Blood characteristic testing device, blood characteristic testing method, image display device for blood sample testing, and image display method for blood sample testing.

Abstract

To accurately and efficiently detect the coagulation state of a blood sample in a blood collection tube in a short time by a simple method.SOLUTION: A blood property testing device 1 for testing a property of a blood sample stored in a blood collection tube includes: sample conveying means 10 capable of conveying the blood collection tube in which the blood sample is stored; an ultrasonic probe 6 arranged in a conveying path by the sample conveying means 10 and capable of transmitting ultrasonic waves to the blood sample in the blood collection tube to be conveyed and receiving reflected waves; an ultrasonic image generating part 72 for generating an ultrasonic tomographic image of the blood sample based on the reflected waves; and a blood property detecting part 74 for detecting the blood property of the blood sample based on the generated ultrasonic tomographic image.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] This disclosure relates to a blood characteristic testing device for examining the characteristics of blood samples, and more particularly to an inspection device for examining the coagulation state of blood samples stored in blood collection tubes. [Background technology]

[0002] In the medical field, peripheral blood tests using blood cell analyzers to examine red blood cell, platelet, and white blood cell counts can lead to decreased test accuracy and medical safety issues if blood samples clot. Therefore, prior to peripheral blood testing, an inspection was performed in which examiners visually determined whether the blood in the collection tubes had clotted, and tubes showing clots were excluded from the test. In recent years, however, a technique has been proposed to test whether the blood in the collection tubes has clotted by irradiating the blood in the tubes with light, rather than relying on visual inspection (for example, Patent Documents 1-3). [Prior art documents] [Patent Documents]

[0003] [Patent Document 1] Japanese Patent Application Publication No. 11-248853 [Patent Document 2] Japanese Patent Publication No. 2014-163933 [Patent Document 3] Japanese Patent Publication No. 2016-061585 [Non-patent literature]

[0004] [Non-Patent Document 1] Morphological examination of platelet aggregation using B-mode ultrasound, Junji Machi, Department of Surgery, University of Illinois School of Medicine, Hematology and Vascular Medicine, Vol. 16, No. 4, 1985, pp. 355-359. [Overview of the project] [Problems that the invention aims to solve]

[0005] However, visual inspection lacks objectivity in its criteria for judgment and is susceptible to human error such as oversights. Furthermore, when blood samples showing coagulation in the collection tube are used for blood cell count tests, and findings suggestive of coagulation are observed, the process of confirmation and the collection of re-examination samples takes a considerable amount of time, placing a significant burden on operations.

[0006] On the other hand, conventional testing methods using optical instruments that irradiate blood collection tubes with light to examine the blood inside the tubes, as described in Patent Documents 1 to 3, have the problem that they have low sensitivity for detecting the coagulation state of blood samples inside blood collection tubes, making it difficult to detect minute coagulation clumps that are hematological aggregates formed by fibrin precipitation.

[0007] This disclosure has been made in view of the above-mentioned problems, and aims to provide a blood properties testing device and a blood properties testing method that can detect the coagulation state of a blood sample in a blood collection tube in a short time with accuracy and efficiency using a simple method, and that can be used for inspecting blood samples in a blood collection tube. [Means for solving the problem]

[0008] To achieve the above objective, a blood properties testing device according to one aspect of the present disclosure is a blood properties testing device for testing the properties of a blood sample stored in a blood collection tube, characterized by comprising: a sample transport means capable of transporting a blood collection tube in which a blood sample is stored; an ultrasonic probe arranged in the transport path of the sample transport means and capable of transmitting ultrasonic waves to the blood sample in the blood collection tube being transported and receiving reflected waves; an ultrasonic image generation unit that generates an ultrasonic tomographic image of the blood sample based on the reflected waves; and a blood properties detection unit that detects the blood properties of the blood sample based on the generated ultrasonic tomographic image. [Effects of the Invention]

[0009] According to one aspect of this disclosure, a blood properties testing device and a blood properties testing method can be used to detect the coagulation state of a blood sample in a blood collection tube in a short time with accuracy and efficiency using a simple method, thereby realizing a blood properties testing device and a blood properties testing method that can be used for inspecting blood samples in blood collection tubes. [Brief explanation of the drawing]

[0010] [Figure 1] This is a plan view showing the configuration of the blood properties testing device 1 according to an embodiment. [Figure 2] This is a front view showing the configuration of the blood properties testing device 1. [Figure 3] This is a functional block diagram showing the configuration of the ultrasonic image generation and analysis device 7. [Figure 4] (a) is a photograph showing the results of a preliminary experiment corresponding to blood quality testing device 1, and (b) is a photograph showing the results of the determination by microscopic photography. [Figure 5] This is a schematic diagram showing the flow of testing in the process of blood quality specimen testing using the blood quality testing device 1. [Figure 6] This is a flowchart showing the processing in the blood properties detection unit 74 of the ultrasound image generation and analysis device 7. [Figure 7] This is a schematic diagram showing the configuration of the experimental apparatus used in the preliminary experiment, which corresponds to blood properties testing device 1 used in the evaluation test. [Figure 8] (a) to (e) are photographs showing the results of a preliminary experiment corresponding to testing device 1, in which blood samples obtained from healthy individuals were captured using an ultrasound diagnostic device to acquire ultrasound tomographic images of blood samples in blood collection tubes, and coagulation findings (ultrasound findings) were determined by interpreting the ultrasound tomographic images. [Figure 9] (a) to (e) are photographs showing the results of microscopic examination of blood samples obtained from healthy individuals to determine coagulation findings (microscopic findings). [Figure 10] This figure shows the test results of blood samples obtained from healthy individuals. [Figure 11](a) to (e) are photographs showing the results of imaging ultrasonic tomographic images of a blood specimen in a blood collection tube using a diagnostic apparatus 1 as a preliminary experiment equivalent to the inspection apparatus 1 with an ultrasonic diagnostic apparatus, and determining coagulation findings (ultrasonic examination findings) by reading the ultrasonic tomographic images. [Figure 12] (a) to (e) are photographs showing the results of determining coagulation findings (microscopic examination findings) by microscopic examination of a blood specimen obtained from a patient. [Figure 13] It is a diagram showing the test results of a blood specimen obtained from a patient. [Figure 14] It is a functional block diagram showing the configuration of ultrasonic image generation 7A in an image display device for blood specimen inspection according to a modified example. [Figure 15] (a) and (b) are schematic diagrams showing the flow of inspection in the process of conventional specimen inspection of blood properties.

Mode for Carrying Out the Invention

[0011] ≪Process to the Mode for Carrying Out the Present Disclosure≫ In a medical field, at the time of blood test, the collected blood specimen is enclosed in a blood collection tube and supplied to a blood test apparatus, and a blood cell count test for examining red blood cells, platelets, and white blood cell counts, a coagulation system test, and a fibrinolysis system test are performed. FIGS. 15(a) and (b) are schematic diagrams showing the flow of inspection in the process of conventional specimen inspection of blood properties. As shown in FIG. 15(a), usually, a blood specimen is enclosed in a blood collection tube and supplied to a blood cell count test, a coagulation system test, and a fibrinolysis system test. At this time, if the blood in the blood collection tube has coagulated, it will cause a decrease in inspection accuracy and become a problem in medical safety. Therefore, as shown in FIG. 15(b), an inspector visually determines whether the blood contained in the blood collection tube has coagulated, and a sample inspection is performed to exclude the blood collection tube in which coagulation is observed from the target of specimen inspection.

[0012] However, visual inspection lacks objectivity in its criteria for judgment and is susceptible to human error such as oversights. If a blood sample showing coagulation within the collection tube is subjected to blood cell count tests, coagulation tests, or fibrinolysis tests, and abnormal values ​​are detected, the inspector must re-examine the sample for coagulation based on their experience using a microscope, and the collection of a new sample for retesting requires considerable time, placing a significant burden on the work. Furthermore, there are concerns that reporting abnormal values ​​could lead to incidents.

[0013] In response to this, a technique has recently been proposed to examine whether or not the blood in a blood collection tube has coagulated, without relying on visual inspection, by irradiating the blood collected in the tube with light.

