint of suppressing the occurrence of thrombus, the valve body 48 may be coated with a known antithrombotic coating.

[0046] The fins 46 can be manufactured, for example, by insert molding a metal piece placed in a soft material such as silicon. Alternatively, instead of the clamping portion 54 described below, a movable metal plate can be inserted into the valve body 48, which is configured in a bag shape protruding into the flow path, and can be configured to move left and right.

[0047] From the viewpoint of reinforcement, it is desirable that the boundary portion between the clamped portion 47 of the fin 46 and the valve body 48 (the portion in contact with the branch portion 44) has a thick structure. This makes it possible to prevent a decrease in strength caused by rotating the fin 46 clockwise or counterclockwise.

[0048] 2 and 7 , the base 50 has a first mounting portion 51 on which the main circuit connecting portion 41 is mounted, a second mounting portion 52 on which the arterial circuit connecting portion 42 is mounted, a third mounting portion 53 on which the venous circuit connecting portion 43 is mounted, and a clamping portion 54 that clamps the clamped portion 47 of the fin 46. With the connecting member 40 placed on the base 50, the clamped portion 47 of the fin 46 is positioned to be clamped by the clamping portion 54.

[0049] The clamping unit 54 is composed of a pair of plate materials as shown in Fig. 2. The clamped portion 47 is disposed in the gap between the pair of plate materials, whereby the clamping unit 54 clamps and holds the clamped portion 47. Note that the clamping unit 54 is not particularly limited as long as it is configured to be able to hold the clamped portion 47. The clamping unit 54 is disposed rotatably in a semicircular gap 59 provided in the base 50 as shown in Figs. 2 and 7.

[0050] The driving unit 55 can rotate the clamping unit 54 in the semicircular gap 59. The driving unit 55 is, but is not limited to, a stepping motor. Angle information of the clamping unit 54 acquired by the absolute angle encoder 56 is transmitted to the control unit 90, and the control unit 90 transmits a signal to the driving unit 55 based on the angle information so as to set the desired angle. Note that the driving unit 55 may be hydraulically operated using a cylinder and a gear pump.

[0051] The control unit 90 can be configured with a microcomputer, etc. The control unit 90 includes a CPU, a ROM for storing the control program for the entire device executed by the CPU and various data, and a RAM for temporarily storing measurement data and various data as a work area.

[0052] As shown in FIGS. 1 and 7, the control unit 90 is electrically connected to the drive motor 31, the detection unit 33, the drive unit 55, the second flow meter 82, and the like.

[0053] The control unit 90 controls the driving of the circulating pump 30. As a result, after blood is drawn from the blood removal circuit 21 and passed through the oxygenator 10, the blood can be returned to the patient P via the blood delivery circuit 22.

[0054] The control unit 90 drives the drive unit 55 of the adjustment mechanism 45 in accordance with the pulsation information of the patient's heart detected by the detection unit 33 to adjust the flow rate of blood into the arterial circuit 24 and the venous circuit 25. More specifically, the control unit 90 drives the fins 46 via the drive unit 55 based on the pulsation information of the patient's heart detected by the detection unit 33, and adjusts the opening degree of the arterial circuit 24 and the venous circuit 25, thereby adjusting the flow rate of blood into the arterial circuit 24 and the venous circuit 25.

[0055] Based on the patient's pulsation information detected by the detection unit 33, the control unit 90 determines the timing to increase the amount of blood sent to the arterial circuit 24 and the timing to increase the amount of blood sent to the venous circuit 25, and sends that command to the drive unit 55.

[0056] The control unit 90 determines the ratio of blood sent to the arterial circuit 24 and the venous circuit 25 based on the pulsation information of the patient detected by the detection unit 33, and adjusts the opening of the fins 46 by the drive unit 55 based on that information. For example, during the diastole of the heart, the flow rate is adjusted to 3 LPM into the arterial circuit 24 and 1 LPM into the venous circuit 25. Also, during the systole of the heart, the flow rate is adjusted to 1 LPM into the arterial circuit 24 and 3 LPM into the venous circuit 25.

[0057] Here, the "diastole" of the heart refers to the period during which the ventricles expand, blood flows into them, and the atria contract, sending even more blood into the ventricles. During diastole, the aortic valve is closed, so the heart is not burdened by the inflow of blood. Therefore, as described above, during diastole, the blood flow into the arterial circuit 24 is increased.

