WO2013073535A1

WO2013073535A1 - Blood purification device

Info

Publication number: WO2013073535A1
Application number: PCT/JP2012/079427
Authority: WO
Inventors: 智洋古橋; 竹内　聡; 寛二村
Original assignee: 日機装株式会社
Priority date: 2011-11-14
Filing date: 2012-11-13
Publication date: 2013-05-23
Also published as: JP5778004B2; JP2013102927A; CN103906538A; CN103906538B

Abstract

[Problem] To provide a blood purification device capable of precisely detecting blockages of an arterial blood circuit in an arterial blood return step. [Solution] A controlling means (19) detects pressure with a venous pressure sensor (21) while also carrying out a plurality of iterations of arterial blood return steps comprising a pressure accumulation step for forward-driving a blood pump (4) while also closing off a flow path with an electromagnetic valve (V2) to accumulate pressure between the installation position of the blood pump (4) and the installation position of the electromagnetic valve (V2), and a pressure release step for reverse-driving the blood pump (4) while also maintaining the closing off of the flow path by the electromagnetic valve (V2) to return blood from the distal end of an arterial blood circuit (2); and blockages of the flow path in an arterial blood circuit (1) can be detected on the basis of the change in pressure at corresponding predetermined points in time in each of the arterial blood return steps.

Description

Blood purification equipment

The present invention relates to a blood purification apparatus for purifying a patient's blood while circulating it extracorporeally, such as dialysis treatment using a dialyzer.

A dialysis device as a blood purification device includes an arterial blood circuit with an arterial puncture needle attached to the tip, a blood circuit comprising a venous blood circuit with a venous puncture needle attached to the tip, an arterial blood circuit, and a vein A dialyzer disposed between the side blood circuits to purify blood flowing through the blood circuit, a blood pump disposed in the arterial blood circuit, and a blood pump disposed in the arterial blood circuit and the venous blood circuit, respectively. It mainly comprises an arterial air trap chamber and a venous air trap chamber for foaming, and a dialyzer body capable of supplying dialysate to the dialyzer.

In addition, a storage bag containing physiological saline is connected between the arterial puncture needle and the blood pump in the arterial blood circuit via a physiological saline supply line, and during priming before dialysis treatment, dialysis is performed. The physiological saline solution in the accommodation bag can be supplied into the blood circuit via the physiological saline supply line at the time of fluid replacement during treatment or when returning blood after dialysis treatment. For example, at the time of returning blood, physiological saline solution is supplied into the blood circuit as a replacement liquid, and blood can be returned by replacing the blood in the blood circuit with the replacement liquid (for example, Patent Document 1). reference).

Recently, there is a growing need to automate various steps in blood purification treatment in order to reduce the burden on medical staff. For example, when blood is returned, the blood pump is driven forward to drive the vein side. Control that alternately performs the venous return process for returning blood to the patient from the tip of the blood circuit and the arterial return process for returning blood to the patient from the tip of the arterial blood circuit by driving the blood pump in reverse. A blood purification apparatus provided with means has been proposed (see, for example, Patent Document 2).

However, since the pressure detection means is generally not provided upstream of the blood pump in the blood circuit, it is not possible to directly detect the occlusion on the artery side blood circuit side in the artery side blood return step. In order to ensure safety in automating blood return, obstruction (blockage of the flow path or narrowing of the flow path, etc.) occurred in any part of the arterial blood circuit during the arterial return process Has been proposed (see, for example, Patent Document 3). According to such a conventional blood purification device, the blood pump is driven to rotate forward while closing the venous side electromagnetic valve disposed at the distal end of the venous side blood circuit, so that the blood pump and the venous side electromagnetic valve are connected to each other. After increasing the internal pressure to a predetermined pressure, the blood pump is driven in reverse to perform the arterial blood return process, and the actual internal pressure and the assumed downward tendency (the arterial blood circuit is assumed not to be blocked) In this case, the presence / absence of blockage can be detected by comparing with a decrease tendency of internal pressure calculated in this case.

JP 2006-280775 A Japanese Patent Laid-Open No. 6-261938 JP 2006-255331 A

However, the conventional blood purification device detects an occlusion of the arterial blood circuit during the arterial blood return process by comparing the actual downward tendency of the internal pressure applied in advance with the assumed downward tendency (calculated value). As a result, the downward trend of assumptions to be calculated differs depending on the dimensions or specifications of the components that make up the blood purification device, or changes in various conditions during blood return. It was difficult to accurately detect the occlusion.

The present invention has been made in view of such circumstances, and it is an object of the present invention to provide a blood purification apparatus capable of accurately detecting the occlusion of the arterial blood circuit in the arterial blood return process.

The invention according to claim 1 is composed of an arterial blood circuit and a venous blood circuit, a blood circuit capable of extracorporeally circulating a patient's blood from the tip of the arterial blood circuit to the tip of the venous blood circuit, and the blood A blood purification means for purifying blood flowing between the artery-side blood circuit and the vein-side blood circuit of the circuit and flowing in the blood circuit; A blood pump capable of flowing the liquid in the blood circuit, and disposed at a predetermined position on the venous blood circuit side from the position of the blood pump in the blood circuit. A closing means capable of closing the path, a fluid pressure detecting means capable of detecting the pressure of the liquid between the disposition position of the blood pump and the disposition position of the closing means in the blood circuit, and replacement after treatment Liquid A blood purification apparatus comprising: a control means capable of supplying blood to the liquid circuit and replacing the blood in the blood circuit with the replacement liquid to return the blood. A pressure accumulating step for closing and accumulating pressure between the disposition position of the blood pump and the disposition position of the closing means; and the blood pump is driven in reverse while maintaining the closing of the flow path by the closing means, and the artery Pressure is detected by the fluid pressure detecting means while performing a plurality of arterial blood return steps including a pressure release step of returning blood from the tip of the side blood circuit, and pressure corresponding to a predetermined time in each arterial blood return step It is possible to detect the blockage of the flow path in the arterial blood circuit based on the change of the above.

