JP7852276B2 - Blood purification device and method for controlling the blood purification device - Google Patents

Description

This disclosure relates to a blood purification device and a method for controlling a blood purification device.

Conventionally, blood purification devices that purify blood by at least one of dialysis and filtration are known. For example, Japanese Patent Publication No. 2019-37674 (Patent Document 1) discloses a hemodialysis device that purifies blood by dialysis. In this hemodialysis device, setting values related to the setting items for dialysis treatment are set.

The hemodialysis machine comprises a priority setting selection means for selecting one of the following setting items: treatment time, target ultrafiltration volume, and ultrafiltration rate; and a setting value update means for updating the setting values of other related setting items based on the setting value of the changed setting item. When one setting value (treatment time) is selected by the priority setting selection means, and one of the other two setting values (ulcer removal rate) is changed, the setting value update means maintains the selected setting value (treatment time) in the priority setting selection means while updating the other setting value (target ultrafiltration volume) based on the changed setting value (ulcer removal rate).

Japanese Patent Publication No. 2019-37674

In a blood purification device, the usability of the device can be improved if the flow rate from the pump can be set based on the pump's flow rate per unit body weight and the patient's weight.

This disclosure has been made in view of the above-mentioned problems, and its purpose is to provide a blood purification device and a method for controlling the blood purification device that can set the flow rate of a pump based on the flow rate per unit body weight of the pump and the patient's weight.

According to a certain aspect of this disclosure, the blood purification device comprises a pump, a receiving means for receiving input of a first flow rate per unit body weight from the pump and the patient's weight, a calculation means for calculating a second flow rate corresponding to the patient's weight based on the first flow rate and the patient's weight, and a pump control means for operating the pump based on the calculated second flow rate.

According to other aspects of this disclosure, a method for controlling a blood purification device comprises the steps of: receiving input of a first flow rate per unit body weight from a pump and the patient's weight; calculating a second flow rate corresponding to the patient's weight based on the first flow rate and the patient's weight; and operating the pump based on the calculated second flow rate.

According to this disclosure, the flow rate of the pump can be set based on the flow rate per unit body weight and the patient's weight.

This diagram shows a schematic overview of the overall configuration of a blood purification device. This diagram illustrates the input settings for a blood purification device. This is a diagram illustrating the first example of operation. This is a diagram illustrating the second example of operation. This is a diagram illustrating a third example of operation. This is a diagram illustrating the fourth example of operation. This is a functional block diagram illustrating the functional configuration of a blood purification device. This is a flowchart illustrating the processing flow performed in a blood purification device.

The embodiments of this disclosure will be described below with reference to the drawings. In the following description, identical components are denoted by the same reference numerals. Their names and functions are also the same. Therefore, detailed descriptions of them will not be repeated.

For more details, the following explanation will use Continuous Renal Replacement Therapy (CRRT) as an example. CRRT is primarily applied to patients with severe conditions such as acute renal failure, where renal function is rapidly declining. In the following explanation, "user" typically refers to healthcare professionals such as physicians and nurses.

<A. Overall configuration>
Figure 1 is a schematic diagram showing the overall configuration of the blood purification device 1. As shown in Figure 1, in this example, the blood purification device 1 comprises a replacement fluid pump 31, a dialysate pump 32, a drainage pump 33, a blood pump 34, a blood filter 50, a syringe 60, and a control device and touchscreen (see Figure 7) which will be described later.

The blood filter 50 removes unwanted or toxic substances from the blood. The blood filter 50 has a hollow fiber membrane. Blood flows through the inside of the hollow fiber membrane. For example, by applying pressure from the inside to the outside of the hollow fiber membrane, moderate amounts of substances such as water, waste products in the blood, and cytokines move from the inner region to the outer region of the hollow fiber membrane within the blood filter 50. This purifies the blood.

The replacement fluid pump 31 supplies replacement fluid 41, also called replacement fluid or fluid replacement fluid, to the blood circuit (flow path). The dialysate pump 32 supplies dialysate 42 to the blood circuit. More specifically, the dialysate pump 32 supplies dialysate to the outer region of the hollow fiber membrane of the hemofilter 50. The drainage pump 33 sends the drainage fluid (dialysis fluid drainage) containing substances (substances from the blood) that have moved to the outer region of the hollow fiber membrane within the hemofilter 50 to the drainage container 43. The drainage pump 33 is also called a "filtration pump."

The operation of the replenishment fluid pump 31, the dialysate pump 32, and the drainage pump 33 is controlled by the control device.

The syringe 60 supplies an anticoagulant to the blood circuit based on user operation, in order to prevent blood clotting in the blood circuit and the hemofilter 50.

Although Figure 1 illustrates a post-dilution apparatus configuration as an example, the process disclosed herein is not limited to this configuration and can also be applied to pre-dilution apparatuses.

<B. Settings Input Items>
Figure 2 is a diagram illustrating the setting input items for the blood purification device 1. As shown in Figure 2, the setting input items differ depending on the CRRT mode (treatment mode, setting mode).

The input settings include the flow rate of replacement fluid per unit body weight (mL/kg/h), the ultrafiltration rate (mL/L), the flow rate of dialysate per unit body weight (mL/kg/h), and the patient's weight (kg). The modes of CRRT include continuous hemofiltration (CHF), continuous hemodialysis (CHD), continuous hemodiafiltration (CHDF), and slow continuous ultrafiltration (SCUF). In this example, the blood purification device 1 is capable of performing all four modes. In this embodiment, the unit body weight is set to "1 kg".

