JP5184066B2 - Internal bleeding detection device and blood component collection device - Google Patents

Description

  The present invention relates to an internal bleeding detection device and a blood component collection device for determining the presence or absence of internal bleeding in a predetermined vicinity including a puncture position of a needle punctured by a donor, for example, after separating blood collected from a donor, The present invention relates to an internal bleeding detection device and a blood component collection device that can be suitably applied to a blood component collection device that collects predetermined blood components and returns the remaining blood components to a donor.

  Blood collection includes whole blood collection in which blood is collected as it is and component blood collection in which only predetermined blood components are extracted. In component blood collection, a predetermined component is extracted by centrifuging blood collected from a donor, and other components are returned to the donor. As a result, the necessary components (plasma and platelets) can be collected more than the whole blood, and the other components are returned, so that the burden on the donor can be reduced. Moreover, a blood component collection apparatus for automatically performing such component blood collection has been put into practical use.

  In the blood component collection device, after the needle is punctured into the donor, the blood collected through the needle is separated into a plurality of components, a predetermined component is collected, and the remaining components are transferred from the needle to the donor. The process of returning blood is automatically performed by rotating the pump under the action of a predetermined control unit. A tube is attached to the pump. When collecting blood, the pump is rotated forward to suck blood from the tube, and when returning blood, the pump is rotated backward to send the remaining components to the tube. The flow rate of blood and blood components in the tube during blood collection and return can be changed according to the rotational speed of the pump.

  Depending on the puncture state of the needle, when blood is returned, the blood component stays in a compressed state, and the pressure in that portion rises to act to push back the needle. As a result, the needle tip comes out of the vein, blood is pumped out of the blood vessel, and internal bleeding occurs. Further, even if the needle tip does not come out of the vein, the same state occurs when blood leaks from the gap between the needle and the blood vessel wall.

  In addition to the pain being noticed by the donor, the donor may feel a little uncomfortable, or the donor or operator may have noticed that the puncture site is swollen. There may be no. When such internal bleeding occurs, the skin may be swollen or discolored in appearance, and it may take a certain amount of time to recover, and may cause discomfort or anxiety to the donor.

  In general, when the donor feels pain or discomfort, blood return is interrupted, and when the donor accepts, the needle is removed, the needle is replaced, the needle is punctured again, and the remaining blood components are returned. However, if the donor does not agree, the blood return is stopped at that time, and the blood component that was scheduled to return is left in the circuit. In this case, since the donor has lost the blood component that could not be returned, it is necessary to leave a predetermined period until the next blood donation. In addition, when returning the remaining blood component, it is necessary to perform puncture again avoiding the site of internal bleeding, which may be unsatisfactory for the donor.

  In addition, even if the donor does not feel uncomfortable during the blood return, sufficient blood collection speed cannot be obtained during blood collection in the next cycle, and blood collection / return is stopped before the required amount of blood components is obtained. There are cases where it is necessary to do so.

  When returning blood, even if internal bleeding occurs, the donor may not be immediately aware of it and cannot take appropriate action immediately. There is a concern that gives a feeling of pleasure or anxiety.

  In order to detect such a state of internal bleeding, in Patent Document 1, a capacitive sensor or a resistance sensor or the like is fixed to the patient's skin at the puncture site, and a parameter that changes due to needle removal is detected. Propose that.

  In patent document 2, the touch sensor which consists of an electrode is provided with respect to a pair of right and left wing parts for fixing a needle | hook to a donor's skin, and it detects that the wing part separated from the patient.

  Japanese Patent Application Laid-Open No. H10-228688 proposes that a material with blood that bleeds well and is elastic, a band having a blood reservoir is wrapped around a patient's arm, and the blood that has oozed into the blood reservoir is detected by an optical sensor. The member that is attached to the skin like this band has been proposed to be white so that the color change due to blood becomes significant.

JP-T-2005-516637 JP 2006-110119 A JP 2007-20738 A

  In each of the above-mentioned patent documents, since the sensor is fixed at or near the puncture site of the patient, it is basically a disposable product, and the cost burden for the patient is large. Further, in Patent Document 1, when an obvious change due to a blood leak occurs, the leak can be detected, and a quicker detection before the occurrence of the obvious change is required.

  In Patent Document 2, only the displacement of the wing portion is detected, and internal bleeding when there is no displacement of the wing portion and the needle cannot be detected. Actually, the mechanism of internal bleeding due to puncture is a subtle phenomenon that has not yet been elucidated, and internal bleeding occurs even when the wing part and the needle are hardly displaced.

  In Patent Document 3, it is detected that blood has leaked out of the body, and internal bleeding cannot be detected.

  The present invention has been made in view of such problems, and an object thereof is to provide an internal bleeding detection device and a blood component collection device that can prevent or moderately suppress the occurrence of internal bleeding due to puncture. To do.

  An internal bleeding detection device according to the present invention includes an irradiation unit that irradiates a predetermined vicinity including a puncture position of a needle punctured by a donor, an imaging unit that images the vicinity over time, and the imaging unit And a control unit that determines that internal bleeding has occurred on the basis of at least one condition that blood is determined to be present in a region other than the veins on the image picked up in (1).

  In this way, by acquiring the image by capturing the reflected light of the puncture site irradiated with the near-infrared light by the irradiation unit and acquiring the image, it is possible to recognize the blood distribution that cannot be seen with the naked eye. Normally, blood flows through a vein, but when internal bleeding occurs, the range of the blood spreads, so it is possible to determine whether internal bleeding has occurred. Therefore, the occurrence of internal bleeding due to puncture can be prevented as much as possible, or can be moderately suppressed.

  The control unit may determine an area where the luminance in the image is lower than a predetermined threshold, and determine that blood exists in a region other than the vein by expanding the area by a predetermined amount. In this way, by obtaining the area of the portion below the predetermined threshold based on the luminance on the image, the blood distribution can be known, and blood in a region other than the vein can be detected.

  The control unit identifies a vein position from a location where the luminance in the image is lower than a predetermined threshold, and when a location where the luminance is lower than the predetermined threshold in a region other than the vein position occurs over a predetermined area, It may be determined that blood is present. In this way, once the vein position is specified, the presence or absence of blood may be examined at other locations.

  In this case, when the control unit is colored and displayed on the screen imaged by the imaging unit in a region other than the vein where the luminance is lower than a predetermined threshold, the location is easily recognized.

  The control unit may determine that blood is present in a region other than the vein based on a shape of a location where the luminance in the image is lower than a predetermined threshold. Since the vein is linear, blood in a region other than the vein can be detected when a portion whose luminance is lower than the predetermined threshold indicates a non-linear shape. Here, the shape is broad and can include position, size, and orientation.

  An analysis range extraction unit that extracts a predetermined analysis range with reference to the puncture position within the range of the image, and the control unit detects occurrence of internal bleeding based on the analysis range extracted by the analysis range extraction unit. You may judge. As described above, when the analysis range is extracted with reference to the puncture position and the analysis is limited to the analysis range, the processing load is reduced and more accurate determination can be made.

  The analysis range extraction unit may extract the analysis range by performing template matching on the image based on a template image including the shape of the needle. Thus, by performing template matching based on the template image, the analysis range can be extracted easily and accurately.

  The needle may have a pair of left and right wings for fixing to the donor's skin, and the template image may include the shape of the wings. The shape of the wing part is characteristic, and the analysis range can be extracted more accurately by using a template image including the shape.

  When a display means for continuously displaying images picked up by the image pickup means is provided, a medical worker can visually confirm the state of internal bleeding. The display means can also be used to select an appropriate vein when puncturing the needle.

  When the imaging unit and the irradiation unit are provided on the same tiltable body that can be tilted, the irradiation unit and the imaging unit can be directed in substantially the same direction.

  After separating blood collected from the donor, the blood component collection device collects a predetermined blood component and returns the remaining blood component to the donor, and has the internal bleeding detection device. An internal hemorrhage determination unit that determines whether internal hemorrhage has occurred may be provided in the blood return step of returning the remaining blood components.

