Blood collection device, blood collection method, and blood collection system

Abstract

The present invention provides a blood collection device, a blood collection method, and a blood collection system with which it is possible to accurately measure, in real time, the volume of blood collected in a blood collection tube from a puncture site where a puncture needle has been inserted into a blood collection subject, regardless of the type of the blood collection tube. This blood collection device comprises: a blood collection unit that collects blood in a blood collection tube; an imaging unit that captures an image of the blood collection tube; and a calculation unit that calculates the rate of increase in volume of the blood in the blood collection tube. The imaging unit takes an image of the blood collection tube and acquires the image. The calculation unit executes a processing for integrating the pixel values of pixels constituting a pixel row, a processing for determining the liquid level height of the blood on the basis of the integrated value, and a processing for determining the rate of increase on the basis of the liquid level height. This blood collection method includes: a step for inserting a puncture needle; and a step for collecting blood in a blood collection tube. In the method, the blood collection tube is imaged to acquire an image, the pixel values of pixels constituting a pixel row are integrated, the liquid level height of the blood is determined on the basis of the integrated value, and the rate of increase is determined on the basis of the liquid level height. This blood collection system is configured such that a management server manages blood volume data.

Description

Blood collection device, blood collection method, and blood collection system

[0001] The present invention relates to a blood collection device, a blood collection method, and a blood collection system for automatically collecting blood from a subject.

[0002] In general hospitals and other facilities, many blood samples are taken every day for pre-examination testing. Medical staff involved in blood collection are required not only to collect blood but also to perform other tasks and duties associated with blood collection, such as preparing and checking blood collection tubes. Blood collection involves a wide variety of complicated tasks and duties, placing a heavy burden on staff, so it is desirable to automate the process as much as possible.

[0003] Blood collection devices that automatically collect blood from the fingers of a person to be collected have been developed. Some blood collection devices have a structure in which the person's fingers are placed in a designated finger rest, a puncture needle is automatically inserted into the finger, and blood flowing out from the puncture site is collected in a blood collection tube. In this type of blood collection device, the puncture needle that punctures the finger and the blood collection tube that collects blood are controlled in position relative to the finger placed in the finger rest, and the puncture with the puncture needle and the collection of blood from the puncture site are automatically performed.

[0004] The amount of blood required for a blood test varies depending on the test item. Therefore, blood collection devices are required to have the function of measuring the amount of blood collected from the puncture site into a blood collection tube. The amount of blood collected into a blood collection tube can be determined by utilizing the correlation between the liquid level of the blood collected in the blood collection tube and the amount of blood in the blood collection tube. One method for determining the liquid level of the blood collected in a blood collection tube is an optical method that measures the attenuation of transmitted light by the blood collected in the blood collection tube.

[0005] Patent Document 1 describes a sample analyzer that estimates the amount of each component in blood separated into serum and clot in a sample container. This device is equipped with a surface light source that irradiates infrared light and a line sensor that detects the transmitted light that passes through the sample container. Two types of infrared light with different light intensities are projected, and intensity profiles of the two types of transmitted light are extracted. The position of the liquid level in the sample container is determined by calculating the first derivative of the profile.

[0006] Patent Document 2 describes a method for detecting an interface in a container that includes an upper layer containing serum or plasma and a lower layer containing cells. In this method, two types of detection light beams with different wavelengths are projected and the two types of detection light beams that have passed through the container are detected. The position of the interface in the container is determined by detecting the detection light beams as a function of position.

[0007] Patent No. 3778355 Patent No. 4225915

[0008] Blood collection devices that automatically collect blood from subjects are required to measure with high accuracy the amount of blood collected from the puncture site into a collection tube. The amount of blood required for blood tests varies depending on the test item, but because blood collection is a significant burden, it is desirable to collect just the necessary amount, neither too much nor too little. Furthermore, since a long blood collection time can lead to contamination with tissue fluid and progress in blood coagulation, it is desirable to complete blood collection within a specified time. If there is strong bleeding from the puncture site, blood will splatter around, so it is important to measure with high accuracy the amount of blood actually collected into the collection tube.

[0009] The amount of blood collected in a blood collection tube can be determined by determining the liquid level of the blood collected in the blood collection tube and then utilizing the correlation between the liquid level of the blood collected in the blood collection tube and the amount of blood in the blood collection tube. Patent Documents 1 and 2 use an optical method that uses two types of light to determine the position of the liquid level in a container. However, a configuration that projects two types of measurement light and detects two types of transmitted light requires the device to include multiple light sources and detection devices, resulting in a problem of increased size of the blood collection device.

[0010] Furthermore, when measuring the amount of blood collected in a blood collection tube using an optical method, errors due to the type of blood collection tube become a problem. Blood collection tubes differ depending on their type in terms of the light transmittance of the tube wall, the shape of the area near the opening and the bottom, and whether or not a separating agent is provided inside. The measurement light projected into the blood collection tube to measure the amount of blood may be optically affected by factors other than blood, depending on the type of blood collection tube. Therefore, a technology that can measure the amount of blood collected in a blood collection tube with high accuracy, regardless of the type of blood collection tube, is desired.

[0011] Furthermore, if the amount of blood collected in the blood collection tube is insufficient or if the blood collection time exceeds the upper limit, it may be appropriate to repeat the blood collection. From the viewpoint of quickly determining whether or not to repeat the blood collection, it is desirable to measure the amount of blood collected in the blood collection tube in real time. From the viewpoint of performing measurement in real time, it is important to be able to detect minute changes in the amount of blood in the blood collection tube over time with high sensitivity.

[0012] Furthermore, blood bleeding from the puncture site may temporarily adhere to the inner surface of the blood collection tube before pooling at the bottom. Because the blood adhering to the inner surface of the blood collection tube is not reflected in the blood level inside the blood collection tube, it can cause errors when measuring the amount of blood collected in the blood collection tube. Therefore, a technology is desired that can accurately measure the amount of blood collected in a blood collection tube in a situation where blood drips toward the bottom of the blood collection tube.

[0013] Therefore, the present invention aims to provide a blood collection device, a blood collection method, and a blood collection system that can measure the amount of blood collected into a blood collection tube from the puncture site of a subject with a puncture needle in real time with high accuracy, regardless of the type of blood collection tube.

[0014] In order to solve the above-mentioned problems, the blood collection device of the present invention is a blood collection device that collects blood from a subject, and includes a blood collection unit that collects blood into a blood collection tube from a puncture site punctured by a puncture needle on the subject, an imaging unit that photographs the blood collection tube to obtain blood images of the blood collected in the blood collection tube, a calculation unit that calculates the rate at which blood increases inside the blood collection tube based on the blood images, and a control unit that controls the operation of the blood collection unit, wherein the imaging unit obtains the blood images at different times while blood is being collected from the puncture site into the blood collection tube, and the calculation unit performs the following operations on the blood images for each pixel region containing pixels representing the blood collected in the blood collection tube: integrating the pixel values ​​of the pixels that make up the pixel row in the horizontal direction to obtain an integrated value;

[0015] Furthermore, a blood collection method according to the present invention is a blood collection method for collecting blood from a person to be collected, comprising the steps of: puncturing the person to be collected with a puncture needle; and collecting blood from the puncture site punctured by the puncture needle into a blood collection tube; while the blood is being collected from the puncture site into the blood collection tube, photographing the blood collection tube at different times to obtain blood images of the blood collected in the blood collection tube; targeting a pixel region containing pixels representing the blood collected in the blood collection tube on the blood images for each time, the method integrates the pixel values ​​of the pixels constituting the pixel row for each pixel row composed of a plurality of pixels arranged in the horizontal direction to obtain an integrated value; determining the liquid level of the blood collected in the blood collection tube based on the integrated value; and determining the rate of increase of the blood collected in the blood collection tube based on the liquid level of the blood.

[0016] Furthermore, the blood collection system according to the present invention is a blood collection system that supports a blood collection device that collects blood from a recipient, and includes: a blood collection device that collects blood from the recipient; and a management server that manages data related to blood collection. The blood collection device includes: a blood collection unit that collects blood into a collection tube from a puncture site punctured by a puncture needle in the recipient; an imaging unit that photographs the collection tube to obtain a blood image of the blood collected in the collection tube; a calculation unit that calculates the rate at which blood increases inside the collection tube based on the blood image; and a control unit that controls the operation of the blood collection unit. The imaging unit monitors the blood flow between the blood collection tube and the puncture site while blood is being collected into the collection tube. The calculation unit acquires the blood images at different times, and for each pixel column consisting of a plurality of pixels arranged horizontally on the blood images for each time, the calculation unit targets a pixel region including pixels representing the blood collected in the blood collection tube, and performs the following processes: accumulating the pixel values ​​of the pixels constituting the pixel column to obtain an integrated value; calculating the liquid level of the blood collected in the blood collection tube based on the integrated value; and calculating the rate of increase based on the blood level; and the management server manages data identifying the person to be blood collected and data on the amount of blood collected in the blood collection tube obtained based on the rate of increase.

[0017] According to the present invention, it is possible to provide a blood collection device, a blood collection method, and a blood collection system that can measure the amount of blood collected into a blood collection tube from the puncture site of a subject with a puncture needle in real time with high accuracy, regardless of the type of blood collection tube.

[0018] FIG. 1 is an external view of a blood collection device according to an embodiment of the present invention. FIG. 2 is a diagram schematically showing an example of a main part of a blood collection device according to an embodiment of the present invention. FIG. 3 is a block diagram showing the configuration of a control unit that controls a blood collection device according to an embodiment of the present invention. FIG. 4 is a diagram explaining the operation of a blood collection device according to an embodiment of the present invention. FIG. 5 is a diagram schematically showing an example of a blood image captured by an imaging unit of a blood collection device. FIG. 6 is a diagram explaining a method of integrated value calculation processing in image analysis targeting a pixel region on a blood image. FIG. 7 is a diagram explaining the contents of integrated value calculation processing in image analysis targeting a pixel region on a blood image. FIG. 8 is a diagram explaining the contents of liquid level height calculation processing based on the integrated value of pixel values. FIG. 9 is a diagram explaining the breakdown of the integrated value of pixel values. FIG. 10 is a diagram explaining the rate of increase of blood inside a blood collection tube. FIG. 11 is a diagram showing the configuration of a blood collection system according to an embodiment of the present invention.

[0019] A blood collection device, a blood collection method, and a blood collection system according to one embodiment of the present invention will be described below. Note that common components in the following drawings will be assigned the same reference numerals, and duplicated explanations will be omitted.

[0020] FIG. 1 is an external view of a blood collection device according to an embodiment of the present invention. FIG. 1 shows a finger blood collection device that automatically collects blood from the fingers of a blood collection recipient as an example of a blood collection device. The symbol P in FIG. 1 is an enlarged partial view of the area around the finger rest of the blood collection device as viewed from below. As shown in FIG. 1, the blood collection device 1 according to this embodiment includes a housing 10, a turntable 11, multiple holders 110 in which blood collection tubes are placed, multiple modules 120 that perform operations related to blood collection, and a finger insertion section 130 into which the fingers of the blood collection recipient are inserted.

