Blood collection device and blood collection method

Abstract

The present invention provides a blood collection device and a blood collection method capable of fixing a finger of a blood collection subject to a puncture needle or a blood collection tube within a prescribed range regardless of individual differences, and performing accurate puncture of the puncture needle and compressing of the blood collection tube to a desired target position of the fingertip, and quick collection of blood from the puncture site. This blood collection device comprises: a puncture means (110) for puncturing fingers; a compression means (13) for compressing the fingers; a control unit; a detection means (19) for detecting a state related to blood flow of the fingers; and a detection means for detecting an output state by the compression means (13), wherein the control unit sets a condition for compressing according to at least one of the size and shape of the fingers, and controls the output by the compression means (13) on the basis of the state related to the blood flow of the fingers and the output state of compressing the fingers. This blood collection method sets a compression condition according to at least one of the size and the shape of the finger, and adjusts the compression force on the basis of the state related to the blood flow of the fingers and a compression state in which the fingers are compressed.

Description

Blood collection device and blood collection method

[0001] The present invention relates to a blood sampling device and a blood sampling method for sampling blood from the fingers of a subject.

[0002] Blood collection devices that automatically collect blood from the fingers of a recipient have been developed. Some blood collection devices automatically collect blood by placing the recipient's fingers in a designated finger rest, automatically puncturing the fingers with a puncture needle, and collecting blood that flows out from the puncture site into a blood collection tube. In this type of blood collection device, the positions of the puncture needle that punctures the finger and the blood collection tube that collects the blood are controlled relative to the fingers placed in the finger rest, thereby automatically collecting blood.

[0003] Patent Document 1 describes a blood collection device that automatically collects blood from a subject's finger. This blood collection device is configured so that the finger from which blood is to be collected is inserted into a hole in a finger clamping mechanism, the fingertip is placed on the blood collection window, and the fingertip is fixed to the blood collection window 140 by closing the finger holding mechanism. A perforator holder containing a puncture needle is configured to rise from below the finger to puncture it. The finger clamping mechanism is configured to adjust the air pressure inside the cuff.

[0004] Patent No. 6994910

[0005] A blood collection device that automatically collects blood from a subject's finger is desired to have a function for targeting a specific blood vessel with a puncture needle. Finger blood collection tends to collect a small amount of blood per collection. Therefore, to ensure the amount of blood needed for blood testing, it is necessary to puncture a large blood vessel or a blood vessel with a large blood flow. It is necessary to detect the blood vessels running through the fingertip and align the puncture needle with the blood vessel that is suitable for blood collection.

[0006] However, there is a problem that if the subject's fingers placed on the finger rest move when the puncture needle is inserted, it becomes difficult to insert the needle into the target puncture position. Furthermore, when the blood collection tube is pressed from below against the puncture site on the fingertip, it is necessary to align the opening of the blood collection tube with the puncture site. Also, when blood is collected into the blood collection tube, there is a problem that if the subject's fingers placed on the finger rest move, it becomes difficult to collect the blood flowing out from the puncture site into the blood collection tube.

[0007] When aligning the puncture needle or blood collection tube, it is important to apply pressure to the subject's fingers placed in the finger rest area with a predetermined load or more to fix them within a predetermined range. By applying sufficient pressure to the fingers and restraining the fingertip within a predetermined range, it is desirable to determine the positional relationship between the target puncture position set on the fingertip and the arrival position of the puncture needle or blood collection tube.

[0008] Generally, methods for immobilizing the fingers of a blood sample recipient include compressing the fingers with a finger clamp or cuff. However, there are individual differences in the thickness, thickness, flexibility, firmness, etc. of the fingers of the blood sample recipient. Simply compressing the fingers of a blood sample recipient with a uniform load can cause a problem in that the positional relationship between the target puncture position and the arrival position of the puncture needle or blood collection tube can shift due to individual differences in the fingers.

[0009] Furthermore, when inserting a puncture needle or collecting blood into a blood collection tube, it is desirable to compress the recipient's fingers to cause blood to stagnate in order to promote bleeding from the puncture site. Simply compressing the recipient's fingers with a uniform load may result in insufficient bleeding from the puncture site due to individual differences in the fingers. In Patent Document 1, the amount of blood from the puncture site is detected, and blood is collected while the fingertip is stagnate. However, this method of detecting the amount of blood bleeding from the puncture site makes it difficult to address issues caused by individual differences in the fingers.

[0010] Therefore, an object of the present invention is to provide a blood collection device and a blood collection method that can fix the fingers of a person to be blood-collected within a predetermined range relative to the puncture needle and blood collection tube regardless of individual differences, and can accurately puncture the puncture needle or press the blood collection tube against the desired target position on the fingertip, and quickly collect blood from the puncture site.

[0011] In order to solve the above problems, the blood collection device of the present invention is a blood collection device comprising: a puncturing means for inserting a puncture needle into a finger of a person to be blood-collected; a compressing means for compressing the finger; a control unit for controlling the operation of the puncturing means and the compressing means; a first detection means for detecting the condition of the finger; and a second detection means for detecting the output state of compressing the finger by the compressing means, wherein the control unit sets output conditions for compressing the finger by the compressing means according to at least one of the size of the finger of the person to be blood-collected and the shape of the finger of the person to be blood-collected, and controls the output of compressing the finger by the compressing means based on the detection results of the condition of the finger and the detection results of the output state of compressing the finger by the compressing means under the setting of the output conditions.

[0012] Furthermore, the blood collection method of the present invention is a blood collection method comprising a puncturing step of inserting a puncture needle into the fingers of a person to be collected, and a compressing step of compressing the fingers, wherein the compression conditions for compressing the fingers are set according to at least one of the size and shape of the fingers of the person to be collected, and the compression force for compressing the fingers under the set compression conditions is adjusted based on the condition of the fingers and the compression state for compressing the fingers.The blood collection method of the present invention comprises a puncturing step of inserting a puncture needle into the fingers of a person to be collected, and a compressing step of compressing the fingers, wherein the compression conditions for compressing the fingers are set according to at least one of the size and shape of the fingers of the person to be collected, and the compression force for compressing the fingers under the set compression conditions is controlled based on the condition of the blood flow in the fingers and the compression state for compressing the fingers.

[0013] According to the present invention, a blood collection device and a blood collection method can be provided that can fix the fingers of a person to be blood-collected within a predetermined range relative to the puncture needle or blood collection tube regardless of individual differences, and can accurately puncture the puncture needle or press the blood collection tube against a desired target position on the fingertip, and quickly collect blood from the puncture site.

[0014] FIG. 1 is a diagram showing the appearance of a blood collection device according to an embodiment of the present invention. FIG. 2 is a diagram showing the configuration of a turntable and a holder built into a blood collection device according to an embodiment of the present invention. FIG. 3 is a diagram showing the configuration of equipment built into a blood collection device according to an embodiment of the present invention. FIG. 4 is a cross-sectional view schematically showing an example of a compression means of a blood collection device according to an embodiment of the present invention. FIG. 5 is a cross-sectional view schematically showing an example of a compression means of a blood collection device according to an embodiment of the present invention. FIG. 6 is a cross-sectional view schematically showing an example of a compression means of a blood collection device according to an embodiment of the present invention. FIG. 7 is a cross-sectional view schematically showing an example of a compression means of a blood collection device according to an embodiment of the present invention. FIG. 8 is a cross-sectional view schematically showing an example of a compression means of a blood collection device according to an embodiment of the present invention. FIG. 9 is a diagram explaining the operation of a blood collection device according to an embodiment of the present invention. FIG. 10 is a block diagram related to the control of the compression means of a blood collection device according to an embodiment of the present invention. FIG. 11 is a diagram explaining the operation of the compression means of a blood collection device according to an embodiment of the present invention. FIG. 12 is a block diagram related to the control of the compression means of a blood collection device according to an embodiment of the present invention.

[0015] A blood collection device and a blood collection method according to one embodiment of the present invention will be described below. Note that common components in the following drawings will be given the same reference numerals, and duplicated explanations will be omitted.

[0016] FIG. 1 is a diagram showing the appearance of a blood collection device according to an embodiment of the present invention. FIG. 1 shows a finger blood collection device, which automatically collects blood from the fingers of a person to be collected, as an example of a blood collection device. The illustration in FIG. 1 is a partial view showing the finger rest area of ​​the blood collection device as viewed from below. As shown in FIG. 1, the blood collection device 1 according to this embodiment includes, on the top surface of a housing 10, a hand rest area where the person to be collected places their hand 15 and a finger rest area 131 where the person to be collected places their finger 134.

[0017] The finger rest 131 is provided with a compression means 13 that compresses the finger 134 of the subject. The compression means 13 is composed of a bag or the like in which a working fluid is sealed, such as an airbag. The subject's finger 134, from which blood is to be collected, is placed in the finger rest 131 and compressed by the compression means 13 so that the fingertip is congested, after which blood is collected by a mechanism built into the housing 10. Compression around the finger makes the fingertip more susceptible to bleeding when punctured with a puncture needle. In addition, the position of the fingertip is fixed within a predetermined range relative to the puncture needle, blood collection tube, etc.

[0018] Housing 10 is formed from a plurality of structural materials, decorative panels, etc. Inside housing 10, there are built-in components such as a turntable 11, a plurality of holders for holding blood collection tubes, puncture devices, hemostatic materials, protective materials, etc., a rotation drive mechanism for rotating turntable 11, an elevation drive mechanism for raising and lowering the holders, and a pressure adjustment mechanism for adjusting the pressure of fixing part 13.

[0019] The compression means 13 is supported at a position where it contacts the vicinity of the first joint of a finger 134 of a person to be blood-collected, which is placed in a finger rest area 131. As shown in the partial view, a blood collection window 132, which is an opening that passes through the finger rest area 131 from top to bottom, is provided in the finger rest area 131. The finger 134 of the person to be blood-collected is placed so that the pad side of the fingertip faces downward from the blood collection window 132, and is fixed in place by the compression means 13. The finger rest area 131 may be formed from disposable parts, or may be formed by covering a structural material for placing the finger with a disposable part.

[0020] Figure 2 is a diagram showing the configuration of a turntable and holders built into a blood collection device according to an embodiment of the present invention. Figure 2 shows a state in which multiple holders 111 to 115 are attached to a turntable 11 built into the blood collection device 1. As shown in Figure 2, multiple holders 111 to 115 that perform operations related to blood collection are attached to the turntable 11 built into the blood collection device 1.

[0021] An example of the holder configuration is shown in Fig. 2. In Fig. 2, a puncture device holder 111 that holds a puncture device 1111, blood collection tube holders 112 and 113 that hold blood collection tubes 1121 and 1131, a hemostatic material holder 114 that holds a hemostatic material 1141 such as gauze, and a protective material holder 115 that holds a protective material 1151 such as a bandage are installed on the turntable 11. As the blood collection tubes 1121 and 1131, a blood collection tube 1121 for a blood count test and a blood collection tube 1131 for a biochemistry / immunology test are installed.

[0022] Holders 111 to 115 are movable relative to finger rest area 131 by rotating turntable 11 or by raising and lowering turntable 11. By the movement of holders 111 to 115, a puncturing operation of inserting the puncture needle into finger 134 of the blood recipient, a blood collection operation of collecting blood from the puncture site inserted with the puncture needle into blood collection tubes 1121 and 1131, and a treatment operation of treating the puncture site with hemostatic material 1141 or protective material 1151 are sequentially performed on finger 134 of the blood recipient placed on finger rest area 131.

