Blood purification device, information processing device, water removal profile setting method, and processing program
The blood purification device dynamically adjusts water removal rates to accommodate individual patient conditions, addressing the inefficiencies of uniform or linear rate methods by gradually decreasing rates, thereby reducing patient burden and enhancing treatment efficiency.
Patent Information
- Application Number
- JP2025191879
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Filing Date
- 2025-11-12
- Publication Date
- 2026-01-23
- Estimated Expiration
- 2045-08-12
AI Technical Summary
Existing blood purification treatments struggle to adequately control water removal rates to minimize patient burden, as these rates are often uniform or linearly decreasing, failing to account for individual patient conditions.
A blood purification device and method that dynamically adjusts water removal rates by gradually decreasing them from the start to the end of treatment, using a calculation unit to determine rates based on achieved water removal progress, accommodating various patient conditions.
This approach allows for efficient water removal processing that reduces patient burden by tailoring water removal profiles to individual patient needs, enhancing treatment efficiency and comfort.
Smart Images

Figure 0007805514000001_ABST
Abstract
Description
[Technical Field]
[0001] The present disclosure relates to controlling water removal during blood purification treatment for a patient. [Background technology]
[0002] As an example of blood purification, dialysis treatment using a blood purification device having a dialyzer and a blood circuit has been known. In dialysis treatment, blood taken from a patient is circulated extracorporeally through a blood circuit, purified using a dialyzer connected to the blood circuit, and the purified blood is returned to the patient. During the blood purification, excess water and waste products are removed from the patient's body.
[0003] In the water removal process to remove such excess water, the amount and speed of water removal are very important. If the amount and speed of water removal are not appropriate, it may cause a drop in blood pressure, muscle cramps, headaches, nausea, vomiting, or loss of consciousness, placing a great burden on the patient during treatment. For this reason, the amount and speed of water removal are set appropriately, taking into account the patient's condition, etc.
[0004] For example, Patent Documents 1 to 3 disclose that the water removal rate, which is normally controlled to a constant value, is reduced from the start of dialysis treatment to the end of treatment in order to reduce the burden on patients. In particular, Patent Document 1 defines the relationship between the water removal time and the water removal rate using a mathematical expression with a negative proportionality constant or a mathematical expression with an inverse proportionality constant. In Patent Document 2, the water removal rate is controlled to decrease linearly and then to a constant value from a predetermined time. And in Patent Document 3, the water removal rate is decreased in stages, and after the decrease, it is controlled to remain constant for one hour. [Prior art documents] [Patent documents]
[0005] [Patent Document 1] Patent No. 3379794 [Patent Document 2] Patent No. 7277269 [Patent Document 3] Japanese Utility Model Application Publication No. 5-76445 Summary of the Invention [Problem to be solved by the invention]
[0006] However, simply decreasing the water removal rate over time can be difficult to adequately reduce the burden on patients. In particular, because the water removal rate is affected by the patient and their condition during treatment, simply decreasing the water removal rate does not adequately control the water removal rate and may actually increase the burden on patients. In other words, there is considerable room for improvement in controlling the water removal rate from the start to the end of treatment in terms of reducing the burden on patients, and there is a growing demand for such improvement from patients and medical professionals.
[0007] The present disclosure has been made in consideration of these problems, and its purpose is to provide a blood purification device, an information processing device, a method for setting a water removal profile, and a processing program that can accommodate a variety of patients and their respective conditions, and that enable water removal control to perform efficient water removal processing while reducing the burden on the patient. [Means for solving the problem]
[0008] According to one aspect of the present disclosure, there is provided a "blood purification device for administering blood purification treatment to a patient, the blood purification device comprising: a memory unit that stores the water removal achievement rate at a predetermined elapsed time during the treatment time of the blood purification treatment; and a calculation unit that sets a water removal profile in which the water removal rate gradually decreases from the start to the end of the blood purification treatment, the calculation unit comprising a water removal rate determination unit that determines the water removal rate for a predetermined time at the predetermined elapsed time based on the water removal achievement rate."
[0009] According to one aspect of the present disclosure, there is provided an information processing device that performs setting processing for blood purification treatment for a patient, the information processing device having: a memory unit that stores the water removal achievement rate at a predetermined elapsed time during the treatment time of the blood purification treatment; and a calculation unit that sets a water removal profile in which the water removal rate gradually decreases from the start to the end of the blood purification treatment, the calculation unit including a water removal rate determination unit that determines the water removal rate for a predetermined time at the predetermined elapsed time based on the water removal achievement rate.
[0010] According to one aspect of the present disclosure, there is provided a "water removal profile setting method in which a calculation unit sets a water removal profile for controlling a water removal pump in blood purification treatment for a patient, the method comprising: a reading step of reading out a water removal achievement rate at a predetermined elapsed time of treatment time of the blood purification treatment; a water removal rate determination step of determining a water removal rate for a predetermined time at the predetermined elapsed time based on the water removal achievement rate; and a setting step of setting a water removal profile in which the water removal rate gradually decreases from the start to the end of the blood purification treatment based on the predetermined elapsed time and the water removal rate for the predetermined time."
[0011] According to one aspect of the present disclosure, there is provided a processing program for performing a setting process for blood purification treatment for a patient, the processing program causing a calculation unit to execute a process for reading out the water removal achievement rate at a predetermined elapsed time during the treatment of the blood purification treatment, determining a predetermined time water removal rate at the predetermined elapsed time based on the water removal achievement rate, and setting a water removal profile in which the water removal rate gradually decreases from the start to the end of the blood purification treatment based on the predetermined elapsed time and the predetermined time water removal rate. [Effects of the Invention]
[0012] According to the present disclosure, it is possible to provide a blood purification device, an information processing device, a method for setting a water removal profile, and a processing program that can accommodate various patients and their respective conditions, and that enable water removal control to perform efficient water removal processing while reducing the burden on the patient.
[0013] It should be noted that the above effects are merely examples for the sake of convenience of explanation, and the effects of the present disclosure are not limited to these. In addition to the above effects, the present disclosure can achieve any of the effects described herein. [Brief explanation of the drawings]
[0014] [Figure 1] FIG. 1 is a schematic diagram showing the mechanical configuration of a blood purification unit according to a first embodiment. [Figure 2] FIG. 2 is a block diagram showing the electrical configuration of the blood purification unit according to the first embodiment. [Figure 3] FIG. 2 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 first embodiment. [Figure 4] FIG. 1 is a functional block diagram of a blood purification unit according to a first embodiment. [Figure 5] FIG. 3 is a flowchart showing the flow of processing related to setting a water removal profile for the blood purification unit according to the first embodiment. [Figure 6] 4 is a graph showing an example of a water removal profile of the blood purification unit according to the first embodiment. [Figure 7] FIG. 3 is a flowchart showing the flow of processing related to correction of the water removal profile of the blood purification unit according to the first embodiment. [Figure 8] 4 is a graph showing correction of the water removal profile of the blood purification unit according to the first embodiment. [Figure 9] 10 is a graph showing a modified example of the water removal profile of the blood purification unit according to the first embodiment. [Figure 10] 10 is a graph showing a modified example of the water removal profile of the blood purification unit according to the first embodiment. [Figure 11] FIG. 10 is a schematic diagram showing the mechanical configuration of a blood purification system according to a second embodiment. [Figure 12] 10 is a functional block diagram of a blood purification system according to a second embodiment. FIG. DETAILED DESCRIPTION OF THE INVENTION
[0015] The blood purification device and blood purification unit including the same according to the present disclosure will be described in detail below with reference to the drawings. The present disclosure is not limited to the content described below and can be modified as desired without departing from the spirit and scope of the present disclosure. The drawings used in each embodiment are schematic illustrations of the blood purification device, its components, and the blood purification unit including these components according to the present disclosure. To facilitate understanding, some parts may be emphasized, enlarged, reduced, or omitted, and the scale and shape of each component may not be accurately represented. Furthermore, some numerical values used in each embodiment are merely examples and can be modified as necessary. The same reference symbols are used to designate components that are common to all drawings.
[0016] First Embodiment (Blood purification unit configuration) First, the configuration of the blood purification unit of the present 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 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.
[0017] 1, the blood purification unit 1 is composed of a blood purification apparatus 1a, which is a dialysis device for performing dialysis treatment, which is an example of blood purification treatment, and a consumables section 1b, which is composed of various consumables. That is, in the blood purification unit 1, a state is created in which the consumables section 1b is connected to the blood purification apparatus 1a, and dialysis treatment is performed on patient H.
