Blood collection device and blood collection method

Abstract

The present invention provides a blood collection device and a blood collection method with which it is possible to avoid, as much as possible, coagulation and drying of blood bled from a puncture site on a finger of a subject, and secure, in a stable manner, the amount of blood collected to a blood collection tube from the puncture site. The blood collection device (1) comprises: a puncture device that punctures a finger of a subject with a puncture needle; a container in which blood bled from a puncture site is collected; a bleeding amount measurement mechanism (109, 117) that measures the amount of blood that has been bled from the puncture site; and a drive mechanism (107, 115) that changes the relative positions of the puncture device and the container with respect to the puncture site. During blood collection, the drive mechanism (107, 115) repeatedly drives, for a prescribed number of times, an operation of bringing the blood that is in contact with the puncture site and the inner surface of the container into contact with each other and then separating the blood from the inner surface of the container. The number of times the operation is repeated is varied in accordance with the bleeding speed. In the blood collection method, the aforementioned operation is repeatedly executed for a predetermined number of times, and the number of times the operation is repeated is varied in accordance with the bleeding speed.

Description

Blood collection device and blood collection method

[0001] The present invention relates to a blood collection device and a blood collection method for collecting blood from the finger of a blood donor.

[0002] In medical treatment and health management, it is important to know the state of blood from the perspective of disease diagnosis and prevention. In medical institutions, blood tests are performed during medical treatment and medical examinations. In a blood test, the components of the blood collected from the patient are quantitatively analyzed. During medical treatment and medical examinations, the state of tissues and organs throughout the body is diagnosed based on the results of the blood test.

[0003] General blood tests are often carried out in medical institutions such as general hospitals. Blood collection for blood tests is performed on the forearm or cubital fossa, and blood is collected from the radial cutaneous vein, median cubital vein, ulnar cutaneous vein, etc. Blood tests may also be performed at home by self-blood collection in a limited range such as measuring blood glucose levels.

[0004] Self-blood collection is often performed on capillaries such as fingers. A skin puncture device for blood collection is used for self-blood collection. In recent years, single-use safety lancets have become commercially available. An automatic safety lancet projects a tiny puncture needle when pressed against the finger of the blood donor to puncture the capillaries of the finger.

[0005] Finger blood collection targeting capillaries does not require advanced techniques and can be easily performed compared to arm blood collection targeting the forearm or cubital fossa. Therefore, collecting the blood required for a blood test by finger blood collection has been considered. However, finger blood collection tends to result in a small amount of blood being collected in a single blood collection. In ensuring the amount of blood required for a blood test, it is important to collect the blood bleeding from the puncture site where the puncture needle has been punctured into the blood collection tube as much as possible.

[0006] Conventionally, blood collection devices have been developed that automatically collect blood from the fingers of the person being collected. In these automated blood collection devices, the person's fingers are placed in a designated finger rest, a lancet is automatically inserted into the finger, and the blood flowing out from the puncture site is collected into a blood collection tube. In this type of blood collection device, the lancet that punctures the finger and the blood collection tube that collects the blood are positioned relative to the finger placed in the finger rest, and blood collection is performed automatically.

[0007] Patent Document 1 describes a device for detecting the presence of a blood sample. This device includes a housing having an opening configured to receive the user's finger, and a camera having a field of view encompassing at least a portion of the opening and configured to capture an image of the user's finger. The camera is configured to capture an image of the incision area after the user's finger has been incised with a lancet and relay the image to a microprocessor. The microprocessor confirms the amount of blood squeezed out from the wound and then controls the movement of the blood collection unit.

[0008] Patent Document 2 describes a system for detecting at least one sample in a bodily fluid. This system includes a lancet for puncturing a portion of the user's skin, a test element for receiving and detecting the sample, and a transport mechanism for transporting the sample to the test element. With respect to a sample such as blood collected by puncturing a portion of the user's skin, this system is configured to detect the actual sample volume using an optical sensor.

[0009] Patent No. 6086916 Patent No. 6076313

[0010] A blood collection device that automatically collects blood from a person's fingertips should ideally have a function to reliably obtain the amount of blood needed for a blood test in a single collection. Finger blood collection tends to yield a small amount of blood in one go. Therefore, from the perspective of reliably obtaining the amount of blood needed for a blood test, it is desirable to collect as much blood as possible from the puncture site where the lancet was inserted into a position-controlled blood collection tube.

[0011] However, blood bled from the puncture site can easily coagulate or dry on the skin's surface, depending on the amount of bleeding and the time elapsed since the puncture. To collect all the blood bled from the puncture site into the blood collection tube, it is important to avoid blood coagulation and drying on the skin's surface as much as possible.