[0023] The turntable 11 is formed in the shape of a disk with a portion cut out. The turntable 11 is rotatably supported inside the housing 10 with its main surface facing up and down. The turntable 11 is formed with holding holes 1112, 1122, 1132, 1142, and 1152 that hold the holders 111 to 115. The holding holes 1112, 1122, 1132, 1142, and 1152 are provided as through holes that pass through the turntable 11 from top to bottom.

[0024] The holding holes 1112, 1122, 1132, 1142, and 1152 are arranged on a circumference of a predetermined diameter that is concentric with the turntable 11. The holding holes 1112, 1122, 1132, 1142, and 1152 are arranged at intervals from one another along the circumferential direction of the turntable 11 on a circumference of a predetermined diameter that passes directly below the finger rest area 131. In each of the holding holes 1112, 1122, 1132, 1142, and 1152, one of the holders 111 to 115 is installed at a pre-designated position.

[0025] The holders 111 to 115 are detachably attached to the turntable 11. Each of the holders 111 to 115 has a portion formed therein whose outer diameter is larger than the diameter of the holding holes 1112, 1122, 1132, 1142, and 1152. Each of the holders 111 to 115 is inserted into the holding holes 1112, 1122, 1132, 1142, and 1152, and the portion with the larger outer diameter is supported from below. With this structure, each of the holders 111 to 115 is held on the turntable 11 in a state in which it can be raised and lowered by being pushed up from below.

[0026] The blood collection tube holders 112 and 113 are locations where blood collection tubes are placed, and various types of blood collection tubes are placed depending on the test items of the blood test to be performed after blood collection. An outer tube containing a blood collection tube can be placed in the blood collection tube holders 112 and 113. As the blood collection tube, a micro blood collection tube with a capacity on the order of several hundred μL can be used. The outer tube is used for purposes such as adjusting the size of the object to be placed in the location where the blood collection tube is placed.

[0027] The blood collection tubes 1121 and 1131 are containers from which blood is collected. The blood collection tube 1121 for blood count tests is a container from which blood is collected for blood count tests, and contains an anticoagulant such as EDTA-2K. The blood collection tube 1131 for biochemistry and immunological tests is a container from which blood is collected for biochemistry tests and immunological tests, and contains a separating agent for separating serum. When the collected blood is centrifuged, it can be separated into clots and serum due to the difference in specific gravity.

[0028] The puncture device 1111 includes a puncture needle (lancet) and a holder serving as a housing that houses the puncture needle. A single-use skin puncture device can be attached to the puncture device holder 111 as the puncture device 1111. When the puncture device 1111 is pressed against the subject's finger 134, it projects the puncture needle and punctures the skin or capillaries. Blood flowing out from the puncture site is collected in blood collection tubes 1121, 1131 transported below the puncture site.

[0029] The hemostatic material 1141 is an absorbent cloth such as gauze that is pressed against the puncture site to absorb and stop the blood that has bled from the puncture site. The protective material 1151 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 1151 is attached to the protective material holder 115 with the absorbent cloth and adhesive surface facing upward.

[0030] The upper surface of the turntable 11 can be protected during blood collection by a protective sheet 116. By forming through holes in the protective sheet 116 at positions corresponding to the holding holes 1112, 1122, 1132, 1142, and 1152, the protective sheet 116 can be installed so as to cover the upper surface of the turntable 11. The protective sheet 116 can prevent contamination of the turntable 11 due to blood adhesion. The protective sheet 116 can be formed from an inexpensive, lightweight, disposable material such as paper, cloth, or resin film.

[0031] Fig. 3 is a diagram showing the configuration of the devices built into the blood collection device according to the embodiment of the present invention. Fig. 3 shows a schematic configuration of the turntable 11 built into the blood collection device 1, the drive mechanism 12 that drives the rotation of the turntable 11 and the elevation of the holders 111 to 115, the blood collection amount measurement mechanism 14 that measures the amount of collected blood, the control unit 16 that controls each mechanism, the pressure adjustment mechanism 17 that adjusts the pressure of the bag of the compression means 13, and the blood vessel image acquisition mechanism 19 that acquires an image of the blood vessels in the fingertip.

[0032] The upper diagram in Fig. 3 shows the periphery of the turntable 11 as viewed from above. The lower diagram in Fig. 3 shows the periphery of the turntable 11 as viewed from the side, together with the configuration of the control unit 16 and the pressure adjustment mechanism 17. In Fig. 3, the finger 134 of the person to be blood-collected is placed on a finger rest 131 (not shown). The position on the turntable 11 directly below the finger rest 131 is the blood collection position where blood is collected from the finger 134 of the person to be blood-collected. At the blood collection position, the holders 111 to 115 perform the puncturing operation, blood collection operation, and treatment operation.

[0033] As shown in Figure 3, the turntable 11 is placed below the finger rest area 131. A drive mechanism 12 is placed below the turntable 11 to drive the rotation of the turntable 11 and the elevation of the holders 111 to 115. A blood collection amount measuring mechanism 14 is placed to the side of the turntable 11 so as to face the side of the holders 111 to 115 placed on the turntable 11. A compression means 13 and a blood vessel image acquisition mechanism 19 are placed around the finger rest area 131. A pressure adjustment mechanism 17 is connected to the bag of the compression means 13 via a tube.

[0034] The drive mechanism 12, blood collection amount measurement mechanism 14, pressure adjustment mechanism 17, and blood vessel image acquisition mechanism 19 are connected to a control unit 16 via signal lines. The control unit 16 controls the operation of each mechanism, processes signals sent to and received from each mechanism, and performs image analysis of blood vessel images acquired by the blood vessel image acquisition mechanism 19. The control unit 16 is connected to an input / output device 18 via wired or wireless signal lines.

[0035] The input / output device 18 inputs instructions regarding the operation of each mechanism, inputs instructions regarding image analysis, inputs settings regarding blood collection conditions, etc., outputs results regarding the operation of each mechanism, outputs measurement results of the amount of collected blood, etc. The input / output device 18 may be built into the blood collection device 1 or may be connected externally to the blood collection device 1. As the external input / output device 18, a personal computer, tablet, etc. can be used.

[0036] The drive mechanism 12 is composed of a rotation drive mechanism 120 that drives the rotational movement of the turntable 11, an elevation drive mechanism 121 that drives the elevation of the holders 111 to 115, and a push rod 122 that pushes up the holders 111 to 115 from below to lift them up. The rotation drive mechanism 120 is installed below the turntable 11. The elevation drive mechanism 121 and the push rod 122 are installed below the blood collection position directly below the finger rest area 131. The power source for the drive mechanism 12 may be an external power source, an internal battery, or a mechanical power source such as a spring. When a spring is used as the power source, it can be used in places where it is difficult to supply electricity.

[0037] The rotation drive mechanism 120 is formed by a shaft coupled to the center of the turntable 11, a motor connected to the shaft, and the like. The turntable 11 is driven to rotate by a predetermined step angle by the rotation drive mechanism 120. The rotation of the turntable 11 transports and removes the holders 111 to 115 to and from the blood collection position directly below the finger rest area 131. At the blood collection position, the holders 111 to 115 are raised and lowered by the lift drive mechanism 121.

[0038] The lifting drive mechanism 121 is an electric actuator and is formed by a combination of a solenoid, a motor, and a conversion mechanism that converts the rotational motion of the motor into linear motion, etc. The push rod 122 is connected to the lifting drive mechanism 121, and is driven to move up and down by the lifting drive mechanism 121.

[0039] When push rod 122 is driven to rise, it pushes up holders 111 to 115 at the blood sampling position from below, causing them to rise. Lancing devices 1111 and the like held in holders 111 to 115 are raised by being pushed up by push rod 122 to a position where they are pressed against finger 134 of the person to be sampled, or to a position close to finger 134 of the person to be sampled. On the other hand, when push rod 122 is driven to fall, it lowers holders 111 to 115 at the blood sampling position to a position where they are supported on turntable 11.

[0040] The blood collection amount measurement mechanism 14 is a mechanism that measures the amount of blood collected in a blood collection tube. The blood collection amount measurement mechanism 14 is composed of a light source that emits planar light and a photodetector. The light source and the photodetector are installed facing each other across the blood collection tube to be measured that has been transported to the blood collection position. The planar light emitted from the light source is projected from the side onto the side of the blood collection tube held in the blood collection tube holders 112, 113. The photodetector detects the planar light that has been emitted from the light source and transmitted through the blood collection tube.

[0041] Planar light emitted from a light source is scattered, reflected, absorbed, etc. by blood, and the intensity of the transmitted light decreases when blood is collected in a blood collection tube. When the transmitted light that has passed through the blood collection tube is detected and the intensity of the transmitted light is measured, the attenuation of the intensity of the transmitted light due to the blood is observed depending on the level of the blood collected in the blood collection tube. Therefore, the amount of blood collected in the blood collection tube can be determined based on the correlation between the level of the blood collected in the blood collection tube and the amount of blood in the blood collection tube, or based on the correlation between the amount of light transmitted through the blood collection tube and the amount of blood in the blood collection tube.

[0042] The correlation between the level of the blood collected in the blood collection tube and the amount of blood in the blood collection tube, and the correlation between the amount of light transmitted through the blood collection tube and the amount of blood in the blood collection tube, can be determined by measurements using a sample with a known amount of blood in the blood collection tube. Measurements using samples with a known amount of blood are performed for each type of blood collection tube using a blood collection tube that corresponds to the test items of the blood test to be performed after blood collection. The level of the blood collected in the blood collection tube and the amount of light transmitted through the blood collection tube can be determined in accordance with the displacement of the drive mechanism 12 by recording the operation of the drive mechanism 12.

[0043] The blood level can be measured as the distance from the bottom of the blood collection tube to the level of the blood collected in the blood collection tube. If the blood collection tube contains a separating agent, the average height of the top of the separating agent can be used as the zero reference point for the blood level. The amount of transmitted light can be measured as an integrated amount over a predetermined range.

[0044] The light source of the blood sample volume measurement mechanism 14 can be a light emitting diode (LED), a chip on board (COB) LED, an organic light emitting diode (OLED), or the like. The light emitted by the light source is preferably visible light or near-infrared light with a wavelength of 300 to 1000 nm. With such wavelengths, attenuation of light intensity due to scattering or reflection by blood and attenuation of light intensity due to absorption by hemoglobin can be detected with high sensitivity.

[0045] The photodetector may be a photodiode array or the like. The photodiode array can measure the two-dimensional distribution of the amount or intensity of light transmitted through the blood collection tube. The photodetector may include optical elements such as an optical filter that attenuates wavelengths other than the emission wavelength of the light source, a lens that changes the detection range by focusing or diverging light, or a mirror that changes the light path.

[0046] The photodetector may be an image sensor such as a CCD (Charge Coupled Device) or a CMOS (Complementary Metal-Oxide-Semiconductor). The image sensor detects transmitted light that has passed through the blood collection tube, and an image of the blood collection tube containing information corresponding to the two-dimensional distribution of the amount and intensity of the transmitted light that has passed through the blood collection tube can be captured. By analyzing the captured image, the liquid level of the blood collected in the blood collection tube and the amount of transmitted light that has passed through a predetermined area of ​​the blood collection tube can be determined.

[0047] The pressure adjustment mechanism 17 is composed of a tube connecting the bag of the compression means 13 and a source of working fluid, a pressure sensor 171 that measures the internal pressure of the bag of the compression means 13, a valve 172 that adjusts the amount of working fluid by opening and closing the tube, and a pump 173 that supplies working fluid to the bag of the compression means 13. The pressure on the subject's finger 134 is adjusted by discharging the working fluid with the valve 172 and supplying the working fluid with the pump 173.

