JP7500461B2 - BLOOD SAMPLING DEVICE AND METHOD FOR PREVENTING MISFUNCTION OF BLOOD SAMPLING DEVICE - Google Patents

Description

The present invention relates to a blood collection device and a method for preventing malfunction of the blood collection device.

For example, Patent Document 1 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.

In the blood collection device described above, the weight of the collected blood is measured using a weight sensor consisting of a load cell such as a strain sensor, and the specific gravity of the blood is converted into the collected blood volume and blood collection speed, which are displayed on the display input unit for management by the user.

Blood collection is carried out in blood donation rooms or blood donation buses (vehicles), but in such locations, the presence of radio equipment such as taxi radios and truck radios, as well as electromagnetic noise from various electronic devices, is unavoidable. Blood collection devices are required to operate reliably without malfunctioning even in the presence of electromagnetic noise.

In conventional blood sampling devices, measures are taken to prevent the intrusion of electromagnetic noise, such as using a filter element to remove intruding noise or surrounding the electronic circuit with a conductive plate.

JP 2004-81305 A

However, in blood collection devices, it is difficult to remove noise from analog signals from sensors with high impedance, such as weight sensors, using filter elements, making it difficult to implement measures against electromagnetic noise. In blood collection devices, the weight sensor must be installed in the storage chamber where the blood bag is inserted and removed, making it difficult to install a strong electromagnetic shield.

As a result, when exposed to strong electromagnetic noise, there is a risk of malfunction, such as an abnormal display of the amount of collected blood or a false detection of a decrease in the amount of collected blood, which may cause the protection circuit of the blood collection device to activate and forcibly end blood collection.

Therefore, one embodiment of the present invention aims to provide a blood collection device that can prevent malfunctions caused by electromagnetic noise and a method for preventing malfunctions of a blood collection device.

One aspect of the disclosure below is a blood collection device that collects whole blood by storing a blood collection bag in a storage chamber and applying negative pressure to the storage chamber, the blood collection device comprising a control unit having a load sensor that detects the weight of the blood collection bag, a blood collection amount data generation unit that generates blood collection amount data representing the change in the blood collection amount from the change in the weight of the blood collection bag, and an error detection unit that detects a decrease in the blood collection amount of the blood collection bag and stops the blood collection operation, a memory unit that stores a noise pattern consisting of a combination of characteristic elements of noise components that are generated in the blood collection amount data due to external radio wave noise, and a display input unit that displays blood collection information including the blood collection amount and an error detection result of the error detection unit, the control unit extracts the characteristic elements of the blood collection amount data, compares the characteristic elements of the blood collection amount data with the characteristic elements of the noise pattern, and stops the error detection of the error detection unit when the noise pattern that matches the characteristic elements of the blood collection amount data is detected.

Another aspect is a method for preventing malfunction of a blood collection device that includes a control unit having a load sensor that detects the weight of a blood collection bag, a blood collection amount data generation unit that generates blood collection amount data representing the change in the blood collection amount from the change in the weight of the blood collection bag, and an error detection unit that detects a decrease in the blood collection amount of the blood collection bag and stops the blood collection operation, a memory unit that stores a noise pattern consisting of a combination of characteristic elements of noise components generated in the blood collection amount data by external radio wave noise, and a display input unit that displays blood collection information including the blood collection amount and an error detection result of the error detection unit, and collects whole blood by storing the blood collection bag in a storage chamber and applying negative pressure to the storage chamber, the method including the steps of: the control unit extracting the characteristic elements of the blood collection amount data; the control unit comparing the characteristic elements of the blood collection amount data with the characteristic elements of the noise pattern; and, when the control unit detects the noise pattern that matches the characteristic elements of the blood collection amount data, stopping the error detection of the error detection unit.

The blood collection device and the method for preventing malfunction of the blood collection device described above can prevent malfunctions caused by electromagnetic noise.