[0058] The "systole" of the heart refers to the period during which the ventricles contract to pump blood out of the heart, while the atria expand and refill with blood. During systole, the aortic valve is open, and blood flows in, creating back pressure, which places a heavy burden on the heart. Therefore, as described above, during systole, the blood flow into the venous circuit 25 is increased.

[0059] Next, a method of using the extracorporeal blood circulation system 1 according to this embodiment will be described.

[0060] 1, various components of the extracorporeal blood circulation system 1 are set. Then, the connecting member 40 is placed on the base 50. As a result, the clamped portion 47 of the fin 46 is clamped by the clamping portion 54 of the base 50.

[0061] Next, the control unit 90 drives the circulation pump 30 to start extracorporeal circulation.

[0062] Next, the detection unit 33, which is an electrocardiograph, detects the pulsation of the patient's heart and transmits the information to the control unit 90. The control unit 90 determines the timing to increase the amount of blood sent to the arterial circuit 24 and the venous circuit 25, and transmits the command to the drive unit 55. The control unit 90 also determines the ratio of blood sent to the arterial circuit 24 and the venous circuit 25. During the diastole of the heart, the flow rate is adjusted to 3 LPM to the arterial circuit 24 and 1 LPM to the venous circuit 25 (see FIG. 9). During the systole of the heart, the flow rate is adjusted to 1 LPM to the arterial circuit 24 and 3 LPM to the venous circuit 25 (see FIG. 10).

[0063] Next, the control unit 90 transmits a signal to the drive unit 55 in accordance with information on the timing to increase blood supply to the arterial circuit 24, the timing to increase blood supply to the venous circuit 25, and the blood supply ratio. The drive unit 55, which has received the signal from the control unit 90, switches the position of the fins 46 in accordance with the diastole and systole of the heart so that the flow rate to the arterial circuit 24 and the venous circuit 25 becomes the desired amount.

[0064] At this time, it is preferable that the second flow meter 82 measures the flow rate flowing through the arterial circuit 24, and if the flow rate measured by the second flow meter 82 is not the desired amount, a signal is sent to the control unit 90 to perform feedback control so that the flow rate becomes the desired amount.

[0065] After the extracorporeal circulation is completed, the blood removal line 21 and the blood transfer line 22 are removed from the blood vessels, and the insertion site is repaired by surgical techniques to stop bleeding as necessary.

[0066] As described above, the extracorporeal blood circulation system 1 according to the present embodiment includes an oxygenator 10 for performing blood gas exchange, a circuit 20 including a blood removal circuit 21 for sending blood drawn from a patient to the oxygenator 10, and a blood sending circuit 22 for sending blood from the oxygenator 10 to the patient, and a circulation pump 30 for sending blood in the circuit 20. The blood sending circuit 22 includes an arterial circuit 24 for sending blood to the patient's artery, and a venous circuit 25 for sending blood to the patient's vein. The extracorporeal blood circulation system 1 includes a branching portion 44 in the blood sending circuit 22 where the arterial circuit 24 and the venous circuit 25 are branched, an adjustment mechanism 45 provided in the branching portion 44 for adjusting the flow rate of blood to the arterial circuit 24 and the venous circuit 25, and a control unit 90 for controlling the adjustment mechanism 45. The control unit 90 drives the adjustment mechanism 45 to adjust the flow rate of blood to the arterial circuit 24 and the venous circuit 25 in accordance with the pulsation cycle of the patient's heart. According to the extracorporeal blood circulation system 1 configured as above, during the systole of the heart, the amount of blood sent to the artery can be reduced and more blood can be sent to the venous side. Therefore, it is possible to suppress back pressure against the pumping of the heart, and to suppress the burden on the heart. Also, during the diastole of the heart, the aortic valve is closed, and even if a large amount of blood is sent to the artery, the burden on the heart can be suppressed. Therefore, during the diastole of the heart, the amount of blood sent to the vein can be reduced and more blood can be sent to the artery. By changing the flow rate of blood sent to the aorta for each heartbeat in this way, the internal pressure of the aorta fluctuates, and the same behavior as pulsation can be obtained. Therefore, the fluctuation in the internal pressure of the aorta causes the pressure of the capillaries to fluctuate, which promotes the deformation of red blood cells and improves the blood flow to organs with many capillaries. From the above, when performing extracorporeal circulation, it is possible to suppress the burden on the heart and suppress the decrease in blood flow to organs with many capillaries.