[0048] The blood vessel image acquisition mechanism 19 is a mechanism for acquiring a blood vessel image of the finger 134 of the person to be blood-collected. The blood vessel image acquisition mechanism 19 is composed of an infrared light imaging device 191 and a near-infrared light source 192. The infrared light imaging device 191 and the near-infrared light source 192 are installed so as to sandwich the finger 134 of the person to be blood-collected, which is placed in the finger rest area 131. The infrared light imaging device 191 is arranged so as to face the pad side of the fingertip. The near-infrared light source 192 is arranged so as to face the nail side of the fingertip.

[0049] The vascular image is a two-dimensional image of the fingertip of the subject's finger 134, and is an image that represents the course of blood vessels at the fingertip using pixel contrast. Hemoglobin in blood absorbs near-infrared light, thereby attenuating the near-infrared light that passes through the subject's finger 134. Therefore, by projecting near-infrared light onto the subject's finger 134 and measuring the light intensity distribution of the near-infrared light that passes through the subject's finger 134, the vascular network at the fingertip can be imaged.

[0050] In a blood vessel image, the course of blood vessels is represented by the contrast of pixel shading. The attenuation of the light intensity of transmitted light due to hemoglobin can be displayed as the gradation of each pixel, for example, the difference in brightness of each pixel. By generating such a blood vessel image, blood vessels running under the skin of a fingertip can be visualized as dark lines consisting of a series of low-brightness pixels with low transmitted light intensity among surrounding pixels with high transmitted light intensity. Based on the blood vessel image, it is possible to determine the target puncture position for the puncture needle and detect the state of blood flow in the finger, which is used to control the compression means 13.

[0051] The infrared light imaging device 191 detects near-infrared light that has passed through the finger 134 of the person to be blood-collected that is placed in the finger rest area 131, and captures an image of the blood vessels of the person to be blood-collected, the finger 134. As the infrared light imaging device 191, 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, or the like can be used.

[0052] The near-infrared light source 192 is a light source that emits near-infrared light, and irradiates the near-infrared light onto the subject's finger 134 placed in the finger rest area 131. An LED (Light Emitting Diode) or the like having an emission wavelength that includes the near-infrared light range can be used as the near-infrared light source 192. The near-infrared light may have a wavelength of 700 nm or more and 2500 nm or less, for example, about 940 nm.

[0053] Fig. 4 is a cross-sectional view showing a schematic example of a compression means of a blood collection device according to an embodiment of the present invention. Fig. 4 shows a schematic cross-sectional structure of the periphery of finger rest 131 formed on the upper part of blood collection device 1. As shown in Fig. 4, finger rest 131, on which a finger 134 of a person to be blood-collected is placed, is provided inside insertion opening 136 formed on the upper surface of housing 10. When blood is collected, the tip side of finger 134 of the person to be blood-collected is inserted into insertion opening 136, the tip side being closer to the first joint.

[0054] Compression means 13 for compressing the fingers of the person to be blood-collected is provided near the opening of insertion port 136. In Fig. 4, puncture device holder 111 holding puncture device 1111 is stationary directly below finger rest area 131. Lancing device 1111 and puncture device holder 111 constitute puncture means 110 for inserting the puncture needle into the finger of the person to be blood-collected.

[0055] Lancing means 110 and compressing means 13 are controlled by control unit 16. Control unit 16 controls the rotation of turntable 11 to transport lancing device holder 111 to the blood collection position directly below finger rest area 131, and moves it up and down relative to turntable 11 to puncture finger 134 of the person to be blood-collected. Control unit 16 also controls the output of compressing the finger by compressing means 13 to compress finger 134 of the person to be blood-collected under preset output conditions.

[0056] Inside the insertion opening 136, there are installed a finger detection mechanism 15 that detects entry of the subject's fingers into the space above the finger rest area 131, and a blood vessel image acquisition mechanism 19 that captures blood vessel images of the subject's fingers. The finger detection mechanism 15 is disposed at the back of the interior of the insertion opening 136. An infrared light imaging device 191 of the blood vessel image acquisition mechanism 19 is disposed so as to face the pad side of the fingertip placed in the finger rest area 131. A near-infrared light source 192 of the blood vessel image acquisition mechanism 19 is disposed so as to face the nail side of the fingertip placed in the finger rest area 131.

[0057] Compression means 13 compresses finger 134 of the subject to be sampled, fixing the fingertip of finger 134 of the subject to be sampled within a predetermined range in the space above finger rest area 131. By restraining the fingertip with compression means 13, the positional relationship between the target puncture position set on the fingertip and the reachable positions of the tip of the puncture needle and the opening of the blood collection tube is determined. By determining these positional relationships, accurate puncture of the target puncture position and appropriate collection of blood flowing out from the puncture site become possible.

[0058] Furthermore, the compression means 13 performs an operation of compressing the subject's finger 134 in order to promote bleeding from the puncture site. The operation of compressing the subject's finger 134 is performed before and during blood collection. By applying pressure around the subject's finger 134, the fingertip is made congested. Congestion of the fingertip makes it easier for blood to flow out of the puncture site, making it easier to ensure the amount of blood necessary for the blood test performed after blood collection.

[0059] In FIG. 4 , the compression means 13 is formed by a bag 138 filled with a working fluid. The bag 138 can adjust the output of compression of the blood collection subject's finger 134 by the compression means 13, i.e., the internal pressure and expansion amount of the bag 138, which affect the compression load, by adjusting the amount of the working fluid filled in the bag 138 through supply and discharge of the working fluid. By adjusting the internal pressure and expansion amount, the blood collection subject's finger 134 is compressed with a load equal to or greater than a predetermined value and firmly fixed. The bag 138 can be an airbag filled with air, or one filled with other gases or liquids such as water. The bag 138 is connected to a valve 172, a pump 173, etc. via tubes.

[0060] 4, the bags 138 are arranged at a position facing the dorsal side of the finger 134 of the person to be blood-collected placed in the finger holder 131, and at a position facing the ventral side of the finger 134 of the person to be blood-collected placed in the finger holder 131. The dorsal bag 138 is placed on the upper surface near the opening of the insertion port 136. The ventral bag 138 is placed on the lower surface near the opening of the insertion port 136.

[0061] The finger detection mechanism 15 detects the entry of the subject's finger 134 onto the finger rest area 131. The finger detection mechanism 15 is composed of a movable member 151 that moves when pushed by the subject's finger 134 inserted into the insertion port 136, and a position sensor 152 that detects the position of the movable member 151. The movable member 151 is arranged to face the tip of the subject's finger 134 that has entered the finger rest area 131. The position sensor 152 is arranged to the side of the movable member 151.

[0062] The movable member 151 is formed as a member that moves like a pendulum. The base end side of the movable member 151 is rotatably supported by a rotation axis that extends in a direction perpendicular to the depth direction of the insertion opening 136. The tip side of the movable member 151 can move between a position on the front side of the insertion opening 136 where it interferes with the tip of the finger 134 of the subject placed in the finger rest area 131, and a position on the back side of the insertion opening 136 as the movable member 151 rotates.

[0063] The position sensor 152 detects the presence or absence of the movable member 151 at a predetermined position on the back side of the insertion opening 136. For example, a photointerrupter can be used as the position sensor 152. When the tip of the subject's finger 134 enters the finger rest area 131, the movable member 151 is pushed from the front side to the back side of the insertion opening 136. Therefore, by detecting the presence or absence of the movable member 151 at a predetermined position of the insertion opening 136, it can be determined whether the subject's finger 134 is placed in the finger rest area 131.

[0064] 4, the bag body 138 is disposed at a position facing the dorsal side of the subject's finger 134 placed in the finger holder 131 and at a position facing the ventral side of the subject's finger 134 placed in the finger holder 131, and compresses the subject's finger 134 placed in the finger holder 131 by pinching it from both the dorsal and ventral sides. This compression method allows the subject's finger 134 to be strongly compressed from both the top and bottom, regardless of individual differences in finger size, thickness, flexibility, firmness, etc. Furthermore, by compressing the subject's finger 134 so as to cover it from all sides, it is possible to reduce misalignment of the fingertip in the up-down and left-right directions.

[0065] 5 and 6 are cross-sectional views schematically showing an example of the compressing means of the blood collection device according to the embodiment of the present invention. Fig. 5 shows a cross-sectional structure of the periphery of finger rest area 131 formed on the upper part of blood collection device 1. Fig. 6 shows a schematic view of the structure shown in Fig. 5 from the rear side of insertion opening 136. As shown in Figs. 5 and 6, compressing means 13 that compresses the fingers of the person to be collected can also be composed of a bag body 138 containing a working fluid and a pressing member 139 against which the fingers of the person to be collected are pressed.

[0066] 5 and 6, the bag body 138 is disposed at a position facing the pad side of the subject's finger 134 placed in the finger rest area 131 and at a position facing the left and right sides of the subject's finger 134 placed in the finger rest area 131. The pressing member 139 is disposed at a position facing the dorsal side of the subject's finger 134 placed in the finger rest area 131. The bag body 138 is disposed on the underside and the left and right sides near the opening of the insertion port 136. The pressing member 139 is disposed on the upper side of the insertion port 136, from the back side of the insertion port 136 where the finger rest area 131 is located to the front side.

[0067] The bag bodies 138 on the left and right side surfaces can be supported by the side surfaces of the insertion opening 136 or by wall members or the like arranged on the side surfaces of the insertion opening 136. The bag body 138 on the bottom surface of the insertion opening 136 and the bag bodies 138 on the left and right side surfaces may be integrally provided as a band-like cuff incorporating one or more bags. The bag body 138 on the bottom surface of the insertion opening 136 and the bag bodies 138 on the left and right side surfaces may supply and discharge the working fluid integrally or individually.

[0068] The pressing member 139 can be made of, for example, resin, elastomer, or the like. A cloth such as a nonwoven fabric, a sponge, a rubber sheet, a resin film, or the like may be attached to the surface of the pressing member 139. It is preferable that an opening 140 is formed in the pressing member 139 to expose the near-infrared light source 192 toward the finger rest area 131 below. Forming the opening 140 reduces interference between the pressing member 139 and the near-infrared light source 192 and scattering and reflection of the near-infrared light, allowing near-infrared light of highly uniform intensity to be projected onto the fingertip.

[0069] 5 and 6 , the bag body 138 is disposed at a position facing the ventral side of the subject's finger 134 placed in the finger holder 131 and at a position facing the left and right sides of the subject's finger 134 placed in the finger holder 131, and compresses the subject's finger 134 placed in the finger holder 131 by pressing the ventral side against the pressing member 139 disposed on the dorsal side. This compression method makes it possible to stably maintain the distance between the surface of the subject's finger 134 and the near-infrared light source 192 within a predetermined range. Since it is possible to irradiate the subject's finger 134 with near-infrared light with high uniformity, it is possible to capture a blood vessel image with high accuracy.

[0070] 5 and 6, the bag body 138 presses the finger 134 of the subject placed in the finger rest 131 by pinching it from both the left and right sides. This type of pressing method allows for fast blood flow to the fingertip by firmly pressing on both the left and right sides, regardless of individual differences in finger size, thickness, flexibility, firmness, etc. Furthermore, by pressing the finger 134 of the subject so as to cover it from both the left and right, it is possible to reduce misalignment of the fingertip in the left-right direction, etc.