[0014] For example, Patent Document 1 discloses a method for determining whether a sample has coagulated without human intervention, by tilting the blood collection tube to move the blood inside the tube, capturing images with a camera, and analyzing the images to determine the presence or absence of coagulated material in the blood.

[0015] Furthermore, Patent Document 2 discloses a device that includes a first light source that irradiates a blood sample contained in a sample container with light, and a photodiode that receives transmitted light that has passed through the blood sample, and detects a clot based on the measurement intensity obtained by the photodiode.

[0016] Furthermore, Patent Document 3 discloses a blood coagulation detection device that detects blood coagulation by irradiating blood contained in a blood collection tube with light and calculating the absorbance over a predetermined wavelength range based on the transmitted light.

[0017] However, conventional testing methods described in Patent Documents 1 to 3, which involve irradiating a blood collection tube with light to examine the blood inside, have the problem of low sensitivity in detecting the coagulation state of the blood sample inside the tube, making it difficult to detect minute coagulation clumps, which are hematological aggregates formed by fibrin precipitation.

[0018] Furthermore, the material of the blood collection tube or the labels used to identify the blood sample can sometimes interfere with the acquisition of stable data.

[0019] On the other hand, among inspection methods that do not use light irradiation, a biomedical examination technique has been proposed that uses ultrasound (echography), which is used to observe tomographic images of living organisms, to examine the coagulation of blood flowing within the blood vessels of a living organism (for example, Non-Patent Document 1). However, no technique has been proposed that allows ultrasound to be used for quality control of blood samples in blood collection tubes.

[0020] In quality control inspections, detecting minute coagulations, which are hematological aggregates formed by fibrin precipitation, requires the construction of a new inspection device that uses a highly sensitive inspection method capable of detecting minute coagulations within blood samples collected in blood collection tubes. Therefore, the inventors have diligently studied inspection devices and methods that can detect the coagulation state of blood samples in blood collection tubes quickly, accurately, and efficiently using a simple method, and that can be used for quality control inspections of blood samples in blood collection tubes, leading to the embodiment described herein.

[0021] Summary of Embodiments for Carrying Out the Invention The blood properties testing device according to the embodiment of the present disclosure is a blood properties testing device for testing the properties of a blood sample stored in a blood collection tube, A specimen transport means capable of transporting a blood collection tube containing a blood sample, An ultrasonic probe is placed in the transport path of the specimen transport means and is capable of transmitting ultrasonic waves to the blood specimen in the collection tube being transported and receiving reflected waves. An ultrasound image generation unit that generates an ultrasound tomographic image of the blood sample based on the reflected wave, The system is characterized by comprising a blood properties detection unit that detects the blood properties of the blood sample based on the generated ultrasound tomography image.

[0022] This configuration makes it possible to detect even minute blood coagulations than those observed in conventional microscopic examinations, enabling accurate and efficient detection of the coagulation state of blood samples in blood collection tubes in a short time using a simple method, thus realizing a blood properties testing device that can be used for inspecting blood samples in blood collection tubes.

[0023] In another embodiment, in any of the above embodiments, the blood properties detection unit may be configured to calculate brightness parameters for a plurality of image units included in the blood image portion corresponding to the blood sample in the ultrasound tomography image, and to identify the region of the blood image portion in which the brightness parameters satisfy a predetermined standard as a coagulation finding region.

[0024] With this configuration, areas in a blood sample where coagulation has occurred due to a coagulation reaction will appear as areas in the cross-sectional image of the blood where the difference in brightness from the surrounding area is relatively large. Therefore, the coagulation state of the blood sample can be detected by using brightness parameters.

[0025] In another embodiment, in any of the above embodiments, the coagulation finding region may be configured to be a region of a predetermined area or larger in the blood image portion where the brightness difference from the surrounding area is greater than or equal to a predetermined value.

[0026] With this configuration, as the coagulation reaction progresses in the blood sample within the blood collection tube, the areas with higher brightness parameters than the surrounding areas change from spot-like to larger island-like areas. Therefore, the degree of coagulation reaction progression in the blood sample within the blood collection tube, i.e., the degree of coagulation clot formation, can be quantitatively represented based on the blood image portion, using coagulation observation areas of a predetermined size or larger where the difference in brightness parameter values ​​with respect to the outside of the area is above a predetermined threshold.

[0027] In another embodiment, in any of the above embodiments, the blood properties detection unit may be configured to derive the degree of coagulation promotion as the blood properties of the blood image portion based on the area ratio of the coagulation finding region to the blood image portion.

[0028] With this configuration, the degree of coagulation reaction in the blood sample within the blood collection tube can be quantitatively expressed by the area ratio of the coagulation region to the total area.

[0029] In another embodiment, in any of the above embodiments, the blood properties detection unit may be configured to derive the degree of coagulation promotion as the blood properties of the blood image portion based on the maximum value of the brightness parameter in the coagulation finding region.

[0030] With this configuration, the progress of the coagulation reaction in the blood sample within the blood collection tube can be quantitatively represented by the maximum value of the brightness parameter in the coagulation region.

[0031] In another embodiment, in any of the above embodiments, the blood properties detection unit may be configured to derive the degree of coagulation promotion as the blood properties of the blood image portion based on the integral value of the brightness parameter in the coagulation finding region.

[0032] With this configuration, the progress of the coagulation reaction in the blood sample within the blood collection tube can be quantitatively represented by the integral value of the brightness parameter of the coagulation region.

[0033] In another embodiment, in any of the above embodiments, the specimen transport means may be configured to transport the blood collection tube in a direction perpendicular to the tube axis while rotating the blood collection tube around the tube axis.

[0034] This configuration allows for the rotation of the blood sample collected within the blood collection tube while the tube is being transported, thereby suppressing the progression of blood sample coagulation.

[0035] In another embodiment, in any of the above embodiments, the specimen transport means may have a plurality of blood collection tube support rollers arranged parallel to the tube axis of the blood collection tube and rotating in conjunction with the transport operation of the blood collection tube, and the blood collection tube may rotate around the tube axis due to the rotation of the blood collection tube support rollers.

[0036] With this configuration, the blood collection tube, supported between two adjacent blood collection tube support rollers 5, rotates around its axis in the opposite direction to the blood collection tube support rollers due to the rotation of the support rollers. Therefore, a mechanism can be realized that allows the blood sample collected inside the blood collection tube to rotate while the blood collection tube is being transported.

[0037] In another embodiment, in any of the above embodiments, the ultrasonic probe may transmit and receive ultrasonic waves multiple times to and from the blood sample in the blood collection tube, the ultrasonic image generation unit may generate ultrasonic tomographic images of the blood sample in multiple cross-sections with different rotational angle phases around the tube axis in the blood collection tube, and the blood properties detection unit may detect the blood properties of the blood sample based on the multiple ultrasonic tomographic images.

[0038] This configuration allows for the detection of blood properties based on ultrasound images of different cross-sections of a single blood sample. This enables observation of the blood sample in the blood collection tube in multiple cross-sections, and even in a more three-dimensional manner, allowing for more accurate examination of the blood sample in the blood collection tube.

[0039] Furthermore, the blood properties testing method according to the embodiments of this disclosure is a blood properties testing method for testing the properties of a blood sample stored in a blood collection tube, The specimen transport means transports the blood collection tube containing the blood sample in a transportable manner. An ultrasonic probe positioned along the transport path of the sample transport means transmits ultrasonic waves to the blood sample in the blood collection tube being transported and receives the reflected waves. Based on the reflected waves, an ultrasound tomographic image of the blood sample is generated. The method is characterized by detecting the blood properties of the blood sample based on the generated ultrasound tomographic image.

[0040] In another embodiment, in any of the above embodiments, the detection of blood properties may involve calculating the brightness parameters of multiple image units included in the blood image portion corresponding to the blood sample in the ultrasound tomography image, and identifying the region of the blood image portion in which the brightness parameters satisfy a predetermined standard as a coagulation finding region.

[0041] In another embodiment, in any of the above embodiments, the identification of the coagulation region may be configured such that a region of a predetermined area or larger in the blood image portion where the brightness difference from the surrounding area is greater than or equal to a predetermined value is identified as the coagulation region.

[0042] This configuration makes it possible to detect even minute blood coagulations than those observed in conventional microscopic examinations, enabling the quick, accurate, and efficient detection of the coagulation state of blood samples in blood collection tubes using a simple method, thus realizing a blood property testing method that can be used for inspecting blood samples in blood collection tubes.