[0067] The extracorporeal blood circulation system 1 further includes a detection unit 33 that detects the pulsation of the patient's heart. According to the extracorporeal blood circulation system 1 configured in this manner, the detection unit 33 can automatically detect the systole and diastole of the patient's heart, which facilitates control to change the target flow rate to the arterial circuit 24 and the venous circuit 25 in the extracorporeal blood circulation system 1 around the timing when the aortic valve closes.

[0068] The adjustment mechanism 45 has fins 46 provided at the branching portion 44 and arranged so as to adjust the opening of the arterial circuit 24 and the venous circuit 25, and a drive unit 55 that drives the fins 46 to adjust the opening of the arterial circuit 24 and the venous circuit 25. According to the extracorporeal blood circulation system 1 configured in this manner, the fins 46 can be driven by the drive unit 55 to adjust the opening of the arterial circuit 24 and the venous circuit 25, so that the flow rate to the arterial circuit 24 and / or the venous circuit 25 in the extracorporeal blood circulation system 1 can be easily controlled compared to a method in which the rotation speed of the centrifugal pump is adjusted each time.

[0069] Furthermore, the control unit 90 drives the fins 46 via the drive unit 55 based on the deviation between the target flow rate set by the detection unit 33 and the second flow meter, and adjusts the opening of the arterial circuit 24 and the venous circuit 25. According to the extracorporeal blood circulation system 1 configured in this manner, the amount of blood in the arterial circuit 24 in the extracorporeal blood circulation system 1 becomes the target flow rate, and the flow rate to the venous circuit 25 can be easily calculated from the flow rate measured by the first flow meter and the flow rate controlled by the second flow meter and the fins 46, making flow rate control easy.

[0070] Furthermore, the control unit 90 determines the timing to increase the amount of blood sent to the arterial circuit 24 and the timing to increase the amount of blood sent to the venous circuit 25 based on the pulsation information of the patient. According to the extracorporeal blood circulation system 1 configured in this manner, the control unit 90 determines the timing to increase the amount of blood sent to the arterial circuit 24 and the timing to increase the amount of blood sent to the venous circuit 25, so that the amount of blood sent to both the arterial circuit 24 and the venous circuit 25 in the extracorporeal blood circulation system 1 can be adjusted to suit the physique of the patient.

[0071] The control unit 90 also determines the ratio of blood sent to the arterial circuit 24 and the venous circuit 25 based on the pulsation information of the patient. According to the thus configured extracorporeal blood circulation system 1, the control unit 90 determines the ratio of blood sent to the arterial circuit 24 and the venous circuit 25. Therefore, in the extracorporeal blood circulation system 1, the blood flow rate to the arterial circuit 24 can be controlled to a constant flow rate by the second flowmeter 82, and the blood flow from the left atrium and left ventricle of the heart to the ascending aorta can be easily secured by adjusting the pressure change caused by the pumping of the heart while checking it with the pressure sensor 83. This contributes to obtaining oxygen and nutrients from the inside of the heart through blood in the forward direction other than the coronary artery, which is necessary for the recovery of cardiac function.

[0072] As described above, the method of using the extracorporeal blood circulating system 1 according to the present embodiment includes an artificial lung 10 for performing blood gas exchange, a circuit 20 including a blood removal circuit 21 for sending blood drawn from a patient to the artificial lung 10 and a blood sending circuit 22 for sending blood from the artificial lung 10 to the patient, and a circulation pump 30 for sending blood in the circuit 20. The blood sending circuit 22 includes an arterial circuit 24 for sending blood to the patient's artery and a venous circuit 25 for sending blood to the patient's vein. The blood sending circuit 22 includes a branching section 44 at which the arterial circuit 24 and the venous circuit 25 are branched, an adjustment mechanism 45 provided at the branching section 44 for adjusting the flow rate of blood into the arterial circuit 24 and the venous circuit 25, and a control unit 90 for controlling the adjustment mechanism 45. The control unit 90 drives the adjustment mechanism 45 in accordance with the pulsation cycle of the patient's heart to adjust the flow rate of blood into the arterial circuit 24 and the venous circuit 25. According to this method of use, during the systole of the heart, the amount of blood sent to the artery can be reduced and more blood can be sent to the venous side. Therefore, it is possible to prevent back pressure from being generated against the pumping of the heart, and to reduce the burden on the heart. Also, during the diastole of the heart, the aortic valve is closed, and even if more blood is sent to the artery side, the burden on the heart can be reduced. Therefore, during the diastole of the heart, the amount of blood sent to the vein can be reduced and more blood can be sent to the artery side. By changing the flow rate of blood sent to the aorta for each heartbeat in this way, the internal pressure of the aorta fluctuates, and the same behavior as pulsation can be obtained. Therefore, the fluctuation in the internal pressure of the aorta causes the pressure of the capillaries to fluctuate, which promotes the deformation of red blood cells and improves the blood flow to organs with many capillaries. From the above, it is possible to reduce the burden on the heart and prevent a decrease in blood flow to organs with many capillaries when performing extracorporeal circulation.

