Blood purification device

Abstract

To provide a blood purification device capable of specifying an abnormality cause when there is an abnormality in a detection value of a drainage concentration detection part or an index value related to the detection value.SOLUTION: The blood purification device for executing a blood purification treatment for purifying blood by circulating blood removed from a patient in vitro through a dialyzer 2 and a blood circuit 1 includes: a piping part having a dialysis fluid introduction line L1 for introducing dialysis fluid to the dialyzer 2 and a drainage discharge line L2 for discharging drainage from the dialyzer 2; a drainage concentration sensor D3 for detecting the concentration of a solute in the drainage discharged in the drainage discharge line L2; a blood state detection part for detecting a state of blood circulated in the blood circuit 1 in vitro; a determination part 9 for determining whether or not there is an abnormality in a detection value of the drainage concentration sensor D3 or an index value related to the detection value; and an abnormality cause specification part 10 for specifying an abnormality cause on the basis of a result of the detection by the blood state detection part when the determination part 9 determines that there is an abnormality.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention relates to a blood purification device for purifying a patient's blood and performing blood purification treatment.

Background Art

[0002] A dialysis device as a blood purification device used in dialysis treatment or the like generally has a piping section for circulating dialysis fluid introduced into a blood purifier and drainage fluid discharged from the blood purifier, and a liquid feeding section for feeding the liquid in the piping section, and is configured by connecting a blood circuit for extracorporeal circulation of a patient's blood to the blood purifier, and is intended to perform dialysis treatment (blood purification treatment) with the blood purifier while extracorporeally circulating the patient's blood in the blood circuit.

[0003] In blood purification treatment, the blood purified by the dialyzer is returned to the patient's body through a puncture needle, and waste products and excess water in the blood are discharged to the outside through a dialysis fluid discharge line together with the dialysis fluid. However, waste products removed from the blood include urea, uric acid, creatinine, etc., and it has been found that in particular, the change in the concentration of urea in the blood is effective as an index indicating dialysis efficiency, and it has been proposed to monitor the change in urea concentration to make the dialysis efficiency appropriate.

[0004] Therefore, conventionally, it has been proposed to provide a drainage concentration sensor in the dialysis fluid discharge line so as to be able to detect in real time the change in urea concentration (an index called "Kt / V") (see, for example, Patent Document 1). Such a conventional drainage concentration sensor includes an LED (light emitting means) capable of irradiating light to the drainage from the dialyzer, a light receiving element (light receiving means) capable of receiving the transmitted light from the LED that has passed through the drainage, and a detection means capable of detecting the light receiving intensity by the light receiving element, and is configured to be able to detect the concentration of the drainage based on the light receiving intensity detected by the detection means.

Prior Art Documents

Patent Documents

[0005] [Patent Document 1] Special Publication No. 2002-516722 [Overview of the project] [Problems that the invention aims to solve]

[0006] However, the drainage concentration sensor (drainage concentration detection unit) of the conventional blood purification device described above was susceptible to external disturbances and tended to have large detection errors. Furthermore, when the detected value of the drainage concentration sensor or the index value related to that detected value was abnormal, it was not easy to identify the cause of the abnormality, which presented a challenge for medical professionals such as doctors to quickly determine appropriate countermeasures.

[0007] The present invention has been made in view of these circumstances, and aims to provide a blood purification device that can identify the cause of an abnormality when the detected value of the drainage concentration detection unit or an index value related to the detected value is abnormal. [Means for solving the problem]

[0008] A blood purification device according to one embodiment of the present invention is a blood purification device that performs blood purification therapy by purifying blood drawn from a patient by circulating the blood extracorporeally through a blood purifier and a blood circuit, and comprises a piping section having a dialysate introduction line for introducing dialysate into the blood purifier and a drainage discharge line for discharging drainage from the blood purifier, a drainage concentration detection unit for detecting the concentration of solute in the drainage discharged through the drainage discharge line, a blood state detection unit for detecting the state of the blood circulating extracorporeally through the blood circuit, a determination unit for determining whether the detected value of the drainage concentration detection unit or an index value related to the detected value is abnormal, and, if the determination unit determines that it is abnormal, an abnormality factor identification unit for identifying the abnormality factor based on the detection result detected by the blood state detection unit. [Effects of the Invention]