For continuous hemofiltration (CHF), input of the replacement fluid flow rate per unit body weight and the patient's weight is required (mandatory). For continuous hemodialysis (CHD), input of the dialysate flow rate per unit body weight and the patient's weight is required. For continuous hemodiafiltration (CHDF), input of the replacement fluid flow rate per unit body weight, the dialysate flow rate per unit body weight, and the patient's weight is required. For continuous slow ultrafiltration (SCUF), input of the ultrafiltration rate (mL/h) and the patient's weight is required.

The patient's weight may be the weight before blood purification, or the weight measured at any given time.

As described above, patient weight input is mandatory for all four modes of CRRT. However, inputting the ultrafiltration rate is optional for continuous hemofiltration (CHF), continuous hemodialysis (CHD), and continuous hemodialysis (CHD). Inputting the ultrafiltration rate is required when ultrafiltration is performed in these three modes.

In this example, the upper limit of the settable range for the flow rate of the replacement fluid per unit body weight is 99.9 (mL/kg/h). The upper limit of the settable range for the flow rate of the dialysate per unit body weight is 99.9 L (mL/kg/h). The upper limit of the settable range for the ultrafiltration rate is 9999 (mL). The upper limit of the settable range for the patient's weight in this example is 199.9 kg. Furthermore, the blood purification device 1 is required to satisfy the following four conditions (1) to (4).

(1) The flow rate (discharge volume) per hour from the replenishment fluid pump 31 is 0 mL/h or more and 8000 mL/h or less.

(2) The flow rate (discharge volume) per hour from the dialysate pump 32 is 0 mL/h or more and 8000 mL/h or less.

(3) The flow rate (discharge volume) per hour from the drainage pump 33 is greater than 0 mL/h and 8000 mL/h or less. Specifically, the sum of the flow rate per hour from the replenishment fluid pump 31, the flow rate per hour from the dialysate pump 32, and the ultrafiltration rate (amount of ultrafiltration removed per hour) is greater than 0 mL/h and 8000 mL/h or less.

The upper limit of "8000 mL/h" in the above conditions (1) to (3) is based solely on the pump capacity of each pump 31 to 33 installed in the blood purification device 1, and is merely an example. This value will vary depending on the type of pump installed in the blood purification device 1.

The blood purification device 1 automatically selects one of the four CRRT modes (treatment modes) based on the input settings. If only the flow rate per unit body weight of the replacement fluid is entered (between the flow rate of the replacement fluid and the flow rate of the dialysate), the blood purification device 1 automatically selects continuous hemofiltration (CHF) as the CRRT mode. If only the flow rate per unit body weight of the dialysate is entered (between the flow rate of the replacement fluid and the flow rate of the dialysate), the blood purification device 1 automatically selects continuous hemodialysis (CHD) as the CRRT mode.

When both the flow rate per unit body weight of the replacement fluid and the flow rate per unit body weight of the dialysate are input, the blood purification device 1 automatically selects continuous hemodiafiltration (CHDF) as the CRRT mode. When neither the flow rate per unit body weight of the replacement fluid nor the dialysate is input, but the ultrafiltration rate is input, the blood purification device 1 automatically selects continuous slow ultrafiltration (SCUF) as the CRRT mode.

The following provides further details regarding the CRRT modes described above. In continuous hemodiafiltration (CHDF), as shown in Figure 1, four pumps 31-34, replacement fluid 41, and dialysate 42 are used. Note that in the blood purification device 1, one drug solution may be used as both replacement fluid 41 and dialysate 42.

In contrast, in continuous hemofiltration (CHF), of the four pumps 31-34, only the replacement fluid pump 31, the drainage pump 33, and the blood pump 34 are used. That is, the dialysate pump 32 is not used. Therefore, in continuous hemofiltration (CHF), only the replacement fluid 41 is used from the replacement fluid 41 and the dialysate 42.

Similarly, in continuous hemodialysis (CHD), only the dialysate pump 32, drainage pump 33, and blood pump 34 are used from the four pumps 31-34. That is, the replacement fluid pump 31 is not used. Therefore, in continuous hemodialysis (CHD), only the dialysate 42 is used from the replacement fluid 41 and dialysate 42.

In continuous slow ultrafiltration (SCUF), only the drainage pump 33 and the blood pump 34 are used out of the four pumps 31-34. That is, the replacement fluid pump 31 and the dialysate pump 32 are not used. Therefore, in continuous slow ultrafiltration (SCUF), the replacement fluid 41 and dialysate 42 are not used.

As mentioned above, the significance of setting the flow rate per kilogram of body weight is to adjust the amount of blood purified according to the patient's physique (weight). A more detailed explanation is as follows:

The amount of blood purified in acute blood purification is expressed by the following formula (1).
Blood purification volume = Total dialysate volume + Total filtration volume = Total dialysate volume + Total replacement fluid volume + Total fluid removal volume ... (1)
Assuming a blood purification volume of 12 L, a child weighing 12 kg and an adult weighing 60 kg will have the same blood purification volume of 12 L. However, when standardized by weight, the volume becomes 1 L/kg for children and 0.2 L/kg for adults. Thus, the value for children is five times larger than that for adults. To achieve the target blood purification volume while considering body size (weight), calculations are necessary. The blood purification device 1 of this embodiment eliminates the need for the above calculations through its function. This is expected to improve usability.