  When the internal bleeding determining unit determines that internal bleeding has occurred, the blood return speed at that time may be maintained or reduced, or the blood return may be stopped.

  After separating blood collected from the donor, an operation of collecting a predetermined blood component and returning the remaining blood component to the donor is performed in a plurality of cycles, and the internal hemorrhage determination unit performs the blood return multiple times In the process, whether or not internal bleeding has occurred may be determined based on the image obtained in the cycle. As described above, in a plurality of blood return steps, if the determination is made based on the image obtained at that time, various data obtained in the previous time becomes unnecessary, and the processing becomes simple. Further, it is possible to make an accurate determination by using only the image of that time without being influenced by the previous images after a predetermined time has passed.

  A blood return line for returning the remaining blood components to the donor; a variable speed blood pump for delivering blood components to the blood return line; and a pressure sensor for detecting the pressure of the blood return line. When blood return is started by rotating, whether or not internal bleeding has occurred may be determined including a condition based on the fluctuation of the pressure detected by the pressure sensor. In a system including such a blood component collection device and an internal bleeding detection device, it is possible to appropriately respond based on the determination of whether internal bleeding has occurred in the blood return process. Further, more accurate determination is possible by making a combined determination including the pressure of the blood return line.

  According to the internal bleeding detection device of the present invention, the distribution of blood that is invisible to the naked eye is recognized by capturing the reflected light of the puncture site irradiated with near-infrared light by the irradiating means with the imaging means. Can do. Normally, blood flows through a vein, but when internal bleeding occurs, the range of the blood spreads, so it is possible to determine whether internal bleeding has occurred. Therefore, the occurrence of internal bleeding due to puncture can be prevented as much as possible, or can be moderately suppressed.

  Hereinafter, an internal bleeding detection device according to the present invention will be described with reference to FIGS.

  As shown in FIG. 1, the internal bleeding detection device 700 according to the present embodiment is used in connection with the blood component collection device 10. The blood component collection device 10 and the internal bleeding detection device 700 are linked by being connected by a connection line 701, and mutual information communication is possible in real time. Communication between the blood component collection device 10 and the internal bleeding detection device 700 may be independent communication between devices, whether wired or wireless, or may be a communication network such as a LAN. The internal bleeding detection device 700 is versatile and can be connected to, for example, an artificial dialysis device in addition to the blood component collection device 10.

  In the present application, the internal bleeding detection device 700 is connected to and integrated with the blood component collection device 10, but the internal bleeding detection device 700 may be used alone when collecting blood or the like. First, the blood component collection device 10 will be described.

  As shown in FIG. 1, the blood component collection device 10 includes a device main body 12 and a blood collection kit 14 attached to the device main body 12.

  As shown in FIG. 2, the apparatus main body 12 includes a box-shaped mechanism main body 15, first and second struts 16 a and 16 b that extend upward from the left and right sides of the mechanism main body 15, and a first strut 16 a. A weigh scale 18 provided on the left side of the upper end of the head, a monitor 20 provided on the upper end of the second support column, and a bag detection sensor 21 for detecting the presence or absence of the multi-chamber bag 126 provided on the right side of the first support column 16a. A sensor 23a for detecting the presence / absence of the sterilization filter 114 provided on the right side of the second support column 16b, and a sensor 23b for detecting the presence / absence of the bubble removal chamber 112 and the dripping of the anticoagulant. The monitor 20 is an input / output device of the blood component collection device 10 and has a large color touch panel 20a and a speaker 20b, and can be easily operated using images and sounds. The speaker 20b is a stereo type.

  The mechanism main body 15 includes a left control mechanism 22 and a right centrifugal mechanism (separation means) 24. The control mechanism unit 22 includes a control unit 26 that comprehensively controls the entire blood component collection device 10, a blood pump 28, an anticoagulant pump 30, a turbidity sensor 32, six bubble sensors 34a, 34b, 34c, 34d, 34e, 34f, seven clamps 36a, 36b, 36c, 36d, 36e, 36f, 36g, a donor pressure sensor 38, and a system pressure sensor 40. As the turbidity sensor 32 and the bubble sensors 34a to 34f, for example, an ultrasonic sensor, an optical sensor, an infrared sensor, or the like can be used. The turbidity sensor 32 and the bubble sensor 34d are integrally configured.

  The centrifuge mechanism 24 is a mechanism that is equipped with a centrifuge bowl (centrifuge) 120 of the blood collection kit 14 and centrifuges the blood introduced into the centrifuge bowl 120.

  The set rotation speed of the centrifuge bowl 120 is set to, for example, about 4200 to 5800 rpm. Thereby, the blood in the blood storage space is separated from the inner layer into a plasma layer (PPP layer), a buffy coat layer (BC layer), and a red blood cell layer (CRC layer). In the vicinity of the centrifuge bowl, an optical sensor (not shown) that detects the position of the interface from the transmittance that changes in accordance with the position of the interface between the plasma layer and the buffy coat layer (hereinafter simply referred to as the interface). Is provided.

  The control unit 26 is provided inside the mechanism main body unit 15. Devices other than the control unit 26 in the control mechanism unit 22 are provided on the upper surface, the front surface, and the support column so that the tube of the blood collection kit 14 can be attached.

  The blood pump 28 and the anticoagulant pump 30 are a roller pump type that pushes the blood inside by continuously rolling the roller against the side of the tube, and can be driven in a non-contact state with respect to the blood. is there. The blood pump 28 and the anticoagulant pump 30 are variable in speed and fluid discharge direction under the action of the control unit 26. The blood pump 28 functions as a suction pump that draws blood by rotating in a predetermined forward direction when blood is collected, and functions as a discharge pump that sends blood components to the tube 104 by rotating in the reverse direction when returning blood.

  The turbidity sensor 32 is a sensor that detects the turbidity of the liquid passing through the sandwiched tube. The bubble sensors 34a to 34f are sensors that detect the presence or absence of liquid passing through the sandwiched tube or bubbles. The clamps 36a to 36g press and close the sandwiched tube from both sides, or open and communicate with each other, and serve as an open / close valve. These clamps 36a to 36g are concentrated in one section on the upper surface of the control mechanism 22 so that the cassette housing 42 can be fitted. The cassette housing 42 is a resin member for integrating and arranging many portions of the tubes of the blood collection kit 14. The cassette housing 42 is fitted into the upper surface of the control mechanism unit 22 to correspond to a predetermined tube. The clamps 36a to 36g are arranged to be openable and closable.

  The donor pressure sensor 38 is a sensor for measuring a donor pressure Pd indicating a pressure of the blood collection / return line by inserting a part of a blood collection path system (blood collection / return line) 14a (see FIG. 4) in the blood collection kit 14. Yes, it acts as a pressure sensor for the blood collection line when collecting blood, and as a pressure sensor for the blood return line when returning blood.

  The system pressure sensor 40 is a sensor into which a part of the processing path system 14b (see FIG. 4) (blood processing circuit) is inserted and measures a system pressure (in-circuit pressure) Ps indicating a pressure in the circuit. In FIG. 1 and FIG. 2, a part of the tube of the blood collection kit 14 is omitted.

  As shown in FIG. 3, the control unit 26 includes a blood pump driver 76, an anticoagulant pump driver 78, a motor driver 80, and a clamp driver 82 for output. 30, the motor 64 and the clamps 36a to 36g are controlled. The blood pump driver 76 controls the speed and discharge direction of the blood pump 28. Anticoagulant pump driver 78 controls the speed of anticoagulant pump 30. The motor driver 80 controls the rotational speed of the motor 64. The clamp driver 82 individually controls the opening and closing of the clamps 36a to 36g.