1 is a perspective view of a blood sampling device according to an embodiment of the present invention. FIG. 2 is an exploded perspective view showing the internal structure of the blood sampling device of FIG. 1. 2 is a block diagram showing the configuration of the blood sampling device of FIG. 1. 4 is a flowchart showing the operation of the blood sampling device of FIG. 1 . 4 is an explanatory diagram showing a transition of a screen of a display input unit of the blood sampling device of FIG. 1. 5 is a flowchart showing the operation of the blood sampling device in the blood sampling abnormality monitoring process of FIG. 4 . 7 is a flowchart showing the operation of the blood sampling device in the noise detection process of FIG. 6 . FIG. 8A is an explanatory diagram showing characteristic elements of collected blood volume data, and FIG. 8B is an explanatory diagram showing noise patterns. 1 is a graph showing blood collection amount data according to the first example, with the vertical axis representing the blood collection amount and the horizontal axis representing elapsed time. 13 is a graph showing blood collection amount data according to the second example. 13 is a graph showing blood collection amount data according to the third example. 13 is a graph showing blood collection amount data according to the fourth example.

A preferred embodiment of the present invention will be described in detail below with reference to the accompanying drawings.

As shown in FIG. 1, the blood collection device 10 according to 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 a blood donation room, a blood donation bus, etc.

The blood collection device 10 comprises a box-shaped housing 14 in which a storage chamber 12 for storing a blood collection bag 200 is formed, and a lid 16 that is provided on the top of the storage chamber 12 of the box-shaped housing 14 so as to be able to be opened and closed. The storage chamber 12 is formed in a concave shape with a peripheral wall and a bottom, and opens upward. As shown in FIG. 2, a hinge 30 is provided on the rear side of the storage chamber 12, and the lid 16 is attached to the hinge 30 so as to be able to be opened and closed.

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

As shown in FIG. 2, the storage chamber 12 is provided with a storage tray 18 for placing the blood collection bag 200, 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 the donor, and is connected to the swinging mechanism 20 via the bracket 22. The bottom surface of the storage tray 18 is provided with an attachment portion 18a, 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 using the attraction force of a magnet may be used.

The bracket 22 is provided with a load sensor 22a. The load sensor 22a detects the weight of the blood collection bag 200 stored in the storage tray 18. The rocking mechanism 20 is equipped with a rocking motor and generates a rocking motion that moves the inclination of the storage tray 18 along the circumferential direction.

As shown in FIG. 3, the storage chamber 12 of the blood collection device 10 is provided with an exhaust pump 24 that exhausts the air 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.

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 be an electrostatic or pressure-sensitive switch, etc. 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 for manually releasing the clamped state (blocked 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 other than the operation panel 32 as a lever-operated switch such as an operation lever (not shown).

The display input unit 38 is, for example, a liquid crystal display and has a touch panel function. Therefore, the display input unit 38 also serves as an input unit that accepts inputs for operating the blood sampling device 10.

As shown in FIG. 3, the blood collection device 10 further includes a control unit 44 and a memory unit 46. The control unit 44 controls the blood collection operation of the blood collection device 10, generates the display image (screen) of the display input unit 38, detects errors during the blood collection operation, and performs various processes on noise signals. Meanwhile, the memory unit 46 stores blood collection data on blood collected from the donor and noise patterns required for noise detection.

The control unit 44 is provided with a blood collection amount data generation unit 44a, an error detection unit 44b, and a mask processing unit 44c. The blood collection amount data generation unit 44a obtains the weight of blood collected in the blood collection bag 200 by subtracting the initial weight of the blood collection bag 200 from the weight of the blood collection bag 200 detected by the load sensor 22a. The blood collection amount data generation unit 44a then detects the blood collection amount (ml) by dividing the weight of the collected blood by the specific gravity. Furthermore, the blood collection amount data generation unit 44a generates blood collection amount data that records the blood collection amount (ml) detected at regular intervals.

The error detection unit 44b detects blood backflow or blood leakage to the donor and performs error detection to ensure the safety of the donor. The blood collection device 10 collects blood into the blood collection bag 200 in which an anticoagulant is enclosed. If the blood contained in the blood collection bag 200 is returned to the donor side, the safety of the donor may be compromised. When the blood collection device 10 is performing a blood collection operation normally, the amount of blood collected during blood collection only increases and does not decrease. An event in which the amount of blood collected during blood collection decreases means that a high-risk situation has occurred in which blood in the blood collection bag 200 is flowing back to the donor side or there is a leak in the blood collection bag 200 or the blood collection tube 202, causing blood to leak. The error detection unit 44b monitors the blood collection amount data, and when a decrease in the amount of blood collected is detected, the error detection result is displayed on the display input unit 38 as a blood collection amount decrease alarm, and the clamp unit 28 is closed to forcibly end the blood collection operation.