<C. User Interface>
This section describes the user interface displayed on the touchscreen of blood purification device 1. Four operation examples are explained below.

(c1. First example of operation)
Figure 3 is a diagram illustrating the first example of operation. As shown in Figure 3, the blood purification device 1 (more specifically, the control device) displays object images 111 (four "+" object images) on the touchscreen 10 that increase each digit of the flow rate of the replacement fluid per unit body weight by 1, and object images 112 (four "-" object images) that decrease each digit of the flow rate of the replacement fluid per unit body weight by 1. The numerical values entered using object images 111 and 112 are displayed in the display area 113. In this example, "10.0" is entered, and "10.0 mL/kg/h" is displayed in the display area 113. The blood purification device 1 also displays the flow rate of the replacement fluid (pump flow rate), calculated by a calculation described later, in the display area 114 on the touchscreen 10.

The blood purification device 1 further displays object images 121 (four "+" object images) on the touchscreen 10, which increment each digit of the flow rate of the dialysate per unit body weight by one, and object images 122 (four "-" object images) which decrease each digit of the flow rate of the dialysate per unit body weight by one. The numerical values entered using object images 121 and 122 are displayed in the display area 123. In this example, "10.0" is entered, and "10.0 mL/kg/h" is displayed in the display area 123. Furthermore, the blood purification device 1 displays the dialysate flow rate (pump flow rate), calculated by a calculation described later, in the display area 124 on the touchscreen 10.

The blood purification device 1 further displays object images 131 (four "+" object images) on the touchscreen 10, which increment each digit of the ultrafiltration rate by one, and object images 132 (four "-" object images) which decrease each digit of the ultrafiltration rate by one. The numerical values entered using object images 131 and 132 are displayed in the display area 133. In this example, "0100" is entered, and "0100 mL/h" is displayed in the display area 133. Furthermore, the blood purification device 1 displays the drainage flow rate (pump flow rate), calculated by a calculation described later, in the display area 134 on the touchscreen 10.

The blood purification device 1 further displays object images 141 (four "+" object images) on the touchscreen 10, which increment each digit (hours digit and minute digit) of the patient's weight by one, and object images 142 (four "-" object images) which decrease each digit of the patient's weight by one. The numerical value entered using object images 141 and 142 is displayed in the display area 143. In this example, "060.0" is entered, and "060.0 kg" is displayed in the display area 143.

The blood purification device 1 displays a cancel button 150 on its touchscreen 10 for canceling settings (specifically, the entered values and calculated values), and a confirm button 160 for registering the calculated values as settings.

Note that in this example, the object images 111, 112, 131, 132, 121, 122, 141, and 142, as well as the cancel button 150 and the confirm button 160, are software keys.

When the flow rate of replacement fluid per unit body weight, the flow rate of dialysate per unit body weight, the ultrafiltration rate, and the patient's weight are input based on user input, the blood purification device 1 calculates the flow rate of replacement fluid (pump flow rate), the flow rate of dialysate (pump flow rate), and the flow rate of drainage fluid (pump flow rate). In this case, continuous hemodiafiltration (CHDF) is automatically selected from among the four CRRT modes.

Specifically, the blood purification device 1 calculates the flow rate of the replacement fluid (pump flow rate) by multiplying the patient's weight of 60.0 kg by the flow rate of the replacement fluid per unit body weight of 10.0 mL/kg/h. The blood purification device 1 then displays the calculated result, 600 mL/h, in the display area 114.

Furthermore, the blood purification device 1 calculates the flow rate of the dialysate (pump flow rate) by multiplying the flow rate of the dialysate per unit body weight, "10.0 mL/kg/h," by the patient's weight, "60.0 kg." The blood purification device 1 displays the calculated result, "600 mL/h," in the display area 124.

The blood purification device 1 calculates the sum of the replacement fluid flow rate, the dialysate flow rate, and the ultrafiltration rate, and displays the calculated sum in the display area 134. In this example, the blood purification device 1 displays 1300 mL/h (= 600 + 600 + 100) in the display area 134.

Incidentally, the replacement fluid flow rate of "600 mL" satisfies the first condition mentioned above: "greater than or equal to 0 mL/h and less than or equal to 8000 mL/h." The dialysate flow rate of "600 mL" satisfies the second condition mentioned above: "greater than or equal to 0 mL/h and less than or equal to 8000 mL/h." Furthermore, the drainage flow rate of "1300 mL/h," which is the sum of the replacement fluid flow rate, the dialysate flow rate, and the ultrafiltration rate, satisfies the third condition mentioned above: "greater than 0 mL/h and less than or equal to 8000 mL/h."

The blood purification device 1 will enable the selection of the confirmation button 160 if all three of the above conditions are met. Therefore, in this example, the blood purification device 1 will activate the confirmation button 160. In other words, the blood purification device 1 will be in a state where it can accept a setting registration operation.

When the user selects the confirmation button 160, the blood purification device 1 sets and registers the flow rates of the replacement fluid, dialysate, and drainage fluid. Based on these calculated flow rates, the blood purification device 1 then operates the respective pumps 31-33.