[0073] Next, the configuration of an extracorporeal blood circulating system 2 according to a modified example will be described with reference to Fig. 13 to Fig. 15. Fig. 13 is a perspective view showing a connecting member 140 and a base 150 of an extracorporeal blood circulating system 2 according to a modified example. Fig. 14 is a front view showing a connecting member 140 and a base 150 of an extracorporeal blood circulating system 2 according to a modified example. Fig. 15 is a view corresponding to Fig. 14 in the case where there is a large amount of blood flow toward the venous circuit side.

[0074] The extracorporeal blood circulating system 2 according to the modified example is different from the extracorporeal blood circulating system 1 according to the above-described embodiment in the configurations of the connecting member 140 and the base 150.

[0075] As shown in FIG. 13, the connecting member 140 has a main circuit connecting portion 41, an arterial circuit connecting portion 42, a venous circuit connecting portion 43, and a branching portion 44.

[0076] As shown in FIG. 13, the base 150 has a first mounting portion 51, a second mounting portion 52, a third mounting portion 53, and an adjustment mechanism 154 that adjusts the flow rate of blood to the arterial circuit 24 and the venous circuit 25.

[0077] The adjustment mechanism 154 is composed of a pair of clamps 155 and 156, as shown in FIG.

[0078] As shown in FIG. 13, one pair of clamps 155 are provided so as to clamp the arterial circuit connecting portion 42, and are provided on the side surfaces of the clamp receiving portions 81 and 82 that face each other.

[0079] The other pair of clamps 156 are provided so as to clamp the venous circuit connecting portion 43, as shown in FIG. 13, and are provided on the side surfaces of the clamp housing portions 82 and 83 that face each other.

[0080] 14 and 15, each of the clamps 155, 156 is connected to a clamp driver 99 for closing and opening the clamp in response to a signal from the control unit 90. Any known clamp driver can be used, and the opening and closing of the clamps can be controlled by, for example, various motors, compressed fluid, etc.

[0081] The control unit 90 drives the clamp drive unit 99 to control the opening / closing rate (blockage rate) of the clamps 155, 156, thereby crushing parts of the arterial circuit connecting unit 42 and the venous circuit connecting unit 43 to create a partial blockage (stenosis), thereby controlling the flow rate of blood into each of the arterial and venous circuits to a desired amount. For example, as shown in Fig. 15, by blocking more of the arterial circuit connecting unit 42, the blood flow toward the venous circuit 25 can be increased.

[0082] As described above, the extracorporeal blood circulating system according to this modified example can produce the same effects as those of the first embodiment by controlling the closing and opening of the connecting parts.

[0083] The above describes the extracorporeal blood circulation system 1 according to the present invention through the embodiments and modified examples. However, the present invention is not limited to the configurations described in the embodiments, and can be modified as appropriate based on the description of the claims.

[0084] For example, in the above-described embodiment, one control unit 90 is provided, but two control units may be provided, one for driving the circulation pump 30 and one for controlling the adjustment mechanism 45, and the two control units may function in conjunction with each other.

[0085] In the above embodiment, an electrocardiograph is used as the detector 33, but a pressure sensor 83 may be used as the detector.

[0086] In addition, in the embodiment described above, the control unit 90 controls the drive unit 55 to control the movement of the valve body 48, but a flow sensor and a control unit may be attached to the valve body itself to detect the flow rate flowing into the valve body and control the movement of the valve body.

