Blood collection device and blood collection method

Abstract

A blood drawing device (10) and a blood drawing method, whereby whole blood is collected by accommodating a blood collecting bag (200) in an accommodation chamber (12) and setting the accommodation chamber (12) to a negative pressure. A control unit (44) monitors a drawn blood flow rate, and if a decrease in the drawn blood flow rate is detected, the control unit (44) compares drawn blood flow rate data and a determination pattern, determines the cause of the decrease in the drawn blood flow rate, and causes warning displays (102-108) including the cause of the decrease in the drawn blood flow rate to be displayed by a display input unit (38).

Description

[Technical Field]

[0001] The present invention relates to a blood collection device and a blood collection method for collecting whole blood from a donor. [Background technology]

[0002] For example, Japanese Patent Application Laid-Open No. 2004-81305 discloses a blood collection device that uses negative pressure to collect blood from a donor into a blood collection bag. This blood collection device collects blood by storing a blood collection bag in a bag storage chamber of the blood collection device, inserting a blood collection needle attached to a blood collection container into a vein in the donor's arm, and creating a negative pressure inside the bag storage chamber with an exhaust pump.

[0003] In blood collection using negative pressure, the blood collection flow rate can decrease due to various factors. If the blood collection time exceeds the specified time due to a decrease in blood collection flow rate, the blood collection will be terminated, which may result in an insufficient volume of blood products and lead to waste.

[0004] Some conventional blood collection devices are also equipped with a function to monitor the blood collection flow rate and sound an alarm to alert the blood collection personnel when the blood collection flow rate drops.The nurse or other blood collection personnel who collects the blood tries to prevent a drop in blood flow rate by observing the alarm display on the blood collection device and the donor's condition, adjusting the suction pressure of the blood collection device, checking for abnormalities in the blood collection line, keeping the arm warm during blood collection, speaking to the donor, and having them grip the hand, etc. Summary of the Invention

[0005] There are situations where blood collection personnel are unable to concentrate on monitoring donors during blood collection because they are busy with post-processing of collected blood bags, preparing blood collection forms, dealing with donors for whom blood collection has already been completed, etc. Furthermore, because a decrease in blood collection flow rate occurs for a variety of reasons and may be temporary and recover quickly, excessive alarms may be issued, and blood collection personnel may miss signs of a decrease in blood collection flow rate that actually require attention.

[0006] An object of the present invention is to provide a blood collection device and a blood collection method that can detect a decrease in the blood collection flow rate that requires attention and prompt the person in charge of collecting the blood to take action.

[0007] One aspect of the following disclosure is a blood collection device that collects whole blood by storing a blood collection bag in a storage chamber and creating negative pressure in the storage chamber, the blood collection device comprising: a load sensor that detects the weight of the blood collection bag; a control unit that detects the blood collection flow rate, which is the change in the amount of blood collected per unit time; a memory unit that stores blood collection flow rate data including changes in the blood collection flow rate over time and a determination pattern; and a display unit that displays blood collection information including the blood collection flow rate during blood collection, wherein the control unit monitors the blood collection flow rate, and when a decrease in the blood collection flow rate is detected, compares the blood collection flow rate data in the memory unit with the determination pattern to determine the cause of the decrease in the blood collection flow rate and causes the display unit to display a warning message including the cause of the decrease in the blood collection flow rate.

[0008] Another aspect is a blood collection method performed by a blood collection device that collects whole blood by creating negative pressure in a storage chamber that contains the blood collection bag, and that includes a load sensor that detects the weight of the blood collection bag, a control unit that detects the blood collection flow rate, which is the change in the amount of blood collected per unit time, a memory unit that stores blood collection flow rate data including changes in the blood collection flow rate over time and a judgment pattern, and a display unit that displays blood collection information including the blood collection flow rate during blood collection, and the blood collection method includes the steps of: monitoring the blood collection flow rate by the control unit; when the control unit detects a decrease in the blood collection flow rate, comparing the blood collection flow rate data with the judgment pattern to determine the cause of the decrease in the blood collection flow rate; and causing the control unit to display a warning message including the cause of the decrease in the blood collection flow rate on the display unit.

[0009] According to the blood collection device and blood collection method of the above aspects, it is possible to detect a decrease in the blood collection flow rate that requires attention, and by including the cause of the decrease in the blood collection flow rate in the warning display, it is possible to prompt the person in charge of collecting blood to take appropriate action. [Brief explanation of the drawings]

[0010] [Figure 1] 1 is a perspective view of a blood collection device according to an embodiment of the present invention. [Figure 2]FIG. 2 is an exploded perspective view showing the internal structure of the blood collection device of FIG. [Figure 3] FIG. 2 is a block diagram showing the configuration of the blood collection device of FIG. 1. [Figure 4] 2 is a flowchart showing the operation of the blood collection device of FIG. 1. [Figure 5] 1. FIG. 4 is an explanatory diagram showing the transition of the display image on the display input unit of the blood collection device of FIG. [Figure 6] 5 is a flowchart showing the operation of the blood collection device in the blood collection abnormality monitoring process of FIG. 4. [Figure 7] 10 is a graph showing changes in blood collection flow rate according to determination pattern 1. [Figure 8] FIG. 10 is an explanatory diagram showing a warning display based on a change in blood collection flow rate according to judgment pattern 1. [Figure 9] 10 is a graph showing changes in blood collection flow rate according to determination pattern 2. [Figure 10] FIG. 10 is an explanatory diagram showing a warning display based on a change in the blood collection flow rate according to determination pattern 2. [Figure 11] 10 is a graph showing changes in blood collection flow rate according to determination pattern 3. [Figure 12] FIG. 10 is an explanatory diagram showing a warning display based on a change in blood collection flow rate according to determination pattern 3. [Figure 13] 10 is a graph showing changes in blood collection flow rate according to determination pattern 4. [Figure 14] FIG. 10 is an explanatory diagram showing a warning display based on a change in blood collection flow rate according to determination pattern 4. [Figure 15] FIG. 10 is an explanatory diagram showing a blood collection end screen. DETAILED DESCRIPTION OF THE INVENTION

[0011] DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Preferred embodiments of the present invention will now be described in detail with reference to the accompanying drawings.