  Further, the control unit 26 includes an input interface 84 that performs input control of each sensor and a monitor interface 86 that performs input and output of the monitor 20. Further, the control unit 26 cooperates with each functional unit to control the operation of the blood component collection process and the blood return process, and the abnormality monitoring that monitors the abnormality based on the input signal of each sensor. Based on the rotation speed of the blood pump 28, the storage unit 92 that stores a predetermined program and data, a timer 94, a communication unit 96 that performs data communication with an external device (such as the internal bleeding detection device 700), and the like. And a speed detection unit 98 for obtaining the blood collection speed and the blood return speed V.

  The mode control unit 88 includes a suction control unit 88a that performs control in the blood collection process (the first to third plasma collection processes in the present embodiment), and a discharge control unit 88b that performs control in the blood return process. The suction control unit 88a and the discharge control unit 88b include a function of controlling the rotation speed N of the blood pump 28 based on the donor pressure Pd.

  Some of the functions in the control unit 26 are realized by reading and executing a program recorded in the storage unit 92 by a CPU (not shown).

  As shown in FIG. 4, the blood collection kit 14 includes a blood collection path system 14a for collecting and returning blood from a donor, and a processing path system 14b for collecting the predetermined blood components by centrifuging the collected blood. Have.

  The blood collection path system 14a includes a hollow blood collection needle 100 for puncturing a donor, a tube 104 having one end connected to the blood collection needle 100 and the other end connected to the processing path system 14b via a branch joint 102, and the tube 104 A chamber 106 provided in the middle of the container, an anticoagulant container connecting needle 108 connected to an anticoagulant container 107 (see FIG. 2) containing an anticoagulant, and one end of the anticoagulant container connecting needle A tube 110 connected to 108, and a bubble removal chamber 112 and a sterilization filter (foreign matter removal filter) 114 provided in the middle of the tube 110. The tube 104 and the tube 110 are connected by a branch joint 116 provided near the blood collection needle 100. The blood collection needle 100 is provided with a pair of left and right wings 101 for fixing to the donor's skin.

  The tube 104 (and a tube 140 described later) is commonly used for blood collection and blood return, and acts as a blood collection line and a blood return line.

  The chamber 106 removes bubbles and microaggregates in the blood passing through the tube 104. A short tube 118 branched from the tube 104 is provided at one end of the chamber 106. The end of the tube 118 is connected to a breathable and bacteria-impermeable filter (not shown) and is inserted into the donor pressure sensor 38 so that the donor pressure Pd can be measured.

  The anticoagulant container 107 connected to the anticoagulant container connecting needle 108 stores an anticoagulant such as ACD-A solution. A part of the tube 110 is attached to the anticoagulant pump 30, and the anticoagulant supplied from the anticoagulant container connecting needle 108 under the action of the anticoagulant pump 30 is connected to the tube 110 and the branch joint 116. Thus, an anticoagulant is mixed in the blood in the tube 104. A bubble sensor 34 a is attached in the middle of the tube 110.

  A bubble sensor 34b and a clamp 36a are mounted between the chamber 106 and the branch joint 102. The clamp 36a is mounted in the vicinity of the branch joint 102, and the blood collection path system 14a and the processing path system 14b communicate with each other by opening the clamp 36a. Two bubble sensors 34e and 34f are attached to the tube 104 in series, and bubbles and air can be reliably detected.

  The processing path system 14b has a centrifuge bowl 120, a plasma collection bag 122, a platelet collection bag 124, an intermediate bag 126a, an air bag 126b, a bag 128, and a leukocyte removal filter 130.

  The plasma collection bag 122 and the platelet collection bag 124 are bags for storing plasma and platelets obtained by a process such as centrifugation. The plasma collection bag 122 is suspended on the hook 18a of the weighing scale 18 (see FIG. 2), and the weight of the stored plasma can be measured. The platelet collection bag 124 is suspended on the front surface of the mechanism main body 15 (see FIG. 2).

  The intermediate bag 126a is a container for temporarily storing collected platelets (concentrated platelets). The air bag 126b is a container for temporarily storing aseptic air in the circuit. The air bag 126b and the intermediate bag 126a are independent containers separated in terms of a circuit, but are physically integrated to form a multi-chamber bag 126. The multi-chamber bag 126 is suspended from the hook 21a of the bag detection sensor 21 (see FIG. 2).

  When blood is collected, the air in the blood storage space of the centrifuge bowl 120 is transferred and stored in the air bag 126b. In the blood return process, the air stored in the air bag 126b is returned to the blood storage space, and a predetermined blood component is returned to the donor.

  The bag 128 is a bag connected to the platelet collection bag 124 and is used when the air in the platelet collection bag 124 is discharged after the component blood collection is completed.

  The plasma collection bag 122, the platelet collection bag 124, the intermediate bag 126a, the air bag 126b, and the bag 128 are each laminated with a flexible sheet material made of resin (for example, soft polyvinyl chloride), and the peripheral portions thereof are fused. (Thermal fusion, high-frequency fusion, ultrasonic fusion, etc.) or a bag formed by bonding with an adhesive is used.

  In addition, as a sheet material used for the platelet collection bag 124, it is more preferable to use a material excellent in gas permeability in order to improve platelet storage stability. As such a sheet material, for example, polyolefin, DnDP plasticized polyvinyl chloride, or the like can be used.

  The leukocyte removal filter 130 is a filter that separates and removes leukocytes in the blood component when the blood component is transferred from the intermediate bag 126a to the platelet collection bag 124. As apparent from FIG. 2, the leukocyte removal filter 130 is disposed at a position lower than the intermediate bag 126 a and higher than the platelet collection bag 124.

  Next, tubes that connect each component device of the processing path system 14b will be described. A tube 140 is connected between the branch joint 102 which is the end of the processing path system 14 b and the inlet of the centrifuge bowl 120. A part of the tube 140 is attached to the blood pump 28. Therefore, by rotating the blood pump 28 forward, blood can be introduced into the centrifuge bowl 120 from the blood collection path system 14a, or a predetermined circulation operation can be performed in the processing path system 14b. Further, by reversing the blood pump 28, a predetermined blood component can be led out to the blood collection path system 14a and returned to the donor.

  A tube 142 is connected to the discharge port of the centrifuge bowl 120, and the tube 142 is branched into three branches via a branch joint 144 and connected to the tube 146, the tube 148, and the tube 150. The tube 142 is connected in series to the turbidity sensor 32 and the bubble sensor 34d.

  The tube 146 is connected to the air bag 126b, and is attached to the clamp 36e along the way. The end of the tube 148 is connected to a breathable and bacteria-impermeable filter (not shown) and is inserted into the system pressure sensor 40 so that the system pressure Ps can be measured.

  The end of the tube 150 is connected to the plasma collection bag 122, and a branch joint 152 is provided in the middle of the tube 150, and is connected to the intermediate bag 126 a via the tube 154. The tube 154 is attached to the clamp 36d. A tube 150 between the branch joint 152 and the plasma collection bag 122 is attached to the clamp 36c.

  The intermediate bag 126a and the platelet collection bag 124 are connected by a tube 156, and a leukocyte removal filter 130 is provided in the middle thereof. A tube 156 between the intermediate bag 126a and the platelet collection bag 124 is attached to the bubble sensor 34c and the clamp 36g. At the end of the leukocyte removal filter 130, a filter 160 branched from the tube 156 is provided. The filter 160 is composed of a bacteria-impermeable vent filter and a cap.

  A branch joint 162 is provided on the tube 156 between the bubble sensor 34c and the clamp 36g, and is connected to the plasma collection bag 122 via the tube 164. A branch joint 166 is provided in the middle of the tube 164. The branch joint 166 and the branch joint 102 are connected by a tube 168. A tube 164 between the branch joint 162 and the branch joint 166 is attached to the clamp 36f. A clamp 36 b is attached to the tube 168 in the vicinity of the branch joint 102.

  The platelet collection bag 124 and the bag 128 are connected by a tube 158.

  The blood collection kit 14 configured in this manner is subjected to a predetermined sterilization process in advance. The blood collection kit 14 is provided with a cassette housing 42 in which tubes are concentrated and a filter cassette 170 (see FIG. 2) that holds a part of the tubes and the filter 160.