The control unit 44 further compares the blood collection volume data with the noise pattern in the memory unit 46 to monitor the influence of external noise components. When the influence of external noise components is detected, the mask processing unit 44c performs processing to stop the error detection operation of the error detection unit 44b in order to prevent blood collection from being stopped due to a malfunction of the error detection unit 44b.

In addition to the blood collection data, the memory unit 46 stores the blood collection volume data generated by the blood collection volume data generation unit 44a and noise patterns. As shown in FIG. 8B, the noise detection pattern data includes multiple types of noise patterns to accommodate multiple types of noise. Each noise pattern is composed of, for example, a threshold value (threshold value of element A) of the absolute value of the blood collection flow rate, which is the rate of change of the blood collection volume over time, a threshold value (threshold value of element B) of the number of changes in the positive and negative sign of the blood collection flow rate per second, and a combination of one or more threshold values for other characteristic elements.

The operation and functions of the blood sampling device 10 are described below with reference to Figures 4 to 12.

When the power switch 34 (see FIG. 1) on the front of the blood collection device 10 is pressed to turn on 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.

The blood collection bag selection button 62 displays the type and capacity (e.g., 200 ml) of the blood collection bag 200 as the initial setting. 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.

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. The control unit 44 then 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 any 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.

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 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 set the negative pressure when collecting blood. When the OFF setting button 74a is selected, the control unit 44 sets the blood collection to be performed by natural drop due to the difference in height between the donor and the blood collection bag 200 without suctioning.

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

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 out blood collection data from the past blood collection from the memory unit 46 and displays the blood collection data screen 76 at the bottom left of FIG. 5 on the display input unit 38. The blood collection data screen 76 includes data selection buttons 76a, 76b, a return button 76c, and a blood collection data display input section 76d. The blood collection data display input section 76d displays blood collection data including the blood collection volume, blood collection start time, blood collection end time, blood collection time, and abnormality history due to a decrease in flow rate (e.g., zero flow rate) along with the data number. When the data selection buttons 76a, 76b are selected, the blood collection data screen 76 switches to display the previous and next blood collection data. When the user selects the return button 76c, the screen returns to the setting screen 60.

As shown in FIG. 1, the operator places the specified blood collection bag 200 on the storage tray 18, sets the blood collection tube 202 in the clamp section 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.

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 blood collection. The control unit 44 starts operating the rocking mechanism 20 and the exhaust pump 24. After the detection value of the pressure sensor 26 reaches a predetermined negative pressure, the control unit 44 opens the clamp unit 28 and starts collecting blood from the donor.

Then, the process proceeds to step S30, and the control unit 44 causes the display input unit 38 to display the blood collection screen 78 at the bottom right of FIG. 5. The blood collection screen 78 includes a blood collection bag display input unit 62A, a suction pressure selection button 64, a history display button 66, a blood collection status display input unit 78d, a blood collection remaining amount display input unit 78e, and a completion prediction display input unit 78f. The blood collection bag display input unit 62A only has a display function that cannot be selected, and displays the type of blood collection bag 200 selected and the amount of blood collected. The suction pressure selection button 64 is a selectable button, and when selected, the process proceeds to the suction pressure setting screen 74 at the top right of FIG. 5. The operator can check the condition of the blood donor and, if necessary, adjust the blood collection speed by changing the suction pressure during blood collection by operating the suction pressure setting screen 74.

In parallel with the processing of step S30, the control unit 44 performs blood collection abnormality monitoring in step S40. In the operation of monitoring blood collection abnormalities in step S40, the control unit 44 performs the blood collection abnormality monitoring operation shown in FIG. 6 and the noise detection processing shown in FIG. 7 in parallel.

First, the monitoring operation for blood collection abnormalities shown in Figure 6 will be described. When the blood collection operation is started, the blood collection amount data generating unit 44a of the control unit 44 detects the amount of blood collected in the blood collection bag 200 based on the detection value of the load sensor 22a, and generates blood collection amount data (step S401). The blood collection amount data includes the amount of blood collected at each time, and the generated blood collection amount data is stored in the memory unit 46. The blood collection amount data is successively updated by the blood collection amount data generating unit 44a by adding the most recent blood collection amount.

Next, the process proceeds to step S402, where the control unit 44 checks whether or not there is a noise detection flag indicating the presence of an external noise component. As described below, the noise detection flag is set when the blood collection volume data and the noise detection pattern data match in the control unit 44, i.e., when a noise component is detected.