[0012] As shown in Figure 1, the blood collection device 10 of this embodiment is a vacuum blood collection device that uses negative pressure to collect blood from a donor into a blood collection bag 200, and is placed in blood donation rooms, blood donation buses, etc.

[0013] The blood collection device 10 comprises a box-shaped housing 14 having a storage chamber 12 for storing a blood collection bag 200, and a lid 16 provided to the top of the storage chamber 12 of the box-shaped housing 14 in an openable and closable manner. The storage chamber 12 is formed in a recessed shape with peripheral walls and a bottom, and is open upward. As shown in FIG. 2, a hinge 30 is provided on the back side of the storage chamber 12, and the lid 16 is attached to the hinge 30 in an openable and closable manner.

[0014] As shown in Figure 1, in the closed state, the lid 16 covers from above the blood collection bag 200 placed on a storage tray 18 (described later). The lid 16 is transparent so that the blood collection bag 200 can be seen from outside during blood collection. A seal member 15 is provided at the upper end of the storage chamber 12 or the lower end of the lid 16 to airtightly seal the lid 16 and the storage chamber 12. The lid 16 also has a tube holder 21 that holds a blood collection tube 202 connected to the blood collection bag 200 in a state where it is extended to the outside.

[0015] As shown in Fig. 2, the storage chamber 12 is provided with a storage tray 18 for placing a blood collection bag 200 thereon, a swinging mechanism 20, and a bracket 22. The storage tray 18 is arranged to be swingable in order to mix the anticoagulant contained in the blood collection bag 200 with the blood (whole blood) collected from a donor, and is connected to the swinging mechanism 20 via the bracket 22. An attachment portion 18a is provided on the bottom surface of the storage tray 18, and the storage tray 18 is fixed to the bracket 22 via the attachment portion 18a by a method such as screwing. Note that instead of fixation by the attachment portion 18a and the bracket 22, a detachable connection structure utilizing the attractive force of a magnet may be used.

[0016] A load sensor 22a is provided on the bracket 22. The load sensor 22a detects the weight of the blood collection bag 200 contained in the storage tray 18. The swinging mechanism 20 is equipped with a swinging motor, and generates a swinging motion that moves the inclination of the storage tray 18 along the circumferential direction.

[0017] As shown in Figure 3, the storage chamber 12 of the blood collection device 10 is provided with an exhaust pump 24 that exhausts air from inside the storage chamber 12 to generate negative pressure, a pressure sensor 26 that detects the negative pressure inside the storage chamber 12, and a clamp unit 28 that closes or opens the blood collection tube 202.

[0018] As shown in FIG. 1 , an operation panel 32 is provided on the front of the housing 14. The operation panel 32 is provided with a power switch 34, an operation switch 36, and a display input unit 38. The operation switch 36 is configured as, for example, a mechanical button switch. The operation switch 36 may also be an electrostatic or pressure-sensitive switch. The operation switch 36 includes, for example, a start / stop switch 40 and a clamp release switch 42. The start / stop switch 40 is a switch for manually starting and stopping blood collection. The clamp release switch 42 is used to manually release the clamped state (occlusion state) of the blood collection tube 202 by the clamp unit 28. The clamp release switch 42 does not need to be provided on the operation panel 32, and may be provided in a location separate from the operation panel 32 as a lever-operated switch such as an operation lever (not shown).

[0019] The display input unit 38 is made up of, for example, a liquid crystal display and has a touch panel function, so that the display input unit 38 also serves as an input unit that accepts inputs for operating the blood collection device 10.

[0020] 3, the blood collection device 10 further includes a memory unit 48 and a control unit 44. The memory unit 48 stores blood collection data on blood collected from a blood donor.

[0021] The control unit 44 comprises a time measurement unit 44a, a flow rate detection unit 44b, and a change rate detection unit 50. Of these, the time measurement unit 44a measures the blood collection start time, the elapsed time since the start of blood collection, and the blood collection end time. The flow rate detection unit 44b detects the amount of blood collected based on the weight of the blood collection bag 200 and the specific gravity of the blood, and detects the blood collection flow rate, which is the blood collection speed, based on the amount of change in the amount of blood collected per unit time. The change in the blood collection flow rate over time is stored in the memory unit 48 as blood collection flow rate data. The blood collection flow rate data in the memory unit 48 is updated as time passes. The change rate detection unit 50 obtains the rate of change in the blood collection flow rate (flow rate change rate) by differentiating the blood collection flow rate data.

[0022] Furthermore, the control unit 44 controls each unit of the blood collection device 10 to perform the blood collection operation. For each blood collection, the control unit 44 acquires blood collection data, such as the amount of blood collected, the start time of blood collection, the end time of blood collection, the time required for blood collection, any blood collection abnormalities, and end information, and stores the blood collection data in the memory unit 48. The blood collection abnormalities recorded in the blood collection data include warning displays due to a decrease in the blood collection flow rate and the rate of change of the flow rate.