[0043] In another embodiment, the blood properties testing device according to the embodiment of the present disclosure is a blood properties testing device for testing the properties of a blood sample stored in a blood collection tube, and may be configured to include: a sample transport means capable of transporting a blood collection tube in which a blood sample is stored; an ultrasonic probe arranged in the transport path of the sample transport means and capable of transmitting ultrasonic waves to the blood sample in the blood collection tube being transported and receiving reflected waves; an ultrasonic image generation unit that generates an ultrasonic tomographic image of the blood sample based on the reflected waves; and a display unit that displays the generated ultrasonic tomographic image.

[0044] In another embodiment, the blood sample testing image display method according to the embodiment of the present disclosure is a blood sample testing image display method that displays an image used for testing the properties of a blood sample stored in a blood collection tube, wherein a blood collection tube in which a blood sample is stored is transported by a sample transport means, an ultrasonic probe arranged in the transport path of the sample transport means transmits ultrasonic waves to the blood sample in the transported blood collection tube and receives the reflected waves, generates an ultrasonic tomographic image of the blood sample based on the reflected waves, and displays the generated ultrasonic tomographic image on a display.

[0045] With this configuration, the examiner can visually inspect the displayed ultrasound tomography image, search for areas showing coagulation findings in the blood image portion of the tomography image based on the difference in brightness between the area outside the image and the area outside the image, and evaluate the progress of the coagulation reaction in the blood sample in the blood collection tube by observing the proportion of the image area occupied by the blood image portion.

[0046] Furthermore, by using an image display device for blood sample testing to visually inspect the displayed ultrasound tomography image, the examiner can inspect the blood sample in the blood collection tube to be used for testing, thereby preventing blood samples showing coagulation from being used for testing.

[0047] <Embodiment> The blood quality testing device 1 according to this embodiment will be described with reference to the drawings. Note that the drawings are schematic diagrams and their scale may differ from that of actual dimensions. Furthermore, the following description is illustrative to explain the configuration and operation / effects of one aspect of this disclosure and is not limited to the following form except for the essential parts of this disclosure. In addition, the above and below in this specification and claims indicate relative positional relationships, with the direction at the top of the paper being the "up" direction and the direction at the bottom of the paper being the "down" direction in the drawings. Furthermore, the downstream direction along the transport direction of the blood collection tube of the blood quality testing device 1 is the "front" direction and the upstream direction is the "back" direction. However, this does not necessarily coincide with an absolute (vertical) up and down positional relationship. Furthermore, in this specification and claims, the symbol "~" used to indicate a numerical range includes the numerical values ​​at both ends.

[0048] <Configuration of Blood Profile Analysis Device 1> (Overall structure) The configuration of the blood quality testing device 1 will be explained using drawings. The blood quality testing device 1 (hereinafter referred to as "testing device 1") is a coagulation testing device that allows physicians and other medical professionals to examine the coagulation state of blood samples collected in blood collection tubes prior to blood cell count tests, coagulation tests, and fibrinolysis tests, and notify the tester of the test results via a display. It is a device that detects the coagulation state of blood samples in blood collection tubes quickly, accurately, and efficiently using a simple method. By using testing device 1 to inspect blood samples in blood collection tubes, it is possible to prevent blood samples showing coagulation in the blood collection tubes from being used for blood cell count tests, coagulation tests, and fibrinolysis tests.

[0049] Figure 1 is a plan view showing the configuration of the blood properties testing device 1 according to an embodiment, and Figure 2 is a front view.

[0050] As shown in Figures 1 and 2, the testing device 1 comprises a sample transport means 10 for transporting blood collection tubes containing blood samples, an ultrasonic probe 6 arranged in the transport path of the sample transport means 10, an ultrasonic image generation and analysis device 7 that supplies transmission pulses to the ultrasonic probe 6 and generates and analyzes ultrasonic tomographic images based on the signals received from the ultrasonic probe 6 to detect the blood properties of the blood sample, a display 8 for displaying the detection results, and a control unit 9.

[0051] In the sample transport means 10, blood samples are transported in blood collection tubes. A blood collection tube is a cylindrical, transparent glass tube for containing and transporting blood samples. The blood sample is stored inside the tube and then vacuum-sealed with a lid such as a rubber stopper to prevent air from entering the tube. Commonly used blood collection tubes in medical settings can be used. A label with identification information indicating the subject and blood sample collection conditions is affixed to the outer circumference of the blood collection tube. However, the configuration of the blood collection tube is not limited to the above.

[0052] (Overview of the structure of each section) The following describes the general configuration of each unit in the inspection device 1.

[0053] [Specimen transport means 10] The specimen transport means 10 is a mechanism unit that transports blood collection tubes in which blood samples are stored.

[0054] In this embodiment, the sample transport means 10 consists of a plurality of conveyors arranged in series in the transport direction, and is driven based on instructions from the control unit 9 to transport a plurality of blood collection tubes at predetermined intervals from left to right (X direction) in the paper in Figures 1 and 2 (T1 in Figures 1 and 2). At this time, the blood collection tubes are transported in a direction perpendicular to the tube axis. However, the transport direction of the blood collection tubes is not limited to the direction perpendicular to the tube axis; for example, the blood collection tubes may be transported in a direction parallel to the tube axis, or in a direction tilted by several tens of degrees from the direction perpendicular to the tube axis.

[0055] The specimen transport means 10 comprises a pair of rollers 2 and 3, two transport belts 41 and 42 (sometimes collectively referred to as "transport belt 4") suspended between them, a plurality of blood collection tube support rollers 51 to 59 (sometimes collectively referred to as "blood collection tube support roller 5") installed between the transport belts 41 and 42, and a motor 31. Furthermore, it may include a passage detection means 11 positioned at a predetermined location on the transport path to detect the passage of the blood collection tube being transported.

[0056] Rollers 2 and 3 are cylindrical rollers arranged side by side at a predetermined distance apart. Conveyor belts 41 and 42 are belt means suspended from rollers 2 and 3 at a predetermined distance apart and transported at a constant speed. Conveyor belts 41 and 42 may be made of metal, rubber, resin, or a composite material thereof. Roller 3, located on the right side of the paper in Figures 1 and 2, is rotated by motor 31 in the R1 direction in Figure 2, and conveyor belt 4 is transported from the left side to the right (T1) in the paper in Figures 1 and 2, and the roller 2 is configured to rotate in the R2 direction as a result of the transport of conveyor belt 4.

[0057] The blood collection tube support rollers 51-59 are installed side-by-side between the transport belts 41 and 42, with bearings at both axial ends, and are configured to rotate (spin) in the R3 direction in Figure 2 as the transport belts 41 and 42 move in the T1 direction. As a result, a blood collection tube supported between two adjacent blood collection tube support rollers 5 rotates around its axis in the R4 direction in Figure 2 due to the rotation of the blood collection tube support rollers 5 in the R3 direction. Thus, according to the sample transport means 10, the blood collection tube containing the blood sample is transported in the T1 direction perpendicular to the tube axis while rotating around the tube axis, which rotates the blood sample stored inside the blood collection tube and suppresses the progression of blood sample coagulation.

[0058] The motor 31 is driven based on a control signal from the control unit 9 and rotates the roller 3 (drive roller).

[0059] The passage detection means 11 is a blood collection tube passage detection means that is positioned at a predetermined location on the transport path of the sample transport means 10 and detects the passage of the blood collection tube. In this embodiment, the passage detection means 11 is positioned at the same location in the transport direction (X direction) as the transducer (row) 6a of the ultrasonic probe 6, and is configured to detect the timing when the blood collection tube passes below the transducer (row) 6a of the ultrasonic probe 6 on the transport path. For example, the passage detection means 11 can be a reflective or transmissive type light sensor, a laser detector, an image sensor, a line camera, etc. Also, the passage detection means 11 may have a light-emitting unit and a light-receiving unit positioned above and below each other on the transport path.