[0018] Specifically, the blood purification unit 1 has a main body 3 installed on a base unit 2, a display 4 connected to the top of the main body 3, and a blood purifier 5 installed to the side of the main body 3. The main body 3 of the blood purification unit 1 also has an information processing unit 6 that processes various information and data, an internal piping unit 7 for circulating dialysate between the main body and the blood purifier 5, and an extracorporeal circulation unit 8 for circulating the blood, which is a bodily fluid of patient H, outside the body. With this configuration, the blood purification unit 1 can extract the blood of patient H from the body (blood removal 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 patient H (blood return process).
[0019] The blood purification device 1a is the base of the blood purification unit 1 and is composed of a base unit 2, a main body 3, a display 4, an information processing unit 6, an internal piping unit 7, and part of an extracorporeal circulation unit 8. Here, the extracorporeal circulation unit 8 includes a blood circuit (described later), a pump connected to the blood circuit, various sensors, and other parts and devices. Of these, the pump, various sensors, and other devices are provided in the blood purification device 1a and therefore become components (constituent devices) of the blood purification device 1a.
[0020] On the other hand, the consumables section 1b is composed of the blood purifier 5 and part of the extracorporeal circulation section 8. Here, the blood circuit and some of the other components included in the extracorporeal circulation section 8 are merely detachably connected to the blood purification device 1a, and are elements (components) that make up the consumables section 1b, not the blood purification device 1a.
[0021] As shown in Figure 2, the blood purification unit 1 is electrically connected to the display 4, information processing unit 6, internal piping unit 7, and extracorporeal circulation unit 8 via control lines and data lines. This allows the blood purification device 1a to transmit and receive various signals, data, and information, and also enables various controls by the information processing unit 6. In the following, data is basically assumed to consist of processed signals, such as numbers, symbols, or characters. Information is basically assumed to be collected or processed data, such as data that the recipient can use for subsequent consideration or that can be utilized by the recipient. However, data and information may be used in accordance with their content and context, regardless of the above assumptions.
[0022] In this embodiment, a hemodialysis device is described as an example of the blood purification device 1a, but the blood purification device 1a is not limited to this. For example, an acute blood purification device, a peritoneal dialysis device, an ultrafiltration device, or a hemofiltration device can also be an example of the blood purification device 1a.
[0023] In addition to the above-described configuration, the blood purification apparatus 1a of the blood purification unit 1 may have a communication interface that enables transmission and reception of information and the like with an external device such as a terminal device or a server device, etc. This allows the blood purification apparatus 1a to obtain various information related to the patient's treatment (patient information) from the external device via the communication interface.
[0024] [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 attached to the base 2a. This allows the blood purification unit 1 and blood purification device 1a to be easily moved. The number of casters 2b is not limited to four, and may be three or five or more as long as it allows the blood purification unit 1 and blood purification device 1a to be moved.
[0025] [Main unit] 1, the main body 3 is composed of a substantially rectangular parallelepiped housing. Inside and on the surface of the main body 3, various components and devices that constitute the internal piping section 7 and extracorporeal circulation section 8 of the blood purification unit 1 are arranged. For example, the components may include various pumps and detectors, and the components may include a blood circuit, a dialysate circuit, and various sensors.
[0026] 〔display〕 1 and 2, the display 4 has a touch panel input interface 4a and a general screen output interface 4b. That is, the display 4 in this embodiment is a touch panel equipped with an input / output interface. The input detection method by the touch panel may be any method, such as a capacitance method or a resistive film method. The operable area and position on the touch panel can be freely set by the administrator of the blood purification unit 1. That is, the arrangement of the input interface 4a and output interface 4b on the display 4 can be set as appropriate.
[0027] The input interface 4a may be separated from the display 4. In this case, the blood purification apparatus 1a may be provided with an input device such as a keyboard with physical key buttons, such as a numeric keypad or character input keys, and a mouse.
[0028] [Blood purifier] 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 at the side of its housing as dialysate-side ports. An arterial blood circuit L1 (described later) is connected to the blood inlet 5a, and a venous blood circuit L2 (described later) is connected to the blood outlet 5b. A dialysate supply pipe (drug solution supply pipe) L3 (described later) is connected to the dialysate inlet 5c, and a dialysate discharge pipe (drug solution discharge pipe) L4 (described later) is connected to the dialysate outlet 5d.
[0029] The blood purifier 5 contains a plurality of hollow fiber membranes (not shown), which constitute a blood purification membrane for purifying blood. Inside the blood purifier 5, a blood flow path through which the blood of patient H flows via the blood purification membrane and a dialysate flow path through which a dialysate, a medicinal solution for blood purification, flows are formed. Furthermore, the hollow fiber membranes constituting the blood purification membranes have many minute pores formed therein that penetrate from the outer peripheral surface to the inner peripheral surface, allowing impurities in the blood to permeate into the dialysate via the hollow fiber membranes.
[0030] The blood purifier 5 is not limited to a dialyzer having the above-described configuration. For example, it may be an adsorption-type blood purifier used in endotoxin adsorption therapy, activated carbon adsorption therapy, bilirubin adsorption therapy, etc. The blood purifier 5 may also be a hemodiafilter.
[0031] [Extracorporeal circulation department] Next, as shown in FIG. 3, the extracorporeal circulation unit 8 has a structure in which an arterial blood circuit L1 is connected to the blood inlet side of the blood purifier 5, and a venous blood circuit L2 is connected to the blood outlet side of the blood purifier 5. That is, the arterial blood circuit L1 and the venous blood circuit L2 constitute a blood circuit L0 through which the patient's blood flows. A gas circuit L21 for adjusting the liquid level of an air trap chamber (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 into or from the air trap chamber. Each of these circuits is made of a flexible material, such as polyvinyl chloride tubing or silicone tubing. That is, the arterial blood circuit L1, the venous blood circuit L2, and the gas circuit L21 are flexible fluid lines for fluid flow.
[0032] The arterial blood circuit L1 has, for example, a connector C1 disposed at one end thereof, and a blood pump P1 and an arterial blood volume sensor 21 (hereinafter also referred to as BV meter 21) disposed midway along the connector C1. The type of blood pump P1 is not particularly limited as long as it can introduce the blood of the patient H into the blood purifier 5. In this embodiment, a peristaltic pump is assumed, but other pumps such as a diaphragm pump may also be used.
[0033] The BV meter 21 is a sensor that measures over time changes in blood volume caused by water removal during blood purification treatment. For example, the BV meter 21 is composed of a light-emitting element and a light-receiving element. In the BV meter 21, the light-emitting element irradiates near-infrared light onto the blood flowing through the arterial blood circuit L1, and the light-receiving element receives the light reflected by the blood. As a result, the BV meter 21 measures the intensity of the reflected light and calculates the concentration (Ht: hematocrit) of the blood flowing through the arterial blood circuit L1.
[0034] For the sake of convenience, some of the components and devices provided in the arterial blood circuit L1 are omitted from the description of this disclosure, and various components, devices, and equipment required for blood purification are provided as appropriate. For example, depending on the specifications of the blood purification device 1a and the blood circuit L0, the arterial blood circuit L1 may be provided with a valve (solenoid valve), an air bubble detector, an air trap chamber, and the like.
[0035] On the other hand, in the venous blood circuit L2, for example, an air trap chamber 22, a venous blood volume sensor 23 (hereinafter also referred to as BV meter 23), and a connector C2 are arranged in this order from the blood purifier 5 toward the patient H. The BV meter 23 has the same configuration as the BV meter 21.
[0036] For the sake of convenience, some components arranged in the venous blood circuit L2 are omitted from the description of this disclosure. Various components, devices, and apparatuses necessary for blood purification are arranged as appropriate. For example, depending on the specifications of the blood purification apparatus 1a and the blood circuit L0, a pressure detector, an air bubble detector, a valve, and the like may be arranged. When the blood purification apparatus 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.
[0037] The gas circuit L21 for adjusting the liquid level is provided with a valve V1, a pressure sensor S1, an air pump P2 for adjusting the liquid level, and an air filter 24, arranged in this order from the air trap chamber 22 toward the outside of the circuit. This configuration makes it possible to drive the air pump P2 to introduce or expel air, thereby adjusting the blood level in the air trap chamber 22. Some of the components arranged in the gas circuit L21 are omitted here for the sake of convenience in explaining this disclosure, and various components, devices, and apparatuses required for adjusting the liquid level are arranged as appropriate.
