WO2025154528A1 - Blood collection device and blood collection method - Google Patents

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

The present invention relates to a blood collection device and a blood collection method for collecting blood from the subject's fingers.

　Conventionally, blood collection devices have been developed that automatically collect blood from the fingers of a person to be collected. In some blood collection devices, the fingers of the person to be collected are placed on a designated finger rest area, a puncture needle is automatically inserted into the finger, and blood that flows out from the puncture site is collected in a collection tube. In this type of blood collection device, the puncture needle that punctures the finger and the collection tube that collects the blood are positioned relative to the fingers placed on the finger rest area to automatically collect blood.

Patent Document 1 describes a blood collection device that automatically collects blood from the subject's fingers. This blood collection device is configured so that the finger from which blood is to be collected is inserted into a hole in the finger clamping mechanism, the fingertip is placed on the blood collection window, and the fingertip is then fixed to the blood collection window 140 by closing the finger holding mechanism. A piercer 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.

Patent No. 6994910

A blood sampling device that automatically draws blood from the subject's fingers is expected to have a function that targets a specific blood vessel with a puncture needle. Finger blood sampling tends to result in a small amount of blood being collected in one attempt. Therefore, in order 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 suitable for blood sampling.

However, if the subject's fingers placed on the finger rest area move when the puncture needle is inserted, it becomes difficult to insert the needle into the target puncture location. In addition, 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. Even when collecting blood into a blood collection tube, if the subject's fingers placed on the finger rest area move, it becomes difficult to collect the blood flowing out from the puncture site into the blood collection tube.

When aligning the puncture needle or blood collection tube, it is important to apply pressure to the subject's fingers, which are placed on the finger rest area, with a specified load and fix them within a specified range. By applying sufficient pressure to the fingers and restraining the fingertips within a specified 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.

　A common method for immobilizing the fingers of a blood sampler is to compress the fingers using a finger clamp or cuff. However, there are individual differences in thickness, flexibility, firmness, etc., of the fingers of the subjects receiving blood samples. Simply compressing the fingers of a blood sampler with a uniform load creates a problem in that the positional relationship between the target puncture position and the arrival position of the puncture needle or blood collection tube will shift due to individual differences in the fingers.

In addition, when inserting a puncture needle or collecting blood into a blood collection tube, it is desirable to compress the subject's fingers to cause blood to stagnate in order to promote bleeding from the puncture site. Simply compressing the subject's fingers with a uniform load may result in insufficient bleeding from the puncture site due to individual differences in fingers. In Patent Document 1, the amount of blood from the site to be punctured is detected, and blood is collected in a state where the fingertip is stagnate. However, methods that detect the amount of blood that has bled from the puncture site make it difficult to address issues caused by individual differences in fingers.

The present invention aims to provide a blood collection device and method that can fix the subject's fingers within a specified range relative to the puncture needle and blood collection tube regardless of individual differences, allowing the puncture needle to be accurately inserted into the desired target position on the fingertip, the blood collection tube to be pressed against the fingertip, and blood to be collected quickly from the puncture site.

In order to solve the above problems, the blood collection device of the present invention is a blood collection device that includes a puncturing means for inserting a puncture needle into the finger of the 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, and 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 result of the condition 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 conditions.

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

The present invention provides a blood collection device and blood collection method that can fix the subject's fingers within a specified range relative to the puncture needle and blood collection tube regardless of individual differences, allowing the puncture needle to accurately puncture the desired target position on the fingertip, the blood collection tube to be pressed against the fingertip, and blood to be collected quickly from the puncture site.

FIG. 1 is a diagram showing the appearance of a blood sampling 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 the blood sampling device according to the embodiment of the present invention. FIG. 2 is a diagram showing the configuration of devices built into the blood sampling device according to the embodiment of the present invention. FIG. 2 is a cross-sectional view showing a schematic example of a compression means of the blood sampling device according to the embodiment of the present invention. FIG. 2 is a cross-sectional view showing a schematic example of a compression means of the blood sampling device according to the embodiment of the present invention. FIG. 2 is a cross-sectional view showing a schematic example of a compression means of the blood sampling device according to the embodiment of the present invention. FIG. 2 is a cross-sectional view showing a schematic example of a compression means of the blood sampling device according to the embodiment of the present invention. FIG. 2 is a cross-sectional view showing a schematic example of a compression means of the blood sampling device according to the embodiment of the present invention. 5A to 5C are diagrams illustrating the operation of the blood sampling device according to the embodiment of the present invention. 6A to 6C are diagrams illustrating the operation of a compression means of the blood sampling device according to the embodiment of the present invention. FIG. 4 is a block diagram relating to control of the compression means of the blood sampling device according to the embodiment of the present invention. 6A to 6C are diagrams illustrating the operation of a compression means of the blood sampling device according to the embodiment of the present invention. 6A to 6C are diagrams illustrating the operation of a compression means of the blood sampling device according to the embodiment of the present invention. FIG. 4 is a block diagram relating to control of the compression means of the blood sampling device according to the embodiment of the present invention.

Below, a blood collection device and a blood collection method according to one embodiment of the present invention will be described. Note that the same reference numerals will be used to designate components that are common to the following figures, and duplicate explanations will be omitted.

FIG. 1 is a diagram showing the external appearance of a blood collection device according to an embodiment of the present invention. FIG. 1 shows, as an example of a blood collection device, a finger blood collection device that automatically collects blood from the fingers of a person to be collected. The opening 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 has, on the top surface of the housing 10, a hand rest area on which the hand 15 of the person to be collected is placed, and a finger rest area 131 on which the finger 134 of the person to be collected is placed.

The finger rest area 131 is provided with a compression means 13 that compresses the finger 134 of the person to be blood-collected. The compression means 13 is composed of a bag in which a working fluid is sealed, such as an airbag. The finger 134 of the person to be blood-collected is placed on the finger rest area 131, and is compressed by the compression means 13 so that the fingertip is in a congested state, after which blood is collected by a mechanism built into the housing 10. The compression around the finger makes the fingertip prone to bleeding when the puncture needle is inserted. In addition, the position of the fingertip is fixed within a predetermined range relative to the puncture needle, blood collection tube, etc.

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

The compression means 13 is supported at a position where it contacts the first joint of the subject's finger 134 placed in the finger rest area 131. As shown in the partial view, the finger rest area 131 is provided with a blood collection window 132, which is an opening that passes through the finger rest area 131 from top to bottom. The subject's finger 134 is placed with the pad side of the fingertip facing 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.