[0009] According to the present invention, if the determination unit determines that there is an abnormality, the system is equipped with an abnormality factor identification unit that identifies the cause of the abnormality based on the detection result detected by the blood condition detection unit. Therefore, if the detected value of the drainage concentration detection unit or an index value related to that detected value is abnormal, the cause of the abnormality can be identified. [Brief explanation of the drawing]

[0010] [Figure 1] A schematic diagram showing a blood purification device according to an embodiment of the present invention. [Figure 2] This graph shows the change in the detected value of the drainage concentration sensor in the blood purification device. [Figure 3] This graph shows the change in the detected value of the venous hematocrit sensor in the same blood purification device. [Figure 4] This graph shows the change in the detected value of the arterial hematocrit sensor in the same blood purification device. [Figure 5] Flowchart showing the control details of the blood purification device. [Modes for carrying out the invention]

[0011] Hereinafter, embodiments of the present invention will be specifically described with reference to the drawings. The blood purification device according to this embodiment is for purifying a patient's blood while circulating it outside the body, and is applied to a hemodialysis machine used in hemodialysis treatment. The hemodialysis machine according to this embodiment is applied to a so-called personal dialysis machine, and as shown in Figure 1, it is configured to include a blood circuit 1 for circulating the patient's blood outside the body, a dialyzer 2 as a blood purifier, a blood pump 3 for delivering blood from the blood circuit 1, a piping section having a dialysate introduction line L1, a drainage discharge line L2 and a bypass line L3, a dual pump 5, a water removal pump 6, an arterial hematocrit sensor D1 and a venous hematocrit sensor D21, a drainage concentration sensor D3 as a drainage concentration detection unit, a blood pressure removal sensor E1, a dialyzer inlet pressure sensor E2, a venous pressure sensor E3 and a dialysate pressure sensor E4, a determination unit 9, an abnormality factor identification unit 10, a notification unit 11 and a memory unit 12.

[0012] As shown in the figure, the blood circuit 1 mainly consists of an arterial blood circuit 1a and a venous blood circuit 1b, both made of flexible tubing, with a dialyzer 2 connected between them. The arterial blood circuit 1a has an arterial (blood withdrawal or blood collection) puncture needle a connected to its tip, and an arterial air trap chamber 4a and a squeezing-type blood pump 3 are located along its length. On the other hand, the venous blood circuit 1b has a venous (blood return) puncture needle b connected to its tip, and a venous air trap chamber 4b is located along its length.

[0013] Then, with the arterial puncture needle a and the venous puncture needle b inserted into the patient, the blood pump 3 is activated. The patient's blood then travels through the arterial blood circuit 1a to the dialyzer 2, where it is purified and water is removed. After this, the blood returns to the patient's body through the venous blood circuit 1b. In this way, the patient's blood is purified by the dialyzer 2 during the extracorporeal circulation process in the blood circuit 1. In this specification, the side of the puncture needle used to withdraw (collect) blood is referred to as the "arterial side," and the side of the puncture needle used to return blood is referred to as the "venous side." The terms "arterial side" and "venous side" are not defined by whether the blood vessel being punctured is an artery or a vein.

[0014] The dialyzer 2 (blood purifier) ​​has a blood inlet port 2a, a blood outlet port 2b, a dialysate inlet port 2c, and a dialysate outlet port 2d formed in its housing. The proximal end of the arterial blood circuit 1a is connected to the blood inlet port 2a, and the proximal end of the venous blood circuit 1b is connected to the blood outlet port 2b. The dialysate inlet port 2c and the dialysate outlet port 2d are connected to the ends of the dialysate inlet line L1 and the drainage line L2, respectively, which extend from the dialysis machine body B.

