Blood purification device, and method for detecting pressure leaks using the blood purification device

Abstract

To accurately and quickly detect pressure leaks in blood circuits or various types of piping. [Solution] The device comprises: a pressurizing unit positioned in a fluid line to pressurize the fluid; a pressure measuring unit that measures the pressure of the fluid between the opening / closing unit and the pressurizing unit in a state where the fluid line is closed by an opening / closing unit capable of closing the fluid line; and a processing unit that corrects the pressure value measured by the pressure measuring unit to compensate for the pressure drop due to the expansion of the fluid line, and determines whether or not there is pressure leakage in the fluid line closed by the opening / closing unit based on the corrected pressure value.

Description

Technical Field

[0005] , ,

[0001] The present disclosure relates to a blood purification device that performs blood purification treatment while extracorporeally circulating a patient's blood, and a method for detecting pressure leakage by the blood purification device.

Background Art

[0002] Conventionally, as an example of treatment by blood purification, dialysis treatment using a blood purification device having a dialyzer and a blood circuit has been known. In this dialysis treatment, while the blood taken out from the patient's body is extracorporeally circulated by the blood circuit, blood purification is performed using a dialyzer provided in the blood circuit, and the treated blood is returned to the patient's body. In such blood purification treatment, when air bubbles are mixed into the blood circuit for extracorporeal circulation, in order to prevent the air bubbles from flowing into the patient's body, a clamp, which is an on-off device, is used to block the blood circuit. <00000​​​​​​​​​​​​​​​​​​​​​​​​​​​​However, when the blood circuit is sealed and pressurized for testing, the flexible tubing used in the blood circuit expands, causing a decrease in fluid pressure within the blood circuit even if there is no pressure leak. Therefore, accurately measuring pressure leaks is difficult. Alternatively, as described in Patent Document 1, it is possible to determine pressure leaks after the pressure drop has stabilized. However, since it takes time for the pressure drop to stabilize, it is difficult to quickly test the clamp performance.

[0006] This disclosure has been made in view of these issues, and its purpose is to provide a blood purification device and a method for detecting pressure leaks using a blood purification device that can accurately and quickly detect pressure leaks in blood circuits or various circuits or piping. [Means for solving the problem]

[0007] According to one aspect of the present disclosure, a blood purification device is provided, comprising: a blood purifier for purifying a patient's blood, and a flexible fluid line for introducing or discharging fluid to or from the blood purifier, the device comprising: a pressurizing unit disposed in the fluid line for pressurizing the fluid; a pressure measuring unit for measuring the pressure of the fluid between the opening / closing unit and the pressurizing unit in the fluid line when the fluid line is closed by an opening / closing unit capable of closing the fluid line; and a processing unit that corrects the pressure value measured by the pressure measuring unit to compensate for the pressure drop due to the expansion of the fluid line, and determines whether or not there is pressure leakage in the fluid line closed by the opening / closing unit based on the corrected pressure value.

[0008] According to one aspect of the present disclosure, a blood purification device is provided, comprising: a blood purifier for purifying a patient's blood, and a flexible fluid line for introducing or discharging fluid to or from the blood purifier, the device comprising: a pressurizing unit disposed in the fluid line for pressurizing the fluid; a pressure measuring unit for measuring the pressure of the fluid between the opening / closing unit and the pressurizing unit in the fluid line when the fluid line is closed by an opening / closing unit capable of closing the fluid line; and a processing unit for determining whether or not there is pressure leakage in the fluid line closed by the opening / closing unit, based on a predetermined pressure value measured in advance by the pressure measuring unit and the pressure value measured by the pressure measuring unit.

[0009] According to one aspect of the present disclosure, a method for detecting pressure leaks by a blood purification device is provided, wherein a blood purification device for purifying a patient's blood is installed, and a flexible fluid line for introducing or discharging fluid to or from the blood purification device is connected to the blood purification device, wherein the fluid line is closed by an opening / closing unit, the fluid is supplied and pressurized by a pressurizing unit located in the fluid line, the pressure of the fluid between the opening / closing unit and the pressurizing unit in the fluid line is measured by a pressure measuring unit, the pressure measured by the pressure measuring unit is corrected to compensate for the pressure drop due to the expansion of the fluid line, and the presence or absence of pressure leaks at the closed portion of the fluid line closed by the opening / closing unit is determined based on the corrected pressure value. [Effects of the Invention]

[0010] According to this disclosure, it is possible to provide a blood purification device and a method for detecting pressure leaks using a blood purification device that can accurately and quickly detect pressure leaks in blood circuits or various circuits or piping.

[0011] 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. [Brief explanation of the drawing]

[0012] [Figure 1] This is a schematic diagram showing the mechanical configuration of the blood purification unit according to the first embodiment. [Figure 2] This is a block diagram showing the electrical configuration of a blood purification unit according to the first embodiment. [Figure 3] 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. [Figure 4] This is a block diagram of the blood purification unit according to the first embodiment. [Figure 5] This graph illustrates the concept of pressure value correction in the blood purification unit according to the first embodiment. [Figure 6] This graph illustrates the concept of pressure value correction in the blood purification unit according to the first embodiment. [Figure 7] This is a flowchart showing the process for detecting pressure leaks in a blood purification unit according to the first embodiment. [Figure 8] This is a schematic diagram showing the mechanical configuration for pressure leak detection in a blood purification unit according to the first embodiment. [Figure 9] This is a schematic diagram showing the mechanical configuration for pressure leak detection in a blood purification unit according to the first embodiment. [Figure 10] This is a schematic diagram showing the mechanical configuration for pressure leak detection in a blood purification unit according to the first embodiment. [Figure 11] This is a schematic diagram showing the mechanical configuration for pressure leak detection in a blood purification unit according to the first embodiment. [Figure 12] This is a schematic diagram showing the mechanical configuration for pressure leak detection in a blood purification unit according to the first embodiment. [Figure 13] This is a block diagram of the blood purification unit according to the second embodiment. [Figure 14] This is a block diagram of the blood purification unit according to the third embodiment. [Figure 15] This graph illustrates the concept of pressure leak detection in the blood purification unit according to the third embodiment.

Mode for Carrying Out the Invention

[0013] Hereinafter, with reference to the drawings, a blood purification device of the present disclosure, a blood purification unit including the same, and pressure leak detection by the blood purification device will be described in detail. Note that the present disclosure is not limited to the content described below, and can be arbitrarily modified and implemented within the scope of not changing the gist thereof. In addition, the drawings used in each embodiment schematically show the blood purification device according to the present disclosure, its components, and the blood purification unit including these, and partial emphasis, enlargement, reduction, or omission is performed for better understanding, and the scale, shape, etc. of each component may not accurately represent the actual situation. Furthermore, some numerical values used in each embodiment are merely examples and can be variously changed as necessary. And for the common configurations in the drawings, the same reference numerals are assigned.

[0014] <First Embodiment> (Configuration of Blood Purification Unit) First, with reference to FIGS. 1 to 4, the configuration of the blood purification unit of the present disclosure will be described.FIG. 1 is a schematic diagram showing the mechanical configuration of the blood purification unit according to the present embodiment.FIG. 2 is a block diagram showing the electrical configuration of the blood purification unit according to the present embodiment.FIG. 3 is a schematic diagram showing the mechanical configuration of the extracorporeal circulation part and the internal piping part of the blood purification unit according to the present embodiment.FIG. 4 is a configuration block diagram of the blood purification unit according to the present embodiment.