If the mask processing unit 44c determines in step S402 that the noise detection flag is set, the process proceeds to step S405, where the mask processing unit 44c masks the error detection by the error detection unit 44b. Note that the mask processing unit 44c may mask the error detection by stopping the provision of blood collection volume data to the error detection unit 44b.

If the control unit 44 determines in step S402 that the noise detection flag is down (NO), the process proceeds to step S403. In step S403, the error detection unit 44b of the control unit 44 determines whether a decrease in the amount of collected blood has occurred. In step S403, if the error detection unit 44b detects a decrease in the amount of collected blood (YES), the process proceeds to step S404, where the control unit 44 displays a blood collection amount decrease error (warning display) on the display input unit 38 and closes the clamp unit 28 to forcibly end the blood collection operation.

If the error detection unit 44b does not detect a decrease in the amount of collected blood in step S403 (NO), the process proceeds to step S405, where the control unit 44 determines whether or not a blood collection termination condition has been reached. The blood collection termination condition is met, for example, when a preset blood collection amount is reached or when a specified blood collection time (e.g., 15 minutes) has elapsed. If the blood collection termination condition is not met in step S405, the process returns to step S401, and monitoring for blood collection abnormalities continues. If the blood collection termination condition is met, blood collection is terminated.

Next, the noise detection process will be described. As shown in FIG. 7, in the noise detection process, when blood collection is started, in step S410, the control unit 44 refers to the blood collection volume data and extracts characteristic elements from the blood collection volume data. As shown in FIG. 8A, the characteristic elements extracted from the blood collection volume data include, for example, the absolute value of the blood collection flow rate (ml/sec), which is the rate of change in the blood collection volume, (element A), and the number of positive and negative changes in the blood collection flow rate per second (element B). Note that the characteristic elements are not limited to the above elements A and B, and may include multiple other elements.

Next, the control unit 44 in FIG. 7 compares the characteristic elements of the blood collection volume data (e.g., elements A and B) with the noise detection pattern data to detect a matching noise pattern. The noise detection pattern data includes noise patterns 1 to 3, for example, as shown in FIG. 8B. As shown in FIG. 7, in step S412, the control unit 44 determines whether the characteristic elements of the blood collection volume data match noise pattern 1.

As shown in FIG. 8B, noise pattern 1 (pulse-like noise pattern) is a condition where the absolute value of the blood collection flow rate (element A) exceeds a threshold value of 1 ml/sec, and the number of positive/negative changes in the blood collection flow rate per second (element B) is one. Noise pattern 1 detects a noise waveform in which the blood collection volume suddenly increases or decreases, and then immediately returns to the original volume. For example, the blood collection volume data of the first example shown in FIG. 9 has pulse-like noise waveforms 91 and 92 in which the blood collection volume suddenly increases (or decreases), and then immediately returns to the original volume, matching noise pattern 1.

In step S412 of FIG. 7, if the control unit 44 determines that the characteristic elements of the blood collection volume data match noise pattern 1 (YES), the process proceeds to step S413, where it sets a noise detection flag and stops (holds) updating the blood collection volume display displayed on the display input unit 38. That is, the blood collection volume displayed on the display input unit 38 is held at the value before noise detection. When the noise detection flag is set, the mask processing unit 44c stops error detection by the error detection unit 44b, as described in step S402 of FIG. 6.

The noise detection flag and blood collection volume are held in step S413 until the noise disappears. That is, in step S414, the control unit 44 determines whether a predetermined noise disappearance condition is met, and if the noise disappearance condition is not met (NO), the state of step S413 is maintained. The noise disappearance condition will be described later.

If the control unit 44 determines in step S412 that the characteristic elements of the blood collection volume data do not match noise pattern 1 (NO), the process proceeds to step S415. In step S415, the control unit 44 determines whether the characteristic elements of the blood collection volume data match noise pattern 2. Noise pattern 2 (sawtooth noise) is a condition in which the number of positive and negative changes in the blood collection volume per second (element B) is two or more, as shown in FIG. 8B.

Noise pattern 2 can detect a sawtooth noise waveform that continuously increases or decreases. As seen in the blood collection volume data of the second example in FIG. 10, sawtooth noise has a noise waveform 93 that repeatedly increases and decreases within one second of the blood collection volume. Noise pattern 2 can detect sawtooth noise by setting element B to 2 or more.

If the control unit 44 determines in step S415 of FIG. 7 that the characteristic elements of the blood collection volume data match noise pattern 2 (YES), the control unit 44 proceeds to step S413, where it sets a noise detection flag and holds the blood collection volume display on the display input unit 38. The control unit 44 then continues step S413 until the noise elimination condition is met (step S414).

