Blood purification device, blood purification monitoring method, information processing device, information processing method, and program

Abstract

Provided is a blood purification device to which a blood purifier for purifying the blood of a patient and a blood circuit for introducing the blood removed from the patient into the blood purifier and returning purified blood from the blood purifier to the patient are connected. The blood purification device includes a processing unit that receives a detection signal from at least one odor sensor that detects a predetermined odor contained in a chemical solution for blood purification introduced into and discharged from the blood purifier, and measures, from the detection signal, a status related to a blood purification treatment.

Description

Blood purification device, method for monitoring blood purification, information processing device, information processing method, and program

[0001] This disclosure relates to a blood purification device that performs blood purification therapy while circulating a patient's blood extracorporeally, a method for monitoring blood purification therein, and an information processing device, information processing method, and program applied thereto that identify the odor of a patient's blood.

[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, monitoring the status of blood purification therapy involves vascular access (VA) recirculation measurement. Specifically, the measurement method involves creating blood markers by concentrating or diluting the blood, and monitoring these blood markers in the blood circuit using 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.

[0005] Incidentally, it is known that in patients suffering from diseases, the concentration of certain substances or components in their blood increases, altering their breath odor and body odor. For example, patients with renal failure have high concentrations of blood urea nitrogen (BUN), resulting in an ammonia-like odor in their breath. Furthermore, sensors exist that detect and measure the concentration of specific odors (volatile substances), and examples of their use include fire alarms and alcohol testers.

[0006] Patent Document 3 discloses a blood alcohol concentration meter capable of measuring alcohol concentration from a person's blood or breath. This blood alcohol concentration meter collects a person's blood at the accident scene and measures the alcohol concentration in the collected blood. This makes it possible to quickly measure blood alcohol concentration at the accident scene, minimizing the time elapsed and enabling accurate measurement of alcohol concentration.

[0007] Japanese Patent Publication No. 2022-113181 Japanese Patent Publication No. 2021-73030 Japanese Patent Publication No. 5822149

[0008] 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.

[0009] Therefore, while non-invasive monitoring is desirable, the blood alcohol concentration measuring devices described above can only measure and identify the blood alcohol concentration (alcohol odor) of the subject. In other words, these concentration measuring devices cannot identify odors related to pathological conditions, such as whether the subject has renal failure or diabetes. Furthermore, there was a problem in that odor-related data could not be continuously acquired and utilized with a one-time measurement.

[0010] This disclosure has been made in view of these challenges, 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. Furthermore, as a non-invasive monitoring method, it is also intended to provide an information processing device, an information processing method, and a program that can acquire odor-related data from the blood of a subject (patient) and quantitatively identify odors related to the patient's condition.

[0011] According to one aspect of the present disclosure, a blood purification device is provided that provides blood purification therapy to a patient using a blood purifier for purifying a patient's blood, and a blood circuit 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 comprising 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 therapy from the detection signal.

[0012] According to one aspect of the present disclosure, a method for monitoring blood purification in a blood purification device that provides blood purification therapy to a patient using a blood purifier for purifying a patient's blood and a blood circuit for introducing blood drawn from the patient into the blood purifier and returning the purified blood to the patient from the blood purifier, 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 drug solution introduced into or out of the blood purifier; and a processing step for measuring the status of blood purification therapy from the detection signal acquired in the odor detection step.

[0013] According to one aspect of the present disclosure, an information processing device for identifying the odor of a patient's blood is provided, comprising: an acquisition unit that receives a detection signal from an odor sensor that detects a predetermined odor contained in the blood, and acquires odor data relating to the predetermined odor from the detection signal; and an identification unit that identifies the odor relating to the patient's condition or the status of blood purification treatment based on the odor data.

[0014] According to one aspect of this disclosure, "an information processing method for identifying the odor of a patient's blood using a computer is provided, comprising the steps of: receiving a detection signal from an odor sensor that detects a predetermined odor contained in the blood; acquiring odor data relating to the predetermined odor from the detection signal; and identifying an odor relating to the patient's condition or the status of blood purification treatment based on the odor data."

[0015] According to one aspect of this disclosure, a program is provided for identifying the odor of a patient's blood, which receives a detection signal from an odor sensor that detects a predetermined odor contained in the blood, obtains odor data related to the predetermined odor from the detection signal, and causes a computer to perform processing to identify the odor related to the patient's medical condition or the status of blood purification treatment based on the odor data.

[0016] According to this disclosure, a blood purification device and a blood purification monitoring method are provided that reduce the extracorporeal blood volume, minimize the impact on the time of the blood purification treatment itself, and enable non-invasive monitoring with a relatively simple configuration. Furthermore, an information processing device, information processing method, and program are provided that can acquire odor-related data from the blood of a subject (patient) taken outside the body as part of the non-invasive monitoring, and quantitatively identify odors related to the patient's condition.

[0017] The effects described above are merely illustrative for the sake of explanation, and the effects relating to this disclosure are not limited to those described above. In addition to the effects described above, any other effects described herein may be achieved.

[0018] This is a schematic diagram showing the mechanical configuration of the blood purification unit according to the first embodiment. This is a block diagram showing the electrical configuration of the blood purification unit according to the first embodiment. 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 first embodiment. This is a functional block diagram of the blood purification unit according to the first embodiment. This is a flowchart showing the processing flow related to monitoring of the blood purification unit according to the first embodiment. This is a schematic diagram showing an example of the usage state of the blood purification unit according to the first embodiment. This is a flowchart showing the processing flow related to measurement processing and display of measurement results in Figure 5 the mechanical configuration of the extracorporeal circulation section and the internal piping section of the blood purification unit according to the second embodiment. This is a schematic diagram showing the mechanical configuration of the extracorporeal circulation section and internal piping section of the blood purification unit according to the third embodiment. This is a block diagram showing the electrical configuration of the information processing device according to the fourth embodiment. This is a functional block diagram of the information processing system according to the fourth embodiment. This is a schematic diagram showing an example of use of the information processing system according to the fourth embodiment. This is a data table stored in the information processing device according to the fourth embodiment. This is a schematic diagram showing an example of use of the information processing system according to the fourth embodiment. This is a functional block diagram of the information processing system according to the fifth embodiment. This is a flowchart showing the flow of setting the learned identification model to be set in the information processing device according to the fifth embodiment. This is a schematic diagram showing information processing by the learned identification model set in the information processing device according to the fifth embodiment.

[0019] 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.

[0020] <First Embodiment> (Configuration of 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.

[0021] 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. To put it another way, the blood purification device 1a uses the consumables, a blood purifier and blood circuit described later, to perform dialysis treatment, an example of blood purification therapy, on the patient.

[0022] Specifically, the blood purification unit 1 includes a main body 3 installed on the base unit 2, a display 4 connected to the upper part of the main body 3, and a blood purifier 5 installed on the side of the main body 3. Further, the main body 3 of the blood purification unit 1 has a processing unit 6 for processing various types of information and data, an internal piping unit 7 for circulating dialysis fluid between the blood purifier 5, and an extracorporeal circulation unit 8 for circulating the blood, which is the body fluid of the patient H, outside the body. With such a configuration, the blood purification unit 1 can take out the patient H's blood outside the body (blood extraction process), remove unnecessary or toxic substances or water from the blood in the blood purifier 5 (blood purification process), and return the purified blood to the patient H (blood return process).