(c2. Second example of operation)
Figure 4 illustrates a second example of operation. As shown in Figure 4, the blood purification device 1 receives input for the flow rate of replacement fluid per unit body weight, the fluid removal rate, and the patient's body weight. In this case, continuous hemofiltration (CHF) is automatically selected from among the four CRRT modes.

The blood purification device 1 calculates the flow rate of the replacement fluid (pump flow rate) by multiplying the patient's weight of 60.0 kg by the flow rate of the replacement fluid per unit body weight of 10.0 mL/kg/h. The blood purification device 1 displays the calculated result of 600 mL/h in the display area 114.

When the blood purification device 1 receives the flow rate of the replacement fluid and the water removal rate, it calculates the sum of these two values and displays the calculated sum in the display area 134. In this example, the blood purification device 1 displays 700 mL/h (= 600 + 100) in the display area 134.

Incidentally, the replenishment fluid flow rate of "600 mL/h" satisfies the first condition mentioned above: "greater than or equal to 0 mL/h and 8000 mL/h or less." The drainage fluid flow rate of "700 mL/h," which is the sum of the replenishment fluid flow rate and the water removal rate, satisfies the third condition mentioned above: "greater than 0 mL/h and 8000 mL/h or less."

The blood purification device 1 will be in a state where the select button 160 can be selected if both of the above two conditions are met. Therefore, in this example, the blood purification device 1 will activate the select button 160. In other words, the blood purification device 1 will be in a state where it can accept a setting registration operation.

When the user selects the confirmation button 160, the blood purification device 1 sets and registers the flow rate of the replacement fluid and the flow rate of the drained fluid. Based on these calculated flow rates, the blood purification device 1 operates the respective pumps 31 and 33.

(c3. Third example of operation)
Figure 5 illustrates a third operating example. As shown in Figure 5, all values are entered: the flow rate of replacement fluid per unit body weight, the flow rate of dialysate per unit body weight, the ultrafiltration rate, and the patient's weight. Therefore, continuous hemodiafiltration (CHDF) is automatically selected from the four CRRT modes.

However, the flow rate of the replacement fluid (pump flow rate), calculated by multiplying the patient's weight of 120.0 kg by the flow rate of the replacement fluid per unit body weight of 90.0 mL/kg/h, becomes 10,800 mL/h.

Thus, the flow rate of the replacement fluid exceeds the upper limit of "8000 mL/h". Furthermore, the flow rate of the replacement fluid exceeds the upper limit of the displayable range in the display area 114, which is "9999 mL/h". Therefore, the blood purification device 1 displays "9999 mL/h" in the display area 114 and displays this value in a different manner than usual. For example, the blood purification device 1 displays the value in the display area 114 in red.

Furthermore, if the blood purification device 1's replacement fluid flow rate exceeds the upper limit of 8000 mL/h, even if it is 9999 mL/h or less, the numerical value displayed in the display area 114 will be displayed in a different format than usual (red display).

On the other hand, the flow rate of the dialysate (pump flow rate), which is calculated by multiplying the flow rate per unit body weight of "10.0 mL/kg/h" by the patient's weight of "120.0 kg," becomes "1,200 mL/h." Therefore, the flow rate of the dialysate (pump flow rate) is less than or equal to the upper limit of "8,000 mL/h." Thus, the flow rate of the dialysate satisfies the second condition mentioned above (0 mL/h or more, and 8,000 mL/h or less). For this reason, the pump flow rate in the display area 124 is displayed in the normal manner.

As mentioned above, the drainage flow rate (pump flow rate) is the sum of the replacement fluid flow rate, the dialysate flow rate, and the ultrafiltration rate. Therefore, in this example, the drainage flow rate is 12,100 mL/h (= 10,800 + 1,200 + 100).

Thus, the drainage flow rate exceeds the upper limit of "8000 mL/h". Furthermore, the drainage flow rate exceeds the upper limit of the displayable range in the display area 134, which is "9999 mL/h". Therefore, the blood purification device 1 displays "9999 mL/h" in the display area 134 and displays this value in a different manner than usual. For example, the blood purification device 1 displays the value in the display area 134 in red.

Furthermore, even if the drainage flow rate of the blood purification device 1 is 9999 mL/h or less, if it exceeds the upper limit of the drainage flow rate of 8000 mL/h, the numerical value displayed in the display area 134 will be displayed in a different format than usual (red display).

The blood purification device 1 will not activate the confirmation button 160 if at least one of the following values—the flow rate of the replacement fluid, the flow rate of the dialysate, and the flow rate of the drained fluid—does not meet the conditions set for each. In this example, since two values (flow rate of replacement fluid and flow rate of drained fluid) do not meet the conditions set for each, the blood purification device 1 will not activate the confirmation button 160, as shown in the figure. Therefore, unlike in Figure 3, the blood purification device 1 will not accept the setting registration operation in this example.

(c4. Fourth example of operation)
Figure 6 is a diagram illustrating the fourth operation example. As shown in Figure 6, the patient's weight is not entered. In this case, even if the flow rate per unit body weight of the replacement fluid, the flow rate per unit body weight of the dialysate, and the ultrafiltration rate are entered, the blood purification device 1 cannot calculate the flow rate of the replacement fluid and the flow rate of the dialysate. In this example, the value of the ultrafiltration rate is displayed in the display area 134 as the flow rate of the drained fluid.

