Blood purification device and method for monitoring blood purification

Abstract

The goal is to reduce the extracorporeal blood volume while minimizing the impact on the duration of dialysis treatment itself, and to enable non-invasive monitoring with a relatively simple configuration. [Solution] A blood purification device comprising a blood purifier for purifying a patient's blood, and a blood circuit connected to the blood purifier for introducing blood drawn from the patient into the blood purifier and returning the purified blood from the blood purifier to the patient, wherein the device includes a processing unit that receives a detection signal from at least one odor sensor that detects a predetermined odor contained in a blood purification solution introduced into and out of the blood purifier, and measures the status of the blood purification treatment from the detection signal.

Description

[Technical Field]

[0001] This disclosure relates to a blood purification device that performs blood purification therapy while circulating a patient's blood extracorporeally, and to a method for monitoring blood purification in the same. [Background technology]

[0002] Traditionally, dialysis treatment using a blood purification device equipped with a dialyzer and a blood circuit has been known as an example of blood purification therapy. In this dialysis treatment, blood taken from the patient is circulated extracorporeally through a blood circuit, and blood purification is performed using a dialyzer connected to the blood circuit. The purified blood is then returned to the patient's body. Furthermore, when performing this dialysis treatment, it is necessary to monitor the patient's condition, the status of the blood purification treatment, and the condition of the blood purification device or consumables to ensure that no problems arise during the ongoing dialysis treatment.

[0003] For example, vascular access (VA) recirculation measurement is used to monitor the status of blood purification therapy. Specifically, blood markers are created by concentrating or diluting the blood, and these blood markers are monitored in the blood circuit by optical or ultrasonic sensors. As a result of this monitoring, the VA recirculation rate is measured. For example, Patent Document 1 describes a system in which hematocrit sensors are provided in the arterial and venous circuits, and the rate of change in circulating blood volume is measured based on the blood concentration detected by these sensors.

[0004] Another example of monitoring the status of blood purification therapy is dialysis volume monitoring. Specifically, the change in absorbance of the dialysate drain is monitored, and as a result, the standardized dialysis volume (Kt / V) and urea removal rate (URR) are measured. For example, in Patent Document 2, by measuring the change in ultraviolet absorbance of the dialysate drain, the change in blood urea nitrogen, which is correlated with the change in absorbance, is calculated, and parameters such as the standardized dialysis volume and urea removal rate are calculated. [Prior art documents] [Patent Documents]

[0005] [Patent Document 1] Japanese Patent Publication No. 2022-113181 [Patent Document 2] Japanese Patent Publication No. 2021-73030 [Overview of the project] [Problems that the invention aims to solve]

[0006] However, the VA recirculation measurement described above requires the creation of blood markers, which involves accessing and concentrating or diluting the blood separately from the actual dialysis treatment, adding extra work and potentially increasing the dialysis treatment time and burdening the patient. On the other hand, the dialysis volume monitoring described above requires ultraviolet light emitters and receivers, resulting in a complex and large sensor structure, which could increase the number of components in the blood purification device and make miniaturization difficult.

[0007] This disclosure has been made in view of these issues, and its purpose is to provide a blood purification device and a blood purification monitoring method that reduce the impact on the time of the blood purification treatment itself and enable non-invasive monitoring with a relatively simple configuration. [Means for solving the problem]

[0008] According to one aspect of the present disclosure, a blood purification device is provided, comprising a blood purifier for purifying a patient's blood, and a blood circuit connected to the blood purifier for introducing blood drawn from the patient into the blood purifier and returning the purified blood from the blood purifier to the patient, the device having a processing unit that receives a detection signal from at least one odor sensor that detects a predetermined odor contained in a blood purification solution introduced into the blood purifier, and measures the status of the blood purification treatment from the detection signal.

[0009] According to one aspect of the present disclosure, there is provided "a method for monitoring blood purification in a blood purification device to which a blood purification device for purifying a patient's blood and a blood circuit for introducing blood drawn from the patient into the blood purification device and returning the purified blood from the blood purification device to the patient are connected, the method including: a smell detection step of detecting a predetermined smell contained in the blood flowing through the blood circuit or a chemical solution for blood purification introduced into and discharged from the blood purification device; and a processing step of measuring the status of blood purification treatment from a detection signal obtained in the smell detection step."

Advantages of the Invention

[0010] According to the present disclosure, it is possible to provide a blood purification device and a method for monitoring blood purification that can reduce the extracorporeal circulation blood volume, reduce the influence on the time of the blood purification treatment itself, and perform non-invasive monitoring with a relatively simple configuration.

[0011] Note that the above effects are merely exemplary for convenience of explanation, and the effects of the present disclosure are not limited to the above. In addition to the above effects, according to the present disclosure, any effect described in the present disclosure can be achieved.

Brief Description of the Drawings

[0012] [Figure 1] It is a schematic diagram showing the mechanical configuration of a blood purification unit according to the first embodiment. [Figure 2] It is a block diagram showing the electrical configuration of a blood purification unit according to the first embodiment. [Figure 3] It is a schematic diagram showing the mechanical configuration of the extracorporeal circulation part and the internal piping part of a blood purification unit according to the first embodiment. [Figure 4] It is a functional block diagram of a blood purification unit according to the first embodiment. [Figure 5] It is a flowchart showing the flow of processing related to monitoring of a blood purification unit according to the first embodiment. [Figure 6]This is a schematic diagram showing an example of the usage state of the blood purification unit according to the first embodiment. [Figure 7] Figure 5 is a flowchart showing the flow of processing related to the measurement process and the display of measurement results. [Figure 8] This is a schematic diagram showing an example of the usage state of the blood purification unit according to the first embodiment. [Figure 9] Figure 5 is a flowchart showing the flow of processing related to the measurement process and the display of measurement results. [Figure 10] This is a schematic diagram showing an example of the usage state of the blood purification unit according to the first embodiment. [Figure 11] Figure 5 is a flowchart showing the flow of processing related to the measurement process and the display of measurement results. [Figure 12] This is a schematic diagram showing an example of the usage state of the blood purification unit according to the first embodiment. [Figure 13] Figure 5 is a flowchart showing the flow of processing related to the measurement process and the display of measurement results. [Figure 14] This is a schematic diagram showing an example of the usage state of the blood purification unit according to the first embodiment. [Figure 15] Figure 5 is a flowchart showing the flow of processing related to the measurement process and the display of measurement results. [Figure 16] This is a schematic diagram showing the mechanical configuration of the extracorporeal circulation section and the internal piping section of the blood purification unit according to the second embodiment. [Figure 17] This is a schematic diagram showing the mechanical configuration of the extracorporeal circulation section and the internal piping section of the blood purification unit according to the third embodiment. [Modes for carrying out the invention]

[0013] The blood purification device and blood purification unit including the same described herein will be explained in detail below with reference to the drawings. Note that this disclosure is not limited to the content described below, and can be modified and implemented as such without altering its essence. Furthermore, the drawings used in each embodiment schematically show the blood purification device, its components, and the blood purification unit including these, and have been partially emphasized, enlarged, reduced, or omitted to enhance understanding, and may not accurately represent the scale or shape of each component. Additionally, some numerical values ​​used in each embodiment are examples only and can be changed as needed. Common components in the drawings are denoted by the same reference numerals.

[0014] <First Embodiment> (Composition of the blood purification unit) First, the configuration of the blood purification unit of this disclosure will be described with reference to Figures 1 to 4. Figure 1 is a schematic diagram showing the mechanical configuration of the blood purification unit according to this embodiment. Figure 2 is a block diagram showing the electrical configuration of the blood purification unit according to this embodiment. Figure 3 is a schematic diagram showing the mechanical configuration of the extracorporeal circulation section and the internal piping section of the blood purification unit according to this embodiment. Figure 4 is a functional block diagram of the blood purification unit according to the first embodiment.