[0023] The blood purification device 1a is the base of the blood purification unit 1 and is composed of a part of the base unit 2, the main body 3, the display 4, the processing unit 6, the internal piping unit 7, and the extracorporeal circulation unit 8. Here, the extracorporeal circulation unit 8 includes a blood circuit described later, a pump connected to the blood circuit, and other components and devices. Among these, since the pump and other devices are provided in the blood purification device 1a, they become components (constituent devices) of the blood purification device 1a.

[0024] On the other hand, the consumable unit 1b is composed of a part of the blood purifier 5 and the extracorporeal circulation unit 8. Here, a part of the blood circuit and other components included in the extracorporeal circulation unit 8 are only detachably connected to the blood purification device 1a and become components (parts) of the consumable unit 1b rather than the blood purification device 1a.

[0025] As shown in FIG. 2, in the blood purification unit 1, a display 4, a processing unit 6, an internal piping unit 7, and an extracorporeal circulation unit 8 are electrically connected to each other via control lines and data lines. Thereby, in the blood purification apparatus 1a, transmission and reception of various signals, data, and information are possible, and various controls by the processing unit 6 are also possible. In the following, data is basically assumed to be composed of numerical values, symbols, characters, etc. obtained by processing signals and the like. Further, information is basically assumed to be something obtained by collecting or processing the data, for example, content that can be used by the receiving side as a subsequent consideration material or utilized by the receiving side. However, data and information may be used in a manner inconsistent with the above assumptions depending on their content and the context before and after.

[0026] In the present embodiment, although the case of a hemodialysis apparatus is described as an example of the blood purification apparatus 1a, it is not limited thereto. For example, an apparatus for acute blood purification, a peritoneal dialysis apparatus, an ultrafiltration apparatus, or a hemofiltration apparatus may also be an example of the blood purification apparatus 1a.

[0027] Further, in addition to the above-described configuration, the blood purification apparatus 1a of the blood purification unit 1 may have a communication unit that enables transmission and reception of information and the like with an external device such as a terminal device or a server device. Thereby, in the blood purification apparatus 1a, various types of information (patient information) related to the treatment of a patient may be acquired from the external device via the communication unit.

[0028] 〔Base Unit〕 As shown in FIG. 1, the base unit 2 is composed of a plate-shaped base 2a connected to the bottom of the main body 3 and four casters 2b installed on the base 2a. Thereby, it becomes possible to easily move the blood purification unit 1 and the blood purification apparatus 1a. The number of casters 2b is not limited to four, and may be three or five or more as long as the blood purification unit 1 and the blood purification apparatus 1a can be moved.

[0029] [Main Body] 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.

[0030] [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.

[0031] 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.

[0032] [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 discharge pipe (drug discharge pipe) L4, which will be described later, is connected to the dialysate outlet 5d.

[0033] The blood purifier 5 houses multiple hollow fiber membranes (not shown) inside, and these hollow fibers 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.

[0034] 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.

[0035] [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. Flexible materials such as polyvinyl chloride tubing or silicone tubing may be used for the piping.

[0036] 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.

[0037] [Extracorporeal Circulation Unit] 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.

[0038] 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 the pump P1 rotates forward (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.

[0039] Furthermore, 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.

[0040] 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. As a result, 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.

[0041] 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.

[0042] 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.

[0043] [Processing Unit] Next, the processing unit 6 according to this embodiment is composed of a processor 6a and a memory 6b, as shown in Figure 2.

[0044] 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 the memory 6b. Specifically, the processor 6a reads from the memory 6b a program for performing treatment to purify the patient's blood or a program for running the OS and executes it.

[0045] 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.

[0046] The processor 6a may consist of a single GPU or CPU, or it may be composed of a combination of multiple CPUs or GPUs.

[0047] 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 to write and read 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.

[0048] 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.

[0049] 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.

[0050] 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.

[0051] 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.

[0052] 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 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.

[0053] 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 the 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.

[0054] The calculation unit 21 then transmits the measurement results to the output unit 4b, including them in the display information. As a result, the measurement results are displayed on the output unit 4b, allowing the operator of the blood purification unit 1 (a medical professional such as a doctor or nurse, or patient H) to easily check the status of the dialysis treatment (including any abnormal changes).

[0055] (Processing in the Blood Purification Unit) Next, an overview of the processing related to treatment and measurement 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.

[0056] 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.

[0057] 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.

[0058] 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.

[0059] 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 step). 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 differs depending on the setting in S1, so a detailed explanation, including actual measurements, will be provided in the explanation from Figure 6 onwards.

[0060] 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.

[0061] 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 rate (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.

[0062] (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.

[0063] [Measurement of Blood Recirculation Occurrence by Acetic Acid Odor] Based on Figures 6 and 7, an example of measuring the presence or absence of blood recirculation using the acetic acid odor in the blood 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 the patient H, so it 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.

[0064] 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 used and may be removed or connected in a state where the sensor function is not performed.

[0065] 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 (S Ａ０ This will be set as the initial value. For example, the initial value could be registered as 0.

[0066] 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.

[0067] 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 Ａ０If an acetic acid odor is present (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.

[0068] 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.

[0069] [Measuring the ratio of blood recirculation using acetic acid odor] Next, an example of measuring the ratio of blood recirculation using the acetic acid odor in the blood will be explained based on Figures 8 and 9. Note that the premise that the blood contains acetic acid odor is the same as in the above example, so that explanation will be omitted.

[0070] 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.

[0071] 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.

[0072] Next, when the detection signal on the venous side is received (S22: Yes), the arithmetic unit 21 of the processing unit 6 calculates the ratio of the acetic acid odor on the arterial side and the venous side (S23). Specifically, the arithmetic unit 21 of the processing unit 6 divides the numerical value of the acetic acid odor (S Ａ ) which is the detection signal by the arterial-side odor sensor 13 by the numerical value of the acetic acid odor (S Ｖ ) which is the detection signal by the venous-side odor sensor 14 and multiplies the result by 100. Here, the numerical value of the acetic acid odor is a value quantified by the concentration of the acetic acid component in the blood or the intensity of the odor index. Then, the arithmetic unit 21 of the processing unit 6 sets the calculated numerical value (%) as the ratio of blood recirculation (VA recirculation rate).

[0073] Next, the arithmetic unit 21 of the processing unit 6 determines whether the ratio of blood recirculation (%) represented by the ratio of the acetic acid odor (%) is equal to or greater than a predetermined threshold value (S24). Here, the predetermined threshold value is a numerical value pre-selected, for example, within the range of 5% to 15%. When the calculated ratio of blood recirculation (%) is less 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, when the numerical value of the acetic acid odor (S Ｖ ) which is the detection signal by the venous-side odor sensor 14 is very small compared to the numerical value of the acetic acid odor (S Ａ ) which is the detection signal by the arterial-side odor sensor 13 (for example, within 10%), it is determined that there is almost no blood with an acetic acid odor on the arterial side, so the ratio of blood recirculation is small and no blood recirculation occurs.