  Next, main procedures for collecting blood components by the blood component collecting apparatus 10 will be described with reference to FIG.

  First, predetermined initial processing is performed in step S1 of FIG. As an initial process, the tube 110 and the blood collection needle 100 of the tube 104 to the chamber 106 are primed with an anticoagulant. Thereafter, an arm band (not shown) is attached to the upper arm of the donor, and a blood collection needle 100 is punctured into the blood vessel of the donor. The arm band is for tightening the upper arm of the donor and can be pressurized to a predetermined pressure by pneumatic means. Thereafter, the component blood collection process is started by operating the color touch panel 20a of the monitor 20. Subsequent procedures are automatically performed mainly under the action of the control unit 26.

  In step S2, a first plasma collection step is performed. The first plasma collection step is a step of collecting plasma obtained by introducing blood into the blood storage space of the centrifugal bowl 120 and centrifuging it into the plasma collection bag 122.

  At this time, the arm of the donor is pressurized with a predetermined pressure (for example, 50 mmHg) by the arm band. In the second and third plasma collection steps of steps S5 and S7, the upper arm of the donor is pressurized by the arm band as in step S2.

  Here, blood (blood added with an anticoagulant) is transferred through the tube 104 and introduced into the blood storage space of the rotor from the inlet of the centrifugal bowl 120. At this time, the air in the centrifuge bowl 120 is sent into the air bag 126b through the tube 142 and the tube 146.

  The rotation of the rotor of the centrifuge bowl 120 is started in a state where a predetermined amount of blood is introduced into the blood storage space. The rotational speed of the rotor is kept constant until step S9. By the rotation of the rotor, the blood introduced into the blood storage space is separated from the inside into three layers: a plasma layer, a buffy coat layer, and a red blood cell layer. In the second cycle and thereafter, the motor 64 is driven simultaneously with the blood pump 28.

  In step S3, the signal of the bubble sensor 34d provided in the tube 142 is monitored, and after detecting that the fluid flowing through the tube 142 has changed from air to plasma, the clamp 36e is closed and the clamp 36c is opened. When blood exceeding the capacity of the blood storage space is introduced into the blood storage space, the plasma flows out from the outlet of the centrifuge bowl 120. Therefore, this timing is detected by the bubble sensor 34d, and the clamping operation is performed. The plasma is switched to be introduced into and collected from the plasma collection bag 122 via 150. The weight of the plasma introduced into the plasma collection bag 122 is measured by the weigh scale 18. After confirming that a predetermined amount of plasma has been collected in the plasma collection bag 122 based on the weight signal obtained from the weigh scale 18, the process proceeds to step S4.

  In step S4, a constant-speed plasma circulation process is performed. The constant-speed plasma circulation step is a step of circulating the plasma in the plasma collection bag 122 at a constant speed in a circulation circuit including a blood storage space. That is, the clamp 36a is closed, the clamp 36b is opened, and the anticoagulant pump 30 is stopped. Thereby, while collecting blood temporarily, the path | route which circulates the plasma in the plasma collection bag 122 is formed. This circulation circuit reaches the blood storage space from the plasma collection bag 122 through the tubes 164, 168 and 140, and plasma flowing out from the discharge port of the centrifuge bowl 120 enters the plasma collection bag 122 through the tubes 142 and 150. It is a route to collect. After performing this constant-speed plasma circulation process for a predetermined time, the process proceeds to step S5.

  In step S5, a second plasma collection step is performed. In the second plasma collection step, plasma collection and centrifugation are performed in the same manner as in the first plasma collection step. As a result, the amount of red blood cells in the blood storage space increases, that is, as the layer thickness of the red blood cell layer increases, the interface gradually approaches the rotation axis of the centrifuge bowl 120, and therefore, based on the detection signal from the optical sensor 62. After confirming that the interface has reached a predetermined level, the process proceeds to step S6.

  In step S6, an accelerated plasma circulation process is performed. The accelerated plasma circulation step is a step of circulating the plasma in the plasma collection bag 122 in the circulation circuit while accelerating the plasma in the blood storage space. After the plasma circulation speed reaches the predetermined speed, the process proceeds to step S7.

  In step S7, a third plasma collection step is performed. In the third plasma collection step, plasma is collected in the same manner as in the first and second plasma collection steps. After confirming that a predetermined amount of plasma has been collected in the plasma collection bag 122, the process proceeds to step S8.

  In step S8, a platelet collecting step is performed. In the platelet collection step, the plasma in the plasma collection bag 122 is circulated while accelerating in the blood storage space at the first acceleration, and then changed to a second acceleration larger than the first acceleration. And circulate while accelerating the blood, allowing platelets to flow out of the blood storage space, and collecting (reserving) concentrated platelets in the intermediate bag 126a. After performing a predetermined operation in the platelet collecting step, the clamp 36e is opened, the other clamps 36a to 36d, 36f and 36g are closed, and the blood pump 28 is stopped.

  In step S9, the rotational speed of the motor 64 is controlled to decelerate and stop the rotor.

  In step S10, the blood return process is started. The blood return step is a step of returning blood components (mainly red blood cells and white blood cells) remaining in the blood storage space of the rotor to the donor. That is, the clamp 36a and the clamp 36e are opened, and the blood pump 28 is reversed. As a result, blood components remaining in the blood storage space of the rotor are discharged from the inlet of the centrifugal bowl 120 and returned (returned) to the donor via the tube 104 (blood collection needle 100). Details of the blood return process will be described later.

  Thereafter, the blood return process is terminated based on a predetermined termination condition.

  In step S11, it is confirmed whether or not the predetermined number of cycles has been completed. If it has not been completed, the process returns to step S2 to continue processing such as blood collection and blood return.

  In the final cycle, the filtration process is started in step S5. The filtration step is a step in which the concentrated platelets temporarily collected (stored) in the intermediate bag 126a are supplied to the leukocyte removal filter 130, and the concentrated platelets are filtered, that is, the leukocytes in the concentrated platelets are separated and removed. . Concentrated platelets from which white blood cells have been removed are stored in a platelet collection bag 124.

  At the start and end of step S9 (blood return process), information indicating the start and end of the process is supplied to the internal bleeding detection device 700 in real time.

  Next, a procedure for detecting internal bleeding performed by the blood component collecting apparatus 10 alone will be described with reference to FIG. In the blood component collection device 10, when the blood pump 28 is rotated to start returning blood, the presence or absence of internal bleeding is determined based on the condition based on the change in the donor pressure Pd detected by the donor pressure sensor 38. For internal hemorrhage, the first type of internal hemorrhage that may cause an uncomfortable feeling to the donor if the return of blood is continued as it is, and the donor does not give the uncomfortable feeling to the donor as it is. There is a second type of internal bleeding in which it is determined that there is a possibility that internal hemorrhage may occur, for example.

  In FIG. 6, graphs 510 and 512 indicated by broken lines are cases where it is determined that there is a possibility that internal bleeding that may cause the donor to feel uncomfortable (the first type of internal bleeding) is indicated by bold lines. The graph 526 does not give a great sense of incongruity to the donor as it is, but it is determined that there is a possibility that internal bleeding may occur due to the blood collection needle 100 being removed from the blood vessel of the donor (second type of internal bleeding). There are graphs 522 and 524 indicated by thin lines when there is no possibility of internal bleeding.

  In FIG. 6, vertical axes 530, 532, and 534 are lines that representatively indicate locations where the blood return speed V of the blood pump 28 reaches 50 mL / min, 60 mL / min, and 90 mL / min. Since the blood collection speed at the time of blood collection is defined as a positive value, the blood return speed V is expressed as a negative value.

  The blood component collection device 10 starts measuring the cumulative rotation speed A of the blood pump 28 and the donor pressure Pd at the start of the blood return process. The donor pressure Pd at the start of blood return is stored as the initial pressure P0.