[0015] As shown in Figure 1, the blood purification unit 1 consists of a blood purification device 1a, which is a dialysis machine for performing dialysis treatment, an example of blood purification therapy, and a consumables unit 1b, which consists of various consumables. In other words, in the blood purification unit 1, the consumables unit 1b is connected to the blood purification device 1a, and dialysis treatment is performed on patient H.

[0016] Specifically, the blood purification unit 1 includes a main body 3 mounted on a base unit 2, a display 4 connected to the top of the main body 3, and a blood purifier 5 mounted on the side of the main body 3. The main body 3 of the blood purification unit 1 also includes a processing unit 6 for processing various information and data, an internal piping unit 7 for circulating dialysate between the main body and the blood purifier 5, and an extracorporeal circulation unit 8 for circulating the patient H's blood outside the body. With this configuration, the blood purification unit 1 is capable of taking the patient H's blood outside the body (blood withdrawal), removing unwanted or toxic substances or water from the blood in the blood purifier 5 (blood purification), and returning the purified blood to the patient H (blood return).

[0017] The blood purification device 1a is the base of the blood purification unit 1 and consists of a base unit 2, a main body 3, a display 4, a processing unit 6, an internal piping unit 7, and a part of the extracorporeal circulation unit 8. Here, the extracorporeal circulation unit 8 includes a blood circuit, a pump connected to the blood circuit, and other parts and devices, which will be described later. Of these, the pump and other devices are provided in the blood purification device 1a and therefore become components (constituent devices) of the blood purification device 1a.

[0018] On the other hand, the consumables section 1b consists of the blood purifier 5 and a part of the extracorporeal circulation section 8. Here, the blood circuit and some other components included in the extracorporeal circulation section 8 are merely detachably connected to the blood purifier 1a, and thus constitute elements (components) of the consumables section 1b, not the blood purifier 1a.

[0019] As shown in Figure 2, the blood purification unit 1 consists of a display 4, a processing unit 6, an internal piping unit 7, and an extracorporeal circulation unit 8, all electrically connected to each other via control lines and data lines. This allows the blood purification device 1a to transmit and receive various signals, data, and information, as well as to perform various controls via the processing unit 6. In the following, "data" is generally assumed to consist of numerical values, symbols, or characters obtained by processing signals, etc. "Information" is generally assumed to be collected or processed data, for example, content that the receiving side can use as material for further consideration or that can be utilized by the receiving side. However, data and information may be used in ways that do not conform to the above assumptions, depending on their content and the surrounding context.

[0020] In this embodiment, a hemodialysis machine is described as an example of a blood purification device 1a, but the invention is not limited to this. For example, a device for acute blood purification, a peritoneal dialysis machine, an ultrafiltration machine, or a hemofiltration machine can also be an example of a blood purification device 1a.

[0021] Furthermore, in addition to the above-described configuration, the blood purification device 1a of the blood purification unit 1 may also have a communication unit that enables the transmission and reception of information with external devices such as terminal devices or server devices. As a result, various information related to the patient's treatment (patient information) may be acquired from the external device via the communication unit in the blood purification device 1a.

[0022] [Base Unit] As shown in Figure 1, the base unit 2 consists of a plate-shaped base 2a connected to the bottom of the main body 3, and four casters 2b installed on the base 2a. This makes it possible to easily move the blood purification unit 1 and the blood purification device 1a. The number of casters 2b is not limited to four; there may be three or five or more, as long as the blood purification unit 1 and the blood purification device 1a can be moved.

[0023] [Main unit] As shown in Figure 1, the main body 3 is composed of a roughly rectangular parallelepiped housing. Various components and devices that constitute the internal piping section 7 and extracorporeal circulation section 8 of the blood purification unit 1 are arranged inside and on the surface of the main body 3. For example, the components may include various pumps and detectors, and the components may include a blood circuit, a dialysate circuit, and various sensors.

[0024] 〔display〕 Next, as shown in Figures 1 and 2, the display 4 has an input unit 4a consisting of a touch panel type input interface and an output unit 4b consisting of a general screen type output interface. In other words, the display 4 in this embodiment is a touch panel equipped with an input / output interface. Here, the method for detecting input by the touch panel may be any method, such as capacitive or resistive. Furthermore, the operable area and position on the touch panel can be freely set by the administrator of the blood purification unit 1, etc. In other words, the arrangement of the input unit 4a and the output unit 4b on the display 4 can be set as appropriate.

[0025] The input interface may be separated from the display 4. In this case, a keyboard with physical key buttons such as a numeric keypad or character input keys, and an input device such as a mouse may be provided on the blood purification device 1a.

[0026] [Blood Purifier] As can be seen from Figures 1 and 3, the blood purifier 5 has a blood inlet 5a and a blood outlet 5b at both ends of its housing as blood-side ports, and a dialysate inlet 5c and a dialysate outlet 5d on the side of its housing as dialysate-side ports. The arterial blood circuit L1, which will be described later, is connected to the blood inlet 5a, and the venous blood circuit L2, which will be described later, is connected to the blood outlet 5b. In addition, the dialysate supply pipe (drug supply pipe) L3, which will be described later, is connected to the dialysate inlet 5c, and the dialysate outlet 5d is connected to the dialysate discharge pipe (drug discharge pipe) L4, which will be described later.

[0027] The blood purifier 5 contains multiple hollow fiber membranes (not shown) inside, which constitute a blood purifying membrane for purifying blood. Inside the blood purifier 5, a blood channel through which patient H's blood flows and a dialysate channel through which dialysate, a drug solution for blood purification, flows are formed. Furthermore, the hollow fiber membrane constituting the blood purifying membrane has numerous minute pores that penetrate its outer and inner surfaces, and is configured so that impurities in the blood can permeate into the dialysate through the hollow fiber membrane.

[0028] Furthermore, the blood purifier 5 is not limited to a dialyzer having the configuration described above. For example, it may be an adsorption-type blood purifier used in endotoxin adsorption therapy, activated carbon adsorption therapy, or bilirubin adsorption therapy. Also, the blood purifier 5 may be a hemodiafilter.

[0029] [Internal piping section] The internal piping section 7 is located inside the main body 3 and is connected via piping to two dialysate inlets 5c and dialysate outlets 5d located on the side of the blood purifier 5. For example, the internal piping section 7 includes various components such as pipes, pumps, valves, sensors, and filters. More specifically, the internal piping section 7 may include a double pump, a water removal pump, a degassing pump, a pressure pump, a pressure reducing valve, a solenoid valve, a temperature sensor, a pressure sensor, and a chemical filter. Furthermore, flexible materials such as polyvinyl chloride tubing or silicone tubing may be used for the piping.

[0030] The internal piping section 7 is assembled by appropriately selecting the above-mentioned components according to the piping configuration and type, and is structured to enable the circulation and cleaning of dialysate. Furthermore, the internal piping section 7 is structured to enable the introduction and discharge of dialysate to and from the blood purifier 5. Note that these specific configurations are not features of the blood purifier of this disclosure, and therefore their explanation is omitted.

[0031] [Extracorporeal circulation department] Next, as shown in Figure 3, the extracorporeal circulation unit 8, which is a blood circuit, has an arterial blood circuit L1 connected to the blood inlet 5a of the blood purifier 5, and a venous blood circuit L2 connected to the blood outlet 5b of the blood purifier 5. The extracorporeal circulation unit 8 also has a pump P1 and an arterial chamber 11 connected to the arterial blood circuit L1. Furthermore, the extracorporeal circulation unit 8 has a venous chamber 12 connected to the venous blood circuit L2. Here, the arterial blood circuit L1 is a circuit that introduces blood drawn from patient H into the blood purifier 5, and the venous blood circuit L2 is a circuit that returns the blood purified by the blood purifier 5 to patient H. The arterial blood circuit L1 and the venous blood circuit L2 thus constitute a blood circuit through which the patient's blood flows.

[0032] One end of the arterial blood circuit L1 is connected to a puncture needle (not shown) that is inserted into the arm of patient H, and the other end is connected to the blood inlet 5a of the blood purifier 5. In addition, the arterial blood circuit L1 is connected in the order of arterial chamber 11 and pump P1 from the puncture needle side. When pump P1 rotates clockwise, blood is drawn from patient H, and patient H's blood passes through the arterial blood circuit L1 to reach the blood purifier 5.