[0015] The dialyzer 2 contains multiple hollow fibers, the interior of which serves as a blood flow path, and the space between the outer surface of the hollow fibers and the inner surface of the housing serves as a dialysate flow path. Numerous tiny pores are formed in the hollow fibers, penetrating both the outer and inner surfaces, forming a hollow fiber membrane. This membrane allows waste products (solutes) and excess water from the blood to permeate into the dialysate.

[0016] The arterial hematocrit sensor D1 and the venous hematocrit sensor D2 consist of concentration sensors installed in the arterial blood circuit 1a and the venous blood circuit 1b, respectively, and detect the concentration of the patient's blood circulating extracorporeally in the blood circuit 1 over time (in real time). These arterial hematocrit sensors D1 and venous hematocrit sensors D2 are equipped with a light-emitting element such as an LED and a light-receiving element such as a photodiode, and detect the hematocrit value, which indicates the concentration of the blood circulating extracorporeally, by irradiating the blood with light from the light-emitting element and receiving the transmitted or reflected light with the light-receiving element.

[0017] However, in this embodiment, the rate of change in circulating blood volume (ΔBV), an index value correlated with the blood concentration, is determined based on the blood concentration detected by the arterial hematocrit sensor D1 and the venous hematocrit sensor D2, respectively. Specifically, if the hematocrit value obtained by the arterial hematocrit sensor D1 or the venous hematocrit sensor D2 is denoted as Ht, the rate of change in circulating blood volume (ΔBV) can be calculated using the formula (Ht at the start of dialysis - Ht at the time of measurement) / Ht at the time of measurement × 100. This makes it possible to sequentially obtain the rate of change in the patient's circulating blood volume (ΔBV) as the blood purification treatment time progresses.

[0018] On one hand, the dialysis device main body B includes a piping section having a dialysate introduction line L1 for introducing dialysate into the dialyzer 2, a drainage discharge line L2 for discharging drainage from the dialyzer 2, and a bypass line L3, a compound pump 5 and a water removal pump 6, and a dialysate preparation section A. The compound pump 5 is disposed across the dialysate introduction line L1 and the drainage discharge line L2, and is used to introduce dialysate from the dialysate introduction line L1 into the dialyzer 2 and discharge the dialysate introduced into the dialyzer 2 together with waste substances and excess water in the blood through the drainage discharge line L2. In addition, means other than such a compound pump 5 (for example, those using a so-called balancing chamber, etc.) may be used.

[0019] The bypass line L3 is composed of a flow path that bypasses and connects the pump chamber on the drainage side of the compound pump 5 in the drainage discharge line L2, and a water removal pump 6 is attached to this bypass line L3. Such a water removal pump 6 is for removing water (excess water) from the blood of the patient flowing through the dialyzer 2.That is, when the water removal pump 6 is driven, the volume of the drainage discharged from the drainage discharge line L2 becomes larger than the volume of the dialysate introduced from the dialysate introduction line L1, and water is removed from the blood by the amount of the larger volume.

[0020] One end of the dialysate introduction line L1 is connected to the dialyzer 2 (dialysate introduction port 2c), and the other end is connected to a water supply port P1 that can introduce clean water. Also, one end of the drainage discharge line L2 is connected to the dialyzer 2 (dialysate derivation port 2d), and the other end is connected to a drainage port P2. Further, a dialysate preparation section A for preparing dialysate is attached to the dialysate introduction line L1.

[0021] This dialysate preparation unit A mainly consists of stirring chambers (7a, 7b) for containing and stirring a predetermined amount of dialysate during the preparation process, and introduction lines (L4, L5) and introduction pumps (8a, 8b) for introducing the stock solutions of agent A and agent B, which are the stock solutions for the dialysate. Agent A stock solution consists of a mixed aqueous solution containing sodium chloride, potassium chloride, calcium chloride, magnesium chloride, and sodium acetate, and is contained in container T1 which is connected to introduction line L4. Agent B stock solution consists of an aqueous solution of sodium bicarbonate and is contained in container T2 which is connected to introduction line L85.