[0071] 7 and 8 are cross-sectional views schematically showing an example of the compression means of the blood collection device according to the embodiment of the present invention. Fig. 7 shows a cross-sectional structure of the periphery of finger rest area 131 formed on the upper part of blood collection device 1. Fig. 8 shows a schematic view of the structure shown in Fig. 7 from the rear side of insertion opening 136. As shown in Figs. 7 and 8, compression means 13 for compressing the fingers of the person to be blood-collected is composed of a bag body 138 and a pressing member 139, and can also be used in combination with compression tool 137 worn on the fingers of the person to be blood-collected.

[0072] 7 and 8, the bag body 138 is disposed in a position facing the ventral side of the subject's finger 134 placed in the finger rest area 131. The pressing member 139 is disposed in a position facing the dorsal side of the subject's finger 134 placed in the finger rest area 131. The bag body 138 is installed on the underside near the opening of the insertion port 136. The pressing member 139 is installed on the upper side of the insertion port 136, from the back side of the insertion port 136 where the finger rest area 131 is located to the front side.

[0073] The compression tool 137 is detachable and is attached near the first joint of the subject's finger 134 when blood is collected. The compression tool 137 is made of an elastic plate material such as resin. The compression tool 137 has a roughly C-shaped cross-section with an inner width slightly smaller than the thickness of a typical finger. When the bottom side of the compression tool 137 is opened and the compression tool 137 is fitted onto the finger, both ends of the compression tool 137 are biased in a closing direction by a restoring force. This elasticity allows the compression tool 137 to be fixed to the finger, and the sides of the fingertip are compressed by the compression tool 137.

[0074] 7 and 8 , the bag body 138 is disposed in a position facing the ventral side of the subject's finger 134 placed in the finger holder 131, and presses the subject's finger 134 placed in the finger holder 131 from the ventral side against a pressing member 139 disposed on the dorsal side together with a pressing tool 137 to compress the subject's finger 134. This type of compression method makes it possible to stably maintain the distance between the surface of the subject's finger 134 and the near-infrared light source 192 within a predetermined range. Since it becomes possible to irradiate the subject's finger 134 with near-infrared light with high uniformity, it becomes possible to capture a blood vessel image with high accuracy.

[0075] 7 and 8, when the compression device 137 is attached to the subject's finger 134, it covers the back and both sides of the finger 134, clamping and compressing the finger 134 from both sides. Compressing the finger with the compression device 137 causes the fingertip to become congested, making it more susceptible to bleeding when the puncture needle is inserted, thereby making it easier to ensure a sufficient amount of blood is collected. Because the left and right sides of the finger can be easily compressed, the function of compressing the sides can be easily supplemented even in the absence of compression means 13 for compressing the sides. Regardless of individual differences in finger size, thickness, flexibility, firmness, etc., the fingertip can be compressed from both sides to quickly congeal the blood.

[0076] The blood collection device 1 equipped with the above-described compression means 13 can strongly compress the fingertip, firmly restraining the fingertip and rapidly causing blood to stagnate in the fingertip. Therefore, regardless of individual differences, the subject's finger can be fixed within a predetermined range relative to the puncture needle or blood collection tube, allowing the puncture needle to accurately puncture the desired target position on the fingertip, the blood collection tube to be pressed against the target position, and blood to be collected quickly from the puncture site.

[0077] In the blood collection method according to this embodiment, the compressing force that compresses the fingers of the person to be collected, i.e., the load caused by compression on the fingers, is adjusted for the compressing means 13. The blood collection method according to this embodiment includes a puncturing step of inserting the puncture needle into the finger of the person to be collected, a compressing step of compressing the finger of the person to be collected, and a blood collection step of collecting blood from the puncture site inserted with the puncture needle into a blood collection tube.

[0078] The pressure conditions for compressing the subject's fingers are set according to at least one of the size and shape of the subject's fingers. Under these pressure conditions, the pressure applied to the fingers is adjusted based on the condition of the subject's fingers and the pressure applied to the subject's fingers. The condition of the subject's fingers can be determined by the position of the fingers or the blood flow in the fingers.

[0079] The states relating to the position of the fingers of the person to be sampled include states distinguished by the distance between the puncturing means for inserting the puncture needle and the fingers of the person to be sampled, which depends on the size and shape of the fingers; states distinguished by the distance between the compression means for compressing the fingers and the fingers, which depends on the size and shape of the fingers; and states distinguished by the time it takes for the compression means for the compression state of the fingers to change due to contact with the fingers.

[0080] The state of blood flow in the subject's fingers can be classified according to the degree of congestion in the fingertips, or the amount of blood in the blood vessels running through the fingertips.

[0081] The pressure conditions for compressing the subject's fingers are preferably set and changed according to the position of the subject's fingers when fixing the fingers to the puncture means or blood collection tube. By setting and changing the conditions according to the position of the fingers, the pressure for compressing the fingers can be appropriately adjusted to fix the fingers in a predetermined position regardless of individual differences in the size and shape of the subject's fingers.

[0082] The pressure conditions for compressing the subject's fingers are preferably set and changed according to the state of blood flow in the subject's fingers when compressing the fingers to cause blood congestion. By setting and changing the pressure according to the blood flow in the fingers, the pressure for compressing the fingers can be appropriately adjusted so that the fingers are in a congested state suitable for blood collection.

[0083] The pressure applied to the fingers can be adjusted based on the condition of the subject's fingers and the pressure applied to the subject's fingers, such that the change in pressure decreases as the distance between the subject's fingers and the puncturing means that inserts the puncture needle, the distance between the subject's fingers and the pressure applying means that applies pressure to the fingers, or the time it takes for the pressure applying means to apply pressure to the fingers to change due to contact with the fingers, decreases. By adjusting in this way, a predetermined pressure can be quickly obtained.

[0084] In the blood collection device 1, the compression means 13 shown in Figures 4 to 8 has output conditions for compressing the fingers of the person to be blood-collected, i.e., the control target values ​​for the internal pressure and expansion amount of the bag body 138 which determine the load for compressing the fingers, which are set and changed by the control unit 16 according to at least one of the size and shape of the fingers of the person to be blood-collected.

[0085] By setting or changing the output conditions of the compression means 13 according to the size and shape of the fingers, the fingers of the blood sample recipient can be strongly compressed with a load equal to or greater than a predetermined load, even if there are individual differences in the fingers. For example, even if the fingers are thin or have an inclined surface, the fingers of the blood sample recipient can be securely fixed within a predetermined range in the space above the finger placement area 131, reducing the positional deviation of the fingertips.

[0086] The output conditions for compressing the subject's fingers are preferably set and changed so that a uniform load is applied to multiple subjects whose fingers vary in size and shape. By applying a uniform pressure to fingers whose fingers vary from person to person, a highly reliable blood collection device 1 can be provided that can collect blood stably from a large number of subjects.

[0087] Specifically, the control unit 16 can set and change the output conditions for compressing the finger by the compression means 13 according to the distance between the finger 134 of the person to be sampled and the puncturing means 110, which depends on the size and shape of the finger, the distance between the finger 134 of the person to be sampled and the compression means 13, which depends on the size and shape of the finger, or the time until the output state of compressing the finger by the compression means 13 changes due to contact between the compression means 13 and the finger 134 of the person to be sampled.

[0088] Furthermore, with the compression means 13 shown in Figures 4 to 8 set under these output conditions, the output of the pump 173 that adjusts the output of compressing the fingers of the person to be blood-collected, i.e., the internal pressure and expansion amount of the bag body 138 that affect the load of compressing the fingers, is controlled by the control unit 16 based on the condition of the fingers of the person to be blood-collected and the output state of compression of the fingers of the person to be blood-collected by the compression means 13, i.e., the control result of the control of the internal pressure and expansion amount of the bag body 138 that affect the load of compressing the fingers.

[0089] The condition of the subject's fingers can be controlled by the condition of the position of the subject's fingers and the condition of the blood flow in the subject's fingers. The condition of the subject's fingers is preferably used to control the fixation of the fingers. The condition of the subject's fingers is preferably used to control the blood flow in the subject's fingers when they are compressed to cause congestion.

[0090] The states relating to the position of the fingers of the person to be sampled include states distinguished by the distance between the finger 134 of the person to be sampled and the puncturing means 110, which depends on the size and shape of the finger; states distinguished by the distance between the finger 134 of the person to be sampled and the compression means 13, which depends on the size and shape of the finger; and states distinguished by the time it takes for the output state of the compression means 13 to compress the finger 134 of the person to be sampled to change due to contact between the compression means 13 and the finger 134 of the person to be sampled.

[0091] The blood flow condition of the subject's fingers can be distinguished by the degree of congestion in the subject's fingertips or the amount of blood in the blood vessels running through the fingertips. The degree of congestion in the fingertips and the amount of blood in the blood vessels running through the fingertips can be quantitatively determined based on the color of the skin and the intensity of near-infrared light transmitted through the fingertips.

[0092] A first detection means for detecting the condition of the subject's fingers is provided around the finger rest area 131. When detecting the condition related to the position of the fingers, the first detection means detects the distance between the subject's finger 134 and the puncturing means 110, the distance between the subject's finger 134 and the compression means 13, and the time it takes for the output state of the compression means 13 compressing the subject's finger 134 to change due to contact between the compression means 13 and the subject's finger 134. On the other hand, when detecting the condition related to the blood flow in the fingers, the first detection means detects the degree of congestion in the subject's finger 134 and the amount of blood in the blood vessels running through the fingertip.

[0093] As the first detection means, when detecting the distance between the subject's finger 134 and the puncturing means 110 or the distance between the subject's finger 134 and the compressing means 13, a distance measuring sensor that measures the distance between the subject's finger 134 and the puncturing means 110 or a distance measuring sensor that measures the distance between the subject's finger 134 and the compressing means 13 can be used. These distance measuring sensors can be installed below the finger rest area 131, around the bag body 138, etc.

[0094] As the first detection means, in the case of detecting the time until the output state of the compression means 13 changes due to contact with the subject's finger 134, a detection means for detecting the output state of the compression means 13 compressing the finger and a timer for counting the time until the output state of the compression means 13 changes can be used. When the bag body 138 expands and comes into contact with the subject's finger 134, the rate of change in the internal pressure and expansion amount of the bag body 138 changes. Therefore, by measuring the time required for the output state to show a change equal to or greater than a threshold, the distance between the subject's finger 134 and the compression means 13 can be indirectly detected.

[0095] As the first detection means, when detecting the degree of congestion in the subject's finger 134 or the amount of blood in the blood vessels running through the fingertip, an infrared imaging device 191 that captures an image of the blood vessels in the fingertip or a camera that captures an external image of the fingertip can be used. The external image of the fingertip can be captured by, for example, an RGB camera. The camera can be installed around the finger rest area 131 on the underside of the insertion port 136.

[0096] In addition, a second detection means is provided in association with the compression means 13, which detects the output state of compression of the fingers of the person to be blood-collected by the compression means 13. The second detection means detects the control results of the internal pressure and expansion amount of the bag body 138, which affect the load compressing the fingers, as the output state of compression of the fingers of the person to be blood-collected by the compression means 13.

[0097] The second detection means may be a pressure sensor 171 that measures the internal pressure of the bag body 138. Alternatively, a positioning sensor that detects the displacement of the surface of the bag body 138, or a load sensor that detects the pressure load on the bag body 138 may be used. These sensors may be installed around the bag body 138, etc.