[0033] The type of pump P1 is not particularly limited, as long as it can introduce patient H's blood into the blood purifier 5. In this embodiment, a peristaltic pump is assumed, but other pumps such as diaphragm pumps may also be used.

[0034] Furthermore, an arterial odor sensor 13 is connected to the arterial chamber 11. In other words, in this embodiment, the arterial odor sensor 13 constitutes the extracorporeal circulation unit 8 and is provided as a component of the blood purification device 1a. That is, in this embodiment, the arterial odor sensor 13 is not a consumable and does not constitute the consumables unit 1b. Moreover, the arterial odor sensor 13 is provided to detect a predetermined odor contained in the blood temporarily stored in the arterial chamber 11. The arterial odor sensor 13 may be of the type of semiconductor or quartz crystal oscillator, for example. Furthermore, an analyzer such as a gas chromatograph that can quantify the concentration of chemical substances constituting the odor may be used as the arterial odor sensor 13. The predetermined odor may be an acetic acid odor contained in the dialysate, a characteristic odor of the blood purification device 5 or blood circuit that does not occur in the body, or an ammonia odor, which is a uremic toxin in the blood. Thus, the arterial odor sensor 13 may detect any of these odors and quantify the concentration of these components or the intensity of the odor index.

[0035] Meanwhile, one end of the venous blood circuit L2 is connected to a puncture needle (not shown) inserted into the arm of patient H, and the other end is connected to the blood outlet 5b of the blood purifier 5. In addition, a venous chamber 12 is connected between the puncture needle and the end of the venous blood circuit L2 that is connected to the blood outlet 5b. When blood is drawn from patient H by the forward rotation (clockwise rotation) of the pump P1, patient H's blood is drawn out from the blood purifier 5, passes through the venous blood circuit L2, and is returned to patient H.

[0036] Furthermore, a venous odor sensor 14 is connected to the venous chamber 12. In other words, in this embodiment, the venous odor sensor 14 constitutes the extracorporeal circulation unit 8 and is provided as a component of the blood purification device 1a. That is, in this embodiment, the venous odor sensor 14 is not a consumable and does not constitute the consumables unit 1b. Moreover, the venous odor sensor 14 is provided to detect a predetermined odor contained in the blood temporarily stored in the venous chamber 12. The type of venous odor sensor 14 may be either semiconductor type or quartz crystal type, similar to the arterial odor sensor 13. Furthermore, an analyzer such as a gas chromatograph that can quantify the concentration of chemical substances constituting the odor may be used as the venous odor sensor 14. The predetermined odor may be acetic acid odor contained in the dialysate, a characteristic odor of the blood purification device 5 or blood circuit that does not occur in the body, or ammonia odor, which is a uremic toxin in the blood. As a result, the venous odor sensor 14 may detect any of these odors and quantify the concentration of these components or the intensity of the odor index.

[0037] [Processing Section] Next, the processing unit 6 according to this embodiment is composed of a processor 6a and a memory 6b, as shown in Figure 2.

[0038] The processor 6a consists of a GPU (Graphics Processing Unit) or a CPU (Central Processing Unit) and functions as a processing unit that controls each component of the blood purification unit 1 (particularly the blood purification device 1a) based on various programs stored in memory 6b. Specifically, the processor 6a reads from memory 6b a program for performing treatment to purify the patient's blood or a program for running the OS and executes it.

[0039] In particular, the processor 6a receives detection signals for predetermined odors from the arterial odor sensor 13 and the venous odor sensor 14, and performs processing to measure the status of dialysis treatment (blood purification treatment) initiated by the operation of the blood purification device 1a. Here, the status of dialysis treatment refers to, for example, blood recirculation, dialysis volume and its abnormal changes, or the removal performance of the blood purifier 5 (dialyzer removal performance) and its abnormal changes.

[0040] The processor 6a may consist of a single GPU or CPU, or it may be composed of a combination of multiple CPUs or GPUs.

[0041] Memory 6b consists of ROM, RAM, non-volatile memory, HDD, etc., and functions as a storage unit. ROM stores instruction commands as a program for performing treatment to purify the patient's blood. RAM is used for writing and reading data while the program stored in ROM is being processed by processor 6a. Non-volatile memory is a storage device in which data is written and read as a result of the program's execution, and the data written there is retained even after the program's execution has finished.

[0042] In particular, in this embodiment, memory 6b stores a program for measuring the status of the dialysis treatment. Specifically, memory 6b stores calculation formulas, etc., for measuring blood recirculation, dialysis volume, or the removal performance of the blood purifier 5 based on the detected odor, as a program for measuring the status. Furthermore, memory 6b stores thresholds set in accordance with predetermined odors. For example, for acetic acid odor, or a characteristic odor of the blood purifier 5 or blood circuit, thresholds for determining the occurrence of abnormal blood recirculation are stored. Then, memory 6b associates these calculation formulas, thresholds, and programs and stores them as odor information.

[0043] Next, with reference to Figure 4, the functional configuration of the processing unit 6 of the blood purification device 1a according to this embodiment will be described. In particular, Figure 4 shows other components of the blood purification unit 1 in addition to the processing unit 6, and also describes the flow of information and signals between each device.

[0044] As shown in Figure 4, the processing unit 6 has an arithmetic unit 21 and a storage unit 22. Each of these units is realized by the operation of the processor 6a and memory 6b of the processing unit 6 itself, or by the processor 6a reading and executing a program stored in memory 6b.

[0045] As shown in Figure 4, the calculation unit 21 receives setting information from the input unit 4a. Here, the setting information includes information for identifying which odors the arterial odor sensor 13 and the venous odor sensor 14 are capable of detecting. The setting information also includes information on what aspects of dialysis treatment are to be measured. Therefore, upon receiving this setting information, the calculation unit 21 recognizes whether the arterial odor sensor 13 and the venous odor sensor 14 are sensors corresponding to either acetic acid odor, the characteristic odor of the blood purifier 5 or the blood circuit, or ammonia odor. In addition, the calculation unit 21 recognizes that the situation to be measured is either blood recirculation, dialysis volume and its abnormal changes, or the removal performance of the blood purifier 5 and its abnormal changes.

[0046] Furthermore, the calculation unit 21 reads predetermined odor information stored in the storage unit 22 to correspond to the received setting information. As a result, when the calculation unit 21 detects any of the following, acetic acid odor, the characteristic odor of the blood purifier 5 or the blood circuit, or ammonia odor, it enters a state where it can measure blood recirculation, dialysis volume and its abnormal changes, or the removal performance of the blood purifier 5 and its abnormal changes. In other words, monitoring conditions are set in the blood purification unit 1.

[0047] Furthermore, the calculation unit 21 receives odor detection signals from the arterial odor sensor 13 and the venous odor sensor 14. Based on the set monitoring conditions, the calculation unit 21 uses these detection signals to perform calculations and measure blood recirculation, dialysis volume and its abnormal changes, or the removal performance of the blood purifier 5 and its abnormal changes.

[0048] The calculation unit 21 then includes the measurement results in the display information and transmits it to the output unit 4b. As a result, the measurement results are displayed on the output unit 4b, and the operator of the blood purification unit 1 (medical professionals such as doctors and nurses, or patient H) can easily check the status of the dialysis treatment (including any abnormal changes).

[0049] (Processing in the blood purification unit) Next, an overview of the treatment and measurement processes by the blood purification unit 1 according to this embodiment will be described with reference to Figure 5. Here, Figure 5 is a flowchart showing the flow of the monitoring process of the blood purification unit 1 according to this embodiment.