[0021] The housing 10 is formed from a plurality of structural materials, decorative panels, etc. Inside the housing 10, there are built-in components such as a turntable 11, a rotation drive mechanism that drives the rotation of the turntable 11, an elevation drive mechanism that drives the elevation of the installed objects and module 120 installed in the holder 110, and a pressure adjustment mechanism that adjusts the pressure of the compression means that compresses the fingers of the person to be blood-collected.

[0022] 1, the top surface of the housing 10 is provided with a hand placement area where the subject's hand is placed, and a circular opening adjacent to the hand placement area. A turntable 11 is located below the opening. A finger insertion section 130 and a finger placement area 131 are provided on the opening side of the hand placement area. The finger insertion section 130 is provided above the finger placement area 131 so as to surround the subject's finger 134 placed in the finger placement area 131.

[0023] As shown in partial view P, a disposable finger rest component 132 can be attached to finger rest area 131. A blood sampling window 133, which is a through-hole, is opened in the center of finger rest component 132. A finger 134 of a person to be blood-collected can be placed on finger rest component 132 with the ventral side facing downward from blood sampling window 133. Finger rest area 131 may be formed from a disposable component, or may be formed by covering a structural material for finger rest with a disposable component.

[0024] A compression means for compressing the periphery of the subject's finger 134 is installed inside the finger insertion section 130 so as to surround the periphery of the finger 134 placed in the finger rest area 131. The compression means is configured, for example, as an airbag or cuff, with a flexible bag or the like containing a working fluid. A valve or a pump is connected to the compression means via a tube. The valve or pump constitutes a pressure adjustment mechanism for adjusting the pressure of the compression means.

[0025] The pressure adjusting mechanism adjusts the internal pressure of the compression means to adjust the compression pressure applied to the subject's finger 134. The compression action of compressing the subject's finger 134 can be performed, for example, before the puncture needle is inserted into the subject's finger 134. By applying pressure around the subject's finger 134, the fingertip is made more susceptible to bleeding when the puncture needle is inserted, making it easier to ensure a sufficient amount of blood is collected.

[0026] The turntable 11 is roughly disk-shaped and rotatably supported inside the housing 10 with its main surfaces facing up and down. The turntable 11 is provided with a plurality of holders 110 that rotate integrally with the turntable 11 and a plurality of holding holes that penetrate the turntable 11 from top to bottom. Modules 120 are inserted and held in the holding holes from top to bottom. The holders 110 and modules 120 are arranged at intervals from one another along the circumferential direction of the turntable 11.

[0027] The holder 110 is a location where blood collection tubes are placed, and various types of blood collection tubes are placed in any number depending on the test items of the blood test to be performed after blood collection. Blood collection tubes of a predetermined size and outer tubes of a predetermined size that contain blood collection tubes can be placed in the holder 110. The outer tube is used, for example, to adjust the size of the object to be placed in relation to the location where the blood collection tubes are placed, when using small micro blood collection tubes.

[0028] A blood collection tube is a container into which blood bled from a puncture site punctured by a puncture needle is collected. Examples of blood collection tubes include blood collection tubes for blood count tests and blood collection tubes for biochemical and immunological tests. Blood collection tubes for blood count tests are containers into which blood is collected for blood count tests and contain an anticoagulant such as EDTA-2K. Blood collection tubes for biochemical and immunological tests are containers into which blood is collected for biochemical tests and immunological tests and contain a separating agent for separating serum. When collected blood is centrifuged, it can be separated into clots and serum due to the difference in specific gravity.

[0029] The outer tube or other installed object mounted on the holder 110 and the module 120 are detachable from the turntable 11. The module 120 is formed with, for example, a flange-like portion having a diameter larger than the inner diameter of the holding hole of the turntable 11. By inserting the module 120 into the holding hole, the module 120 can be installed with the flange-like portion supported from below. The outer tube or other installed object and the module 120 are held on the turntable 11 in a state in which they can be raised and lowered by pushing them up from below and releasing the pushing-up force.

[0030] As the module 120, a plurality of different types of modules can be installed on the turntable 11. The types of modules include a puncture module, a hemostatic module, and a protective module. A puncture device is detachably attached to the puncture module. A hemostatic material such as gauze is detachably attached to the hemostatic module. A protective material such as a bandage is detachably attached to the protective module.

[0031] The outer tube and other installed components mounted on the holder 110 and the module 120 are driven to move relative to the fingertip of the subject's finger 134 placed in the finger rest 131, thereby sequentially performing operations related to blood collection. The operations related to blood collection include a puncturing operation in which the puncture needle is inserted into the fingertip, a blood collection operation in which blood is collected from the puncture site into a blood collection tube, and a treatment operation in which the puncture site is treated. The treatment operations include a hemostatic operation in which bleeding is stopped at the puncture site with a hemostatic material and a protection operation in which the puncture site is protected with a protective material.

[0032] The positions of each holder 110 and each holding hole on the turntable 11 are designated in advance. By designating the positions, the installed objects such as blood collection tubes installed in the multiple holders 110 and the multiple modules 120 are distinguished from one another. Each installed object and each module 120 is driven to move relative to the fingertip of the finger 134 of the subject in the designated order.

[0033] The lancing device includes a lancet and a holder that acts as a housing that houses the lancet. A single-use skin puncture device can be attached to the lancet module. When pressed against the subject's finger, the lancing device projects the lancet and punctures the skin and capillaries of the subject's finger. Blood bleeds from the puncture site and is collected in a blood collection tube placed below the fingertip.

[0034] The hemostatic material is an absorbent cloth such as gauze that is pressed against the puncture site to absorb and stop the bleeding from the puncture site. The protective material is an adhesive sheet such as a bandage with an absorbent cloth attached that is pressed against and attached to the puncture site to stop the bleeding and protect the puncture site. The protective material is attached to the protective module with the absorbent cloth and adhesive surface facing upward.

[0035] Fig. 2 is a diagram showing an example of the main components of a blood collection device according to an embodiment of the present invention. Fig. 2 shows an example of the structure around the turntable 11 inside the blood collection device 1. As shown in Fig. 2, the blood collection device 1 contains the turntable 11, shaft 12, rotation drive mechanism 13, movable support member 14, lift drive mechanism 15, camera 16, photography light source 17, etc.

[0036] 2, a holder 110, which is a location for placing a blood collection tube, is supported on a turntable 11. An outer tube 102 containing a blood collection tube 101 is placed in the holder 110 as an object 100. The blood collection tube 101 and the outer tube 102 are formed as transparent containers that are optically transparent. The holder 110 is provided with a slit 111, which is a groove-shaped opening.

[0037] The turntable 11 is installed below an opening formed on the top surface of the housing 10 and below the finger rest area 131. Below the turntable 11 are installed a rotation drive mechanism 13 that drives the rotation of the turntable 11 and an elevation drive mechanism 15 that drives the elevation of the installed object 100 and module 120 installed in the holder 110. A camera 16 and a light source 17 for photography are installed near the turntable 11.

[0038] A shaft 12 is connected to the center of the turntable 11. The other end of the shaft 12 is rotatably supported by a rotation drive mechanism 13. The rotation drive mechanism 13 is composed of a motor 13a and a power transmission mechanism 13b. The power transmission mechanism 13b connects the output shaft of the motor 13a to the shaft 12 via a predetermined mechanical mechanism. The rotational motion of the motor 13a is transmitted to the shaft 12 by the power transmission mechanism 13b.

[0039] The rotation drive mechanism 13 rotates the shaft 12 to drive the rotation of the turntable 11. The turntable 11 can be rotated both clockwise and counterclockwise by the rotation drive mechanism 13 about a rotation axis passing through the center of the main surface. The turntable 11 is controlled to rotate by a predetermined step angle in accordance with the blood collection operation or treatment operation. The holder 110 and the module 120 are each transported to a blood collection position on the turntable 11 located directly below the finger rest area 131 by the rotation of the turntable 11.

[0040] At the blood collection position, the following steps are performed in order: puncturing the finger 134 with the puncturing needle by the puncturing module 120, stopping the bleeding with gauze or the like by the hemostasis module 120, and applying a bandage or the like by the protection module 120. The finger 134 of the person to be blood-collected is compressed by the compression means, and then punctured with the puncturing needle by the puncturing device attached to the puncturing module 120. Blood flowing out from the puncture site is collected in a blood collection tube 101 transported to the blood collection position on the turntable 11.

[0041] A movable support member 14 is disposed below the blood collection position. The movable support member 14 is supported by an elevation drive mechanism 15 so that it can be raised and lowered. The elevation drive mechanism 15 is composed of a motor 15a and a power transmission mechanism 15b. The power transmission mechanism 15b connects the output shaft of the motor 15a to the movable support member 14 via a predetermined mechanical mechanism. The rotational motion of the motor 15a is converted into vertical linear motion by the power transmission mechanism 15b.

[0042] When the installed object 100 and module 120 placed on holder 110 are transported to the blood collection position by the rotation of turntable 11, they are pushed up from below by the rise of movable support member 14 and pulled down by the fall of movable support member 14, thereby driving vertical movement relative to finger rest area 131. Through such actions, the puncture device is pressed against finger 134 of the person to be blood-collected, the blood collection tube 101 is pressed against the puncture site, and the hemostatic material and protective material are pressed against the puncture site.

[0043] The lancing device, puncturing module 120, movable support member 14, and lifting drive mechanism 15 constitute a puncturing unit that inserts the puncturing needle into the fingertip of the recipient's finger. When the puncturing device attached to puncturing module 120 is pressed against the recipient's finger, it projects the puncturing needle and punctures the skin and capillaries of the recipient's finger. Holder 110, where the blood collection tube is placed, movable support member 14, and lifting drive mechanism 15 constitute a blood collection unit that collects blood into a blood collection tube from the puncture site where the puncturing needle is inserted.

[0044] The hemostatic material, hemostatic module 120, protective material, protective module 120, movable support member 14, and lifting drive mechanism 15 constitute a treatment unit that treats the puncture site punctured by the puncture needle. When the hemostatic material, such as gauze, attached to the hemostatic module 120 is pressed against the puncture site of the subject, it absorbs blood that has bled from the puncture site and stops the bleeding. When the protective material, such as a bandage, attached to the protective module 120 is pressed against the puncture site of the subject, it is attached to cover the puncture site and stops the bleeding and protects the puncture site.

[0045] The camera 16 and the photographing light source 17 constitute an imaging unit that photographs the blood collection tube 101 placed in the holder 110. The imaging unit photographs the blood collection tube 101 to obtain a blood image of the blood collected in the blood collection tube 101. The camera 16 and the photographing light source 17 are placed so as to face each other with the blood collection tube 101 placed in the holder 110 in between.