When the cumulative rotational speed A is A <2.5, the pressure difference between the donor pressure Pd and the initial pressure P0 (hereinafter referred to as the donor pressure Pd ₀ ) and the blood return limiting pressure P _L1 (for example, P _L1 = 100 mmHg), and if Pd ₀ ≧ P _L1, it is determined that the first type of internal bleeding has occurred. When Pd ₀ <P _L1 , there is no occurrence of internal bleeding.

When the cumulative rotation speed A is A ≧ 2.5, the inclination value ΔP of the donor pressure Pd ₀ is compared with the inclination threshold value P _L2 (for example, P _L2 = 20 mmHg while the blood pump 28 rotates 0.5 times). If ΔP ≧ P _L2, it is determined that the second type of internal bleeding has occurred. When ΔP <P _L2 , there is no occurrence of internal bleeding.

Of course, the method for determining the presence or absence of internal bleeding based on the donor pressure Pd (or Pd ₀ ) is not limited to this.

  Next, the internal bleeding detection apparatus 700 according to the first embodiment will be described.

  As shown in FIG. 7, the internal bleeding detection device 700 is installed on an armrest 714 on which a donor arm 712 provided in a blood collection bed is placed. The internal hemorrhage detection device 700 includes a support column 716 that is connected to the side end of the armrest 714 and is erected, a table 718 that is provided above the column 716, and a monitor (display unit) 720 that is disposed on the upper surface of the table 718. Have The arm 712 placed on the armrest 714 may be either the right arm or the left arm.

  The armrest 714 has an appropriate length for placing a portion of the arm 712 ahead of the elbow 724, and the donor places the arm 712 on the armrest 714 with the palm side facing up. The base 718 is arranged at an appropriate height and protrudes above the armrest 714. The monitor 720 is, for example, in a liquid crystal format, and can be adjusted in an appropriate range (for example, ± 20 °) in the vertical and horizontal directions. The monitor 720 is a vertical type and can display the arm 712 over a long range. The monitor 720 may be omitted, and the monitor 20 (see FIG. 2) may be used instead.

  The internal bleeding detection device 700 further includes an imaging unit 726 provided on the lower surface of the table 718 and a control unit 728 provided inside the armrest 714. The control unit 728 may be integrated with the control unit 26 described above.

  The imaging unit 726 includes a tilting body 734 whose orientation can be adjusted, a near-infrared camera (imaging means) 736 and a plurality of near-infrared LEDs (irradiation means) 738 attached to the tilting body 734. Since the near-infrared camera 736 and the near-infrared LED 738 are provided on the same tilting body 734, both are directed in substantially the same direction even if the tilting direction is changed.

  Near-infrared LED 738 irradiates near-infrared rays to the puncture site of blood collection needle 100 and its vicinity on the opposite surface of elbow 724 in arm 712. Here, near-infrared light is light having a wavelength of 700 nm to 2500 nm. A plurality of near-infrared LEDs 738 are provided, and all of them may be light sources having a single wavelength, or light sources having a plurality of wavelengths may be combined.

  The near-infrared camera 736 continuously images portions of the arm 712 that are irradiated with near-infrared rays by the near-infrared LED 738. The captured image is supplied and displayed on the monitor 720 via the control unit 728. Examples of the near-infrared camera 736 include a CCD type or a CMOS type. The near infrared camera 736 may be provided with a zoom function, a sensitivity adjustment function, and the like.

  The direction of the tilting body 734 can be adjusted by, for example, a ball joint, and the direction of the near-infrared camera 736 and the near-infrared LED 738 can be changed according to the difference in the donor's arm 712. Since a plurality of near-infrared LEDs 738 are provided, it is possible to irradiate near-infrared rays over a reasonably wide range. Since the direction of the near-infrared camera 736 is adjusted integrally with the near-infrared LED 738, the near-infrared LED 738 can capture a range irradiated with the near-infrared ray. Since the imaging unit 726 is provided on the lower surface of the base 718 protruding above the arm 712, the near-infrared LED 738 can easily irradiate near-infrared light to the arm 712 and can be easily imaged by the near-infrared camera 736. .

  By the way, as shown in FIG. 8, many veins 740 exist in the shallow location near the skin. The hemoglobin in the red blood cells flowing in the vein 740 has a large amount of reduced hemoglobin that has lost oxygen. Since reduced hemoglobin has a property of absorbing near-infrared light, when the near-infrared LED 738 is irradiated with near-infrared light on the arm 712, only the portion where the vein 740 exists is less reflected and darkened on the image by the near-infrared camera 736. 740 images can be captured. In FIG. 8, a solid line arrow indicates a moderately strong near infrared ray, and a broken line arrow indicates a near infrared ray whose energy is attenuated.

  As illustrated in FIG. 9, the control unit 728 includes an image determination unit 750 and a communication unit 754 that are connected to each other via a bus. The communication unit 754 is connected to the communication unit 96 of the blood component collection device 10 via a connection line 701, and mutual information communication is possible in real time.

  The shadow image determination unit 750 displays a shadow image obtained from the near-infrared camera 736 on the monitor 720 and controls lighting of the near-infrared LED 738. The image determination unit 750 can perform various image processing on the image obtained from the near-infrared camera 736. For example, the image determination processing, density enhancement processing, and predetermined information imposition processing can be performed. it can.

  The image determination unit 750 further includes an analysis range extraction unit 760 and an internal bleeding determination unit 762. The analysis range extraction unit 760 performs template matching processing using a template image 764 recorded in advance, and within a range of the image obtained from the near infrared camera 736, a predetermined analysis range 722 based on the puncture position (FIG. 11). Reference) is extracted. The template image 764 is image data including the shapes of the blood collection needle 100 and the pair of left and right wings 101, and is obtained, for example, by photographing the actual blood collection needle 100.

  The internal bleeding determination unit 762 determines the presence or absence of internal bleeding for the analysis range extracted by the analysis range extraction unit 760, and notifies the control unit 26 of the blood component collection device 10 via the communication unit 754.

  The internal bleeding detection device 700 can be used with the near-infrared LED 738 and the near-infrared camera 736 removed (for example, with the entire imaging unit 726 removed). For infants and patients who cannot move, the near-infrared LED 738 and the near-infrared LED 738 are used. The camera 736 can be removed and used in close proximity to the patient's arm 712 to confirm (select) the appropriate vein 740.

  Next, the operation of the internal bleeding detection apparatus 700 configured as described above will be described with reference to FIG.

  In step S101 of FIG. 10, when the internal bleeding detection device 700 is activated, the near-infrared LED 738 is turned on to irradiate the arm 712 with near-infrared light, and the near-infrared camera 736 continuously (temporally) captures the location. The captured image is displayed on the monitor 720 via the control unit 728. At this time, depending on the environment and time zone in which the internal bleeding detection device 700 is installed, the brightness of the image displayed on the monitor 720 is affected by the sunlight entering through the window glass and the light quantity of the fluorescent lamp. If necessary, the amount of light of the near-infrared LED 738 is adjusted.

  The light amount may be adjusted manually by visually checking the monitor 720, or by measuring the light amount of the near-infrared irradiation portion or a corresponding portion with a predetermined sensor and matching the measured value. A light amount adjusting means for adjusting the light amount of the near infrared LED 738 may be provided to automatically adjust the light amount.

  Thereafter, irradiation by the near-infrared LED 738, imaging by the near-infrared camera 736, and display on the monitor 720 are continued until the processing shown in FIG.

  At this point, while checking the vein 740 of the donor's arm 712 on the monitor 720, the medical staff selects the vein 740 suitable for puncturing the blood collection needle 100, and the blood collection needle is selected in the selected vein 740. Puncture 100. The blood collection needle 100 fixes the wing 101 to the donor's skin after puncturing. For example, a transparent tape may be used to fix the wing 101 to the skin.

  Furthermore, after that, the blood component collection device 10 is activated to start collection of blood components. As described above, this collection processing includes a blood collection step (steps S2, S5 and S7) for collecting blood from a donor, a separation collection step (steps S4, S6 and S8) for separating the collected blood and collecting predetermined blood components. And a blood return step (step SS10) for returning the remaining blood components to the donor.