[0050] First, as shown in Figure 5, the odor sensors are configured in the blood purification unit 1 (S1: Sensor configuration step). Specifically, the operator of the blood purification unit 1 operates the input unit 4a to select and configure the types of arterial odor sensors 13 and venous odor sensors 14. This transmits configuration information from the input unit 4a to the calculation unit 21 of the processing unit 6. Upon receiving this configuration information, the calculation unit 21 recognizes whether the arterial odor sensor 13 and venous odor sensors 14 correspond to either acetic acid odor, the characteristic odor of the blood purifier 5 or the blood circuit, or ammonia odor.

[0051] Next, as shown in Figure 5, the measurement method is set in the blood purification unit 1 (S2: measurement method setting step). Specifically, the operator of the blood purification unit 1 operates the input unit 4a to select and set the type of situation to be measured. As a result, the setting information is transmitted from the input unit 4a to the calculation unit 21 of the processing unit 6. Upon receiving the setting information, the calculation unit 21 recognizes that the situation to be measured is either blood recirculation, dialysis volume and its abnormal changes, or the removal performance of the blood purifier 5 and its abnormal changes. In other words, the calculation unit 21 recognizes the situation to be monitored based on the setting information.

[0052] Next, as shown in Figure 5, dialysis treatment is initiated in the blood purification unit 1 (S3: dialysis treatment process). Specifically, the operator of the blood purification unit 1 prepares the blood purifier 5 and the patient H for dialysis treatment (puncture, etc.), and also operates the input unit 4a to input the program for executing the dialysis treatment. As a result, the processor 6a reads the program for dialysis treatment from the memory 6b and executes it, and the dialysis treatment proceeds sequentially.

[0053] Next, as shown in Figure 5, odor detection is initiated in the blood purification unit 1 while dialysis treatment is being performed (S4: Odor detection process). Specifically, the arterial odor sensor 13 and the venous odor sensor 14, or only the arterial odor sensor 13, operate, and the sensors detect a predetermined odor. Note that the odor detection process differs depending on the settings in S1, so a detailed explanation, including actual measurements, will be provided in the explanation from Figure 6 onwards.

[0054] Next, as shown in Figure 5, measurement processing is performed in the blood purification unit 1 (S5: processing step). Specifically, when the processing unit 6 receives an odor detection signal from the arterial odor sensor 13 and the venous odor sensor 14, or from the arterial odor sensor 13 only, calculations are performed using the detection signal based on the set monitoring conditions, and blood recirculation, dialysis volume and its abnormal changes, or the removal performance of the blood purifier 5 and its abnormal changes are measured. Note that this measurement differs depending on the settings of S1 and S2, so a detailed explanation, including odor detection, will be provided in the explanation from Figure 6 onwards.

[0055] Next, as shown in Figure 5, the blood purification unit 1 displays the measurement results (S6: Measurement result display step). Specifically, the calculation unit 21 of the processing unit 6 transmits the measurement results to the output unit 4b, which then displays the measurement results. For example, the display 4 may show a notification that blood recirculation is occurring, or a notification that there has been an unexpected change in the dialysis volume or the removal performance of the blood purifier 5. The measurement results displayed on the display 4 may include the blood recirculation ratio (VA recirculation rate), the dialysis volume (Kt / V), or a numerical value for the removal performance of the blood purifier 5. In other words, if the situation, state, and content that change according to the progress of dialysis treatment can be determined by the odor in the blood, the measurement results may include each of these situations, states, and content, as well as combinations thereof.

[0056] (Measurement in the blood purification unit) Next, the measurement process and display of measurement results in the blood purification unit 1 will be explained in relation to the sensor settings and measurement setting types, with reference to Figures 6 to 15. Here, Figures 6, 8, 10, 12, and 14 are schematic diagrams showing an example of the usage state of the blood purification unit according to the embodiment. Also, Figures 7, 9, 11, 13, and 15 are flowcharts showing the processing flow related to the measurement process and display of measurement results in Figure 5.

[0057] [Measurement of blood recirculation occurrence based on acetic acid odor] Based on Figures 6 and 7, an example of using the acetic acid odor in the blood to measure the occurrence of blood recirculation will be explained. First, as a premise, as shown in Figure 6, the dialysate, which is a drug solution supplied from the internal piping section 7 to the blood purifier 5 via the dialysate supply pipe L3, generally contains an acetic acid odor. Therefore, during dialysis treatment, when the dialysate and blood come into contact via the blood purifier 5, the acetic acid odor contained in the dialysate is transferred to the blood, and blood with an acetic acid odor flows through the venous blood circuit L2. On the other hand, the blood flowing through the arterial blood circuit L1 is drawn from patient H and therefore does not normally contain an acetic acid odor. However, if blood recirculation occurs, blood with an acetic acid odor will flow through the arterial blood circuit L1.

[0058] To measure whether or not the blood flowing through the arterial blood circuit L1 contains an acetic acid odor, an odor sensor for detecting acetic acid odor is prepared as an arterial odor sensor 13 connected to the arterial chamber 11. On the other hand, the venous odor sensor 14 connected to the venous chamber 12 is not in use and may be removed or left connected in a state where the sensor function is not performed.

[0059] In the above configuration, immediately after the start of dialysis treatment, the calculation unit 21 of the processing unit 6 determines whether or not a detection signal has been received from the arterial odor sensor 13 (S11). If no detection signal is received (S11: No), S11 is repeated until a detection signal is received. If a detection signal is received (S11: Yes), the calculation unit 21 of the processing unit 6 sets the initial odor of the arterial blood based on the detection signal. Here, immediately after the start of dialysis treatment, blood recirculation has not occurred, and the arterial blood does not have an acetic acid odor, so the initial odor without an acetic acid odor is set (S A0 This will be set as the initial value. For example, the initial value could be registered as 0.

[0060] Next, while the dialysis treatment is progressing for a predetermined time, the calculation unit 21 of the processing unit 6 determines whether or not a detection signal has been received from the arterial odor sensor 13 (S13). If no detection signal is received (S13: No), S13 is repeated until a detection signal is received. If a detection signal is received (S13: Yes), the calculation unit 21 of the processing unit 6 performs a detection process for the acetic acid odor of the arterial blood based on the detection signal (S14). Specifically, the calculation unit 21 determines the initial odor (S A0 Based on the detection signal, it is determined whether or not an acetic acid odor not included in the specified range is detected.

[0061] Initial odor (S A0 If the odor does not contain acetic acid (S14: No), the process returns to S13, and it is determined whether or not a detection signal has been received by the arterial odor sensor 13. On the other hand, the odor in the initial state (S A0 If the blood contains an acetic acid odor (S14: Yes), the calculation unit 21 of the processing unit 6 determines that blood recirculation is occurring, based on the detection of an acetic acid odor from the arterial blood. In this case, the calculation unit 21 of the processing unit 6 outputs a notification from the output unit 4b indicating the occurrence of blood recirculation.

[0062] As described above, in this example, the processing unit 6 can monitor blood recirculation based on the presence or absence of an acetic acid odor in the blood flowing through the arterial blood circuit L1. Furthermore, in this example, the occurrence of blood recirculation can be detected without concentrating or diluting the blood. This makes it possible to measure the odor of blood non-invasively, and also allows the operator of the blood purification unit 1 to be notified of the occurrence of blood recirculation at an early stage.

[0063] [Measuring the rate of blood recirculation based on the odor of acetic acid] Next, based on Figures 8 and 9, we will explain an example of using the acetic acid odor in the blood to measure the blood recirculation rate. Note that the premise that the blood contains acetic acid odor is the same as in the above example, so we will omit that explanation.

[0064] In this example, the acetic acid odor of the blood flowing through the arterial blood circuit L1 is compared with the acetic acid odor of the blood flowing through the venous blood circuit L2, and the blood recirculation ratio is measured based on the results of this comparison. For this reason, an odor sensor for detecting acetic acid odor is prepared as the arterial odor sensor 13 connected to the arterial chamber 11. Similarly, an odor sensor for detecting acetic acid odor is also prepared as the venous odor sensor 14 connected to the venous chamber 12.