[0015] As shown in FIG. 1, the blood purification unit 1 is composed of a blood purification device 1a which is a dialysis device for performing dialysis treatment which is an example of blood purification treatment, and a consumable part 1b composed of various consumables.That is, in the blood purification unit 1, a state is formed in which the consumable part 1b is connected and attached to the blood purification device 1a, and dialysis treatment is performed on the patient H.In other words, in the blood purification unit 1, the consumable part 1b is installed with respect to the blood purification device 1a.

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

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

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

[0019] As shown in Figure 2, the blood purification unit 1 consists of a display 4, a processing unit 6, an internal piping unit 7, and an extracorporeal circulation unit 8, all of which are electrically connected to each other via control lines and data lines. This allows the blood purification device 1a to transmit and receive various signals, data, and information, as well as to perform various controls via the processing unit 6. It should be noted that not all components in the internal piping unit 7 and the extracorporeal circulation unit 8 are electrically connected via control lines and data lines; rather, the electrical devices, equipment, and components constituting the internal piping unit 7 and the extracorporeal circulation unit 8 are electrically connected via control lines and data lines.

[0020] In the following, "data" is generally understood to refer to numerical values, symbols, or characters resulting from the processing of signals, etc. "Information" is generally understood to refer to collected or processed data, such as content that the recipient 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.

[0021] In this embodiment, a hemodialysis machine is described as an example of a blood purification device 1a, but the invention is not limited to this. For example, a device for acute blood purification, a peritoneal dialysis machine, an ultrafiltration machine, or a hemofiltration machine can also be an example of a blood purification device 1a.

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

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

[0024] 〔display〕 Next, as shown in Figures 1 and 2, the display 4 has an input unit 4a consisting of a touch panel type input interface and an output unit 4b consisting of a general screen type output interface. For example, 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 operator of the blood purification unit 1. In other words, the arrangement of the input unit 4a and the output unit 4b on the display 4 can be set as appropriate.

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

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

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

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

[0029] [Extracorporeal circulation department] Next, as shown in Figure 3, the extracorporeal circulation unit 8 has a structure in which the arterial blood circuit L1 is connected to the blood introduction side to the blood purifier 5, and the venous blood circuit L2 is connected to the blood discharge side to the blood purifier 5. That is, the arterial blood circuit L1 and the venous blood circuit L2 constitute the blood circuit L0 through which the patient's blood flows. In addition, a gas circuit L21 for adjusting the liquid level of the air trap chamber, which will be described later, is connected to branch off from the venous blood circuit L2. Here, the gas circuit L21 functions as an open line for introducing or discharging air to the air trap chamber. Flexible materials such as polyvinyl chloride tubing or silicone tubing are used for each of these circuits. That is, the arterial blood circuit L1, the venous blood circuit L2, and the gas circuit L21 become flexible fluid lines for fluid flow.

[0030] The arterial blood circuit L1 is equipped with, for example, a connector C1 at one end and a blood pump P1 in the middle. The type of blood 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. Some of the components and devices equipped in the arterial blood circuit L1 have been omitted for the sake of clarity in this disclosure, and various components, equipment, and devices necessary for blood purification will be appropriately equipped. For example, depending on the specifications of the blood purifier 1a and the blood circuit L0, the arterial blood circuit L1 may be equipped with a valve (solenoid valve), a bubble detector, a blood concentration detector, and an air trap chamber, etc.

[0031] Furthermore, in the venous blood circuit L2, for example, an air trap chamber 21, a clamp 22, and a connector C2 are arranged in order from the blood purifier 5 toward patient H. Here, some of the components arranged in the venous blood circuit L2 are omitted for the sake of clarity in this disclosure, and various components, equipment, and devices necessary for blood purification will be arranged as appropriate. For example, depending on the specifications of the blood purification device 1a and the blood circuit L0, a flow detector, pressure detector, bubble detector, and valves may be provided. When the blood purification device 1a is driven to purify the blood of patient H, an arterial puncture needle (not shown) is connected to connector C1, and a venous puncture needle (not shown) is connected to connector C2, and each puncture needle is inserted into the arm of patient H.

[0032] In the gas circuit L21 for liquid level adjustment, a valve V1, a pressure sensor S1, an air pump P2 for liquid level adjustment, and an air filter 23 are arranged in order from the air trap chamber 21 toward the outside of the circuit. With this configuration, the air pump P2 can be driven to introduce or discharge air, thereby adjusting the liquid level in the air trap chamber 21. Here, some of the components arranged in the gas circuit L21 have been omitted for the sake of convenience in explaining this disclosure, and various components, equipment, and devices necessary for liquid level adjustment will be arranged as appropriate.

[0033] The various pumps, valves V1, and clamps 22 described above are controlled based on control signals supplied from the processing unit 6. These pumps, valves V1, and clamps 22 can also transmit data indicating their operating status to the processing unit 6. Similarly, the pressure sensor S1 can transmit its measured pressure value to the processing unit 6. This allows the processing unit 6 to control the operation of the components of the extracorporeal circulation unit 8 and to understand various states within the extracorporeal circulation unit 8.

[0034] As described above, the extracorporeal circulation unit 8 is assembled by appropriately selecting the above-mentioned parts and devices according to the circuit configuration and type, and a structure is formed that enables blood withdrawal and blood return processing. Furthermore, the extracorporeal circulation unit 8 is assembled by appropriately selecting the above-mentioned parts and devices according to the circuit configuration and type, and a structure is formed that enables liquid level adjustment.

[0035] [Internal piping section] Next, as shown in Figure 3, the internal piping section 7 has a structure in which the main pipe L3 is connected to the fluid supply side of the blood purifier 5, the main pipe L4 is connected to the fluid drain side, and a bypass pipe L31 is connected between the main pipes L3 and L4 to bypass the blood purifier 5. In addition, a bypass pipe L41 is connected in parallel to the main pipe L4 to bypass a portion of the main pipe L4. For example, flexible materials such as polyvinyl chloride tubing or silicone tubing are used for each pipe. That is, the main pipes L3 and L4, the bypass pipes L31 and L41 constitute the dialysate piping L50 through which the dialysate flows, forming a flexible fluid line for fluid flow.

[0036] As can be seen from Figure 3, pumps, valves, sensors, etc., are installed in each pipe. Specifically, in the main pipe L3, a degassing pump P11, which is one of the dialysate pumps, a double pump P12, which is one of the dialysate pumps, a pressure sensor S11, and a valve V11 are installed in order from the fluid supply terminal side of the internal piping section 7 toward the dialysate inlet 5c of the blood purifier 5. Here, some of the parts and devices installed in the main pipe L3 have been omitted for the sake of convenience in explaining this disclosure, and various parts, equipment, and devices necessary for blood purification will be installed as appropriate. For example, depending on the specifications of the blood purification device 1a and the dialysate pipe L50, other valves (pressure reducing valves, solenoid valves, back pressure valves), chambers, filters, and temperature sensors may be installed in the main pipe L3.

[0037] Furthermore, in the main piping L4, valve V12, pressure sensor S12, pressurizing pump P13 (one of the dialysate pumps), and double pump P12 are arranged in order from the dialysate outlet 5d of the blood purifier 5 toward the drainage terminal side of the internal piping section 7. Hereinafter, some of the components and devices installed in the main piping L4 have been omitted for the sake of convenience in explaining this disclosure, and various components, equipment, and devices necessary for blood purification will be installed as appropriate. For example, depending on the specifications of the blood purification device 1a and dialysate piping L50, other valves (solenoid valves, back pressure valves), degassing chambers, flow detectors, etc., may be installed in the main piping L4.

[0038] Furthermore, a valve V13 is installed in the bypass piping L31. And a water removal pump P14, which is one of the dialysate pumps, is installed in the bypass piping L41. Here, some of the parts and devices installed in the bypass piping L31 and bypass piping L41 have been omitted for the sake of clarity in this disclosure, and various parts, equipment, and devices necessary for blood purification will be installed as appropriate. For example, depending on the specifications of the blood purification device 1a and the dialysate piping L50, other valves (solenoid valves, etc.) may be installed in the bypass piping L41.