FIG. 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. FIG. 2 shows a state in which multiple holders 111-115 are attached to a turntable 11 built into the blood collection device 1. As shown in FIG. 2, multiple holders 111-115 that perform operations related to blood collection are attached to the turntable 11 built into the blood collection device 1.

Figure 2 shows an example of the holder configuration. In Figure 2, a puncture device holder 111 that holds a puncture device 1111, blood collection tube holders 112, 113 that hold blood collection tubes 1121, 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, 1131, a blood collection tube 1121 for a blood count test and a blood collection tube 1131 for a biochemistry/immunology test are installed.

The holders 111 to 115 can move relative to the finger rest area 131 by rotating the turntable 11 and by raising and lowering the turntable 11. By moving the holders 111 to 115, a puncturing operation of inserting the puncture needle into the subject's finger 134, a blood collection operation of collecting blood from the puncture site inserted by the puncture needle into the blood collection tubes 1121, 1131, and a treatment operation of treating the puncture site with a hemostatic material 1141 or a protective material 1151 are sequentially performed on the subject's finger 134 placed on the finger rest area 131.

The turntable 11 is formed in a circular plate shape with a portion cut out. The turntable 11 is supported for free rotation 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.

The holding holes 1112, 1122, 1132, 1142, and 1152 are arranged on a circumference of a specified 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 specified diameter that passes directly below the finger rest area 131. Each of the holders 111 to 115 is installed in a pre-specified position in each of the holding holes 1112, 1122, 1132, 1142, and 1152.

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

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

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 immunology tests is a container from which blood is collected for biochemistry and immunology 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.

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

The hemostatic material 1141 is an absorbent cloth such as gauze that is pressed against the puncture site to absorb blood that has bled from the puncture site and stop the bleeding. The protective material 1151 is an adhesive sheet such as a bandage with 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 so that the absorbent cloth and adhesive surface face upwards.

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

Fig. 3 is a diagram showing the configuration of the devices built into the blood collection device according to an 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 111-115, the blood collection amount measurement mechanism 14 that measures the amount of blood collected, the control unit 16 that controls each mechanism, the pressure adjustment mechanism 17 that adjusts the pressure of the bag body of the compression means 13, and the blood vessel image acquisition mechanism 19 that acquires an image of the blood vessels in the fingertip.

The upper diagram in Figure 3 shows the area around the turntable 11 as viewed from above. The lower diagram in Figure 3 shows the area around the turntable 11 as viewed from the side, together with the configuration of the control unit 16 and the pressure adjustment mechanism 17. In Figure 3, the finger 134 of the person to be blood-collected is placed on a finger rest area 131 (not shown). The position directly below the finger rest area 131 on the turntable 11 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 puncturing operation, blood collection operation, and treatment operation are performed by each of the holders 111-115.

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

The drive mechanism 12, blood collection amount measurement mechanism 14, pressure adjustment mechanism 17, and blood vessel image acquisition mechanism 19 are connected to the 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 the input/output device 18 via wired or wireless signal lines.

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, and outputs measurement results of the amount of blood collected. The input/output device 18 may be built into the blood collection device 1, or may be connected to the blood collection device 1 as an external device. A personal computer, tablet, etc. can be used as the external input/output device 18.

The drive mechanism 12 is composed of a rotation drive mechanism 120 that drives the rotational movement of the turntable 11, a lift drive mechanism 121 that drives the raising and lowering of the holders 111-115, and a push rod 122 that pushes up the holders 111-115 from below to raise them. The rotation drive mechanism 120 is installed below the turntable 11. The lift drive mechanism 121 and the push rod 122 are installed below the blood collection position directly below the finger placement 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.

The rotation drive mechanism 120 is formed by a shaft connected to the center of the turntable 11, a motor connected to the shaft, etc. The turntable 11 is driven to rotate at a predetermined step angle by the rotation drive mechanism 120. The rotation of the turntable 11 transports and removes the holders 111-115 to the blood collection position directly below the finger placement area 131. At the blood collection position, the lift drive mechanism 121 lifts and lowers the holders 111-115.

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. 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.

When the push rod 122 is driven to rise, it pushes up from below the holders 111-115 in the blood collection position, causing them to rise. The puncture devices 1111 and the like held by the holders 111-115 are raised by the push rod 122 to a position where they are pressed against the finger 134 of the person to be drawn or to a position close to the finger 134 of the person to be drawn. On the other hand, when the push rod 122 is driven to descend, it lowers the holders 111-115 in the blood collection position to a position where they are supported on the turntable 11.

The blood collection amount measuring mechanism 14 is a mechanism that measures the amount of blood collected into a blood collection tube. The blood collection amount measuring mechanism 14 is composed of a light source that emits planar light and a photodetector. The light source and the photodetector are installed so as to face 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 emitted from the light source that has passed through the blood collection tube.

The planar light emitted from the light source is scattered, reflected, absorbed, etc. by blood, so 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, a decrease in the intensity of the transmitted light due to the blood is observed depending on the level of the blood in the blood collection tube. Therefore, the amount of blood collected in the blood collection tube can be calculated based on the correlation between the level of the blood collected in the blood collection tube and the amount of blood in the blood collection tube, or the correlation between the amount of transmitted light that has passed through the blood collection tube and the amount of blood in the blood collection tube.

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 item of the blood test 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 according to the displacement of the drive mechanism 12 by recording the operation of the drive mechanism 12.

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 tube. If the blood collection tube contains a separating agent, for example, the average height of the top end 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 integral amount over a specified range.

The light source for the blood collection volume measuring mechanism 14 can be an LED (Light Emitting Diode), a COB (Chip On Board) LED, an OLED (Organic Light Emitting Diode), etc. 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 a wavelength, it is possible to detect with high sensitivity the attenuation of light intensity caused by scattering or reflection by blood, and the attenuation of light intensity caused by absorption by hemoglobin.

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

As the light detector, an image sensor such as a CCD (Charge Coupled Device) or a CMOS (Complementary Metal-Oxide-Semiconductor) can be used. The image sensor detects the 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 of light and light intensity of the transmitted light that has passed through the blood collection tube can be captured. By performing image analysis on the captured image, it is possible to determine the liquid level of the blood collected in the blood collection tube and the amount of transmitted light that has passed through a specified area of the blood collection tube.

The pressure adjustment mechanism 17 is composed of a tube that connects the bag of the compression means 13 to the source of the 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.