[0038] The operations of the various pumps and valve V1 described above are controlled based on control signals supplied from the information processing unit 6. Furthermore, these various pumps and valve V1 can transmit data indicating their operating states to the information processing unit 6. Similarly, the BV meter 21, the BV meter 23, and the pressure sensor S1 can transmit detection signals, which are measurement values, to the information processing unit 6. This enables the information processing unit 6 to control the operations of the components of the extracorporeal circulation unit 8 and to grasp various states in the extracorporeal circulation unit 8.
[0039] As described above, the extracorporeal circulation unit 8 is assembled by appropriately selecting the above-mentioned components and devices according to the circuit configuration and model, and has a structure that enables blood removal and return. The extracorporeal circulation unit 8 is also assembled by appropriately selecting the above-mentioned components and devices according to the circuit configuration and model, and has a structure for detecting blood volume. Note that the structure for detecting blood volume may be configured such that only one of the BV meter 21 and the BV meter 23 is provided.
[0040] [Internal piping section] Next, as shown in Fig. 3, the internal piping section 7 has a structure in which a main pipe (dialysate supply pipe) L3 is connected to the supply side of the blood purifier 5, a main pipe (dialysate discharge pipe) L4 is connected to the discharge side, and a bypass pipe L31 is connected between the main pipe L3 and the main pipe L4 so as to bypass the blood purifier 5. In addition, a bypass pipe L41 is connected in parallel to the main pipe L4 midway through the main pipe L4 so as to bypass a portion of the main pipe L4. For example, each pipe is made of a flexible material such as polyvinyl chloride tubing or silicone tubing. That is, the main pipe L3, the main pipe L4, the bypass pipe L31, and the bypass pipe L41 constitute the dialysate pipe L50 through which the dialysate flows, and serve as a flexible fluid line for fluid flow.
[0041] As can be seen from FIG. 3 , each pipe is provided with a pump, a valve, a sensor, and the like. Specifically, in the main pipe L3, a degassing pump P11, which is one of the dialysis fluid pumps, a duplex pump P12, which is one of the dialysis pumps, a pressure sensor S11, and a valve V11 are arranged in this order from the fluid supply terminal side of the internal pipe section 7 toward the dialysate inlet 5c of the blood purifier 5. Here, some of the components and devices arranged in the main pipe L3 are omitted for the convenience of explanation of this disclosure, and various components, devices, and apparatuses necessary for blood purification are arranged 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, temperature sensors, and the like may be arranged in the main pipe L3.
[0042] In addition, in the main pipe L4, a valve V12, a pressure sensor S12, a pressure pump P13 which is one of the dialysate pumps, and a duplex pump P12 are arranged in this order from the dialysate outlet 5d of the blood purifier 5 toward the drain terminal side of the internal pipe section 7. Here, some of the components and devices arranged in the main pipe L4 are omitted for the convenience of explanation in this disclosure, and various components, equipment, and devices necessary for blood purification are arranged as appropriate. For example, depending on the specifications of the blood purification device 1a and the dialysate pipe L50, other valves (solenoid valves, back pressure valves), a degassing chamber, a flow rate detector, etc. may be arranged in the main pipe L4.
[0043] Furthermore, a valve V13 is provided in the bypass pipe L31. A water removal pump P14, which is one of the dialysis fluid pumps, is provided in the bypass pipe L41. The water removal pump P14 applies negative pressure to remove only excess water from the blood through the membrane of the blood purifier 5. That is, by controlling the operation of the water removal pump P14, the water removal process described below is performed according to a desired profile.
[0044] For the sake of convenience, some of the components and devices provided in the bypass piping L31 and the bypass piping L41 are omitted from the description of this disclosure, and various components, devices, and equipment required for blood purification are provided as appropriate. For example, depending on the specifications of the blood purification device 1a and the dialysate piping L50, other valves (solenoid valves) and the like may be provided in the bypass piping L41.
[0045] The operations of the various pumps and valves V11 to V13 described above are controlled based on control signals supplied from the information processing unit 6. In particular, in this embodiment, the operation of the water removal pump P14 is controlled based on a water removal profile set in the information processing unit 6, and a water removal speed corresponding to the water removal profile is achieved. Furthermore, these various pumps and valves V11 to V13 are capable of transmitting data indicating their operating states to the information processing unit 6. Similarly, the pressure sensors S11 and S12 are also capable of transmitting pressure values, which are measured values, to the information processing unit 6. This allows the information processing unit 6 to control the operations of the components of the internal piping unit 7 and to grasp various states of the internal piping unit 7.
[0046] 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 model, and has a structure that enables the circulation and cleaning of the dialysate. The internal piping section 7 also has a structure that enables the introduction and discharge of the dialysate to and from the blood purifier 5.
[0047] [Information Processing Section] Next, the information processing unit 6 according to this embodiment is composed of a processor 6a and a memory 6b, as shown in FIG.
[0048] The processor 6a is composed of a GPU (Graphics Processing Unit) or a CPU (Central Processing Unit), and functions as a calculation unit (described later) for controlling the components of the blood purification unit 1 (particularly the blood purification device 1a) based on various processing programs stored in the memory 6b. Specifically, the processor 6a reads and executes a processing program for performing treatment to purify the patient's blood or a processing program for running the OS from the memory 6b.
[0049] The processor 6a controls the operation of various component devices, etc., from the setting up to the end of blood purification treatment, performs predetermined calculations using signals received from each component device, and re-controls the operation of various component devices, etc. In particular, in this embodiment, the processor 6a executes a calculation process (described later) based on the total water removal volume (S) and treatment time (T) input via the input interface 4a, and sets a water removal profile in which the water removal rate gradually decreases. More specifically, the processor 6a executes a processing program that performs setting processing for blood purification treatment for patient H. The processing program reads the water removal achievement rate during a predetermined elapsed time in the first half of the blood purification treatment, calculates the uniform water removal rate during the treatment time based on the received total water removal volume and the treatment time of the blood purification treatment, calculates the arrival time until the water removal rate reaches the uniform water removal rate based on the treatment time, determines the predetermined time water removal rate during the predetermined elapsed time based on the uniform water removal rate, the arrival time, and the water removal achievement rate, and sets a water removal profile in which the water removal rate gradually decreases from the start to the end of the blood purification treatment based on the treatment time, the arrival time, the predetermined elapsed time, the uniform water removal rate, and the predetermined time water removal rate. Furthermore, the processor 6a determines the condition of the patient H from the detection signals (changes in blood volume over time: ΔBV) detected by the BV meters 21 and 23, and corrects the set water removal profile. That is, the processor 6a executes a processing program for correcting the water removal profile. These processes will be described in detail later.
[0050] Furthermore, the processor 6a may continuously receive pressure values from the pressure sensors S1, S11, and S12 and measure the status of the blood purification treatment initiated by the operation of the blood purification device 1a. The processor 6a may be configured with a single GPU or CPU, or may be configured with a combination of multiple CPUs or GPUs.
[0051] The memory 6b is composed of ROM, RAM, non-volatile memory, HDD, etc., and functions as a storage unit (described later). The ROM stores instructions and commands for carrying out treatment to purify the patient's blood as a processing program. The RAM is used to write and read data while the processing program stored in the ROM is being processed by the processor 6a. The non-volatile memory is a storage device into which data is written and read by the execution of the processing program, and the data written therein is retained even after the execution of the processing program has ended.
[0052] In particular, in this embodiment, the memory 6b stores a processing program for calculation processing to set a water removal profile in which the water removal rate gradually decreases based on the total water removal volume and treatment time input via the input interface 4a. The memory 6b also stores predetermined conditions required for setting the water removal profile. Here, the predetermined conditions may be, for example, a water removal achievement rate at a predetermined elapsed time in the first half of the treatment time and a calculation coefficient for calculating the time (Ta) until the water removal rate reaches an equal water removal rate (described later). These predetermined conditions are information input in advance via the input interface 4a. Furthermore, the memory 6b stores a processing program for determining the condition of the patient H from the detection signals, which are the detection results of the BV meters 21 and 23, and a processing program for correcting the water removal profile based on the detection signals. Details of these processing programs will be described later.
[0053] In this embodiment, the treatment time is the period from the start of treatment to the end of treatment. The treatment time is divided into a first half and a second half based on T / 2, which is half of that time. In particular, in the first half of the treatment time, the burden on patient H is not large, so the water removal speed can be set high, and in the second half of the treatment, the burden on patient H due to the treatment gradually accumulates, so the water removal speed is set low.