[0039] The various pumps and valves V11-V13 described above are controlled based on control signals supplied from the processing unit 6. These pumps and valves V11-V13 can also transmit data indicating their operating status to the processing unit 6. Similarly, pressure sensors S11 and S12 can transmit measured pressure values ​​to the processing unit 6. This allows the processing unit 6 to control the operation of components within the internal piping section 7 and to understand various states within the internal piping section 7.

[0040] As described above, the internal piping section 7 is assembled by appropriately selecting the above-mentioned parts and devices according to the piping configuration and type, and a structure is formed that enables the circulation and cleaning of dialysate. Furthermore, the internal piping section 7 is formed that enables the introduction and discharge of dialysate to and from the blood purifier 5.

[0041] [Processing Section] Next, the processing unit 6 according to this embodiment is composed of a processor 6a and a memory 6b, as shown in Figure 2.

[0042] The processor 6a consists of a GPU (Graphics Processing Unit) or a CPU (Central Processing Unit) and functions as a calculation unit, described later, for controlling each component of the blood purification unit 1 (especially the blood purification device 1a) based on various programs stored in memory 6b. Specifically, the processor 6a reads and executes a program from memory 6b for performing treatment to purify the patient's blood or a program for driving the OS.

[0043] In particular, the processor 6a continuously receives pressure values ​​from pressure sensors S1, S11, and S12, and performs not only processing to measure the status of dialysis treatment (blood purification treatment) initiated by the operation of the blood purification device 1a, but also processing to detect pressure leaks in valves V1, V11-V13, and clamp 22 using these pressure values. The detailed processing related to this pressure leak detection will be described later.

[0044] The processor 6a may consist of a single GPU or CPU, or it may be composed of a combination of multiple CPUs or GPUs.

[0045] Memory 6b consists of ROM, RAM, non-volatile memory, HDD, etc., and functions as a storage unit, as described later. ROM stores instruction commands as a program for performing treatment to purify the patient's blood. RAM is used for writing and reading data while the program stored in ROM is being processed by processor 6a. Non-volatile memory is a storage device in which data is written and read as a result of the execution of the program, and the data written there is retained even after the execution of the program has finished.

[0046] In particular, in this embodiment, memory 6b stores not only a program for measuring the status of the dialysis treatment, but also a program for detecting pressure leaks in valve V1, valves V11-V13, and clamp 22 by utilizing the pressure value measured by the pressure sensor. Memory 6b also stores correction information for correcting the pressure value measured by the pressure sensor. For example, this correction information may be a correction value or a correction formula. In particular, if the correction information is a correction value, memory 6b may store pressure fluctuation data due to expansion when fluid is supplied to the blood circuit L0, gas circuit L21, and dialysate piping L50 and pressurized, as the correction value.

[0047] Here, the fluids supplied to the blood circuit L0, the gas circuit L21, and the dialysate piping L50 may be either liquids or gases. In the case of the blood circuit L0, blood flows as the fluid during blood purification therapy, but when detecting pressure leaks, a liquid such as dialysate or a gas such as air may be supplied. Similarly, in the case of the gas circuit L21, air flows as the fluid during blood purification therapy, but when detecting pressure leaks, a liquid such as dialysate may be supplied. Furthermore, in the case of the dialysate piping L50, dialysate flows as the fluid during blood purification therapy, but when detecting pressure leaks, a gas such as air may be supplied. In other words, the fluids supplied to the blood circuit L0, the gas circuit L21, and the dialysate piping L50 may differ between the actual blood purification therapy and the pressure leak detection described herein. However, in the blood circuit L0, gas circuit L21, and dialysate piping L50, it is assumed that the degree of expansion (pressure fluctuation data) when liquid is supplied as a fluid and pressurized is the same as the degree of expansion (pressure fluctuation data) when gas is supplied as a fluid and pressurized.

[0048] (Pressure leak detection configuration) Next, the configuration of pressure leak detection in the blood purification unit 1 according to this embodiment will be described with reference to Figures 4 to 6. Figure 4 is a block diagram of the blood purification unit 1 according to this embodiment. In particular, Figure 4 shows the mechanical and electrical connection relationships of each part constituting the blood purification unit 1. Figures 5 and 6 are graphs for explaining the concept of pressure value correction in the blood purification unit 1 according to this embodiment. In particular, Figure 5 shows a graph of pressure fluctuations before and after correction when there is no pressure leak, and Figure 6 shows a graph of pressure fluctuations before and after correction when there is a pressure leak. Note that pressure leak refers to a pressure drop caused by leakage from a blocked part of the fluid line.

[0049] First, as shown in Figure 4, in the blood purification unit 1 according to this embodiment, a pressurizing unit 31 and an opening / closing unit 32 are arranged in the fluid line L60. That is, the pressurizing unit 31 and the opening / closing unit 32 are mechanically connected via the flexible fluid line L60. The pressurizing unit 31 can supply fluid to the opening / closing unit 32 via the fluid line L60. On the other hand, the opening / closing unit 32 can open and close the fluid line L60, creating a state in which fluid flows or stagnates in the fluid line L60. In other words, the opening / closing unit 32 is a member that can close the fluid line L60. Therefore, when the opening / closing unit 32 closes the fluid line L60, fluid is supplied from the pressurizing unit 31 to the opening / closing unit 32, causing the fluid pressure in the fluid line L60 to increase. In other words, the pressurizing unit 31 pressurizes the fluid in the fluid line L60.

[0050] Here, the pressurizing section 31 in this embodiment corresponds to the blood pump P1, degassing pump P11, double pump P12, pressurizing pump P13, and water removal pump P14 in Figure 3. The opening / closing section 32 in this embodiment corresponds to the clamp 22, valve V1, and valves V11 to V13. Furthermore, the fluid line L60 in this embodiment corresponds to the blood circuit L0, gas circuit L21, and dialysate piping L50. In other words, the pressurizing section 31, the opening / closing section 32, and the fluid line L60 correspond to existing devices, equipment, or parts that constitute the blood purification unit 1. With this configuration, the fluid in this embodiment corresponds to a liquid such as blood or dialysate, or a gas such as air, as described above.

[0051] The pressurizing unit 31, the opening / closing unit 32, and the fluid line L60 are not limited to the specific devices, equipment, or parts described above, but may be other devices, equipment, or parts constituting the blood purification unit 1 not shown in Figure 3. For example, the fluid line L60 may be another circuit or piping (bypass line, branch line) through which the fluid flows. The pressurizing unit 31 may be any other pump or the like that can apply pressure to the fluid. The opening / closing unit 32 may be any other clamp, pressure reducing valve, solenoid valve, or back pressure valve that can open and close the fluid line L60.

[0052] Next, as shown in Figure 4, the fluid line L60 is provided with a pressure measuring unit 33 for measuring the fluid pressure in the fluid line L60. In particular, as an example of this embodiment, the pressure measuring unit 33 is located between the opening / closing unit 32 and the pressurizing unit 31, and measures the fluid pressure between the opening / closing unit 32 and the pressurizing unit 31. The pressure measuring unit 33 transmits the measured pressure value to the processing unit 6. Here, in this embodiment, the pressure measuring unit 33 corresponds to the pressure sensors S1, S11, and S12 in Figure 3. That is, the pressure measuring unit 33 corresponds to the pressure sensors conventionally provided in the circuit or piping that constitutes the blood purification unit 1. However, the pressure measuring unit 33 is not limited to only the pressure sensors S1, S11, and S12, but may also be pressure sensors provided in the circuit or piping, or pressure sensors built into a pump, etc., as long as they can measure the fluid pressure in the fluid line L60.