[0023] The determination patterns are stored in the memory unit 48 together with the blood collection data and blood collection flow rate data. The determination patterns are used for matching with the blood collection flow rate data to identify the cause of the decrease in the blood collection flow rate, and include parameters relating to the change in the blood collection flow rate immediately before the decrease in the blood collection flow rate, the rate of change in the flow rate when the blood collection flow rate decreases, and the change in the blood collection flow rate after the decrease in the blood collection flow rate.

[0024] The control unit 44 monitors the blood collection flow rate during the blood collection operation, and when a decrease in the blood collection flow rate is detected, compares the blood collection flow rate data with the judgment pattern to determine the cause of the decrease in the blood collection flow rate, and then causes the display unit to display a warning message including the cause of the decrease in the blood collection flow rate.

[0025] The operation and function of the blood collection device 10 will be described below with reference to FIGS.

[0026] When the power switch 34 (see FIG. 1) on the front of the blood collection device 10 is pressed to turn on the power of the blood collection device 10, the process proceeds to step S10 in FIG. 4, and the blood collection device 10 displays the setting screen 60 shown in FIG. 5 on the display input unit 38. As shown in the center of FIG. 5, the setting screen 60 includes a blood collection bag selection button 62, a suction pressure selection button 64, a history display button 66, and a blood collection start button 68.

[0027] The blood collection bag selection button 62 displays the type and capacity (e.g., 200 ml) of the blood collection bag 200 as initial settings. When the blood collection bag selection button 62 is touched, the control unit 44 switches the display of the display input unit 38 to a blood collection selection screen 72 shown in the upper left of Fig. 5. The blood collection selection screen 72 includes bag selection buttons 72a to 72f, which display the type (manufacturer name) and capacity of the blood collection bag 200, and a return button 72g.

[0028] When the operator selects the desired volume and type of blood collection bag 200 on the blood collection selection screen 72, the control unit 44 returns the display of the display input unit 38 to the setting screen 60. Then, the control unit 44 displays the type and volume of the selected blood collection bag 200 on the blood collection bag selection button 62 on the setting screen 60. Note that when the return button 72g is touched on the blood collection selection screen 72 without selecting one of the bag selection buttons 72a to 72f, the control unit 44 returns the display of the display input unit 38 to the setting screen 60 without changing the type and volume of the blood collection bag 200. In this case, the blood collection bag selection button 62 on the setting screen 60 displays the type and volume of the blood collection bag 200 before selection.

[0029] When the operator touches the suction pressure selection button 64, the control unit 44 causes the display input unit 38 to display the suction pressure setting screen 74 shown in the upper right corner of Fig. 5. The suction pressure setting screen 74 displays an OFF setting button 74a, a weak setting button 74b, a medium setting button 74c, and a strong setting button 74d, which are used to set the negative pressure when collecting blood. When the OFF setting button 74a is selected, the control unit 44 sets the blood collection so that it does not perform suction when collecting blood, but rather allows the blood to fall naturally due to the difference in height between the donor and the blood collection bag 200.

[0030] By selecting the weak setting button 74b, the medium setting button 74c, or the strong setting button 74d, the user can select weak, medium, or strong negative pressure during blood collection. The negative pressure increases in the order of weak, medium, and strong. For example, when the weak setting button 74b is selected, the control unit 44 controls the exhaust pump 24 to operate intermittently during blood collection so as to maintain a negative pressure in a preset range of -10 mmHg to -100 mmHg. Furthermore, when the medium setting button 74c is selected, the control unit 44 controls the exhaust pump 24 to operate intermittently during blood collection so as to maintain a negative pressure in a range of -40 mmHg to -150 mmHg. Furthermore, when the strong setting button 74d is selected, the control unit 44 controls the exhaust pump 24 to operate intermittently during blood collection so as to maintain a negative pressure in a range of -80 mmHg to -200 mmHg. Although there is some overlap in the above numerical ranges, this indicates the numerical range that can be set during standard operation, and the specific set negative pressure is set appropriately from the above numerical ranges so as to satisfy the relationship of increasing negative pressure in the order of weak, medium, and strong settings.

[0031] When the operator sets any negative pressure on the suction pressure setting screen 74, the screen returns to the setting screen 60 in the center of FIG. 5. When the operator touches the history display button 66, the control unit 44 reads blood collection data from the memory unit 48 and displays the blood collection data screen 76 in the lower left of FIG. 5 on the display input unit 38. The blood collection data screen 76 includes data selection buttons 76a and 76b, a return button 76c, and a blood collection data display section 76d. The blood collection data display section 76d displays blood collection data including the data number, the blood collection volume, blood collection start time, blood collection end time, blood collection duration, and abnormality history due to a decrease in flow rate (e.g., zero flow rate). When the data selection buttons 76a and 76b are selected, the blood collection data screen 76 switches to display the previous or next blood collection data. When the return button 76c is selected, the screen returns to the setting screen 60.

[0032] 1, the operator places the desired blood collection bag 200 on the storage tray 18, sets the blood collection tube 202 in the clamp 28, closes the lid 16, and inserts the blood collection needle into the donor, completing preparations for blood collection. After that, when the operator touches the blood collection start button 68 on the setting screen 60 in FIG. 5, the blood collection device 10 starts blood collection.

[0033] When the blood collection start button 68 is selected, the process proceeds to step S20 in Fig. 4, and the blood collection device 10 starts collecting blood. The control unit 44 starts operating the rocking mechanism 20 and the exhaust pump 24. After the value detected by the pressure sensor 26 reaches a predetermined negative pressure, the control unit 44 opens the clamp unit 28 to start collecting blood from the donor.