The blood vessel image acquisition mechanism 19 is a mechanism for acquiring a blood vessel image of the subject's finger 134. 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 subject's finger 134 placed in the finger placement area 131. The infrared light imaging device 191 is positioned so as to face the pad side of the fingertip. The near-infrared light source 192 is positioned so as to face the nail side of the fingertip.

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

In a blood vessel image, the course of blood vessels is represented by contrast due to the shade of pixels. 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, the blood vessels running under the skin of the fingertip can be visualized as dark lines that are a series of low-brightness pixels with low light intensity of transmitted light surrounded by surrounding pixels with high light intensity of transmitted light. 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 to be used for controlling the compression means 13.

The infrared light imaging device 191 detects near-infrared light that has passed through the subject's finger 134 placed in the finger placement area 131, and captures an image of the blood vessels in the subject's finger 134. The infrared light imaging device 191 can be an infrared camera capable of detecting infrared light and near-infrared light, or a near-infrared camera capable of detecting near-infrared light with high sensitivity.

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 placement area 131. As the near-infrared light source 192, an LED (Light Emitting Diode) whose emission wavelength includes the near-infrared light range can be used. As the near-infrared light, light with a wavelength of 700 nm or more and 2500 nm or less, for example, light of about 940 nm can be used.

FIG. 4 is a cross-sectional view showing a schematic example of a compression means of a blood sampling device according to an embodiment of the present invention. FIG. 4 shows a schematic cross-sectional structure around a finger holder 131 formed on the top of the blood sampling device 1. As shown in FIG. 4, the finger holder 131 on which the subject's finger 134 is placed is provided inside an insertion port 136 formed on the top surface of the housing 10. When blood is sampled, the tip side of the subject's finger 134 is inserted into the insertion port 136, rather than near the first joint.

A compression means 13 for compressing the subject's fingers is provided near the opening of the insertion port 136. In FIG. 4, a puncture device holder 111 holding a puncture device 1111 is stationary directly below the finger placement area 131. The puncture device 1111 and the puncture device holder 111 constitute the puncture means 110 for inserting the puncture needle into the subject's fingers.

The puncturing means 110 and the compression means 13 are controlled by the control unit 16. The control unit 16 controls the rotation of the turntable 11 to transport the puncturing device holder 111 to the blood collection position directly below the finger placement area 131, and raises and lowers it relative to the turntable 11 to puncture the finger 134 of the person to be sampled. The control unit 16 also controls the output of the compression means 13 to compress the finger, and compresses the finger 134 of the person to be sampled under preset output conditions.

Inside the insertion port 136 are placed a finger detection mechanism 15 that detects entry of the subject's fingers into the space above the finger placement 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 port 136. The 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 placement area 131. The 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 placement area 131.

The compression means 13 compresses the finger 134 of the person to be sampled, and fixes the fingertip of the person to be sampled within a predetermined range in the space above the finger placement area 131. By restraining the fingertip with the compression means 13, the positional relationship between the target puncture position set on the fingertip and the reachable position of the tip of the puncture needle and the opening of the blood collection tube is determined. By determining these positional relationships, it becomes possible to accurately puncture the target puncture position and appropriately collect blood flowing out from the puncture site.

The compression means 13 also performs the action of compressing the subject's finger 134 in order to promote bleeding from the puncture site. The action of compressing the subject's finger 134 is performed before and during blood collection. By applying pressure around the subject's finger 134, blood is congested at the fingertip. Congesting the fingertip makes it easier for blood to flow out from the puncture site, making it easier to ensure the amount of blood required for the blood test performed after blood collection.

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 the compression means 13 pressing on the subject's finger 134, i.e., the internal pressure and amount of expansion of the bag 138, which affect the load caused by compression, by adjusting the amount of the working fluid filled in by supplying and discharging the working fluid. By adjusting the internal pressure and amount of expansion, the subject's finger 134 is compressed with a load equal to or greater than a predetermined value and is firmly fixed in place. 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 a tube.

In FIG. 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. The dorsal bag body 138 is disposed on the upper surface side near the opening of the insertion port 136. The ventral bag body 138 is disposed on the lower surface side near the opening of the insertion port 136.

The finger detection mechanism 15 detects when the subject's finger 134 enters the finger placement 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 positioned to face the tip of the subject's finger 134 that has entered the finger placement area 131. The position sensor 152 is positioned to the side of the movable member 151.

The movable member 151 is formed as a member that moves like a pendulum. The base end side of the movable member 151 is supported so as to be freely rotatable by a rotation axis that extends in a direction perpendicular to the depth direction of the insertion port 136. The tip side of the movable member 151 can move as the movable member 151 rotates between a position on the front side of the insertion port 136 where it interferes with the tip of the finger 134 of the person to be blood-collected that is placed in the finger placement area 131, and a position on the back side of the insertion port 136.

The position sensor 152 detects the presence or absence of the movable member 151 at a predetermined position on the rear side of the insertion port 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 placement area 131, the movable member 151 is pushed from the front side of the insertion port 136 to the rear side. Therefore, by detecting the presence or absence of the movable member 151 at a predetermined position of the insertion port 136, it can be determined whether the subject's finger 134 is placed in the finger placement area 131.

In FIG. 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. With this type of compression method, the subject's finger 134 can 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 fingertips in the up-down and left-right directions.

Figures 5 and 6 are cross-sectional views showing an example of a compression means of a blood sampling device according to an embodiment of the present invention. Figure 5 shows a cross-sectional structure of the area around a finger rest 131 formed on the top of the blood sampling device 1. Figure 6 shows a schematic view of the structure shown in Figure 5 from the rear side of the insertion port 136. As shown in Figures 5 and 6, the compression means 13 that compresses the fingers of the person to be sampled can also be composed of a bag 138 containing a working fluid and a pressing member 139 against which the fingers of the person to be sampled are pressed.

In Figures 5 and 6, the bag body 138 is disposed in a position facing the ventral side of the subject's finger 134 placed in the finger placement area 131, and in a position facing the left and right sides of the subject's finger 134 placed in the finger placement 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 placement area 131. The bag body 138 is installed on the underside near the opening of the insertion port 136 and on the left and right sides. 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 placement area 131 is located to the front side.