[0046] The camera 16 photographs the blood collection tube 101 transported to the blood collection position while blood is being collected from the puncture site into the blood collection tube 101, and obtains a blood image that captures the appearance of the blood collection tube 101 as well as the blood collected in the blood collection tube 101. As the camera 16, an RGB camera, an infrared camera that can detect infrared light and near-infrared light, a near-infrared camera that can detect near-infrared light with high sensitivity, etc. can be used.

[0047] The camera 16 may be an image sensor such as a charge coupled device (CCD) or a complementary metal-oxide-semiconductor (CMOS). The camera 16 may also include an optical element for detecting predetermined light. Examples of the optical element include an optical filter that attenuates light other than the emission wavelength emitted by the imaging light source 17, and a lens that changes the focal position by converging or diverging light.

[0048] The imaging light source 17 projects imaging light for photographing the blood collected in the blood collection tube 101. The imaging light is projected onto the space inside the blood collection tube 101 transported to the blood collection position, where the blood is collected. Light having a two-dimensional spread in a direction perpendicular to the optical axis is used as the imaging light. The blood collection tube 101 onto which the imaging light is projected is photographed by the camera 16 detecting the transmitted light.

[0049] The imaging light source 17 may be a light emitting diode (LED), an organic light emitting diode (OLED), a fluorescent lamp, or the like. Visible light such as white light or blue light, or near-infrared light, or the like, may be used as the imaging light, from the viewpoint of detecting the blood collected in the blood collection tube 101 with high sensitivity. It is preferable to use blue light having a wavelength of 400 nm or more and 500 nm or less as the imaging light. With such a wavelength, attenuation of light intensity due to scattering or reflection by blood can be detected with high sensitivity.

[0050] The holder 110 is provided with a slit 111, which is a groove-shaped opening through which light can pass. The slit 111 is formed so as to penetrate the side wall of the holder 110 in a direction parallel to the radial direction of the turntable 11. The slit 111 is preferably provided with a width and height greater than the space inside the blood collection tube 101 where blood is collected. The imaging light emitted by the imaging light source 17 passes through the slit 111, the side wall of the blood collection tube 101, and the space inside the blood collection tube 101 to reach the camera 16.

[0051] The blood images are two-dimensional images of the blood collection tube 101 placed in the holder 110 and the blood flowing out from the puncture site and collected in the blood collection tube 101. The blood images are taken continuously at different predetermined time intervals after the puncture needle has punctured the subject's finger 134 and after the blood collection tube 101 has been transported to the blood collection position while blood is being collected from the puncture site into the blood collection tube 101. The blood images are used to determine the rate at which blood increases inside the blood collection tube and the amount of blood collected in the blood collection tube.

[0052] Because the imaging light emitted from the imaging light source 17 is scattered, reflected, absorbed, etc. by blood, the intensity of the transmitted light decreases when blood is collected in the blood collection tube. When the transmitted light that has passed through the blood collection tube is detected and the light intensity is measured, the attenuation of the light intensity of the transmitted light due to the blood is measured according to the level of the blood collected in the blood collection tube. Therefore, the amount of blood collected in the blood collection tube can be calculated based on the correlation between the level of the blood collected in the blood collection tube and the amount of blood inside the blood collection tube.

[0053] The level of the blood collected in the blood collection tube can be measured by taking blood images at predetermined time intervals and analyzing each blood image. Applying the measurement results of the blood level at each predetermined time interval to a correlation, the amount of blood inside the blood collection tube at each predetermined time interval can be calculated. Therefore, the rate of increase of blood inside the blood collection tube can be calculated as the change in the amount of blood inside the blood collection tube over time. Furthermore, the amount of blood collected in the blood collection tube can be calculated by integrating the rate of increase of blood inside the blood collection tube.

[0054] The correlation between the liquid level of blood collected in the blood collection tube and the amount of blood inside the blood collection tube can be determined by measurement using a sample with a known amount of blood inside the blood collection tube. Measurement using a sample with a known amount of blood is performed for each type of blood collection tube depending on the test items of the blood test performed after blood collection. The liquid level of blood collected in the blood collection tube 101 and the light intensity of light transmitted through the blood collection tube 101 can be determined according to the vertical displacement of the blood collection tube 101 by recording the operation of the lift drive mechanism 15.

[0055] 2 , the camera 16 is installed radially outward of the turntable 11 from the blood collection tube 101 and to the side of the blood collection tube 101. The photography light source 17 is installed radially inward of the turntable 11 from the blood collection tube 101 and to the side of the blood collection tube 101 in the horizontal direction. However, the camera 16 may be installed radially outward of the turntable 11 from the blood collection tube 101. The photography light source 17 may be installed radially outward of the turntable 11 from the blood collection tube 101.

[0056] Although the camera 16 may be installed in a position where it photographs the blood collection tube 101 placed in the holder 110 from diagonally below, it is preferably installed in a position where it photographs the blood collection tube 101 placed in the holder 110 from the side. The camera 16 and the photography light source 17 are preferably installed on the side in the horizontal direction of the blood collection tube 101. With such an arrangement, the liquid level of the blood collected in the blood collection tube 101 can be measured with high accuracy.

[0057] The image may be captured by the camera 16 by raising and lowering the camera 16 relative to the stationary blood collection tube 101, or by raising and lowering the blood collection tube 101 relative to the stationary camera 16. When the camera 16 is raised and lowered, an elevation drive mechanism for driving the camera 16 to rise and lower can be installed near the turntable 11.

[0058] Fig. 3 is a block diagram showing the configuration of a control unit that controls the blood collection device according to the embodiment of the present invention. Fig. 3 shows an example of the configuration of a control unit 200 built into the blood collection device 1. As shown in Fig. 3, the control unit 200 includes a calculation unit 201, a storage unit 202, an input unit 203, an output unit 204, a communication unit 205, a drive control unit 206, an imaging control unit 207, etc.

[0059] The drive control unit 206 is connected to the rotation drive mechanism 13 and the lift drive mechanism 15 via signal lines and interfaces. The imaging control unit 207 is connected to the camera 16 and the imaging light source 17 via signal lines and interfaces. Other devices can be connected to the communication unit 205 via wired communication lines.

[0060] The control unit 200 controls operations related to blood collection and capturing of blood images by the blood collection device 1. The control unit 200 is provided, for example, as a system controller. The control unit 200 executes the puncturing operation, blood collection operation, treatment operation by the blood collection device 1, the photographing operation for capturing blood images, the process of analyzing the blood images, the process of calculating the rate at which blood increases inside the blood collection tube, and the process of calculating the amount of blood collected in the blood collection tube.

[0061] The calculation unit 201 executes processing according to a program, reads programs and data, and controls the operation of each mechanism and device, calculation processing, etc. of the blood collection device 1. The calculation unit 201 is composed of a main storage device such as a CPU (Central Processing Unit), RAM (Random Access Memory), and ROM (Read Only Memory).

[0062] The storage unit 202 stores various data and programs. The storage unit 202 is configured with a storage device such as a semiconductor memory, a hard disk, etc. The storage unit 202 stores data on the subject, data on blood collection conditions, data on blood images taken by the camera 16, data used to calculate the blood increase rate and blood volume, and data on the calculation results of the blood increase rate and blood volume.

[0063] The input unit 203 is composed of a device or controller that accepts input from the operator of the blood collection device 1. The input unit 203 is composed of, for example, a touch panel, various switches, etc. Input and selection of blood collection conditions for each blood recipient, input and selection of calculation conditions, input of various data and instructions, etc. can be performed via the input unit 203 or an external device.

[0064] The output unit 204 is composed of devices and controllers that output information about the subject, information about the blood collection conditions, information about the operation of the blood collection device 1, information about the results of calculations, information about the results of blood collection, etc. The output unit 204 is composed of, for example, a processor and memory that generate images showing various types of information, an output interface, a display, etc.

[0065] The communication unit 205 transmits and receives various data to and from other devices. The control unit 200 can transmit and receive data via wired or wireless communication with, for example, a terminal that manages the blood collection device 1 or a higher-level system that supports blood collection. Information about the subject, information about blood collection conditions, information about blood collection results, etc. can be transmitted and received between the terminal and the higher-level system.

[0066] The drive control unit 206 controls the operation of the rotation drive mechanism 13, the lift drive mechanism 15, etc., to perform the puncturing operation, blood collection operation, and treatment operation by the blood collection device 1. The drive control unit 206 is composed of various drive controllers. The drive control unit 206 transmits and receives control signals for controlling the operation of each mechanism to and from the rotation drive mechanism 13, the lift drive mechanism 15, etc.

[0067] The imaging control unit 207 controls the camera 16 and the imaging light source 17 to control the capturing of blood images. The imaging control unit 207 is configured by an imaging controller equipped with an interface. The imaging control unit 207 transmits and receives control signals to and from the camera 16 and the imaging light source 17 to control the operation of the camera 16 and the imaging light source 17. The imaging control unit 207 also receives data of blood images captured by the camera 16.

[0068] The blood collection method according to this embodiment is a method for collecting blood from a subject, and calculates the rate at which blood increases inside a blood collection tube and the amount of blood collected in the blood collection tube based on a blood image, and switches between continuing and terminating blood collection based on the rate at which blood increases inside the blood collection tube and the amount of blood collected in the blood collection tube.

[0069] The blood collection method according to this embodiment includes the steps of inserting a puncture needle into a subject and collecting blood from the puncture site into a blood collection tube. After the blood collection, steps of stopping bleeding at the puncture site with a hemostatic material such as gauze and protecting the puncture site with a protective material such as a bandage can be performed.

[0070] In the process of collecting blood into a blood collection tube, the blood collection tube placed in a holder is photographed to obtain a blood image, and the rate at which blood increases inside the blood collection tube and the amount of blood collected in the blood collection tube are calculated based on the blood image. The photographing of the blood image and the calculation of the rate at which blood increases and the amount of blood are performed in real time while blood is being collected from the puncture site into the blood collection tube.

[0071] The process of collecting blood into a blood collection tube can be continued or terminated based on the calculation result of the blood increase rate. If the blood increase rate inside the blood collection tube is insufficient, the collection of blood into the blood collection tube can be stopped. On the other hand, if the blood increase rate inside the blood collection tube is appropriate, the collection of blood into the blood collection tube can be continued. By determining the blood increase rate inside the blood collection tube, appropriate blood collection can be performed, collecting the required amount of blood within a predetermined blood collection time with an upper limit limited depending on the blood circulation in the subject's fingers, etc.