[0054] (Setting the water removal profile) Next, the configuration and method for setting a water removal profile in the blood purification unit 1 according to this embodiment will be described with reference to Figures 4 to 6. Figure 4 is a functional block diagram of the blood purification unit 1 according to this embodiment. In particular, Figure 4 shows the mechanical and electrical connections of the components that make up the blood purification unit 1. Figure 5 is a flow chart showing the process flow for setting a water removal profile in the blood purification unit 1 according to this embodiment. In particular, Figure 5 describes various processes in the information processing unit 6. Furthermore, Figure 6 is a graph showing an example of a water removal profile in the blood purification unit 1 according to this embodiment. In particular, in Figure 6, the horizontal axis represents time and the vertical axis represents the water removal rate.
[0055] 4, in the blood purification unit 1 according to this embodiment, the information processing unit 6 includes an arithmetic unit 61 that functions when the processor 6a executes a predetermined processing program, and a storage unit 62 that functions when the memory 6b stores the processing program, processing conditions, and processing results. That is, the information processing unit 6 includes the arithmetic unit 61 that performs a predetermined process among the many processes executed by the processor 6a, and the storage unit 62 that stores a predetermined processing program, data, information, etc. among the information stored in the memory 6b. In particular, in this embodiment, the arithmetic unit 61 performs processes related to setting, correcting, and executing a water removal profile.
[0056] The blood purification unit 1 according to this embodiment also has, as its functions, an input section 63 and an output section 64. Here, the input section 63 functions when the processor 6a executes a predetermined processing program to operate the input interface 4a. That is, the input section 63 functions to input various settings in advance for the blood purification unit 1. Similarly, the output section 64 functions when the processor 6a executes a predetermined processing program to operate the output interface 4b. That is, the output section 64 functions to output various settings and states for the blood purification unit 1.
[0057] 4, the calculation unit 61 includes an equal water removal rate calculation unit 61a, an arrival time calculation unit 61b, and a water removal rate determination unit 61c to execute various processes related to the water removal profile. As a result, the calculation unit 61 compiles the processing results of each unit and controls the water removal process in the blood purification therapy overall.
[0058] As shown in FIG. 4 , the calculation unit 61 receives the total amount of water removed (unit: liters), the treatment time (unit: hours), and the water removal success rate (unit: percentage) from the input unit 63. In particular, in this embodiment, the calculation unit 61 executes a calculation process (described later) using the received total amount of water removed and the treatment time, and stores the received water removal success rate in the memory unit 62. Here, the total amount of water removed refers to the amount of water removed from the patient H during blood purification treatment. In other words, the total amount of water removed refers to the amount of water lost from the body by blood purification treatment. The treatment time refers to the time from the start to the end of blood purification treatment. The water removal success rate is a numerical value indicating the extent to which water removal has been completed relative to the total amount of water removed within a predetermined time (predetermined elapsed time) since the start of blood purification treatment. In other words, the water removal success rate is a numerical value obtained by multiplying the amount of water removed from the start of blood purification treatment until the predetermined time has elapsed by the total amount of water removed, and multiplying this value by 100.
[0059] The uniform water removal rate calculation unit 61a of the calculation unit 61 calculates the uniform water removal rate (L / h) based on the received total water removal rate and treatment time. Here, the uniform water removal rate is a water removal rate that enables the removal of the total water removal rate during the treatment time, and is a water removal rate that is assumed to be maintained constant during the treatment time. In other words, the uniform water removal rate is a value obtained by dividing the total water removal rate by the treatment time.
[0060] The arrival time calculation unit 61b of the calculation unit 61 calculates the arrival time required for the water removal rate to reach the uniform water removal rate based on the received treatment time. In particular, in this embodiment, the arrival time calculation unit 61b uses a preset calculation coefficient to perform calculations so that the arrival time falls in the first half of the treatment time. For example, the calculation coefficient may be 0.375, and if a treatment time of 4 hours is input, the time required to reach the uniform water removal rate is calculated as 1.5 hours. The calculation coefficient may be read from the storage unit 62 or may be a value preset in the processing program for calculating the arrival time. Therefore, the calculation coefficient may be changeable based on input information from the input unit 63.
[0061] The water removal rate determination unit 61c of the calculation unit 61 determines the water removal rate at a predetermined elapsed time (predetermined time water removal rate) based on the calculated uniform water removal rate and arrival time, and the water removal achievement rate read from the memory unit 62. In particular, the water removal rate determination unit 61c of the calculation unit 61 determines the water removal rate at a predetermined elapsed time so that the water removal achievement rate can be exceeded. Here, the predetermined elapsed time is an arbitrarily set time elapsed from the start of treatment, and is the same as the predetermined elapsed time related to the water removal achievement rate stored in the memory unit 62. In other words, the predetermined time water removal rate calculated by the water removal rate determination unit 61c is the water removal rate when the preset water removal achievement rate is reached.
[0062] Furthermore, at least one time within the treatment time is set as the predetermined elapsed time. For example, at least a time that is 20% to 30% of the treatment time and a time that is 45% to 50% of the treatment time may be selected as the predetermined elapsed time. In particular, in this embodiment, T / 4, which is 25% of the treatment time (T), is set as the first elapsed time, and T / 2, which is 50%, is set as the second elapsed time. Note that, although it is preferable to select a time in the first half of the treatment time as the predetermined elapsed time, a time in the second half of the treatment time may also be selected in addition to the first half. For example, 25%, 50%, or 75% of the treatment time (T) may be selected as the predetermined elapsed time.
[0063] Furthermore, the water removal achievement rate may be appropriately selected within a range of, for example, 10% to 70%. Here, the settable range of the water removal achievement rate may vary depending on the predetermined elapsed time. For example, the closer the predetermined elapsed time is from the start of treatment, the smaller the selectable water removal achievement rate value, and the narrower the range may be. More specifically, when the predetermined elapsed time is T / 4, the water removal achievement rate may be selected within a range of 10% to 35%, and when the predetermined elapsed time is T / 2, the water removal achievement rate may be selected within a range of 30% to 70%. In particular, in this embodiment, when the predetermined elapsed time is T / 4 (first elapsed time), the first water removal achievement rate is set to 25%, and when the predetermined elapsed time is T / 2 (second elapsed time), the second water removal achievement rate is set to 50%.
[0064] In this way, in this embodiment, the water removal achievement rate is set in the first half of the treatment. The reason for this is that in the first half of the treatment, the burden on the patient H is not large, so the water removal speed can be set high, and therefore it is preferable to set the water removal achievement rate in the first half of the treatment relatively high and allow the treatment to proceed further.
[0065] The water removal rate determining unit 61c may set the predetermined time water removal rate higher than the uniform water removal rate when the set predetermined elapsed time is shorter than the calculated arrival time. On the other hand, the water removal rate determining unit 61c may set the predetermined time water removal rate lower than the uniform water removal rate when the set predetermined elapsed time is longer than the calculated arrival time. For example, if the predetermined elapsed times are T / 4 (first elapsed time) and T / 2 (second elapsed time) and the arrival time is T / 3, the water removal rate at T / 4 (first water removal rate) will be higher than the uniform water removal rate, and the water removal rate at T / 2 (second water removal rate) will be lower than the uniform water removal rate.
[0066] In order to calculate such a water removal rate, other information may be stored in the processing program, or may be read from the storage unit 62 and used as appropriate. The other information may be the rate of decrease in the water removal rate corresponding to the elapsed time of treatment, the water removal rate or its range at the start of treatment, and the water removal rate or its range at the end of treatment, etc.
[0067] In addition, the calculation unit 61 sets a water removal profile based on the received treatment time, the set predetermined elapsed time, the calculated arrival time, the uniform water removal rate, and the predetermined time water removal rate (first water removal rate, second water removal rate). In the set water removal profile, the water removal rate gradually decreases from the start to the end of blood purification treatment. Here, a gradual decrease in the water removal rate refers to a gradual decrease in the water removal rate over time, a decline that slopes downwards over the entire treatment time, but also includes cases where the water removal rate temporarily increases. In other words, the set water removal profile may be a linear decrease, a stepwise decrease, or an exponential decrease, and there may be time periods where the water removal rate temporarily increases.
[0068] The calculation unit 61 also stores the set water removal profile in the memory unit 62 and outputs it from the output unit 64. Furthermore, the calculation unit 61 controls the water removal pump P14 so as to correspond to the set water removal profile. Specifically, the calculation unit 61 generates a control signal for controlling the drive of the water removal pump P14 so as to realize the set water removal profile, and transmits the control signal to the water removal pump P14.