[0074] On the other hand, when 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, when the numerical value of the acetic acid odor (S Ｖ ) which is the detection signal by the venous-side odor sensor 14 is relatively large compared to the numerical value of the acetic acid odor (S Ａ ) which is the detection signal by the arterial-side odor sensor 13 (for example, 10% or more), it is determined that blood with an acetic acid odor exists on the arterial side, so the ratio of blood recirculation is large and blood recirculation has occurred.

[0075] As described above, in this example, 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 blood circuit L1 and the acetic acid odor in the blood flowing through the venous blood circuit L2. 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.

[0076] [Measuring the Ratio of Blood Recirculation Using the Odor Unique to Dialysis Treatment] Next, based on Figures 10 and 11, we will explain an example of using the odor unique to dialysis treatment in the blood to measure the ratio of blood recirculation. First, as a premise, as shown in Figure 10, there is a unique odor related to the blood purifier 5 or the blood circuit (i.e., an odor unique to dialysis treatment). Therefore, during dialysis treatment, as blood passes through the blood purifier 5 and the blood circuit, the unique odor is gradually imparted to the blood, and the 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 distance through the blood circuit and has not passed through the blood purifier 5, so the unique odor is almost nonexistent or very weak. However, when blood recirculation occurs, the blood with the unique odor flows through the arterial blood circuit L1.

[0077] 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 an arterial odor sensor 13 connected to the arterial chamber 11. Similarly, an odor sensor for detecting this characteristic odor is also prepared as a venous odor sensor 14 connected to the venous chamber 12.

[0078] 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.

[0079] 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 ) is set as follows: 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 following. 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.

[0080] 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.

[0081] 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 ＤThe 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).

[0082] 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.

[0083] 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.

[0084] As described above, in this example, a characteristic 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.

[0085] [Measurement of Dialysis Volume Using Ammonia Odor] Based on Figures 12 and 13, an example of using the ammonia odor in the blood to measure the dialysis volume and detect abnormal changes in the dialysis volume will be explained. 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 in response to the progress of dialysis treatment, 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.

[0086] 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.

[0087] 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, since uremic toxins have not been removed from the patient H's blood, the initial odor is strong (S Ａ０ The numerical value of (i.e., the ammonia odor value) is initially set. Here, the ammonia odor value is a numerical value that is quantified by the concentration of ammonia in the blood or the intensity of the odor index.

[0088] 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 amount is measured (S44). Specifically, the calculation unit 21 of the processing unit 6 measures the dialysis amount from the change in ammonia odor of 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.

[0089] 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.

[0090] 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.

[0091] [Measurement of the removal performance of the blood purifier using ammonia odor] Next, based on Figures 14 and 15, an example of use in measuring the removal performance of the blood purifier 5 and any abnormal changes therein using the ammonia odor in the blood will be explained. Note that the premise that ammonia odor is present in the blood is the same as in the above example of use, so that explanation will be omitted.

[0092] 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.

[0093] 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.

[0094] 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.

[0095] 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. ＵＦ This is the ultrafiltration rate.

[0096] 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 flow rate 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.

[0097] 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.

[0098] (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 the 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 is monitored. This reduces the impact on the time of the dialysis treatment itself and allows for non-invasive monitoring with a relatively simple configuration.

[0099] (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 that constitutes the blood circuit. However, the location of the odor sensor is not limited to such a location. For example, the odor sensor may be directly installed in either the arterial side blood circuit L1 or the venous side blood circuit L2.

[0100] 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.

[0101] 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.

[0102] <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, blood recirculation and dialysis volume, blood recirculation and the removal performance of the blood purifier 5, or all three simultaneously may be monitored. 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.

[0103] 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.

[0104] 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.

[0105] (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 the 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. Therefore, the impact on the time of dialysis treatment itself is reduced, and non-invasive monitoring can be performed with a relatively simple configuration.

[0106] <Third Embodiment> In the first and second embodiments, the odor sensor was connected to the blood circuit. However, the odor sensor may be connected to the dialysate piping connecting the internal piping section 7 and the blood purifier 5, and the odor of the dialysate in the dialysate piping may be detected. A configuration that allows monitoring based on such odor detection will be described as the 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 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.

[0107] 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.

[0108] 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.

[0109] (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 dialysis treatment is monitored from the 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. This reduces the impact on the time of dialysis treatment itself and allows for non-invasive monitoring with a relatively simple configuration.

[0110] 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.

[0111] <Fourth Embodiment> (Configuration and Processing of Information Processing Device) The configuration of the information processing device and information processing system according to the present disclosure, as well as the flow of information processing, will be described with reference to Figures 18 to 21. Figure 18 is a block diagram showing the electrical configuration of the information processing device according to this embodiment. Figure 19 is a functional block diagram of the information processing system according to this embodiment, which also shows the flow of information and signals between each component. Figure 20 is a schematic diagram showing an example of use of the information processing system according to this embodiment. Figure 21 is a data table stored in the information processing device according to this embodiment.

[0112] The information processing device 101 is typically a wireless communication device such as a large computer, but it is not limited to such a device. For example, any device capable of executing the program related to this disclosure can be suitably applied, such as a feature phone, a personal digital assistant, a PDA, a smartphone, a desktop computer, a laptop computer, a portable game console, or a home game console. Furthermore, the information processing device 101 does not need to be housed in a single enclosure as shown in Figure 18, and it is possible to distribute each component and processing of the information processing device 101 to multiple server devices or cloud server devices.

[0113] As shown in Figure 18, the information processing device 101 has an output interface 111, a processor 112, a memory 113, a communication interface 114 including a communication processing circuit 114a and an antenna 114b, and an input interface 115. These components are electrically connected to each other via control lines and data lines. Note that the information processing device 1 does not need to have all the components shown in Figure 18; it is possible to omit some components or add other components.

[0114] With the above configuration, the information processing device 101 is capable of transmitting and receiving various signals, data, and information. 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, such as content that the receiving party can use for further consideration or utilize. However, data and information may be used in ways that do not conform to the above assumptions, depending on their content and surrounding context.

[0115] The output interface 111 has the function of outputting various displays, which are produced by executing the program according to this disclosure in accordance with instructions from the processor 112, to devices such as displays and printers. The display is composed of, for example, a liquid crystal display, an organic EL display, or electronic paper.

[0116] The processor 112 consists of a CPU (Central Processing Unit) or a GPU (Graphics Processing Unit) and has the function of controlling other connected components based on various programs stored in the memory 113. Specifically, the processor 112 reads and executes programs for executing information processing according to this disclosure and programs for executing the OS from the memory 113. In this embodiment, the processor 112 particularly executes processing related to the information shown in Figures 19 and 21. The processor 112 may consist of a single CPU or GPU, or it may be composed of a combination of multiple CPUs and GPUs.