[0098] 9 is a diagram illustrating the operation of the blood collection device according to the embodiment of the present invention. Fig. 9 shows the flow of blood collection using the compression means 13 by the blood collection device 1. As shown in Fig. 9, the puncturing operation, blood collection operation, and treatment operation by the blood collection device 1 are performed with the finger 134 of the subject being compressed and fixed by the compression means 13.

[0099] When blood is collected using the blood collection device 1, first, the holders 111 to 115, to which the puncture device 1111, the blood collection tubes 1121, 1131, the hemostatic material 1141, and the protective material 1151 are attached, are placed on the turntable 11 (step S101). The blood collection tubes 1121, 1131 are set to a type corresponding to the test items of the blood test to be performed after blood collection for each subject from whom blood is to be collected.

[0100] Next, the blood collection device 1 is started, and each device, such as the turntable 11, drive mechanism 12, compression means 13, blood collection amount measurement mechanism 14, pressure adjustment mechanism 17, and blood vessel image acquisition mechanism 19, is reset and the operation of each device is checked (step S102). After checking whether each device, the bag body 138 of the compression means 13, etc., can operate normally within a predetermined operating range, they are initialized to a predetermined initial state. If an abnormal operation is detected, a warning can be displayed on the display of the input / output device 18, etc.

[0101] Next, the finger 134 of the person to be sampled is fixed on the finger holder 131 by the compression means 13 (step S103). The finger 134 of the person to be sampled is inserted into the insertion port 136 provided on the top surface of the blood sampling device 1 and is compressed by the bag body 138 with a load of at least a predetermined value. The finger 134 of the person to be sampled is fixed within a predetermined range in the space above the finger holder 131 with the pad side of the fingertip facing downward through the blood sampling window 132.

[0102] Next, the information labels attached to the blood collection tubes 1121, 1131 are read (step S104). By reading the information labels, the type of blood collection tube corresponding to the test items of the blood test to be performed after blood collection is confirmed, and blood collection conditions for each type of blood collection tube are set. Based on the results of reading the information labels, the type of blood collection tube for each blood collection recipient is verified, and blood collection conditions for each type of blood collection tube are set.

[0103] The information labels attached to the blood collection tubes 1121, 1131 are read by a reader installed at a reading position on the turntable 11. The blood collection tube holders 112, 113 holding the blood collection tubes 1121, 1131 are transported to the reading position in sequence. The reader optically reads the information labels attached to the transported blood collection tubes 1121, 1131 and stores the reading results in a storage device of the blood collection device 1.

[0104] The information label can be attached by any appropriate method, such as attaching a barcode label, printing a barcode, attaching a two-dimensional code label, printing a two-dimensional code, attaching a data matrix code label, printing a data matrix code, embedding an IC chip, etc. The information label may be attached to the side surface of the blood collection tubes 1121, 1131, or may be attached to the side surface of the outer tube that houses the blood collection tubes 1121, 1131.

[0105] Next, a blood vessel image of the subject's finger 134 is acquired, and the subject's finger 134 is compressed by the compression means 13 (step S105). The control unit 16 controls the blood vessel image acquisition mechanism 19 to capture a blood vessel image of the subject's finger 134, and receives the image capture result data from the blood vessel image acquisition mechanism 19. The blood vessel image is visualized based on the image capture result data. The control unit 16 determines the target puncture position of the puncture needle on the subject's finger 134 based on the blood vessel image. The control unit 16 also controls the output of the compression means 13 to compress the subject's finger.

[0106] Next, a puncturing operation is performed on finger 134 of the blood sample recipient (step S106). Control unit 16 controls rotation drive mechanism 120 to rotate turntable 11 so that the position of the puncture needle in a planar view coincides with the target puncture position determined based on the blood vessel image. Then, control unit 16 controls elevation drive mechanism 121 to raise puncture device holder 111 to a height at which puncture device 1111 is pressed against finger 134 of the blood sample recipient. When puncture device 1111 is pressed against finger 134 of the blood sample recipient, it extends the puncture needle and punctures the target puncture position.

[0107] Next, a blood collection operation is performed to collect blood from the subject's finger 134 (step S107). The control unit 16 controls the rotation drive mechanism 120 to rotate the turntable 11 so that the blood collection tube holders 112, 113 are sequentially transported to the blood collection position directly below the finger rest area 131. After the rotation, the control unit 16 controls the elevation drive mechanism 121 to sequentially raise the blood collection tube holders 112, 113 to a height at which the blood collection tubes 1121, 1131 are pressed against the puncture site. Blood bleeding from the puncture site is sequentially collected into the pressed blood collection tubes 1121, 1131.

[0108] The blood collection operation is usually performed in the order of biochemistry / immunology test blood collection tube 1131 first, followed by blood count test blood collection tube 1121. At the start of the blood collection operation, control unit 16 controls lifting drive mechanism 121 to repeatedly lift and lower blood collection tube holders 112, 113 in a short period of time. By repeatedly lifting and lowering, blood collection tubes 1121, 1131 are repeatedly pressed against the puncture site, and blood that has leaked out from the puncture site is wiped away, allowing blood to be collected quickly.

[0109] During the blood collection operation, the control unit 16 controls the blood collection volume measurement mechanism 14 to measure the volume of blood collected in the collection tubes 1121, 1131. The control unit 16 also measures the blood collection time using a built-in timer. The blood collection time is the time elapsed since the start of blood collection into the collection tube. The blood collection time affects the time it takes for blood to clot and the components that flow out from the puncture site. Therefore, the upper limit of the blood collection time is limited for each type of collection tube depending on the test items of the blood test performed after blood collection.

[0110] During the blood collection operation, the control unit 16 compares the amount of blood collected measured by the blood collection amount measurement mechanism 14 with a target blood collection amount preset for each type of blood collection tube to determine whether the amount of blood collected into the blood collection tube has reached the target amount. Also, the control unit 16 compares the blood collection time measured by the built-in timer with a maximum blood collection time preset for each type of blood collection tube to determine whether the blood collection time elapsed since the start of blood collection into the blood collection tube has reached the maximum blood collection time.

[0111] If, as a result of measuring the amount of collected blood, the amount of blood collected in the collection tubes 1121, 1131 is less than the target blood amount and the blood collection time has not exceeded the upper limit, blood collection continues into the collection tubes 1121, 1131. On the other hand, if the amount of blood collected in the collection tubes 1121, 1131 is less than the target blood amount and the blood collection time has exceeded the upper limit, collection of blood into the collection tubes 1121, 1131 is stopped because it may be difficult to secure the amount of blood required for the blood test, or tissue fluid may have been mixed in or blood coagulation may have progressed.

[0112] On the other hand, if the measurement of the blood collection volume indicates that the amount of blood collected in the blood collection tubes 1121, 1131 is equal to or greater than the target blood volume, the controller 16 terminates the collection of blood into the blood collection tubes 1121, 1131. The controller 16 controls the rotation drive mechanism 120 to transport the blood collection tube holders 112, 113 from the blood collection position. If any blood collection tubes 1121, 1131 from which blood has not yet been collected remain, the remaining blood collection tube holders 112, 113 are transported to the blood collection position, and blood flowing out from the puncture site is collected into the blood collection tubes 1121, 1131.

[0113] Next, a treatment operation is performed on finger 134 of the person to be blood sampled (step S108). Control unit 16 controls rotation drive mechanism 120 to rotate turntable 11 so that hemostatic material holder 114 and protective material holder 115 are sequentially transported to the blood sampling position directly below finger rest area 131. After turntable 11 has rotated, control unit 16 controls lift drive mechanism 121 to sequentially raise hemostatic material holder 114 and protective material holder 115 to a height at which hemostatic agent 1141 and protective material 1151 are pressed against the puncture site. The puncture site is stopped from bleeding or protected by the pressure of hemostatic agent 1141 and protective material 1151.

[0114] Next, the blood collection tubes 1121, 1131 containing collected blood are removed from the blood collection device 1 (step S109). After being removed from the blood collection device 1, the blood collection tubes 1121, 1131 are inverted to mix the blood as needed and then transported to an automatic analyzer or the like that performs a blood test. The blood collection tubes 1121, 1131 containing collected blood are managed according to the information labels individually assigned to them. Data indicating the measurement results of the amount of collected blood can be stored in association with the information label data.

[0115] Fig. 10 is a diagram illustrating the operation of the compression means of the blood collection device according to the embodiment of the present invention. Fig. 10 shows an example flow of a process (step S103) in which the finger 134 of the subject is fixed on the finger rest 131 by the compression means 13. As shown in Fig. 10, when the finger 134 of the subject is fixed by the compression means 13, the output conditions for compressing the finger by the compression means 13 can be set based on the detection results of the state of the subject's finger.

[0116] When the subject's finger 134 is fixed on the finger rest 131, the position sensor 152 of the finger detection mechanism 15 is first activated (step S201). The position sensor 152 enters a reception state in which it detects the movement of the movable member 151.

[0117] Next, it is determined whether or not the entry of the subject's finger 134 onto the finger rest area 131 has been detected (step S202). When the subject's finger 134 is inserted into the insertion opening 136 and the fingertip enters the finger rest area 131, the fingertip presses the movable member 151. When the movable member 151 is pressed, the position sensor 152 detects whether the movable member 151 is in a predetermined position, and entry of the fingertip onto the finger rest area 131 is detected.

[0118] If the entry of the fingertip onto the finger rest area 131 is detected (step S202; YES), the process proceeds to step S203. On the other hand, if the entry of the fingertip onto the finger rest area 131 is not detected (step S202; NO), the process returns to step S201, and the reception state continues. If the entry of the fingertip onto the finger rest area 131 is not detected within a predetermined reception time, the blood collection may be stopped.

[0119] Next, the state of the subject's fingers is detected on the finger rest area 131 (step S203). As the state of the subject's fingers, it is preferable to detect the state related to the position of the subject's fingers, and it is preferable to detect the distance between the subject's finger 134 and the puncturing means 110, the distance between the subject's finger 134 and the compressing means 13, and the time it takes for the output state of the compressing means 13 to compress the subject's finger 134 to change due to contact between the compressing means 13 and the subject's finger 134.

[0120] Next, based on the detection result of the condition of the subject's fingers, the output conditions for compressing the subject's fingers by the compressing means 13 are set (step S204). The control unit 16 sets the control target values ​​for the internal pressure and expansion amount of the bag body 138, which affect the load compressing the fingers, based on the detection result by the distance measurement sensor, etc.

[0121] Next, under the set output conditions, the output of the compression means 13 for compressing the fingers of the blood recipient is controlled to compress the fingers of the blood recipient and fix them on the finger rest 131 (step S205). The control unit 16 controls the output of the compression means 13 for compressing the fingers of the blood recipient in accordance with the preset output conditions to compress the fingers with a load equal to or greater than a predetermined load. The output state of the compression means 13 for compressing the fingers of the blood recipient, i.e., the control results of the internal pressure and expansion amount of the bag body 138 which affect the load for compressing the fingers, are continuously monitored by the pressure sensor 171 etc.

[0122] Next, it is determined whether or not immobilization of the subject's fingers has been completed (step S206). Whether or not immobilization of the fingers has been completed is determined based on whether or not the output state of compressing the subject's fingers by the compression means 13 has reached a target state. For example, it can be determined that immobilization of the fingers has been completed when it is detected that the internal pressure or expansion amount of the bag body 138 has reached a predetermined target range.

[0123] If the determination result indicates that the fixation of the fingertip is complete (step S206; YES), the process of fixing the finger (step S103) is terminated, and the process of reading the information label (step S104) is carried out. On the other hand, if the fixation of the fingertip is not complete (step S206; NO), the process returns to step S205. If the fixation of the fingertip is not completed within a predetermined time, a warning may be displayed on the display of the input / output device 18, for example.