[0053] Next, as shown in Figure 4, the processing unit 6 is electrically connected to the pressurizing unit 31 and the opening / closing unit 32 in order to control the pressurizing unit 31 and the opening / closing unit 32. The processing unit 6 also generates a drive signal (control signal) to control the driving of the pressurizing unit 31 and an opening / closing signal (control signal) to control the opening and closing of the opening / closing unit 32. Furthermore, the processing unit 6 transmits the generated drive signal to the pressurizing unit 31 to control the pressurizing process by driving the pressurizing unit 31. Then, the processing unit 6 transmits the generated opening / closing signal to the pressurizing unit 31 to control the opening and closing processes by opening and closing the opening / closing unit 32.

[0054] In addition, the processing unit 6 includes an arithmetic unit 61 that functions when the processor 6a executes a predetermined program, and a storage unit 62 that functions when the memory 6b stores the program and processing results. That is, the processing unit 6 has an arithmetic unit 61 that performs predetermined processing among the many processes that the processor 6a executes, and a storage unit 62 that stores predetermined programs, data, and information among the information stored in the memory 6b.

[0055] The calculation unit 61 determines, based on the received pressure value, whether or not there is a pressure leak in the fluid line that has been blocked by the closing of the open / closed section 32, which is the subject of the test. When making this determination, the calculation unit 61 does not use the received pressure value as is, but uses the correction value, which is correction information stored in the storage unit 62, to generate determination data that enables a quick and accurate determination, and compares the determination data (corrected data) with the determination criterion data to determine whether or not there is a pressure leak. In this embodiment, the correction value, which is correction information, is, for example, pressure fluctuation data due to expansion when fluid is supplied to the fluid line L60 and pressurized.

[0056] The memory unit 62 stores a program for executing the processing performed by the calculation unit 61 described above, correction values ​​which are correction information, judgment data which are the corrected data, and the received pressure value. In particular, the memory unit 62 may store multiple correction values ​​depending on the type of fluid line 60 (blood circuit L0, gas circuit L21, or dialysate piping L50). In this case, information on the subject and the fluid line 60 will be selected or input by the operator of the blood purification unit 1 before the judgment processing is performed by the calculation unit 61.

[0057] Next, the specific correction will be explained with reference to Figures 5 and 6. In Figures 5 and 6, the upper graph shows the state before correction, where the received pressure value is graphed as is. On the other hand, in Figures 5 and 6, the lower graph shows the state after correction, where the received pressure value has been corrected and used as data for judgment. In particular, in the graphs of Figures 5 and 6, the horizontal axis is time (seconds). Also, in the upper graph of Figures 5 and 6, the vertical axis is pressure value (kPa). Furthermore, in the lower graph of Figures 5 and 6, the vertical axis is relative pressure value (kPa).

[0058] First, as shown in the upper graph of Figure 5, if there is no pressure leakage in the open / close unit 32, which is the subject of the experiment, the pressure value is constant before the fluid line L60 is closed (sealed) by the open / close unit 32. For example, although this pressure value varies depending on the specifications of the blood purification unit 1, it is approximately 100 kPa. When the fluid line L60 is closed by the open / close unit 32 and sealed, and fluid is supplied from the pressurizing unit 31 to the open / close unit 32 via the fluid line L60 and pressurized, the pressure value decreases due to the expansion of the fluid line L60. After a predetermined time has elapsed, the fluid line L60 stops expanding, and the pressure value becomes constant.

[0059] Then, as shown in the lower graph of Figure 5, the calculation unit 61 performs a correction to eliminate the pressure drop due to the expansion of the fluid line L60. In other words, the calculation unit 61 performs a correction to compensate for the pressure drop due to the expansion of the fluid line L60. In Figure 5, since there is no pressure leakage in the open / close unit 32, which is the subject of the test, the relative pressure value in the corrected graph becomes constant (zero), and the graph itself becomes a straight line. For this reason, the storage unit 62 stores pressure fluctuation data due to the expansion of the fluid line L60 when the fluid is pressurized, which can eliminate such pressure drops. Here, the pressure fluctuation data is the pressure decrease value (corrected value) for each elapsed time from the start of closure of the fluid line L60 until the pressure value becomes constant. The calculation unit 61 performs a correction by subtracting the pressure fluctuation data from the received pressure value, thereby increasing the actual pressure value, and generates data for judgment. For this reason, if no pressure fluctuation occurs due to pressure leakage, the relative pressure value will be zero.

[0060] On the other hand, as shown in the upper graph of Figure 6, if there is a pressure leak in the open / closed section 32, which is the subject of the test, the pressure value is constant before the fluid line L60 is closed by the open / closed section 32 (before sealing). When the fluid line L60 is closed by the open / closed section 32 and sealed, and fluid is supplied from the pressurizing section 31 to the open / closed section 32 via the fluid line L60 and pressurized, the pressure value drops significantly compared to the upper graph of Figure 5 due to the expansion of the fluid line L60. After a predetermined time has elapsed, the fluid line L60 stops expanding, and the pressure value becomes constant.

[0061] If the correction according to this embodiment is not performed, pressure leak detection is required in the upper graph of Figure 6, and therefore, a judgment cannot be made until the expansion of the fluid line L60 subsides and the pressure value becomes constant. In addition, the passing range, which is the judgment criterion data, must be adjusted to include the pressure value fluctuation due to the expansion of the fluid line L60, which enlarges the range. For this reason, if the correction according to this embodiment is not performed, it will take longer to make a judgment, and the accuracy of the judgment may also decrease. For example, the time to make a judgment is approximately 150 seconds, and the passing range is approximately 8 kPa.

[0062] In response, the calculation unit 61 corrects the received pressure value by subtracting the pressure fluctuation data stored in the storage unit 62 from the received pressure value, thereby increasing the actual pressure value and generating data for determination. Here, since the fluid line L60 in Figures 5 and 6 is assumed to be the same, the pressure fluctuation data in Figures 5 and 6 is the same data. In Figure 6, because there is a pressure leak in the open / closed section 32, which is the subject of the test, the pressure drop is smaller than in the upper graph of Figure 6, but the pressure value gradually decreases to a constant value. In particular, in the lower graph of Figure 6, the pressure drop due to the expansion of the fluid line L60 has been removed, so only the fluctuation due to the pressure drop associated with the actual pressure leak is shown.

[0063] This correction shortens the time it takes for the pressure drop to stabilize and the pressure value to become constant, allowing for earlier judgment compared to the case without the correction according to this embodiment. Furthermore, since there is no need to add pressure fluctuations due to the expansion of the fluid line L60, and the pass range, which is the judgment criterion data, can be determined solely from pressure fluctuations caused by pressure leakage, the pass range can be set smaller, improving the judgment accuracy. For example, the time to judgment is approximately 60 seconds, and the pass range is approximately 5 kPa.

[0064] (Pressure leak detection process) Next, an overview of the pressure leak detection process in the blood purification unit 1 according to this embodiment will be described with reference to Figure 7. Here, Figure 7 is a flowchart showing the flow of the pressure leak detection process in the blood purification unit according to this embodiment.

[0065] First, as shown in Figure 7, in the blood purification unit 1, the open / close section 32, which is the subject to be detected for pressure leaks, operates to close, thereby blocking the fluid line L60 (S101: Blocking process). Specifically, the operator of the blood purification unit 1 operates the input section 4a to select and set the open / close section 32 to be blocked. This sends the setting information from the input section 4a to the processing unit 6. Upon receiving the setting information, the processing unit 6 generates an open / close signal to block the selected open / close section 32 and transmits the open / close signal to the selected open / close section 32. Upon receiving the open / close signal, the open / close section 32 blocks the fluid line L60 via a blocking operation. If the open / close section 32 is not controlled by the processing unit 6 (for example, if the open / close section 32 is a clamp), the operator of the blood purification unit 1 may manually block the open / close section 32.