[0022] Then, the purified water supplied from the water supply port P1 and the concentrated solution of agent A introduced from container T1 by the drive of the introduction pump 8a are stirred and dissolved in the stirring chamber 7a. After that solution and the concentrated solution of agent B introduced from container T2 by the drive of the introduction pump 8b are stirred and dissolved in the stirring chamber 7b to produce a dialysate of a predetermined concentration. The dialysate thus produced is then delivered by the drive of the dual pump 5 and introduced into the dialyzer 2.

[0023] The drain fluid concentration sensor D3, which serves as the drain fluid concentration detection unit, consists of a sensor installed in the drain fluid discharge line L2 within the dialysis machine body B, and is capable of detecting the concentration of solutes in the drain fluid that flows as a result of blood purification by the dialyzer 2 (for example, the concentration of solutes such as urea and uric acid contained in the drain fluid). Such a drain fluid concentration sensor D3 is equipped with a light-emitting element such as an LED and a light-receiving element such as a photodiode, and detects the concentration of solutes in the drain fluid by irradiating the blood with light from the light-emitting element and receiving the transmitted or reflected light with the light-receiving element.

[0024] However, in this embodiment, the standardized dialysis dose (Kt / V), which is an index value correlated with the solute concentration, is determined based on the solute concentration detected by the drainage concentration sensor D3. Specifically, the standardized dialysis dose (Kt / V) is an index obtained by substituting the change in urea nitrogen concentration in the drainage fluid at the start of hemodialysis treatment and the current time (monitoring time), the amount of fluid removed in blood purification treatment, and the blood purification treatment time into a predetermined calculation formula: -ln(C(e) / C(s)-0.008t)+(4-3.5×C(e) / C(s))×(V UF The calculation formula is given by / DW) (where C(s) is the urea nitrogen concentration at the start of hemodialysis treatment (initial value), C(e) is the urea nitrogen concentration at the current time (monitoring time), V UF This can be determined from the amount of fluid removed (where DW indicates the patient's dry weight).

[0025] In this embodiment, the system includes a blood pressure drainage sensor E1 connected upstream of the blood pump 3 in the arterial blood circuit 1a (between the tip of the arterial blood circuit 1a and the installation position of the blood pump 3), a dialyzer inlet pressure sensor E2 connected to the arterial air trap chamber 4a, a venous pressure sensor E3 connected to the venous air trap chamber 4b, and a dialysate pressure sensor E4 connected between the dialyzer 2 and the dual pump 5 in the drainage line L2.

[0026] The pressure relief sensor E1 consists of a load sensor attached to the gripping portion on the upstream side (the tip side of the arterial blood circuit 1a) of the squeeze tube handled by the roller of the blood pump 3. When blood is collected from the patient and flowed through the arterial blood circuit 1a, a negative pressure is generated between the tip of the arterial blood circuit 1a and the blood pump 4. This reduces the fluid pressure inside the squeeze tube, causing the portion gripped by the upstream gripping portion of the squeeze tube to be displaced radially (its diameter decreases), resulting in a decrease in the load detected by the pressure relief sensor E1. By detecting this decrease in load with the pressure relief sensor E1, it is possible to detect that negative pressure is present in the arterial blood circuit 1a.

[0027] Furthermore, the blood pressure drainage sensor E1 according to this embodiment can detect blood pressure drainage by detecting the load on the covering tube, and can also convert the detected value into flow rate (actual blood flow rate). As a result, the blood pressure drainage sensor E1 can detect not only the negative pressure generated in the arterial blood circuit 1a, but also the flow rate (actual blood flow rate) of blood circulating extracorporeally through the blood circuit 1 by the drive of the blood pump 3.

[0028] The dialyzer inlet pressure sensor E2 consists of a pressure sensor connected to the air phase side of the arterial air trap chamber 4a and is capable of detecting the pressure of the fluid flowing through the passage between the blood pump 3 and the dialyzer 2 in the arterial blood circuit 1a. The venous pressure sensor E3 consists of a pressure sensor connected to the air phase side of the venous air trap chamber 4b and is capable of detecting the pressure of the fluid flowing through the passage in the venous blood circuit 1b. Furthermore, the dialysate pressure sensor E4 is capable of detecting the pressure of the drainage fluid flowing through the passage between the dialyzer 2 and the dual pump 5 in the drainage discharge line L2.