The bag bodies 138 on the left and right side sides can be supported by the side of the insertion opening 136 or by wall members arranged on the side of the insertion opening 136. The bag body 138 on the bottom side of the insertion opening 136 and the bag bodies 138 on the left and right side sides may be integrally provided as a band-shaped cuff with one or more bags built in. The bag body 138 on the bottom side of the insertion opening 136 and the bag bodies 138 on the left and right side sides may be integrally supplied with and discharged from the working fluid, or may be individual.

The pressing member 139 can be made of, for example, resin, elastomer, etc. A cloth such as a nonwoven fabric, a sponge, a rubber sheet, a resin film, etc. 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 placement area 131 below. By forming the opening 140, interference between the pressing member 139 and the near-infrared light source 192 and scattering and reflection of the near-infrared light can be reduced, so that near-infrared light with a highly uniform light intensity can be projected onto the fingertips.

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 the subject's finger 134 placed in the finger holder 131 is pressed from the ventral side against the pressing member 139 disposed on the dorsal side to compress it. With this type of compression method, the distance between the surface of the subject's finger 134 and the near-infrared light source 192 can be stably maintained within a specified range. Since it becomes possible to irradiate the subject's finger 134 with near-infrared light with a high degree of uniformity, it becomes possible to capture an image of the blood vessels with high accuracy.

In addition, in Figures 5 and 6, the bag body 138 presses the finger 134 of the person to be sampled, which is placed in the finger placement area 131, by pinching it from the left and right sides. With this type of compression method, regardless of individual differences in finger size, thickness, flexibility, firmness, etc., the fingertip can be strongly compressed from both the left and right sides, and blood can be rapidly congested in the fingertip. In addition, by compressing the finger 134 of the person to be sampled so that it is covered from the left and right, positional deviation of the fingertip in the left and right direction, etc. can be reduced.

Figures 7 and 8 are cross-sectional views showing an example of a compression means of a blood sampling device according to an embodiment of the present invention. Figure 7 shows a cross-sectional structure of the area around a finger rest 131 formed on the top of the blood sampling device 1. Figure 8 shows a cross-sectional structure of the structure shown in Figure 7 as viewed from the back side of the insertion port 136. As shown in Figures 7 and 8, the compression means 13 for compressing the fingers of the person to be sampled is composed of a bag body 138 and a pressing member 139, and can also be used in conjunction with a compression tool 137 worn on the fingers of the person to be sampled.

In Figures 7 and 8, the bag body 138 is positioned opposite the ventral side of the subject's finger 134 placed in the finger placement area 131. The pressing member 139 is positioned opposite the dorsal side of the subject's finger 134 placed in the finger placement 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 placement area 131 is located to the front side.

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 rough C-shape in cross section with an inner width slightly smaller than the thickness of a typical finger. When the valley side of the compression tool 137 is opened and inserted into the finger, both ends of the compression tool 137 are urged in the closing direction by a restoring force. This elasticity fixes the compression tool 137 to the finger, and the sides of the fingertip are compressed by the compression tool 137.

In Figures 7 and 8, the bag body 138 is positioned opposite the ventral side of the subject's finger 134 placed in the finger holder 131, and the finger 134 of the subject placed in the finger holder 131 is pressed from the ventral side together with the compression tool 137 against the pressing member 139 placed on the dorsal side to compress it. With this compression method, the distance between the surface of the subject's finger 134 and the near-infrared light source 192 can be stably maintained within a specified range. Since it becomes possible to irradiate the subject's finger 134 with near-infrared light with a high degree of uniformity, it becomes possible to capture an image of the blood vessels with high accuracy.

In addition, in Figures 7 and 8, when the compression tool 137 is attached to the finger 134 of the person to be blood-collected, it covers the back and both left and right sides of the finger 134 of the person to be blood-collected, and pinches and compresses the finger 134 of the person to be blood-collected from both left and right sides. When the finger is compressed with the compression tool 137, the fingertip becomes congested and is prone to bleeding when the puncture needle is inserted, making it easier to ensure the amount of blood to be collected. Since 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 the thickness, flexibility, firmness, etc. of the fingers, the fingertip can be compressed from both the left and right sides to quickly cause blood to congeal.

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

In the blood collection method according to this embodiment, the compression force applied to the fingers of the person to be collected by the compression means 13, i.e., the load applied by compression to the fingers, is adjusted. The blood collection method according to this embodiment includes a puncturing step of inserting the puncturing 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 by the puncturing needle into a blood collection tube.

The compression conditions for compressing the subject's fingers are set according to at least one of the size of the subject's fingers and the shape of the subject's fingers. With these compression conditions set, the compression force for compressing the fingers is adjusted based on the condition of the subject's fingers and the compression condition for compressing the subject's fingers. The condition of the subject's fingers may be the condition related to the position of the fingers or the condition related to the blood flow in the subject's fingers.

The conditions related to the position of the subject's fingers include conditions that are distinguished by the distance between the subject's fingers and the puncturing means that inserts the puncturing needle, depending on the size and shape of the fingers; conditions that are distinguished by the distance between the subject's fingers and the compressing means that compresses the fingers, depending on the size and shape of the fingers; and conditions that are distinguished by the time it takes for the compressing means to change the state of compression of the fingers due to contact with the fingers.

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

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

The compression 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 to congest. By setting and changing the conditions according to blood flow in the fingers, the pressure applied to the fingers can be appropriately adjusted so that the fingers are in a congested state suitable for blood collection.

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 so that the change in pressure decreases as the time it takes for the pressure to change due to contact with the fingers, such as the distance between the subject's fingers and the puncturing means for inserting the puncturing needle, the distance between the subject's fingers and the pressure applying means, 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 making such adjustments, the desired pressure can be obtained quickly.

In the blood collection device 1, the compression means 13 shown in Figures 4 to 8 has output conditions for compressing the subject's fingers, i.e., the control target values for the internal pressure and expansion amount of the bag body 138 that affect the load for compressing the fingers, set and changed by the control unit 16 according to at least one of the size of the subject's fingers and the shape of the subject's fingers.

By setting or changing the output conditions of the compression means 13 according to the size and shape of the fingers, the subject's fingers 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 subject's fingers are thin or the surface of the fingers is inclined, the subject's fingers can be securely fixed within a predetermined range in the space above the finger placement area 131, reducing the positional deviation of the fingertips.

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 from one another in size and shape. By applying pressure with a uniform strength to fingers that vary from one person to another, it is possible to provide a highly reliable blood collection device 1 that is capable of stable blood collection from multiple subjects.