[0124] Fig. 11 is a block diagram relating to the control of the compressing means of the blood sampling device according to the embodiment of the present invention. Fig. 11 shows a method of controlling the compressing means 13 for fixing the finger 134 of the subject on the finger rest 131 in the operation of fixing the finger shown in Fig. 10. As shown in Fig. 11, the compressing means 13 can be controlled based on the detection results of the state of the subject's finger and the detection results of the output state for compressing the subject's finger when fixing the finger.

[0125] 11 , the control unit 16 performs feedback (FB) control of the output of the compression means 13 compressing the fingers of the blood recipient based on the detection result of the output state of the compression means 13 compressing the fingers of the blood recipient. As the output of the compression means 13, the output of the pump 173 of the pressure adjustment mechanism 17 is controlled. The output of the compression means 13 can be controlled by proportional (P) control, proportional integral (PI) control, proportional differential (PD) control, PID control, etc.

[0126] It is preferable that the control unit 16 perform proportional control to reduce the change in the amount of expansion of the bag body 138 as the distance between the subject's finger 134 placed on the finger rest and the puncture needle of the puncturing means 110 decreases, as the distance between the subject's finger 134 placed on the finger rest and the bag body 138 of the compressing means 13 decreases, or as the time it takes for the output state of the compressing means 13 to change due to contact with the subject's finger 134 decreases. Such proportional control makes it possible to quickly control the state related to the position of the finger toward the target state.

[0127] 11 , the detection results for the state of the position of the subject's fingers are the detection result of the distance between the subject's finger 134 and the puncturing means 110, the detection result of the distance between the subject's finger 134 and the compressing means 13, and the detection result of the time it takes for the output state of the compressing means 13 compressing the subject's finger 134 to change due to contact between the compressing means 13 and the subject's finger 134. The detection results for the state of the position of the fingers are acquired by the distance measuring sensor 151. In this control method, the detection results for the state of the position of the subject's fingers are used to set the output conditions for the compressing means 13.

[0128] 11 , the internal pressure of the bag body 138 is detected as the output state of the compression means 13 compressing the fingers. The internal pressure of the bag body 138 is detected by a pressure sensor 171 of the pressure adjustment mechanism 17. As the output state, the amount of expansion of the bag body 138 may be detected by a positioning sensor that detects the displacement of the surface of the bag body 138 or a load sensor that detects the load. In this control method, the output state of the compression means 13 is used for feedback (FB) control of the output by the compression means 13.

[0129] The target value setting unit 201 and the FB control amount calculation unit 202 are functionally realized by the control unit 16 being hardware. The target value setting unit 201 and the FB control amount calculation unit 202 may be realized by a calculation device such as a CPU (Central Processing Unit) executing a predetermined program, or may be realized by an analog circuit.

[0130] The target value setting unit 201 sets the output conditions for the compression means 13 to compress the fingers of the person to be blood-collected, i.e., the target value of the internal pressure of the bag body 138. The output conditions for the compression means 13 are set based on the detection results of the state related to the position of the fingers of the person to be blood-collected. The target value of the internal pressure of the bag body 138 can be set, for example, to match the internal pressure of the bag body 138 when the finger 134 of the person to be blood-collected is restrained with a predetermined load at a predetermined target position in the space above the finger rest area 131.

[0131] 11 , when the subject's finger 134 is fixed, the entry of the fingertip into the finger rest area 131 is detected, and then the distance measurement sensor 151 acquires the state of the subject's finger position. The detection result of the state of the finger position is input to the target value setting unit 201. The target value setting unit 201 determines the position of the subject's finger based on the input detection result data, and sets a target value for the internal pressure of the bag body 138. The target value setting result is output to the adder.

[0132] The target value can be set to a value smaller than the standard value if the subject's fingers have a thickness or shape suitable for fixation. For example, if the width of the distal joint of the subject's fingers exceeds a general standard thickness, or if the shape of the subject's fingers has a large contact area with the bag body 138 or the pressing member 139, a target value smaller than the initial general standard value can be set.

[0133] On the other hand, if the subject's fingers are not of a suitable thickness or shape for fixation, a target value larger than the standard value can be set. For example, if the width of the distal joint of the subject's fingers is smaller than the standard thickness, or if the shape of the subject's fingers has a small contact area with the bag body 138 or the pressing member 139, a target value larger than the initially set standard value can be set.

[0134] The FB control amount calculation unit 202 calculates a target control amount for feedback-controlling the output of the compression means 13 compressing the fingers toward a control target value, based on the input from the adder. Specifically, the FB control amount calculation unit 202 calculates a target control amount for the output of the pump 173 for feedback-controlling the internal pressure of the bag body 138 toward a target value. The target control amount is calculated using the detection result of the output state of the compression means 13 compressing the fingers, i.e., the detection result of the internal pressure of the bag body 138 by the pressure sensor 171. The target control amount can be set so that the internal pressure of the bag body 138 reaches the target value within a predetermined range of load applied to the fingers or within a predetermined required time. The calculation result of the target control amount is output to the controller 203.

[0135] The controller 203 outputs a control signal of the calculated target control amount to the pump 173, and controls the output of the pump 173 toward the target control amount. By controlling the output of the pump 173 toward the target control amount, the amount of working fluid supplied to the bag 138 is adjusted. By adjusting the amount of working fluid supplied to the bag 138, the internal pressure of the bag 138 is controlled toward a predetermined target value. The bag 138 is controlled so that the amount of expansion increases and the finger 134 of the blood sample recipient is compressed with a load equal to or greater than a predetermined value.

[0136] The pressure sensor 171 continuously measures the internal pressure of the bag body 138 while the output of the compressing means 13 compressing the fingers is controlled toward the control target value. The measurement result of the internal pressure of the bag body 138 by the pressure sensor 171 is fed back to the adder.

[0137] The adder compares the target value of the internal pressure of bag 138 with the measurement result of the internal pressure of bag 138 and calculates the deviation between them. FB control amount calculation unit 202 calculates the target control amount of the output compressing the fingers by compression means 13 so as to reduce the deviation input from the adder. When the output compressing the fingers by compression means 13, i.e., the target control amount of the output of pump 173, is set or changed to control the internal pressure of bag 138 to the target value, bag 138 expands to a predetermined amount, and finger 134 of the subject is compressed with a load equal to or greater than a predetermined value, completing fixation on finger rest 131.

[0138] According to this control method, the output from the compression means 13 that compresses the subject's fingers is feedback-controlled based on the output state of the compression means 13, so that the subject's fingers 134 can be compressed with a load equal to or greater than a predetermined load and firmly fixed in the space above the finger rest area 131. Furthermore, because the output conditions for compressing the fingers by the compression means 13 are set based on the state of the subject's fingers, even if there are individual differences in the thickness, shape, etc. of the subject's fingers, displacement of the fingertips and loosening of the restraint are unlikely to occur, and the fingertips can be stably fixed within a predetermined range in the space above the finger rest area 131. Therefore, regardless of individual differences, the subject's fingers can be fixed within a predetermined range relative to the puncture needle or blood collection tube, allowing for accurate puncture of the puncture needle and pressing of the blood collection tube against the desired target position on the fingertip, and rapid blood collection from the puncture site.

[0139] Fig. 12 is a diagram illustrating the operation of the compression means of the blood collection device according to the embodiment of the present invention. Fig. 12 shows an example flow of the process (step S105) of compressing the finger 134 of the blood collection recipient with the compression means 13 to cause blood congestion. As shown in Fig. 12, when compressing the finger 134 of the blood collection recipient with the compression means 13 to cause blood congestion, the output conditions for compressing the finger by the compression means 13 can be set based on the detection results of the condition of the blood collection recipient's fingers.

[0140] When compressing the subject's finger 134 to cause blood congestion, first, image capture of the fingertip of the subject's finger 134 placed on the finger rest 131 is started to detect the condition of the subject's fingers (step S301). The condition of the subject's fingers is detected by detecting the state of blood flow in the subject's fingers. The fingertip image can be a blood vessel image captured by the infrared imaging device 191 or an external image captured by a camera installed near the finger rest 131. The control unit 16 controls the infrared imaging device 191 and the camera to continuously capture fingertip images of the subject's finger 134.

[0141] Next, the control unit 16 activates the pump 173 of the pressure adjustment mechanism 17 (step S302). The control unit 16 activates the pump 173 to start supplying the working fluid to the bag body 138. When the supply of the working fluid to the bag body 138 starts, the bag body 138 starts to expand.

[0142] Next, based on the detection result of the condition of the subject's fingers, the output conditions for compressing the subject's fingers by the compressing means 13 are set (step S303). The control unit 16 sets the control target values ​​for the internal pressure and expansion amount of the bag body 138, which affect the load compressing the fingers, based on the detection result by the infrared light imaging device 191 and the camera.

[0143] Next, under the set output conditions, the output of the compression means 13 for compressing the subject's finger 134 is controlled to compress the subject's finger 134 and cause blood congestion (step S304). When the expansion amount of the bag body 138 increases and the subject's finger 134 is compressed, the blood flow to the fingertip decreases. Therefore, the state of blood flow in the finger changes toward a state of congestion.

[0144] Next, it is determined whether the blood flow condition in the finger has reached the target state (step S305). The target state is set in advance before blood sampling as a state in which the degree of congestion in the fingertip and the blood flow rate in the blood vessels running through the fingertip are appropriate for ensuring a sufficient amount of blood to be sampled. Whether the blood flow condition in the finger has reached the target state can be determined by comparing the amount of transmitted light detected on the vascular image with a reference value corresponding to the amount of light in the predetermined target state. Alternatively, it can be determined by comparing the skin chromaticity detected on the appearance image with a reference range corresponding to the skin chromaticity in the predetermined target state.

[0145] If the determination result indicates that the blood flow state of the fingers has reached the target state (step S305; YES), the process proceeds to step S306. On the other hand, if the blood flow state of the fingers has not reached the target state (step S305; NO), the process returns to step S304. If the blood flow state of the fingers does not reach the target state within a predetermined time, a warning may be displayed on the display of the input / output device 18, or blood collection from the fingers placed in the finger rest area 131 may be stopped.

[0146] Next, a target insertion position of the puncture needle relative to the fingertip of the subject's finger 134 is determined (step S306). Based on the vascular image, the control unit 16 determines the distribution of blood vessels running through the fingertip, the thickness of the blood vessels, etc. Based on the determination result, the control unit 16 determines the insertion position of the puncture needle relative to the subject's finger 134 so as to ensure the amount of blood required for the blood test to be performed after blood collection.

[0147] The target puncture position of the puncture needle can be specified on the blood vessel image as an intersection point between the arc-shaped trajectory of the puncture needle caused by the rotation of the turntable 11 and a typical blood vessel running through the fingertip. Typical blood vessels include blood vessels with a high blood flow, blood vessels with a large diameter, and blood vessels running shallow from the surface of the finger.

[0148] When the target puncturing position is determined, the process of compressing the subject's finger 134 (step S105) is terminated, and the process moves to the puncturing operation (step S106) of the subject's finger 134. Compression of the subject's finger 134 by the compression means 13 can be continued until the blood collection operation (step S107) of collecting blood from the subject's finger 134 is completed.