[0065] In the above configuration, when dialysis treatment is started, the calculation unit 21 of the processing unit 6 determines whether or not a detection signal has been received from the arterial odor sensor 13 (S21). If no detection signal is received from the arterial side (S21: No), S21 is repeated until a detection signal is received. On the other hand, if a detection signal is received (S21: Yes), the calculation unit 21 of the processing unit 6 determines whether or not a detection signal has been received from the venous odor sensor 14 (S22). If no detection signal is received from the venous side (S22: No), S22 is repeated until a detection signal is received.

[0066] Next, when a detection signal is received from the venous side (S22: Yes), the calculation unit 21 of the processing unit 6 calculates the ratio of acetic acid odor on the arterial side to the venous side (S23). Specifically, the calculation unit 21 of the processing unit 6 calculates the numerical value of the acetic acid odor, which is the detection signal from the arterial side odor sensor 13 (S A ) is the numerical value of the acetic acid odor, which is the detection signal from the venous odor sensor 14 (S V Divide by ) and multiply by 100. Here, the value for acetic acid odor is a value quantified by the concentration of acetic acid components in the blood or the intensity of the odor index. Then, the calculation unit 21 of the processing unit 6 takes the calculated value (%) as the blood recirculation rate (VA recirculation rate).

[0067] Next, the arithmetic unit 21 of the processing unit 6 determines whether the ratio (%) of blood recirculation represented by the ratio (%) of acetic acid odor is equal to or greater than a predetermined threshold value (S24). Here, the predetermined threshold value is a numerical value preselected within a range of, for example, 5% to 15%. If the calculated ratio (%) of blood recirculation is not equal to or greater than the predetermined threshold value (S24: No), the arithmetic unit 21 of the processing unit 6 determines that no abnormality due to blood recirculation has occurred, and this flow ends. That is, for the numerical value (S V ) of acetic acid odor, which is the detection signal of the venous-side odor sensor 14, when the numerical value (S A ) of acetic acid odor, which is the detection signal of the arterial-side odor sensor 13, is very small (for example, within 10%), since there is almost no blood with acetic acid odor on the arterial side, the ratio of blood recirculation is small, and it is determined that no blood recirculation has occurred.

[0068] On the other hand, if the calculated ratio (%) of blood recirculation is equal to or greater than the predetermined threshold value (S24: Yes), the arithmetic unit 21 of the processing unit 6 determines that an abnormality due to blood recirculation has occurred (S25). That is, for the numerical value (S V ) of acetic acid odor, which is the detection signal of the venous-side odor sensor 14, when the numerical value (S A ) of acetic acid odor, which is the detection signal of the arterial-side odor sensor 13, is relatively large (for example, 10% or more), blood with acetic acid odor exists on the arterial side, the ratio of blood recirculation is large, and it is determined that blood recirculation has occurred.

[0069] As described above, in this exemplary use, the processing unit 6 can monitor the ratio of blood recirculation based on the ratio of acetic acid odor in the blood flowing through the arterial-side blood circuit L1 and the ratio of acetic acid odor in the blood flowing through the venous-side blood circuit L2. Also, in this exemplary use, the occurrence of blood recirculation is detected without concentrating or diluting the blood. Thereby, it becomes possible to non-invasively measure the odor of blood, and furthermore, the occurrence of blood recirculation is detected and notified to the operator of the blood purification unit 1 early and with high accuracy.

[0070] 〔Measurement of the ratio of blood recirculation by the odor specific to dialysis treatment〕 Next, based on Figures 10 and 11, we will explain an example of using the dialysis treatment-specific odor in the blood to measure the rate of blood recirculation. First, as a premise, as shown in Figure 10, there is a specific odor associated with the blood purifier 5 or the blood circuit (i.e., a dialysis treatment-specific odor). Therefore, during dialysis treatment, as blood passes through the blood purifier 5 and the blood circuit, the specific odor is gradually imparted to the blood, and the specific odor becomes stronger in the blood flowing through the venous blood circuit L2. On the other hand, the blood flowing through the arterial blood circuit L1 has a shorter passage distance through the blood circuit and has not passed through the blood purifier 5, so the specific odor is almost nonexistent or very weak. However, when blood recirculation occurs, the blood with this specific odor flows through the arterial blood circuit L1.

[0071] In this example, the characteristic odor of the blood flowing through the arterial blood circuit L1 is compared with the characteristic odor of the blood flowing through the venous blood circuit L2, and the blood recirculation ratio is measured based on the results of this comparison. For this reason, an odor sensor for detecting this characteristic odor is prepared as the arterial odor sensor 13 connected to the arterial chamber 11. Similarly, an odor sensor for detecting this characteristic odor is also prepared as the venous odor sensor 14 connected to the venous chamber 12.

[0072] In the above configuration, immediately after the start of dialysis treatment, the calculation unit 21 of the processing unit 6 determines whether or not a detection signal has been received from the arterial odor sensor 13 (S31). If no detection signal is received from the arterial side (S31: No), S31 is repeated until a detection signal is received. On the other hand, if a detection signal is received (S31: Yes), the calculation unit 21 of the processing unit 6 determines whether or not a detection signal has been received from the venous odor sensor 14 (S32). If no detection signal is received from the venous side (S32: No), S32 is repeated until a detection signal is received.

[0073] Next, when a detection signal is received from the venous side (S32: Yes), the calculation unit 21 of the processing unit 6 calculates the difference in odor between the arterial side and the venous side (S33). Specifically, the calculation unit 21 of the processing unit 6 calculates the numerical value of the odor, which is the detection signal from the venous side odor sensor 14 immediately after the start of treatment (S V0 ) From this, the odor value (S) is the detection signal from the arterial odor sensor 13 immediately after the start of treatment. A0 ) subtract the characteristic smell (S D Set as ). That is, the odor on the venous side immediately after the start of treatment (S V0 ) From the arterial side (S A0 The characteristic odor is extracted by subtracting the specified value. Here, the numerical value of the characteristic odor is a value quantified by the concentration of the characteristic odor in the blood or the intensity of the odor index.

[0074] Next, while the dialysis treatment is progressing for a predetermined time, the calculation unit 21 of the processing unit 6 determines whether or not a detection signal has been received from the arterial odor sensor 13 (S34). If no detection signal is received (S34: No), S34 is repeated until a detection signal is received. If a detection signal is received (S34: Yes), the calculation unit 21 of the processing unit 6 performs a detection process for the characteristic odor of arterial blood based on the detection signal.

[0075] Next, when a detection signal is received from the arterial side (S34: Yes), the calculation unit 21 of the processing unit 6 calculates the ratio of the specific odor on the arterial side (S35). Specifically, the calculation unit 21 of the processing unit 6 calculates the ratio of the specific odor set in S33 (S D The value of the odor (S) is based on the newly received detection signal (odor measured on the arterial side during dialysis treatment). A The result is divided by ) and multiplied by 100. Then, the calculation unit 21 of the processing unit 6 takes the calculated value (%) as the blood recirculation rate (VA recirculation rate).

[0076] Next, the calculation unit 21 of the processing unit 6 determines whether the blood recirculation rate (%), which is expressed by the ratio (%) of a specific odor, is above a predetermined threshold (S36). Here, the predetermined threshold is, for example, a number selected in advance within the range of 5% to 15%. If the calculated blood recirculation rate (%) is not above the predetermined threshold (S36: No), the calculation unit 21 of the processing unit 6 determines that no abnormality due to blood recirculation has occurred, and this flow ends. That is, the numerical value of the odor (S) which is the detection signal from the arterial odor sensor 13. A ) has a distinctive smell (S D =S V0 -S A0 If the value is very small (for example, within 10%), it is determined that there is almost no blood with a distinctive odor on the arterial side, resulting in a low rate of blood recirculation and the absence of blood recirculation.

[0077] On the other hand, if the calculated blood recirculation rate (%) is above a predetermined threshold (S36: Yes), the calculation unit 21 of the processing unit 6 determines that an abnormality due to blood recirculation has occurred (S37). That is, the numerical value of the odor, which is the detection signal from the arterial odor sensor 13 (S A ) has a distinctive smell (S D =S V0 -S A0 If the value is relatively large (for example, 10% or more), it means that blood with a distinctive odor is present on the arterial side, indicating a high rate of blood recirculation and that blood recirculation is occurring.