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 blood recipient and the puncture means 110 in accordance with the size and shape of the finger, the distance between the finger 134 of the blood recipient and the compression means 13 in accordance with the size and shape of the finger, or the time until the output state of the compression means 13 compressing the finger changes due to contact between the compression means 13 and the finger 134 of the blood recipient.

In addition, with the compression means 13 shown in Figures 4 to 8 set under such output conditions, the output of the pump 173 that adjusts the output of compression on the subject's fingers, i.e., the internal pressure and expansion amount of the bag body 138 that affect the load of compression on the fingers, is controlled by the control unit 16 based on the condition of the subject's fingers and the output state of compression on the subject's fingers by the compression means 13, i.e., the control result of the internal pressure and expansion amount of the bag body 138 that affect the load of compression on the fingers.

The condition of the subject's fingers can be controlled by the condition related to the position of the subject's fingers and the condition related to the blood flow in the subject's fingers. The condition related to the position of the subject's fingers is preferably used to control when the fingers are fixed. The condition related to the blood flow in the subject's fingers is preferably used to control when pressure is applied to cause blood congestion in the fingers.

The states related to the position of the subject's fingers include states that are distinguished by the distance between the subject's finger 134 and the puncturing means 110 according to the size and shape of the finger, states that are distinguished by the distance between the subject's finger 134 and the compression means 13 according to the size and shape of the finger, and states that are distinguished by 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.

The state of blood flow in the subject's fingers can be distinguished by the degree of congestion in the subject's fingertips, or by 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 light intensity of near-infrared light transmitted through the fingertips.

A first detection means is provided around the finger placement area 131 to detect the condition of the subject's fingers. When detecting the condition of the position of the fingers, the first detection means detects the distance between the subject's finger 134 and the puncture means 110, the distance between the subject's finger 134 and the compression means 13, and the time until the output state of the compression means 13 compressing the subject's finger 134 changes due to contact between the compression means 13 and the subject's finger 134. When detecting the condition of 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.

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 compression 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 compression means 13 can be used. These distance measuring sensors can be installed below the finger placement area 131, around the bag body 138, etc.

When detecting the time until the output state of the compression means 13 changes due to contact with the subject's finger 134, the first detection means can be 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. 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 amount of expansion of the bag body 138 changes. Therefore, by measuring the time required for the output state to change by a threshold value or more, the distance between the subject's finger 134 and the compression means 13 can be indirectly detected.

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 placement area 131 on the underside of the insertion port 136.

In addition, a second detection means is provided in association with the compression means 13, which detects the output state of the compression means 13 compressing the subject's fingers. 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 the compression means 13 compressing the subject's fingers.

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, etc. may be used. These sensors may be installed around the bag body 138, etc.

FIG. 9 is a diagram explaining the operation of a blood collection device according to an 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 person to be blood-collected compressed and fixed by the compression means 13.

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

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

Then, the subject's finger 134 is fixed on the finger placement area 131 by the compression means 13 (step S103). The subject's finger 134 is inserted into an insertion port 136 provided on the top surface of the blood collection device 1 and is compressed by the bag body 138 with a load equal to or greater than a predetermined value. The subject's finger 134 is fixed within a predetermined range in the space above the finger placement area 131 with the pad side of the fingertip facing downward through the blood collection window 132.

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

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.

The information label can be attached by any suitable 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 of the blood collection tubes 1121, 1131, or to the side of the outer tube that contains the blood collection tubes 1121, 1131.

Next, a vascular 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 vascular image acquisition mechanism 19 to capture a vascular image of the subject's finger 134, and receives the image capture data from the vascular image acquisition mechanism 19. The vascular image is visualized based on the image capture data. The control unit 16 determines the target puncture position of the puncture needle on the subject's finger 134 based on the vascular image. The control unit 16 also controls the output of the compression means 13 to compress the subject's finger.

Then, a puncture operation is performed on the subject's finger 134 (step S106). The control unit 16 controls the rotation drive mechanism 120 to rotate the 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, the control unit 16 controls the lift drive mechanism 121 to raise the puncture device holder 111 to a height where the puncture device 1111 is pressed against the subject's finger 134. When the puncture device 1111 is pressed against the subject's finger 134, it protrudes the puncture needle and punctures the target puncture position.

Then, 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 transported sequentially to the blood collection position directly below the finger placement area 131. After the rotation, the control unit 16 controls the lift 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 collected sequentially into the pressed blood collection tubes 1121, 1131.

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

The control unit 16 controls the blood collection volume measuring mechanism 14 during the blood collection operation to measure the volume of blood collected in the collection tubes 1121, 1131. In addition, a built-in timer measures the blood collection time. The blood collection time is the time elapsed from 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. For this reason, 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.

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, and determines whether the amount of blood collected into the blood collection tube has reached the target blood collection amount. It also 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, and determines whether the blood collection time elapsed since starting blood collection into the blood collection tube has reached the maximum blood collection time.

If the result of measuring the amount of collected blood is that 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, collection of blood into the collection tubes 1121, 1131 continues. 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 blood testing, or tissue fluid may have been mixed in or blood coagulation may have progressed.

On the other hand, when the result of measuring the amount of collected blood is that the amount of blood collected in the blood collection tubes 1121, 1131 is equal to or greater than the target blood amount, collection of blood into the blood collection tubes 1121, 1131 is terminated. The control unit 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 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.

Then, a treatment operation is performed on the subject's finger 134 (step S108). The control unit 16 controls the rotation drive mechanism 120 to rotate the turntable 11 so that the hemostatic material holder 114 and the protective material holder 115 are transported sequentially to the blood collection position directly below the finger placement area 131. After the turntable 11 rotates, the lift drive mechanism 121 is controlled to sequentially raise the hemostatic material holder 114 and the protective material holder 115 to a height at which the hemostatic agent 1141 and the protective material 1151 are pressed against the puncture site. The puncture site is stopped from bleeding or protected by the pressing of the hemostatic agent 1141 and the protective material 1151.

Then, the blood collection tubes 1121, 1131 from which blood has been collected 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 from which blood has been collected are inverted to mix as necessary, and then transported to an automatic analyzer or the like that performs blood tests. The blood collection tubes 1121, 1131 from which blood has been collected are managed according to information labels that are individually assigned to them. Data indicating the measurement results of the amount of blood collected can be associated with the information label data and stored.