  In step S102, information obtained from the blood component collection device 10 is monitored to check whether or not the blood component collection device 10 has started the blood return process. If a blood return process is started, it will move to step S103 and will wait if it is before a start. Considering an appropriate margin time, the process may proceed to step S103 at a time slightly before the start of the blood return process.

  In step S103, an image obtained from the near-infrared camera 736 is recorded in a predetermined recording unit as an initial image 770 (see FIG. 11).

  In step S104, as shown in FIG. 11, based on the template image 764, template matching is performed on the initial image 770, and an analysis range 772 is extracted. That is, on the initial image 770, the template image 764 is sequentially moved in the vertical and horizontal directions for each minute distance, the bit is compared within the moved range, and the portion having the highest degree of matching is extracted as the analysis range 772. To do. Since the direction in which the blood collection needle 100 is punctured is generally constant, it is easy to perform template matching. Since the near-infrared camera 736 is supported by the stand 718, the height is constant, and the blood collection needle 100 is imaged to a constant size, and template matching is easy to perform.

  If the degree of matching is low, template matching may be performed again after the template image 764 is inclined by a minute angle. The obtained analysis range 772 is recorded in a predetermined recording unit. The analysis range 772 does not need to be the same size as the template image 764. For example, only the upper half 772a including the needle tip portion 100a may be used.

  Thus, by performing template matching based on the template image 764, the analysis range 772 can be extracted easily and accurately. The shape of the wing 101 is characteristic, and by using the template image 764 including the shape, the analysis range 772 can be extracted more accurately, and the movement of the donor arm 712 is allowed to some extent during blood return. Is done. By performing the analysis only within the analysis range 772, the influence of the background 778 other than the arm 712 can be eliminated.

  Template matching may be performed using a predetermined software tool. Means other than template matching may be used to extract the analysis range 772.

  In step S105, an image obtained from the near-infrared camera 736 is recorded in a predetermined recording unit as a comparative image 774 (see FIG. 12).

  In step S106, as shown in FIG. 12, based on the template image 764, template matching is performed on the comparison image 774, and an analysis range 776 is extracted. This procedure is the same as the template matching in step S104. The obtained analysis range 776 is recorded in a predetermined recording unit. In FIG. 12, reference numeral 766 indicates an internal bleeding site. If the internal bleeding part 766 is colored in red, for example, and displayed on the monitor 720, the part can be easily recognized.

  In step S107, the analysis range 772 and the analysis range 776 are compared to determine whether blood is present in a region other than the vein 740. This determination method will be described later.

  In step S <b> 108, the control unit 26 of the blood component collection device 10 is notified via the communication unit 754 of the determination disconnection result as to whether blood is present in a region other than the vein 740.

  In step S109, the information obtained from the control unit 26 is monitored to check whether or not the blood component collection device 10 has completed the blood return process. When the blood return process is completed, the process proceeds to step S110, and when it is being executed, the process returns to step S105.

  In step S110, information obtained from the blood component collection device 10 is monitored to check whether or not all the steps of blood component collection have been completed. When all the processes are completed, the process shown in FIG. 10 is terminated. If all processes are not completed, the process returns to step S102 and waits until the next blood return process starts.

  Next, three example procedures for determining whether blood is present in a region other than the vein 740 in step S107 will be described. Three example procedures may be applied in combination. First, a first procedure example for determining whether blood is present in a region other than the vein 740 will be described.

  In step S201 of FIG. 13, the areas A1 and A2 of the areas where the luminance in the analysis range 772 in the initial image 770 and the analysis range 776 in the comparison image 774 are lower than the predetermined threshold (the area ratio to the analysis ranges 774 and 776 is substantially the same. Each). On each image, it can be determined that a portion where the luminance is lower than the predetermined threshold is a portion where blood is present under the skin. This predetermined threshold value may be adjusted by a change in ambient brightness or the like.

  The areas A1 and A2 are basically determined by determining the brightness for each bit. However, the brightness of the surrounding bits is also referred to, and the brightness of the surroundings can be reduced even when the brightness of a predetermined bit is small. When it is large, the bit may be judged as noise (see reference numeral 780 in FIG. 12) and ignored. In addition, a predetermined filter, interpolation processing, or the like may be performed in order to accurately obtain the areas A1 and A2.

  In step S202, it is checked whether or not the area A2 has expanded by a predetermined amount T or more with respect to the area A1. That is, it is confirmed whether A2-A1> T. Here, the area A1 corresponds to the area where the vein 740 exists, and the area A2-area A1 is the place where blood leaking from the vein 740 exists (that is, the internal bleeding point 766 in FIG. 12). Is equivalent to the area. The predetermined amount T is an appropriate numerical value for preventing erroneous determination due to noise or the like. If the condition is satisfied, the process proceeds to step S203. If the condition is not satisfied, the process proceeds to step S204. The predetermined amount T as the threshold value is not fixed and may be adjusted by a change in ambient brightness or the like.

  In step S203, it is determined that internal bleeding has occurred, and in step S204, it is determined that no internal bleeding has occurred.

  As described above, by obtaining the areas A1 and A2 at locations below the predetermined threshold based on the luminance on the image, the blood distribution can be found, and by obtaining the difference between them, blood in a region other than the vein 740 can be detected.

  Since internal bleeding is considered to occur on the basis of the portion of the needle tip portion 100a, the determination may be made by weighting according to the distance from the needle tip portion 100a. That is, the fact that the location close to the needle tip portion 100a has changed is highly likely that internal bleeding has occurred. Since it is unlikely that internal bleeding has occurred, it is better to make a comparative weighting with a small weight. Note that extracting the analysis ranges 772 and 776 from the initial image 770 and the comparison image 774 and performing the analysis is a kind of weighting process itself.

  Next, a second procedure example for determining whether or not blood exists in a region other than the vein 740 will be described.

  In step S301 of FIG. 14, the position of the vein 740 is specified from the location where the luminance is lower than the predetermined threshold in the analysis range 772 in the initial image 770. The specified position of the vein 740 is recorded in bit units.

  In step S302, the area A3 of the portion where the luminance is lower than the predetermined threshold is obtained for the portion where the vein 740 does not exist (that is, the portion other than the portion recorded in step S301) in the analysis range 776 in the comparison image 774. This area A3 corresponds to the area where the blood leaking from the vein 740 exists. The area A3 is colored and displayed on the monitor 720.

  In step S303, the area A3 is compared with the predetermined amount T. If A3> T, the process proceeds to step S304, and if the condition is not satisfied, the process proceeds to step S305.

  In step S304, it is determined that internal bleeding has occurred, and in step S305, it is determined that internal bleeding has not occurred.

  In this way, if the position of the vein 740 is specified in advance, it is only necessary to check the presence or absence of blood at other locations thereafter, the processing load is reduced, and more accurate determination is possible.

  Next, a third procedure example for determining whether blood exists in a region other than the vein 740 will be described. In the third procedure example, the determination is performed based on the shape (which may include the position, size, and orientation) of the portion where the luminance in the analysis range 776 in the comparison image 774 is lower than the predetermined threshold.

  In step S401 of FIG. 15, as shown in FIG. 16, a template image 782 having a round shape (or an ellipse, a fan shape, etc.) is moved every minute distance within the analysis range 776 to perform template matching. The template matching may be limited to a location with reference to the needle tip portion 100a. If the internal bleeding portion 766 is substantially circular, it can be easily understood that the degree of matching with the internal bleeding portion 766 is considerably high when the template image 782 having a circular shape is arranged on the needle tip portion 100a.

  In step S402, as a result of the template matching described above, it is checked whether or not there is a location where the degree of matching with the template image 782 is equal to or greater than a predetermined value. If it exists, the process proceeds to step S403.

  In step S403, it is determined that internal bleeding has occurred, and in step S404, it is determined that no internal bleeding has occurred.