[0078] As described above, in this example, a distinctive odor can be extracted from the difference between the odor of the blood flowing through the arterial blood circuit L1 immediately after the start of dialysis treatment and the odor of the blood flowing through the venous blood circuit L2. The rate of blood recirculation can then be monitored by subtracting the odor of the blood flowing through the arterial blood circuit L1 after a predetermined time has elapsed since the start of dialysis treatment. Furthermore, in this example, the occurrence of blood recirculation can be detected without concentrating or diluting the blood. This makes it possible to measure the odor of blood non-invasively, and moreover, the occurrence of blood recirculation can be detected and reported to the operator of the blood purification unit 1 early and with high accuracy.

[0079] [Measurement of dialysis volume by ammonia odor] Based on Figures 12 and 13, we will explain an example of using the ammonia odor in the blood to measure the dialysis volume and detect abnormal changes in the dialysis volume. First, as a premise, patient H has an increased concentration of uremic toxins in his blood due to decreased renal function. That is, patient H's blood will have an ammonia odor compared to that of a normal person. Then, dialysis treatment removes the uremic toxins from patient H's blood. Therefore, as dialysis treatment progresses, the concentration of uremic toxins in patient H's blood decreases, and the ammonia odor in the blood also decreases. Because of this decrease in uremic toxin concentration as dialysis treatment progresses, it becomes possible to measure the dialysis volume by detecting and utilizing the ammonia odor in the blood flowing at least in the arterial blood circuit L1.

[0080] In this example, to utilize the detection of ammonia odor in the blood flowing through the arterial blood circuit L1, an odor sensor for detecting ammonia odor is prepared as an arterial odor sensor 13 connected to the arterial chamber 11. On the other hand, the venous odor sensor 14 connected to the venous chamber 12 is not used and may be removed or left connected in a state where the sensor function is not performed.

[0081] In the above configuration, immediately after the start of dialysis treatment, the calculation unit 21 of the processing unit 6 determines whether or not a detection signal has been received from the arterial odor sensor 13 (S41). If no detection signal is received (S41: No), S41 is repeated until a detection signal is received. If a detection signal is received (S41: Yes), the calculation unit 21 of the processing unit 6 sets the initial value of the ammonia odor based on the detection signal (S42). That is, the initial ammonia odor of the arterial blood is set. Here, immediately after the start of dialysis treatment, uremic toxins have not been removed from the patient H's blood, so the initial odor is strong (S A0 The value of (i.e., the ammonia odor value) is initially set. Here, the ammonia odor value is a value quantified by the concentration of ammonia in the blood or the intensity of the odor index.

[0082] Next, while the dialysis treatment progresses for a predetermined time, the calculation unit 21 of the processing unit 6 determines whether or not a detection signal has been received from the arterial odor sensor 13 (S43). If no detection signal is received (S43: No), S43 is repeated until a detection signal is received. On the other hand, if a detection signal is received (S43: Yes), the calculation unit 21 of the processing unit 6 calculates a numerical value for ammonia odor based on the newly received detection signal (S A ) and the initial odor (S) set to the initial value. A0 Based on this, the dialysis dose is measured (S44). Specifically, the calculation unit 21 of the processing unit 6 measures the dialysis dose from the change in ammonia odor of the arterial blood over time. More specifically, the calculation unit 21 calculates Kt / V = -In(S A / S A0 The formula used will be ). Here, Kt / V is the standardized dialysis dose.

[0083] Subsequently, the calculation unit 21 of the processing unit 6 may determine whether or not an abnormal change in the dialysis amount has occurred based on the measured dialysis amount. That is, the numerical value of the ammonia odor (S) based on the newly received detection signal. AIf the value remains relatively high, the change in dialysis volume will cease, and it can be determined that there is a problem with the dialysis treatment. For example, it can be estimated that there is a malfunction in the blood purifier 5, a malfunction in another device, or that blood recirculation is occurring. In particular, if the value of the monitored dialysis volume rises rapidly in a short period of time, it can be determined that blood recirculation is occurring, as blood from which uremic toxins have been removed is being removed again.

[0084] As described above, in this example of use, the processing unit 6 can calculate the dialysis volume and measure abnormal changes in the dialysis volume based on the degree of ammonia odor in the blood flowing through the arterial blood circuit L1. This allows the operator of the blood purification unit 1 to be notified of the dialysis volume measurement results early, enabling prompt action if there is a problem with the treatment.

[0085] [Measurement of the removal performance of blood purifiers by ammonia odor] Next, based on Figures 14 and 15, we will explain an example of using the ammonia odor in the blood to measure the removal performance of the blood purifier 5 and any abnormal changes therein. Note that the premise that the blood contains ammonia odor is the same as in the above example, so we will omit that explanation.

[0086] In this example, a predetermined calculation is performed using the ammonia odor of the blood flowing through the arterial blood circuit L1 and the ammonia odor of the blood flowing through the venous blood circuit L2. Based on the results of this calculation, the removal performance of the blood purifier 5 and any abnormal changes thereto are measured. For this reason, an odor sensor for detecting ammonia odor is prepared as the arterial odor sensor 13 connected to the arterial chamber 11. Similarly, an odor sensor for detecting ammonia odor is also prepared as the venous odor sensor 14 connected to the venous chamber 12.

[0087] In the above configuration, when dialysis treatment begins, the calculation unit 21 of the processing unit 6 determines whether or not a detection signal has been received from the arterial odor sensor 13 (S51). If no detection signal is received (S51: No), S51 is repeated until a detection signal is received.

[0088] On the other hand, if a detection signal is received (S51: Yes), it is determined whether or not a detection signal has been received by the arterial odor sensor 13 (S52). If no detection signal is received (S52: No), S52 is repeated until a detection signal is received.

[0089] If a detection signal is received (S52: Yes), the calculation unit 21 of the processing unit 6 measures the removal performance of the blood purifier 5 from the difference between the ammonia odor value on the arterial side and the ammonia odor value on the venous side (S53). Specifically, the calculation unit 21 (S A -S V ) / S A ×(Q bo -Q UF )+Q UF The removal performance [ml / min] of the blood purifier 5 is measured using the formula shown. Here, Q bo Q is the blood flow rate at the blood outlet 5b of the blood purifier 5, and UF This is the ultrafiltration rate.

[0090] Subsequently, the calculation unit 21 of the processing unit 6 may determine whether or not an abnormal change has occurred in the removal performance of the blood purifier 5 based on the measured removal performance of the blood purifier 5. That is, the numerical value of ammonia odor on the arterial side (S A If the blood purifier (5) remains relatively high, it indicates that dialysis treatment is not progressing, and it can be concluded that there is a malfunction in the blood purifier (5). For example, it can be estimated that a blockage has occurred in the blood purifier (5).

[0091] As described above, in this example of use, the processing unit 6 can calculate the removal performance of the blood purifier 5 and measure any abnormal changes thereto based on the degree of ammonia odor in the blood flowing through the arterial blood circuit L1 and the venous blood circuit L2. This allows the operator of the blood purification unit 1 to be notified of the measurement results of the removal performance of the blood purifier 5 at an early stage, enabling prompt action if there are any problems with the treatment.

[0092] (Effects of the first embodiment) In this embodiment, a detection signal is received from an odor sensor that detects a predetermined odor contained in the blood flowing through the blood circuit, and the status of dialysis treatment is monitored from this detection signal. In particular, by selecting an odor sensor according to the odor to be detected, blood recirculation, dialysis volume, or the removal performance of the blood purifier can be monitored. This reduces the impact on the time of the dialysis treatment itself and allows for non-invasive monitoring with a relatively simple configuration.