[0117] In this embodiment, the processor 112 receives a detection signal of a predetermined odor from the odor sensor 120, which will be described later, and performs processing to identify the status of blood purification treatment (dialysis treatment) initiated by the operation of the blood purification unit, and odors related to the patient's condition. Here, the status of blood purification treatment refers to, for example, the blood recirculation rate (VA recirculation rate), the amount of dialysis (dialysis efficiency), and their changes over time. Odors related to the patient's condition refer to, for example, the odor of the blood of a patient with renal failure or the odor of the blood of a patient with diabetes. The processing for identifying these will be described later.

[0118] Memory 113 consists of ROM, RAM, non-volatile memory, HDD, etc., and functions as a storage unit 122. ROM stores instruction commands for executing the application and OS according to this disclosure as a program. RAM is used to write and read data while the program stored in ROM is being processed by the processor 112. Non-volatile memory is memory in which data is written and read as a result of the execution of the program, and the data written therein is saved even after the execution of the program has finished.

[0119] Memory 113 stores a program for executing processing related to the information shown in Figures 19 and 21. More specifically, this program is a program for identifying the odor of a patient's blood, which receives a detection signal from an odor sensor that detects a predetermined odor contained in the blood, obtains odor information related to the predetermined odor from the detection signal, and causes the information processing device 101 (i.e., processor 112), which is a computer, to execute processing for identifying the odor related to the patient's condition or the status of blood purification treatment based on the odor information. In this embodiment, memory 113 also stores various types of received information as shown in Figures 19 and 21.

[0120] Memory 113 stores a program for identifying odors related to the patient's condition or the status of blood purification treatment. In particular, memory 113 stores the type and numerical value of an odor set in accordance with a predetermined odor. Here, the type of odor refers to the type of odor, such as ammonia or acetone, and the numerical value of the odor is a numerical representation of the component concentration or odor index intensity of the odor. Memory 113 then associates these odor types, numerical values, and programs and stores them as odor information.

[0121] The communication interface 114 functions as a communication unit that sends and receives information with other terminal devices via the communication processing circuit 114a and antenna 114b. The communication interface 114 performs processing to send and receive information from other terminal devices, such as programs and various types of information used in the information processing system 110, as processing progresses.

[0122] The communication processing circuit 114a processes data based on a wideband wireless communication method such as LTE, but it can also process data based on a narrowband wireless communication method such as wireless LAN (as represented by IEEE 802.11) or Bluetooth®, or a contactless wireless communication method. In addition, wired communication can be used instead of or in addition to wireless communication.

[0123] The input interface 115 has the function of receiving instruction inputs related to the execution of the program according to this embodiment, and operation inputs for registering various information. The input interface 115 may consist of, for example, a mouse, hard keys, or a touch panel, and if a touch panel is used, known methods such as resistive touch, capacitive coupling, and ultrasonic surface acoustic wave methods can be used.

[0124] As shown in Figure 19, the information processing system 110 consists of an information processing device 101, which is a device for identifying the odor of the patient's (subject's) blood, and an odor sensor 120 for detecting the odor of the patient's blood.

[0125] Furthermore, as shown in Figure 20, the odor sensor 120 is installed in the extracorporeal circulation section 105 of the blood purification unit (blood purification device) for circulating the patient's blood outside the body. The blood purification unit is a unit capable of taking the patient's blood outside the body (blood withdrawal), removing unnecessary or toxic substances or water from the blood in a blood purifier (blood purification), and returning the purified blood to the patient (blood return).

[0126] In this embodiment, the application of the information processing system 110 is described as being to a blood purification unit, but it is not limited to this. For example, devices for acute blood purification, peritoneal dialysis machines, ultrafiltration machines, or hemofiltration machines can also be applied to the information processing system 110. Furthermore, the specific configuration of the blood purification unit is not a feature of the information processing system described herein, so its description is omitted.

[0127] As shown in Figure 20, a pump P101 and a chamber 103 are connected to the arterial blood circuit L101, which is provided in the extracorporeal circulation section 105 of the blood purification unit. The arterial blood circuit L101 is a circuit that introduces blood drawn from patient H into a blood purifier (not shown). A venous blood circuit (not shown) is also connected to the blood purifier, and the blood purified by the blood purifier is returned to patient H. The arterial blood circuit L101 and the venous blood circuit constitute the blood circuit through which the patient's blood flows.

[0128] One end of the arterial blood circuit L101 is connected to a puncture needle (not shown) that is inserted into the arm of patient H, and the other end is connected to a blood purifier. In the arterial blood circuit L101, the connections are made in the order of chamber 103 and pump P101 from the puncture needle side. When pump P101 rotates clockwise, blood is drawn from patient H, and patient H's blood passes through the arterial blood circuit L101 to reach the blood purifier.

[0129] Furthermore, the type of pump P101 is not particularly limited as long as it can introduce patient H's blood into the blood purifier. In this embodiment, a peristaltic pump is assumed, but other pumps such as diaphragm pumps may also be used.

[0130] An odor sensor 120 is connected to the chamber 103 on the arterial blood circuit L101. In other words, in this embodiment, the odor sensor 120 constitutes the extracorporeal circulation unit 105 and is provided as a consumable part of the blood purification unit, rather than being a component of the information processing device 101. The odor sensor 120 is also provided to detect a predetermined odor contained in the blood temporarily stored in the chamber 103. The odor sensor 120 may be of the type of semiconductor or quartz crystal oscillator. In addition, an analyzer such as a gas chromatograph that can quantify the concentration of chemical substances constituting the odor may be used as the odor sensor 120. The odor sensor 120 transmits the predetermined odor detected from the blood stored in the chamber 103 as a detection signal to the acquisition unit 121 of the information processing device 101.

[0131] As shown in Figure 19, the information processing device 101 includes an acquisition unit 121, a storage unit 122, an identification unit 123, an input unit 141, and an output unit 142. The acquisition unit 121, the storage unit 122, and the identification unit 123 are realized by the processor 112 and the memory 113 themselves functioning, or by the processor 112 reading and executing a program stored in the memory 113.

[0132] First, the acquisition unit 121 receives setting information from the input unit 141. The setting information is information used to construct a data table (see Figure 21) that is referenced when identifying the odor related to the patient's condition or the status of blood purification treatment. As an example, the data table stores "type," "numerical value," "blood purification treatment," and "result" as setting information (odor information).

[0133] Here, "type" refers to information related to the type of odor, such as ammonia odor or acetone odor. "Value" refers to information that quantifies the concentration of odor components or the intensity of the odor index. In the data table in Figure 21, for example, "ammonia odor" is stored as the type for identifying the odor as being related to the blood of a patient with renal failure, and the value for this type is a predetermined value, "A1". This means that if the value for ammonia odor is A1 or higher, it is identified as the odor being related to the blood of a patient with renal failure. Furthermore, "blood purification treatment" in the same data table refers to information related to the necessity of blood purification treatment in order to identify the odor related to the patient's condition or the status of blood purification treatment. For example, in order to identify "low dialysis efficiency" or "high blood recirculation rate", the patient must be undergoing blood purification treatment, so this is stored as "○" in the data table. On the other hand, in order to identify it as "the smell of blood from a patient with renal failure," it is not necessarily required that the patient be undergoing blood purification therapy. Identification is possible even with small amounts of blood collected for blood tests, etc., and therefore it is recorded as "—" in the data table.