If the control unit 44 determines in step S415 that the characteristic elements of the blood collection volume data do not match noise pattern 2 (NO), the process proceeds to step S416. In step S416, the control unit 44 determines whether the characteristic elements of the blood collection volume data match noise pattern 3. Noise pattern 3 (continuous noise) is a condition in which the absolute value of the blood collection flow rate (element A) exceeds the threshold value of 1 ml/sec, and the number of positive/negative changes in the blood collection flow rate per second (element B) is 0, as shown in FIG. 8B.

Noise pattern 3 can detect a noise waveform that is continuously increasing or continuously decreasing. Continuously increasing or continuously decreasing noise has a relatively smooth noise waveform 94, as can be seen in the blood collection volume data of the third example in FIG. 11, and the change in the blood collection volume due to the noise resembles the change in the actual blood collection volume. However, the rate of increase or decrease in the blood collection volume shows a change greater than 1 ml/sec, which does not occur in the change in the actual blood collection volume. Noise pattern 3 can detect a noise waveform that is continuously increasing or continuously decreasing by setting the threshold value of element A to greater than 1 ml/sec.

If the control unit 44 determines in step S416 of FIG. 7 that the characteristic elements of the blood collection volume data match noise pattern 3 (YES), the process proceeds to step S417 and sets a noise detection flag. In this embodiment, the processing content for noise differs depending on the matching noise pattern, and in step S417, the control unit 44 does not hold the blood collection volume display on the display input unit 38. The control unit 44 continues the state in which the noise detection flag is set in step S417 until the noise disappearance condition is satisfied (step S418).

Next, the noise elimination conditions in steps S414 and S418 will be described. In the blood collection device 10, when the electromagnetic noise disappears, the collected blood volume returns to the volume before the noise occurred, and the collected blood volume increases with a stable blood collection flow rate. Therefore, in this embodiment, the control unit 44 determines that the electromagnetic noise has disappeared when it detects a state in the blood collection volume data where the collected blood volume has returned to the volume before the noise was detected, and the collected blood volume continues to increase at a flow rate of 0.1 to 1 ml/sec.

If the control unit 44 determines in step S414 or step S418 that the noise elimination condition is met (YES), the process proceeds to step S419, where the noise detection flag is turned off. In the case of step S414, the control unit 44 releases the hold on the blood collection volume display on the display input unit 38 in step S420 prior to step S419.

Then, the process proceeds to step S421, where the control unit 44 determines whether or not the blood collection end condition has been met. If the control unit 44 determines that the blood collection end condition has not been met (NO), the process returns to step S410, and the noise detection process continues. If the control unit 44 determines in step S421 that the blood collection end condition has been met (YES), the process ends.

In addition, with the above noise patterns 1 to 3, it is possible to detect noise waveforms that combine pulse noise, continuous increase (continuous decrease) noise, and sawtooth noise, as in the blood collection volume data of the fourth example in Figure 12.

The types of noise patterns included in the noise detection pattern data are not limited to three, and may be more than three. The feature elements used to match the blood collection volume data with the noise detection pattern data are not limited to the blood collection flow rate and the number of changes in the positive and negative signs of the blood collection flow rate, and multiple other feature elements may be added.

The above blood collection device 10 and method for preventing malfunction of the blood collection device 10 provide the following effects.

The blood collection device 10 of this embodiment is a blood collection device that collects whole blood by storing a blood collection bag 200 in a storage chamber 12 and applying negative pressure to the storage chamber 12. It is equipped with a control unit 44 having a load sensor 22a that detects the weight of the blood collection bag 200, a blood collection amount data generation unit 44a that generates blood collection amount data representing the change in the blood collection amount from the change in the weight of the blood collection bag 200, and an error detection unit 44b that detects a decrease in the blood collection amount of the blood collection bag 200 and stops the blood collection operation, a memory unit 46 that stores noise patterns consisting of a combination of characteristic elements of noise components generated in the blood collection amount data due to external radio wave noise, and a display input unit 38 that displays blood collection information including the blood collection amount and the error detection result of the error detection unit 44b. The control unit 44 extracts the characteristic elements of the blood collection amount data, compares the characteristic elements of the blood collection amount data with the characteristic elements of the noise pattern, and stops the error detection of the error detection unit 44b when a noise pattern matching the characteristic elements of the blood collection amount data is detected.