[0072] Fig. 4 is a diagram illustrating the operation of the blood collection device according to the embodiment of the present invention. Fig. 4 shows a flowchart of the puncturing operation, blood collection operation, and treatment operation performed by the blood collection device 1. As shown in Fig. 4, the blood collection device 1 performs, in real time during the blood collection operation, a process of photographing the blood collection tube placed in the holder to obtain a blood image, a blood increase rate calculation process that calculates the rate at which blood increases inside the blood collection tube, and a blood collection volume calculation process that calculates the volume of blood collected in the blood collection tube.

[0073] In the blood collection device 1, the operation of the rotation drive mechanism 13, the lift drive mechanism 15, etc. is controlled based on the calculation result of the rate at which blood increases inside the collection tube. The continuation or termination of the blood collection operation is switched based on the rate at which blood increases inside the collection tube. By determining the rate at which blood increases inside the collection tube, an appropriate blood collection is performed in which the required amount of blood is collected within a predetermined blood collection time with an upper limit, depending on the blood circulation in the subject's fingers, etc.

[0074] When collecting blood using the blood collection device 1, first, a blood collection tube is placed in the holder 110, and the puncture module 120, hemostasis module 120, and protection module 120 are placed on the turntable 11 (step S101).

[0075] Next, the blood collection device 1 is reset (step S102). By resetting the blood collection device 1 after startup, the rotation drive mechanism 13, the lift drive mechanism 15, etc. are initialized to a standby state in a predetermined initial position. In addition, it is confirmed whether the turntable 11, the movable support member 14, etc. operate normally within a predetermined range.

[0076] Next, a puncturing operation is performed to puncture the finger of the subject (step S103). By performing the puncturing operation, the puncture needle punctures the fingertip, and blood begins to flow out from the punctured site.

[0077] In the puncturing operation, drive control unit 206 drives rotation drive mechanism 13 to rotate turntable 11 and transport puncturing module 120 to the blood sampling position. Then, drive elevation drive mechanism 15 to lift movable support member 14 and raise puncturing module 120 to a height at which the puncturing device is pressed against the surface of finger 134 of the blood sample recipient. Thereafter, drive elevation drive mechanism 15 to lower movable support member 14 and lower puncturing module 120 to a height at which it is supported on turntable 11.

[0078] Next, a blood collection operation is started to collect blood from the puncture site punctured by the puncture needle into the blood collection tube 101 (step S104). With the start of the blood collection operation, collection of blood flowing out from the puncture site into the blood collection tube 101 begins.

[0079] In the blood collection operation, the drive control unit 206 drives the rotation drive mechanism 13 to rotate the turntable 11 and transport the holder 110 with the blood collection tube 101 placed therein to the blood collection position. Then, the drive control unit 206 drives the elevation drive mechanism 15 to raise the movable support member 14 and raise the blood collection tube 101 to a height at which it can be pressed against the puncture site. By pressing the blood collection tube 101 against the puncture site, blood that has flowed out from the puncture site flows down the inner wall of the blood collection tube 101 or drips toward the bottom of the blood collection tube 101 and is collected.

[0080] Subsequently, while blood is being collected from the puncture site into the blood collection tube 101, blood images of the blood collected in the blood collection tube 101 are acquired (step S105). The blood images are captured intermittently at preset, mutually different time intervals. The intermittent capturing is performed continuously in real time while the blood is being collected.

[0081] During blood collection, the drive control unit 206 controls the camera 16 and the imaging light source 17 to capture an image of the blood collection tube 101 placed in the holder 110. The camera 16 captures an image of the blood collected in the blood collection tube 101. The captured image of the blood is stored in the storage unit 202. The blood image may be captured with the blood collection tube 101 raised to near the fingertip, or may be captured with the blood collection tube 101 lowered to near the turntable 11, as long as the side of the blood collection tube 101 can be captured.

[0082] Next, the blood increase rate, which is the rate at which the blood increases inside the blood collection tube, is calculated based on the captured blood image (step S106).

[0083] When the blood images are captured, the calculation unit 201 reads out data of a series of blood images acquired at predetermined time intervals, and executes a blood increase rate calculation process to calculate the blood increase rate based on the blood images of the blood collected in the blood collection tube 101. The calculation result of the blood increase rate is stored in the memory unit 202.

[0084] Next, it is determined whether the calculated blood increase rate has reached a required increase rate (step S107). The required increase rate is set in advance before blood collection begins as an allowable lower limit for the blood increase rate. For example, a lower limit for the blood increase rate can be set so that the required amount of blood can be collected within a predetermined blood collection time with a limited upper limit.

[0085] When the blood increase rate is calculated, the calculation unit 201 compares the calculation result of the blood increase rate calculated in the blood increase rate calculation process with a predetermined required increase rate, and determines whether the calculation result of the blood increase rate is equal to or greater than the required increase rate.

[0086] If the result of the determination is that the calculated blood increase rate is less than the required increase rate (step S107; NO), blood collection by the blood collection device 1 is terminated. In this case, since proper blood collection is difficult, blood collection from the selected blood collection site is terminated. The drive control unit 206 drives the lift drive mechanism 15 to lower the movable support member 14, and then drives the rotation drive mechanism 13 to rotate the turntable 11, thereby removing the holder 110 with the blood collection tube 101 placed therein from the blood collection position. The process then proceeds to redo the blood collection, change the blood collection site, or cancel the blood collection, etc.

[0087] On the other hand, if the calculated blood increase rate is equal to or greater than the required increase rate (step S107; YES), the process proceeds to step S108. In this case, the amount of blood collected in the blood collection tube, which is the amount of blood inside the blood collection tube, is calculated based on the calculated blood increase rate (step S108). The drive control unit 206 holds the holder 110 in which the blood collection tube 101 is placed at the blood collection position without driving the rotation drive mechanism 13.

[0088] If the calculation result of the blood increase rate is equal to or greater than the required increase rate, the calculation unit 201 reads out the calculation result of the blood increase rate and executes a blood collection volume calculation process to calculate the amount of blood collected in the blood collection tube. The calculation unit 201 calculates the current amount of blood actually collected in the blood collection tube 101 and the future amount of blood to be collected in the blood collection tube 101 after a predetermined time. The calculation result of the blood collection volume is stored in the memory unit 202.

[0089] Next, it is determined whether the amount of blood collected in the blood collection tube has reached the required amount (step S109). The required amount of blood is set in advance before blood collection begins as the allowable lower limit of the amount of blood to be collected. For example, the required amount of blood can be set as the lower limit of the amount of blood required for a blood test to be performed after blood collection.

[0090] When the amount of blood to be collected is calculated, the calculation unit 201 compares the calculation result of the amount of blood to be collected calculated in the blood collection amount calculation process with a predetermined required amount of blood to be collected, and determines whether the calculation result of the amount of blood to be collected is equal to or greater than the required amount of blood to be collected.

[0091] If the result of the determination is that the calculated blood collection volume is less than the required volume (step S109; NO), the process returns to step S105. In this case, the amount of blood collected in the blood collection tube is insufficient, so the blood collection operation is resumed. On the other hand, if the result of the determination is that the calculated blood collection volume is equal to or greater than the required volume (step S109; YES), the process proceeds to step S110.

[0092] Next, it is determined whether or not blood collection has been completed for all of the blood collection tubes 101 to be collected (step S110).

[0093] When the amount of collected blood reaches the required amount, the calculation unit 201 checks the blood collection operation log against the detection results of the blood collection tubes 101 at each position on the turntable 11 to determine whether or not the blood collection operation has been performed for all of the blood collection tubes 101 placed on the turntable 11. The presence or absence of blood collection tubes 101 at each position on the turntable 11 can be detected by an optical sensor or the like.

[0094] If the determination result shows that blood collection into all of the blood collection tubes 101 has not been completed (step S110; NO), the process returns to step S104. In this case, the blood collection operation is resumed for the remaining blood collection tubes 101 that are to be collected. On the other hand, if the determination result shows that blood collection into all of the blood collection tubes 101 has been completed, the process proceeds to step S111.

[0095] Next, a hemostatic operation is performed to stop bleeding at the puncture site using a hemostatic material such as gauze (step S111).

[0096] When the blood sampling operation is completed, the drive control unit 206 drives the rotation drive mechanism 13 to rotate the turntable 11 and transport the hemostatic module 120 with the attached hemostatic material to the blood sampling position. Then, the drive control unit 206 drives the lift drive mechanism 15 to raise the movable support member 14 and raise the hemostatic module 120 to a height where the hemostatic material is pressed against the puncture site. The lift drive mechanism 15 is then driven to lower the movable support member 14 and lower the hemostatic module 120 to a height where it is supported on the turntable 11.

[0097] Next, a protection operation is performed to protect the puncture site with a protective material such as a bandage (step S112).

[0098] When the hemostasis operation is complete, the drive control unit 206 drives the rotation drive mechanism 13 to rotate the turntable 11 and transport the protective module 120 with the attached protective material to the blood collection position. Then, the drive control unit 206 drives the lift drive mechanism 15 to raise the movable support member 14 and raise the protective module 120 to a height where the protective material is pressed against the puncture site. The drive control unit 206 then drives the lift drive mechanism 15 to lower the movable support member 14 and lower the protective module 120 to a height where it is supported on the turntable 11.

[0099] Thereafter, blood collection by the blood collection device 1 is completed. The blood collection tube 101 from which the blood has been collected is removed from the blood collection device 1. The puncture device, hemostatic material, and protective material are replaced or replenished as necessary. After being removed from the blood collection device 1, the blood collection tube 101 from which the blood has been collected is inverted to mix as necessary and then transported to an automatic analyzer or the like that performs a blood test.

[0100] With this blood collection device 1 and blood collection method, the rate at which blood increases inside the blood collection tube can be determined, making it possible to measure the amount of blood actually collected in the blood collection tube. Even if the bleeding from the puncture site is strong enough to cause blood to splatter around, the amount of blood actually collected in the blood collection tube can be determined with high accuracy. Furthermore, since the rate at which blood increases inside the blood collection tube can be determined, it is possible to predict not only the current amount of blood actually collected in the blood collection tube, but also the future amount of blood to be collected from the blood collection tube after a predetermined time. Because the future amount of blood to be collected can be predicted, appropriate blood collection, in which the required amount of blood is collected within a limited upper limit of the blood collection time, can be performed more reliably than with conventional methods.

[0101] Furthermore, with this blood collection device 1 and blood collection method, the blood collected in the blood collection tube is photographed during collection, so the rate at which blood increases inside the blood collection tube and the amount of blood collected in the blood collection tube can be determined in real time while the blood is being collected. Unlike measuring the amount of collected blood after collection, the progress of blood collection can be monitored. This makes it possible to quickly decide whether to repeat the blood collection, change the blood collection site, or stop the blood collection. This reduces the burden on the subject and the effort involved in the blood collection process.

[0102] In the flowchart shown in Figure 4, step S107 determines whether the blood increase rate has reached the required increase rate, but this determination regarding the blood increase rate may be omitted. Whether to continue collecting blood into the collection tube may also be determined by determining whether the amount of blood collected based on the blood increase rate has reached the required amount. Alternatively, in addition to determining whether the amount of blood collected has reached the required amount, a determination may be made as to whether the blood collection time has reached the maximum blood collection time.