[0060] [Ultrasound probe 6] In the ultrasonic probe 6 (hereinafter referred to as "probe 6"), multiple ultrasonic transducers 6a (hereinafter referred to as "transducers 6a") made of piezoelectric elements are arranged in a linear row on the tip surface to form a transducer row. The probe 6 is positioned above the transport path of the sample transport means 10 with the transducers 6a facing downwards, with the row of transducers 6a parallel to the tube axis of the blood collection tube transported by the sample transport means 10.

[0061] Specifically, the probe 6 is positioned at a height (Z direction) such that when the position of the transducer (row) 6a on the transport path is the same as the position of the transport tube in the transport direction (X direction), the surface of the transducer 6a faces the surface of the blood collection tube, and the two surfaces are separated by a predetermined distance. As a result, the surface of the transducer 6a is kept in close proximity to the surface of the blood collection tube, but at a very small distance.

[0062] Alternatively, by applying, for example, an ultrasonic gel to the surface of the transducer 6a to a predetermined thickness, the space between the surface of the blood collection tube and the transducer surface of the probe 6 may be filled with ultrasonic gel.

[0063] The probe 6 converts the pulsed electrical signal (hereinafter referred to as the "transmitted signal") supplied from the transmitting / receiving unit 71, described later, into pulsed ultrasound. The probe 6 transmits an ultrasonic beam, consisting of ultrasound waves emitted from multiple transducers 6a, towards the blood sample in the blood collection tube. The probe 6 then receives multiple reflected waves from the blood sample and converts these reflected waves into electrical signals using the multiple transducers 6a, which are then supplied to the transmitting / receiving unit 71 as received signals.

[0064] [Ultrasound Image Generation and Analysis Device 7] The ultrasound image generation and analysis device 7 (hereinafter sometimes referred to as "analyzer 7") is an ultrasound image generation and analysis device that supplies a transmission signal to the probe 6, generates an ultrasound tomographic image based on the signal received from the probe 6, and performs image analysis of the ultrasound tomographic image to detect the blood properties of a blood sample.

[0065] Figure 3 is a functional block diagram showing the configuration of the analyzer 7. As shown in Figure 3, the analyzer 7 includes a transmitting / receiving unit 71, an ultrasound image generation unit 72, a data storage unit 73, and a blood properties detection unit 74.

[0066] Each component of the analytical device 7 can be a single circuit component, or it can be a collection of multiple circuit components.

[0067] The transmitting / receiving unit 71, the ultrasound image generation unit 72, and the blood properties detection unit 74 are each implemented as a computer equipped with, for example, a general-purpose processor such as a CPU (Central Processing Unit) or GPU (Graphics Processing Unit), RAM (Random Access Memory), and a program to be executed on them. Alternatively, they may be implemented using hardware circuits such as FPGA (Field Programmable Gate Array) or ASIC (Application Specific Integrated Circuit).

[0068] Furthermore, the data storage unit 73 is a computer-readable recording medium that stores programs necessary for the operation of the analysis device 7, and also functions as a temporary storage area for temporarily storing received signals and generated ultrasound tomography images. The data storage unit 73 is composed of, for example, volatile memory such as DRAM and non-volatile memory such as a hard disk. Alternatively, the data storage unit 73 may be an external storage device connected to the analysis device 7.

[0069] The following describes the general functions of each unit in the analyzer 7.

[0070] The transmitting / receiving unit 71 controls the timing of high voltage application to each transducer 6a of the probe 6 in order to transmit ultrasound, and based on the reflected ultrasound waves received by the probe 6, amplifies the electrical signals obtained by the multiple transducers 6a, performs A / D conversion, and performs phase-correction summing to generate a received signal which is then output to the next stage. The transmitting / receiving unit 71 causes the probe 6 to transmit ultrasound at predetermined time intervals, such as a few msec, when the position of the blood collection tube in the transport direction (X direction) is the same as the position of the transducer (row) 6a in the X direction, and repeats the above process for each ultrasound transmission to output a received signal for one frame to the next stage.

[0071] The ultrasonic image generation unit 72 performs processing such as envelope detection and logarithmic compression on the received signal, which is the output signal from the transmitting / receiving unit 71, to convert it to brightness, and then converts the brightness signal to a Cartesian coordinate system to generate an ultrasonic tomographic image (B-mode image). Based on the received signal for one frame, the ultrasonic image generation unit 72 generates ultrasonic tomographic image data for one frame and outputs it to the data storage unit 73.

[0072] The data storage unit 73 receives the output of ultrasound tomography images from the ultrasound image generation unit 72 and temporarily stores the ultrasound tomography images frame by frame. At the same time, it stores the images in association with information that identifies the subject or blood sample corresponding to the ultrasound tomography image.

[0073] The blood properties detection unit 74 is a circuit that performs image analysis of the generated ultrasound tomography image to detect the blood properties of a blood sample. The blood properties detection unit 74 includes a brightness parameter calculation unit 741, a coagulation finding region extraction unit 742, and a blood properties output unit 743.

[0074] The luminance parameter calculation unit 741 calculates the luminance parameters of multiple image units contained in the blood image portion corresponding to the blood sample in one frame of the ultrasound tomography image. Identifying the blood image portion involves detecting the tube wall of the blood collection tube in the tomography image and selecting the image portion located inside it to identify the blood image portion corresponding to the blood sample collected in the blood collection tube. The luminance parameters are calculated based on the luminance data values ​​for each image unit contained in the blood image portion. In this case, the luminance data for each image unit may be the average value of the pixel luminance data contained in the image unit. Here, as "image unit," for example, a matrix of square pixels such as 1, 4, 9, 16, 25, 36, or 64 pixels, or for example, a matrix of rectangular pixels consisting of 2 to 100 pixels may be used.

[0075] According to the inventor's research, in ultrasound tomographic images of blood samples taken in blood collection tubes, areas where coagulation has occurred due to a coagulation reaction are recognized as areas in the cross-sectional image of the blood where the difference in brightness from the surrounding area is relatively large. Therefore, by calculating a brightness parameter based on brightness data for each image unit, the coagulation state of the blood sample can be detected using this brightness parameter.

[0076] Next, the coagulation finding region extraction unit 742 identifies a region of the blood image where the brightness parameter satisfies a predetermined standard as a coagulation finding region. Specifically, a region of a predetermined area or larger in the blood image where the difference in brightness parameter value between the region and the area outside the region is above a predetermined threshold may be defined as a coagulation finding region.

[0077] The coagulation reaction in blood samples progresses over time. In the secondary hemostasis stage, fibrogen is activated, forming a network of fibrin where blood cells are trapped, leading to the formation of a coagulated mass. Over time, the number of coagulated masses increases, the volume ratio of coagulated masses in the blood increases, and the coagulated masses combine with each other to form a blood clot. In this specification, the increase in the volume ratio of coagulated masses in the blood is referred to as "coagulation acceleration," and the degree of increase in the volume ratio of coagulated masses in the blood is referred to as the "degree of coagulation acceleration."

[0078] Furthermore, according to the inventors' research, in ultrasound examination of blood samples in blood collection tubes, although the overall brightness of the ultrasound tomography image fluctuates depending on the contact state between the transducer (row) 6a of the probe 6 and the blood collection tube, it has been found that as the coagulation reaction progresses, i.e., as the formation of coagulation clots is accelerated, coagulation clots in the blood are recognized as image areas in the ultrasound tomography image of the blood sample in the blood collection tube where the brightness parameter value is larger than the surrounding area. It has also been found that the acceleration of coagulation clot formation is recognized as an image area where the brightness parameter value is larger than the surrounding area, and as a process of changing from spot-like areas to larger island-like regions.

[0079] Therefore, by identifying island-like regions of a predetermined area or larger where the difference in brightness parameter values ​​from the outside of the region is above a predetermined threshold, and evaluating these coagulation region, the degree of coagulation promotion can be quantitatively detected from ultrasound tomography images of blood samples in blood collection tubes. Here, the "predetermined threshold" for brightness parameters refers to the brightness difference between adjacent image regions on the ultrasound tomography image, which may be approximately 1% when the brightness change range is set to 0-100%. The "predetermined area" refers to the actual area read from the scale on the ultrasound tomography image, for example, approximately 1 mm. 2 That is also acceptable.