[0069] The storage unit 62 stores a processing program for executing the processing by the calculation unit 61 described above, conditions required for setting a water removal profile, the set water removal profile, and detection signals received from various sensors. Conditions required for setting a water removal profile include, for example, a water removal achievement rate (first water removal achievement rate, second water removal achievement rate), a predetermined elapsed time (first elapsed time, second elapsed time), and a calculation coefficient for calculating the arrival time. The storage unit 62 may also store the rate of decrease in water removal speed corresponding to the elapsed time of treatment, the water removal speed or its range at the start of treatment, and the water removal speed or its range at the end of treatment.
[0070] As a specific flow of the method for setting a water removal profile, as shown in Figure 5, the calculation unit 61 determines whether or not it has received the total water removal volume and treatment time (S101). If the calculation unit 61 has received the total water removal volume and treatment time via the input unit 63 (S101: Yes), it starts the processing from S102 onwards for setting the water removal profile. On the other hand, if the calculation unit 61 has not received the total water removal volume and treatment time via the input unit 63 (S101: No), it waits for input information without proceeding with the processing for setting the water removal profile.
[0071] When the total water removal volume and treatment time are received via the input unit 63 (S101: Yes), the calculation unit 61 reads out the water removal achievement rate stored in the memory unit 62 (S102: reading step). Specifically, the calculation unit 61 reads out the water removal achievement rate at the first elapsed time T / 4 (25%) and the water removal achievement rate at the second elapsed time T / 2 (50%) as the water removal achievement rate stored in the memory unit 62.
[0072] Next, the uniform water removal rate calculation unit 61a of the calculation unit 61 calculates the uniform water removal rate (L / h) for the current blood purification treatment (S103: uniform water removal rate calculation step). Specifically, the uniform water removal rate calculation unit 61a of the calculation unit 61 calculates the uniform water removal rate by dividing the received total water removal volume by the received treatment time. As shown by the dashed line in Figure 6, the uniform water removal rate is a constant water removal rate until the treatment time (T), which is the end time of the treatment, and is the rate at which the total water removal volume is achieved by maintaining this water removal rate during the treatment time (T).
[0073] Next, the arrival time calculation unit 61b of the operation unit 61 calculates the arrival time (Ta), which is the time required to reach an uniform water removal rate in the current blood purification treatment (S104: arrival time calculation step). Specifically, the arrival time calculation unit 61b calculates the arrival time (Ta) by multiplying the treatment time (T) by a predetermined calculation coefficient. Here, the calculation coefficient may be read from the storage unit 62 and used, or may be set in advance in the processing program used for the calculation.
[0074] Next, the water removal rate determination unit 61c of the calculation unit 61 determines a predetermined time water removal rate at a predetermined elapsed time corresponding to the read-out water removal achievement rate (S105: water removal rate determination step). Specifically, the water removal rate determination unit 61c calculates a first water removal rate at a first predetermined elapsed time (T / 4), which is one of the predetermined elapsed times, and a second water removal rate at a second predetermined elapsed time (T / 2), which is another predetermined elapsed time. More specifically, the water removal rate determination unit 61c determines the first water removal rate and the second water removal rate based on the calculated uniform water removal rate and arrival time, and the two read-out water removal achievement rates. Taking the calculated uniform water removal rate and arrival time into consideration, the water removal rate determination unit 61c determines the first water removal rate and the second water removal rate so that the water removal achievement rate at the first predetermined elapsed time (T / 4) is 25% or more and the water removal achievement rate at the second predetermined elapsed time (T / 2) is 50% or more.
[0075] For example, by presetting the rate of decrease in the water removal rate from the start of treatment through a first predetermined elapsed time (T / 4) to the arrival time (Ta), and the rate of decrease in the water removal rate from the arrival time (Ta) through a second predetermined elapsed time (T / 2) to the end of treatment, each water removal rate can be uniquely determined. Here, the rate of decrease in the water removal rate is not limited to the slope of the straight line in Figure 6, but may be a predetermined mathematical formula, approximate function, or the like. Note that each water removal rate may be uniquely determined by presetting the water removal rate at the start of treatment and the water removal rate at the end of treatment.
[0076] Next, the calculation unit 61 sets a water removal profile based on the received treatment time (T), the set predetermined elapsed time (first predetermined elapsed time, second predetermined elapsed time), the calculated arrival time (Ta), the uniform water removal rate, and each water removal rate (first water removal rate, second water removal rate) (S106: setting step). Specifically, the calculation unit 61 uses the above information to set a water removal profile in which the water removal rate gradually decreases from the start to the end of blood purification treatment.
[0077] 6, for example, the calculation unit 61 sets a right-sloping water removal profile in which the water removal speed decreases at a first decrease rate (slope) from the start of treatment to the arrival time (Ta), decreases at a second decrease rate (slope) from the arrival time (Ta) to a second predetermined elapsed time (T / 2), and decreases at a third decrease rate (slope) from the second predetermined elapsed time (T / 2) to the end of treatment. In particular, the first decrease rate is greater than the second decrease rate, and the second decrease rate is greater than the third decrease rate.
[0078] Furthermore, as can be seen from Figure 6, the amount of water removed from the start of treatment to the arrival time (Ta) is greater than the uniform amount of water removed from the start of treatment to the arrival time (Ta). Here, the uniform amount of water removed is the amount of water removed when water is removed at a uniform water removal rate within a predetermined time. On the other hand, the amount of water removed from the arrival time (Ta) to the second predetermined elapsed time (T / 2) is smaller than the uniform amount of water removed from the arrival time (Ta) to the second predetermined elapsed time (T / 2). Similarly, the amount of water removed from the second predetermined elapsed time (T / 2) to the end of treatment is smaller than the uniform amount of water removed from the second predetermined elapsed time (T / 2) to the end of treatment.
[0079] With such a water removal profile, the treatment can be progressed more in the first half of the treatment, when the burden on patient H is not great, and the burden on patient H in the second half of the treatment can be reduced. In other words, compared to a water removal profile that simply reduces the water removal rate, such a water removal profile can further reduce the burden on patient H and prevent side effects and complications from blood purification treatment.
[0080] Next, the calculation unit 61 outputs and stores the set water removal profile (S107). Specifically, the calculation unit 61 outputs the set water removal profile from the output unit 64. That is, the water removal profile is displayed on the display 4, allowing the operator of the blood purification unit 1 to visually confirm it. The calculation unit 61 also stores the set water removal profile in the memory unit 62. This allows the calculation unit 61 to read out a previously set water removal profile and set it again, and may even allow a new water removal profile to be set using a previously set water removal profile.
[0081] Next, the calculation unit 61 determines whether or not treatment is to be initiated in the blood purification unit 1 (S108). For example, when the operator of the blood purification unit 1 presses the treatment start button displayed on the display 4, the calculation unit 61 receives an instruction to start blood purification treatment and determines that the blood purification unit 1 is in a treatment start state (S108: Yes). On the other hand, if the treatment start button is not pressed and an instruction to start blood purification treatment is not received, the calculation unit 61 enters a state of waiting for an instruction to start treatment (S108: No).
[0082] Next, when the blood purification unit 1 enters a treatment start state, the calculation unit 61 executes control to start blood purification treatment. In particular, in this embodiment, the calculation unit 61 controls the water removal pump P14 based on the set water removal profile (S109). Specifically, the calculation unit 61 generates and supplies a control signal for controlling the rotation speed of the water removal pump P14, driving the water removal pump P14 at the desired rotation speed. This realizes the water removal profile shown in FIG. 6, and blood purification treatment, including water removal treatment, for patient H progresses.
[0083] (Correction of water removal profile) Next, an overview of the process for correcting the water removal profile in the blood purification unit 1 according to this embodiment will be described with reference to Figures 4, 7, and 8. Here, Figure 7 is a flow chart showing the process flow for correcting the water removal profile in the blood purification unit 1 according to this embodiment. Also, Figure 8 is a graph showing the correction of the water removal profile in the blood purification unit 1 according to this embodiment.
[0084] 4, the arterial blood volume sensor (BV meter) 21 located upstream of the blood purifier 5 and the venous blood volume sensor (BV meter) 23 located downstream of the blood purifier 5 detect blood volumes, and transmit the detected blood volumes as detection signals to the calculation unit 61. That is, the blood volumes in the arterial blood circuit L1 and the venous blood circuit L2 are detected by the respective BV meters, and the change over time in the blood volume of the patient H (ΔBV) is calculated in the calculation unit 61.