Therefore, the blood purification device 1 displays the symbol "----" in the display areas 114 and 124 to indicate that calculation is not possible. Furthermore, as shown in the figure, the blood purification device 1 does not activate the confirmation button 160. Therefore, unlike in Figure 3, in this example, the blood purification device 1 does not accept the setting registration operation.

<D. Functional Blocks>
Figure 7 is a functional block diagram illustrating the functional configuration of the blood purification device 1. As shown in Figure 7, the blood purification device 1 comprises a touchscreen 10, a control device 20, and a pump group 30.

The touchscreen 10 includes a touch panel 11 and a display 12. The touch panel 11 is installed superimposed on the display 12. The pump group 30 includes a replacement fluid pump 31, a dialysate pump 32, a drainage pump 33, and a blood pump 34.

The control device 20 includes an input receiving unit 21, a calculation unit 22, a determination unit 23, a display control unit 24, and a pump control unit 25. The control device 20 also includes a processor and memory (not shown).

The following explanation will focus on the processing of each part of the control device 20. For ease of explanation, the case of continuous hemodiafiltration (CHDF) using four pumps 31-34 will be used as an example.

The input reception unit 21 receives input from the user via the touch panel 11, including the flow rate of the replacement fluid per unit body weight, the flow rate of the dialysate per unit body weight, the ultrafiltration rate, and the patient's weight (process (i)). These numerical values are entered using object images 111, 112, 121, 122, 131, 132, 141, and 142, as described above (see Figure 3, etc.). The input reception unit 21 sends the entered data (input data) to the calculation unit 22 (process (ii)).

The input reception unit 21 then sends the input data to the display control unit 24. In this case, when the input reception unit 21 receives data input via the touch panel 11, the display control unit 24 reflects the input on the display 12 (process (v)). For example, when the object image 111 in Figure 3 is selected, the numerical value of the flow rate per unit weight of the replenishment fluid displayed in the display area 113 is updated.

The calculation unit 22 calculates the flow rate of the replacement fluid according to the patient's weight, based on the flow rate of the replacement fluid per unit body weight and the patient's weight (see display area 114 in Figure 3). The calculation unit 22 also calculates the flow rate of the dialysate according to the patient's weight, based on the flow rate of the dialysate per unit body weight and the patient's weight (see display area 124 in Figure 3). Finally, the calculation unit 22 calculates the flow rate of the drained fluid by summing the calculated flow rates of the replacement fluid, dialysate, and ultrafiltration rate (see display area 134 in Figure 3).

The calculation unit 22 sends the three calculated values to the determination unit 23. Specifically, the calculation unit 22 sends the flow rate of the replenishment fluid (pump flow rate of the replenishment fluid), the flow rate of the dialysate (pump flow rate of the dialysate), and the flow rate of the drained fluid (pump flow rate of the drained fluid) to the determination unit 23 (process (iii)).

The determination unit 23 determines whether the flow rate of the replacement fluid, the flow rate of the dialysate, and the flow rate of the drained fluid are within predetermined ranges.

In this example, the determination unit 23 determines whether the flow rate of the replenishment solution is 0 mL/h or more and 8000 mL/h or less. In this example, the range of 0 mL/h or more and 8000 mL/h or less corresponds to the "first range" of this disclosure.

The determination unit 23 determines whether the flow rate of the dialysate is 0 mL/h or more and 8000 mL/h or less. In this example, the range of 0 mL/h or more and 8000 mL/h or less corresponds to the "second range" of this disclosure.

The determination unit 23 determines whether the flow rate of the drained liquid is greater than 0 mL/h and 8000 mL/h or less. In this example, the range greater than 0 mL/h and 8000 mL/h or less corresponds to the "third range" of this disclosure.

The determination unit 23 sends the three determination results to the display control unit 24. If all three determination results are "OK" (all three values are within the range), the display control unit 24 activates the display state of the confirmation button 160 on the display 12, for example, as shown in Figure 3 (process (v)). If at least one of the three determination results is "NG" (at least one value is outside the range), the display control unit 24 keeps the display state of the confirmation button 160 inactive, for example, as shown in Figure 5.

When the confirmation button 160 is displayed in an active state, the user selects the confirmation button 160 via the touch panel 11, thereby transmitting a setting registration instruction from the touch screen 10 to the input reception unit 21 of the control device 20 (process (vi)).

The input reception unit 21 sends a setting registration instruction to the calculation unit 22. Upon receiving the setting registration instruction, the calculation unit 22 sends the results of the above calculation to the pump control unit 25. Specifically, the calculation unit 22 sends three numerical values (replacement fluid flow rate, dialysate flow rate, ultrafiltration rate, and drainage fluid flow rate) calculated based on the input data of process (ii) to the pump control unit 25.

The pump control unit 25 controls the pump group 30 based on three numerical values obtained from the calculation unit 22. Specifically, the pump control unit 25 operates the replenishment fluid pump 31 based on the calculated replenishment fluid flow rate. The pump control unit 25 operates the dialysate pump 32 based on the calculated dialysate flow rate. The pump control unit 25 operates the drainage pump 33 based on the calculated drainage fluid flow rate.