[0080] The blood properties output unit 743 outputs the degree of coagulation promotion as the blood properties of the blood sample based on information regarding the coagulation region, as follows:

[0081] For example, the blood properties output unit 743 may specifically derive the degree of coagulation acceleration in the blood image portion based on the area ratio of the coagulation region to the blood image portion. That is, it may calculate the ratio of the total area of ​​the coagulation region to the area of ​​the blood image portion and derive the degree of coagulation acceleration in the blood image portion based on that ratio.

[0082] Alternatively, the blood properties output unit 743 may calculate the maximum value of the brightness parameter in all coagulation area regions and derive the degree of coagulation acceleration as the blood properties of the blood image portion based on the maximum value.

[0083] Alternatively, the blood properties output unit 743 may calculate the integral value of the brightness parameter in all coagulation finding regions and derive the degree of coagulation promotion as the blood properties of the blood image portion based on the integral value.

[0084] This configuration allows for the quantitative expression of the degree of coagulation promotion according to the characteristics of the blood sample in the blood collection tube.

[0085] Information indicating the characteristics of the blood sample, such as a display image showing the coagulation state of the blood sample and information indicating the degree of coagulation, is output to the display unit 8. In addition, this information may be output to and stored in a storage device.

[0086] [others] The display unit 8 is, for example, a display device (monitor) such as a liquid crystal display. The display unit 8 displays information that identifies the subject and the blood sample, an ultrasound image of the blood sample in the blood collection tube that is being tested, and a display image and information representing the coagulation state of the blood sample.

[0087] The control unit 9 is electrically connected to the sample transport means 10, the probe 6, the analyzer 7, and the passage detection means 11, and outputs control signals to control the operation of each unit.

[0088] The control unit 9 is implemented, for example, as a computer equipped with a general-purpose CPU, RAM, and a program to be executed on them. The control unit 9 reads a control program for the inspection device 1 from a storage device or the like into RAM and executes it, thereby controlling each unit constituting the inspection device 1 to operate in coordination with each other, and realizing the functions of the inspection device 1.

[0089] Figure 4(a) is a photograph showing the results of a preliminary experiment corresponding to the testing device 1, and (b) is a photograph showing the results of the assessment using a microscope. As shown in Figure 4(b), fibrin deposition is observed in the microscope image and is judged to be a coagulation finding. In contrast, as shown in Figure 4(a), in the ultrasound tomography image obtained by the testing device 1, multiple areas that appear to be coagulation findings are confirmed in the tomography image of the blood sample in the blood collection tube, and coagulation findings can be read from the ultrasound tomography image.

[0090] Figure 5 is a schematic diagram showing the flow of testing in the blood characteristics specimen testing process using the testing device 1. As described above, the testing device 1 can detect the coagulation state of blood samples in blood collection tubes quickly, accurately, and efficiently using a simple method. Therefore, by using the testing device 1 to inspect blood samples in blood collection tubes that are to be used for blood sample testing in the blood characteristics specimen testing process, it is possible to prevent blood samples showing coagulation in the blood collection tubes from being used for blood cell count tests, coagulation system tests, and fibrinolysis system tests.

[0091] <Regarding the operation of inspection device 1> Next, we will explain the operation of the inspection device 1.

[0092] In the testing device 1, while the sample transport means 10 is moving the blood collection tube containing the blood sample in the T1 direction perpendicular to the tube axis while rotating around the tube axis, the control unit 9 outputs a control signal to the probe 6 based on the receipt of a signal from the passage detection means 11 that the tube has passed, causing ultrasound to be transmitted and received between the probe 6 and the blood sample in the tube. The analyzer 7 generates an ultrasound tomographic image based on the acquired ultrasound received signal, detects the blood properties of the blood sample based on the tomographic image, and the display unit 8 displays the test results.

[0093] The following describes in detail the detection operation of blood characteristics of blood samples based on ultrasound tomography images in the analyzer 7, using diagrams.

[0094] Figure 6 is a flowchart showing the processing in the blood properties detection unit 74 of the analyzer 7.

[0095] First, one frame of ultrasound tomography is read from the data storage unit 73 (step S1), and the portion of the blood image corresponding to the blood sample collected inside the blood collection tube is identified by detecting the tube wall of the blood collection tube in the tomography image (step S2). At this time, along with the ultrasound tomography image, information identifying the subject and blood sample corresponding to the ultrasound tomography image is also read out simultaneously.

[0096] Alternatively, the ultrasound tomography images for multiple frames acquired in a time series may be read out, the blood image portion in each ultrasound tomography image may be identified, and the ultrasound tomography image with the largest blood image portion may be selected as the examination target, as it was acquired at a timing when the position of the blood collection tube in the transport direction (X direction) was the same as the position of the transducer (row) 6a in the X direction.

[0097] Next, brightness parameters corresponding to image units within the blood image portion are calculated (step S3). Specifically, brightness parameters are calculated based on brightness data values ​​for each of the multiple image units contained in the blood image portion corresponding to the blood sample in one frame of ultrasound tomography. At this time, the brightness data for each image unit may be the average value of the pixel brightness data contained in the image unit. In addition, the pixel brightness data or the brightness data for each image unit may be subjected to, for example, thresholding, bright spot or region extraction, edge detection, edge enhancement, contour extraction, and image transformation processing combining these.

[0098] Next, a region of the blood image where the brightness parameter satisfies a predetermined standard is identified as the coagulation region, for example, a region of a predetermined area or larger in the blood image where the difference in brightness parameter value between the region and the area outside the region is greater than or equal to a predetermined threshold (step S4). Here, the identification of the coagulation region may be carried out by the following steps 1) to 4).

[0099] 1) Calculate the maximum point within the blood image portion of the brightness parameters corresponding to the image unit calculated in step S3.

[0100] 2) Focus on a matrix-like pixel region containing an image unit that indicates a maximum point. For image units located on the outer edge of the pixel region, calculate the difference in luminance parameter values ​​between them and adjacent image units outside the region. If this difference is below a predetermined threshold, incorporate the adjacent image units into the pixel region. In this case, the average value of the difference in luminance parameter values ​​between image units included in the pixel region may be used as the threshold.

[0101] 3) For each captured image unit, the difference in luminance parameter value between it and an adjacent image unit outside the region is calculated to determine whether it exceeds a threshold. If it is below the threshold, the adjacent image unit is incorporated into the pixel region.

[0102] 4) Repeat the same process until the difference in luminance parameter values ​​between the region and adjacent image units outside the region exceeds a threshold, and define the pixel region containing the captured region as the coagulation region.

[0103] As described above, in ultrasound images of blood samples in a blood collection tube, as the coagulation reaction progresses, i.e., as the formation of a coagulation clot is accelerated, the areas with higher brightness parameters than the surrounding areas change from spotty to larger island-like areas. Therefore, the degree of coagulation reaction progression in the blood sample in the blood collection tube, i.e., the degree of coagulation clot acceleration, can be quantitatively represented based on the blood image portion, using coagulation areas of a predetermined size or larger where the difference in brightness parameter values ​​with respect to the surrounding area is above a predetermined threshold.

[0104] Next, the blood properties output unit 743 outputs the degree of coagulation acceleration as the blood properties of the blood image portion (step S5). At this time, for example, the degree of coagulation acceleration of the blood sample may be output based on the area ratio of the coagulation finding region to the blood image portion. Alternatively, the degree of coagulation acceleration of the blood sample may be output based on the maximum value of the brightness parameter in all coagulation finding regions. Alternatively, the degree of coagulation acceleration of the blood sample may be output based on the integral value of the brightness parameter in all coagulation finding regions.

[0105] Finally, the results of the blood properties are output (step S6), and the display unit 8 displays information identifying the subject and blood sample, an ultrasound image of the blood sample in the blood collection tube that is being tested, and a display image and information representing the coagulation state of the blood sample, and then the processing operation of the analyzer 7 is completed.

[0106] <Evaluation Test> The following describes preliminary experiments and performance evaluation tests using the inspection apparatus 1 corresponding to the embodiment and comparative examples. The results are described below.

[0107] [Evaluation Test 1] We observed the coagulation process over a time axis, using a single blood sample obtained from a healthy individual, allowing it to stand until it coagulated.