[0103] 4, the blood increase rate calculation process (step S106) is composed of an integrated value calculation process, a liquid surface height calculation process, and a blood increase rate calculation process. By executing a predetermined program, the calculation unit 201 of the blood collection device 1 performs image processing to sample the blood image captured by the camera 16, and then performs image analysis of the sampled blood image to perform integrated value calculation process, liquid surface height calculation process, and blood increase rate calculation process in this order.

[0104] The integrated value calculation process is a process for calculating an integrated value by horizontally integrating the pixel values ​​of the pixels constituting each pixel row, which is composed of a plurality of horizontally arranged pixels, for a pixel region including pixels representing the blood collected in the blood collection tube on blood images captured at predetermined time intervals during the blood collection operation. The integrated value calculation process is performed on a plurality of blood images captured over time while blood is being collected from the puncture site into the blood collection tube.

[0105] The liquid level calculation process is a process for calculating the liquid level of blood collected in a blood collection tube based on the integrated value of pixel values ​​for each pixel row at each predetermined time interval calculated by the integrated value calculation process. The liquid level calculation process is performed on multiple blood images captured over time while blood is being collected from the puncture site into the blood collection tube. The liquid level of blood collected in the blood collection tube is calculated for each blood image captured over time.

[0106] The blood increase rate calculation process is a process for calculating the increase rate of blood inside the blood collection tube based on the liquid level calculated for each predetermined time period by the liquid level calculation process. The increase rate of blood inside the blood collection tube can be calculated as the time rate of change of the liquid level of blood collected in the blood collection tube or the time rate of change of the blood volume inside the blood collection tube. The blood volume inside the blood collection tube is calculated by applying the measurement result of the liquid level of blood collected in the blood collection tube to the correlation between the liquid level of blood collected in the blood collection tube and the blood volume inside the blood collection tube.

[0107] The integrated value calculation process, liquid level calculation process, and blood increase rate calculation process can be performed by manual processing using appropriate hardware, software, image analysis software, etc. In the process of collecting blood into a blood collection tube, calculations corresponding to the integrated value calculation process, the liquid level calculation process, and the blood increase rate calculation process are performed in this order. The continuation and termination of the process of collecting blood into a blood collection tube can be switched based on the calculation results of the blood increase rate inside the blood collection tube. Alternatively, the switch can be switched based on whether the amount of blood collected based on the calculation results of the blood increase rate has reached the required amount of blood to be collected.

[0108] 5 is a diagram showing an example of a blood image captured by the imaging unit of the blood collection device. In FIG. 5, reference numeral 300 denotes a blood image captured by camera 16, and reference numeral 310 (the area enclosed by the dashed line) denotes a pixel area to be subjected to image analysis. Reference numeral 101 denotes a blood collection tube, reference numeral 102 denotes an outer tube, reference numeral 150 denotes an information label, reference numeral 151 denotes a printed portion, reference numeral 160 denotes blood pooled at the bottom of the blood collection tube, and reference numeral 161 denotes a blood droplet adhering to the inner surface of the sidewall of the blood collection tube.

[0109] 5 , the blood collection tube 101 placed in the holder 110 is photographed by the camera 16 constituting the imaging unit. The camera 16 photographs the blood collection tube 101 while blood is being collected from the puncture site into the blood collection tube 101, and obtains a blood image 300 of the blood 160 collected in the blood collection tube 101.

[0110] The field of view of the camera 16 is set to a range that includes the entire space in which the blood 160 is contained inside the blood collection tube 101. For example, the field of view can be set to a range that includes the entire blood collection tube, a range that includes the entire space inside the blood collection tube 101, or a range that includes the entire space inside the blood collection tube 101 that contains the required amount of blood to be collected.

[0111] The integrated value calculation process is performed by image analysis of blood image 300. The image analysis is performed on a predetermined pixel region 310 on blood image 300, as shown by the dotted line in Fig. 5. Pixel region 310 is an area on blood image 300, and is set so as to include an image of blood 160 accumulated at the bottom of blood collection tube 101. For example, the image analysis is performed on an area including the entire internal space of blood collection tube 101, or an area including the entire space inside blood collection tube 101 that contains the required amount of blood to be collected.

[0112] As shown in FIG. 5 , an information label 150 may be affixed to the side of the blood collection tube 101 placed in the holder 110. The information label 150 has a printed portion 151. The printed portion 151 may also be printed directly on the side of the blood collection tube 101. The printed portion 151 may include characters for identifying the specimen collected in the blood collection tube, characters indicating the type or model number of the blood collection tube, or a barcode encoding this information. Typically, the information label 150 and the printed portion 151 have a different optical transparency than the side wall of the blood collection tube 101.

[0113] 5, a blood droplet 161 that has bled from the puncture site may adhere to the inner surface of the sidewall of the blood collection tube 101 placed in the holder 110. Although the blood droplet 161 can be detected by optical techniques, it is located above the blood 160 that has accumulated at the bottom of the blood collection tube 101, and is therefore not in a state where there is a correlation between the liquid level of the blood collected in the blood collection tube and the amount of blood inside the blood collection tube. Therefore, the blood droplet 161 that has adhered to the inner surface can cause a measurement error.

[0114] If such information label 150, printed portion 151, or blood droplet 161 is present, these will cause measurement errors, making it impossible to accurately determine the rate of blood increase inside the blood collection tube or the amount of blood collected in the blood collection tube based on the correlation between the liquid level of the blood collected in the blood collection tube and the amount of blood inside the blood collection tube. Therefore, an integrated value calculation process is performed to calculate the integrated value of pixel values ​​for each pixel column, targeting pixel region 310 on blood image 300.

[0115] FIG. 6 is a diagram illustrating a method of integrated value calculation processing in image analysis targeting a pixel region on a blood image. FIG. 6 shows a sampled blood image used in integrated value calculation processing and the scanning direction of pixel rows on the sampled blood image. In FIG. 6, reference numeral 310 (the region within the dashed-line frame) indicates the pixel region that is the subject of image analysis, and reference numeral 340 indicates a shadow image on the sampled blood image. The arrow indicates the scanning direction of the pixel row that is the subject of integrated value calculation processing. In FIG. 6, the horizontal direction is the lateral direction. One pixel row is one horizontal line.

[0116] As shown in Figure 6, the integrated value calculation process is performed after blood image 300 captured at predetermined time intervals is sampled so that pixel values ​​contain only luminous intensity information, such as grayscale. After blood image 300 as shown in Figure 5 is sampled, pixel region 310 is subjected to image analysis. When the luminous intensity of each pixel, which corresponds to the intensity of transmitted light, is used as an index for sampling, image processing is performed as shown in Figure 6. Sampling using only luminous intensity as an index converts the image into one expressed in shades of two colors and their intermediate colors. Sampling is preferably performed so that pixel values ​​have three or more gradations, for example, 256 gradations.

[0117] When blood image 300 is sampled, it is possible to easily distinguish, based on pixel values, between areas where blood is present and transmitted light is easily attenuated and areas where blood is not present and transmitted light is not easily attenuated. Therefore, the level of blood collected in the blood collection tube can be determined with high accuracy. Furthermore, unlike binarization, when pixel values ​​have multiple gradations, it is easy to distinguish between information label 150, printed portion 151, blood droplet 161, and blood 160 accumulated at the bottom of the blood collection tube based on differences in pixel values. Therefore, even when these factors attenuate the light used for photography, the level of blood 160 accumulated at the bottom of the blood collection tube can be detected with high sensitivity.

[0118] In Figure 6, pixel region 310 has a pixel value of 0 in the region where the luminous intensity of transmitted light is greatest, and a pixel value of a region where the luminous intensity of transmitted light is relatively low, set to a positive number. In such a case, blood 160 collected in a blood collection tube forms a shadow image 340 corresponding to the shadow of the transmitted light. However, blood image 300 may be sampled by setting the pixel value of a region where the luminous intensity of transmitted light is relatively low to 0, and the pixel value of a region where the luminous intensity of transmitted light is relatively high, as opposed to Figure 6.

[0119] As shown by the arrows in Figure 6, the scanning direction of the pixel rows that are the target of the integrated value calculation process, i.e., the order in which the integrated value calculation process is performed among the multiple pixel rows that make up the pixel region 310, is preferably from the bottom to the top of the pixel region 310, i.e., from the bottom to the top of the blood collection tube. This scanning direction allows the time change in the liquid level of the blood collected in the blood collection tube to be determined with a small amount of calculation. Furthermore, the integrated value calculation process can be terminated early when the liquid level of the blood collected in the blood collection tube is detected.

[0120] Figure 7 is a diagram illustrating the details of the integrated value calculation process in image analysis targeting a pixel region on a blood image. Figure 7 shows an enlarged view of the sampled blood image used in the integrated value calculation process, schematically illustrating some of the pixels that make up the blood image. In Figure 7, reference numeral 310 denotes the pixel region that is the subject of image analysis, reference numeral 320 denotes the pixels that make up the pixel region, and reference numeral 330 denotes the pixel row that makes up the pixel region. The arrow indicates the scanning direction of the pixel row that is the subject of the integrated value calculation process.

[0121] As shown in Fig. 7, a pixel region 310 that is the subject of image analysis is made up of a plurality of regularly arranged pixels 320. In Fig. 7, the pixel region 310 is made up of pixels 320 arranged in a matrix of n rows and m columns. The pixel region 310 is made up of a total of m pixel columns 330. Each pixel column 330 is made up of a total of n pixels 320 arranged in the horizontal direction on the pixel region 310. n and m represent any positive integers.

[0122] Each pixel 320 constituting pixel region 310 has a pixel value corresponding to the content of blood image 300. The pixel value reflects luminosity corresponding to the light intensity of transmitted light. For example, when sampling is performed using luminosity as an index to have 256 gradations, the pixel value can be expressed as a numerical value between 0 and 255. The pixel value data for each pixel 320 constituting pixel region 310 is stored in storage unit 202 together with information indicating the coordinates of each pixel 320.

[0123] The integrated value calculation process is performed by horizontally integrating the pixel values ​​of pixels 320 constituting each pixel row 330 for each pixel row 330 arranged horizontally on pixel region 310. Calculation unit 201 reads out pixel value data for each pixel 320 constituting pixel region 310, integrates the pixel values ​​of pixels 320 constituting each pixel row 330, and finds the relationship between the height of pixel row 320 in pixel region 310 and the integrated value of the pixel values. The relationship between the height of pixel row 320 in pixel region 310 and the integrated value of the pixel values ​​is found for each blood image 300 captured at each time.