[0085] As shown in FIG. 4, the calculation unit 61 includes a profile correction unit 61d for correcting the water removal profile. If the calculated ΔBV decreases by a predetermined amount or more during the first half of the treatment time, the profile correction unit 61d determines that the condition of patient H has worsened and corrects the set water removal profile. In other words, if the rate of decrease in patient H's blood volume exceeds a predetermined value, the calculation unit 61 resets the water removal profile to reduce the burden on patient H. Specifically, the profile correction unit 61d temporarily or overall decreases the first-half water removal speed during the first half of the treatment, or temporarily or overall increases the rate of decrease of the first-half water removal speed, thereby reducing the amount of water removal and the water removal achievement rate during the first half of the treatment compared to the initial settings. As a result, the ΔBV during the first half of the treatment is less than the predetermined value. Meanwhile, the calculation unit 61 temporarily or overall increases the second-half water removal speed during the second half of the treatment, or temporarily or overall increases the rate of decrease of the second-half water removal speed, to compensate for the decrease in the amount of water removal due to the correction during the first half of the treatment.
[0086] The calculation unit 61 stores the newly set water removal profile obtained by the above correction in the memory unit 62. The calculation unit 61 also outputs the newly set water removal profile obtained by the above correction via the output unit 64, allowing the operator to visually confirm it. Furthermore, the calculation unit 61 generates a new control signal based on the newly set water removal profile and transmits the control signal to the water removal pump P14 to re-control the operation of the water removal pump P14.
[0087] As a specific flow of the method for correcting the water removal profile, as shown in Fig. 7, the calculation unit 61 determines whether it is the first half of the treatment time (S111). If it is the first half of the treatment time (S111: Yes), the calculation unit 61 starts the processing from S112 onwards for correcting the water removal profile. On the other hand, if it is the second half of the treatment time (S111: No), the calculation unit 61 ends this flow without performing the processing for correcting the water removal profile. This is because in the second half of the treatment time, the water removal speed is slower than in the first half, and it is difficult in terms of time and water removal speed to compensate for the decrease in the amount of water removed due to the correction.
[0088] Next, if it is the first half of the treatment time (S111: Yes), the calculation unit 61 calculates ΔBV from the detection signal received from the BV meter 21 or BV meter 23 (S112: blood volume calculation step). Next, the calculation unit 61 determines whether the calculated ΔBV has decreased by a predetermined amount or more (S113). If the ΔBV has not decreased by a predetermined amount or more (S113: No), the calculation unit 61 determines that the burden on the patient H has not increased and that correction of the water removal profile is unnecessary, and ends this flow.
[0089] On the other hand, if ΔBV has decreased by more than a predetermined amount (S113: Yes), the profile correcting unit 61d of the calculation unit 61 determines that the burden on the patient H is increasing, and corrects the water removal profile (S114: correction step). Specifically, as shown in Fig. 8, the profile correcting unit 61d corrects the rate of decrease in the water removal speed to be larger from the time when a significant decrease in ΔBV is detected until the arrival time (Ta), and corrects the water removal achievement rate at the arrival time (Ta) to be lower. Also, as shown in Fig. 8, the profile correcting unit 61d corrects the rate of decrease in the water removal speed to be smaller from the second predetermined elapsed time (T / 2), which is the latter half of the treatment, until the end of the treatment, and corrects the water removal speed at the end of the treatment to be higher.
[0090] The correction coefficients or formulas, etc. for this correction are set in advance and stored in the storage unit 62. In particular, the correction coefficients or formulas, etc. are set and adjusted so as to ensure the initially set total amount of water removal while reducing the burden on patient H in the first half of treatment and preventing excessive burden on patient H even in the second half of treatment, when the burden on patient H is likely to be greater.
[0091] Next, the calculation unit 61 changes the control of the water removal pump P14 based on the reset water removal profile (S115). Specifically, the calculation unit 61 generates and supplies a control signal for readjusting the rotation speed of the water removal pump P14, and drives the water removal pump P14 at the desired rotation speed. This achieves the corrected water removal profile shown in Fig. 8, and blood purification therapy including the water removal process progresses in a state where the burden on the patient H is reduced.
[0092] Regarding the correction of the water removal profile, the graph showing the corrected water removal profile may decrease or increase linearly, may decrease or increase exponentially, or may decrease or increase in a stepwise (step-like) manner. That is, in order to accommodate a significant decrease in ΔBV, the decrease rate of the water removal rate in the first half of the treatment may be increased, and the water removal that could not be performed in the first half of the treatment may be compensated for in the second half of the treatment, so that the decrease rate and increase rate of the water removal rate can be adjusted appropriately.
[0093] (Operation and effect of the first embodiment) In this embodiment, the water removal rate is gradually reduced in the second half of the treatment time while ensuring the water removal achievement rate at any time in the first half of the treatment time, so that the water removal rate can be set to a relatively high optimal value in the first half of the treatment time, which is less burdensome for patient H, and the water removal rate can be set to a relatively low optimal value in the second half of the treatment time, which is more burdensome for patient H. This makes it possible to control water removal in a way that can respond to the conditions of patient H and each patient, and to perform an efficient water removal process while reducing the burden on patient H. In other words, it is possible to prevent a drop in patient H's blood pressure, etc., while completing treatment within the set treatment time.
[0094] Furthermore, in this embodiment, the water removal profile is automatically set by the operator of the blood purification unit 1 simply inputting conditions, thereby reducing the burden on the operator and the number of work steps.
[0095] (Modification of the first embodiment) In the above embodiment, the two predetermined elapsed times related to the water removal achievement rate stored in the memory unit 62 were the first predetermined elapsed time (T / 4) and the second predetermined elapsed time (T / 2), but only one of them may be used. An example of a water removal profile set in such a case is shown in FIG. 9 or 10. Here, FIGS. 9 and 10 are graphs showing modified water removal profiles of the blood purification unit 1 according to this embodiment. In particular, in FIGS. 9 and 10, the horizontal axis represents time and the vertical axis represents the water removal rate.
[0096] When the predetermined elapsed time related to the water removal achievement rate stored in the memory unit 62 is only the first predetermined elapsed time (T / 4), an example of a water removal profile set by the calculation unit 61 is a graph as shown in Fig. 9. As shown in Fig. 9, the calculation unit 61 sets a water removal profile that slopes downward to the right, such that the water removal speed decreases at a first decrease rate (slope) from the start of treatment to the first predetermined elapsed time (T / 4), and then decreases at a second decrease rate (slope) from the first predetermined elapsed time (T / 4) to the end of treatment. In particular, the first decrease rate is greater than the second decrease rate.
[0097] In this modified example, as can be seen from Figure 9, the amount of water removed from the start of treatment until the first predetermined elapsed time (T / 4) is greater than the uniform amount of water removed from the start of treatment until the first predetermined elapsed time (T / 4). Similarly, the amount of water removed from the first predetermined elapsed time (T / 4) to the arrival time (Ta) is greater than the uniform amount of water removed from the first predetermined elapsed time (T / 4) to the arrival time (Ta). On the other hand, the amount of water removed from the arrival time (Ta) to the end of treatment is smaller than the uniform amount of water removed from the first predetermined elapsed time (T / 4) to the end of treatment.
[0098] When the predetermined elapsed time related to the water removal achievement rate stored in the memory unit 62 is only the second predetermined elapsed time (T / 2), an example of a water removal profile set by the calculation unit 61 is a graph as shown in Fig. 10. As shown in Fig. 10, the calculation unit 61 sets a water removal profile that slopes downward to the right, such that the water removal speed decreases at a first decrease rate (slope) from the start of treatment to the second predetermined elapsed time (T / 2), and then decreases at a second decrease rate (slope) from the second predetermined elapsed time (T / 2) to the end of treatment. In particular, the first decrease rate is greater than the second decrease rate.
[0099] In this modified example, as can be seen from Figure 10, the amount of water removed from the start of treatment to the arrival time (Ta) is greater than the uniform amount of water removed from the start of treatment to the arrival time (Ta). On the other hand, the amount of water removed from the arrival time (Ta) to the second predetermined elapsed time (T / 2) is smaller than the uniform amount of water removed from the arrival time (Ta) to the second predetermined elapsed time (T / 2). Similarly, the amount of water removed from the second predetermined elapsed time (T / 2) to the end of treatment is smaller than the uniform amount of water removed from the second predetermined elapsed time (T / 2) to the end of treatment.