FIG. 10 is a diagram explaining the operation of the compression means of the blood sampling device according to an embodiment of the present invention. FIG. 10 shows a flow of an example of a process (step S103) in which the finger 134 of the person to be sampled is fixed on the finger placement area 131 by the compression means 13. As shown in FIG. 10, when the finger 134 of the person to be sampled is fixed by the compression means 13, the output conditions for the output of the compression means 13 compressing the finger can be set based on the detection result of the condition of the person to be sampled's fingers.

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

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

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

Next, the state of the subject's fingers on the finger placement area 131 is detected (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 puncture 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.

Next, based on the detection results of the condition of the subject's fingers, the output conditions for the compression means 13 to compress the subject's fingers 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 that compresses the fingers, based on the detection results of the distance measurement sensor, etc.

Next, under the set output conditions, the output of the compression means 13 for compressing the subject's fingers is controlled to compress the subject's fingers and fix them on the finger placement area 131 (step S205). The control unit 16 controls the output of the compression means 13 for compressing the subject's fingers in accordance with 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 subject's fingers, 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.

Next, it is determined whether fixation of the subject's fingers has been completed (step S206). Whether fixation of the fingers has been completed is determined based on whether the output state of compression of the subject's fingers by the compression means 13 has reached a target state. For example, it can be determined that fixation 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.

If the result of the determination is that the fixation of the fingertips is complete (step S206; YES), the process of fixing the fingers (step S103) is terminated, and the process of reading the information label (step S104) proceeds. On the other hand, if the fixation of the fingertips is not complete (step S206; NO), the process returns to step S205. If the fixation of the fingertips is not completed within a preset specified time, a warning may be displayed on the display of the input/output device 18, etc.

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

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

The control unit 16 preferably performs 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 holder and the puncture needle of the puncture means 110 decreases, as the distance between the subject's finger 134 placed on the finger holder and the bag body 138 of the compression means 13 decreases, or as the time it takes for the output state of the compression 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 fingers toward the target state.

In FIG. 11, the detection results for the state of the position of the subject's fingers include 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 compression means 13, and the detection result of 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. The detection results for the state of the finger position 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 compression means 13.

In addition, in FIG. 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, 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.

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.

The target value setting unit 201 sets the output conditions for the compression means 13 to compress the subject's fingers, 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 related to the position of the subject's fingers. The target value for 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 subject's fingers 134 are restrained with a specified load at a specified target position in the space above the finger rest area 131.

As shown in FIG. 11, when the subject's finger 134 is fixed, the entry of the fingertip onto the finger placement area 131 is detected, and then the state of the subject's finger position is acquired by the distance measurement sensor 151. 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.

The target value can be set to a value smaller than the standard value if the subject's fingers are of a suitable thickness or shape for fixation. For example, if the distal joint width of the subject's fingers exceeds the 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 set general standard value can be set.

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 distal joint width of the subject's fingers is smaller than the general standard width, 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 initial general standard value can be set.

Based on the input from the adder, 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. 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, that is, 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 becomes a target value within a specified range of load on the fingers or within a specified required time. The calculation result of the target control amount is output to the controller 203.

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 body 138 is adjusted. By adjusting the amount of working fluid supplied to the bag body 138, the internal pressure of the bag body 138 is controlled toward a predetermined target value. The bag body 138 is controlled so that the amount of expansion increases and the finger 134 of the person to be blood-collected is compressed with a load equal to or greater than a predetermined value.

The pressure sensor 171 continuously measures the internal pressure of the bag body 138 while the output of the compression 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.

The adder compares the target value of the internal pressure of the bag body 138 with the measurement result of the internal pressure of the bag body 138, and calculates the deviation between them. The FB control amount calculation unit 202 calculates the target control amount of the output compressing the fingers by the compression means 13 so that the deviation input from the adder is reduced. 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 body 138 to the target value, the bag body 138 expands to a predetermined amount, and the finger 134 of the person to be blood-collected is compressed with a load equal to or greater than the predetermined load, completing the fixation on the finger rest 131.

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 placement area 131. In addition, 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 thickness, shape, etc., in the subject's fingers, the fingertips are less likely to shift position or become loose, and the fingertips can be stably fixed within a predetermined range in the space above the finger placement area 131. Therefore, the subject's fingers can be fixed within a predetermined range relative to the puncture needle or blood collection tube regardless of individual differences, and the puncture needle can be accurately punctured into the desired target position of the fingertip, the blood collection tube can be pressed against the blood collection tube, and blood can be rapidly collected from the puncture site.

FIG. 12 is a diagram for explaining the operation of the compression means of the blood sampling device according to an embodiment of the present invention. FIG. 12 shows an example flow of the process (step S105) of compressing the finger 134 of the person to be sampled with the compression means 13 to cause blood congestion. As shown in FIG. 12, when compressing the finger 134 of the person to be sampled 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 person to be sampled's fingers.

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 placement area 131 is started to detect the condition of the subject's fingers (step S301). The condition of the subject's fingers is detected based on the state of the blood flow in the subject's fingers. The fingertip image can be a blood vessel image captured by the infrared light imaging device 191 or an external image captured by a camera installed around the finger placement area 131. The control unit 16 controls the infrared light imaging device 191 and the camera to continuously capture fingertip images of the subject's finger 134.

Then, the pump 173 of the pressure adjustment mechanism 17 is operated (step S302). The control unit 16 operates 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 expanding.

Next, based on the detection results of the condition of the subject's fingers, the output conditions for the compression means 13 to compress the subject's fingers 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 that compresses the fingers, based on the detection results of the infrared light imaging device 191 and the camera.

Next, under the set output conditions, the output of the compression means 13 for compressing the subject's fingers is controlled to compress the subject's fingers 134 and cause blood congestion (step S304). When the expansion amount of the bag body 138 increases and the subject's fingers 134 are compressed, the blood flow to the fingertips decreases. As a result, the state of the blood flow in the fingers changes toward a congested state.

Next, it is determined whether the state of blood flow in the fingers has reached the target state (step S305). The target state is set in advance before blood collection 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 collected. Whether the state of blood flow in the fingers 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 preset target state. Alternatively, it can be determined by comparing the chromaticity of the skin detected on the appearance image with a reference range corresponding to the chromaticity of the skin in the preset target state.

If the result of the determination is that the state of blood flow in the fingers has reached the target state (step S305; YES), the process proceeds to step S306. On the other hand, if the state of blood flow in the fingers has not reached the target state (step S305; NO), the process returns to step S304. If the state of blood flow in the fingers does not reach the target state within a preset specified 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 placement area 131 may be stopped.