[0149] Fig. 13 is a diagram illustrating the operation of the compression means of the blood sampling device according to the embodiment of the present invention. Fig. 13 shows an example flow of the puncturing operation (step S106) of finger 134 of the subject of blood sampling, and the blood sampling operation (step S107) of sampling blood from finger 134 of the subject of blood sampling. As shown in Fig. 13, during the puncturing operation and the blood sampling operation, the output conditions for compressing the finger by compression means 13 can be set based on the detection results of the condition of the subject's fingers.

[0150] When the puncture needle is inserted into the finger 134 of the person to be sampled, the finger 134 of the person to be sampled, which is placed on the finger holder 131, is compressed by the compression means 13, and an image of the fingertip of the finger 134 of the person to be sampled is captured (step S401). The control unit 16 can keep the bag body 138 inflated from the time the finger 134 of the person to be sampled is fixed until the time it is punctured. In addition, the control unit 16 can continue capturing an image of the fingertip of the finger 134 of the person to be sampled.

[0151] Next, the puncture needle is inserted into finger 134 of the person to be sampled (step S402). Control unit 16 controls rotation drive mechanism 120 and elevation drive mechanism 121 to press puncture device 1111 held by puncture device holder 111 against the target puncture position, and inserts the puncture needle into the target puncture position. Because finger 134 of the person to be sampled is compressed by compression means 13, it can be accurately punctured at the set target puncture position.

[0152] Next, the blood collection tube holders 112, 113 are transported to the blood collection position directly below the finger rest area 131 (step S403). The control unit 16 controls the rotation drive mechanism 120 to rotate the turntable 11, and sequentially transports the blood collection tube holders 112, 113 holding the blood collection tubes 1121, 1131 to the blood collection position in accordance with the recommended blood collection order. The blood collection order is registered in advance in the blood collection device 1. The blood collection order is controlled by reading the information labels attached to the blood collection tubes 1121, 1131 and referring to the read results.

[0153] Next, blood is collected from the puncture site of the subject's finger 134 into the blood collection tubes 1121, 1131 (step S404). The control unit 16 controls the rotation drive mechanism 120 and the elevation drive mechanism 121 to sequentially press the blood collection tubes 1121, 1131 against the puncture site, and collect the blood flowing out from the puncture site. Because the subject's finger 134 is compressed by the compression means 13, the edges of the openings of the blood collection tubes 1121, 1131 and the scoop-shaped protrusions formed on the openings can be accurately pressed against the puncture site.

[0154] Next, it is determined whether or not blood collection has been completed for all of the blood collection tubes 1121, 1131 placed on the turntable 11 (step S405). The status of blood collection for the blood collection tubes 1121, 1131 can be determined, for example, by detecting the transport of the blood collection tube holders 112, 113 placed at each position on the turntable 11. The transport at each position can be detected by a reader placed at a reading position on the turntable 11 or a position sensor that detects the displacement of the turntable 11.

[0155] If the determination result indicates that blood collection has been completed for all of the blood collection tubes 1121, 1131 (step S405; YES), the process proceeds to step S406. On the other hand, if blood collection has not been completed for all of the blood collection tubes 1121, 1131 (step S405; NO), the process returns to step S403.

[0156] Next, the compression means 13 releases the compression of the subject's finger 134 (step S406). The control unit 16 opens the valve 172 of the pressure adjustment mechanism 17 to discharge the working fluid from the bag 138. The discharge of the working fluid causes the bag 138 to contract, releasing the subject's finger 134 that had been restrained. The compression means 13 may be completely released to the initial state, or may be partially released to the intermediate state.

[0157] Next, the blood collection tube holders 112 and 113 are removed from the blood collection position directly below the finger rest area 131 (step S407). The control unit 16 controls the rotation drive mechanism 120 to rotate the turntable 11, removing the blood collection tube holders 112 and 113 and transporting the hemostatic material holder 114 holding the hemostatic agent 1141 to the blood collection position. Once the blood collection tube holders 112 and 113 have been removed, the blood collection operation (step S107) ends and the process proceeds to the treatment operation (step S108).

[0158] Fig. 14 is a block diagram relating to the control of the compressing means of the blood collection device according to the embodiment of the present invention. Fig. 14 shows a method for controlling the compressing means 13 for causing blood to stagnate in the finger 134 of the person to be blood-collected in the operation of compressing the finger shown in Fig. 12 and Fig. 13. As shown in Fig. 14, the compressing means 13 for compressing the finger 134 of the person to be blood-collected can be controlled based on the detection results of the state of the finger of the person to be blood-collected and the detection results of the output state of compressing the finger of the person to be blood-collected when compressing the finger to cause blood to stagnate.

[0159] 14, the control unit 16 performs feedback (FB) control of the output of the compression means 13 compressing the fingers of the blood recipient based on the detection result of the output state of the compression means 13 compressing the fingers of the blood recipient. As the output of the compression means 13, the output of the pump 173 of the pressure adjustment mechanism 17 is controlled. The output of the compression means 13 can be controlled by proportional (P) control, proportional integral (PI) control, proportional differential (PD) control, PID control, etc.

[0160] The control unit 16 also performs feedforward (FF) control of the output of the compression means 13 to compress the fingers of the subject based on the detection result of the condition of the subject's fingers. As the condition of the subject's fingers, it is preferable to use the condition related to the blood flow in the subject's fingers.

[0161] It is preferable that the control unit 16 performs proportional control to reduce the change in the expansion amount of the bag body 138 as the degree of congestion in the fingertip increases or as the amount of blood in the blood vessels running through the fingertip increases. Such proportional control allows the state of blood flow in the finger to be quickly controlled toward the target state.

[0162] 14, the detection results of the state of blood flow in the subject's fingers include the detection results of the degree of congestion in the subject's finger 134 and the detection results of the amount of blood in the blood vessels running through the fingertip of the subject's finger 134. The degree of congestion and the amount of blood in the blood vessels running through the fingertip are detected as changes in the gradation of pixels on the fingertip image. In this control method, the detection results of the state of blood flow in the fingers are used to set the output conditions for the compression means 13 and for feedforward (FF) control of the output from the compression means 13.

[0163] 14 , the internal pressure of the bag 138 is detected as the output state of the compression means 13 compressing the fingers of the person to be blood-collected. The internal pressure of the bag 138 is detected by a pressure sensor 171 of the pressure adjustment mechanism 17. As the output state, the amount of expansion of the bag 138 may be detected by a positioning sensor that detects the displacement of the surface of the bag 138, a load sensor that detects the load, or the like. In this control method, the output state of the compression means 13 is used for feedback (FB) control of the output by the compression means 13.

[0164] The target value setting unit 201, the FB control amount calculation unit 202, and the FF control amount calculation unit 204 are functionally realized by the control unit 16 being hardware. The target value setting unit 201, the FB control amount calculation unit 202, and the FF control amount calculation unit 204 may be realized by a calculation device such as a CPU executing a predetermined program, or may be realized by an analog circuit.

[0165] The target value setting unit 201 sets the output conditions for the compression means 13 to compress the fingers of the subject, i.e., the target value for the internal pressure of the bag body 138. The output conditions for the compression means 13 are set based on the detection results of the state of blood flow in the subject's fingers. The target value for the internal pressure of the bag body 138 can be set, for example, so that the degree of congestion in the subject's fingers 134 or the amount of blood in the blood vessels running through the tips of the subject's fingers 134 is appropriate for blood collection. Image data of fingertip images showing the state of blood flow in the fingers is input to the target value setting unit 201 from the infrared imaging device 191 or a camera installed in the vicinity of the finger rest area 131.

[0166] For example, when using the infrared light imaging device 191, an image of the blood vessels of the subject's finger 134 is captured, and the amount of light transmitted through the blood vessels can be measured as an integrated amount within a predetermined range on the blood vessel image. If the amount of light is below a preset threshold, it can be determined that the fingertip is congested or has a high blood flow rate. On the other hand, if the amount of light is above a preset threshold, it can be determined that the fingertip is not congested or has a low blood flow rate. By determining in advance the correlation between the amount of light and the amount of blood that can be extracted for a typical subject, the degree of blood flow in the fingers can be quantified.

[0167] Alternatively, when an RGB camera or the like is used, an external image of the subject's finger 134 can be captured, and the chromaticity of the skin due to congestion can be measured within a predetermined range on the external image. If the chromaticity falls within a preset range of red chromaticity coordinates, it can be determined that the fingertip is congested or has a high blood flow rate. On the other hand, if the chromaticity does not fall within the preset range of red chromaticity coordinates, it can be determined that the fingertip is not congested or has a low blood flow rate. By determining in advance the correlation between chromaticity and the amount of blood that can be collected for a typical subject, the degree of blood flow in the fingers can be quantified.

[0168] As shown in Fig. 14, when compressing the subject's finger 134 to cause blood to stagnate, after the entry of the fingertip into the finger rest area 131 is detected, a fingertip image showing the state of blood flow in the subject's finger is captured by the infrared light imaging device 191 or a camera. The detection result of the state of blood flow in the finger is input to the target value setting unit 201. Based on the input detection result data, the target value setting unit 201 quantifies the amount of transmitted light and the chromaticity of the skin, and sets a target value for the internal pressure of the bag body 138. The target value setting result is output to the first adder and the FF control amount calculation unit 204.

[0169] The target value can be set to a value smaller than the standard value when the blood flow condition in the finger is suitable for blood collection. For example, when the amount of transmitted light exceeds a preset reference value or when the chromaticity of the skin is within a preset range of chromaticity coordinates on the red side, a target value smaller than the initially set general standard value or a target range smaller than the standard range can be set.

[0170] On the other hand, if the condition of the blood flow in the fingers is not suitable for blood sampling, a value larger than the standard value can be set as the target value. For example, if the amount of transmitted light is below a preset reference value or if the chromaticity of the skin is not included in a preset range of chromaticity coordinates on the red side, a target value larger than the initially set general standard value or a target range smaller than the standard range can be set.

[0171] The feedback control amount calculation unit 202 calculates an feedback control amount for feedback-controlling the output of the compression means 13 compressing the fingers toward a control target value based on the input from the first adder. Specifically, the feedback control amount calculation unit 202 calculates an feedback control amount for the output of the pump 173 for feedback-controlling the internal pressure of the bag body 138 toward a target value. The feedback control amount is calculated using the detection result of the output state of the compression means 13 compressing the fingers, i.e., the detection result of the internal pressure of the bag body 138 by the pressure sensor 171. The feedback control amount can be set so that the internal pressure of the bag body 138 reaches the target value within a predetermined range of load applied to the fingers or within a predetermined required time. The calculation result of the feedback control amount is output to the second adder.

[0172] The FF control amount calculation unit 204 calculates an FF control amount for feedforward control of the output of the compression means 13 compressing the fingers based on the detection results of the blood flow status of the fingers. Specifically, the FF control amount calculation unit 204 calculates an FF control amount for the output of the pump 173 for feedforward control of the internal pressure of the bag body 138 based on the quantification results of the amount of transmitted light and the chromaticity of the skin. The FF control amount can be set so that the degree of congestion in the fingertip and the degree of blood flow in the blood vessels running through the fingertip reach target states within a specified range of load on the finger and a specified range of inflation time. The calculation result of the FF control amount is output to the second adder.

[0173] The second adder adds the FB control amount and the FF control amount to calculate a target control amount for controlling the output of the pump 173 toward the control target value. The calculation result of the target control amount is output to the controller 203.

[0174] The controller 203 outputs a control signal of the calculated target control amount to the pump 173, and controls the output of the pump 173 toward the target control amount. By controlling the output of the pump 173 toward the target control amount, the amount of working fluid supplied to the bag 138 is adjusted. By adjusting the amount of working fluid supplied to the bag 138, the internal pressure of the bag 138 is controlled toward a predetermined target value. The bag 138 is controlled so that the amount of expansion increases and the finger 134 of the blood sample recipient is compressed with a load equal to or greater than a predetermined value.