The blood collection device 10 described above can continue to collect blood normally, even in an environment where electromagnetic noise is present, without malfunction (stopping collection) due to abnormal detection of the collected blood volume. Furthermore, the blood collection device 10 can flexibly adopt a defense method according to the type of noise by matching preregistered noise patterns with collected blood volume data. This can increase reliability in an environment where electromagnetic noise is present.

In the above blood collection device 10, the characteristic elements of the blood collection volume data and noise pattern may include at least one of the blood collection flow rate (element A), which is the amount of change in the blood collection volume per unit time, and the number of positive and negative changes in the blood collection flow rate within a certain period of time (element B). With this configuration, pulse noise, sawtooth noise, or continuous increase (continuous decrease) noise can be detected.

In the blood collection device 10, the memory unit 46 may store, as noise patterns, a pulsed noise pattern (noise pattern 1) consisting of characteristic elements representing a change in the amount of collected blood that suddenly increases or decreases, followed by a return to the amount of collected blood before the change; a sawtooth noise pattern (noise pattern 2) consisting of characteristic elements representing a continuous sawtooth increase or decrease; and a continuous noise pattern (noise pattern 3) consisting of characteristic elements representing a change in a continuous increase or decrease at a speed faster than the normal blood collection speed. With this configuration, appropriate measures can be taken according to the three types of noise patterns.

In the above blood collection device 10, when the characteristic elements of the blood collection volume data match the pulse noise pattern, the control unit 44 may stop error detection by the error detection unit 44b and may stop updating the value of the blood collection volume displayed on the display input unit 38. This configuration can prevent blood collection from being stopped and the display of the blood collection volume from being disturbed due to the error detection unit 44b malfunctioning due to pulse noise.

In the above blood collection device 10, when the characteristic element of the blood collection volume data matches a continuous increase (continuous decrease) noise pattern, the control unit 44 may stop the error detection by the error detection unit 44b and may display the detected blood collection volume as is on the display input unit 38. This configuration can prevent the error detection unit 44b from malfunctioning due to continuous noise.

In the above blood collection device 10, the characteristic element of the noise pattern is an absolute value of the blood collection flow rate (element A) exceeding 1 ml/sec, and the control unit 44 may stop error detection by the error detection unit 44b when the absolute value of the blood collection flow rate of the blood collection volume data exceeds 1 ml/sec. With this configuration, blood collection flow rates greater than the blood collection flow rates that occur in normal blood collection can be detected as noise, and malfunction of the error detection unit 44b due to various types of noise can be prevented.

In the above blood sampling device 10, the characteristic element of the noise pattern is the number of positive/negative sign changes of the blood sampling flow rate per second (element B), and if the number of sign changes is 2 or more, the error detection by the error detection unit 44b may be stopped. With this configuration, it is possible to prevent the error detection unit 44b from malfunctioning due to sawtooth noise.

In the above blood collection device 10, the control unit 44 may further determine that the noise has disappeared and cause the error detection unit 44b to resume error detection when the blood collection volume data indicates that the blood collection volume has returned to the previous blood collection volume that matches the noise pattern, and the blood collection flow rate, which is the rate of change in the blood collection volume, is between 0.1 ml/sec and 1 ml/sec. With this configuration, the error detection by the error detection unit 44b can be returned to normal after the noise has disappeared, improving the reliability of the blood collection device 10.

The method for preventing malfunction of the blood collection device 10 of this embodiment includes a control unit 44 having a load sensor 22a that detects the weight of the blood collection bag 200, a blood collection amount data generation unit 44a that generates blood collection amount data representing the change in the blood collection amount from the change in the weight of the blood collection bag 200, and an error detection unit 44b that detects a decrease in the blood collection amount in the blood collection bag 200 and stops the blood collection operation, a memory unit 46 that stores a noise pattern consisting of a combination of characteristic elements of noise components that occur in the blood collection amount data due to external radio wave noise, and blood collection information including the blood collection amount and the error detection result of the error detection unit 44b. The method for preventing malfunction of the blood collection device 10 includes a display input unit 38 that displays the result of the detection and input of ...

The present invention has been described above with reference to preferred embodiments, but it goes without saying that the present invention is not limited to the above embodiments, and various modifications are possible without departing from the spirit of the present invention.