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

The target puncture position of the puncture needle can be specified as the intersection point on the vascular image between the arc-shaped puncture needle path caused by the rotation of the turntable 11 and a representative blood vessel running through the fingertip. Representative 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.

Once the target puncture position has been determined, the process of compressing the subject's finger 134 (step S105) is terminated, and the process moves to the puncture operation of the subject's finger 134 (step S106). 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.

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

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 to the time it is punctured. Also, the image of the fingertip of the finger 134 of the person to be sampled can be continuously captured.

Then, the puncture needle is inserted into the subject's finger 134 (step S402). The control unit 16 controls the rotation drive mechanism 120 and the lift drive mechanism 121 to press the puncture device 1111 held by the puncture device holder 111 against the target puncture position, and the puncture needle is inserted into the target puncture position. Because the subject's finger 134 is compressed by the compression means 13, it can be accurately punctured into the set target puncture position.

Then, the blood collection tube holders 112, 113 are transported to the blood collection position directly below the finger placement 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 in accordance with the recommended blood collection order to the blood collection position. 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.

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

Then, it is determined whether blood collection has been completed for all 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 using a reader placed at a reading position on the turntable 11 or a position sensor that detects the displacement of the turntable 11.

If the determination result indicates that blood collection has been completed for all 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 blood collection tubes 1121, 1131 (step S405; NO), the process returns to step S403.

Next, the compression means 13 is released from 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 body 138. The discharge of the working fluid causes the bag body 138 to contract, and the subject's finger 134, which had been restrained, is released. The compression means 13 may be released completely to the initial state, or may be released partially to the intermediate state.

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

FIG. 14 is a block diagram relating to the control of the compression means of the blood sampling device according to an embodiment of the present invention. FIG. 14 shows a method of controlling the compression means 13 for causing blood to stagnate in the finger 134 of the person to be sampled in the action of compressing the finger shown in FIG. 12 and FIG. 13. As shown in FIG. 14, the compression means 13 for compressing the finger 134 of the person to be sampled can be controlled based on the detection result of the state of the finger of the person to be sampled and the detection result of the output state for compressing the finger of the person to be sampled when compressing to cause blood to stagnate.

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

The control unit 16 also performs feedforward (FF) control of the output of the compression means 13 for compressing the subject's fingers 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.

The control unit 16 preferably performs proportional control to reduce the change in the amount of expansion 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. This type of proportional control makes it possible to quickly control the state of blood flow in the fingers toward a target state.

In FIG. 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 by the compression means 13 and for feedforward (FF) control of the output by the compression means 13.

In addition, in FIG. 14, the internal pressure of the bag body 138 is detected as the output state of the compression means 13 compressing the subject's 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, 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.

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.

The target value setting unit 201 sets the output conditions for the compression means 13 to compress the subject's fingers, 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 and the amount of blood in the blood vessels running through the fingertips of the subject's fingers 134 are suitable for blood collection. Image data of fingertip images showing the state of blood flow in the fingers are input to the target value setting unit 201 from the infrared light imaging device 191 or a camera installed near the finger placement area 131.

For example, when using the infrared light imaging device 191, an image of the blood vessels of the subject's finger 134 can be captured, and the amount of light transmitted through the blood vessels can be measured as an integrated amount for a specified 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 that there is a large amount of blood flow. 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 that there is a small amount of blood flow. By determining in advance the correlation between the amount of light and the amount of blood that can be collected for a typical blood subject, the degree of the condition of the blood flow in the fingers can be quantified.

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 specified range on the external image. If the chromaticity falls within a preset range of chromaticity coordinates on the red side, 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 a preset range of chromaticity coordinates on the red side, 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 the condition of the blood flow in the fingers can be quantified.

As shown in FIG. 14, when compressing the subject's finger 134 to cause blood to stagnate, after the entry of the fingertip onto the finger placement area 131 is detected, a fingertip image showing the state of blood flow in the subject's fingers is captured by the infrared light imaging device 191 or the camera. The detection result of the state of blood flow in the fingers 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.

The target value can be set to a value smaller than the standard value if the blood flow condition in the fingers is suitable for blood sampling. For example, if the amount of transmitted light exceeds a preset reference value or if 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.

On the other hand, if the condition of the blood flow in the fingers is not suitable for blood sampling, a target value larger than the standard value can be set. 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 the 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.

The FB control amount calculation unit 202 calculates an FB 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 FB control amount calculation unit 202 calculates an FB control amount of the output of the pump 173 for feedback-controlling the internal pressure of the bag body 138 toward a target value. The FB control amount is calculated using the detection result of the output state of the compression means 13 compressing the fingers, that is, the detection result of the internal pressure of the bag body 138 by the pressure sensor 171. The FB control amount can be set so that the internal pressure of the bag body 138 becomes a target value within a specified range of load on the fingers or within a specified required time range. The calculation result of the FB control amount is output to the second adder.

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 result of the state related to the blood flow of the fingers. Specifically, the FF control amount calculation unit 204 calculates an FF control amount of the output of the pump 173 for feedforward control of the internal pressure of the bag body 138 based on the quantitative 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 a target state within a specified range of load on the finger and a specified range of expansion time. The calculation result of the FF control amount is output to a second adder.

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.

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 body 138 is adjusted. By adjusting the amount of working fluid supplied to the bag body 138, the internal pressure of the bag body 138 is controlled toward a predetermined target value. The bag body 138 is controlled so that the amount of expansion increases and the finger 134 of the person to be blood-collected is compressed with a load equal to or greater than a predetermined value.

The pressure sensor 171 continuously measures the internal pressure of the bag body 138 while the output of the compression 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 and input to the first adder.

The first adder compares the target value of the internal pressure of the bag body 138 with the measurement result of the internal pressure of the bag body 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 that the deviation input from the adder is reduced. 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 body 138 to the target value, the bag body 138 expands to a predetermined amount, and the finger 134 of the person to be blood-collected is compressed with a load above a predetermined level, resulting in a state of congestion.

When compressing the fingers to cause blood to stagnate, 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 the bag body 138 to increase the amount of expansion and the bag body 138 to decrease the amount of expansion 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 during the period from the puncture site of the finger 134 of the person to be sampled to the blood collection tubes 1121, 1131 until the blood collection is completed.

Before the needle is inserted 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.

For example, when a preset time has elapsed after compression began, 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. By switching from compression to release, blood can be allowed to flow into the blood vessels in the fingertip.