[0029] Furthermore, the arterial hematocrit sensor D1, venous hematocrit sensor D2, blood pressure drainage sensor E1, dialyzer inlet pressure sensor E2, venous pressure sensor E3, and dialysate pressure sensor E4 (sensors other than drainage fluid concentration sensor D3) constitute the blood state detection unit of the present invention, and enable monitoring of the blood drainage state by detecting the state (concentration or pressure) of the blood circulating extracorporeally in the blood circuit 1.

[0030] In this embodiment, however, the dialyzer differential pressure and the transmembrane pressure difference (TMP) can be calculated based on the detected values ​​of the dialyzer inlet pressure sensor E2, the venous pressure sensor E3, and the dialysate pressure sensor E4. The dialyzer differential pressure is the pressure difference between the fluid pressure of the arterial blood circuit 2 near the inlet side of the dialyzer 2 and the fluid pressure of the venous blood circuit 3 near the outlet side, and is calculated based on the detected values ​​of the dialyzer inlet pressure sensor E2 and the venous pressure sensor E3. By monitoring this dialyzer differential pressure, blockage of the flow path within the purifying membrane (hollow fiber membrane) in the dialyzer 2 (clogging within the hollow fibers) can be detected.

[0031] Furthermore, the transmembrane pressure difference (TMP) is the pressure difference between the fluid pressure on the blood flow path side and the fluid pressure on the dialysate flow path side in the dialyzer 2, and is calculated based on the detected values ​​of the dialyzer inlet pressure sensor E2 or venous pressure sensor E3 and the dialysate pressure sensor E4. By monitoring this TMP, it is possible to detect blockage of the pores (clogging inside and outside the hollow fibers) of the purification membrane (hollow fiber membrane) in the dialyzer 2.

[0032] Furthermore, in this embodiment, the recirculation rate can be calculated based on the detected values ​​of the arterial hematocrit sensor D1 and the venous hematocrit sensor D2. This recirculation rate refers to the proportion of blood that is purified by extracorporeal circulation of the blood circuit 1 and returned to the body, but is reintroduced through the arterial puncture needle a without passing through the patient's organs, etc. (recirculated blood), and can be calculated, for example, as follows.

[0033] The system assigns a specific peak to the patient's blood circulating in the blood flow path within dialyzer 2, indicating changes in concentration (for example, blood concentration due to rapid and short-duration water removal), while simultaneously monitoring changes in hematocrit values ​​(blood concentration) using venous hematocrit sensor D2 and arterial hematocrit sensor D1. If a rapid change in hematocrit value is detected by venous hematocrit sensor D2, it can be confirmed that a specific peak has been assigned. Furthermore, if a change in hematocrit value corresponding to the specific peak is detected by arterial hematocrit sensor D1, recirculating blood can be detected.

[0034] For example, by driving the water removal pump 6 at high speed, a characteristic peak can be added to the hematocrit value detected by the venous hematocrit sensor D2, as shown in Figure 3. Subsequently, if the blood returns to the arterial blood circuit 1a and recirculates, the characteristic peak remaining in the recirculated blood can be detected by the arterial hematocrit sensor D1, as shown in Figure 4. This allows the venous hematocrit sensor D2 to confirm whether or not a characteristic peak has been added by the water removal pump 6, and the arterial hematocrit sensor D1 to detect the presence or absence of recirculated blood.

[0035] Furthermore, by comparing the hematocrit values ​​(specific peaks) detected by the arterial hematocrit sensor D1 and the venous hematocrit sensor D2, it is possible to calculate the proportion of recirculated blood in the blood flowing through the arterial blood circuit 1a (recirculation rate). Specifically, based on the time-hematocrit graphs shown in Figures 3 and 4, the changes in the hematocrit value detected by the arterial hematocrit sensor D1 (see Figure 4) and the changes in the hematocrit value detected by the venous hematocrit sensor D2 (see Figure 3) are determined, and the area of ​​the time portion (change portion) to be compared is calculated using mathematical methods such as integration.