10: Blood collection device 12: Storage chamber 22a: Load sensor 38: Display input unit 44: Control unit 44a: Blood collection amount data generating unit 44b: Error detection unit 46: Memory unit 200: Blood collection bag

Claims (9)

A blood collection device that collects whole blood by storing a blood collection bag in a storage chamber and creating a negative pressure in the storage chamber,
a load sensor for detecting a weight of the blood collection bag;
a control unit having a blood collection amount data generating unit that generates blood collection amount data representing a change in the collected blood amount from a change in the weight of the blood collection bag, and an error detecting unit that detects a decrease in the collected blood amount in the blood collection bag and stops the blood collection operation;
a memory unit that stores a noise pattern consisting of a combination of characteristic elements of noise components that occur in the blood collection volume data due to external radio wave noise;
a display input unit that displays blood collection information including the blood collection amount and an error detection result of the error detection unit,
The control unit is
Extracting feature elements of the blood collection volume data;
comparing the feature elements of the blood collection volume data with the feature elements of the noise pattern;
when the noise pattern coincident with a characteristic element of the blood collection amount data is detected, the error detection unit stops error detection.
Blood collection device. A blood collection device according to claim 1, wherein the characteristic elements of the blood collection volume data and noise pattern include at least one of the blood collection flow rate, which is the amount of change in the blood collection volume per unit time, and the number of positive and negative changes in the blood collection flow rate within a certain period of time. 3. The blood sampling apparatus according to claim 2, wherein the memory unit stores the following as the noise pattern:
a pulsating noise pattern having characteristic elements representing a pulsating waveform in which the amount of collected blood suddenly increases or decreases, and then returns to the amount of collected blood before the change;
a sawtooth noise pattern comprising features representing a sawtooth waveform;
a continuous noise pattern consisting of feature elements that represent a continuous increase or decrease in a rate faster than a normal blood sampling rate;
Stores the blood collection device. A blood collection device according to claim 3, wherein the control unit stops error detection by the error detection unit and stops updating the value of the blood collection volume displayed on the display input unit when a characteristic element of the blood collection volume data matches the pulse noise pattern. A blood collection device according to claim 3, in which the control unit stops error detection by the error detection unit when a characteristic element of the blood collection volume data matches the continuous noise pattern, and causes the display input unit to display the detected blood collection volume as is. A blood collection device according to claim 2, wherein the characteristic element of the noise pattern is an absolute value of the blood collection flow rate exceeding 1 ml/sec, and the control unit stops error detection by the error detection unit when the absolute value of the blood collection flow rate of the blood collection volume data exceeds 1 ml/sec. A blood sampling device according to claim 2, in which the characteristic element of the noise pattern is the number of positive/negative sign changes of the blood sampling flow rate per second, and when the number of sign changes is 2 or more, the error detection by the error detection unit is stopped. The blood collection device according to any one of claims 2 to 7, wherein the control unit determines that the noise has disappeared and restarts error detection by the error detection unit when the blood collection volume data indicates a blood collection volume that matches the noise pattern and the blood collection flow rate, which is the rate of change in the blood collection volume, is 0.1 ml/sec or more and 1 ml/sec or less. The blood collection device according to any one of claims 2 to 7, wherein the control unit determines that the noise has disappeared and restarts error detection by the error detection unit when the blood collection volume data indicates a blood collection volume that matches the noise pattern and the blood collection flow rate, which is the rate of change in the blood collection volume, is 0.1 ml/sec or more and 1 ml/sec or less. a control unit having a load sensor for detecting the weight of a blood collection bag, a blood collection amount data generating unit for generating blood collection amount data representing a change in the collected blood amount from a change in the weight of the blood collection bag, and an error detecting unit for detecting a decrease in the amount of blood collected from the blood collection bag and stopping a blood collection operation; a memory unit for storing noise patterns formed by a combination of characteristic elements of noise components generated in the blood collection amount data by external radio wave noise; and a display input unit for displaying blood collection information including the collected blood amount and an error detection result of the error detecting unit, the blood collection device collecting whole blood by storing the blood collection bag in a storage chamber and applying negative pressure to the storage chamber, comprising:
A step of the control unit extracting a feature element of the blood collection amount data;
a step of the control unit comparing a feature element of the blood collection amount data with a feature element of the noise pattern;
When the control unit detects the noise pattern that matches a characteristic element of the blood collection amount data, the control unit stops error detection of the error detection unit.
A method for preventing malfunction of a blood sampling device comprising the steps of:

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