[0175] The pressure sensor 171 continuously measures the internal pressure of the bag body 138 while the output of the compressing means 13 compressing the fingers is controlled toward the control target value. The measurement result of the internal pressure of the bag body 138 by the pressure sensor 171 is fed back to the first adder.

[0176] The first adder compares the target value of the internal pressure of the bag 138 with the measurement result of the internal pressure of the bag 138 and calculates the deviation between them. The FB control amount calculation unit 202 calculates the FB control amount of the output compressing the fingers by the compression means 13 so as to reduce the deviation input from the adder. When the output compressing the fingers by the compression means 13, i.e., the target control amount of the output of the pump 173, is set or changed to control the internal pressure of the bag 138 to the target value, the bag 138 expands to a predetermined amount, and the finger 134 of the subject is compressed with a load greater than a predetermined value, resulting in congestion.

[0177] When compressing the fingers to cause blood congestion, the compression means 13 can repeatedly compress and release the finger 134 of the person to be sampled. The control unit 16 can repeatedly control to increase the amount of expansion of the bag body 138 and control to decrease the amount of expansion of the bag body 138 before the puncture needle is inserted into the finger 134 of the person to be sampled placed in the finger holder 131, after the puncture needle is inserted into the finger 134 of the person to be sampled placed in the finger holder 131, and until blood collection from the puncture site of the finger 134 of the person to be sampled into the blood collection tubes 1121, 1131 is completed.

[0178] Before inserting the needle into the subject's finger 134, switching from pressure to release or from release to pressure can be performed depending on the state of blood flow in the finger. By repeating pressure and release, blood flow in the blood vessels running through the fingertip can be promoted.

[0179] For example, when a preset time has elapsed after the start of compression, when the amount of transmitted light is equal to or greater than a preset reference value, or when the chromaticity of the skin is within a preset range of chromaticity coordinates on the red side, the valve 172 can be controlled to discharge the working fluid from the bag 138. Switching from compression to release allows blood to flow into the blood vessels in the fingertip.

[0180] On the other hand, if a preset time has elapsed after the start of release, if the amount of transmitted light is less than a preset reference value, or if the chromaticity of the skin is not within a preset range of chromaticity coordinates on the red side, the pump 173 is controlled according to a control target value to supply working fluid to the bag body 138. By switching from release to compression, blood can be accumulated in the blood vessels of the fingertip.

[0181] Furthermore, after the puncture needle has punctured the subject's finger 134 placed in the finger holder 131, and before the blood collection from the puncture site on the subject's finger 134 to the blood collection tubes 1121 and 1131 is completed, switching from compression to release or from release to compression can be performed depending on the state of blood flow in the finger and the amount of blood collected in the blood collection tubes 1121 and 1131. By repeating compression and release, it is possible to promote blood flow in the blood vessels running through the fingertip and squeeze blood from the puncture site.

[0182] For example, when the amount of transmitted light is equal to or greater than a preset reference value, when the chromaticity of the skin is within a preset range of chromaticity coordinates on the red side, or when the rate at which the amount of blood collected in the blood collection tubes 1121 and 1131 is increasing is faster than a reference value, the valve 172 can be controlled to discharge the working fluid from the bag 138. By switching from compression to release, blood can be allowed to flow into the blood vessels in the fingertip.

[0183] On the other hand, if the amount of transmitted light is less than a preset reference value, if the chromaticity of the skin is not within a preset range of chromaticity coordinates on the red side, or if the rate of increase in the amount of blood collected in the blood collection tubes 1121 and 1131 is slower than the reference value, the pump 173 is controlled according to the control target value to supply working fluid to the bag 138. By switching from release to compression, blood can be pooled in the blood vessels of the fingertip or squeezed out.

[0184] According to this control method, the output from the compression means 13 compressing the subject's fingers is feedback-controlled based on the output state of the compression means 13 and feedforward-controlled based on the detection results of the blood flow status in the fingers. Therefore, the subject's fingers 134 can be compressed with a load equal to or greater than a predetermined load, regardless of disturbances such as changes in swelling and tension due to congestion in the fingers, finger shaking, and temperature changes. Furthermore, because the output conditions for compressing the fingers by the compression means 13 are set based on the condition of the subject's fingers, the strength of compression on the fingertip can be adjusted depending on the degree of congestion in the fingertip and the blood flow rate in the blood vessels running through the fingertip. Therefore, even if there are individual differences in the thickness and shape of the subject's fingers, the subject's fingers 134 can be appropriately compressed to achieve a congested state that facilitates the collection of a sufficient amount of blood. Unlike conventional methods, there is no need to reflect the measurement results of the amount of blood collected in the blood collection tube in the control. This eliminates the need to quickly achieve a congested state that facilitates the collection of a sufficient amount of blood, thereby completing the blood collection operation in a short time. This allows accurate insertion of the puncture needle into the desired target position on the fingertip, pressing of the blood collection tube, and rapid collection of blood from the puncture site. When repeatedly compressing and releasing the finger, the pressure of the compression can be adjusted according to the state of blood flow in the finger.

[0185] 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.

[0186] For example, the operations shown in Figures 9, 10, 12, and 13 and the controls shown in Figures 11 and 14 may be applied to any of the compression means 13 configurations shown in Figures 4, 5, 6, and 7, and 8. When the compression tool 137 is used in combination, the output conditions for compressing the fingers by the compression means 13 can be set to conditions different from those when the compression tool 137 is not used in combination. In the above operations and controls, the internal pressure of the bag body 138 is controlled or detected as the output state of the compression means 13, but the load due to compression, the displacement of a predetermined position due to compression, etc. may also be controlled or detected. The compression means 13 may be fixed on either the dorsal side or the ventral side, and the working fluid may be supplied to the bag body 138 on the unfixed side.

[0187] Furthermore, if the compressing means 13 is controlled based on the detection results of the finger condition and the output state of the compressing means 13 in the process of compressing the subject's finger 134 to cause blood to stagnate (step S105), the compressing means 13 may be controlled based only on the detection results of the output state of the compressing means 13 in the process of immobilizing the subject's finger 134 (step S103). The target value of the internal pressure of the bag body 138 may be controlled to a single predetermined value for multiple subjects. This type of control makes it possible to provide a blood collection device 1 that can immobilize the fingers of multiple subjects with a constant load and perform stable blood collection.

[0188] 1 Blood collection device 10 Housing 11 Turntable 12 Drive mechanism 13 Compression means 14 Blood collection amount measurement mechanism 16 Control unit 15 Finger detection mechanism 17 Pressure adjustment mechanism 18 Input / output device 19 Blood vessel image acquisition mechanism 110 Puncture means 111 Puncture device holder 112 Blood collection tube holder 113 Blood collection tube holder 114 Hemostatic material holder 115 Protective material holder 116 Protective sheet 120 Rotation drive mechanism 121 Lifting drive mechanism 122 Push rod 131 Finger rest 134 Finger of blood collection recipient 136 Insertion port 137 Compression tool 138 Bag body 139 Pressing member 140 Opening 151 Movable member 152 Position sensor 171 Pressure sensor 172 Valve 173 Pump 191 Infrared light imaging device 192 Near-infrared light source

Claims

1. A blood collection device comprising: a puncturing means for puncturing a finger of a blood donor with a puncturing needle; a compressing means for compressing the finger; a control unit for controlling the operations of the puncturing means and the compressing means; a first detecting means for detecting the state of the finger; and a second detecting means for detecting an output state of compressing the finger by the compressing means, wherein the control unit sets an output condition for compressing the finger by the compressing means according to at least one of the size and the shape of the finger of the blood donor, and controls the output of compressing the finger by the compressing means based on the detection result of the state of the finger and the detection result of the output state of compressing the finger by the compressing means under the setting of the output condition.

2. The blood collection device according to claim 1, wherein the state of the finger is a state related to the position of the finger or a state related to the blood flow of the finger, the state related to the position of the finger is a state distinguished by the distance between the finger of the blood donor and the puncturing means according to the size and the shape of the finger, a state distinguished by the distance between the finger of the blood donor and the compressing means according to the size and the shape of the finger, or a state distinguished by the time until the output state of compressing the finger by the compressing means changes due to contact with the finger, and the state related to the blood flow of the finger is a state distinguished by the degree of congestion at the fingertip of the finger or a state distinguished by the blood volume in the blood vessel running through the fingertip of the finger.

3. The blood collection device according to claim 1, wherein the control unit performs feedback control on the output of compressing the finger by the compressing means based on the detection result of the output state of compressing the finger by the compressing means.

4. The blood collection device according to claim 1, wherein the control unit performs feedforward control on the output of compressing the finger by the compressing means based on the detection result of the state of the finger.

5. The blood collection device according to claim 1, wherein the compressing means is disposed at a position facing the dorsal side of the finger placed in the finger placement area and at a position facing the ventral side of the finger placed in the finger placement area, and compresses the finger placed in the finger placement area by sandwiching it from the dorsal side and the ventral side.

6. The blood collection device according to claim 1, wherein the pressing means is disposed at a position facing the ventral side of the finger placed in the finger placement area and at positions facing the left and right side surfaces of the finger placed in the finger placement area, and the blood collection device presses the finger placed in the finger placement area by sandwiching it from the left and right side surfaces and pressing it against a member disposed on the dorsal side from the ventral side.

7. The blood collection device according to claim 1, wherein a pressing tool that covers the dorsal side and the left and right side surfaces of the finger of the blood donor and presses and compresses the finger by sandwiching it from the left and right side surfaces is attached to the finger of the blood donor, and the pressing means is disposed at a position facing the ventral side of the finger placed in the finger placement area, and the pressing tool is attached and the finger placed in the finger placement area is pressed and fixed together with the pressing tool against a member disposed on the dorsal side.

8. The blood collection device according to claim 1, wherein the pressing means is a bag body filled with a working fluid, and the blood collection device can adjust the output of pressing the finger by adjusting the amount of the working fluid enclosed in the bag body.

9. The blood collection device according to claim 8, wherein the control unit performs proportional control to reduce the change in the inflation amount of the bag body as the distance between the finger of the blood donor and the puncturing means, the distance between the finger of the blood donor and the pressing means, or the time until the output state of pressing the finger by the pressing means changes due to contact with the finger becomes smaller.

10. The blood collection device according to claim 8, wherein the control unit repeatedly executes control to increase the inflation amount of the bag body and control to decrease the inflation amount of the bag body at least in one of before puncturing the finger placed in the finger placement area with the puncturing needle, after puncturing the finger placed in the finger placement area with the puncturing needle, and until the blood collection from the finger is completed.

11. A blood collection method including a puncturing step of puncturing a puncturing needle into the finger of a blood donor and a pressing step of pressing the finger, wherein the pressing conditions for pressing the finger are set according to at least one of the size and shape of the finger of the blood donor, and the pressing force for pressing the finger is adjusted based on the state of the finger and the pressing state of pressing the finger under the setting of the pressing conditions.

12. The blood collection method according to claim 11, wherein a distance between the finger of the blood donor and a puncturing means for puncturing the puncturing needle, a distance between the finger of the blood donor and a compressing means for compressing the finger, according to the size and shape of the finger, or a blood collection method for setting a compressing condition for compressing the finger according to a time until a compressing state of compressing the finger by the compressing means changes due to contact with the finger.

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