[0036] For example, if we let Sv be the area of ​​the change detected by the venous hematocrit sensor D2 (see Figure 3) and Sa be the area of ​​the change detected by the arterial hematocrit sensor D1 (see Figure 4), then the recirculation rate Rrec can be calculated using the following formula. Rrec(%) = Sa / Sv × 100

[0037] The determination unit 9 consists of a microcontroller and the like, which is installed in the dialysis machine body B, and is configured to determine whether the detected value of the drainage fluid concentration sensor D3 or an index value related to that detected value (in this embodiment, an index value called the standardized dialysis amount (Kt / V)) is abnormal. Furthermore, the determination unit 9 according to this embodiment is configured to determine that the detected value of the drainage fluid concentration sensor D3 or an index value related to that detected value is abnormal if it changes rapidly with the passage of treatment time, as shown in Figure 2(a), or if it differs from the predicted value (predicted curve α), as shown in Figure 2(b).

[0038] The abnormality factor identification unit 10 consists of a microcomputer and the like, which is installed in the dialysis machine body B. When the determination unit 9 determines that there is an abnormality, it is configured to identify the abnormality factor based on the detection result detected by the blood condition detection unit. Here, as described above, the blood condition detection unit consists of sensors other than the drainage fluid concentration sensor D3, which detects the state of the blood circulating extracorporeally in the blood circuit 1 and monitors the blood withdrawal state. In this embodiment, it consists of an arterial hematocrit sensor D1 and a venous hematocrit sensor D2, a blood pressure withdrawal sensor E1, a dialyzer inlet pressure sensor E2, a venous pressure sensor E3, and a dialysate pressure sensor E4.

[0039] In other words, the blood condition detection unit according to this embodiment has pressure sensors (blood pressure withdrawal sensor E1, dialyzer inlet pressure sensor E2, venous pressure sensor E3, and dialysate pressure sensor E4) that detect the pressure of the liquid in the blood circuit 1 or piping (in this embodiment, the drained fluid from the drainage discharge line L2), and concentration sensors (arterial hematocrit sensor D1 and venous hematocrit sensor D2) that detect the concentration of the blood circulating extracorporeally through the blood circuit 1. The abnormality factor identification unit 10 is configured to identify abnormalities such as poor blood withdrawal, recirculation, clogging of the hollow fiber membrane (purification membrane) of the dialyzer 2, or patient movement based on the detection results of these pressure sensors or concentration sensors. Furthermore, the abnormality factor identification unit 10 according to this embodiment is configured to identify the relevant abnormality from among a plurality of abnormalities.

[0040] The notification unit 11 notifies the abnormal factors identified by the abnormal factor identification unit 10, and consists of, for example, a monitor, warning lights, and a speaker capable of outputting voice and sound effects, etc., installed on the dialysis machine body B. When the abnormal factors are notified by the notification unit 11, surrounding medical personnel can accurately and quickly grasp the abnormal factors, and can easily take action if the detected value of the drainage fluid concentration sensor D3 or an indicator value related to that detected value is abnormal.

[0041] The storage unit 12 consists of a storage medium such as memory, and stores the detected value of the drainage concentration sensor D3, which the determination unit 9 determines to be abnormal, or an index value related to the detected value, in association with the abnormality factor identified by the abnormality factor identification unit 10.

[0042] Next, the control of the blood purification device according to this embodiment will be explained using the flowchart in Figure 5. First, the treatment time or amount of fluid removed in the blood purification treatment process is set in advance as the set treatment time or set amount of fluid removed. Then, the blood circuit 1 removes water (excess water) and solutes (waste products) from the blood circulating outside the body via the dialyzer 2, and the water and solutes removed via the dialyzer 2 are discharged via the drainage line L2, thereby executing the blood purification treatment process.