[0034] The process then proceeds to step S30, where the control unit 44 causes the display input unit 38 to display the blood collection screen 78 shown in the lower right of FIG. 5. The blood collection screen 78 includes a blood collection bag display section 62A, a suction pressure selection button 64, a history display button 66, a blood collection status display section 78d, a remaining blood collection amount display section 78e, and a completion prediction display section 78f. The blood collection bag display section 62A only has a display function that cannot be selected, and displays the type of blood collection bag 200 currently selected and the amount of blood collected. The suction pressure selection button 64 is a selectable button, and selecting it switches to the suction pressure setting screen 74 shown in the upper right of FIG. 5. The operator can check the donor's condition and, if necessary, adjust the blood collection speed by changing the suction pressure during blood collection by operating the suction pressure setting screen 74.

[0035] In parallel with the processing of step S30, the control unit 44 monitors for blood collection abnormalities in step S40. In monitoring for blood collection abnormalities in step S40, the flow rate detection unit 44b of the control unit 44 calculates the blood collection flow rate (ml / min) from the increase in weight of the blood collection bag 200 per fixed blood collection time. The blood collection flow rate is associated with time and stored in the memory unit 48 as blood collection flow rate data. The blood collection flow rate data is updated successively. Details of the blood collection flow rate monitoring process will be described below with reference to FIG. 6.

[0036] The control unit 44 monitors the blood collection flow rate detected by the flow rate detection unit 44b and detects a decrease in the blood collection flow rate. A decrease in the blood collection flow rate is determined, for example, by whether the blood collection flow rate has fallen below a predetermined threshold (e.g., 80%) of the blood collection flow rate at the beginning of blood collection. If the control unit 44 detects a decrease in the blood collection flow rate in step S400, the process proceeds to step S401, where the determination pattern is matched with the blood collection flow rate data, and processing begins to determine the cause of the decrease in the blood collection amount.

[0037] In step S401, the control unit 44 reads the blood collection flow rate data from the memory unit 48, and extracts from the blood collection flow rate data the trend in the blood collection flow rate before the blood collection flow rate is reduced (element A), the flow rate change rate when the blood collection flow rate is reduced (element B), the minimum blood collection flow rate (element C), and the trend in the blood collection flow rate after the blood collection flow rate is reduced (element D).

[0038] The transition of the blood collection flow rate before the decrease (element A) can be determined, for example, by taking the moving average of the blood collection flow rate for a predetermined period before the decrease in the blood collection flow rate is detected.

[0039] The rate of change in the blood collection flow rate (element B) when the blood collection flow rate is decreased can be calculated, for example, as the rate of change in the blood collection flow rate when the decrease in the blood collection flow rate is detected. Alternatively, the rate of change in the blood collection flow rate (element B) when the blood collection flow rate is decreased can be calculated as the average rate of change in the blood collection flow rate over a predetermined time range before and after the decrease in the blood collection flow rate is detected.

[0040] The minimum blood collection flow rate (element C) is calculated by finding the minimum value of the blood collection flow rate in the range from when the rate of change of the blood collection flow rate (element B) when the blood collection flow rate decreases changes from negative to positive and when the decrease in the blood collection flow rate stops. Since the blood collection flow rate is 0 or greater, the minimum value of the blood collection flow rate is 0 or greater.

[0041] The transition of the blood collection flow rate after the decrease in the blood collection flow rate (element D) can be calculated as the maximum value of the blood collection flow rate during a predetermined period Δt2 (e.g., 1 minute) after the rate of change of the blood collection flow rate during the decrease in the blood collection flow rate (element B) changes from negative to positive and the decrease in the blood collection flow rate stops. Note that element D may be calculated as the average value of the blood collection flow rate during the period Δt2 instead of the maximum value of the blood collection flow rate.

[0042] Next, the control unit 44 proceeds to step S402 and determines which of the determination patterns stored in the memory unit 48 the combination of elements A to D obtained in step S401 corresponds to. In this embodiment, determination patterns 1 to 4 are stored in the memory unit 48. The control unit 44 determines which of these determination patterns 1 to 4 the combination corresponds to. Note that in step S402, if the blood collection flow rate data does not correspond to any of determination patterns 1 to 4, the process returns to step S401.

[0043] A specific example of the process will be described below with reference to collected blood flow rate data that corresponds to any one of determination patterns 1 to 4.

[0044] The processing performed when determination pattern 1 is matched in step S402 will be described. Determination pattern 1 occurs when element A is equal to or greater than a first flow rate (e.g., 30 ml / min) and element B is equal to or greater than a first rate of change (e.g., 30 ml / min / sec). As shown in FIG. 7, blood collection flow rate data matching determination pattern 1 occurs when the blood collection flow rate suddenly changes from a normal (steady) blood collection flow rate of 30 ml / min to near zero. Such a change in blood collection flow rate occurs when the blood collection tube 202 (blood collection line) is blocked by a clamp or a cooker, when the blood collection tube 202 is blocked by the clamp unit 28 of the blood collection device 10, or when the blood collection tube 202 is mechanically blocked, such as when the blood collection tube 202 is blocked by being bent or crushed.

[0045] If the blood collection flow rate data matches determination pattern 1, the process proceeds to step S403 in FIG. 6. In step S403, the control unit 44 causes the display input unit 38 to display a warning display 102 (see FIG. 8). As shown in FIG. 8, the warning display 102 includes a message indicating that the blood collection line is blocked as a cause of the decrease in the blood collection flow rate. The warning display 102 also includes a method of dealing with the cause of the decrease. In this case, the warning display 102 presents a countermeasure of releasing the clamp unit 28 of the blood collection device 10 and a countermeasure of releasing a blockage in the blood collection line due to bending, crushing, or the like.