[0087] In the above-described embodiment, the first flow meter and the second flow meter may be integral with the adjustment mechanism, and in particular, in a modified example, may be provided near the clamp.

[0088] In the above-described embodiment, the flow rate to the arterial circuit 24 and the venous circuit 25 is adjusted by the valve element 48. However, as shown in Figs. 11 and 12, it is also possible to use the valve element 48 to seal the flow path and allow blood to flow only through the arterial circuit 24 or only through the venous circuit 25, thereby switching between VA and VV. [Explanation of symbols]

[0089] 1. Extracorporeal blood circulation system, 10 artificial lung, 20 circuits, 21 Blood removal circuit, 22 Blood supply circuit, 24 arterial circuit, 25 Venous circuit, 30 Circulation pump, 44 Branch section, 45 Adjustment mechanism; 46 Finn, 55 Drive unit, 90 Control section.

Claims

1. An artificial lung that exchanges gases with the blood; a blood removal circuit for sending the blood drawn from a patient to the oxygenator, and a blood sending circuit for sending the blood from the oxygenator to the patient; A circulation pump for pumping the blood in the circuit, The blood supply circuit includes: an arterial circuit delivering the blood to an artery of the patient; a venous circuit for delivering the blood to a vein of the patient; a branching portion in the blood supply circuit where the arterial circuit and the venous circuit are branched; an adjustment mechanism provided at the branching portion for adjusting the flow rate of the blood into the arterial circuit and the venous circuit; A control unit that controls the adjustment mechanism, The control unit drives the adjustment mechanism to adjust the flow rate of blood to the arterial circuit and the venous circuit in accordance with the heartbeat period of the patient.

2. The extracorporeal blood circulation system according to claim 1 , further comprising a detector for detecting the pulsation of the patient's heart.

3. The adjustment mechanism includes: a fin provided at the branching portion and arranged so that an opening degree of the arterial circuit and the venous circuit can be adjusted; 3. The extracorporeal blood circulation system according to claim 2, further comprising: a drive unit that drives the fins to adjust the opening degree of the arterial circuit and the venous circuit.

4. 4. The extracorporeal blood circulation system according to claim 3, wherein the control unit drives the fins via the drive unit based on pulsation information of the patient detected by the detection unit, and adjusts the opening degree of the arterial circuit and the venous circuit.

5. 3. The extracorporeal blood circulation system according to claim 1, wherein the control unit determines a timing to increase blood supply to the arterial circuit and a timing to increase blood supply to the venous circuit based on pulsation information of the patient.

6. 3. The extracorporeal blood circulation system according to claim 1, wherein the control unit determines a ratio of blood sent to the arterial circuit and the venous circuit based on pulsation information of the patient.

7. The extracorporeal blood circulation system according to claim 4 , wherein the pulsation information includes an electrocardiogram length from an electrocardiogram and a pressure in the blood supply circuit.

8. The adjustment mechanism includes: a first clamp for clamping an arterial circuit connector connected to the arterial circuit; a second clamp that clamps a venous circuit connector that is connected to the venous circuit, 2. The extracorporeal blood circulation system according to claim 1, wherein the control unit controls the opening and closing ratios of the first clamp and the second clamp in accordance with the heartbeat period of the patient to adjust the flow rate of the blood into the arterial circuit and the venous circuit.

9. An artificial lung that exchanges gases with the blood; a blood removal circuit for sending the blood drawn from a patient to the oxygenator, and a blood sending circuit for sending the blood from the oxygenator to the patient; a circulation pump for pumping the blood in the circuit, The blood supply circuit includes: an arterial circuit delivering the blood to an artery of the patient; a venous circuit for delivering the blood to a vein of the patient; a branching portion in the blood supply circuit where the arterial circuit and the venous circuit are branched; A method of using an extracorporeal blood circulation system having an adjustment mechanism provided at the branching portion for adjusting the flow rate of the blood to the arterial circuit and the venous circuit, and a control unit for controlling the adjustment mechanism, comprising: A method of using an extracorporeal blood circulation system, in which the control unit drives the adjustment mechanism in accordance with the pulsation cycle of the patient's heart to adjust the flow rate of blood to the arterial circuit and the venous circuit.

Citation Information

Patent Citations

  • Method and system for filling and de-airing an extracorporeal blood processing device with stepwise filter immersion.

    JP2014504906A