[0134] Next, the acquisition unit 121 receives an odor detection signal from the odor sensor 120. Specifically, the acquisition unit 121 receives the odor of the patient's blood detected by the odor sensor 120 as a detection signal. Subsequently, the acquisition unit 121 acquires odor data from the detection signal and transmits the odor data to the identification unit 123. The odor data includes a predetermined type and numerical value of the odor, but may also include the date of detection and the detection environment. The odor data is used to identify the odor related to the patient's condition or the status of blood purification treatment by comparing it with the odor information in the data table shown in Figure 21.

[0135] Next, the identification unit 123 compares the odor data received from the acquisition unit 121 with the odor information read from the data table of the storage unit 122 to identify the odor related to the patient's condition or the status of blood purification treatment. Specifically, the identification unit 123 refers to the data table and determines whether the "type" included in the data table matches the type of odor included in the odor data, and also determines whether the numerical value of the odor included in the odor data is greater than or equal to the "numerical value" included in the data table. For example, if the type of odor related to the acquired odor data is acetone odor and its numerical value is A2 or higher, the identification unit 123 acquires "odor of blood of a diabetic patient" as the identification result.

[0136] The identification unit 123 then includes the identification result in the display information and transmits it to the output unit 142. As a result, the identification result is displayed on the output unit 142, and the operator of the information processing device 101 (a medical professional such as a doctor or nurse, or patient H) can check the odor related to the patient's condition or the status of blood purification treatment.

[0137] In addition to the above-described configuration, the information processing device 101 may also have a communication unit that enables the transmission and reception of information with external devices such as terminal devices or server devices. In this case, the information processing device 101 may acquire various types of information related to the patient's treatment (patient information) from the external device via the communication unit.

[0138] In this embodiment, the specified odor may be, for example, an ammonia odor, acetone odor, indole odor, hydrogen sulfide odor contained in the patient's blood, an acetic acid odor contained in the dialysis fluid, or a unique odor of a blood purifier or blood circuit that does not occur in the body. The odor sensor 120 is capable of detecting the volatile substances that constitute these odors. The odor sensor 120 may also quantify the component concentration or odor index intensity of the detected odor.

[0139] Here, we will explain an example of using the ammonia odor in the blood to identify odors related to a patient's condition. First, as a premise, patient H has an elevated concentration of uremic toxins in his blood due to decreased renal function. In other words, patient H's blood has a higher ammonia odor level compared to a healthy person. Therefore, by detecting and utilizing the ammonia odor in the blood flowing through the arterial blood circuit L101, it is possible to identify the odor of the blood of a patient with decreased renal function (renal failure).

[0140] Furthermore, uremic toxins are removed from patient H's blood through blood purification therapy (dialysis). As a result, the concentration of uremic toxins in patient H's blood decreases over time as blood purification therapy progresses, and the ammonia odor level in the blood also decreases. In this way, the decrease in uremic toxin concentration as blood purification therapy progresses makes it possible to detect the change in ammonia odor level in the blood flowing through the arterial blood circuit L101 over time and use it as time-series data, which also allows for the identification of the dialysis volume (dialysis efficiency).

[0141] As described above, in this example of use, the identification unit 123 can identify the odor of blood from patients with impaired renal function (renal failure) and the amount of dialysis (dialysis efficiency) in blood purification therapy (dialysis therapy) from the numerical value of ammonia odor in the blood flowing through the arterial blood circuit L101. In particular, when identifying the amount of dialysis, the identification result is reported to the operator of the information processing device 1, allowing the operator to confirm that a problem has occurred in the treatment and take early action.

[0142] In this embodiment, the identification unit 123 can identify odors related to the patient's condition not only from the numerical value of ammonia odor in the patient H's blood, but also from numerical values ​​related to other odors. For example, as shown in Figure 21, a high value of acetone odor in the blood indicates the odor of a diabetic patient's blood, a high value of indole odor indicates the odor of a constipated patient's blood, and a high value of hydrogen sulfide odor indicates the odor of a gastritis patient's blood. By storing these values ​​as a data table in the storage unit 122, it can be used to identify odors related to the patient's condition.

[0143] Next, we will explain an example of using the acetic acid odor in the blood to identify the status of blood purification therapy. First, as a premise, the dialysate, which is the drug solution supplied to the blood purifier in blood purification therapy (dialysis therapy), generally contains an acetic acid odor. Therefore, during dialysis therapy, when the dialysate and blood come into contact via the blood purifier, 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. On the other hand, the blood flowing through the arterial blood circuit L101 is drawn from patient H, so it does not normally contain an acetic acid odor. However, when blood recirculation occurs, blood with an acetic acid odor flows through the arterial blood circuit L101. In other words, the value of acetic acid odor in the blood increases. Therefore, by detecting the change in the value of acetic acid odor in the blood flowing through the arterial blood circuit L101 over time and using it as time-series data, the blood recirculation rate can also be identified.

[0144] As described above, in this example of use, the identification unit 123 can identify the blood recirculation rate in blood purification therapy (dialysis therapy) from the numerical value of the acetic acid odor in the blood flowing through the arterial blood circuit L101. In this case, the identification result is notified to the operator of the information processing device 1, allowing the operator to confirm that a problem has occurred in the treatment and take early action.

[0145] Next, we will explain an example of using the odor characteristic of dialysis treatment in the blood to identify the blood recirculation rate. First, as a premise, the blood purifier or blood circuit has a characteristic odor (i.e., an odor characteristic of dialysis treatment). Therefore, during dialysis treatment, as blood passes through the blood purifier and blood circuit, the characteristic odor is gradually imparted to the blood, and this characteristic odor becomes stronger in the blood flowing through the venous blood circuit. On the other hand, the blood flowing through the arterial blood circuit L101 has a shorter passage distance through the blood circuit and has not passed through the blood purifier, so this characteristic odor is almost nonexistent or very weak. However, when blood recirculation occurs, blood with this characteristic odor flows through the arterial blood circuit L101. In other words, the value of this characteristic odor in the blood increases. Therefore, by detecting the change in the value of the odor characteristic of dialysis treatment in the blood flowing through the arterial blood circuit L101 over time and using it as time-series data, the blood recirculation rate can also be identified.

[0146] As described above, in this example of use, the identification unit 123 can identify the blood recirculation rate in blood purification therapy (dialysis therapy) from the numerical value of the odor characteristic of dialysis therapy in the blood flowing through the arterial blood circuit L101. In this case, the identification result is notified to the operator of the information processing device 101, allowing the operator to confirm that a problem has occurred in the treatment and take early action.

[0147] (Effects of the Fourth 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 odor related to the patient's condition or the status of blood purification therapy is identified from the detection signal. This makes it possible to quantitatively identify the odor of the blood, leading to the early detection of diseases the patient has and early response to malfunctions in blood purification therapy.