On the other hand, if a preset time has elapsed after release began, if the amount of transmitted light is less than a preset reference value, or if the chromaticity of the skin is not within the preset range of chromaticity coordinates on the red side, the pump 173 can be 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.

Furthermore, after the puncture needle has been inserted into the subject's finger 134 placed in the finger holder 131, and before blood collection from the puncture site of the subject's finger 134 into the blood collection tubes 1121, 1131 is completed, switching from compression to release, or from release to compression, can be performed according to the state of blood flow in the finger and the amount of blood collected in the blood collection tubes 1121, 1131. By repeating compression and release, blood flow in the blood vessels running through the fingertip can be promoted and blood can be squeezed out from the puncture site.

For example, if the amount of transmitted light is equal to or greater than a preset reference value, if the chromaticity of the skin is within a preset range of chromaticity coordinates on the red side, or if 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.

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 the preset range of chromaticity coordinates on the red side, or if the rate at which the amount of blood collected in the blood collection tubes 1121, 1131 increases is slower than the reference value, 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 pooled in the veins of the fingertip or the blood can be squeezed out.

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 is feedforward-controlled based on the detection result of the state of the blood flow in the fingers, so that the subject's fingers 134 can be compressed with a load equal to or greater than a predetermined load, regardless of external disturbances such as changes in swelling and tension due to congestion in the fingers, shaking of the fingers, and temperature changes. In addition, since the output conditions for compressing the fingers by the compression means 13 are set based on the state of the subject's fingers, the strength of compression on the fingertips can be adjusted according to the degree of congestion in the fingertips and the degree of blood flow in the blood vessels running through the fingertips. Therefore, even if there are individual differences in the thickness, shape, etc. of the subject's fingers, the subject's fingers 134 can be appropriately compressed to create a congested state that makes it easy to ensure the amount of blood to be collected. Since there is no need to reflect the measurement results of the amount of blood collected in the blood collection tube in the control as in the conventional method, it is possible to quickly obtain a congested state that makes it easy to ensure the amount of blood to be collected, and the blood collection operation can be completed 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, it becomes possible to adjust the compression load according to the state of blood flow in the finger.

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 without departing from the spirit of the present invention. For example, the present invention is not necessarily limited to 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.

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 by the compression means 13, but the load due to compression, the displacement of a specified 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 side that is not fixed.

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

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 holder 134 Blood collection subject's finger 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 (12)

A puncturing means for inserting a puncturing needle into a finger of a person to be blood-collected;
A compression means for compressing the finger;
A control unit that controls the operation of the puncture means and the compression means;
A first detection means for detecting a state of the finger;
A blood sampling device comprising: a second detection means for detecting an output state of the pressing means pressing the finger;
The control unit is
setting an output condition for compressing the finger by the compression means according to at least one of a size of the finger of the blood subject and a shape of the finger of the blood subject;
A blood sampling device that controls the output of compressing the finger by the compression 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 compression means under the setting of the output conditions. 2. The blood collection device of claim 1,
The condition of the finger is a condition related to a position of the finger or a condition related to blood flow of the finger,
The state relating to the position of the finger is a state distinguished by a distance between the finger of the blood recipient and the puncturing means according to a size and a shape of the finger, a state distinguished by a distance between the finger of the blood recipient and the pressing means according to a size and a shape of the finger, or a state distinguished by a time until an output state of pressing the finger by the pressing means changes due to contact with the finger,
A blood sampling device in which the condition of blood flow in the finger is classified according to the degree of congestion in the fingertip of the finger, or the amount of blood in the blood vessels running through the fingertip of the finger. 2. The blood collection device of claim 1,
The control unit feedback-controls the output of the compression means for compressing the finger based on a detection result of an output state of the compression means for compressing the finger. 2. The blood collection device of claim 1,
The control unit is a blood sampling device that feedforward controls an output of the pressing means for pressing the finger based on a detection result of a state of the finger. 2. The blood collection device of claim 1,
The compression means is disposed at a position facing the dorsal side of the finger placed in the finger rest area and at a position facing the ventral side of the finger placed in the finger rest area, and compresses the finger placed in the finger rest area by pinching it from the dorsal side and the ventral side. 2. The blood collection device of claim 1,
The compression means is disposed at a position facing the ventral side of the finger placed in the finger rest area and at a position facing the left and right sides of the finger placed in the finger rest area, and the blood sampling device clamps the finger placed in the finger rest area from the left and right sides and presses the ventral side against a member disposed on the dorsal side to compress the finger. 2. The blood collection device of claim 1,
A compression device is attached to the subject's fingers to cover the back and left and right side sides of the fingers and to pinch and compress the fingers from the left and right side sides,
The compression means is positioned opposite the ventral side of the finger placed in the finger holder, and the blood sampling device presses and fixes the finger, to which the compression tool is attached and placed in the finger holder, against a member positioned on the dorsal side together with the compression tool. 2. The blood collection device of claim 1,
The compression means is a bag in which a working fluid is sealed,
The blood sampling device wherein the output of the pressure applied to the finger can be adjusted by adjusting the amount of the working fluid enclosed in the bag. 9. The blood collection device according to claim 8,
The control unit of this blood collection device performs proportional control to reduce the change in the amount of expansion of the bag body as the distance between the subject's fingers and the puncture means, the distance between the subject's fingers and the compression means, or the time until the output state of the compression means compressing the fingers changes due to contact with the fingers becomes shorter. 9. The blood collection device according to claim 8,
The control unit of the blood collection device repeatedly performs control to increase the amount of expansion of the bag body and control to decrease the amount of expansion of the bag body at least either before the puncture needle is inserted into the finger placed on the finger rest area, and after the puncture needle is inserted into the finger placed on the finger rest area and until blood collection from the finger is completed. a puncturing step of puncturing a finger of a blood sample recipient with a puncture needle;
A blood sampling method comprising:
setting a pressing condition for pressing the finger according to at least one of a size of the finger of the blood subject and a shape of the finger of the blood subject;
The blood sampling method includes adjusting a pressure applied to the fingers based on a condition of the fingers and a pressure applied to the fingers under the pressure condition. The blood collection method according to claim 11,
A blood sampling method in which the compression conditions for compressing the fingers are set according to the distance between the fingers of the subject and a puncturing means for inserting the puncture needle, which is based on the size and shape of the fingers, the distance between the fingers of the subject and a compression means for compressing the fingers, which is based on the size and shape of the fingers, or the time it takes for the compression state of the fingers by the compression means to change due to contact with the fingers.