[0093] (Modification of the first embodiment) In the above embodiment, each odor sensor for detecting the odor of blood was connected to the arterial side chamber 11 of the arterial side blood circuit L1 or the venous side chamber 12 of the venous side blood circuit L2, which constitute the blood circuit. However, the location of the odor sensor is not limited to these locations. For example, the odor sensor may be directly installed in either the arterial side blood circuit L1 or the venous side blood circuit L2.

[0094] Furthermore, in the above embodiment, each odor sensor is installed inside or on the surface of the main body 3 of the blood purification device 1a, and is therefore provided as a component of the blood purification device 1a. However, each odor sensor may also be provided as a component of the consumables section 1b. In other words, each odor sensor may be treated as a consumable, similar to the blood circuit.

[0095] Furthermore, in the above embodiment, either the dialysis volume or the removal performance of the blood purifier 5 was monitored, but since these measurements are processed based on the detection results of ammonia odor, these monitoring may be performed simultaneously. That is, the calculation unit 21 of the processing unit 6 may measure the dialysis volume and the removal performance of the blood purifier 5 based on the ammonia odor of the blood flowing in the arterial blood circuit L1 and the ammonia odor of the blood flowing in the venous blood circuit L2, further measure any abnormal changes in these, and display the measurement results on the display 4.

[0096] <Second Embodiment> In the first embodiment, either blood recirculation, dialysis volume, or the removal performance of the blood purifier 5 was monitored. However, by preparing an odor sensor capable of detecting different odors, it is possible to monitor blood recirculation and dialysis volume, blood recirculation and the removal performance of the blood purifier 5, or all three simultaneously. A configuration that allows such monitoring will be described as the second embodiment with reference to Figure 16. Here, Figure 16 is a schematic diagram showing the mechanical configuration of the extracorporeal circulation section and the internal piping section of the blood purification unit according to this embodiment. Note that the parts that differ from the first embodiment will be described in principle, and the same content will be omitted from the description, and the same reference numerals will be used in the drawings in principle.

[0097] As shown in Figure 16, on the arterial side of the blood purification unit 1 according to this embodiment, arterial odor sensors 13 and 15, which can detect different odors from each other, are connected to the arterial chamber 11. For example, it is assumed that arterial odor sensor 13 can detect acetic acid odor and arterial odor sensor 15 can detect ammonia odor. On the other hand, on the venous side of the blood purification unit 1, venous odor sensors 14 and 16, which can detect different odors from each other, are connected to the venous chamber 12. For example, it is assumed that venous odor sensor 14 can detect acetic acid odor and venous odor sensor 16 can detect ammonia odor.

[0098] Thus, in the blood purification unit 1 according to this embodiment, acetic acid odor and ammonia odor can be detected simultaneously. Therefore, while measuring blood recirculation based on the detection of acetic acid odor, it is possible to measure either the dialysis volume or the removal performance of the blood purifier 5, or both. Note that each measurement is the same as the measurement in the first embodiment, so its explanation will be omitted.

[0099] (Effects of the second embodiment) As described above, in this embodiment as well, a detection signal is received from an odor sensor that detects a predetermined odor contained in the blood flowing through the blood circuit, and the status of dialysis treatment is monitored from this detection signal. In particular, by selecting two types of odor sensors according to the two types of odors to be detected, it is possible to measure either the dialysis volume or the removal performance of the blood purifier 5, or both, while measuring blood recirculation. This reduces the impact on the time of the dialysis treatment itself and enables non-invasive monitoring with a relatively simple configuration.

[0100] <Third Embodiment> In the first and second embodiments, odor sensors were connected to the blood circuit, but odor sensors may also be connected to the dialysate piping connecting the internal piping section 7 and the blood purifier 5, and odor detection of the dialysate in the dialysate piping may be performed. A configuration that enables monitoring based on such odor detection will be described as a third embodiment with reference to Figure 17. Here, Figure 17 is a schematic diagram showing the mechanical configuration of the extracorporeal circulation section and the internal piping section of the blood purification unit according to this embodiment. Note that only the parts that differ from the first embodiment will be described in detail, and the same content will be omitted from the explanation, and the same reference numerals will generally be used in the drawings.

[0101] As shown in Figure 17, in the blood purification unit 1 according to this embodiment, a supply-side odor sensor 17 is connected to the dialysate supply pipe L3, and a discharge-side odor sensor 18 is connected to the dialysate discharge pipe L4. Here, the supply-side odor sensor 17 and the discharge-side odor sensor 18 are odor sensors capable of detecting ammonia odor.

[0102] Similar to the first embodiment where ammonia odor detection is used, patient H's blood has an ammonia odor compared to that of a normal person, and when it comes into contact with the dialysate in the blood purifier 5, this ammonia odor is imparted to the dialysate. On the other hand, as dialysis treatment progresses, the concentration of uremic toxins in patient H's blood decreases, and the ammonia odor in the blood also decreases, so the imparting of ammonia odor to the dialysate also decreases. Therefore, by detecting this ammonia odor, the amount of dialysis and the removal performance of the blood purifier 5 can be measured. Note that the measurement based on ammonia odor is the same as the measurement in the first embodiment, so its explanation is omitted.

[0103] (Effects of the third embodiment) As described above, in this embodiment, a detection signal is received from an odor sensor that detects a predetermined odor (ammonia odor) contained in the dialysate flowing through the blood purifier 5, and the status of the dialysis treatment is monitored from this detection signal. In particular, by selecting an odor sensor according to the odor to be detected, the amount of dialysis or the removal performance of the blood purifier is monitored. Therefore, the impact on the time of the dialysis treatment itself is reduced, and non-invasive monitoring can be performed with a relatively simple configuration.

[0104] Furthermore, in this embodiment, since it is not necessary to connect an odor sensor to the blood circuit, the blood circuit can be kept clean. In addition, there is no need to change or replace the odor sensor as a consumable item.

[0105] <Embodiments of this disclosure> A first embodiment of the present disclosure is a blood purification device comprising a blood purifier for purifying a patient's blood, and a blood circuit connected to the blood purifier for introducing blood drawn from the patient into the blood purifier and returning the purified blood from the blood purifier to the patient, the blood purification device having a processing unit that receives a detection signal from at least one odor sensor that detects a predetermined odor contained in the blood flowing through the blood circuit or in a blood purification solution introduced into or out of the blood purifier, and measures the status of blood purification treatment from the detection signal.

[0106] By using the detection signals from such odor sensors to measure the status of blood purification therapy, access to the blood is unnecessary for the measurement, and complex equipment for performing the measurement is not required. Therefore, the impact on the duration of the blood purification therapy itself is reduced, and non-invasive monitoring can be performed with a relatively simple configuration.

[0107] A second embodiment of this disclosure is that, in the first embodiment, the processing unit measures blood recirculation, dialysis volume, or the removal performance of the blood purifier based on the numerical value of the odor of the blood or the drug solution that changes as it passes through the blood purifier. This allows for monitoring of various conditions of blood purification therapy and enables notification of various conditions to the operator of the blood purification device.

[0108] A third embodiment of this disclosure is, in the second embodiment, the odor sensor is placed in the arterial blood circuit constituting the blood circuit, and the processing unit measures whether or not blood recirculation is occurring based on the presence or absence of the odor in the blood flowing through the arterial blood circuit. This enables more accurate non-invasive monitoring with a relatively simple configuration.

[0109] A fourth embodiment of the present disclosure is, in the second embodiment, the odor sensor is connected to the arterial and venous blood circuits constituting the blood circuit, and the processing unit measures the rate of blood recirculation by the ratio of the odor in the blood flowing through the arterial blood circuit to the odor in the blood flowing through the venous blood circuit. This enables more accurate non-invasive monitoring with a relatively simple configuration.

[0110] A fifth embodiment of this disclosure is, in the second embodiment, the odor sensor is connected to the arterial and venous blood circuits constituting the blood circuit, and the processing unit measures the rate of blood recirculation by dividing the difference between the odor value in the blood flowing through the arterial blood circuit immediately after the start of blood purification therapy and the odor value in the blood flowing through the venous blood circuit by the odor value in the blood flowing through the arterial blood circuit after a predetermined time has elapsed since the start of blood purification therapy. This enables more accurate non-invasive monitoring with a relatively simple configuration.