[0043] In this embodiment, during the blood purification treatment process, the concentration of blood circulating extracorporeally through the blood circuit 1 is detected over time (in real time) by the arterial hematocrit sensor D1 and the venous hematocrit sensor D2, and the rate of change in circulating blood volume (ΔBV) is obtained sequentially. At the same time, the concentration of solute in the drained fluid discharged through the drained fluid discharge line L2 is detected over time (in real time) by the drained fluid concentration sensor D3, and the standardized dialysis volume (Kt / V) is obtained sequentially.

[0044] The determination unit 9 then determines whether the standardized dialysis dose (Kt / V) obtained sequentially during the blood purification treatment process is abnormal. If it determines that it is abnormal, it proceeds to control by the abnormality factor identification unit 10, which determines whether Kt / V has decreased (S1). If Kt / V has not decreased, it is determined in S2 whether ΔBV has decreased. If it is determined that ΔBV has not decreased, it is identified that the abnormality factor is that the patient moved (especially moving from a standing position to a lying position). If it is determined in S2 that ΔBV has decreased, it is identified that recirculation is the abnormality factor by detecting whether or not recirculation has occurred.

[0045] On the other hand, if it is determined in S1 that Kt / V has decreased, it is determined in S3 whether or not ΔBV has changed. If it is determined that ΔBV has changed, it is identified that the abnormal factor is that the patient moved (especially from a supine position to a standing position). If it is determined that ΔBV has not changed in S3, the process proceeds to S4, where it is determined whether or not the blood drainage pressure has changed. If it is determined that the blood drainage pressure has changed, it is identified that poor blood drainage is the abnormal factor. If it is determined that the blood drainage pressure has not changed, it is identified that the abnormal factor is that dialyzer 2 is clogged.

[0046] According to this embodiment, if the determination unit 9 determines that there is an abnormality, the abnormality factor identification unit 10 is provided to identify the abnormality factor based on the detection result detected by the blood state detection unit. Therefore, if the detected value of the drainage fluid concentration sensor D3 or an index value related to that detected value is abnormal, the abnormality factor can be identified. In particular, the blood state detection unit has pressure sensors (exhaust pressure sensor E1, dialyzer inlet pressure sensor E2, venous pressure sensor E3, and dialysate pressure sensor E4) that detect the pressure of the liquid in the blood circuit 1 or piping, or concentration sensors (arterial hematocrit sensor D1 and venous hematocrit sensor D21) that detect the concentration of the blood circulating extracorporeally in the blood circuit 1. Therefore, sensors provided in the blood purification device can be reused.

[0047] Furthermore, the abnormality factor identification unit 10 identifies poor blood drainage, recirculation, clogging of the purifying membrane of the dialyzer 2, or patient movement as abnormality factors based on the detection results of the pressure sensor or concentration sensor. This allows for the selective and easy identification of possible abnormality factors such as poor blood drainage, recirculation, clogging of the purifying membrane of the dialyzer 2, or patient movement. In particular, when identifying recirculation as an abnormality factor, the sensor equipped in the blood purification device does not need to be operated continuously. Instead, the sensor can be activated only when the determination unit 9 determines that there is an abnormality, allowing the abnormality factor identification unit 10 to identify the abnormality factor (recirculation). Additionally, by using the sensor equipped in the blood purification device, body movement, which cannot be directly detected by these sensors, can be identified as an abnormality factor.

[0048] The determination unit 9 determines that an abnormality exists if the detected value of the drainage concentration sensor D3 or the index value (Kt / V) related to that detected value changes rapidly as treatment time progresses, or if it differs from the expected value, thus enabling accurate transition to the identification process by the abnormality factor identification unit 10. Furthermore, it is possible to associate each identified abnormality factor with the detected value of the drainage concentration sensor D3 or the index value (Kt / V) related to that detected value, allowing for a comprehensive and time-series retrospective analysis of the causal and correlational relationship between dialysis efficiency and multiple factors that negatively affect treatment. Additionally, the storage unit 12 stores the detected value of the drainage concentration sensor D3 or the index value related to that detected value that the determination unit 9 determines to be abnormal, in association with the abnormality factor identified by the abnormality factor identification unit 10, so that the data stored in the storage unit 12 can be utilized in subsequent blood purification treatments.