[0066] Next, as shown in Figure 7, fluid supply and pressurization are performed by the pressurizing unit 31 in the blood purification unit 1 (S102: pressurization process). Specifically, the operator of the blood purification unit 1 operates the input unit 4a to select and set the pressurizing unit 31 to be driven. This sends the setting information from the input unit 4a to the processing unit 6. Upon receiving the setting information, the processing unit 6 generates a drive signal to drive the selected pressurizing unit 31 and transmits the drive signal to the selected pressurizing unit 31. Upon receiving the drive signal, the pressurizing unit 31 is driven to supply fluid to the opening / closing unit 32 via the fluid line L60. If the pressurizing unit 31 is not driven by the processing unit 6, the operator of the blood purification unit 1 may directly operate the pressurizing unit 31 to drive it.

[0067] Next, as shown in Figure 7, in the blood purification unit 1, the pressure measuring unit 33 continuously measures the pressure of the fluid in the fluid line L60, and the pressure value, which is the measurement result, is transmitted from the pressure measuring unit 33 to the processing unit 6 (S103: pressure measurement step). Here, the pressure measuring unit 33 may transmit the pressure of the pressurized fluid when the fluid line L60 is closed as a pressure value to the processing unit 6 as it occurs, or it may transmit data on the change in pressure value over time as a pressure value after a certain period of time has elapsed.

[0068] Next, as shown in Figure 7, in the blood purification unit 1, the calculation unit 61 of the processing unit 6 performs a correction on the received pressure value to compensate for the pressure drop in the fluid line 61 (S104: correction process). Specifically, the calculation unit 61 reads a predetermined program stored in the storage unit 62 and executes the correction process. During this correction process, the calculation unit 61 subtracts predetermined pressure fluctuation data stored in the storage unit 62 from the received pressure value, thereby removing the pressure drop due to the expansion of the fluid line L60. This generates data for determining pressure leakage in the opening / closing unit 32. The pressure fluctuation data used for correction is set in advance by the operator of the blood purification unit 1 operating the input unit 4a.

[0069] Next, as shown in Figure 7, in the blood purification unit 1, the calculation unit 61 of the processing unit 6 determines whether or not there is a pressure leak in the opening / closing unit 32 based on the corrected pressure value (S105: determination step). Specifically, the calculation unit 61 reads a predetermined program stored in the storage unit 62 and executes the determination process. The calculation unit 61 then determines whether or not the corrected pressure value is within a predetermined range (acceptable range). That is, the calculation unit 61 determines that there is no pressure leak if the corrected pressure value is within the predetermined range (S106), and determines that there is a pressure leak if the corrected pressure value is outside the predetermined range (S107). The predetermined range, which is the comparison data for determination, is set in advance by the operator of the blood purification unit 1 operating the input unit 4a.

[0070] By going through the above steps, the pressure leak detection in this embodiment is completed. This pressure leak detection may be performed when the blood purification device 1a is shipped as a product, or periodically during maintenance of the blood purification unit 1.

[0071] Furthermore, each of the above steps may be set to be automatically performed at predetermined timings by the processing unit 6 of the blood purification device 1a. For example, the pressure leak detection method may be applied as part of the diagnostic content of the self-diagnosis of the blood purification device 1a or the blood purification unit 1.

[0072] (Specific application examples in blood purification units) Next, specific application examples of pressure leak detection in the blood purification unit 1 will be described with reference to Figures 8 to 12. Here, Figures 8 to 12 are schematic diagrams showing the mechanical configuration of pressure leak detection in the blood purification unit 1 according to this embodiment. In particular, Figure 8 shows an application example of pressure leak detection in the blood circuit L0, Figure 9 shows an application example of pressure leak detection in the gas circuit L21, and Figures 10 to 12 show an application example of pressure leak detection in the dialysate piping L50.

[0073] [Pressure leak detection in blood circuits] As shown in Figure 8, pressure leak detection in the blood circuit L0 can be applied to pressure leak detection at clamp 22. For example, the blood circuit L0 and gas circuit L21 may be connected to the blood purification device 1a, and the pressure leak detection may be performed when the blood purification unit 1 is in use. Specifically, the gap between the gas circuit L21 and the connector C2 on the venous blood circuit L2 is closed by clamp 22, and the blood pump P1 is driven to supply air, which is a fluid, to clamp 22. At this time, valve V1 is in an open state and air pump P2 is in a stopped state. Furthermore, for the blood purifier 5, it is preferable to moisten the hollow fiber membrane that constitutes the blood purification membrane once in order to prevent air from leaking from the minute pores of the hollow fiber membrane.

[0074] Then, the pressure sensor S1 functions as a pressure measuring unit 33, measuring the air pressure in the venous blood circuit L2 and the gas circuit L21. Subsequently, the measured pressure value is transmitted to the processing unit 6, which determines whether or not there is a pressure leak in the clamp 22. This makes it possible to accurately and quickly test the sealing performance of the clamp 22 installed in the venous blood circuit L2. Consequently, the preparation time for blood purification therapy is reduced, and the burden on medical personnel and patients performing blood purification therapy is also reduced.

[0075] [Pressure leak detection in gas circuits] As shown in Figure 9, pressure leak detection in the gas circuit L21 can be applied to pressure leak detection at valve V1. For example, the blood circuit L0 and gas circuit L21 may be connected to the blood purification device 1a, and the pressure leak detection may be performed when the blood purification unit 1 is in use. Specifically, valve V1 closes the gap between valve V1 of the gas circuit L21 and the air filter 23, and the air pump P2 is driven to supply air, which is a fluid, to valve V1. At this time, clamp 22 is in an open state, and blood pump P1 is in a stopped state.

[0076] Then, the pressure sensor S1 functions as a pressure measuring unit 33, and the pressure of the air in the gas circuit L21 is measured. Subsequently, the measured pressure value is transmitted to the processing unit 6, which determines whether or not there is a pressure leak in the valve V1. This makes it possible to accurately and quickly perform a sealing performance test of the valve V1 installed in the gas circuit L21. Consequently, the preparation time for blood purification therapy is reduced, and the burden on medical personnel and patients performing blood purification therapy is also reduced.

[0077] [Pressure leak detection in dialysis fluid piping] As shown in Figure 10, pressure leak detection in the dialysate piping L50 can be applied to pressure leak detection at valves V11 to V13. For example, this pressure leak detection may be performed at the shipping stage of the blood purification device 1a. Specifically, valves V11 to V13 block the main pipes L3 and L4, and the bypass pipe L31 of the dialysate piping L50, and the pressurizing pump P13 and the water removal pump P14 are driven to supply air, which is the fluid, to valves V12 and V13. At this time, the degassing pump P11 and the double pump P12 are stopped. Furthermore, for the blood purifier 5, it is preferable to wet the hollow fiber membrane that constitutes the blood purification membrane once in order to prevent air from leaking from the minute pores of the hollow fiber membrane.

[0078] Then, pressure sensors S11 and S12 function as a pressure measuring unit 33, measuring the air pressure in the main pipe L3 and bypass pipe L31, and the air pressure in the main pipe L4 and bypass pipe L31. Subsequently, the measured pressure values ​​are transmitted to the processing unit 6, which determines whether or not there is a pressure leak in valves V11 to V13. Specifically, if the corrected data of the pressure value received from pressure sensor S12 does not exist within a predetermined range, it is determined that there is a pressure leak in at least one of valves V12 and V13. On the other hand, if the corrected data of the pressure value received from pressure sensor S11 does not exist within a predetermined range, it is determined that there is a pressure leak in both valves V11 and V12, or in valve V13. If a pressure leak occurs in valves V12 and V13, it is determined that there is a defect in the blood purification device 1a before shipment, and repairs or replacement of parts are carried out.