[0148] (Modification of the fourth embodiment) In this embodiment, the odor sensor 120 for detecting the odor of blood was connected to the chamber 103 of the arterial blood circuit L101, but the location of the odor sensor 120 is not limited to this location. For example, the odor sensor 120 may be installed directly in the arterial blood circuit L101 instead of the chamber 103.

[0149] In this embodiment, the odor sensor 120 was provided as a consumable item in the arterial blood circuit L101, but the odor sensor 120 may also be a component of the information processing device 101. That is, the odor sensor 120 may be installed inside or on the surface of the information processing device 101.

[0150] In this embodiment, during treatment with the blood purification unit, odor data of the blood is acquired while the patient's blood is removed from the body, and the odor related to the patient's condition and the status of the blood purification treatment are identified. However, as shown in Figure 22, it is also possible to acquire odor data from the blood after it has been collected by the blood collector 151 and identify the odor related to the patient H's condition. In Figure 22, blood is collected from patient H using the blood collector 151 and injected into the blood collection tube 152. An odor sensor 120 is connected to the blood collection tube 152, and the acquisition unit 121 of the information processing device 101 receives the detection signal from the odor sensor 120. The subsequent processing is the same as described above, so its explanation is omitted. In this case, the odor of the blood can be quantitatively identified from the blood collected by blood tests, and only a small amount of blood needs to be removed from the body, thus reducing the burden on patient H.

[0151] In this embodiment, the identification unit 123 identified one of the following: the odor of blood from a patient with renal failure, the odor of blood from a patient with diabetes, the odor of blood from a patient with liver dysfunction, the odor of blood from a patient with constipation, the odor of blood from a patient with gastritis, a decrease in dialysis efficiency, or an increase in the blood recirculation rate. However, it may identify multiple odors simultaneously. For example, in Figure 21, if odor data is obtained in which the value of ammonia odor in the blood is A1 or higher and the value of acetone odor is A2 or higher, the identification unit 123 may identify it as "the odor of blood from a patient with renal failure and diabetes."

[0152] In this embodiment, the identification unit 123 definitively identified the odor related to the patient's condition and the status of blood purification treatment, but these may also be identified with probability and confidence. For example, when identifying the odor related to the blood of a patient with renal failure, the "probability that it is the odor related to the blood of a patient with renal failure" may be stored in the data table for each of several numerical values ​​related to ammonia odor. Specifically, for example, if the identification unit 123 acquires odor data where the ammonia odor value is A1 or higher, it may identify that "the probability that it is the odor related to the blood of a patient with renal failure is 15%", and if numerical values ​​higher than A1 are stored in the data table in stages, it may identify that "the probability that it is the odor related to the blood of a patient with renal failure is 20%", "the probability that it is the odor related to the blood of a patient with renal failure is 30%", and so on.

[0153] <Fifth Embodiment> In the fifth embodiment, the patient's condition, odor, or the status of blood purification treatment was identified by using a data table. However, artificial intelligence (AI) may be used to identify these. This case will be described as the fifth embodiment with reference to Figures 23 to 25. Here, Figure 23 is a functional block diagram of the information processing system according to this embodiment. Figure 24 is a flowchart showing the flow of setting the trained identification model set in the information processing device according to this embodiment. Figure 25 is a schematic diagram showing information processing by the trained identification model set in the information processing device according to this embodiment. Note that only the parts that differ from the fourth embodiment will be described in detail, and the same content will be omitted from the explanation, and the same reference numerals will be used in the drawings.

[0154] As shown in Figure 23, in the information processing system 210 according to this embodiment, the identification unit 223 of the information processing device 201 has a trained identification model 224. The identification unit 223 inputs odor data received from the acquisition unit 121 into the trained identification model 224 in order to identify the odor of blood using the trained identification model 224. The trained identification model 224 uses artificial intelligence to identify the odor of blood from the input data and outputs the identification result, which is the odor related to the patient's condition or the status of blood purification treatment. When the identification unit 223 acquires the output data (identification data) of the trained identification model 224, it transmits the data to the output unit 142 as display information.

[0155] During the generation and implementation of the trained identification model 224, the information processing device 201 undergoes initial setup. Here, initial setup refers to the preparatory processing necessary to identify the odor of blood using AI. In other words, the initial setup generates the trained identification model 224, and the trained identification model 224 is implemented in the information processing device 201.

[0156] Specifically, as shown in Figure 24, the processor 112 of the information processing device 201 acquires training data for generating a trained identification model 224 (S101). Here, as an example of training data, as shown in Figure 25, odor data related to the blood of healthy individuals, odor data related to the blood of patients with renal failure, odor data related to the blood of diabetic patients, odor data related to the blood of cancer patients, and odor data related to the blood undergoing blood purification therapy may be used. Furthermore, this data may be input by the administrator of the information processing device 201 via the input unit 141, or received via the communication unit.

[0157] Odor data for the blood of healthy individuals consists of odor data from blood samples taken from multiple healthy individuals who are not suffering from any disease. Odor data for the blood of patients with renal failure consists of odor data from blood samples taken from multiple patients with renal failure. Odor data for the blood of patients with diabetes consists of odor data from blood samples taken from multiple patients with diabetes. Odor data for the blood of cancer patients consists of odor data from blood samples taken from multiple cancer patients. Odor data for blood undergoing blood purification therapy consists of odor data from blood samples taken from multiple patients undergoing blood purification therapy, and may include information related to dialysis volume and blood circulation rate. Furthermore, this odor data may include information related to the distribution of odors, and may also include information that quantifies the concentration of odor components or the intensity of the odor index.

[0158] As described above, in this embodiment, in order to generate the trained identification model 224, odor data from the blood of multiple healthy individuals, multiple patients with renal failure, multiple patients with diabetes, multiple cancer patients, and odor data from blood undergoing blood purification therapy are associated and used. While it is preferable that all of this data be associated, some data may be excluded. On the other hand, additional data may be added, and the associations between the data may be appropriately modified according to the machine learning described later.

[0159] Next, the processor 112 of the information processing device 201 performs annotation processing on the acquired training data (S102). Specifically, the annotation processing involves adding annotations to the acquired training data to generate training data. For example, the processor 112 tags standard odor data and generates correct answer data to which this odor data is linked.

[0160] Next, the processor 112 of the information processing device 201 performs machine learning using the acquired training data and annotated training data (S103). As an example, this machine learning is performed by providing training data and training data to a neural network composed of combinations of neurons, and repeatedly adjusting the parameters of each neuron so that the output of the neural network matches the correct data from the training data. Note that the above machine learning is merely an example, and machine learning using scoring may also be performed.

[0161] Next, the processor 112 of the information processing device 101 evaluates the trained identification model 224 generated by machine learning (S104). Here, the processor 112 uses evaluation data different from the training data used for machine learning to evaluate the trained identification model 224. For example, as shown in Figure 25, the processor 112 inputs data related to the type and numerical value of the odor as evaluation data into the trained identification model 224. Then, the processor 112 evaluates whether the blood odor or blood purification treatment status related to the patient's condition, which is output as identification data from the trained identification model 224, is a correct result. As a specific evaluation method, the processor 112 determines whether the blood odor or blood purification treatment status related to the actual patient's condition corresponding to the evaluation data matches the blood odor or blood purification treatment status related to the patient's condition corresponding to the identification data. If they do not match, the process is restarted from acquiring the training data, and machine learning is performed again.