[0124] In pixel region 310 on one blood image 300, the sum of pixel values ​​is calculated for each pixel column 330. For example, when accumulating pixel values ​​in the m-th column, the pixel values ​​of the pixels constituting the m-th column are P １ｍ , P ２ｍ ...P ｎｍ When ΣP ｉｍ (i=1 to n) is calculated. The calculation result of the integrated value of the pixel values ​​is stored in the storage unit 202.

[0125] When this integrated value calculation process is performed, an integrated value of pixel values ​​corresponding to the content of blood image 300 is calculated for each pixel row 330 along the height direction of the blood collection tube. As shown in FIG. 5 , even if information label 150, printed portion 151, or blood droplet 161 is present on the side of blood collection tube 101, the pixel values ​​of pixels representing the internal space of the blood collection tube located at the same height are added together. The influence of these factors on the imaging light is relatively small, making it easier to reflect the state of blood 160 pooled at the bottom of blood collection tube 101. Therefore, it is possible to determine the liquid level of blood collected in the blood collection tube with high accuracy.

[0126] Furthermore, by performing this integrated value calculation process, even if the increase in the blood level of the blood collected in the blood collection tube is small over time, the small increase can be easily detected as a change in the integrated value of pixel values. This makes it possible to detect small changes over time in the blood level inside the blood collection tube with high sensitivity. Therefore, when blood is dripping toward the bottom of the blood collection tube, it is possible to accurately determine the rate at which the blood level inside the blood collection tube increases and the amount of blood collected in the blood collection tube in real time.

[0127] 8 is a diagram illustrating the content of the liquid level height calculation process based on the integrated value of pixel values. Fig. 8 shows an example of the relationship between the integrated value of pixel values, which is the result of the integrated value calculation process, and the height of the pixel row for which the integrated value was calculated. In Fig. 8, the horizontal axis represents the integrated value of pixel values ​​for each pixel row, and the vertical axis represents the height of the pixel row, which is the position of the pixel row in the height direction on the pixel region that is the target of image analysis.

[0128] 8, pixel values ​​in areas where the luminous intensity of transmitted light is relatively low are set to 0, and pixel values ​​in areas where the luminous intensity of transmitted light is relatively high are set to positive numbers. The solid curve shows the results based on the blood image captured at time t1, the dashed curve shows the results based on the blood image captured at time t2, and the dotted curve shows the results based on the blood image captured at time t3. The dashed straight line shows the threshold set for the integrated value of pixel values.

[0129] 8, when blood images are captured while blood is being collected from the puncture site into the blood collection tube and integrated value calculation processing is performed, an integrated value of pixel values ​​is obtained for each pixel column. Pixel columns with low heights and small integrated pixel values ​​correspond to regions where blood is present at the bottom of the blood collection tube, i.e., regions on the lower side of the blood collection tube. Pixel columns with high heights and large integrated pixel values ​​correspond to regions where no blood is present, i.e., regions above the surface of the blood that has collected at the bottom of the blood collection tube and on the upper side of the blood collection tube.

[0130] As the blood collection time elapses, during which blood is collected from the puncture site into the blood collection tube, the height of the pixel row with a large integrated pixel value gradually shifts upward as blood accumulates inside the blood collection tube. In Figure 8, as the blood collection time elapses from time t1 to t2 and from t2 to t3, the height of the pixel row with a large integrated pixel value shifts upward. This upward shift indicates a rise in the liquid level of the blood collected in the blood collection tube.

[0131] In Figure 8, at time t1, the height of the pixel row where the integrated value of pixel values ​​exceeds the threshold is low. This state corresponds to the start of blood collection when the amount of blood collected in the blood collection tube is small. In contrast, at time t2, which is a time that has passed since time t1, and at time t3, which is a time that has passed since time t2, the height of the pixel row where the integrated value of pixel values ​​exceeds the threshold is high. This state corresponds to a state where blood collection time has passed.

[0132] As shown in Figure 8, the height of the pixel row at which the integrated value of pixel values ​​changes significantly with increasing height of the pixel row is the height at which the liquid level of the blood collected in the blood collection tube exists. The liquid level of the blood collected in the blood collection tube can be calculated as the distance between the height at which the liquid level of the blood collected in the blood collection tube exists and a reference point for the height. For example, if the blood collection tube does not contain a separating agent, the height of the bottom of the blood collection tube can be used as the zero reference point for the height. If the blood collection tube contains a separating agent, the average height of the top edge of the separating agent can be used.

[0133] 9 is a diagram illustrating the breakdown of the integrated value of pixel values. Fig. 9 schematically shows an example of the relationship between the integrated value of pixel values, which is the result of the integrated value calculation process, and the height of the pixel row for which the integrated value was calculated. In Fig. 9, the horizontal axis represents the height of the pixel row, which is the position of the pixel row in the height direction in the pixel region that is the target of image analysis, and the vertical axis represents the integrated value of pixel values ​​for each pixel row.

[0134] 9, pixel values ​​in areas where the luminous intensity of transmitted light is relatively low are set to 0, and pixel values ​​in areas where the luminous intensity of transmitted light is relatively high are set to positive numbers. The solid curve shows the results based on the blood image captured at time t1, and the dashed curve shows the results based on the blood image captured at time t2.

[0135] In Figure 9, a valley-shaped signal where the integrated value of pixel values ​​decreases occurs in a pixel column with a low height in the pixel region. Such a signal represents blood accumulating at the bottom of the blood collection tube. The decrease in the integrated value of pixel values ​​indicates a decrease in the luminous intensity of transmitted light caused by absorption, scattering, or reflection of the imaging light by the blood. The inflection point where the curve begins to rise after descending in a valley-like manner is the bottom end of the meniscus, and indicates the liquid level of blood accumulating at the bottom of the blood collection tube.

[0136] As shown by the dashed line in Figure 9, at time t2, which is some time after time t1, the signal indicating the blood level shifts toward the pixel row with a higher height in the pixel area. This signal shift represents the change over time in the height of the blood level collected in the blood collection tube. When blood images are captured at predetermined time intervals and analyzed, an inflection point is generated where the integrated pixel value changes significantly as the height of the pixel row increases.

[0137] Therefore, by detecting such an inflection point where the integrated value of pixel values ​​changes significantly by comparing the integrated value of pixel values ​​with a threshold, the position of the blood level in the blood collection tube can be determined. Furthermore, the blood level height in the blood collection tube can be determined based on the position of the blood level. By capturing blood images at predetermined time intervals and determining the time change in the blood level height in the blood collection tube, the increasing rate of blood collected in the blood collection tube can be calculated.

[0138] In Figure 9, multiple valley-shaped signals, where the integrated pixel values ​​decrease moderately, appear in the tall pixel columns in the pixel region. These signals represent the printed portion on the side of the blood collection tube. Such signals also appear when an information label or blood droplet is present on the side of the blood collection tube. The printed portion, information label, and blood droplet on the side of the blood collection tube have a small area and poor light-blocking properties, so they show weaker signals than the blood that has accumulated at the bottom of the blood collection tube.

[0139] Therefore, by setting an appropriate threshold for the integrated value of pixel values, it is possible to determine the level of the blood collected at the bottom of the blood collection tube while reducing the influence of the printed portion on the side of the blood collection tube, the information label, and blood droplets on the imaging light. Because the signal indicating the blood level is detected as the integrated value of the pixel row, even in a situation where blood is dripping into the blood collection tube, minute changes in the amount of blood inside the blood collection tube over time can be detected with high sensitivity. Therefore, the amount of blood collected in the blood collection tube can be measured in real time with high accuracy.

[0140] The liquid level calculation process can be performed by comparing the calculated integrated value of pixel values ​​for each pixel row at each predetermined time interval with a preset threshold value. The threshold value can be set in advance before blood collection begins, so that the integrated value of pixel values ​​for pixel rows that represent blood accumulated at the bottom of the blood collection tube can be distinguished from the integrated value of pixel values ​​for pixel rows that represent an area where no blood is present at the bottom of the blood collection tube.

[0141] Calculation unit 201 reads out the calculation result of the integrated value of pixel values ​​calculated by the integrated value calculation process, and compares it with a threshold value for determining the blood level based on the relationship between the height of pixel row 320 in pixel region 310 and the integrated value of pixel values ​​calculated for each time blood image 300 was captured. The integrated value of pixel values ​​is compared with a preset threshold value to detect the presence or absence of blood collected in the blood collection tube at the height of each pixel row 320, and the height of the blood level collected in the blood collection tube is calculated based on the height of pixel row 320 where blood is detected.

[0142] For example, the threshold value can be set to the sum of pixel values ​​when an arbitrary percentage of pixels constituting a pixel row represent blood accumulated at the bottom of a blood collection tube. Examples of the percentage of pixels representing blood include 50% or more, 70% or more, 90% or more, etc. The threshold value is preferably set to a value that allows the information label, printed portion, and blood droplets on the side of the blood collection tube to be distinguished from the blood accumulated at the bottom of the blood collection tube.

[0143] The integrated value of pixel values ​​can be corrected in advance before comparison with the threshold value to eliminate the influence of the printed portion or information label on the side of the blood collection tube on the imaging light. The influence of the printed portion or information label on the side of the blood collection tube on the imaging light can also be eliminated by a method such as subtracting the pixel value of the printed portion or information label from the integrated value of pixel values ​​at the height where blood is present. This is because the height of the signal representing the printed portion, etc., as shown in Figure 9, does not change in the pixel region even after the blood collection time has passed.

[0144] The comparison of the integrated pixel values ​​with the threshold value can be performed by determining whether the coordinates showing the results of the integrated value calculation process are in an area exceeding the threshold value on a graph showing the relationship between the integrated pixel values ​​and the height of the pixel row. Alternatively, the comparison can be performed by determining whether the difference between the latest integrated pixel value in the scanning direction of the pixel area and the previous integrated pixel value in the scanning direction of the pixel area has increased to or exceeds a reference value. The reference value can be preset to a value obtained by adding a margin to the threshold value for determining the blood level.

[0145] For example, in sampling a blood image, if pixel values ​​in areas where the luminosity of transmitted light is relatively low are set to 0 and pixel values ​​in areas where the luminosity of transmitted light is relatively high are set to positive numbers, the threshold value can be set to a value smaller than the integrated value of pixel values ​​of a pixel row where an information label, printed portion, or blood droplet is present on the side of the blood collection tube but no blood is present inside the blood collection tube.When the coordinates indicating the result of the integrated value calculation process are in an area equal to or greater than the threshold, or when the difference between the latest integrated value of pixel values ​​and the previous integrated value of pixel values ​​is equal to or greater than a reference value, it can be determined that the level of blood accumulated at the bottom of the blood collection tube has reached the height of the pixel row.Also, when the coordinates indicating the result of the integrated value calculation process are in an area below the threshold, or when the difference between the latest integrated value of pixel values ​​and the previous integrated value of pixel values ​​is less than the reference value, it can be determined that the level of blood accumulated at the bottom of the blood collection tube has not reached the height of the pixel row.