[0079] Furthermore, since the above determination does not detect pressure leakage at valve V11 alone, further pressurization and determination are performed as shown in Figure 11. Specifically, only valve V12 is opened, and valves V11 and V13 close the main pipes L3, L4, and bypass pipe L31 of the dialysate piping L50, and the pressurizing pump P13 and the water removal pump P14 are driven to supply air, which is the fluid, to valves V12 and V13. At this time, the degassing pump P11 and the double pump P12 are stopped.

[0080] Then, pressure sensors S11 and S12 function as a pressure measuring unit 33, measuring the air pressure in the main pipe L3 and bypass pipe L31, and the air pressure in the main pipe L4 and bypass pipe L31. Here, if it has been determined that there is no pressure leak in valve V13 based on the previous pressurization and determination, and the corrected data of the pressure values ​​received from pressure sensors S11 and S12 does not exist within a predetermined range, it can be determined that there is a pressure leak in valve V11.

[0081] This makes it possible to accurately and quickly perform sealing performance tests on valves V11 to V13 installed in the dialysate piping L50. Consequently, the inspection time at the time of product shipment can be shortened, reducing the burden at the time of product shipment. In the above test, air was used as the fluid, but the test may also be performed using actual dialysate. Furthermore, the opening and closing of valves V11 to V13 and the supply of fluid are merely examples, and the combination of valves to be closed can be changed as appropriate. For example, the opening and closing order of valves V11 to V13 may be set so that the location of pressure leakage can be identified. Moreover, as shown in Figure 12, the degassing pump P11 and the double pump P12 may be driven to supply air from the main piping L3 side while pressurizing.

[0082] (Effects of the first embodiment) In this embodiment, after measuring the pressure of the pressurized fluid in the fluid line L60, the processing unit 6 corrects the pressure drop due to the expansion of the fluid line L60 during pressurization from the measured pressure value, and determines whether or not there is a pressure leak in the opening / closing section 32 based on the corrected pressure value. As a result, the pressure drop due to the expansion of the fluid line L60 is removed from the judgment data, which is the corrected pressure value, making it easy to grasp pressure fluctuations caused by the airtightness of the opening / closing section 32. In other words, in this embodiment, pressure leaks in the fluid line L60, which is the blood circuit L0, gas circuit L21, and dialysate piping L50, can be detected accurately and quickly.

[0083] (Modified version of the first embodiment) In the above embodiment, the inspection target was pressure leakage at the opening / closing section 32 of the fluid line L60. However, the inspection target may also be a component that does not contribute to the opening and closing of the fluid line L60 and which must not leak liquid or gas. For example, the blood purifier 5 may be the component to be inspected for pressure leakage. In this case, while supplying fluid to the blood purifier 5, the fluid is pressurized and the pressure in or near the blood purifier 5 is measured. The pressure value obtained from this measurement is then corrected in the same way to determine if there is any pressure leakage in the blood purifier 5.

[0084] Furthermore, in the above embodiment, when determining whether or not there is a pressure leak in the fluid line L60, the calculation unit 61 of the processing unit 6 corrected the measured pressure value. However, the determination of whether or not there is a pressure leak may be made without correction. For example, the calculation unit 61 of the processing unit 6 may determine whether or not there is a pressure leak based on a predetermined pressure value measured in advance and a pressure value measured immediately before the determination. In this case, the pressure value measured in advance may be the pressure value of a sample determined to have no pressure leak, and the pressure value of a sample determined to have a pressure leak. Moreover, each of the pressure values ​​of the sample determined to have no leak and the pressure value of the sample determined to have a pressure leak may include multiple pressure values ​​(measurement data) depending on the degree of pressure leak. The pressure values ​​measured in advance are stored in the storage unit 62.

[0085] <Second Embodiment> In the first embodiment, when correcting the pressure drop due to the expansion of the fluid line L60 during fluid pressurization from the received pressure value, only the pressure fluctuation data due to the expansion of the fluid line L60 during fluid pressurization was subtracted. However, correction may be performed considering other factors that affect the expansion of the fluid line L60. A form in which such correction is performed considering various factors will be described as the second embodiment with reference to Figure 13. Here, Figure 13 is a block diagram of the blood purification unit 101 according to this embodiment. Note that the parts that differ from the first embodiment will be described in principle, and the explanation of the same content will be omitted, and the same reference numerals will be used in the drawings in principle.

[0086] As shown in Figure 13, the fluid line L60 is provided with a temperature measuring unit 134 that measures the temperature of the fluid line L60 or the fluid. The temperature measuring unit 134 transmits the temperature data, which is the measurement result, to the processing unit 106. Here, the temperature measuring unit 134 corresponds to a temperature sensor (not shown) provided in the blood circuit L0, gas circuit L21, or dialysate piping L50 in Figure 3. In other words, the temperature measuring unit 134 corresponds to a temperature sensor that has been conventionally provided in the circuits or piping that constitute the blood purification unit 101. However, the temperature measuring unit 134 is not limited to such temperature sensors; it may also be a temperature sensor provided in other circuits, other piping, or around them, as long as it can measure the temperature of the fluid line L60 or the fluid.

[0087] Next, as shown in Figure 13, the processing unit 106 is electrically connected to the pressurizing unit 31 and the opening / closing unit 32 in order to control the pressurizing unit 31 and the opening / closing unit 32. The processing unit 106 also generates a drive signal to control the driving of the pressurizing unit 31 and an opening / closing signal to control the opening and closing of the opening / closing unit 32. Furthermore, the processing unit 106 transmits the generated drive signal to the pressurizing unit 31 to control the pressurizing process by driving the pressurizing unit 31. Then, the processing unit 106 transmits the generated opening / closing signal to the pressurizing unit 31 to control the opening and closing processes by opening and closing the opening / closing unit 32.

[0088] In addition, the processing unit 106 includes an arithmetic unit 161 and a storage unit 162. That is, the processing unit 106 has an arithmetic unit 161 that performs predetermined processing among the many processes executed by the processor 6a, and a storage unit 162 that stores predetermined programs, data, and information among the information stored in the memory 6b.

[0089] The storage unit 162 stores a program for executing processing by the calculation unit 161, various correction information necessary for correcting the pressure value, judgment data which is the corrected data, and the received pressure value. In particular, the storage unit 162 includes a dimension-based database 162a (hereinafter referred to as dimension-based DB162a), a temperature-based database 162b (hereinafter referred to as temperature-based DB162b), a material-based database 162c (hereinafter referred to as material-based DB162c), and a past measurement database 162d (hereinafter referred to as past measurement DB162d). Here, the dimension-based DB162a stores fluctuation data of pressure drop associated with the expansion of the fluid line L60, according to the dimensions of the fluid line L60. The temperature-based DB162b stores fluctuation data of pressure drop associated with the expansion of the fluid line L60, according to the temperature of the fluid line L60 or the fluid. Furthermore, the material-driven DB162c stores data on pressure drop fluctuations associated with the expansion of the fluid line L60, depending on the material of the fluid line L60. The past measurement DB162d stores data on pressure drop fluctuations measured in past pressure leak detections. These fluctuation data may be correction values ​​to be subtracted from the received pressure value, or they may be coefficients or functions to perform predetermined calculations on the received pressure value.