  As a determination based on the shape, in addition to this, the shape of the portion where the luminance in the analysis range 776 is lower than the predetermined threshold is examined, and the shape is not in the direction in which the arm 712 extends, that is, the vertical line in FIG. It may be determined that internal bleeding has occurred (for example, when the lateral width in FIG. 16 is greater than a predetermined value). That is, the vein 740 is generally linear in the direction in which the arm 712 extends, so that blood in a region other than the vein 740 can be detected when a portion where the luminance is lower than the predetermined threshold indicates a non-linear shape.

  Although the initial image 770 is not used in the third procedure example, it is a matter of course that a more accurate determination can be made by comparing the image with the comparative image 774.

  Next, in the blood component collection device 10, two procedures for controlling the blood pump 28 in the blood return process (step S10 in FIG. 5) will be described with reference to information on the presence or absence of internal bleeding obtained from the internal bleeding detection device 700. . The following processing is performed based on the cumulative rotational speed A, for example, every A = 0.25 revolutions. The donor pressure Pd is also measured every A = 0.25 revolutions. These processes performed by the control unit 26 may be performed based on, for example, the elapsed time from the start of blood return in addition to the cumulative rotation speed A. First, the first procedure will be described.

In step S501 of FIG. 17, step in the donor pressure Pd ₀ and blood return limit pressure P _L1 comparing (see FIG. 6), when a Pd ₀ ≧ P _L1 (if the first type of internal bleeding occurs) The process moves to S503, and if Pd ₀ <P _L1 , the process moves to Step S502.

  In step S502, the information obtained from the internal bleeding detection device 700 is confirmed, and if it is determined that internal bleeding has occurred as a result of analysis of the infrared image, the process proceeds to step S503, where it is determined that no internal bleeding has occurred. If YES, step S504 follows.

  In step S503, a predetermined pump stop process is performed. That is, the rotation of the blood pump 28 is stopped, and a predetermined preparation process for ending or restarting the blood return process is performed.

  In step S504, the value of the accumulated rotational speed A is confirmed. If A ≧ 2.5, the process proceeds to step S505, and if A <2.5, the process returns to step S501.

In step S505 of FIG. 18, compares the gradient value [Delta] P of the donor pressure Pd ₀ and tilt threshold P _L2, moves to step S506 if it is [Delta] P ≧ P _L2 (if the second type of bleeding occurs) , ΔP <P _L2 , the process proceeds to step S508.

  In step S506, as in step S502, the information obtained from the internal bleeding detection device 700 is confirmed. If it is determined that internal bleeding has occurred, the process proceeds to step S507, and there is no occurrence of internal bleeding. When it determines, it moves to step S509.

  In step S507, a pump stop process similar to that in step S503 is performed.

  In step S508, as in step S502, the information obtained from the internal bleeding detection device 700 is confirmed. If it is determined that internal bleeding has occurred, the process proceeds to step S509, and there is no occurrence of internal bleeding. When it determines, it moves to step S511.

  In step S509, the number of times that the internal bleeding alleviation process (step S510) has been continuously executed is determined with reference to a predetermined counter value. When the internal bleeding mitigation process is continuously executed X times, the process proceeds to step S507, and when it is less than X times, the process proceeds to step S510.

  In step S510, internal bleeding relief processing is performed. For example, the rotational speed of the blood pump 28 is maintained, decelerated, or rotational acceleration is decreased. In other words, the relaxation processing maintains the blood return speed or maintains the speed or reduces the acceleration when the blood return speed is accelerating. Thereafter, the process returns to step S505.

In the step S510, the judgment of bleeding based on the slope value ΔP donor pressure Pd ₀ (step S505), either only one of the conditions of the determination of hemorrhage due to the infrared image of the bleeding detecting device 700 (step S506, S508) is satisfied However, since the other condition is not established, the degree of internal bleeding is light, and by performing appropriate relaxation processing, the internal bleeding may be reduced and the blood return process may be continued. On the other hand, if the improvement is not improved even if the relaxation process is continuously executed X times, the process proceeds to step S507 by the condition determination in step S509, and the pump stop process is performed.

  In step S511, it is confirmed whether or not the mitigation process in step S510 is being executed. When it is being executed, the process proceeds to step S512, and when it is being stopped, the process proceeds to step S513.

  In step S512, the relaxation process is stopped. That is, the rotational speed or rotational acceleration of the blood pump 28 is returned to a predetermined specified value, and a counter indicating the number of executions of the relaxation process is initialized. As a result, the blood return process returns to the prescribed state, and quick blood return is possible. The rotational speed and rotational acceleration of the blood pump 28 may be gradually returned to the specified values. Thereafter, the process proceeds to step S513.

  In step S513, whether or not the blood return process is completed is confirmed based on the value of the cumulative rotation speed A. If the blood return process is not completed, the process returns to step S505.

  As shown in FIGS. 19 and 20, in the second procedure for controlling the blood pump 28 in the blood return process, steps S601 to S613 are performed in steps S501 to S501 in the first procedure (see FIGS. 17 and 18). This corresponds to S513, and the branch destination of the condition determination in step S608 is different.

  That is, in step S608, the information obtained from the internal bleeding detection device 700 is confirmed. If it is determined that internal bleeding has occurred as a result of analysis of the infrared image, the process proceeds to step S607 (pump stop processing), and internal bleeding is detected. If it is determined that there is no occurrence, the process proceeds to step S611.

In this second procedure, the determination of internal bleeding based on the slope value ΔP of the donor pressure Pd ₀ (step S605) and the determination of internal bleeding based on the infrared image of the internal bleeding detection device 700 (step S608) are not handled in the same row. It is highly probable that internal bleeding has actually spread, and it is possible to respond more quickly by preferentially judging the conditions.

  Next, an internal bleeding detection apparatus 800 according to the second embodiment will be described.

  Note that differences from the internal bleeding detection device 700 according to the first embodiment will be mainly described, and description of the common points will be simplified.

  The internal bleeding detection device 800 is connected to and integrated with the blood component collection device 10 by a connection line 701. However, the internal bleeding detection device 800 may be used alone when collecting blood or the like.

  As shown in FIG. 21A, the internal bleeding detection device 800 is an arm insertion type (arm-in type), and has a cylindrical armband portion 810, an armrest 814, an imaging unit 826, a monitor (display means) 820, And a control unit 828.

  The arm band 810 corresponds to the arm band of the blood component collection device 10 and is accommodated in the housing 811. The imaging unit 826, the monitor 820, and the control unit 828 correspond to the imaging unit 726, the monitor 720, and the control unit 728 of the internal bleeding detection device 700.

  The upper arm of the donor is pushed into the armband portion 810, and a portion ahead of the donor's elbow is placed on the armrest 814. The arm band portion 810 has an appropriate inner diameter for inserting the upper arm of the donor, and the armrest 814 has a concave shape so that the donor arm can be easily placed. It is almost fixed with. An annular pressurizing body is provided on the inner peripheral portion of the armband portion 810, and in the blood collection process (the first to third plasma collection processes of steps S2, S5, and S7), the upper arm of the donor is pressed at a predetermined pressure. Can be pressurized (tightened).

  A near-infrared camera 836 and a plurality of near-infrared LEDs 838 are provided on the lower surface of the distal end of the imaging unit 826, and images can be taken by irradiating the donor's arm with near-infrared rays. An image captured by the near-infrared camera 836 is displayed on the monitor 820. The imaging unit 826 can tilt in the vertical direction (that is, the tilt direction) with the base end as a reference, and can adjust the near-infrared irradiation position and imaging position of the donor's arm.

  The monitor 820 is provided on the upper surface of the armband 810, and is directed in the direction opposite to the donor, that is, in the direction of the medical staff. The monitor 820 may be tiltable within an excessive range.

  As shown in FIG. 21B, the armrest 814 is connected to one side of the housing 811 so as to be tiltable with respect to the lower end of the surface 812, and can be folded so as to be in contact with the surface 812.