[0100] In any of the above-described modified examples, the water removal rate is gradually reduced in the second half of the treatment time while ensuring the water removal achievement rate at any time in the first half of the treatment time, so that the water removal rate can be set to a relatively large optimal value in the first half of the treatment time when it is less burdensome for the patient H, and the water removal rate can be set to a relatively small optimal value in the second half of the treatment time when it is more burdensome for the patient H. This makes it possible to respond to the conditions of the patient H and each patient, and to perform water removal control to perform an efficient water removal process while reducing the burden on the patient H.
[0101] Furthermore, the predetermined elapsed time associated with the stored water removal achievement rate is not limited to T / 4 and T / 2, and can be selected arbitrarily in the first or second half of the treatment time. From the viewpoint of making the amount of water removed in the first half of treatment greater than the uniform amount of water removal, it is preferable that one of the predetermined elapsed times selected be the first half of treatment. On the other hand, storing more water removal achievement rates for predetermined elapsed times makes it possible to set a more precise water removal profile.
[0102] Furthermore, in the above-described embodiment, the calculation unit 61 includes the uniform water removal rate calculation unit 61a and the arrival time calculation unit 61b, but these two units may not be included. In this case, the calculation unit 61 may receive the uniform water removal rate and the arrival time via the input unit 63, or may use other input information or setting information that can determine the water removal rate for a predetermined time. In other words, if a water removal profile is set in which the water removal rate gradually decreases from the start to the end of blood purification treatment, the calculation unit 61 can use various information.
[0103] Second Embodiment In the first embodiment, the blood purification unit 1 had a calculation unit 61 that performs processing to set the water removal profile and a memory unit 62 that stores the processing program and setting information required for the setting. However, an information processing device communicably connected to the blood purification unit 1 may have functions in place of the calculation unit 61 and the memory unit 62. This configuration will be described as the second embodiment with reference to FIGS. 11 and 12. FIG. 11 is a schematic diagram showing the mechanical configuration of the blood purification system according to this embodiment. FIG. 12 is a functional block diagram of the blood purification system according to this embodiment. In this embodiment, differences from the first embodiment will be basically described, and descriptions of the same contents will be omitted, and the same reference numerals will be used in the drawings.
[0104] 11 and 12, the blood purification system 300 according to this embodiment is made up of a blood purification unit 101 that performs blood purification treatment on patient H, and a terminal device 201, which is an information processing device that is communicatively connected to the blood purification unit 101. The blood purification unit 101 and terminal device 201 may be installed in the same building, i.e., a hospital, but the terminal device 201 may also be installed in a different building, or may be installed as a server device on the cloud.
[0105] 11 and 12, the blood purification unit 101 has the same basic configuration for blood purification therapy as the blood purification unit 1 of the first embodiment. Unlike the blood purification unit 1 of the first embodiment, the blood purification unit 101 does not have functions for calculating, setting, correcting, etc., related to the water removal profile. That is, although the information processing unit 106 of the blood purification unit 101 includes a calculation unit 161 and a memory unit 162, the calculation unit 161 and the memory unit 162 execute various processes related to blood purification therapy other than the processes related to the water removal profile. Therefore, information related to the setting of the water removal profile, such as the total water removal volume, treatment time, and water removal achievement rate, input from the input unit 63, is not processed by the calculation unit 161 or the memory unit 162, but is transmitted from the calculation unit 161 to the terminal device 201 via the communication unit 165.
[0106] 12, the terminal device 201 has a calculation unit 261, a storage unit 262, and a communication unit 265. The calculation unit 261 has the same configuration as the calculation unit 61 of the first embodiment and performs the same processing. The storage unit 262 has the same configuration as the storage unit 62 of the first embodiment and performs the same processing. Therefore, the terminal device 201 performs various processes related to setting and correcting the water removal profile in the blood purification unit 101 in place of the blood purification unit 101.
[0107] Furthermore, the water removal profile calculated in the terminal device 201 is transmitted to the blood purification unit 101 via the communication unit 265. In the blood purification unit 101, the calculation unit 161 transmits the received water removal profile to the output unit 64, and the water removal profile is displayed so that it can be visually confirmed by the operator of the blood purification unit 101. The calculation unit 161 also controls the water removal pump P14 in accordance with the water removal profile.
[0108] (Operation and effect of the second embodiment) As described above, this embodiment can also achieve the same effects as the first embodiment. Furthermore, in this embodiment, the part that sets the water removal profile is separated from the blood purification unit 101, which reduces the processing load on the blood purification unit 101 and further reduces the cost of the blood purification unit 101. Furthermore, multiple water removal profiles can be managed collectively, which makes it easier to set, manage, and operate the water removal profiles.
[0109] <Embodiments of the present disclosure> A first embodiment of the present disclosure is a blood purification device that administers blood purification treatment to a patient, and includes a memory unit that stores the water removal achievement rate for a predetermined elapsed time in the first half of the treatment time of the blood purification treatment, and a calculation unit that sets a water removal profile in which the water removal rate gradually decreases from the start to the end of the blood purification treatment, and the calculation unit is equipped with a water removal rate determination unit that determines the water removal rate for a predetermined time in the predetermined elapsed time based on the water removal achievement rate.
[0110] In this way, the water removal rate is gradually reduced in the second half of the treatment time while ensuring the water removal achievement rate at any time in the first half of the treatment time. This allows the water removal rate to be set to a relatively high optimal value in the first half of the treatment time, when the patient is less burdened, and the water removal rate to be set to a relatively low optimal value in the second half of the treatment time, when the patient is more burdened. This enables water removal control that can respond to the patient and their condition and perform an efficient water removal process while reducing the burden on the patient. In other words, it is possible to prevent a drop in the patient's blood pressure while completing the treatment within the set treatment time.
[0111] In a second embodiment of the present disclosure, in the first embodiment, the calculation unit includes an equal water removal rate calculation unit that calculates an equal water removal rate for the treatment time based on the received total water removal volume and the treatment time of the blood purification treatment, an arrival time calculation unit that calculates an arrival time for the water removal rate to reach the equal water removal rate based on the treatment time, and the water removal rate determination unit determines the predetermined time water removal rate based on the equal water removal rate and the arrival time. This allows the water removal profile to be set more accurately based on the equal water removal rate, making it possible to respond to the patient and their condition and to control water removal to perform efficient water removal treatment while reducing the burden on the patient.
[0112] In a third embodiment of the present disclosure, in the second embodiment, the water removal rate determining unit sets the predetermined time water removal rate higher than the uniform water removal rate when the predetermined elapsed time is shorter than the arrival time, and sets the predetermined time water removal rate lower than the uniform water removal rate when the predetermined elapsed time is longer than the arrival time. This allows the water removal profile to be set more accurately based on the uniform water removal rate, making it possible to respond to the patient and their condition and to control water removal to perform efficient water removal treatment while reducing the burden on the patient.
[0113] In a fourth embodiment of the present disclosure, in the second or third embodiment, the arrival time calculation unit uses a calculation coefficient so that the arrival time is in the first half of the treatment time, which makes it possible to easily calculate and uniquely determine the arrival time, thereby improving the accuracy of setting the water removal profile.
[0114] In a fourth embodiment of the present disclosure, in any of the first to fourth embodiments, the memory unit stores a first water removal achievement rate at a first predetermined elapsed time in the first half of the treatment time of the blood purification treatment and a second water removal achievement rate at a second predetermined elapsed time in the first half of the treatment time of the blood purification treatment that is later than the first predetermined elapsed time, and the water removal rate determination unit determines the first water removal rate at the first predetermined elapsed time and the second water removal rate at the second predetermined elapsed time. This enables water removal control that can accurately respond to the patient and the condition of each patient and performs an efficient water removal process while further reducing the burden on the patient.
[0115] A sixth embodiment of the present disclosure is the fifth embodiment, wherein the first predetermined elapsed time is 20% to 30% of the treatment time, the first water removal achievement rate is 10% to 35%, the second predetermined elapsed time is 45% to 50% of the treatment time, and the second water removal achievement rate is greater than the first water removal achievement rate and is 30% to 60%. This enables water removal control to more appropriately respond to the patient and the condition of each patient, and to perform efficient water removal treatment while further reducing the burden on the patient.
[0116] A seventh embodiment of the present disclosure is any of the first to sixth embodiments, further comprising a blood volume sensor for detecting the volume of blood in a blood circuit connected to a blood purifier that purifies the patient's blood, thereby enabling changes in the patient's condition during treatment to be monitored.