[0090] Furthermore, in order for the calculation unit 161 to determine which fluctuation data from each DB to use, the subject and fluid line 60 information may be selected or input by the operator of the blood purification unit 1 before the calculation unit 161 performs the determination process. Alternatively, the calculation unit 161 may be configured to automatically select the optimal fluctuation data.

[0091] The calculation unit 161 determines whether or not there is a pressure leak in the open / closed section 32, which is the subject of the test, based on the received pressure value and temperature data. When making this determination, the calculation unit 161 does not use the received pressure value as is, but uses correction information stored in the storage unit 162 to generate judgment data that enables a quick and accurate determination, and compares this judgment data (corrected data) with the judgment criterion data to determine whether or not there is a pressure leak. In particular, in this embodiment, the calculation unit 161 performs the correction using fluctuation data caused by dimensions, temperature, and material of the fluid line L60, as well as fluctuation data measured in the past. Furthermore, since the calculation unit 161 uses temperature data received from the temperature measurement unit 134, it can perform the correction in accordance with temperature changes corresponding to the surrounding environment of the blood purification unit 101.

[0092] (Effects of the second embodiment) As described above, in this embodiment, even if the degree of expansion of the fluid line L60 changes due to the length of the fluid line L60 and the material of the fluid line L60, the pressure drop due to the expansion of the fluid line L60 will be accurately eliminated. Furthermore, the past degree of expansion of the fluid line L60 can be taken into consideration, and the pressure drop due to the expansion of the fluid line L60 will be eliminated more accurately. Moreover, even if the degree of expansion of the fluid line L60 changes due to the temperature of the fluid line L60, the pressure drop due to the expansion of the fluid line L60 will be accurately eliminated. As a result, pressure fluctuations caused by the airtightness of the opening / closing section 32 can be easily grasped, and pressure leaks in the fluid line L60 can be detected accurately and quickly.

[0093] <Third Embodiment> In the first and second embodiments, the presence or absence of pressure leakage in the fluid line L60 was determined, but the abnormal state of the opening / closing section 32 may be determined according to the degree of pressure leakage. A configuration for performing such determination will be described as the third embodiment with reference to Figures 14 and 15. Here, Figure 14 is a block diagram of the blood purification unit 201 according to this embodiment. Figure 15 is a graph for explaining the concept of pressure leakage detection in the blood purification unit 201 according to this embodiment.

[0094] As shown in Figure 14, the processing unit 206 is electrically connected to the pressurizing unit 31 and the switching unit 32 in order to control the pressurizing unit 31 and the switching unit 32. The processing unit 206 also includes an arithmetic unit 261 and a storage unit 262.

[0095] The storage unit 262 stores a program for executing processing by the calculation unit 261, various correction information necessary for correcting the pressure value, judgment data which is the corrected data, and the received pressure value. In particular, the storage unit 262 includes a correction value database 262a (hereinafter referred to as the correction value DB262a) and an abnormal sample database 262b (hereinafter referred to as the abnormal sample DB262b). Here, the correction value DB262a stores pressure fluctuation data due to the expansion of the fluid line L60 when the fluid is pressurized as a preset value, similar to the first embodiment. On the other hand, the abnormal sample DB262b stores abnormal information such as malfunctions of the opening / closing unit 32 corresponding to the relative pressure value which is the degree of pressure leakage. For example, the location of the failure and the nature of the failure (e.g., scratches, cracks, damage, cuts) of the opening / closing unit 32 may be stored corresponding to the relative pressure value.

[0096] The calculation unit 261 determines whether or not there is a pressure leak in the open / close unit 32, which is the subject of the test, based on the received pressure value, and also determines the abnormal state of the open / close unit 32. Specifically, as shown in Figure 15, if the relative pressure value at the time of determination is within the acceptable range, it is determined that there is no pressure leak, and if the relative pressure value at the time of determination is outside the acceptable range, it is determined that there is a pressure leak. Here, the degree of pressure leak is set according to the relative pressure value, and the abnormality of the open / close unit 32 corresponding to the relative pressure value is stored in the storage unit 262, so the calculation unit 261 refers to the stored information and determines the degree of pressure leak and the abnormality of the open / close unit 32. The abnormality determined by the calculation unit 261 may also be output from the output unit 4b of the blood purification device 1a.

[0097] (Effects of the third embodiment) As described above, in this embodiment, the degree of pressure leakage and the nature of the abnormality in the opening / closing section 32 are stored as correlated data, so that the abnormality in the opening / closing section 32 can be identified based on the received pressure value. Furthermore, it becomes possible to take appropriate action according to the abnormal state of the opening / closing section 32.

[0098] <Embodiments of this disclosure> A first embodiment of the present disclosure is a blood purification device in which a blood purifier for purifying a patient's blood is installed, and a flexible fluid line for introducing or discharging fluid to the blood purifier is connected to the blood purifier, the blood purification device comprising: a pressurizing unit disposed in the fluid line for pressurizing the fluid; a pressure measuring unit for measuring the pressure of the fluid between the opening / closing unit and the pressurizing unit in the fluid line when the fluid line is closed by an opening / closing unit capable of closing the fluid line; and a processing unit that corrects the pressure value measured by the pressure measuring unit to compensate for the pressure drop due to the expansion of the fluid line, and determines whether or not there is pressure leakage in the fluid line closed by the opening / closing unit based on the corrected pressure value.

[0099] With this configuration, the pressure drop due to fluid line expansion is removed from the judgment data, which is the corrected pressure value. This makes it easy to grasp pressure fluctuations caused by the degree of sealing of the opening and closing parts, and thus allows for accurate and rapid detection of pressure leaks in the fluid line.

[0100] A second embodiment of the present disclosure is that, in the first embodiment, the processing unit stores pressure fluctuation data due to the expansion of the fluid line when the fluid is pressurized, and corrects the pressure value by subtracting the pressure fluctuation data. This prevents the correction process by the processing unit from becoming complicated, and suppresses increased costs and complexity associated with the correction process.

[0101] A third embodiment of the present disclosure is that, in the second embodiment, the pressure fluctuation data includes fluctuation data due to the length of the fluid line, fluctuation data due to the material of the fluid line, and fluctuation data previously measured by the fluid line. This ensures that pressure drops due to fluid line expansion are accurately eliminated, even when the degree of expansion of the fluid line changes due to the length of the fluid line and the material of the fluid line. Furthermore, past degrees of expansion of the fluid line can be taken into account, resulting in more accurate elimination of pressure drops due to fluid line expansion.

[0102] A fourth embodiment of the present disclosure is a second or third embodiment which includes a temperature measuring unit for measuring the temperature of the fluid line or the fluid, wherein the processing unit receives temperature data from the temperature measuring unit when the fluid is pressurized and corrects the pressure fluctuation data by including fluctuation data corresponding to the temperature data. This ensures that even if the degree of expansion of the fluid line changes due to the temperature of the fluid line, the pressure drop due to the expansion of the fluid line is accurately eliminated.

[0103] A fifth embodiment of this disclosure involves storing abnormal sample data of the opening / closing unit corresponding to the corrected pressure value in any of the first to fourth embodiments, and determining the abnormal state of the opening / closing unit based on the corrected pressure value. This makes it possible to identify abnormalities in the opening / closing unit and to take appropriate action according to the abnormal state of the opening / closing unit.

[0104] A sixth embodiment of the present disclosure is a blood purification device having a blood purifier for purifying a patient's blood installed, and a flexible fluid line for introducing or discharging fluid to or from the blood purifier connected to the blood purifier, the blood purification device comprising: a pressurizing unit disposed in the fluid line for pressurizing the fluid; a pressure measuring unit for measuring the pressure of the fluid between the opening / closing unit and the pressurizing unit in the fluid line when the fluid line is closed by an opening / closing unit capable of closing the fluid line; and a processing unit for determining whether or not there is pressure leakage in the fluid line closed by the opening / closing unit, based on a predetermined pressure value measured in advance by the pressure measuring unit and the pressure value measured by the pressure measuring unit.