In detail, the pump control unit 25 operates each of the pumps 31, 32, 33, and 34 based on the reception of an operation by a medical professional (such as pressing a button not shown in the diagram). Furthermore, the pump control unit 25 operates the blood pump 34 at a pre-instructed pump flow rate, regardless of the calculation result of the calculation unit 22.

(summary)
The configuration and processing of blood purification device 1 can be summarized as follows:

(1) The blood purification device 1 comprises pumps (31, 32), an input receiving unit 21 that receives input of a first flow rate per unit body weight from the pumps (in this embodiment, the flow rate of the replacement fluid per unit body weight and the flow rate of the dialysate per unit body weight) and the patient's weight, a calculation unit 22 that calculates a second flow rate corresponding to the patient's weight (in this embodiment, the flow rate of the replacement fluid and the flow rate of the dialysate) based on the first flow rate and the patient's weight, and a pump control unit 25 that operates the pumps based on the calculated second flow rate.

With this configuration, the flow rate of the pump can be set based on the flow rate per unit body weight and the patient's weight. Therefore, the blood purification device 1 can improve usability.

(2) The input receiving unit 21 further accepts the setting registration operation for the second flow rate, provided that the second flow rate is within a predetermined range (in this embodiment, the first range and the second range). When the pump control unit 25 registers the second flow rate through the setting registration operation, it operates the pump based on the second flow rate.

With this configuration, the blood purification device 1 will not accept a flow rate setting registration operation if the flow rate from the pump is outside a predetermined range. Therefore, the blood purification device 1 can prompt the user to set the first flow rate per unit body weight from the pump and the patient's weight so that the flow rate from the pump falls within a predetermined range.

(3) Focusing on the replenishment fluid, the following applies: The pump includes the replenishment fluid pump 31. The first flow rate mentioned above includes the flow rate of the replenishment fluid. The calculation unit 22 calculates the flow rate of the replenishment fluid as the second flow rate mentioned above. The input reception unit 21 accepts the setting registration operation for the flow rate of the replenishment fluid, provided that the flow rate of the replenishment fluid is within the first range described above. When the flow rate of the replenishment fluid is set and registered by the setting registration operation, the pump control unit 25 operates the replenishment fluid pump 31 based on the set and registered flow rate of the replenishment fluid.

With this configuration, the blood purification device 1 will not accept a setting registration operation for the replacement fluid flow rate if the flow rate of the replacement fluid from the replacement fluid pump 31 is outside the first range. Therefore, the blood purification device 1 can prompt the user to set the flow rate of the replacement fluid per unit body weight from the replacement fluid pump 31 and the patient's weight so that the flow rate from the replacement fluid pump 31 falls within the first range.

(4) Focusing on the dialysate, the following applies: The pump includes the dialysate pump 32. The first flow rate mentioned above includes the dialysate flow rate. The calculation unit 22 calculates the dialysate flow rate as the second flow rate mentioned above. The input reception unit 21 accepts the dialysate flow rate setting registration operation, provided that the dialysate flow rate is within the second range described above. When the dialysate flow rate is set and registered through the setting registration operation, the pump control unit 25 operates the dialysate pump 32 based on the set and registered dialysate flow rate.

With this configuration, the blood purification device 1 will not accept a setting registration operation for the dialysate flow rate if the dialysate flow rate from the dialysate pump 32 is outside the second range. Therefore, the blood purification device 1 can prompt the user to set the dialysate flow rate per unit body weight from the dialysate pump 32 and the patient's weight so that the flow rate from the dialysate pump 32 falls within the second range.

(5) Focusing on the drainage, the following applies. The pump includes a drainage pump 33. The input receiving unit 21 further receives input for the water removal rate. The calculation unit 22 further calculates the drainage flow rate based on the second flow rate and water removal rate. The input receiving unit 21 accepts a setting registration operation for the drainage flow rate, provided that the drainage flow rate is within the third range described above. When the drainage flow rate is set and registered by the setting registration operation, the pump control unit 25 operates the drainage pump 33 based on the set and registered drainage flow rate.

With this configuration, the blood purification device 1 will not accept a setting registration operation for the drainage flow rate if the drainage flow rate from the drainage pump 33 is not within the third range. Therefore, the blood purification device 1 can prompt the user to set the flow rate of the dialysate per unit body weight from the drainage pump 33 and the patient's weight so that the flow rate from the drainage pump 33 falls within the third range.

(6) The blood purification device 1 further comprises a touchscreen 10 and a display control unit 24 that displays a confirmation button 160 (object image) on the touchscreen 10. The setting registration operation described above is a touch operation on the confirmation button 160. With this configuration, medical personnel can register the flow rate setting by touching the confirmation button 160.

<E. Control Structure>
The following explanation will use the example of a case where a healthcare professional selects continuous hemodiafiltration (CHDF) as the treatment plan. Furthermore, it will be assumed that the healthcare professional has chosen to perform fluid removal. In other words, the explanation will use the example of a healthcare professional entering values into the four setting input fields mentioned above.

Figure 8 is a flowchart illustrating the processing flow performed in the blood purification device 1. As shown in Figure 8, in step S1, the control device 20 (specifically, the processor) of the blood purification device 1 sets the select button 160 to an unselectable state (i.e., an inactive state). In step S2, the control device 20 determines whether it has received input for the flow rate of the replacement fluid per unit body weight, the flow rate of the dialysate per unit body weight, the ultrafiltration rate, and the patient's weight.