[0117] An eighth embodiment of the present disclosure is the seventh embodiment, in which the calculation unit has a profile correction unit that corrects the water removal profile based on the detection signal received from the blood volume sensor, thereby optimizing the water removal profile in accordance with the patient's condition.
[0118] A ninth embodiment of the present disclosure is the eighth embodiment, wherein the profile correction unit, when the rate of decrease in the blood volume in the first half of the treatment time is equal to or greater than a predetermined value, decreases the first half water removal speed in the first half of the treatment time and increases the second half water removal speed in the second half of the treatment time. This makes it possible to continue the water removal process in accordance with the patient's condition without extending the treatment time.
[0119] A tenth embodiment of the present disclosure is an information processing device that performs setting processing for blood purification treatment for a patient, and includes a memory unit that stores the water removal achievement rate for a predetermined elapsed time in the first half of the treatment time of the blood purification treatment, and a calculation unit that sets a water removal profile in which the water removal rate gradually decreases from the start to the end of the blood purification treatment, and the calculation unit is an information processing device that includes a water removal rate determination unit that determines the water removal rate for a predetermined time in the predetermined elapsed time based on the water removal achievement rate.
[0120] In this way, the water removal rate is gradually reduced in the second half of the treatment time while ensuring the water removal achievement rate at any time in the first half of the treatment time. This allows the water removal rate to be set to a relatively high optimal value in the first half of the treatment time, when the patient is less burdened, and the water removal rate to be set to a relatively low optimal value in the second half of the treatment time, when the patient is more burdened. This enables water removal control that can respond to the patient and their condition and perform an efficient water removal process while reducing the burden on the patient. In other words, it is possible to prevent a drop in the patient's blood pressure while completing the treatment within the set treatment time.
[0121] An eleventh embodiment of the present disclosure is a method for setting a water removal profile in which a calculation unit sets a water removal profile for controlling a water removal pump in blood purification treatment for a patient, the method comprising: a reading step for reading out the water removal achievement rate at a predetermined elapsed time in the first half of the treatment time of the blood purification treatment; a water removal rate determination step for determining the water removal rate for a predetermined time at the predetermined elapsed time based on the arrival time and the water removal achievement rate; and a setting step for setting a water removal profile in which the water removal rate gradually decreases from the start to the end of the blood purification treatment based on the predetermined elapsed time and the water removal rate for the predetermined time.
[0122] In this way, the water removal rate is gradually reduced in the second half of the treatment time while ensuring the water removal achievement rate at any time in the first half of the treatment time. This allows the water removal rate to be set to a relatively high optimal value in the first half of the treatment time, when the patient is less burdened, and the water removal rate to be set to a relatively low optimal value in the second half of the treatment time, when the patient is more burdened. This enables water removal control that can respond to the patient and their condition and perform an efficient water removal process while reducing the burden on the patient. In other words, it is possible to prevent a drop in the patient's blood pressure while completing the treatment within the set treatment time.
[0123] A twelfth embodiment of the present disclosure is a processing program for setting up blood purification treatment for a patient, which reads out the water removal achievement rate for a predetermined elapsed time in the first half of the treatment time of the blood purification treatment, determines a predetermined time water removal rate for the predetermined elapsed time based on the water removal achievement rate, and sets a water removal profile in which the water removal rate gradually decreases from the start to the end of the blood purification treatment based on the predetermined elapsed time and the predetermined time water removal rate.
[0124] In this way, the water removal rate is gradually reduced in the second half of the treatment time while ensuring the water removal achievement rate at any time in the first half of the treatment time. This allows the water removal rate to be set to a relatively high optimal value in the first half of the treatment time, when the patient is less burdened, and the water removal rate to be set to a relatively low optimal value in the second half of the treatment time, when the patient is more burdened. This enables water removal control that can respond to the patient and their condition and perform an efficient water removal process while reducing the burden on the patient. In other words, it is possible to prevent a drop in the patient's blood pressure while completing the treatment within the set treatment time. [Explanation of symbols]
[0125] 1. Blood purification unit 1a Blood purification device 1b Consumables section 2 base units 3 Main unit 4. Display 5. Blood Purifier 6. Information Processing Section 7 Internal piping section 8 Extracorporeal Circulation Department 21 Arterial blood volume sensor (BV meter) 23 Venous blood volume sensor (BV meter) 61 Arithmetic section 61a Equal water removal rate calculation section 61b Arrival time calculation section 61c Water removal speed determination section 61d Profile correction section 62 Storage section L0 blood circuit L1 arterial blood circuit L2 venous blood circuit L3 Dialysis fluid supply pipe (medicinal fluid supply pipe) L4 Dialysis fluid drainage pipe (medication solution drainage pipe) P14 Water removal pump H patient
Claims
1. A blood purification device that administers blood purification therapy to a patient, a memory unit that stores the water removal achievement rate at a predetermined elapsed time during the blood purification treatment; a calculation unit that sets a water removal profile in which the water removal rate gradually decreases from the start to the end of the blood purification treatment, The calculation unit The blood purification apparatus includes a water removal rate determining unit that determines a water removal rate for a predetermined time period during the predetermined elapsed time period based on the water removal achievement rate.
2. The blood purification apparatus according to claim 1, wherein the water removal achievement rate stored in the memory unit is the rate at a predetermined time in the latter half of the treatment time of the blood purification treatment.
3. The calculation unit includes an equal water removal rate calculation unit that calculates an equal water removal rate during the treatment time based on the received total water removal amount and the treatment time of the blood purification treatment, and an arrival time calculation unit that calculates an arrival time until the water removal rate reaches the equal water removal rate based on the treatment time. The blood purification apparatus according to claim 2 , wherein the water removal rate determining unit determines the predetermined time water removal rate based on the uniform water removal rate and the arrival time.
4. The water removal rate determination unit When the predetermined elapsed time is shorter than the arrival time, the predetermined time water removal speed is set to be greater than the uniform water removal speed, 4. The blood purification apparatus according to claim 3, wherein when the predetermined elapsed time is longer than the arrival time, the predetermined time water removal rate is set to be lower than the uniform water removal rate.
5. 5. The blood purification apparatus according to claim 3, wherein the arrival time calculation unit uses a calculation coefficient so that the arrival time falls in the latter half of the treatment time.
6. the memory unit stores a first water removal achievement rate at a first predetermined elapsed time in the latter half of the treatment time of the blood purification treatment, and a second water removal achievement rate at a second predetermined elapsed time in the latter half of the treatment time of the blood purification treatment, the second predetermined elapsed time being later than the first predetermined elapsed time; The blood purification apparatus according to claim 3 or 4, wherein the water removal rate determining unit determines a first water removal rate at the first predetermined elapsed time and a second water removal rate at the second predetermined elapsed time.
7. 5. The blood purification apparatus according to claim 3, further comprising a blood volume sensor for detecting the volume of blood in a blood circuit connected to a blood purifier that purifies the patient's blood.
8. 8. The blood purification apparatus according to claim 7, wherein the calculation unit includes a profile correction unit that corrects the water removal profile based on a detection signal received from the blood content sensor.
9. An information processing device that performs setting processing for blood purification treatment for a patient, a memory unit that stores the water removal achievement rate at a predetermined elapsed time during the blood purification treatment; a calculation unit that sets a water removal profile in which the water removal rate gradually decreases from the start to the end of the blood purification treatment, The calculation unit An information processing device comprising a water removal rate determination unit that determines a water removal rate for a predetermined time period during the predetermined elapsed time based on the water removal achievement rate.
10. A method for setting a water removal profile for controlling a water removal pump in blood purification therapy for a patient, the method comprising the steps of: a reading step of reading out the water removal achievement rate at a predetermined elapsed time during the blood purification treatment; A water removal rate determination step of determining a water removal rate for a predetermined time at the predetermined elapsed time based on the water removal achievement rate; A method for setting a water removal profile, comprising: a setting step of setting a water removal profile in which the water removal rate gradually decreases from the start to the end of the blood purification treatment based on the specified elapsed time and the specified time water removal rate.
11. A processing program for performing setting processing for blood purification treatment for a patient, reading out the water removal achievement rate at a predetermined elapsed time during the blood purification treatment; Based on the water removal achievement rate, a predetermined time water removal rate is determined at the predetermined elapsed time, A processing program that causes a calculation unit to execute a process for setting a water removal profile in which the water removal rate gradually decreases from the start to the end of the blood purification treatment based on the specified elapsed time and the specified time water removal rate.
Citation Information
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