The invention according to claim 2 is the blood purification apparatus according to claim 1, wherein the corresponding predetermined time point in the arterial blood return step is a time point when the pressure accumulation step is shifted to the pressure release step. To do.

The invention described in claim 3 is characterized in that, in the blood purification apparatus according to claim 1, the corresponding predetermined time point in the arterial blood return step is a time point when each arterial blood return step is completed.

According to a fourth aspect of the present invention, in the blood purification apparatus according to any one of the first to third aspects, the control means performs a specific arterial blood return step among a plurality of arterial blood return steps. In the arterial blood circuit, by setting an alarm value and determining whether or not the pressure at a predetermined time detected by the fluid pressure detecting means in the subsequent arterial blood return step exceeds the alarm value. The blockage of the flow path can be detected.

According to a fifth aspect of the present invention, in the blood purification apparatus according to any one of the first to fourth aspects, an arterial valve means provided so as to be able to open and close a tip end of the arterial blood circuit, and the venous side And a venous valve means provided so that the vicinity of the tip of the blood circuit can be opened and closed, and the closing means comprises the venous valve means.

A sixth aspect of the present invention is the blood purification apparatus according to any one of the first to fifth aspects, wherein the bubbles are removed from the liquid connected to the venous blood circuit and flowing through the venous blood circuit. And a venous pressure sensor capable of detecting venous pressure, which is the pressure of blood flowing through the venous blood circuit by detecting the pressure in the air trap chamber, and the fluid pressure detecting means Comprises the venous pressure sensor.

According to the first aspect of the present invention, the arterial blood is returned based on a change in pressure at a predetermined time point in each arterial blood return process, with the fluid pressure detecting means detecting the pressure while performing the arterial blood return process a plurality of times. Since the blockage of the flow path in the circuit can be detected, it is possible to accurately detect the blockage of the arterial blood circuit in the arterial blood return step.

According to the invention of claim 2, since the predetermined time point corresponding to the arterial blood return step is the time point when the pressure accumulation step is shifted to the pressure release step, the arterial blood circuit in the arterial blood return step is earlier. Blockage can be detected.

According to the invention of claim 3, since the corresponding predetermined time point in the arterial blood return step is the time point when each arterial blood return step is completed, the arterial blood circuit in the arterial blood return step can be more accurately performed. Blockage can be detected.

According to the invention of claim 4, the control means sets an alarm value at the time of a specific arterial blood return step among a plurality of arterial blood return steps, and detects the fluid pressure in the subsequent arterial blood return step. Since it is possible to detect the blockage of the flow path in the arterial blood circuit by determining whether or not the pressure at a predetermined time detected by the means exceeds the alarm value, the blockage of the flow path can be detected more accurately and smoothly. Detection can be performed.

According to the invention of claim 5, the arterial valve means provided so that the vicinity of the tip of the arterial blood circuit can be opened and closed, and the venous valve means provided so that the vicinity of the tip of the venous blood circuit can be opened and closed. In addition, since the closing means is composed of the venous valve means, the venous valve means used in the steps related to blood purification treatment can be used to detect blockage of the flow path in the arterial blood circuit.

According to the invention of claim 6, an air trap chamber connected to the venous blood circuit for removing bubbles in the liquid flowing through the venous blood circuit, and detecting the pressure in the air trap chamber A venous pressure sensor capable of detecting venous pressure, which is the pressure of blood flowing through the venous blood circuit, and the fluid pressure detecting means comprises a venous pressure sensor, so that the vein used in the process related to blood purification treatment The blockage of the flow path in the arterial blood circuit can be detected by using the pressure sensor.

1 is a schematic view showing a blood purification apparatus (during a venous side blood return step) according to a first embodiment of the present invention. Schematic showing the blood purification device (at the time of pressure accumulation in the arterial blood return process) Schematic showing the blood purification device (at the time of pressure release in the arterial blood return process) The graph which shows the change of the pressure when there is no obstruction at the time of an arterial blood return process in the blood purification device The graph which shows the change of the pressure when there is obstruction at the time of an arterial blood return process in the blood purification device The flowchart which shows the control content at the time of the artery side blood return by the control means of the blood purification apparatus The graph which shows the change of the pressure when there is no obstruction | occlusion at the time of an artery side blood return process in the blood purification apparatus which concerns on the 2nd Embodiment of this invention. The graph which shows the change of the pressure when there is obstruction at the time of an arterial blood return process in the blood purification device The flowchart which shows the control content at the time of the artery side blood return by the control means of the blood purification apparatus

Hereinafter, embodiments of the present invention will be specifically described with reference to the drawings.
The blood purification apparatus according to the first embodiment includes a dialysis apparatus for performing dialysis treatment. As shown in FIGS. 1 to 3, a blood circuit including an arterial blood circuit 1 and a venous blood circuit 2, and an artery Dialyzer 3 (blood purification means) interposed between the side blood circuit 1 and the venous side blood circuit 2 to purify blood flowing through the blood circuit, the blood pump 4, the arterial side blood circuit 1 and the venous side blood circuit 2 An arterial side air trap chamber 5 and a venous side air trap chamber 6, a dialyzer body B capable of supplying dialysate to the dialyzer 3, a physiological saline supply line 8 (substitution fluid supply line), An accommodating means 9 containing a physiological saline solution as a replacement liquid, a venous pressure sensor 21 as a fluid pressure detecting means, an electromagnetic valve V1 as an arterial side valve means, and an electromagnetic valve V2 (closing means) as a venous side valve means. , It is mainly a control unit 19..