[0146] On the other hand, when sampling a blood image, if pixel values ​​in areas where the luminosity of transmitted light is relatively high are set to 0 and pixel values ​​in areas where the luminosity of transmitted light is relatively low are set to positive numbers, the threshold can be set to a value greater than the integrated value of pixel values ​​of a pixel row where an information label, printed portion, or blood droplet is present on the side of the blood collection tube but no blood is present inside the blood collection tube.When the coordinates indicating the result of the integrated value calculation process are in an area below the threshold or when the difference between the latest integrated value of pixel values ​​and the previous integrated value of pixel values ​​is below a reference value, it can be determined that the level of blood accumulated at the bottom of the blood collection tube has reached the height of the pixel row.Also, when the coordinates indicating the result of the integrated value calculation process are in an area above the threshold or when the difference between the latest integrated value of pixel values ​​and the previous integrated value of pixel values ​​exceeds the reference value, it can be determined that the level of blood accumulated at the bottom of the blood collection tube has not reached the height of the pixel row.

[0147] Fig. 10 is a diagram illustrating the rate at which blood increases inside a blood collection tube. Fig. 10 shows an example of the relationship between the blood level of the blood collected in the blood collection tube, which is the result of the liquid level calculation process, and the blood collection time calculated from the start of blood collection into the blood collection tube. In Fig. 10, the horizontal axis represents the blood collection time, and the vertical axis represents the blood level of the blood collected in the blood collection tube.

[0148] As shown in Figure 10, when blood collection into the blood collection tube begins, the blood level in the blood collection tube is at its lowest and the inside of the blood collection tube is empty. As collection time passes, the blood level in the blood collection tube gradually rises. By calculating the blood level in the blood collection tube at each predetermined time each time a blood image is captured, the rate at which the blood increases inside the blood collection tube can be determined as the slope of the curve in the graph showing the relationship between the blood level in the blood collection tube and the blood collection time.

[0149] When the blood increase rate calculation process is performed to determine the rate of increase of blood inside the blood collection tube as the time rate of change of the blood level height of the blood collected in the blood collection tube, the process can be performed by reading out the calculation result of the blood level height calculated by the blood level calculation process and calculating the time derivative of the calculation result of the blood level height for each predetermined time. Alternatively, when the blood increase rate of blood inside the blood collection tube is determined as the time rate of change of the blood volume inside the blood collection tube, the process can be performed by reading out the calculation result of the blood level height calculated by the blood level calculation process, applying the calculation result of the blood level height for each predetermined time to the correlation between the blood level height of the blood collected in the blood collection tube and the blood volume inside the blood collection tube to determine the blood volume inside the blood collection tube for each predetermined time, and then calculating the time derivative of the calculation result of the blood volume inside the blood collection tube for each predetermined time. The calculation result of the blood increase rate inside the blood collection tube is stored in the memory unit 202.

[0150] In the blood increase rate calculation process, the calculation results of the blood increase rate inside the blood collection tube for each specified time can be subjected to linear regression or curvilinear regression by regression calculation. The regression calculation can obtain a profile showing the time change rate of the blood increase rate. The profile may show different trends for each blood collection depending on the blood circulation in the fingertip of each blood collection subject. Therefore, the blood increase rate at a specified time can be estimated with higher accuracy based on the profile.

[0151] A profile showing the time rate of change in blood flow rate can be used for prediction by interpolation or extrapolation. For example, by performing interpolation, in which an arbitrary time is fitted to a line or curve representing the profile, the blood flow rate at an arbitrary time can be estimated. Furthermore, by performing extrapolation, in which an arbitrary time is fitted to a line or curve representing the profile, the blood flow rate after a predetermined time has passed can be predicted.

[0152] The blood collection volume calculation process is performed by integrating the calculation result of the blood increase rate for each predetermined time period over a predetermined interval. The calculation unit 201 reads out the calculation result of the blood increase rate inside the blood collection tube calculated by the blood increase rate calculation process, and calculates the integration of the calculation result of the blood increase rate for each predetermined time period over a specified predetermined interval. The amount of blood collected in the blood collection tube can be determined by using the collection time calculated from the start of blood collection into the blood collection tube as the integration interval.

[0153] For example, in the blood collection volume calculation process, if the rate of increase in blood inside the blood collection tube is determined as the time rate of change of the blood level height of the blood collected in the blood collection tube, a process can be performed in which the time integral of the time rate of change of the blood level height of the blood collected in the blood collection tube over an arbitrary time interval is calculated and then multiplied by the inner area of ​​the blood collection tube. Alternatively, if the rate of increase in blood inside the blood collection tube is determined as the time rate of change of the blood volume inside the blood collection tube, a process can be performed in which the time integral of the time rate of change of the blood volume inside the blood collection tube over an arbitrary time interval is calculated.

[0154] The blood collection volume calculation process may calculate the current volume of blood actually collected in the blood collection tube, or may calculate the future volume of blood to be collected in the blood collection tube after a predetermined time. The time integration interval can be set to any time. Calculating the current volume of blood to be collected more reliably ensures that the required volume of blood is collected. On the other hand, calculating the future volume of blood to be collected allows for early preparations for the end of the blood collection operation. When it is predicted that the required volume of blood will be collected, preparations can be started to lower the blood collection tube from near the fingertip or to end the blood collection operation.

[0155] The blood collection device 1 is equipped with a puncturing device, a puncturing module 120, a movable support member 14, and a lifting drive mechanism 15 as a puncturing part that punctures the puncture needle into the subject to be blood-collected. However, a blood collection device that performs the process of acquiring blood images, the process of calculating the blood increase rate, and the process of calculating the amount of blood collected may be configured in a manner that does not include a puncturing device, a puncturing module 120, or an apparatus that performs the puncturing operation, i.e., a configuration that does not include a puncturing part and only performs the blood collection operation, or a configuration that does not include a puncturing part and only performs the blood collection operation and treatment operation.

[0156] In a configuration in which the blood collection device does not have a puncturing unit, the puncturing operation of inserting the puncture needle into the subject can be performed by a doctor, medical staff, or the subject themselves. After the puncturing operation is performed, the blood collection tube can be set in a blood collection device that does not have a puncturing unit but has a blood collection unit, and blood can be collected from the puncture site into the blood collection tube. While blood is being collected into the blood collection tube installed in the blood collection device, the blood collection device can perform processes such as acquiring blood images, calculating the blood increase rate, and calculating the blood collection volume. The blood increase rate calculation process can also be performed manually using image analysis software, etc.

[0157] FIG. 11 is a diagram showing the configuration of a blood collection system according to an embodiment of the present invention. FIG. 11 schematically shows an example of the configuration of a blood collection system that supports a blood collection device 1 that collects blood from a recipient. As shown in FIG. 11, a blood collection system 400 according to this embodiment can be formed by incorporating a blood collection device 424, which performs processes for acquiring blood images, calculating the blood increase rate, and calculating the blood collection volume, into a host system equipped with server functions. The blood collection device 424 may incorporate the blood collection device 1 described above, or may incorporate a blood collection device that does not have a puncture unit.

[0158] The blood collection system 400 is a system that supports blood collection-related operations and manages data, and supports a blood collection device 424 that collects blood from a recipient. The blood collection system 400 is composed of an electronic medical record system 410, a blood collection support system 420, a test information system 430, etc. The blood collection system 400 can be established, for example, within a hospital.

[0159] The electronic medical record system 410, the blood collection support system 420, and the test information system 430 each function as a management server. These systems manage data, transfer data, share data, etc. These systems are connected to each other via communication lines such as a LAN, and are configured to send and receive data to and from each other.

[0160] The electronic medical record system 410 is a system for managing electronic medical records, and writes information to the electronic medical records, reads information from the electronic medical records, edits the electronic medical records, etc. A plurality of input terminals 411 are connected to the electronic medical record system 410 via communication lines.

[0161] The input terminal 411 is a terminal for performing operations on the electronic medical record, and is used to input information into the electronic medical record, output information from the electronic medical record, view the electronic medical record, etc. The input terminal 411 is composed of a computer, a tablet, etc. The input terminal 411 is operated by a doctor or medical staff. The input terminal 411 can be used to input blood sample recipient information into the electronic medical record and output blood sample recipient information from the electronic medical record.

[0162] The blood collection support system 420 is a system that provides support regarding blood collection, and performs operations such as registering data regarding blood collection, updating data, and managing data, and issuing sample IDs to be added as information labels. A blood collection reception machine 421, a blood collection preparation device 422, a blood collector terminal 423, and a blood collection device 424 are connected to the blood collection support system 420 via communication lines.

[0163] The blood collection reception machine 421 is a device that receives blood samples from recipients, collates the recipient's ID, issues a blood collection slip, etc. The blood collection reception machine 421 is operated by, for example, the recipient, a doctor, or medical staff. Information such as the recipient's name and recipient's ID is added to the blood collection slip by printing a barcode or the like.

[0164] The blood collection preparation device 422 is a device that makes preparations for blood collection, and stocks blood collection tubes and outer tubes, prepares blood collection tubes and outer tubes for each blood collection subject, and attaches information labels such as specimen IDs to the blood collection tubes and outer tubes, for example, attaches barcode labels, prints barcodes, etc. The blood collection tubes for each blood collection subject used for each test item in a blood test can be provided by the blood collection preparation device 422 as a set with an information label attached.

[0165] The blood collector terminal 423 is a terminal for performing operations related to blood collection, and inputs, reads, and outputs data related to blood collection. The blood collector terminal 423 is composed of a computer, a tablet, or the like. The blood collector terminal 423 is operated by medical staff, etc. Using the blood collector terminal 423, it is possible to register the blood collection recipient ID, input blood collection date information, blood collection location information, and test item information, and check various information.

[0166] The blood collection device 424 is a blood collection device that automatically collects blood from a subject, and transmits and receives data to and from the blood collection support system 420. The blood collection device 424 executes processes to acquire blood images, calculate the blood increase rate, and calculate the amount of blood to be collected, and collects blood from the puncture site of the subject punctured by the puncture needle into a collection tube. Any number of blood collection devices 424 can be connected to the blood collection support system 420.

[0167] The test information system 430 is a system that manages information related to blood tests, and performs data input, data registration, data update, and data management related to test results regarding blood tests. A test terminal 431 and multiple analyzers 432 are connected to the test information system 430 via communication lines.

[0168] The testing terminal 431 is a terminal for performing operations related to blood tests, and is used to operate the analyzer 432, input data, output data, check the test status and test results, etc. The testing terminal 431 is composed of a computer or the like. The testing terminal 431 is operated by the examiner of the blood test. The testing terminal 431 can be used to check the test status and test results of the blood collected in the blood collection container, and input data for reporting the test results.