If the control device 20 determines that four values have been received (YES in step S2), in step S3, it calculates the flow rate of the replacement fluid (pump flow rate), the flow rate of the dialysate (pump flow rate), and the flow rate of the drained fluid (pump flow rate) based on the patient's weight. If the control device 20 determines that four values have not been received (NO in step S2), it returns to step S2.

In step S4, the control device 20 determines whether the flow rate of the replacement fluid calculated in step S3 is within the first range described above (in this example, 0 mL/h or more and 8000 mL/h or less). If it is determined that the flow rate is within the first range (YES in step S4), the control device 20 determines in step S5 whether the flow rate of the dialysate calculated in step S3 is within the second range described above (in this example, 0 mL/h or more and 8000 mL/h or less). If it is determined that the flow rate is outside the first range (NO in step S4), the control device 20 proceeds to step S11.

If the flow rate of the dialysate calculated in step S3 is determined to be within the second range (YES in step S5), the control device 20 determines in step S6 whether the flow rate of the drained fluid calculated in step S3 is within the third range described above (in this example, 0 mL/h or more and 8000 mL/h or less). If the flow rate is determined to be outside the fourth range (NO in step S6), the control device 20 proceeds to step S11. The order of the processes in steps S4 to S6 is not particularly limited.

After step S6, in step S7, the control device 20 sets the OK button 160 to a selectable state (i.e., an active state). The control device 20 changes the state of the OK button 160. In step S8, the control device 20 determines whether the cancel button 150 has been selected.

If the cancel button 150 is selected (YES in step S8), the control device 20 returns to step S2. If the cancel button 150 is not selected (NO in step S8), in step S9, the control device 20 determines whether the confirm button 160 was selected or not.

If it is determined that the confirmation button 160 has been selected (YES in step S9), in step S10, the control device 20 sets and registers the calculation result calculated in step S3. In this example, the control device 20 stores the flow rate of the replacement fluid, the flow rate of the dialysate, and the flow rate of the drain fluid in a predetermined area of the memory.

Furthermore, based on the calculation results, the control device 20 operates the replacement fluid pump 31, the dialysate pump 32, and the drainage pump 33 upon receiving further user input (dialysis initiation operation).

If it is determined that the OK button 160 is not selected (NO in step S9), the control device 20 returns to step S8.

In step S11, the control device 20 determines whether the cancel button 150 was selected. If it is determined that the cancel button 150 was selected (YES in step S11), the control device 20 returns to step S2. If the cancel button 150 was not selected, in step S12, the control device 20 determines whether it has received a user operation to change at least one of the following: the flow rate of the replacement fluid per unit body weight, the flow rate of the dialysate per unit body weight, the ultrafiltration rate, and the patient's weight.

If the control device 20 determines that user input has been received (YES in step S12), it returns to step S3. If the control device 20 determines that user input has not been received (NO in step S12), it returns to step S11.

In the above explanation, continuous hemodiafiltration (CHDF) was used as an example among the four modes of CRRT, but the above treatment can also be applied to the other three modes. Furthermore, it is not limited to CRRT, but can also be applied to non-continuous methods such as hemodialysis (HD), extracorporeal ultrafiltration (ECUM), hemofiltration (HF), and hemodiafiltration (HDF).

The embodiments disclosed herein should be considered in all respects to be illustrative and not restrictive. The scope of this disclosure is indicated by the claims, and all modifications within the meaning and scope of the claims are intended to be included.

1. Blood purification device, 10. Touchscreen, 11. Touch panel, 12. Display, 20. Control unit, 21. Input reception unit, 22. Calculation unit, 23. Judgment unit, 24. Display control unit, 25. Pump control unit, 31. Replacement fluid pump, 32. Dialysis fluid pump, 33. Drainage pump, 34. Blood pump, 41. Replacement fluid, 42. Dialysis fluid, 43. Drainage container, 50. Hemofilter, 60. Syringe, 111, 112, 121, 122, 131, 132, 141, 142. Object images, 113, 114, 123, 124, 133, 134, 143. Display area, 150. Cancel button, 160. Confirm button.

Claims (7)