[0046] Next, the processing when matching to determination pattern 2 in step S402 of Fig. 6 will be described. In determination pattern 2, element A is less than the first flow rate (30 ml / min), element B is less than the first rate of change (30 ml / min / sec), element C is less than the second flow rate (5 ml / min), and element D is less than the second flow rate (5 ml / min). As shown in Fig. 9, the blood collection flow rate data matching determination pattern 2 shows a gradual decrease in the blood collection flow rate, with the blood collection flow rate (or its moving average value; element A) just before the decrease in the blood collection flow rate is detected being below 30 ml / min. Furthermore, the rate of change of the blood collection flow rate gradually decreases at less than 30 ml / min / sec, and the blood collection flow rate after the decrease (elements C and D) fluctuates between zero and a low flow rate (less than 5 ml / min) near zero.

[0047] 9 occurs when a blood clot forms in the blood collection needle or blood collection tube 202, blocking the flow path. Therefore, when the blood collection flow rate data matches determination pattern 2, the control unit 44 displays the warning display 104 in step S403 of FIG.

[0048] 10, the warning display 104 includes a message indicating that a blood clot has formed at the needle tip or inside the blood collection line as a cause of the decrease in blood collection flow rate. The warning display 104 also includes a method for dealing with the cause of the decrease. Here, the blood collection device 10 presents a method for dealing with the cause of the decrease in blood collection flow rate in the warning display 104, urging the user to remove the blood clot in accordance with the blood clot removal procedure.

[0049] Next, the processing when matching determination pattern 3 in step S402 of FIG. 6 will be described. Determination pattern 3 is where element A is less than the first flow rate (30 ml / min), element B is less than the first rate of change (30 ml / min / sec), element C is less than the second flow rate (5 ml / min), and element D is equal to or greater than the third flow rate (10 ml / min). As shown in FIG. 11, the blood collection flow rate data matching determination pattern 3 shows a gradual decrease in the blood collection flow rate, with the blood collection flow rate (or its moving average value; element A) just before the decrease in the blood collection flow rate is detected being below 30 ml / min. Furthermore, the rate of change in the blood collection flow rate gradually decreases at less than 30 ml / min / sec, satisfying element B. The blood collection flow rate decreases to zero (element C), but then recovers naturally.

[0050] This change in blood collection flow rate is thought to be caused by the tip of the blood collection needle coming into contact with the inner wall of the blood vessel, temporarily blocking the blood inflow path. The cause of this decrease in blood collection flow rate is thought to be the blood collection technician inserting the blood collection needle close to the bent elbow, which can be misaligned due to the donor's body movements, or the influence of the donor's vein size and the needle's insertion angle. When the blood collection needle sticks to the vein wall, the blood supply in the vessel increases, causing the vessel to expand, naturally eliminating the sticking. Therefore, as shown in Figure 11, the blood collection flow rate drops to nearly zero, but then recovers naturally. However, if the blood volume in the vessel decreases due to blood collection, the blood collection needle sticks to the inner wall of the vessel again, resulting in a repeated decrease in blood collection flow rate.

[0051] Therefore, in step S402 of FIG. 6, if the blood collection flow rate data matches determination pattern 3, the control unit 44 proceeds to step S403 and causes the display input unit 38 to display a warning display 106. As shown in FIG. 12, the warning display 106 includes a message indicating that the cause of the decrease in blood collection flow rate is contact of the needle tip with the inner wall of the blood vessel. The warning display 106 also includes a message indicating how to deal with the decrease in blood collection flow rate. In other words, the warning display 106 presents a method of dealing with the decrease in blood collection flow rate, urging the user to adjust the needle tip position.

[0052] Next, the process of matching determination pattern 4 in step S402 of FIG. 6 will be described. Determination pattern 4 is where element B is equal to or less than the first rate of change (e.g., 30 ml / min / sec), element C is equal to or greater than the second flow rate (e.g., 5 ml / min), and element D is in the range of the second flow rate (5 ml / min) to the fourth flow rate (e.g., 35 ml / min). In the blood collection flow rate data shown in FIG. 13, at the time when a decrease in the blood collection flow rate was detected, the rate of change in the blood collection flow rate was relatively small, and the decrease in the blood collection flow rate progressed gradually, satisfying element B (30 ml / min / sec). Furthermore, the minimum flow rate (element C) during the decrease in the blood collection flow rate was greater than the second flow rate (5 ml / min). Furthermore, element D is in the range of the second flow rate (5 ml / min) to the fourth flow rate (35 ml / min). In other words, the flow rate is so low that a sufficient amount of blood cannot be collected within the specified blood collection time. Therefore, the blood collection flow rate data shown in FIG. 13 matches determination pattern 4.

[0053] The blood collection flow rate data shown in Figure 13 is caused by a decrease in the amount of blood supplied to the blood vessel where the blood collection needle is inserted. This may be because the donor falls asleep during blood collection, causing a decrease in heart rate and a decrease in blood supply to the blood vessels in the arm, or because a decrease in the surface temperature of the arm from which blood is being collected causes the blood vessels to contract, resulting in a decrease in blood supply.

[0054] Therefore, in the blood collection device 10 of this embodiment, when the collected blood flow rate data matches determination pattern 4, the control unit 44 determines that the cause of the decrease in the collected blood flow rate is a decrease in the blood supply to the blood collection site, and in step S403, the control unit 44 causes the display input unit 38 to display a warning display 108 indicating that the blood supply to the blood collection site is decreasing. As shown in FIG. 14, the warning display 108 includes a message indicating that the cause of the decrease in the collected blood flow rate is a decrease in blood flow in the arm due to sleep or a decrease in body temperature. The warning display 108 also includes a method of dealing with the cause of the decrease. For example, the method of dealing with the decrease may include speaking to the donor to wake them up, keeping their arm warm, and encouraging the donor to grip the donor's arm.