The arterial blood circuit 1 is connected with an arterial puncture needle at the tip thereof, and an iron-type blood pump 4 and an arterial air trap chamber 5 for defoaming are disposed in the middle of the arterial blood circuit 1. A venous puncture needle is connected to the distal end of the side blood circuit 2, and a venous air trap chamber 6 is connected to the side blood circuit 2. An air layer is formed in the arterial air trap chamber 5 and the venous air trap chamber 6, and bubbles in the liquid flowing through the arterial blood circuit 1 can be removed, and a filtration network (not shown) is provided. For example, a thrombus or the like when returning blood can be captured.

The arterial air trap chamber 5 is disposed downstream of the blood pump 4 in the arterial blood circuit 1 (between the blood pump 4 and the dialyzer 3 in the arterial blood circuit 1), and venous air The trap chamber 6 is disposed on the downstream side of the dialyzer 3 in the venous blood circuit 2 (between the tip of the venous blood circuit 2 and the dialyzer 3).

Furthermore, a venous pressure sensor 21 is connected to the venous air trap chamber 6 via a monitor tube, and the fluid pressure in the venous air trap chamber 6 (that is, the pressure of blood flowing through the venous blood circuit 2). The venous pressure) can be detected. The venous pressure sensor 21 is disposed between the position where the blood pump 4 is disposed in the blood circuit and the position where the electromagnetic valve V2 (venous valve means) serving as the closing means is disposed. The pressure of the liquid can be detected. An overflow line 20 is extended from the upper part (air layer side) of the venous air trap chamber 6, and an electromagnetic valve V4 is disposed in the middle thereof. Then, by opening the electromagnetic valve V4, the liquid (priming liquid or the like) flowing in the blood circuit can be overflowed via the overflow line 20.

The blood pump 4 is composed of a squeezing type pump disposed in the arterial blood circuit 1 and is capable of normal rotation and reverse rotation and allows fluid in the blood circuit to flow in the driving direction. That is, the arterial blood circuit 1 is connected to a corrugated tube 1a that is softer and larger in diameter than the other flexible tubes that constitute the arterial blood circuit 1, and the blood pump 4 includes the corrugated tube 1a. A roller for squeezing the tube 1a in the longitudinal direction is provided. When the blood pump 4 is driven in this manner, the roller rotates to squeeze the ironing tube 1a, and the liquid inside can flow in the driving direction (rotating direction of the roller).

When the blood pump 4 is driven to rotate forward (left rotation in the figure) while the patient is punctured with the arterial puncture needle and the venous puncture needle, the blood of the patient passes through the arterial blood circuit 1 and the dialyzer. After reaching 3, blood purification is performed by the dialyzer 3, and defoaming is performed in the venous air trap chamber 6, and then returns to the patient's body through the venous blood circuit 2. That is, the blood of the patient can be purified by the dialyzer 3 while circulating externally from the tip of the arterial blood circuit 1 to the tip of the venous blood circuit 2 of the blood circuit.

The dialyzer 3 is formed with a blood introduction port 3a, a blood outlet port 3b, a dialysate inlet port 3c, and a dialysate outlet port 3d in the casing. Among these, the blood inlet port 3a includes the arterial blood circuit 1. However, the venous blood circuit 2 is connected to the blood outlet port 3b. The dialysate introduction port 3c and the dialysate lead-out port 3d are connected to a dialysate introduction line La and a dialysate discharge line Lb extending from the dialyzer body B, respectively.

A plurality of hollow fibers are accommodated in the dialyzer 3, the inside of the hollow fibers is used as a blood flow path, and the flow of dialysate is between the hollow fiber outer peripheral surface and the inner peripheral surface of the housing. It is considered a road. A hollow fiber membrane is formed in the hollow fiber by forming a large number of minute holes (pores) penetrating the outer circumferential surface and the inner circumferential surface, and impurities in the blood are passed through the membrane in the dialysate. It is comprised so that it can permeate | transmit.

On the other hand, the dialyzer main body B is provided with a dual pump 17 across the dialysate introduction line La and the dialysate discharge line Lb, and the bypass line Lc that bypasses the dual pump 17 is provided in the dialyzer 3. A dewatering pump 18 is provided for removing water from the flowing patient's blood. Furthermore, one end of the dialysate introduction line La is connected to the dialyzer 3 (dialyte introduction port 3c), and the other end is connected to a dialysate supply device (not shown) for preparing a predetermined concentration of dialysate. In addition, one end of the dialysate discharge line Lb is connected to the dialyzer 3 (dialysate outlet port 3d), and the other end is connected to a drain means (not shown), and the dialysate supplied from the dialysate supply device After passing through the dialysate introduction line La to the dialyzer 3, it is sent to the drainage means through the dialysate discharge line Lb.

A physiological saline supply line 8 (substitution liquid supply line) is connected at one end to a T-shaped tube T between the position of the blood pump 4 in the artery-side blood circuit 1 and the tip of the artery-side blood circuit 1. The flow path (for example, a flexible tube etc.) which can supply the physiological saline solution (substitution liquid) for replacing with the blood in the blood circuit to the artery side blood circuit 1 is provided. The other end of the physiological saline supply line 8 is connected to a storage means 9 that stores a predetermined amount of physiological saline, and an air trap chamber 7 is connected in the middle. Reference numeral 16 in the figure denotes a tube detector comprising a sensor or the like for detecting the presence or absence of the physiological saline supply line 8.