[0169] The analyzer 432 is a device that performs analyses related to blood tests, and performs analysis for each test item specified in the test order using blood collected in a blood collection tube as a specimen. Any number of analyzers 432 can be connected to the test information system 430. The analyzer 432 can be configured using various types of automatic biochemical analyzers that analyze blood components.

[0170] In the blood collection system 400, a specimen ID for identifying a specimen for a blood test, blood collection tube information for identifying the type of blood collection tube, etc. are attached as information labels to the blood collection tubes used in the blood collection device 424. This information can be read by a reader installed near the location where the blood collection tube is installed in the blood collection device 424, and then collated with information registered in the blood collection support system 420.

[0171] Furthermore, in the blood collection system 400, the blood collection support system 420 functions as a management server that manages data related to blood collection, and manages blood collection subject information for each blood collection subject, blood collection tube information for each blood collection tube, and blood sample information for each blood sample. This information is stored as a database in a storage device associated with the blood collection support system 420. This information is saved in the blood collection support system 420 and can be sent to the electronic medical record system 410 or the test information system 430 or output to a terminal or the like according to instructions from a doctor, medical staff, or examiner.

[0172] Blood collection subject information is information about the blood collection subject, and includes a blood collection subject ID that identifies the blood collection subject, blood type information that indicates the blood type of the blood collection subject, blood collection date information that indicates the date of blood collection, blood collection location information that indicates the blood collection location, and test item information that indicates the type of blood test item. The blood type information, blood collection date information, blood collection location information, and test item information are associated with the blood collection subject ID. Blood collection subject information is registered in advance for each blood collection subject before blood is collected. The type of test item is specified by a test order. The test order is entered by a doctor or medical staff. After blood collection, blood collection result information that indicates the results of the blood collection is associated with the blood collection subject information.

[0173] The blood collection tube information indicates the type of blood collection tube, and is assigned to each type of blood collection tube used for blood collection. The types of blood collection tubes include types according to the purpose of the blood collection tube, types according to the manufacturer that produced the blood collection tube, and types according to the model number of the blood collection tube. There are many types of blood collection tube uses that are distinguished by the test items in blood tests. There are many types of blood collection tube model numbers that are distinguished by the shape of the bottom of the blood collection tube, and sizes such as inner diameter, outer diameter, and height. The blood collection tube information is registered by the system operator, etc.

[0174] Specimen information is information relating to a blood test specimen, and includes a specimen ID that identifies the specimen, test date information indicating the date of the test, test location information indicating the test location, and test item information indicating the type of test item in the blood test. The test date information, test location information, and test item information are associated with the specimen ID. The specimen information is registered in advance for each specimen before the blood test. After the blood test, test result information indicating the results of the blood test is associated with the specimen information.

[0175] The blood collection device 424 receives the recipient information registered in the blood collection support system 420 before blood collection and can collect blood for each recipient. Based on the received test item information, the type and number of blood collection tubes placed in the holder 110 can be verified. The blood collection device 424 can also transmit blood collection result information indicating the results of blood collection to the blood collection support system 420 in association with the information label for each blood collection tube. Examples of blood collection result information include information indicating the measurement results of the amount of blood collected from each blood collection tube and information indicating the time required to collect blood from each blood collection tube.

[0176] The blood collection support system 420 stores the data transmitted from the blood collection device 424 in association with registered blood collection subject information and specimen information, and can manage data identifying the subject whose blood was collected by the blood collection device 424, data on the information label read from the blood collection tube, data on the rate of increase of blood collected in the blood collection tube, data on the amount of blood collected in the blood collection tube, and profile data showing the time rate of change of the rate of increase of blood, together with existing registered information data. These data can be transmitted to the test information system 430 and referenced at the time of a blood test or the next blood collection, etc.

[0177] With this blood collection system 400, the contents of the information label read from the blood collection tube can be compared with data transmitted from a host system, and can be associated with the blood collection results and transmitted to the host system. This reduces the burden on blood collection personnel in managing blood collection tubes for each subject and managing blood collection results for each subject. Since data on the rate of increase of blood collected in the blood collection tube and profile data showing the time rate of change of the blood increase rate can also be managed, it becomes possible to appropriately change the blood collection conditions, the size of the blood collection tube, etc. for each blood collection.

[0178] Although the embodiments of the present invention have been described above, the present invention is not limited to the above-described embodiments, and various modifications are possible within the scope of the present invention. For example, the present invention is not necessarily limited to those having all of the configurations of the above-described embodiments. It is possible to replace part of the configuration of an embodiment with another configuration, add part of the configuration of an embodiment to another form, or omit part of the configuration of an embodiment.

[0179] 1, 2, and 3, the blood collection device 1 may have other configurations and structures as long as it includes a blood collection unit that collects blood into a collection tube from the puncture site of the subject punctured by the puncture needle, an imaging unit that photographs the collection tube to obtain a blood image of the blood collected in the collection tube, a calculation unit that calculates the rate at which blood increases inside the collection tube based on the blood image, and a control unit that controls the operation of the puncturing unit and the blood collection unit. The blood collection method described above can also be performed with blood collection devices having other configurations and structures.

[0180] REFERENCE SIGNS LIST 1 Blood collection device 10 Housing 11 Turntable 12 Shaft 13 Rotation drive mechanism 14 Movable support member 15 Elevation drive mechanism 16 Camera 17 Photography light source 100 Installed object 101 Blood collection tube 102 Outer tube 110 Holder 111 Slit 120 Module 130 Finger insertion section 131 Finger rest 132 Finger rest part 133 Blood collection window 134 Blood collection recipient's finger 150 Information label 151 Printed portion 160 Blood 161 Blood drop 300 Blood image 310 Pixel area 320 Pixel 330 Pixel row 340 Shadow image

Claims

1. A blood collection device for collecting blood from a subject, comprising: a blood collection unit that collects blood into a blood collection tube from a puncture site where a puncture needle has been inserted into the subject; an imaging unit that photographs the blood collection tube to obtain blood images of the blood collected in the tube; a calculation unit that calculates the rate at which blood increases inside the blood collection tube based on the blood images; and a control unit that controls the operation of the blood collection unit, wherein the imaging unit obtains the blood images at different times while blood is being collected from the puncture site into the blood collection tube, and the calculation unit performs the following steps on the blood images for each time period: integrating the pixel values ​​of the pixels that make up a pixel column composed of a plurality of pixels arranged horizontally, for a pixel region including pixels representing the blood collected in the blood collection tube, to obtain an integrated value; 2. A blood collection device according to claim 1, wherein the control unit controls the operation of the blood collection unit based on the increasing speed.

3. A blood collection device according to claim 1, wherein the calculation unit determines the relationship between the height of the pixel row in the pixel area and the integrated value for each time period, and determines the liquid level height based on the relationship between the height of the pixel row and the integrated value.

4. A blood collection device according to claim 3, wherein the calculation unit compares the integrated value with a preset threshold value to determine whether or not blood has been collected in the blood collection tube at the height of the pixel row, and calculates the liquid level based on the height of the pixel row at which the blood is detected.

5. A blood collection device according to claim 1, wherein the calculation unit determines the rate of increase based on the relationship between the liquid level and the time calculated from the start of blood collection into the blood collection tube, or the relationship between the amount of blood inside the blood collection tube calculated based on the liquid level and the time calculated from the start of blood collection into the blood collection tube.

6. A blood collection device according to claim 1, wherein the calculation unit calculates the amount of blood collected in the blood collection tube based on the rate of increase.

7. A blood collection device according to claim 1, wherein the blood image is sampled so that pixel values ​​have only luminous intensity information, and then the pixel regions are subjected to image analysis.

8. A blood collection device according to claim 1, wherein the imaging unit comprises a light source that projects imaging light onto the blood collection tube, and an imaging device that images the blood collection tube onto which the imaging light is projected, and the imaging light has a wavelength of 400 nm or more and 500 nm or less.

9. A blood collection device according to any one of claims 1 to 8, comprising a puncturing unit that inserts a puncture needle into a subject to be blood-collected, and the control unit controls the operation of the blood collection unit and the puncturing unit.

10. A blood collection method for collecting blood from a subject, comprising: a step of inserting a puncture needle into the subject; and a step of collecting blood into a blood collection tube from the puncture site punctured by the puncture needle, wherein while the blood is being collected from the puncture site into the blood collection tube, the blood collection tube is photographed at different times to obtain blood images of the blood collected in the blood collection tube, and on the blood images taken at each time, a pixel region containing pixels representing the blood collected in the blood collection tube is targeted, and for each pixel row composed of a plurality of pixels arranged in the horizontal direction, the pixel values ​​of the pixels constituting the pixel row are calculated to obtain an integrated value, the liquid level of the blood collected in the blood collection tube is calculated based on the integrated value, and the rate of increase of the blood collected in the blood collection tube is calculated based on the liquid level of the blood.

11. The blood collection method according to claim 10, wherein the continuation and termination of the blood collection process are switched based on the rate of increase.

12. A blood collection method according to claim 11, wherein the relationship between the height of the pixel row in the pixel region and the integrated value is determined for each time period, and the liquid level height is determined based on the relationship between the height of the pixel row and the integrated value.

13. A blood collection method as claimed in claim 12, wherein the integrated value is compared with a preset threshold value to determine whether or not blood has been collected in the blood collection tube at the height of the pixel row, and the liquid level is calculated based on the height of the pixel row at which the blood is detected.

14. A blood collection method according to claim 10, wherein the rate of increase is determined based on the relationship between the liquid level and the time calculated from the start of blood collection into the blood collection tube, or the relationship between the amount of blood inside the blood collection tube calculated based on the liquid level and the time calculated from the start of blood collection into the blood collection tube.

15. A blood collection method according to claim 10, wherein the amount of blood collected in the blood collection tube is determined based on the rate of increase.

16. A blood collection system supporting a blood collection device that collects blood from a subject, comprising: a blood collection device that collects blood from a subject; and a management server that manages data related to blood collection, wherein the blood collection device comprises: a blood collection unit that collects blood into a blood collection tube from a puncture site where a puncture needle has been inserted into the subject; an imaging unit that photographs the blood collection tube to obtain blood images of the blood collected in the blood collection tube; a calculation unit that calculates the rate at which blood increases inside the blood collection tube based on the blood images; and a control unit that controls the operation of the blood collection unit, wherein the imaging unit obtains the blood images at different times while blood is being collected from the puncture site into the blood collection tube, The calculation unit performs the following processes on the blood image for each time period: targeting a pixel region including pixels representing the blood collected in the blood collection tube, for each pixel column consisting of a plurality of pixels arranged horizontally, integrating the pixel values ​​of the pixels constituting the pixel column to obtain an integrated value; calculating the liquid level of the blood collected in the blood collection tube based on the integrated value; and calculating the rate of increase based on the blood level; and the management server is a blood collection system that manages data identifying the person to be blood collected and data on the amount of blood collected in the blood collection tube obtained based on the rate of increase.

Images