[0055] In step S403 of Figure 6, warning displays 102 to 108 including the cause of the decrease in blood collection flow rate are displayed on the display input unit 38 of the blood collection device 10, allowing the person in charge of blood collection to notice the decrease in blood collection flow rate that requires attention, and can then take measures to quickly eliminate the cause of the decrease in blood collection flow rate by following the countermeasures presented in the warning displays 102 to 108.

[0056] Thereafter, in step S404, the control unit 44 determines whether the blood collection flow rate has recovered. Here, the control unit 44 can detect the recovery of the blood collection flow rate by monitoring whether the blood collection flow rate has recovered to the blood collection flow rate of element A. If the blood collection flow rate has not recovered (NO), the blood collection device 10 continues to display the warning on the display input unit 38. If the blood collection flow rate has recovered, the blood collection device 10 cancels the warning on the display input unit 38 and continues to monitor the blood collection flow rate.

[0057] 7, the blood collection flow rate begins to recover from time t1, and returns to the value before the flow rate decrease at time t2. Therefore, at time t2, the recovery of the blood collection flow rate is detected in step S404, and the warning display is canceled. When the warning display is canceled in step S404, the process returns to step S400, and the control unit 44 continues to monitor whether the blood collection flow rate has decreased.

[0058] The processes in steps S400 to S404 are continued until the blood collection is completed.

[0059] Thereafter, as shown in step S50 of FIG. 4, the blood collection device 10 performs a blood collection termination process based on the passage of a predetermined blood collection time (e.g., 15 minutes), the reaching of a preset blood collection volume (e.g., 200 ml, 400 ml, etc.), or the input of a blood collection termination instruction by the blood collection personnel.

[0060] In step S50, the control unit 44 closes the clamp unit 28 (see FIG. 3), stops the exhaust pump 24 and the swinging mechanism 20, and opens the storage chamber 12 to the atmosphere. The control unit 44 also records the blood collection start time, blood collection end time, required blood collection time, and collected blood volume in the blood collection data, as well as a record that the blood collection has been completed, and ends the blood collection.

[0061] The control unit 44 also causes the display input unit 38 to display a blood collection completion screen 90 shown in FIG. 15. The blood collection completion screen 90 includes a blood collection bag display section 62A, a suction setting display section 64A, an end display section 92, a blood collection data display section 94, and a confirmation button 96. The blood collection bag display section 62A displays the type of blood collection bag 200 selected and the amount of blood collected, and the suction setting display section 64A displays the suction setting status. The end display section 92 displays a normal completion message, indicating that blood collection has reached the set amount and is complete. The blood collection data display section 94 also displays the actual amount of blood collected, the blood collection start and end times, the blood collection duration, and whether or not a warning message was displayed in response to a decrease in blood collection flow rate. When the confirmation button 96 is selected on the blood collection completion screen 90, the blood collection device 10 proceeds to step S10 of FIG. 4 and displays the setting screen 60 (see FIG. 5) for accepting the next blood collection.

[0062] The blood collection device 10 and blood collection method of this embodiment have the following advantages.

[0063] The blood collection device 10 of this embodiment is a blood collection device 10 that collects whole blood by storing a blood collection bag 200 in a storage chamber 12 and creating a negative pressure in the storage chamber 12, and is equipped with a load sensor 22a that detects the weight of the blood collection bag 200, a control unit 44 that detects the blood collection flow rate, which is the change in the amount of blood collected per unit time, a memory unit 48 that stores blood collection flow rate data including changes in the blood collection flow rate over time and judgment patterns, and a display input unit 38 that displays blood collection information including the blood collection flow rate during blood collection.The control unit 44 monitors the blood collection flow rate, and when it detects a decrease in the blood collection flow rate, it compares the blood collection flow rate data in the memory unit 48 with judgment patterns 1 to 4 to determine the cause of the decrease in the blood collection flow rate, and causes the display input unit 38 to display warning displays 102 to 108 including the cause of the decrease in the blood collection flow rate.

[0064] According to the above configuration, the display input unit 38 of the blood collection device 10 displays any decrease in blood collection flow rate that requires attention along with the cause, thereby preventing the person in charge of collecting blood from overlooking the decrease in blood collection flow rate and preventing the production of preparations with insufficient blood collection volume.

[0065] In the above-described blood collection device 10, determination patterns 1 to 4 may include data on the change in the blood collection flow rate before the blood collection flow rate decreases (element A), the rate of change in the flow rate when the blood collection flow rate decreases (element B), and the change in the blood collection flow rate after the blood collection flow rate decreases (elements C and D). With this configuration, causes such as blockage of the blood collection line, aggregation of thrombus, adhesion of the blood collection needle to the blood vessel, and a decrease in the intravascular flow rate can be identified from the blood collection flow rate data.

[0066] In the above-described blood collection device 10, when the blood collection flow rate data suddenly drops from a steady blood collection flow rate to near zero, the control unit 44 may determine that the cause of the drop in blood collection flow rate is blockage of the blood collection line (blood collection tube 202) connecting the blood collection bag 200 and the blood collection needle, and may cause the display input unit 38 to display a warning display 102 indicating that the blood collection line is blocked. This configuration makes it possible to prompt the user to take appropriate measures against mechanical blockage caused by bending or crushing the blood collection tube 202, for example.