In addition, the physiological saline solution supply line 8 according to the present embodiment is provided with a solenoid valve V3. The electromagnetic valve V3 is provided so that the physiological saline supply line 8 can be opened and closed, and the flow path can be closed and opened. By opening and closing the electromagnetic valve V3, the physiological saline supply line 8 flows. It is possible to arbitrarily switch between a closed state in which the path is closed and a flowing state in which a physiological saline solution (substitution solution) can flow. The electromagnetic valve V3 is configured such that the opening / closing operation at the time of returning blood is controlled by the control means 19 described in detail later.

Further, in the vicinity of the arterial puncture needle in the arterial blood circuit 1 (near the tip of the arterial blood circuit 1 and the connection portion of the physiological saline supply line 8 (position of the T-shaped tube T) and the arterial puncture needle. Between the vein side blood circuit 2 and the vicinity of the vein side puncture needle (near the tip of the vein side blood circuit 2 and between the vein side air trap chamber 6 and the vein side puncture needle). And a solenoid valve V2 (closing means) as a venous valve means. These solenoid valves V1 and V2 are capable of closing and opening the flow paths in the respective portions provided by opening and closing operations, and the opening and closing operations at the time of returning blood are performed by the control means 19 described in detail later. It is configured to be controlled.

In addition, an arterial-side bubble detecting means 10 is disposed in the vicinity of the tip of the arterial blood circuit 1 (near the electromagnetic valve V1 as the arterial-side valve means), and in the vicinity of the tip of the venous-side blood circuit 2 (the venous valve). In the vicinity of the electromagnetic valve V2 as a means), the venous side bubble detecting means 11 is disposed. The arterial-side bubble detection means 10 and the venous-side bubble detection means 11 are composed of sensors that can detect bubbles in the liquid flowing in the flow path, and are electrically connected to the control means 19. In the figure,

reference numerals

12 and 13 and

reference numerals

14 and 15 denote blood discriminators disposed near the tip of the arterial blood circuit 1 and near the tip of the venous blood circuit 2 (where blood flows in the flow path). And a tube detector (a sensor or the like for detecting the presence or absence of the arterial blood circuit 1 and the venous blood circuit 2).

In the dialyzer main body B according to the present embodiment, a control means 19 composed of, for example, a microcomputer is disposed. The control means 19 includes, for example, actuators such as the blood pump 4 and electromagnetic valves V1, V2, and V3, venous pressure sensors 21, arterial-side bubble detection means 10 and venous-side bubble detection means 11, and

blood discriminators

12, 13 and the like. After the blood purification treatment, the physiological valve (replacement liquid) is supplied to the blood circuit after the blood purification treatment, and the blood in the blood circuit is replaced with the physiological saline (replacement). The blood can be returned to the blood.

More specifically, the control means 19 drives the blood pump 4 to rotate forward at the time of returning blood, and from the connection portion (position of the T-shaped tube T) to the physiological saline supply line 8 in the blood circuit, the venous blood circuit 2 is connected to the physiological saline supply line 8 in the blood circuit by reversely driving the blood pump 4 to return the blood up to the tip of the blood 2 by replacing the blood with physiological saline to return the blood. It is supposed that an arterial blood return step (see FIG. 3) for returning blood by replacing the blood from (position of the T-shaped tube T) to the tip of the arterial blood circuit 1 with physiological saline. .

Here, the control means 19 according to this embodiment drives the blood pump 4 to rotate forward while the flow path is closed by the electromagnetic valve V2 (venous side electromagnetic valve), and the arrangement position of the blood pump 4 and the electromagnetic valve The pressure accumulation step (see FIG. 2) for accumulating pressure between the position where V2 is disposed and the blood pump 4 is driven in reverse while maintaining the closing of the flow path by the electromagnetic valve V2, and blood is returned from the tip of the arterial blood circuit 1 The pressure is detected by the venous pressure sensor 21 (hydraulic pressure detecting means) while performing the arterial blood return step including the pressure release step (see FIG. 3) to be performed a plurality of times, and corresponding predetermined time points in each arterial blood return step It is assumed that the blockage of the flow path in the arterial blood circuit 1 can be detected based on the change in pressure of the blood flow.

More specifically, in the pressure accumulating step, as shown in FIG. 2, the solenoid valve V3 and the solenoid valve V2 are closed while the solenoid valve V1 and the solenoid valve V2 are closed under the control of the control means 19, and the blood pump 4 is set to the normal state. This is a step of accumulating by increasing the pressure of the liquid between the disposition position of the blood pump 4 and the disposition position of the electromagnetic valve V2 by rolling driving (clockwise driving in the figure). By this pressure accumulating step, a predetermined amount of replacement liquid used when returning blood from the tip of the arterial blood circuit 1 can be stored and secured. In the pressure release process, as shown in FIG. 3, the solenoid valve V1 is opened while the solenoid valve V2 and the solenoid valve V3 are closed under the control of the control means 19, and the blood pump 4 is driven in reverse (same as above). This is a step of returning blood to the patient from the tip of the arterial blood circuit 1 while releasing the pressure applied in the pressure accumulation step.

Then, the pressure accumulation process and the pressure release process as described above are performed once to complete one venous blood return process. In this embodiment, the venous blood return process is performed a plurality of times. However, the venous pressure sensor 21 is configured to detect the pressure. When the pressure is detected by the venous pressure sensor 21 while repeatedly performing the venous side blood return step including the pressure accumulation step and the pressure release step, as shown in the graph of FIG. A plurality will be formed according to the side blood return process.