[0108] Blood samples were collected using a 5 mL syringe, dispensed into a plate at a time of 1 mL, and then dispensed into a 5 mL LEDTA-filled blood collection tube at each time point corresponding to the blood coagulation time course (blood samples left standing for 0, 10, 15, 20, and 25 minutes). The presence or absence of coagulation findings was determined based on ultrasound imaging and microscopic images. In addition, the presence or absence of errors in the hematology analyzer during blood cell counting tests and the blood cell counts (red blood cell count, white blood cell count, platelet count) were measured.

[0109] Figure 7 is a schematic diagram showing the configuration of the experimental apparatus in a preliminary experiment corresponding to blood quality testing device 1 used in the evaluation test. Using an ultrasound diagnostic device manufactured by Fujifilm Corporation, an ultrasound tomographic image was acquired by pressing the transducer 6a of probe 6 against the blood collection tube, and the coagulation findings (ultrasound examination findings) were determined by interpreting the ultrasound tomographic image, which served as a preliminary experiment corresponding to testing device 1. In the preliminary experiment, no ultrasound gel was filled between the blood collection tube and the transducer 6a of probe 6.

[0110] Furthermore, microscopic examination was performed to determine coagulation findings, and this was used as a comparative example. Blood cell counts were also measured using a hemocytometer, and the presence or absence of errors in the hemocytometer was investigated.

[0111] Figures 8(a) to (e) are photographs showing the results of a preliminary experiment corresponding to testing device 1, in which blood samples obtained from healthy individuals were captured using an ultrasound diagnostic device to acquire ultrasound tomographic images of blood samples in blood collection tubes, and coagulation findings (ultrasound findings) were determined by interpreting the ultrasound tomographic images.

[0112] Figures 9(a) to (e) are photographs showing the results of microscopic examination of blood samples obtained from healthy individuals to determine coagulation findings (microscopic findings).

[0113] Figure 10 shows the test results of blood samples obtained from healthy individuals, where WBC represents the white blood cell count (×10).2 ( / μl), RBC is the red blood cell count (×10 4 Hb is hemoglobin concentration (g / dl), Ht is hematocrit concentration (%), MCV is mean corpuscular volume (fl), and Plt is platelet count (×10⁻¹⁰). 4 The values ​​shown (per μl) indicate the presence or absence of fibrin deposition in the smear as microscopic findings, the presence or absence of errors in the hematology analyzer during peripheral blood testing, and the degree of coagulation acceleration as read from the ultrasound tomography as ultrasound findings.

[0114] First, regarding the measurement results of platelet count (Plt), as shown in Figure 10, the blood samples left for 10, 15, and 20 minutes showed a platelet count of 21.8 (×10) compared to the blood sample left for 0 minutes (pre-standing sample). 4 For ( / μl), 15.2, 15.5, 14.7, 0.7 (×10 4 The values ​​have decreased to ( / μl). The normal range for platelets is usually 15-33 (×10 4 While the measurement is given per μL, it is thought that in blood samples left for 10, 15, and 20 minutes, the measured platelet count is lower than the true platelet count in the blood due to the aggregation of blood cells observed in the blood coagulation reaction.

[0115] Next, regarding the microscopic findings, as shown in Figures 9 and 10, no coagulation findings were observed in blood samples left for 0, 10, 15, and 20 minutes, while fibrin precipitation and coagulation findings were observed only in the blood sample left for 25 minutes.

[0116] Furthermore, as shown in Figure 10, no errors occurred in the hemocytometer for blood samples left for 0, 10, 15, and 20 minutes, and errors occurred only in the blood sample left for 25 minutes.

[0117] As a result, it can be said that, even with conventional microscopic examination findings, it is possible to ensure that the blood cell analyzer operates correctly during peripheral blood testing, although there is little margin for error in the blood cell analyzer.

[0118] In contrast, in a preliminary experiment corresponding to blood characteristic testing device 1, as shown in Figure 8, the coagulation state of the blood sample inside the blood collection tube could be observed using ultrasound imaging without being affected by the material or label of the blood collection tube. In the obtained ultrasound findings, as shown in Figures 8 and 10, the blood image portion was uniform and no coagulation findings were observed in the blood sample left for 0 minutes.

[0119] On the other hand, blood samples left for 10, 15, 20, and 25 minutes showed "non-uniform characteristics" in the blood image area. Specifically, in the tomographic images of the blood samples, multiple areas that appear to be coagulation regions were identified as areas with higher brightness than the surrounding areas within the blood image. Furthermore, the number of areas that appear to be coagulation regions increased with increasing waiting time, and as a result, the ratio of the area occupied by coagulation regions to the blood image area increased.

[0120] These results confirm that ultrasound examination can detect minute blood coagulation reactions occurring in blood samples left for 10, 15, and 20 minutes, which cannot be observed by microscopic examination alone.

[0121] In particular, ultrasound examination allows for the determination of coagulation findings in blood samples left for 10, 15, and 20 minutes, and therefore, 15.2~14.7 (×10) in the same blood sample. 4 It was confirmed that a decrease in platelet count within the range of ( / μL) can be detected, and that ultrasound findings can detect fibrin precipitation and hemagglutination, which are signs of blood coagulation that are often overlooked by microscopic findings.

[0122] From these results, it can be seen that, when examining blood samples obtained from healthy individuals, ultrasound findings equivalent to preliminary experiments with testing device 1 can detect even minute blood coagulations compared to conventional microscopic findings. This allows for a more lenient determination of the error level of the hematological analyzer necessary for the proper operation of the hematological analyzer during peripheral blood testing.

[0123] [Evaluation Test 2] Using three blood samples obtained from patients (samples determined to have coagulation), the coagulation findings on the time axis until coagulation occurred after leaving them standing were observed.

[0124] Figures 11(a) to (c) are photographs showing the results of imaging ultrasonic tomographic images of blood samples in blood collection tubes using an ultrasonic diagnostic apparatus as a preliminary experiment corresponding to the inspection apparatus 1, and determining the coagulation findings (ultrasonic examination findings) by reading the ultrasonic tomographic images, using blood samples obtained from patients.

[0125] Figures 12(a) to (c) are photographs showing the results of determining the coagulation findings (microscopic examination findings) by microscopic examination of blood samples, using blood samples obtained from patients.

[0126] Figure 13 is a diagram showing the test results of blood samples obtained from patients, and shows the same items as in Figure 10.

[0127] First, as shown in Figure 13, for the measurement results of the platelet count (Plt), in the blood samples of Patients No. 1 and 2, they were 19.1 and 17.3 (×10 4 / μl), and in the blood sample of Patient No. 3, it was 1.5 (×10 4 / μl).

[0128] Next, regarding the microscopic examination findings, as shown in Figures 12 and 13, no coagulation findings were seen in the blood sample of Patient No. 1, and blood cell aggregation due to fibrin deposition was observed and coagulation findings were seen in the blood samples of Patients No. 2 and 3.

[0129] On the other hand, as shown in Figure 13, there were no errors in the blood cell measuring device for the blood samples of Patients No. 1 and 2, and an error occurred in the blood cell measuring device only in the blood sample of Patient No. 3. That is, for the blood samples obtained from patients, in the blood sample of Patient No. 2, no coagulation findings were seen in the microscopic examination, but an error occurred in the blood cell measuring device.

[0130] From this, microscopic examination of the blood samples obtained from the patient reveals that the necessary tests for determining the error level of the hematological analyzer, which is essential for the proper operation of the hematological analyzer during peripheral blood testing, have not been performed.

[0131] In contrast, as shown in Figures 11 and 13, ultrasound examination findings revealed "heterogeneous characteristics" in the blood image portion of all blood samples from patients No. 1, 2, and 3. Multiple coagulation regions were identified in the blood image portion, which were recognized as areas with higher brightness than the surrounding areas, indicating coagulation findings.

[0132] These results confirm that ultrasound findings, compared to microscopic findings, can detect minute blood coagulation reactions occurring in the blood samples of patients No. 1 and 2.

[0133] Furthermore, ultrasound findings revealed a 17.3 (×10) value in the blood sample of patient No. 2, which could not be detected by microscopic examination. 4 The coagulation findings in blood samples from patients No. 1 and 2, including a decrease in platelet count (value of / μL), can be assessed. This confirmed that ultrasound examination can detect fibrin precipitation and hemagglutination, which are observed in blood coagulation reactions and may be missed by microscopic examination.