[0067] In the above-described blood collection device 10, when the blood collection flow rate data indicates that the blood collection flow rate gradually decreases and continues to be zero or a low flow rate near zero, the control unit 44 may determine that the cause of the decrease in the blood collection flow rate is blood coagulation occurring inside the blood collection needle or the blood collection line, and may cause the display input unit 38 to display a warning display 104 indicating that blood coagulation has occurred. This configuration makes it possible to prompt appropriate measures to be taken in response to the decrease in the blood collection flow rate due to blood coagulation.

[0068] In the above-described blood collection device 10, when the blood collection flow rate data indicates that the blood collection flow rate gradually decreases to zero or a low flow rate near zero and then returns to the blood collection flow rate before the decrease, the control unit 44 may determine that the decrease in blood collection flow rate is due to the blood collection needle sticking to the inner wall of the blood vessel, and may cause the display input unit 38 to display a warning display 106 indicating that the blood collection needle is stuck to the inner wall of the blood vessel. This configuration makes it possible to prompt the user to take appropriate measures in response to the decrease in blood collection flow rate caused by the blood collection needle sticking to the inner wall of the blood vessel.

[0069] In the above-described blood collection device 10, when the blood collection flow rate data indicates that the blood collection flow rate gradually decreases and then stabilizes at a low flow rate that does not allow a sufficient amount of blood to be collected within the specified blood collection time, the control unit 44 may determine that the decrease in the blood collection flow rate is due to a decrease in the amount of blood supplied to the donor's blood collection site, and may cause the display input unit 38 to display a warning display 108 indicating that the amount of blood supplied to the donor's blood collection site is decreasing. This configuration makes it possible to prompt the user to take appropriate measures in response to the decrease in blood flow rate in the blood vessel punctured by the blood collection needle.

[0070] In the above-mentioned blood collection device 10, the control unit 44 may be configured to determine that the cause of the decrease in blood collection flow rate is mechanical blockage of the blood collection line (blood collection tube 202) connecting the blood collection bag 200 and the blood collection needle when, in the blood collection flow rate data, the blood collection flow rate (element A) before the blood collection flow rate decreases is equal to or greater than a first flow rate (e.g., 30 ml / min) and the flow rate change rate (element B) when the blood collection flow rate decreases is faster than the first change rate (e.g., 30 ml / min / sec).

[0071] In the above-mentioned blood collection device 10, the control unit 44 may be configured to determine that the cause of the decrease in blood collection flow rate is due to blood coagulation occurring inside the blood collection needle or blood collection line (blood collection tube 202) if, in the blood collection flow rate data, the flow rate change rate (element B) when the blood collection flow rate decreases falls below a first change rate (e.g., 30 ml / min / sec) and the blood collection flow rate (elements C, D) after the blood collection flow rate decreases falls below a second flow rate (e.g., 5 ml / min) near zero and does not recover to above a third flow rate (e.g., 10 ml / min) greater than the second flow rate within a certain period of time.

[0072] In the above-mentioned blood collection device 10, the control unit 44 may be configured to determine that the cause of the decrease in blood collection flow rate is the blood collection needle sticking to the inner wall of the blood vessel if, in the blood collection flow rate data, the flow rate change rate (element B) when the blood collection flow rate decreases falls below a first change rate (e.g., 30 ml / min / sec) and the blood collection flow rate (elements C, D) after the blood collection flow rate decreases falls below a second flow rate (e.g., 5 ml / min) near zero and recovers to above a third flow rate (e.g., 10 ml / min) greater than the second flow rate within a certain period of time.

[0073] In the above-mentioned blood collection device 10, if the blood collection flow rate data shows that the flow rate change rate (element B) when the blood collection flow rate decreases is below the first change rate (e.g., 30 ml / min / sec) and the blood collection flow rate (elements C, D) after the blood collection flow rate decrease is stable at a low rate between the second flow rate (e.g., 5 ml / min) and the fourth flow rate (e.g., 35 ml / min), the control unit 44 determines that the cause of the decrease in the blood collection flow rate is a decrease in the amount of blood supply to the donor's blood vessels.

[0074] This blood collection method is performed by a blood collection device (10) that collects whole blood by creating negative pressure in a storage chamber (12) containing the blood collection bag (200), and is equipped with a load sensor (22a) that detects the weight of the blood collection bag (200), a control unit (44) that detects the blood collection flow rate, which is the change in the amount of blood collected per unit time, a memory unit (48) that stores blood collection flow rate data including the change in blood collection flow rate over time and a judgment pattern, and a display input unit (38) that displays blood collection information including the blood collection flow rate during blood collection.The blood collection method includes a step S400 in which the control unit (44) monitors the blood collection flow rate, and if the control unit (44) detects a decrease in the blood collection flow rate (YES in step S400), steps S401 and S402 in which the control unit (44) compares the blood collection flow rate data with the judgment pattern to determine the cause of the decrease in the blood collection flow rate, and a step S403 in which the control unit (44) causes the display input unit (38) to display warning displays (102-108) including the cause of the decrease in the blood collection flow rate.

[0075] According to the above-described blood collection method, the display input unit 38 displays any decrease in blood collection flow rate that requires attention along with the cause, thereby preventing the person in charge of collecting blood from overlooking the decrease in blood collection flow rate and preventing the production of preparations with insufficient blood collection volume.

[0076] Although the present invention has been described above by citing preferred embodiments, it goes without saying that the present invention is not limited to the above embodiments, and various modifications are possible within the scope of the present invention.