[0049] Although this embodiment has been described above, the present invention is not limited thereto. For example, a sensor other than the drainage concentration sensor D3 may be used as the blood state detection unit. For example, a flow meter that measures the actual flow rate of blood circulating extracorporeally in the blood circuit 1 may be used. The drainage concentration sensor D3 may be a different type of sensor that detects the concentration of solute in the drainage discharged in the drainage discharge line L2. In addition, although this embodiment is equipped with an arterial hematocrit sensor D1 and a venous hematocrit sensor D2, only one of these hematocrit sensors may be equipped.

[0050] In addition, the concentration of the blood circulating extracorporeally in blood circuit 1 may be hematocrit, hemoglobin concentration, water content, total protein content, etc., and the concentration of solutes in the drainage fluid flowing through drainage line L2 may be urea, uric acid, creatinine, β2MG, etc. [Industrial applicability]

[0051] The present invention can be applied to any blood purification device that is equivalent to the spirit of the present invention, even if it has a different external shape or additional functions. [Explanation of Symbols]

[0052] 1 Blood circuit 1a Arterial blood circuit 1b Venous blood circuit 2. Dialyzer (blood purifier) 3. Blood pump 4a Arterial side air trap chamber 4b Venous side air trap chamber 5. Double-acting pump 6. Water removal pump 7a, 7b Mixing Chambers 8a, 8b Inlet pump 9 Judgment section 10. Abnormal Factor Identification Department 11 Hochi Department 12 Storage section L1 Dialysis fluid infusion line L2 Drainage Line L3 Bypass Line L4, L5 implementation line A. Dialysis fluid preparation section B Dialysis machine main unit D1 Arterial hematocrit sensor D2 Venous hematocrit sensor D3 Drainage fluid concentration sensor (drainage fluid concentration detection unit) E1 Blood pressure sensor E2 Dialyzer Inlet Pressure Sensor E3 Venous Pressure Sensor E4 Dialysis Fluid Pressure Sensor a Arterial puncture needle b. Venous puncture needle P1 Water supply port P2 Drainage port T1, T2 containers (container sections)

Claims

1. A blood purification device for performing blood purification therapy in which blood drawn from a patient is circulated extracorporeally through a blood purifier and a blood circuit, thereby purifying the blood, a piping section having a dialysate introduction line for introducing dialysate into the blood purifier and a waste fluid discharge line for discharging waste fluid from the blood purifier; a waste liquid concentration detection unit for detecting the concentration of a solute in the waste liquid discharged through the waste liquid discharge line; a blood condition detection unit that detects the condition of blood circulating extracorporeally through the blood circuit; a determination unit that determines whether a detection value of the wastewater concentration detection unit or an index value related to the detection value is abnormal; an abnormality factor identifying unit that identifies an abnormality factor based on the detection result detected by the blood condition detecting unit when the determining unit determines that there is an abnormality; A blood purification device comprising:

2. 2. The blood purification apparatus according to claim 1, wherein the blood condition detection unit has a pressure sensor that detects the pressure of the blood in the blood circuit, or a concentration sensor that detects the concentration of the blood circulating extracorporeally through the blood circuit.

3. 3. The blood purification apparatus according to claim 2, wherein the abnormality factor identifying unit identifies insufficient blood removal, recirculation, clogging of the purification membrane of the blood purifier, or body movement of the patient as the abnormality factor based on the detection results of the pressure sensor or concentration sensor.

4. 4. The blood purification apparatus according to claim 1, further comprising a notification unit that notifies the abnormality factor identified by the abnormality factor identification unit.

5. The blood purification device according to any one of claims 1 to 4, wherein the determination unit determines that an abnormality exists when the detection value of the effluent concentration detection unit or an index value related to the detection value changes rapidly with the passage of treatment time or when the detection value differs from a previously predicted value.

6. The blood purification device according to any one of claims 1 to 5, further comprising a memory unit that stores the detected value of the effluent concentration detection unit or an index value related to the detected value that the determination unit determines to be abnormal, in association with the abnormality factor identified by the abnormality factor identification unit.

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