[0105] With this configuration, when determining whether or not there is a pressure leak in the fluid line, the previously measured pressure value can be taken into consideration, allowing for accurate and rapid detection of pressure leaks in the fluid line.

[0106] A seventh embodiment of this disclosure is that, in any of the first to sixth embodiments, a clamp or valve is provided as the opening / closing part. This makes it possible to perform sealing performance testing of the clamp or valve provided in the blood purification device accurately and in a shorter time.

[0107] An eighth embodiment of the present disclosure is, in any of the first to sixth embodiments, the fluid line is 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 opening / closing part is a clamp placed in the blood circuit, and the pressurizing part is a blood pump connected to the blood circuit. This makes it possible to accurately and quickly perform sealing performance testing of the clamp placed in the blood circuit.

[0108] A ninth embodiment of the present disclosure is, in any of the first to sixth embodiments, the fluid line comprises a venous blood circuit for returning purified blood from the blood purifier to the patient and a gas circuit branching from the venous blood circuit, the opening / closing unit is a valve located in the gas circuit, and the pressurizing unit is an air pump connected to the gas circuit. This makes it possible to accurately and quickly perform sealing performance testing of the valve provided in the gas circuit.

[0109] A tenth embodiment of the present disclosure is, in any of the first to sixth embodiments, that the fluid line is a dialysate piping that supplies dialysate to the blood purifier and discharges the dialysate as wastewater, the opening / closing unit is a valve located in the dialysate piping, and the pressurizing unit is a dialysate pump connected to the dialysate piping. This makes it possible to accurately and quickly perform sealing performance tests on the valves provided in the dialysate piping.

[0110] An eleventh embodiment of the present disclosure is a method for detecting pressure leaks using a blood purification device, wherein a blood purifier for purifying a patient's blood is installed, and a flexible fluid line for introducing or discharging fluid to or from the blood purifier is connected to the blood purifier, wherein the fluid line is closed by an opening / closing unit, This pressure leak detection method involves supplying and pressurizing the fluid using a pressurizing unit located in the fluid line, measuring the pressure of the fluid between the opening / closing unit and the pressurizing unit in the fluid line using a pressure measuring unit, correcting the pressure value measured by the pressure measuring unit to compensate for the pressure drop due to the expansion of the fluid line, and determining whether or not there is pressure leakage at the closed portion of the fluid line closed by the opening / closing unit based on the corrected pressure value.

[0111] This method removes pressure drops due to fluid line expansion from the corrected pressure value data used for judgment, making it easy to understand pressure fluctuations caused by the airtightness of the opening and closing parts. As a result, pressure leaks in the fluid line can be detected accurately and quickly.

[0112] A twelfth embodiment of this disclosure is to correct the pressure value data by subtracting pressure fluctuation data due to the expansion of the fluid line when the fluid is pressurized, in the tenth embodiment. This prevents the correction process from becoming complicated in the correction step and suppresses increased costs and complexity associated with the correction process. [Explanation of Symbols]

[0113] 1. Blood purification unit 1a Blood purification device 1b Consumables section 2 Base Units 3 Main unit 4 displays 5. Blood Purifier 6 Processing Unit 7 Internal piping section 8 Extracorporeal Circulation Department 31 Pressurized section 32 Opening / Closing Section 33 Pressure measuring section 61 Arithmetic section 62 Storage section L0 blood circuit L21 Gas Circuit L50 Dialysate piping L60 Fluid Line Patient H

Claims

1. A blood purification device is provided, comprising a blood purifier for purifying a patient's blood, and a flexible fluid line for introducing or discharging fluid to the blood purifier, A pressurizing unit is arranged in the fluid line to pressurize the fluid, A pressure measuring unit measures the pressure of the fluid between the opening / closing unit and the pressurizing unit in the fluid line when the fluid line is closed by an opening / closing unit capable of closing the fluid line, A blood purification device comprising: a processing unit that corrects the pressure value measured by the pressure measuring unit to compensate for the pressure drop due to the expansion of the fluid line, and determines whether or not there is pressure leakage in the fluid line closed by the opening / closing unit based on the corrected pressure value.

2. The blood purification apparatus according to claim 1, wherein the processing unit stores pressure fluctuation data due to the expansion of the fluid line when the fluid is pressurized, and corrects the pressure value by subtracting the pressure fluctuation data.

3. The blood purification apparatus according to claim 2, wherein the pressure fluctuation data includes fluctuation data due to the length of the fluid line, fluctuation data due to the material of the fluid line, and fluctuation data previously measured by the fluid line.

4. It has a temperature measuring unit for measuring the temperature of the fluid line or the fluid, The blood purification apparatus according to claim 2 or 3, wherein the processing unit receives temperature data from the temperature measuring unit when the fluid is pressurized, and corrects the pressure fluctuation data by including the fluctuation data corresponding to the temperature data.

5. The blood purification apparatus according to claim 1 or 2, wherein the processing unit stores abnormal sample data of the opening / closing unit corresponding to the corrected pressure value, and determines the abnormal state of the opening / closing unit based on the corrected pressure value.

6. A blood purification device is provided, comprising a blood purifier for purifying a patient's blood, and a flexible fluid line for introducing or discharging fluid to the blood purifier, A pressurizing unit is arranged in the fluid line to pressurize the fluid, A pressure measuring unit measures the pressure of the fluid between the opening / closing unit and the pressurizing unit in the fluid line when the fluid line is closed by an opening / closing unit capable of closing the fluid line, A blood purification device having a processing unit that determines whether or not there is pressure leakage in the fluid line closed by the opening / closing unit, based on a predetermined pressure value measured in advance by the pressure measuring unit and the pressure value measured by the pressure measuring unit.

7. The blood purification device according to claim 1 or 6, comprising a clamp or valve as the opening / closing part.

8. The fluid line is 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 opening and closing part is a clamp placed in the blood circuit, The blood purification apparatus according to claim 1 or 6, wherein the pressurizing unit is a blood pump connected to the blood circuit.

9. The fluid line comprises a venous blood circuit for returning purified blood from the blood purifier to the patient, and a gas circuit branching off from the venous blood circuit. The opening / closing part is a valve arranged in the gas circuit, The blood purification apparatus according to claim 1 or 6, wherein the pressurizing unit is an air pump connected to the gas circuit.

10. The fluid line is a dialysis fluid piping that supplies dialysis fluid to the blood purifier and discharges the dialysis fluid as wastewater. The opening / closing part is a valve located in the dialysis fluid piping. The blood purification apparatus according to claim 1 or 6, wherein the pressurizing unit is a dialysate pump connected to the dialysate piping.

11. A method for detecting pressure leaks using a blood purification device, wherein a blood purifier for purifying a patient's blood is installed, and a flexible fluid line for introducing or discharging fluid to the blood purifier is connected to the blood purifier, The fluid line is closed by the opening / closing part, The fluid is supplied and pressurized by a pressurizing unit located in the fluid line, The pressure of the fluid between the opening / closing section and the pressurizing section in the fluid line is measured by the pressure measuring section. A pressure leak detection method comprising: correcting the pressure value measured by the pressure measuring unit to compensate for the pressure drop due to the expansion of the fluid line; and determining whether or not there is pressure leakage at the closed portion of the fluid line closed by the opening / closing unit based on the corrected pressure value.

12. The pressure leak detection method according to claim 11, wherein when determining whether or not there is a pressure leak, the pressure value is corrected by subtracting pressure fluctuation data due to the expansion of the fluid line when the fluid is pressurized.

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