However, when there is no blockage of the flow path in the arterial blood circuit 1, almost all of the pressure applied in the pressure accumulation process is released in the pressure release process (that is, all the replacement fluid stored in the pressure accumulation process flows). As shown in FIG. 4, the plurality of pressure waveforms sequentially formed in accordance with the venous side blood return process change at substantially the same pressure value, whereas the flow path in the arterial blood circuit 1 is blocked. If it occurs, the pressure applied in the pressure accumulation process cannot be released even in the pressure release process due to blockage of the flow path (that is, part or all of the replacement liquid stored in the pressure accumulation process does not flow). As shown in FIG. 5, the pressure waveform formed in accordance with the venous blood return process sequentially rises and changes.

Therefore, since it is possible to detect the blockage of the flow path in the arterial blood circuit 1 based on a change in pressure at a corresponding predetermined time in each arterial blood return step, in the present embodiment, FIG. As shown in FIG. 4, the blood pump 4 between the pressure accumulation process and the pressure release process is stopped when the corresponding predetermined time (the pressure change monitoring time) in the arterial blood return process is shifted from the pressure accumulation process to the pressure release process. And a change in pressure at that time (ac) is monitored, and by determining whether or not the pressure at the predetermined time exceeds the alarm value, It is configured to detect the blockage of the flow path in the arterial blood circuit 1. In FIG. 5 of the present embodiment, the pressure at the predetermined time point c exceeds the alarm value in the pressure waveform corresponding to the third arterial blood return step, and thereby the blockage of the flow path is detected. . In the present embodiment, the corresponding predetermined time points (pressure change monitoring time points) in the arterial blood return step are time points a to c when the blood pump 4 is stopped between the pressure accumulation step and the pressure release step. The blood pump 4 does not need to be stopped at the time when the pressure accumulation process is shifted to the pressure release process.

In the present embodiment, the control means 19 sets an alarm value during a specific arterial blood return step (preferably during the first arterial blood return step) among a plurality of arterial blood return steps. Then, it is determined whether or not the pressure at a predetermined time point (time points a to c at which the pressure accumulation process is shifted to the pressure release process) detected by the venous pressure sensor 21 in the arterial blood return process performed thereafter has exceeded the alarm value. Thus, the blockage of the flow path in the arterial blood circuit 1 can be detected.

Next, the contents of control performed by the control means 19 according to the first embodiment at the time of return of the artery side will be described based on the flowchart of FIG.
When the venous blood return process is completed, the blood pump 4 is stopped (S1), and then the blood pump 4 is driven to rotate forward to perform the pressure accumulation process (S2). In this pressure accumulating step, as described above, the electromagnetic valve V3 is opened while the electromagnetic valve V1 and the electromagnetic valve V2 are closed (see FIG. 2). Thereafter, the blood pump is stopped (S3), the pressure is detected by the venous pressure sensor 21 (S4), and an alarm value is set based on the detected pressure (S5). In the present embodiment, a value obtained by adding a predetermined value α (see FIGS. 4 and 5) determined in advance to the pressure value detected in S4 is set as an alarm value.

Then, the blood pump 4 is driven in reverse to perform the pressure release process (S6). In this pressure release process, as described above, the solenoid valve V2 and the solenoid valve V3 are closed while the solenoid valve V1 is opened, and the saline solution supplied from the saline supply line 8 is used. The physiological saline and blood are replaced, and blood is returned from the tip of the arterial blood circuit 1 (see FIG. 3). Thereafter, it is determined whether or not the liquid that has flowed by driving the blood pump 4 has reached a predetermined amount (S7). If it is determined that the predetermined amount has been reached, the blood pump 4 is stopped (S8) and the first time. The arterial blood return process is completed.

Next, the blood pump 4 is driven to rotate forward again to perform the pressure accumulation process (S9), and when the pressure accumulation process S9 is completed (in this embodiment, a predetermined time point b when the pressure accumulation process is shifted to the pressure release process). It is determined whether or not the pressure exceeds the alarm value set in S5 (S10). Here, if it is determined that the pressure at the predetermined time point b exceeds the alarm value, an alarm indicating that the flow path is blocked in the artery side blood circuit 1 is output (S11). Note that the alarm may be any of sound and sound effect generation, image display, lighting by a lighting means or blinking display, and control may be performed so as to stop blood return simultaneously with the alarm.

On the other hand, if it is determined in S10 that the pressure at the predetermined time point b does not exceed the alarm value, the blood pump 4 is stopped (S12), and then the blood pump 4 is driven in reverse to perform the pressure release step (S13). The blood is returned from the tip of the arterial blood circuit 1, and it is determined whether or not the fluid that has flowed by driving the blood pump 4 has reached a predetermined amount (S14), and it is determined that the predetermined amount has been reached. Then, the blood pump 4 is stopped (S15), and the second arterial blood return step is completed.

Thereafter, since the return of blood on the side of the arterial blood circuit 1 is started, the introduced physiological saline solution (replacement solution) can sufficiently perform the return of blood on the side of the arterial blood circuit 1 (the number of times may be specified). ) Has been reached (S16). If it is determined that the prescribed amount has been reached, a series of blood return on the side of the arterial blood circuit 1 is completed. If it is determined in S16 that the prescribed amount has not been reached, the process returns to S9, and the pressure accumulation step S9 and the pressure release step S13 are performed again sequentially, and the next (third and subsequent) arterial blood return step is performed. Will be.