[0111] A sixth embodiment of this disclosure is, in the second embodiment, the odor sensor is connected to the arterial blood circuit constituting the blood circuit and detects the ammonia odor contained in the blood, and the processing unit measures the amount of dialysis based on the change in the ammonia odor in the blood flowing through the arterial blood circuit over time. This enables more accurate non-invasive monitoring with a relatively simple configuration.

[0112] A seventh embodiment of the present disclosure, in a second embodiment, is that the odor sensor is connected to the arterial and venous blood circuits constituting the blood circuit, detects the ammonia odor contained in the blood, and the processing unit measures the removal performance of the blood purifier based on the difference in ammonia odor in the blood flowing through the arterial and venous blood circuits. This enables more accurate non-invasive monitoring with a relatively simple configuration.

[0113] An eighth embodiment of the present disclosure further comprises an internal piping section for introducing and discharging the drug solution to and from the blood purifier, wherein the odor sensor is connected to a drug solution discharge pipe constituting the internal piping section and detects the ammonia odor contained in the drug solution, and the processing unit measures the dialysis amount based on the change in the ammonia odor in the drug solution flowing through the drug solution discharge pipe over time. This enables more accurate non-invasive monitoring with a relatively simple configuration.

[0114] A ninth embodiment of the present disclosure further comprises an internal piping section for introducing and discharging the chemical solution to and from the blood purifier, wherein the odor sensor is connected to a chemical solution supply pipe and a chemical solution discharge pipe constituting the internal piping section, detects the ammonia odor contained in the chemical solution, and the processing unit measures the removal performance of the blood purifier based on the difference in ammonia odor in the chemical solution flowing through the chemical solution supply pipe and the chemical solution discharge pipe. This enables more accurate non-invasive monitoring with a relatively simple configuration.

[0115] A tenth embodiment of the present disclosure is that any of the first to ninth embodiments includes the odor sensor. This makes the odor sensor part of the blood purification device, allowing for more precise control of the odor sensor and more accurate reception of detection signals from the odor sensor.

[0116] An eleventh embodiment of the present disclosure is a method for monitoring blood purification in a blood purification apparatus, which includes a blood purifier for purifying a patient's blood, and a blood circuit connected to the blood purifier for introducing blood drawn from the patient into the blood purifier and returning the purified blood from the blood purifier to the patient, the method comprising: an odor detection step for detecting a predetermined odor contained in the blood flowing through the blood circuit or in a blood purification solution introduced into or out of the blood purifier; and a processing step for measuring the status of blood purification treatment from the detection signal acquired in the odor detection step.

[0117] By using the detection signals from such odor sensors to measure the status of blood purification therapy, access to the blood is unnecessary for the measurement, and complex equipment for performing the measurement is not required. Therefore, the impact on the duration of the blood purification therapy itself is reduced, and non-invasive monitoring can be performed with a relatively simple configuration.

[0118] A twelfth embodiment of this disclosure is, in the eleventh embodiment, the processing step is to measure blood recirculation, dialysis volume, or the removal performance of the blood purifier based on the numerical value of the odor of the blood or the drug solution that changes as it passes through the blood purifier. This makes it possible to monitor various conditions of blood purification therapy and to inform the operator of the blood purification device of various conditions. [Explanation of Symbols]

[0119] 1. Blood purification unit 1a Blood purification device 1b Consumables section 2 Base Units 3 Main unit 4 displays 5. Blood Purifier 6 Processing Unit 7 Internal piping section 8 Extracorporeal Circulation Department 11 Arterial side chamber 12 Venous side chamber 13. Arterial odor sensor 14. Venous odor sensor 21 Arithmetic section 22 Memory section L1 arterial blood circuit L2 venous blood circuit L3 Dialysis fluid supply tube (medication supply tube) L4 Dialysis fluid drainage tube (drug drainage tube) P1 Pump H patient

Claims

1. A blood purifier for purifying a patient's blood, and a blood purification device comprising a blood circuit connected to the blood purifier for introducing blood drawn from the patient into the blood purifier and returning the purified blood from the blood purifier to the patient, A blood purification device having a processing unit that receives a detection signal from at least one odor sensor that detects a predetermined odor contained in the blood flowing through the blood circuit or in the blood purification drug solution introduced into the blood purifier, and measures the status of blood purification treatment from the detection signal.

2. The blood purification apparatus according to claim 1, wherein the processing unit measures blood recirculation, dialysis volume, or the removal performance of the blood purification device based on the numerical value of the odor of the blood or the drug solution that changes as it passes through the blood purification device.

3. The odor sensor is connected to the arterial blood circuit that constitutes the blood circuit. The blood purification apparatus according to claim 2, wherein the processing unit measures whether or not blood recirculation occurs based on the presence or absence of the odor in the blood flowing through the arterial blood circuit.

4. The odor sensor is connected to the arterial blood circuit and the venous blood circuit that constitute the blood circuit. The blood purification apparatus according to claim 2, wherein the processing unit measures the rate of blood recirculation based on the ratio of the odor in the blood flowing through the arterial blood circuit to the odor in the blood flowing through the venous blood circuit.

5. The odor sensor is connected to the arterial blood circuit and the venous blood circuit that constitute the blood circuit. The blood purification apparatus according to claim 2, wherein the processing unit measures the rate of blood recirculation by dividing the difference between the odor value of the blood flowing through the arterial blood circuit immediately after the start of blood purification treatment and the odor value of the blood flowing through the venous blood circuit by the odor value of the blood flowing through the arterial blood circuit after a predetermined time has elapsed since the start of blood purification treatment.

6. The odor sensor is connected to the arterial blood circuit that constitutes the blood circuit and detects the ammonia odor contained in the blood. The blood purification apparatus according to claim 2, wherein the processing unit measures the amount of dialysis based on the change over time in the ammonia odor of the blood flowing through the arterial blood circuit.

7. The odor sensor is connected to the arterial and venous blood circuits that constitute the blood circuit, and detects the ammonia odor contained in the blood. The blood purification apparatus according to claim 2, wherein the processing unit measures the removal performance of the blood purifier based on the difference in ammonia odor in the blood flowing through the arterial blood circuit and the venous blood circuit.

8. The device further includes an internal piping section for introducing and discharging the aforementioned drug solution to and from the blood purifier. The odor sensor is connected to the chemical solution discharge pipe that constitutes the internal piping section and detects the ammonia odor contained in the chemical solution. The blood purification apparatus according to claim 2, wherein the processing unit measures the amount of dialysis based on the change over time in the ammonia odor of the drug solution flowing through the drug solution discharge pipe.

9. The device further includes an internal piping section for introducing and discharging the aforementioned drug solution to and from the blood purifier. The odor sensor is connected to the chemical supply pipe and chemical discharge pipe that constitute the internal piping section, and detects the ammonia odor contained in the chemical solution. The blood purification apparatus according to claim 2, wherein the processing unit measures the removal performance of the blood purifier based on the difference in ammonia odor in the chemical solution flowing through the chemical solution supply pipe and the chemical solution discharge pipe.

10. The blood purification device according to any one of claims 1 to 9, having the odor sensor.

11. A blood purification device comprising a blood purifier for purifying a patient's blood, and a blood circuit connected to the blood purifier for introducing blood drawn from the patient into the blood purifier and returning the purified blood from the blood purifier to the patient, wherein the blood purification device comprises a blood purifier for purifying a patient's blood, and a method for monitoring blood purification in such a device, A method for detecting a predetermined odor contained in the blood flowing through the blood circuit or in the blood purification solution introduced into the blood purifier, A method for monitoring blood purification, comprising a processing step of measuring the status of blood purification treatment from a detection signal acquired in the odor detection step.

12. The blood purification monitoring method according to claim 11, wherein the processing step measures blood recirculation, dialysis volume, or the removal performance of the blood purifier based on the numerical value of the odor of the blood or the drug solution that changes as it passes through the blood purifier.

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