[0162] If the above conditions are met, the processor 112 of the information processing device 201 implements the generated trained identification model 224 (S105). Specifically, the processor 112 stores the generated trained identification model 224 in the memory 113. As a result, the identification unit 223 in the information processing device 201, which has the trained identification model 224, becomes functional.

[0163] (Effects of the Fifth Embodiment) 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 odor related to the patient's condition and the status of blood purification treatment are identified from the detection signal. In particular, in this embodiment, when data related to the type and value of the odor is input to a trained identification model 224, which is generated by machine learning by associating odor data related to the blood of healthy individuals, odor data related to the blood of patients with renal failure, odor data related to the blood of diabetic patients, odor data related to the blood of cancer patients, and odor data related to the blood undergoing blood purification treatment, the trained identification model 224 outputs the odor related to the patient's condition or the status of blood purification treatment. Since the trained identification model 224 is generated by machine learning by associating the various data mentioned above, it is possible to output identification results with higher reliability. Furthermore, according to the above machine learning, it is possible to identify odors in which odor substances such as cancer odor have not been identified.

[0164] (Modification of the Fifth Embodiment) In this embodiment, during treatment with the blood purification unit, odor data of the blood is acquired while the blood is removed from the body, and the odor related to the patient's condition and the status of the blood purification treatment are identified. However, similar to the fourth embodiment, it is also possible to acquire odor data from the blood after it has been collected with a blood collection device and identify the odor related to the patient's condition. In this case, the odor of the blood can be quantitatively identified from the blood collected by blood tests, etc., and only a small amount of blood needs to be removed from the body, thus reducing the burden on the patient.

[0165] In this embodiment as well, the location of the odor sensor 120 is not particularly limited. It may be connected to the chamber of the arterial blood circuit, or it may be directly attached to the arterial blood circuit instead of being attached to the chamber.

[0166] In this embodiment as well, the odor sensor 120 may be provided in the arterial blood circuit as a consumable item, or the odor sensor 120 may be a component of the information processing device 201. That is, the odor sensor 120 may be installed inside or on the surface of the information processing device 201.

[0167] In this embodiment as well, the identification unit 223 may identify multiple odors simultaneously. For example, if odor data such as high values ​​for both ammonia odor and acetone odor in the blood is input to the trained identification model 224, the trained identification model 224 may output identification data indicating that it is "odor related to the blood of a patient with renal failure and diabetes."

[0168] In this embodiment as well, the identification unit 223 may identify odors related to the patient's condition and the status of blood purification treatment with probability and confidence. For example, when identifying the odor related to the blood of a patient with renal failure, the trained identification model 224 may output the "probability that it is the odor related to the blood of a patient with renal failure" as identification data. Specifically, if odor data indicating a high ammonia odor value is input to the trained identification model 224, the trained identification model 224 may output identification data indicating that "the probability that it is the odor related to the blood of a patient with renal failure is 15%."

[0169] <Embodiments of the Disclosure> A first embodiment of the Disclosure is a blood purification device that provides blood purification therapy to a patient using a blood purifier for purifying a patient's blood, and a blood circuit 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 comprising 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 drug solution introduced into and out of the blood purifier, and measures the status of the blood purification therapy from the detection signal.

[0170] 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.

[0171] A second embodiment of this disclosure is, in the first embodiment, that 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 makes it possible to monitor various conditions of blood purification therapy and to inform the operator of the blood purification device of various conditions.

[0172] 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.

[0173] 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.

[0174] 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.

[0175] A sixth embodiment of the present 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.

[0176] A seventh embodiment of the present disclosure, in the 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.

[0177] 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, the odor sensor being connected to a drug solution discharge pipe constituting the internal piping section and detecting the ammonia odor contained in the drug solution, and the processing unit measuring 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.

[0178] 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.

[0179] 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.

[0180] An eleventh embodiment of the present disclosure is a method for monitoring blood purification in a blood purification device that provides blood purification therapy to a patient using a blood purifier for purifying a patient's blood and a blood circuit 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 drug solution introduced into or out of the blood purifier; and a processing step for measuring the status of the blood purification therapy from the detection signal acquired in the odor detection step.

[0181] 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.

[0182] A twelfth embodiment of the present 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.

[0183] A thirteenth embodiment of the present disclosure is an information processing device for identifying the odor of a patient's blood, comprising: an acquisition unit that receives a detection signal from an odor sensor that detects a predetermined odor contained in the blood and acquires odor data related to the predetermined odor from the detection signal; and an identification unit that identifies the odor related to the patient's condition or the status of blood purification treatment based on the odor data.

[0184] This allows for the acquisition of odor-related data from a patient's blood extracted from the body, enabling quantitative identification of odors related to the patient's condition and the status of blood purification therapy. Furthermore, identifying the odor of the blood can lead to the early detection of diseases the patient may have and early intervention for problems with blood purification therapy.

[0185] A fourteenth embodiment of this disclosure is, in the thirteenth embodiment, that the identification unit identifies the dialysis volume or blood recirculation rate based on the change in the numerical value of a predetermined odor over time during the blood purification treatment. This makes it possible to acquire and utilize odor data related to the status of the blood purification treatment as time-series data. Furthermore, it is possible to inform the operator of the blood purification unit of the treatment status, which leads to early response to treatment malfunctions.

[0186] A 15th embodiment of this disclosure is, in the 14th embodiment, having a database that associates the predetermined odor type and numerical value with the odor related to the patient's condition and the status of the blood purification treatment, wherein the identification unit refers to the database to identify the odor related to the patient's condition or the status of the blood purification treatment from the acquired odor data. This makes it possible to identify the odor related to the patient's condition and the status of the blood purification treatment, leading to the early detection of diseases the patient has and early response to malfunctions in the blood purification treatment.

[0187] A sixteenth embodiment of this disclosure is that, in the fifteenth embodiment, the odor data includes the predetermined odor type and numerical value. This makes it possible to identify odors related to the patient's condition and the status of blood purification therapy, leading to early detection of diseases the patient has and early response to malfunctions in blood purification therapy.

[0188] A seventeenth embodiment of this disclosure is, in the thirteenth embodiment, that the identification unit inputs the odor data into a trained identification model that has been machine-learned to identify the odor related to the patient's condition or the status of the blood purification treatment, thereby obtaining identification data related to the odor related to the patient's condition or the status of the blood purification treatment. This improves the accuracy of identification related to the odor related to the patient's condition or the status of the blood purification treatment using the trained identification model, enabling more reliable identification.

[0189] The eighteenth embodiment of this disclosure is that, in the seventeenth embodiment, the trained identification model is generated by machine learning by associating odor data related to the blood of healthy individuals, odor data related to the blood of patients with renal failure, odor data related to the blood of patients with diabetes, odor data related to the blood of cancer patients, and odor data related to the blood undergoing blood purification therapy. This improves the accuracy of identifying odors related to the patient's condition or the status of the blood purification therapy, enabling more reliable identification.