According to the embodiment, the corresponding predetermined time point in the arterial blood return step (that is, the time point at which the pressure change in each arterial blood return step is monitored) is set as the time point when the pressure accumulation step is shifted to the pressure release step. Therefore, the peak of the pressure waveform formed in accordance with the venous blood return process is monitored, and the occlusion of the arterial blood circuit in the arterial blood return process can be detected with higher accuracy. Further, an alarm value is set during the first arterial blood return process, and it is determined whether or not the alarm value has been exceeded in the subsequent arterial blood return process. It can be done early.

In this embodiment, an alarm value is set when the first arterial blood return process is completed, and the alarm value is exceeded at the end of the subsequent arterial blood return process with reference to the alarm value. Although it is configured to determine whether or not, for example, the alarm value may be set again after the determination of S10. The alarm value can be set by various methods in addition to the present embodiment. Furthermore, even before reaching the time points a, b, and c at the time of each arterial blood return step, if the detected pressure exceeds an alarm value, an alarm can be generated when the detected pressure exceeds the alarm value. In this case, the abnormal state can be grasped earlier.

Next, a blood purification apparatus according to a second embodiment of the present invention will be described.
The blood purification apparatus according to the present embodiment includes a dialysis apparatus for performing dialysis treatment. The apparatus configuration is the same as that of the first embodiment (see FIGS. 1 to 3), and the first The control content at the time of blood return on the arterial blood circuit 1 side by the control means 19 is different from that of the embodiment. The specific apparatus configuration according to this embodiment is the same as that of the first embodiment, and thus detailed description thereof is omitted here.

Similarly to the first embodiment, the control means 19 according to the present embodiment drives the blood pump 4 to rotate forward while closing the flow path with the electromagnetic valve V2 (venous side electromagnetic valve), and the blood pump 4 is arranged. The pressure accumulation step (see FIG. 2) for accumulating pressure between the installed position and the position where the electromagnetic valve V2 is disposed, and the blood pump 4 is driven in reverse while maintaining the flow path closed by the electromagnetic valve V2, thereby causing the arterial blood circuit 1 The pressure is detected by the venous pressure sensor 21 (hydraulic pressure detecting means) while performing the arterial blood return process including the pressure release process (see FIG. 3) for returning blood from the tip of each of the arteries, and each arterial blood return process. The blockage of the flow path in the arterial blood circuit 1 can be detected based on the corresponding change in pressure at a predetermined time.

Here, in this embodiment, as shown in FIGS. 7 and 8, the corresponding predetermined time point (pressure change monitoring time point) in the arterial blood return step is the time point at which each arterial blood return step ends (each arterial side) The time point d to f) is the time when the blood return process is completed and the blood pump 4 is stopped, and the pressure change at that time (d to f) is monitored. By determining whether or not the alarm value is exceeded, the blockage of the flow path in the arterial blood circuit 1 can be detected. In FIG. 8, the pressure at a predetermined time point e exceeds the alarm value in the pressure waveform corresponding to the second arterial blood return step, and thus the blockage of the flow path is detected.

In the present embodiment, the control means 19 sets an alarm value during a specific arterial blood return step (preferably during the first arterial blood return step) among a plurality of arterial blood return steps. Then, it is determined whether or not the pressure at a predetermined time point detected by the venous pressure sensor 21 in the subsequent arterial blood return process (time points d to f when each arterial blood return process is completed) exceeds the alarm value. Thus, the blockage of the flow path in the arterial blood circuit 1 can be detected.

Next, the content of control at the time of artery side blood return by the control means 19 according to the second embodiment will be described based on the flowchart of FIG.
When the venous blood return process is completed, the blood pump 4 is stopped (S1), the pressure is detected by the venous pressure sensor 21 (S2), and an alarm value is set based on the detected pressure (S3). In the present embodiment, a value obtained by adding a predetermined value α (see FIGS. 7 and 8) to the pressure value detected in S2 is set as the alarm value.

Thereafter, the blood pump 4 is driven forward to perform the pressure accumulation step (S4). In this pressure accumulating step, as described above, the electromagnetic valve V3 is opened while the electromagnetic valve V1 and the electromagnetic valve V2 are closed (see FIG. 2). Subsequently, after stopping the blood pump (S5), the blood pump 4 is driven in reverse to perform the pressure release step (S6). In this pressure release process, as described above, the solenoid valve V2 and the solenoid valve V3 are closed while the solenoid valve V1 is opened, and the saline solution supplied from the saline supply line 8 is used. The physiological saline and blood are replaced, and blood is returned from the tip of the arterial blood circuit 1 (see FIG. 3).

Then, it is determined whether or not the liquid that has flowed by driving the blood pump 4 has reached a predetermined amount (S7). If it is determined that the predetermined amount has been reached, the blood pump 4 is stopped (S8) and the first time. When the arterial blood return process is completed, it is determined whether or not the pressure at this time point (in this embodiment, the predetermined time point d when the arterial blood return process is completed) exceeds the alarm value set in S3. (S9). Here, if it is determined that the pressure at the predetermined time point d exceeds the alarm value, an alarm indicating that the flow path is blocked in the arterial blood circuit 1 is output (S10). Note that the alarm may be any of sound and sound effect generation, image display, lighting by a lighting means or blinking display, and control may be performed so as to stop blood return simultaneously with the alarm.

On the other hand, if it is determined in S9 that the pressure at the predetermined time point d does not exceed the alarm value, the blood pump 4 is driven forward again to perform the pressure accumulation step (S11). Thereafter, the blood pump 4 is stopped (S12), and then the blood pump 4 is driven in reverse to perform a pressure release step (S13) to return blood from the distal end of the arterial blood circuit 1, and the blood pump 4 It is determined whether or not the amount of fluid that has flowed through the driving has reached a predetermined amount (S14). If it is determined that the predetermined amount has been reached, the blood pump 4 is stopped (S15), and the second arterial return is performed. The process ends.