[0134] From these results, it can be seen that, for blood samples obtained from patients, ultrasound examination findings, which are equivalent to preliminary experiments with testing device 1, can detect even minute blood coagulation reactions than microscopic examination findings. This allows for a safer determination of the error level of the hematological analyzer necessary for the normal operation of the hematological analyzer in blood cell count tests.

[0135] As described above, in the process of blood specimen testing, by using the testing device 1 to inspect blood specimens in blood collection tubes that are to be used for blood specimen testing, it is possible to prevent blood specimens showing coagulation in the blood collection tube from being used for blood cell count tests, coagulation tests, and fibrinolysis tests.

[0136] <Summary> As described above, the blood properties testing device 1 according to the embodiment is a blood properties testing device 1 for testing the properties of a blood sample stored in a blood collection tube, and is characterized by comprising: a sample transport means 10 capable of transporting a blood collection tube in which a blood sample is stored; a probe 6 arranged in the transport path of the sample transport means 10 and capable of transmitting ultrasound to the blood sample in the transported blood collection tube and receiving reflected waves; an ultrasound image generation unit 72 that generates an ultrasound tomographic image of the blood sample based on the reflected waves; and a blood properties detection unit 74 that detects the blood properties of the blood sample based on the generated ultrasound tomographic image.

[0137] As mentioned above, conventional testing methods that involve irradiating blood collection tubes with light to examine the blood inside have low sensitivity in detecting the coagulation state of blood samples within the tubes, and there is a problem in that it is difficult to detect minute coagulation clots, which are hematological aggregates formed by fibrin precipitation.

[0138] In contrast, the inspection device 1 with the above configuration can detect blood coagulations that are smaller than those found in conventional microscopic examinations, and it is possible to determine the error level of the blood cell analyzer necessary for the proper operation of the blood cell analyzer during peripheral blood testing with greater safety. Therefore, it is possible to detect the coagulation state of blood samples in blood collection tubes quickly, accurately, and efficiently using a simple method, and a blood properties testing device that can be used for inspecting blood samples in blood collection tubes can be provided.

[0139] Furthermore, the blood properties detection unit 74 may be configured to calculate the brightness parameters of multiple image units included in the blood image portion corresponding to the blood sample in the ultrasound tomography image, and to identify the region of the blood image portion in which the brightness parameters satisfy a predetermined standard as a coagulation finding region.

[0140] With this configuration, the areas in a blood sample where coagulation has occurred due to a coagulation reaction will be areas in the cross-sectional image of the blood where the difference in brightness from the surrounding area is relatively large. For example, by calculating a brightness parameter based on the brightness value of each image unit, the coagulation state of the blood sample can be detected using the brightness parameter.

[0141] Furthermore, the coagulation region may be defined as a region of a predetermined area or larger in the blood image portion where the difference in brightness parameters between the region and the area outside the region is above a predetermined threshold.

[0142] With this configuration, as the coagulation reaction progresses in the blood sample within the blood collection tube, i.e., as the formation of a coagulation clot is accelerated, the areas with higher brightness parameters than the surrounding areas change from spot-like to larger island-like areas. Therefore, the degree of coagulation reaction progression in the blood sample within the blood collection tube, i.e., the degree of coagulation clot acceleration, can be quantitatively represented based on the blood image portion, using coagulation findings areas of a predetermined size or larger where the difference in brightness parameter values ​​with respect to the outside of the area is above a predetermined threshold.

[0143] ≪Variations≫ The specific configuration of this disclosure has been described above using embodiments as examples. However, this disclosure is not limited in any way to the embodiments described above, except for its essential characteristic components. For example, forms obtained by applying various modifications to the embodiments, and forms realized by arbitrarily combining the components and functions of each embodiment without departing from the spirit of the present invention are also included in this disclosure.

[0144] Below, we will describe a variation as an example of such a form. (1) In the above embodiment, the inspection device 1 is equipped with an ultrasonic image generation and analysis device 7 that generates and analyzes ultrasonic tomographic images based on signals received from an ultrasonic probe 6 to detect the blood properties of a blood sample. The blood properties detection unit 74 of the ultrasonic image generation and analysis device 7 performs image analysis of the generated ultrasonic tomographic images to detect and output the blood properties of the blood sample.

[0145] In contrast, as a modified version of the blood characteristic testing device 1, the configuration may consist of an image display device for blood sample testing equipped with an ultrasonic image generator 7A, which is an ultrasonic image generator 7 from which the blood characteristic detection unit 74 has been removed, instead of the ultrasonic image generator 7.

[0146] In other words, the modified image display device for blood sample testing is an image display device for blood sample testing that displays an image used for testing the properties of a blood sample stored in a blood collection tube, and comprises a sample transport means 10 capable of transporting a blood collection tube in which a blood sample is stored, an ultrasonic probe 6 arranged in the transport path of the sample transport means and capable of transmitting ultrasonic waves to the blood sample in the transported blood collection tube and receiving reflected waves, an ultrasonic image generation unit 7A that generates an ultrasonic tomographic image of the blood sample based on the reflected waves, and a display unit 8 that displays the generated ultrasonic tomographic image.

[0147] In the image display device for blood sample testing, the components other than the ultrasound image generation unit 7A, namely the sample transport means 10, the ultrasound probe 6, and the display unit 8, are the same as those in the testing device 1, so their explanation will be omitted.

[0148] The ultrasound image generation unit 7A is a circuit that supplies a transmission signal to the probe 6, generates an ultrasound tomography image based on the received signal from the probe 6, and outputs the generated ultrasound tomography image to the display unit 8. Figure 14 is a functional block diagram showing the configuration of the ultrasound image generation unit 7A. As shown in Figure 14, the ultrasound image generation unit 7A has the same configuration as the transmitting / receiving unit 71, ultrasound image generation unit 72, and data storage unit 73 in the ultrasound image generation and analysis device 7 of the inspection device 1.

[0149] According to the image display device for blood sample testing having the above configuration, in the operation state in which the sample transport means 10 transports the blood collection tube containing the blood sample in the T1 direction perpendicular to the tube axis while rotating around the tube axis, the probe 6 transmits and receives ultrasound between the probe and the blood sample in the blood collection tube, the ultrasound image generation unit 7A generates an ultrasound tomography image based on the acquired ultrasound received signal, and the ultrasound tomography image including the blood image portion corresponding to the blood sample in the blood collection tube can be displayed on the display unit 8.

[0150] As described above, in ultrasound images of blood samples taken inside a blood collection tube, areas where coagulation has occurred due to the coagulation reaction are visible to the examiner as areas with a relatively large difference in brightness compared to the surrounding area in the cross-sectional image of the blood. As the coagulation reaction progresses, the areas with higher brightness than the surrounding area in the blood image portion of the ultrasound image of the blood sample taken inside the blood collection tube change from spot-like areas to larger island-like areas.

[0151] Therefore, by displaying the ultrasound tomography image of the blood sample in the blood collection tube on the display unit 8, the examiner can visually inspect the ultrasound tomography image and identify the image area corresponding to a coagulation finding region in the blood image portion of the tomography image where the difference in brightness from the outside of the region is above a predetermined threshold and the area is above a predetermined size. By observing the proportion of the image area occupied by the blood image portion, the progress of the coagulation reaction in the blood sample in the blood collection tube can be evaluated.

[0152] Here, visual identification of the image region corresponding to the coagulation region may be performed, for example, by interpretation criteria that show the characteristics of the coagulation region. For example, multiple reference sample images of the image region corresponding to the coagulation region may be prepared according to the degree of coagulation acceleration, and the examiner may perform the identification by simultaneously visually comparing the ultrasound tomography image displayed on the display unit 8 with the reference sample images.

[0153] Furthermore, by using an image display device for blood sample testing to visually inspect the ultrasound tomography image displayed on the display unit 8, the examiner can inspect the blood sample in the blood collection tube to be used for sample testing, thereby preventing blood samples showing coagulation in the blood collection tube from being used for blood cell count tests, coagulation tests, and fibrinolysis tests. (2) In the above embodiment, the inspection device 1 is configured to detect the blood properties of the blood sample in the blood collection tube based on an ultrasound tomographic image acquired at a timing when the position of the blood collection tube in the transport direction (X direction) is the same as the position of the transducer (row) 6a in the X direction.