Pump and
A receiving means for receiving input of a first flow rate per unit body weight from the pump and the patient's weight,
A calculation means for calculating a second flow rate corresponding to the patient's weight based on the first flow rate and the patient's weight,
The system includes a pump control means for operating the pump based on the calculated second flow rate,
The receiving means further accepts the setting registration operation for the second flow rate, provided that the second flow rate is within a predetermined range.
When the second flow rate is set and registered by the setting registration operation, the pump control means operates the pump based on the second flow rate.
The aforementioned pump includes a pump for supplying the replenishment fluid.
The first flow rate includes the flow rate of the replenishment liquid,
The calculation means calculates the flow rate of the replenishment liquid as the second flow rate,
The aforementioned predetermined range includes the range of the replenishment fluid,
The receiving means accepts a setting registration operation for the flow rate of the replenishment liquid, provided that the flow rate of the replenishment liquid is within the range of the replenishment liquid.
The pump control means operates the pump for the replacement fluid based on the set and registered flow rate of the replacement fluid when the flow rate of the replacement fluid is set and registered by the setting registration operation , in a blood purification device. Pump and
A receiving means for receiving input of a first flow rate per unit body weight from the pump and the patient's weight,
A calculation means for calculating a second flow rate corresponding to the patient's weight based on the first flow rate and the patient's weight,
The system includes a pump control means for operating the pump based on the calculated second flow rate,
The receiving means further accepts the setting registration operation for the second flow rate, provided that the second flow rate is within a predetermined range.
When the second flow rate is set and registered by the setting registration operation, the pump control means operates the pump based on the second flow rate.
The aforementioned pump includes a pump for dialysate,
The first flow rate includes the flow rate of the dialysate,
The calculation means calculates the flow rate of the dialysis fluid as the second flow rate,
The aforementioned predetermined range includes the range of the dialysate,
The receiving means accepts a setting registration operation for the flow rate of the dialysate, provided that the flow rate of the dialysate is within the range of the dialysate.
The pump control means, when the flow rate of the dialysate is set and registered by the setting registration operation, operates the pump for the dialysate based on the set and registered flow rate of the dialysate , in a blood purification device. Pump and
A receiving means for receiving input of a first flow rate per unit body weight from the pump and the patient's weight,
A calculation means for calculating a second flow rate corresponding to the patient's weight based on the first flow rate and the patient's weight,
The system includes a pump control means for operating the pump based on the calculated second flow rate,
The receiving means further accepts the setting registration operation for the second flow rate, provided that the second flow rate is within a predetermined range.
When the second flow rate is set and registered by the setting registration operation, the pump control means operates the pump based on the second flow rate.
The aforementioned pump includes a drainage pump,
The receiving means further receives input of the water removal rate,
The calculation means further calculates the flow rate of the drained liquid based on the second flow rate and the water removal rate,
The aforementioned predetermined range includes the range of the drained liquid,
The receiving means accepts a setting registration operation for the flow rate of the drainage liquid, provided that the flow rate of the drainage liquid is within the range of the drainage liquid.
The pump control means operates the drainage pump based on the drainage flow rate set and registered by the setting registration operation, in a blood purification device. Touchscreen and
The touchscreen further comprises display control means for displaying an object image,
The blood purification device according to any one of claims 1 to 3 , wherein the setting registration operation is a touch operation on the object image. The blood purification device receives input of a first flow rate per unit body weight from a pump and the patient's weight.
The control device of the blood purification device performs the step of calculating a second flow rate corresponding to the patient's weight based on the first flow rate and the patient's weight,
The blood purification device accepts a setting registration operation for the second flow rate, provided that the second flow rate is within a predetermined range.
When the second flow rate is set and registered by the setting registration operation, the control device operates the pump based on the second flow rate,
The aforementioned pump includes a pump for supplying the replenishment fluid.
The first flow rate includes the flow rate of the replenishment liquid,
The step of calculating the second flow rate includes the step of calculating the flow rate of the replenishment liquid as the second flow rate,
The aforementioned predetermined range includes the range of the replenishment fluid,
The step of accepting the second flow rate setting registration operation includes the step of accepting the flow rate setting registration operation of the replenishment liquid, provided that the flow rate of the replenishment liquid is within the range of the replenishment liquid.
A method for controlling a blood purification device, wherein the step of operating the pump includes the step of operating the pump for the replacement fluid based on the set and registered flow rate of the replacement fluid when the flow rate of the replacement fluid is set and registered by the setting registration operation. The blood purification device receives input of a first flow rate per unit body weight from a pump and the patient's weight.
The control device of the blood purification device performs the step of calculating a second flow rate corresponding to the patient's weight based on the first flow rate and the patient's weight,
The blood purification device accepts a setting registration operation for the second flow rate, provided that the second flow rate is within a predetermined range.
When the second flow rate is set and registered by the setting registration operation, the control device operates the pump based on the second flow rate,
The aforementioned pump includes a pump for dialysate,
The first flow rate includes the flow rate of the dialysate,
The step of calculating the second flow rate includes the step of calculating the flow rate of the dialysate as the second flow rate,
The aforementioned predetermined range includes the range of the dialysate,
The step of accepting the second flow rate setting registration operation includes the step of accepting the flow rate setting registration operation of the dialysate, provided that the flow rate of the dialysate is within the range of the dialysate.
A method for controlling a blood purification device, wherein the step of operating the pump includes the step of operating the pump for the dialysate based on the set and registered flow rate of the dialysate when the flow rate of the dialysate is set and registered by the setting registration operation. The blood purification device receives input of a first flow rate per unit body weight from a pump and the patient's weight.
The control device of the blood purification device performs the step of calculating a second flow rate corresponding to the patient's weight based on the first flow rate and the patient's weight,
The blood purification device accepts a setting registration operation for the second flow rate, provided that the second flow rate is within a predetermined range.
When the second flow rate is set and registered by the setting registration operation, the control device operates the pump based on the second flow rate,
The aforementioned pump includes a drainage pump,
The blood purification device includes the step of receiving input for the rate of fluid removal,
The control device further comprises the step of calculating the flow rate of the drained liquid based on the second flow rate and the water removal rate,
The aforementioned predetermined range includes the range of the drained liquid,
The blood purification device further includes a step of accepting a setting registration operation for the flow rate of the drained fluid, provided that the flow rate of the drained fluid is within the range of the drained fluid.
A method for controlling a blood purification device, wherein the step of operating the pump includes the step of operating the drainage pump based on the set and registered drainage flow rate when the drainage flow rate is set and registered by the setting and registration operation .