Thereafter, since the return of blood on the side of the arterial blood circuit 1 is started, the introduced physiological saline solution (replacement solution) can sufficiently perform the return of blood on the side of the arterial blood circuit 1 (the number of times may be specified). ) Has been reached (S16). If it is determined that the prescribed amount has been reached, a series of blood return on the side of the arterial blood circuit 1 is completed. If it is determined in S16 that the specified amount has not been reached, the process returns to S9, and after the determination in S9 is performed again, the next (third and subsequent) arterial blood return step is performed.

According to the above-described embodiment, a predetermined time point corresponding to the arterial blood return process (that is, a time point at which a change in pressure in each arterial blood return process is monitored) is a time point at which each arterial blood return process is completed. Therefore, the blockage of the arterial blood circuit 1 in the arterial blood return process can be detected earlier. Further, an alarm value is set when the first arterial blood return process is completed, and it is determined whether or not the alarm value is exceeded at the end of the subsequent arterial blood return process. The occlusion can be detected at an early stage.

In this embodiment, an alarm value is set when the first arterial blood return process is completed, and the alarm value is exceeded at the end of the subsequent arterial blood return process with reference to the alarm value. Although it is configured to determine whether or not, for example, the alarm value may be set again after the determination of S9. The alarm value can be set by various methods in addition to the present embodiment.

According to the first and second embodiments, the pressure is detected by the venous pressure sensor 21 (hydraulic pressure detecting means) while performing the arterial blood return process a plurality of times, and the corresponding predetermined time points in each arterial blood return process Since the blockage of the flow path in the arterial blood circuit 1 can be detected based on the change in pressure, the blockage of the arterial blood circuit 1 in the arterial blood return process can be detected with high accuracy. Note that the corresponding predetermined time point (the time point at which the pressure is monitored) is not limited to the time point when the pressure accumulation step is shifted to the pressure release step and the time point when each arterial blood return step is completed as in the above embodiment. The time point may be any time point, such as when a predetermined time has elapsed since the start of the arterial blood return step.

Further, the control means 19 sets an alarm value during a specific arterial blood return process among a plurality of arterial blood return processes, and in the subsequent arterial blood return process, the venous pressure sensor 21 (hydraulic pressure detection means) ), It is possible to detect the blockage of the flow path in the arterial blood circuit 1 by determining whether or not the pressure at the predetermined time point detected in (1) has exceeded the alarm value, so that the flow path is blocked more accurately and smoothly. Can be detected.

Further, an electromagnetic valve V1 (arterial side valve means) provided to be able to open and close the vicinity of the distal end of the arterial blood circuit 1 and an electromagnetic valve V2 (venous side valve) provided to be able to open and close the distal end of the venous blood circuit 2 And means for closing the flow path of the blood circuit by being disposed at a predetermined position on the venous blood circuit 2 side from the position of the blood pump 4 in the blood circuit. ) Comprises an electromagnetic valve V2 (venous side valve means), and the blockage of the flow path in the arterial blood circuit 1 is detected by diverting the electromagnetic valve V2 (venous side valve means) used in the process related to blood purification treatment. can do.

Furthermore, an air trap chamber (corresponding to the venous air trap chamber 6 of the present embodiment) connected to the venous blood circuit 2 for removing bubbles in the liquid flowing through the venous blood circuit 2, and the air And a venous pressure sensor 21 capable of detecting venous pressure, which is the pressure of blood flowing through the venous blood circuit 2 by detecting the pressure in the trap chamber, and the fluid pressure detecting means (in the blood circuit) according to the present invention. The means for detecting the pressure of the liquid in the blood circuit, which is arranged between the position where the blood pump 4 is disposed and the position where the closing means is disposed, comprises the venous pressure sensor 21, and is therefore involved in blood purification treatment. The venous pressure sensor 21 used in the process can be used to detect blockage of the flow path in the arterial blood circuit 1.

As mentioned above, although the blood purification apparatus which concerns on this embodiment was demonstrated, this invention is not limited to these, The substitution liquid used at the time of a blood return is not limited to a physiological saline, For example, a dialysate introduction line By connecting the La or dialysate discharge line Lb and the T-shaped tube T, or by reversely filtering the dialysate from the dialyzer 3 (blood purification means), the arterial blood circuit 1 and the venous blood are obtained using the dialysate as a replacement liquid. It may be supplied to the circuit 2. In this case, in the pressure accumulating step, the compound pump 17 or the dewatering pump is used instead of the blood pump 4 or together with the blood pump 4 in a state where the flow path is closed by the closing means (the electromagnetic valve V2 in the present embodiment). 18 may be driven so that the dialysate is back-filtered between the disposition position of the blood pump 4 and the disposition position of the closing means to accumulate pressure.

In this embodiment, the arterial blood circuit is determined by determining whether or not the pressure at a predetermined time detected by the venous pressure sensor 21 (hydraulic pressure detecting means) in the arterial blood return step exceeds an alarm value. 1, it is sufficient if it is possible to detect the blockage of the flow path in the arterial blood circuit 1 based on the corresponding change in pressure at a predetermined time in each arterial blood return step. The pressures at the corresponding predetermined time points in the plurality of arterial blood return steps may be compared, and an alarm may be issued when the difference is greater than or equal to a predetermined value.