[0154] However, the probe 6 may be configured to transmit and receive ultrasound signals multiple times between the probe 6 and the blood sample inside the blood collection tube while the blood collection tube is rotated, and the ultrasound image generation unit 72 may be configured to generate ultrasound tomographic images of the blood sample at multiple cross-sections with different rotational angle phases around the tube axis inside the blood collection tube.

[0155] This configuration makes it possible to detect blood properties based on ultrasound images of different cross-sections of a single blood sample, enabling more accurate examination of blood samples in blood collection tubes at multiple cross-sections.

[0156] Furthermore, by rotating the blood collection tube and performing multiple ultrasound transmissions and receptions between the tube and the blood sample inside, a large number of 2D cross-sectional images, for example 500 to 100, with different rotational angles and phases around the tube axis inside the tube, can be generated. These images can then be plotted in 3D for each pixel, thereby generating 3D volume data of the blood sample inside the blood collection tube. This makes it possible to observe the blood sample inside the blood collection tube in a more three-dimensional way, and to examine the blood sample inside the blood collection tube with greater accuracy.

[0157] Alternatively, an image may be generated by integrating or averaging multiple 2D cross-sectional images. By removing measurement noise, it becomes possible to improve measurement accuracy. (3) In another embodiment, a reactive substance may be attached to the inner wall of the blood collection tube, and ultrasound waves may be irradiated from the outside to acquire an ultrasound tomographic image. This makes it possible to detect blood substances that are difficult to image with conventional ultrasound tomographic images, as well as minute amounts of blood substances. (4) In another embodiment, the blood properties may be observed using ultrasound imaging, and the detection results may be used for disease evaluation and diagnosis. (5) In another embodiment, disseminated intravascular coagulation (DIC) and other conditions may be diagnosed using carotid ultrasound and used for physiological function testing.

[0158] ≪Additional Information≫ The embodiments described above all represent preferred specific examples of the present invention. The numerical values, shapes, materials, components, arrangement and connection configurations of components, processes, and order of processes shown in the embodiments are examples only and are not intended to limit the present invention. Furthermore, components in the embodiments that are not described in the independent claims representing the highest-level concept of the present invention are described as any components that constitute a more preferred form.

[0159] Furthermore, the order in which the above methods are performed is illustrative for the purpose of specifically illustrating the present invention, and may be performed in a different order. Also, some of the above methods may be performed simultaneously (in parallel) with other methods.

[0160] Furthermore, for the sake of easier understanding of the invention, the scale of the components shown in the figures of each embodiment described above may differ from that of the actual components. Moreover, the present invention is not limited by the descriptions of each embodiment described above, and can be modified as appropriate without departing from the spirit of the invention.

[0161] Furthermore, at least some of the functions of each embodiment and its modified form may be combined. [Industrial applicability]

[0162] A blood properties testing device and blood properties testing method according to one aspect of this disclosure can be widely used as a means of testing the coagulation state of a blood sample. [Explanation of Symbols]

[0163] 1. Blood characteristic analysis device 10. Specimen transport means 2. Roller (driven) 3 Rollers (Drive) 31 Motor 4. Conveyor belt 5 (51, 52, 53, 54, 55, 56, 57, 58, 59) Blood collection tube support roller 11. Passage detection means 6. Ultrasound probe 7. Ultrasonic Image Generation and Analysis Device 7A Ultrasonic image generation device 71 Transmitter / Receiver 72 Ultrasound Image Generation Unit 73 Data Storage Unit 74 Blood properties detection unit 741 Brightness parameter calculation unit 742 Coagulation finding region extraction part 743 Blood property derivation section 8 Display 9. Control Unit

Claims

1. A blood characteristics testing device for examining the characteristics of a blood sample collected in a blood collection tube, A specimen transport means capable of transporting a blood collection tube containing a blood sample, An ultrasonic probe is placed in the transport path of the specimen transport means and is capable of transmitting ultrasonic waves to the blood specimen in the collection tube being transported and receiving reflected waves. An ultrasound image generation unit that generates an ultrasound tomographic image of the blood sample based on the reflected wave, A blood properties detection unit detects the blood properties of the blood sample based on the generated ultrasound tomography image. A blood properties testing device equipped with the following features.

2. The blood properties detection unit calculates brightness parameters for multiple image units included in the blood image portion corresponding to the blood sample in the ultrasound tomography image, and identifies the region of the blood image portion where the brightness parameters satisfy a predetermined standard as a coagulation finding region. The blood properties testing apparatus according to claim 1.

3. The coagulation region is a region in the blood image portion that has a predetermined area or larger in which the difference in brightness parameters between the coagulation region and the area outside the coagulation region is equal to or greater than a predetermined threshold. The blood properties testing apparatus according to claim 2.

4. The blood properties detection unit derives the degree of coagulation promotion as the blood properties of the blood image portion based on the area ratio of the coagulation finding region to the blood image portion. The blood properties testing apparatus according to claim 2.

5. The blood properties detection unit derives the degree of coagulation promotion as the blood properties of the blood image portion based on the maximum value of the brightness parameter in the coagulation finding region. The blood properties testing apparatus according to claim 2.

6. The blood properties detection unit derives the degree of coagulation promotion as the blood properties of the blood image portion based on the integral value of the brightness parameter in the coagulation finding region. The blood properties testing apparatus according to claim 2.

7. The specimen transport means transports the blood collection tube in a direction perpendicular to the tube axis while rotating the blood collection tube around the tube axis. The blood properties testing apparatus according to claim 1.

8. The specimen transport means has a plurality of collection tube support rollers arranged parallel to the tube axis of the collection tube and rotating in conjunction with the transport operation of the collection tube. The blood collection tube rotates around its axis due to the rotation of the blood collection tube support roller. The blood properties testing apparatus according to claim 7.

9. The ultrasound probe transmits and receives ultrasound signals multiple times to and from the blood sample in the blood collection tube. The ultrasound image generation unit generates ultrasound tomographic images of the blood sample in multiple cross-sections with different rotational angle phases around the tube axis within the blood collection tube. The blood properties detection unit detects the blood properties of the blood sample based on a plurality of ultrasound tomographic images. The blood properties testing apparatus according to claim 7.

10. A blood sample testing image display device that displays an image used for testing the properties of a blood sample collected in a blood collection tube, A specimen transport means capable of transporting a blood collection tube containing a blood sample, An ultrasonic probe is placed in the transport path of the specimen transport means and is capable of transmitting ultrasonic waves to the blood specimen in the collection tube being transported and receiving reflected waves. An ultrasound image generation unit that generates an ultrasound tomographic image of the blood sample based on the reflected wave, Display unit for displaying the generated ultrasound tomography image An image display device for blood sample testing equipped with the following features.

11. A blood characteristics test method for examining the characteristics of a blood sample collected in a blood collection tube, The specimen transport means transports the blood collection tube containing the blood sample in a transportable manner. An ultrasonic probe positioned along the transport path of the sample transport means transmits ultrasonic waves to the blood sample in the blood collection tube being transported and receives the reflected waves. Based on the reflected waves, an ultrasound tomographic image of the blood sample is generated. Based on the generated ultrasound tomography image, the characteristics of the blood sample are detected. Methods for blood type testing.

12. In detecting the blood properties, brightness parameters are calculated for multiple image units included in the blood image portion corresponding to the blood sample in the ultrasound tomography image, and the region of the blood image portion where the brightness parameters satisfy a predetermined standard is identified as a coagulation finding region. The blood characteristics test method according to claim 11.

13. In identifying the coagulation region, the coagulation region is defined as an area of ​​a predetermined size or larger in the blood image portion where the brightness difference from the surrounding area is greater than or equal to a predetermined value. The blood characteristics test method according to claim 12.

14. A blood sample testing image display method for displaying images used for testing the properties of blood samples collected in blood collection tubes, The specimen transport means transports the blood collection tube containing the blood sample in a transportable manner. An ultrasonic probe positioned along the transport path of the sample transport means transmits ultrasonic waves to the blood sample in the blood collection tube being transported and receives the reflected waves. Based on the reflected waves, an ultrasound tomographic image of the blood sample is generated. The generated ultrasound tomography image is displayed on the display unit. Image display method for blood sample testing.

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