  Further, the imaging unit 826 can be folded so as to be substantially contained in the recess 813 on the upper surface of the housing 811. When the imaging unit 826 is tilted down, the near-infrared camera 836 and the near-infrared LED 838 at the tip are arranged at a position ahead of the surface 812. The near-infrared camera 836 and the near-infrared LED 838 are housed in the recess 815 at the tip of the armrest 814 by folding the armrest 814. Thus, the internal bleeding detection device 800 can be folded compactly and is convenient for movement and storage when not in use.

  As described above, in the internal bleeding detection devices 700 and 800 and the blood component collection device 10 according to the present embodiment, the reflected light of the puncture site irradiated with the near-infrared light by the infrared LED 738 is captured by the near-infrared camera 736. By acquiring, it is possible to recognize the distribution of blood that cannot be seen with the naked eye. Normally, blood flows through a vein, but the range is expanded when internal bleeding occurs. Therefore, it is possible to determine the presence or absence of internal bleeding even if the blood collection needle 100 and the wing 101 are not displaced. Therefore, the occurrence of internal bleeding due to puncture can be prevented as much as possible, or can be moderately suppressed. The internal hemorrhage detection device 700 basically has no disposal product, can be used repeatedly, and is economical.

In the blood component collection device 10, more accurate determination can be made by determining whether or not there is internal bleeding in combination with the donor pressure Pd (or Pd ₀ ).

  Of course, the internal bleeding detection device and the blood component collection device according to the present invention are not limited to the above-described embodiments, and various configurations can be adopted without departing from the gist of the present invention.

It is a perspective view of the blood component collection device concerning this embodiment. It is a perspective view of a blood component collection device. It is a block block diagram of a blood component collection device. It is a circuit diagram of a blood collection kit. It is a flowchart which shows the procedure of the component blood collection performed with the blood component collection device. It is a graph which shows the change of the donor pressure in the blood return process, and the blood return speed. It is a perspective view of the internal bleeding detection apparatus which concerns on 1st Embodiment. It is explanatory drawing which shows the mode of reflection of near infrared rays with respect to a vein, and absorption. It is a block block diagram of an internal bleeding detection apparatus. It is a flowchart which shows the operation | movement procedure of an internal bleeding detection apparatus. It is an initial image obtained from a near-infrared camera. It is a comparative image obtained from a near-infrared camera. It is a flowchart which shows the 1st procedure which determines whether blood exists in area | regions other than a vein. It is a flowchart which shows the 2nd procedure which determines whether blood exists in area | regions other than a vein. It is a flowchart which shows the 3rd procedure which determines whether blood exists in area | regions other than a vein. It is a figure which shows a mode that an internal bleeding location is investigated by template matching in the analysis range. It is a flowchart (the 1) which shows the 1st procedure which controls a blood pump in a blood return process. It is a flowchart (the 2) which shows the 1st procedure which controls a blood pump in a blood return process. It is a flowchart (the 1) which shows the 2nd procedure which controls a blood pump in a blood return process. It is a flowchart (the 2) which shows the 2nd procedure which controls a blood pump in a blood return process. FIG. 21A is a perspective view of a vein display device according to the second embodiment, and FIG. 21B is a perspective view of the vein display device according to the second embodiment in a folded state.

Explanation of symbols

DESCRIPTION OF SYMBOLS 10 ... Blood component collection apparatus 12 ... Apparatus main body 26,728 ... Control part 96,754 ... Communication part 100 ... Blood collection needle 100a ... Needle tip part 101 ... Wing part 700,800 ... Internal bleeding detection apparatus 701 ... Connection line 712 ... Arm 714 ... armrests 726, 826 ... imaging unit 736 ... near infrared camera (imaging means) 738 ... infrared LED (irradiation means)
740 ... Veins 750 ... Image determination unit 760 ... Analysis range extraction unit 762 ... Internal bleeding determination units 764, 782 ... Template image 766 ... Internal bleeding site 770 ... Initial image 772, 776 ... Analysis range 774 ... Comparison image

Claims (13)

Irradiation means for irradiating near infrared rays to a predetermined vicinity including a puncture position of a needle punctured by a donor;
Imaging means for imaging the vicinity in time,
A control unit that determines that internal bleeding has occurred on at least one condition that blood is determined to be present in a region other than a vein on the image captured by the imaging unit;
I have a,
Wherein the control unit obtains an area of a portion brightness in the image is below a predetermined threshold value, by which the area is expanded a predetermined amount, hemorrhage detection device characterized that you determined blood is present in the region other than the vein . Irradiation means for irradiating near infrared rays to a predetermined vicinity including a puncture position of a needle punctured by a donor;
Imaging means for imaging the vicinity in time,
A control unit that determines that internal bleeding has occurred on at least one condition that blood is determined to be present in a region other than a vein on the image captured by the imaging unit;
Have
The control unit identifies a vein position from a location where the luminance in the image is lower than a predetermined threshold, and when a location where the luminance is lower than the predetermined threshold in a region other than the vein position occurs over a predetermined area, A device for detecting internal bleeding, wherein it is determined that blood is present. In the internal bleeding detection device according to claim 2 ,
The internal bleeding detection device, wherein the control unit displays a colored portion on a screen imaged by the imaging unit in a region other than the vein where the luminance is lower than a predetermined threshold value. Irradiation means for irradiating near infrared rays to a predetermined vicinity including a puncture position of a needle punctured by a donor;
Imaging means for imaging the vicinity in time,
A control unit that determines that internal bleeding has occurred on at least one condition that blood is determined to be present in a region other than a vein on the image captured by the imaging unit;
Have
The internal bleeding detection device, wherein the control unit determines that blood is present in a region other than a vein based on a shape of a location where the luminance in the image is lower than a predetermined threshold. In the internal bleeding detection device according to any one of claims 1 to 4 ,
An analysis range extracting means for extracting a predetermined analysis range with reference to the puncture position within the range of the image;
Wherein, bleeding detecting apparatus characterized by determining the hemorrhage has occurred based on the analysis range extracted by the analysis range extracting means. In the internal bleeding detection device according to claim 5 ,
The internal bleeding detection device, wherein the analysis range extraction unit performs template matching on the image based on a template image including the shape of the needle and extracts the analysis range. The internal hemorrhage detection device according to claim 6 ,
The needle has a pair of left and right wings for fixing to the donor's skin;
The internal bleeding detection apparatus, wherein the template image includes a shape of the wing portion. In the internal bleeding detection device according to any one of claims 1 to 7 ,
An internal hemorrhage detection apparatus comprising display means for continuously displaying images taken by the imaging means. In the internal bleeding detection device according to any one of claims 1 to 8 ,
The internal bleeding detection device, wherein the imaging unit and the irradiation unit are provided on the same tiltable body that can tilt. After separating blood collected from a donor, a predetermined blood component is collected, and in the blood component collection device for returning the remaining blood component to the donor,
The internal bleeding detection device according to any one of claims 1 to 9 ,
The blood component collection apparatus, wherein the control unit includes an internal bleeding determination unit that determines whether or not internal bleeding has occurred during a blood return step of returning the remaining blood components to the donor. The blood component collection device according to claim 10 ,
A blood component collection device characterized in that when the internal bleeding determination unit determines that internal bleeding has occurred, the blood return speed at that time is maintained or slowed, or the blood return is stopped. The blood component collection device according to claim 10 or 11 ,
After separating blood collected from the donor, the operation of collecting a predetermined blood component and returning the remaining blood component to the donor is performed in multiple cycles,
The internal bleeding determining unit determines whether or not internal bleeding has occurred in a plurality of blood return steps based on images obtained in that cycle. In the blood component collection device according to any one of claims 10 to 12 ,
A return line that returns the remaining blood components to the donor,
A variable speed blood pump for delivering blood components to the return line;
A pressure sensor for detecting the pressure of the blood return line;
Have
Blood component collection, characterized by determining whether or not internal bleeding has occurred, including conditions based on fluctuations in the pressure detected by the pressure sensor when the blood pump is rotated to start returning blood apparatus.

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