[0190] A 19th embodiment of the present disclosure is that, in any of the 13th to 18th embodiments, the odor sensor is included. This makes the odor sensor part of the configuration of the information processing device, allowing for more precise control of the odor sensor and more accurate reception of detection signals from the odor sensor.

[0191] A 20th embodiment of this disclosure is, in the 13th embodiment, that the patient's blood is collected by a blood collection device or by a blood purification device during blood purification therapy. This makes it possible to identify the odor related to the patient's condition and the status of blood purification therapy, regardless of whether the blood is collected during blood purification therapy, during blood donation processing, or for blood tests, etc.

[0192] A 21st embodiment of this disclosure is an information processing method for identifying the odor of a patient's blood using a computer, comprising the steps of: receiving a detection signal from an odor sensor that detects a predetermined odor contained in the blood; acquiring odor data related to the predetermined odor from the detection signal; and identifying the odor related to the patient's disease state or the status of blood purification treatment based on the odor data. This makes it possible to acquire odor-related data from a patient's blood taken outside the body and quantitatively identify the odor related to the patient's disease state and the status of blood purification treatment. Furthermore, by identifying the odor of the blood, it is possible to lead to the early detection of diseases the patient has and to early response to malfunctions in blood purification treatment.

[0193] A 22nd embodiment of this disclosure is a program for identifying the odor of a patient's blood, which receives a detection signal from an odor sensor that detects a predetermined odor contained in the blood, obtains odor data related to the predetermined odor from the detection signal, and causes a computer to perform processing to identify the odor related to the patient's condition or the status of blood purification treatment based on the odor data. This makes it possible to obtain odor data from a patient's blood taken outside the body and quantitatively identify the odor related to the patient's condition and the status of blood purification treatment. Furthermore, by identifying the odor of the blood, it is possible to lead to the early detection of diseases the patient has and to early response to malfunctions in blood purification treatment.

[0194] 1 Blood purification unit 1a Blood purification device 1b Consumables section 2 Base unit 3 Main unit 4 Display 5 Blood purifier 6 Processing unit 7 Internal piping section 8 Extracorporeal circulation section 11 Arterial side chamber 12 Venous side chamber 13 Arterial side odor sensor 14 Venous side odor sensor 21 Calculation unit 22 Memory unit 101 Information processing unit 110 Information processing system 120 Odor sensor 121 Acquisition unit 122 Memory unit 123 Identification unit 141 Input unit 142 Output unit 224 Learned identification model L1 Arterial side blood circuit L2 Venous side blood circuit L3 Dialysis fluid supply pipe (drug supply pipe) L4 Dialysis fluid discharge pipe (drug discharge pipe) L101 Arterial side blood circuit P1 Pump P101 Pump H Patient

Claims

1. A blood purification device that provides blood purification therapy to a patient using a blood purifier for purifying a patient's blood, and a blood circuit for introducing blood drawn from the patient into the blood purifier and returning the purified blood to the patient from the blood purifier, the device comprising: 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 the blood purification therapy 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 apparatus based on the numerical value of the odor of the blood or the drug solution that changes as it passes through the blood purification apparatus.

3. The blood purification device according to claim 2, wherein the odor sensor is connected to the arterial blood circuit constituting the blood circuit, and 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 blood purification device according to claim 2, wherein the odor sensor is connected to the arterial blood circuit and the venous blood circuit constituting the blood circuit, and 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 blood purification device according to claim 2, wherein the odor sensor is connected to the arterial blood circuit and the venous blood circuit 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 treatment and the odor value in the blood flowing through the venous blood circuit by the odor in the blood flowing through the arterial blood circuit after a predetermined time has elapsed since the start of blood purification treatment.

6. The blood purification apparatus according to claim 2, wherein 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.

7. The blood purification device according to claim 2, wherein the odor sensor is connected to the arterial blood circuit and the venous blood circuit 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 blood circuit and the venous blood circuit.

8. The blood purification apparatus according to claim 2, further comprising an internal piping section for introducing and discharging the drug solution to and from the blood purifier, the odor sensor being connected to a drug solution discharge pipe constituting the internal piping section for detecting the ammonia odor contained in the drug solution, and the processing unit measuring the dialysis amount based on the change over time in the ammonia odor in the drug solution flowing through the drug solution discharge pipe.

9. The blood purification device according to claim 2, further comprising 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 and 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.

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

11. A method for monitoring blood purification in a blood purification apparatus that provides blood purification therapy to a patient using a blood purifier for purifying a patient's blood and a blood circuit for introducing blood drawn from the patient into the blood purifier and returning the purified blood to the patient from the blood purifier, 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 therapy from the detection signal obtained 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 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.

13. An information processing device for identifying the odor of a patient's blood, comprising: an acquisition unit that receives a detection signal from an odor sensor that detects a predetermined odor contained in the blood and acquires odor data related to the predetermined odor from the detection signal; and an identification unit that identifies the odor related to the patient's condition or the status of blood purification treatment based on the odor data.

14. The information processing apparatus according to claim 13, wherein the identification unit identifies the dialysis volume or blood recirculation rate based on the change in the numerical value of the predetermined odor over time as the blood purification treatment progresses.

15. The information processing device according to claim 14, comprising a database that associates the predetermined odor type and numerical value with the odor related to the patient's condition and the status of the blood purification treatment, wherein the identification unit refers to the database to identify the odor related to the patient's condition or the status of the blood purification treatment from the acquired odor data.

16. The information processing apparatus according to claim 15, wherein the odor data includes the predetermined type and numerical value of the odor.

17. The information processing apparatus according to claim 13, wherein the identification unit inputs the odor data into a trained identification model that has been trained using machine learning to identify the odor related to the patient's condition or the status of the blood purification treatment, and acquires identification data related to the odor related to the patient's condition or the status of the blood purification treatment.

18. The information processing apparatus according to claim 17, wherein the trained identification model is generated by machine learning by associating odor data related to the blood of healthy individuals, odor data related to the blood of patients with renal failure, odor data related to the blood of patients with diabetes, odor data related to the blood of cancer patients, and odor data related to the blood undergoing blood purification therapy.

19. The information processing apparatus according to any one of claims 13 to 18, comprising the odor sensor.

20. The information processing apparatus according to claim 13, wherein the patient's blood is collected by a blood collection device or by a blood purification device during blood purification therapy.

21. An information processing method for identifying the odor of a patient's blood using a computer, comprising the steps of: receiving a detection signal from an odor sensor that detects a predetermined odor contained in the blood; acquiring odor data related to the predetermined odor from the detection signal; and identifying the odor related to the patient's condition or the status of blood purification treatment based on the odor data.

22. A program for identifying the odor of a patient's blood, the program receiving a detection signal from an odor sensor that detects a predetermined odor contained in the blood, acquiring odor data related to the predetermined odor from the detection signal, and causing a computer to perform processing to identify the odor related to the patient's condition or the status of blood purification treatment based on the odor data.

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