Further, in the present embodiment, the closing means is configured by diverting the electromagnetic valve V2 (venous valve means) that has been conventionally provided in the blood purification apparatus, but is separate from the electromagnetic valve V2. It may be arranged in the. In this case, the disposition position of the closing means is not limited to the vicinity of the distal end of the venous blood circuit, but may be a predetermined position on the venous blood circuit 2 side (downstream side) from the disposition position of the blood pump 4 in the blood circuit. Any position may be sufficient.

Furthermore, in the present embodiment, the fluid pressure detecting means is configured by diverting the venous pressure sensor 21 that has been conventionally provided in the blood purification apparatus, but separately from the venous pressure sensor 21. It may be arranged. In this case, the disposition position of the fluid pressure detecting means is not limited to the venous air trap chamber 6, and any position between the disposition position of the blood pump 4 and the disposition position of the closing means in the blood circuit. It may be. The fluid pressure detecting means can detect the pressure of the liquid between the position where the blood pump 4 is disposed in the blood circuit and the position where the closing means (the electromagnetic valve V2 in this embodiment) is disposed. For example, a dialysis fluid pressure sensor that is disposed in the dialysis fluid discharge line and detects the fluid pressure of the dialysis fluid flowing through the dialysis fluid discharge line may be used. May be.

In this embodiment, the present invention is applied to a dialysis apparatus used at the time of dialysis treatment, but other forms of blood purification apparatus (for example, blood filtration dialysis method, blood filtration method) that can purify the patient's blood while circulating it extracorporeally. Alternatively, the present invention may be applied to blood purification devices, plasma adsorption devices, etc. used in AFBF.

An accumulating step of closing the flow path by the closing means and accumulating pressure between the arrangement position of the blood pump and the arrangement position of the closing means, and driving the blood pump in reverse while maintaining the closing of the flow path by the closing means A pressure release step including a pressure release step for returning the blood from the tip of the arterial blood circuit and detecting the pressure by the fluid pressure detecting means while performing the arterial blood return step a plurality of times. As long as it is a blood purification device provided with a control means capable of detecting blockage of the flow path in the arterial blood circuit based on the pressure change, it can be applied to devices to which other functions are added.

1 Arterial blood circuit 2 Venous blood circuit 3 Dialyzer (blood purification means)
4 Blood pump 5 Arterial side air trap chamber 6 Vein side air trap chamber 7 Air trap chamber 8 Saline supply line 9 Accommodating means 10 Arterial side bubble detecting means 11 Vein side

bubble detecting means

12, 13

Blood discriminators

14, 15 16 Tube detector 17 Duplex pump 18 Dewatering pump 19 Control means 20 Overflow line 21 Vein pressure sensor (hydraulic pressure detection means)
V1 solenoid valve (arterial valve means)
V2 Solenoid valve (Venous valve means) (closing means)

Claims

A blood circuit comprising an arterial blood circuit and a venous blood circuit, and capable of extracorporeally circulating the patient's blood from the distal end of the arterial blood circuit to the distal end of the venous blood circuit;
A blood purification means for purifying blood flowing between the arterial blood circuit and the venous blood circuit of the blood circuit and flowing through the blood circuit;
A blood pump that is disposed in the arterial blood circuit and is capable of normal rotation and reverse rotation and capable of flowing fluid in the blood circuit;
A closing means that is disposed at a predetermined position on the venous blood circuit side from an arrangement position of the blood pump in the blood circuit, and capable of closing a flow path of the blood circuit;
Fluid pressure detecting means capable of detecting the pressure of the liquid between the blood pump arrangement position and the closing means arrangement position in the blood circuit;
Control means for supplying a replacement fluid to the blood circuit after treatment, and replacing the blood in the blood circuit with the replacement fluid to return blood;
A blood purification apparatus comprising:
The control means includes
A pressure accumulation step of closing the flow path by the closing means and accumulating pressure between the arrangement position of the blood pump and the arrangement position of the closing means;
A pressure release step of driving the blood pump in a reverse direction while maintaining the closing of the flow path by the closing means, and returning blood from the tip of the arterial blood circuit;
The fluid pressure detecting means detects the pressure while performing the arterial blood return step including a plurality of times, and the flow path of the arterial blood circuit is changed based on a change in pressure at a predetermined time point corresponding to each arterial blood return step. A blood purification apparatus capable of detecting an obstruction.
The blood purification apparatus according to claim 1, wherein the corresponding predetermined time point in the arterial blood return step is a time point when the pressure accumulation step is shifted to the pressure release step.
The blood purification apparatus according to claim 1, wherein the corresponding predetermined time point in the arterial blood return step is a time point at which each arterial blood return step is completed.
The control means sets an alarm value during a specific arterial blood return process among a plurality of arterial blood return processes, and the predetermined pressure detected by the fluid pressure detection means in the subsequent arterial blood return process 4. The blockage of the flow path in the arterial blood circuit can be detected by determining whether or not the pressure at the time exceeds the alarm value, according to any one of claims 1 to 3. Blood purification device.
An arterial valve means provided to be capable of opening and closing the vicinity of the distal end of the arterial blood circuit;
Venous valve means provided so as to be able to open and close the tip of the venous blood circuit; and
The blood purification apparatus according to any one of claims 1 to 4, wherein the closing means includes the vein-side valve means.
An air trap chamber connected to the venous blood circuit for removing bubbles in the liquid flowing through the venous blood circuit;
A venous pressure sensor capable of detecting venous pressure, which is the pressure of blood flowing through the venous blood circuit, by detecting the pressure in the air trap chamber;
The blood purification apparatus according to any one of claims 1 to 5, wherein the fluid pressure detecting means includes the venous pressure sensor.