Claims

1. A blood collection device that collects whole blood by storing a blood collection bag in a storage chamber and creating negative pressure in the storage chamber, a load sensor for detecting the weight of the blood collection bag; a control unit for detecting a blood collection flow rate, which is a change in the amount of blood collected per unit time; a memory unit that stores a time series pattern in which the blood collection flow rate gradually decreases to a low flow rate and then returns to the blood collection flow rate before the decrease as a first determination pattern specific to the phenomenon in which the blood collection needle sticks to the inner wall of a blood vessel; a display unit that displays blood collection information including the blood collection flow rate during blood collection, The control unit Monitor the blood collection flow rate, When a decrease in the blood collection flow rate is detected, a matching process is performed between the blood collection flow rate data, which indicates a transition pattern of the blood collection flow rate over time detected by the load sensor, and the first judgment pattern, and when a match is found, it is determined that the cause of the decrease in the blood collection flow rate is due to the blood collection needle sticking to the inner wall of the blood vessel, displaying a warning message on the display unit indicating that the blood collection needle has stuck to the inner wall of a blood vessel; Blood collection device.

2. The blood collection device according to claim 1, the first determination pattern includes data relating to a change in the blood collection flow rate before the blood collection flow rate is reduced, a rate of change in the flow rate when the blood collection flow rate is reduced, and a change in the blood collection flow rate after the blood collection flow rate is reduced; Blood collection device.

3. The blood collection device according to claim 1 or 2, The memory unit further stores a second determination pattern in which the blood collection flow rate suddenly drops from a steady state to a value close to zero, The control unit If the blood collection flow rate data matches the second determination pattern, it is determined that the cause of the decrease in the blood collection flow rate is due to blockage of the blood collection line connecting the blood collection bag and the blood collection needle, causing the display unit to display a warning message indicating that the blood collection line is blocked; Blood collection device.

4. The blood collection device according to any one of claims 1 to 3, The memory unit further stores a third determination pattern in which the blood collection flow rate gradually decreases and continues to be zero or a low flow rate near zero; The control unit If the blood collection flow rate data matches the third determination pattern, the cause of the decrease in the blood collection flow rate is determined to be the occurrence of blood coagulation inside the blood collection needle or blood collection line, displaying a warning message indicating that blood coagulation has occurred on the display unit; Blood collection device.

5. The blood collection device according to any one of claims 1 to 4, the memory unit stores a fourth determination pattern in which the blood collection flow rate gradually decreases and then stabilizes at a flow rate so low that a sufficient amount of blood cannot be collected within a specified blood collection time; The control unit If the blood collection flow rate data matches the fourth determination pattern, the cause of the decrease in the blood collection flow rate is determined to be a decrease in the amount of blood supplied to the donor's blood collection site; displaying a warning message on the display unit indicating that the amount of blood supply to the blood collection site of the donor is decreasing; Blood collection device.

6. The blood collection device according to claim 2, the memory unit further stores a second determination pattern in which the steady-state blood collection flow rate is equal to or greater than a first flow rate, and the rate of change of the flow rate when the blood collection flow rate is reduced is faster than the first rate of change; The control unit If the blood collection flow rate data matches the second determination pattern, it is determined that the cause of the decrease in the blood collection flow rate is due to mechanical blockage of the blood collection line connecting the blood collection bag and the blood collection needle. Blood collection device.

7. The blood collection device according to claim 2, the storage unit further stores a third determination pattern in which the rate of change of the flow rate when the blood collection flow rate is reduced is lower than the first rate of change, and the blood collection flow rate after the reduction in the blood collection flow rate is lower than a second flow rate near zero and does not recover until it exceeds a third flow rate that is larger than the second flow rate within a certain period of time; The control unit If the blood collection flow rate data matches the third determination pattern, it is determined that the cause of the decrease in the blood collection flow rate is due to blood coagulation occurring inside the blood collection needle or blood collection line. Blood collection device.

8. The blood collection device according to claim 2, the first determination pattern includes a time series pattern in which the rate of change of the flow rate when the blood collection flow rate is reduced is lower than a first rate of change, and the blood collection flow rate after the reduction in the blood collection flow rate is lower than a second flow rate near zero and then recovers to a third flow rate greater than the second flow rate within a certain period of time, The control unit If the blood collection flow rate data matches the first determination pattern, it is determined that the cause of the decrease in blood collection flow rate is that the blood collection needle has stuck to the inner wall of the blood vessel. Blood collection device.

9. The blood collection device according to claim 2, the memory unit further stores a fourth determination pattern in which the rate of change of the blood flow rate when the blood collection flow rate is reduced is lower than the first rate of change, and the blood collection flow rate after the reduction is stable at a low rate between the second flow rate and the fourth flow rate; The control unit If the blood collection flow rate data matches the fourth determination pattern, the cause of the decrease in blood collection flow rate is determined to be a decrease in the amount of blood supply to the donor's blood vessels. Blood collection device.

10. a load sensor for detecting the weight of a blood collection bag; a control unit for detecting a blood collection flow rate, which is a change in the amount of blood collected per unit time; a memory unit for storing a time series pattern in which the blood collection flow rate gradually decreases to a low flow rate and then returns to the blood collection flow rate before the decrease as a first determination pattern specific to the phenomenon in which the blood collection needle sticks to the inner wall of a blood vessel; and a display unit for displaying blood collection information including the blood collection flow rate during blood collection, the blood collection method being carried out by a blood collection device that collects whole blood by applying negative pressure to a storage chamber that stores a blood collection bag; the control unit monitoring the blood collection flow rate; When the control unit detects a decrease in the blood collection flow rate, it performs a matching process between the blood collection flow rate data, which indicates a transition pattern of the blood collection flow rate over time, detected by the load sensor and the first judgment pattern, and when a match is found, it determines that the cause of the decrease in the blood collection flow rate is due to the blood collection needle sticking to the inner wall of the blood vessel; a step of displaying a warning message on the display unit indicating that the blood collection needle has stuck to the inner wall of a blood vessel; A blood collection method.

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