[0012] For example, to avoid blood clotting, it is important to minimize the time that blood bleeding from the puncture site remains on the skin surface and to complete blood collection before a large amount of tissue fluid leaks out from the puncture site. Also, to avoid blood drying, it is important to minimize the time that the blood bleeding from the puncture site and the blood collection tube are in contact with each other. This is because when blood and the blood collection tube are in contact with each other, the blood spreads thinly between the skin and the blood collection tube, making it more prone to drying.

[0013] Therefore, a blood collection device that automatically collects blood from a person's finger is required to quickly collect the blood flowing from the puncture site into the blood collection tube and to minimize the contact time between the blood at the puncture site and the blood collection tube. These operations must be performed while simultaneously collecting the necessary amount of blood for blood testing into the blood collection tube.

[0014] However, in the device described in Patent Document 1, the amount of blood is confirmed by a camera, and then the blood sample is absorbed by a blood collection unit. The blood collection unit is simply configured to be in contact with or in close proximity to the user's finger. With such a configuration, the time that blood bleeds from the puncture site remains on the surface of the skin may be prolonged. Also, the time that the blood bleeds from the puncture site is in contact with the blood collection unit may be prolonged. With such a configuration, there is a high possibility that blood coagulation and drying will progress more easily.

[0015] Furthermore, in the system described in Patent Document 2, the sample is transported to the test element by a capillary, and optical detection is performed on the test element or within the capillary. In this configuration, the blood flowing out from the puncture site is transported by the capillary before it reaches a certain volume. As a result, the blood spreads thinly around the puncture site, and the blood dries easily.

[0016] Therefore, the present invention aims to provide a blood collection device and blood collection method that can stably secure a blood volume from the puncture site to the blood collection tube while avoiding, as much as possible, the coagulation and drying of the blood bled from the puncture site on the fingers of the person from whom blood is collected.

[0017] To solve the above problems, the blood collection device according to the present invention comprises a lancing device for puncturing the finger of a person to be given blood, a container for collecting blood bled from the puncture site where the lancing device was inserted, a blood loss measurement mechanism for measuring the amount of blood bled from the puncture site, and a drive mechanism for changing the relative position of the lancing device and the container with respect to the puncture site. The drive mechanism repeatedly drives an operation to bring the blood in contact with the puncture site and the inner surface of the container into contact with each other and then separate them a predetermined number of times when collecting blood, and the number of times the operation is repeated is changed according to the bleeding rate calculated based on the measurement result measured by the blood loss measurement mechanism.

[0018] Furthermore, the blood collection method according to the present invention includes a puncture step of inserting a puncture needle into the finger of a person from whom blood is to be collected, a compression step of compressing the finger, and a blood collection step of collecting blood bled from the puncture site into a container, wherein in the blood collection step, the operation of bringing the blood in contact with the puncture site and the inner surface of the container into contact with each other and then separating them is repeatedly performed a predetermined number of times, and the number of times the operation is repeated is changed according to the bleeding rate calculated based on the measurement result of the amount of blood bleeding from the puncture site.

[0019] According to the present invention, it is possible to provide a blood collection device and blood collection method that can stably secure a blood volume from the puncture site to the blood collection tube while avoiding, as much as possible, the coagulation and drying of the blood bled from the puncture site on the finger of the person from whom blood is collected.

[0020] This is a diagram showing the configuration of the equipment built into the blood collection device according to an embodiment of the present invention. This is a diagram illustrating the fingertip image taken during blood collection. This is a diagram illustrating the fingertip image taken during blood collection. This is a flowchart showing the operation of the blood collection device according to an embodiment of the present invention. This is a diagram showing the positional relationship between the patient's finger and the lancing device during puncture. This is a diagram showing the positional relationship between the patient's finger and the lancing device during puncture. This is a diagram showing the positional relationship between the patient's finger and the lancing device during puncture. This is a diagram showing the positional relationship between the patient's finger and the lancing device during puncture. This is a flowchart showing the operation of the blood collection device from the puncture process to the blood collection process. This is a diagram showing the positional relationship between the patient's finger and the blood collection tube during blood collection. This is a diagram showing the positional relationship between the patient's finger and the blood collection tube during blood collection. This is a diagram showing the positional relationship between the patient's finger and the blood collection tube during blood collection. This is a diagram showing the positional relationship between the patient's finger and the blood collection tube during blood collection. This is a diagram showing the positional relationship between the patient's finger and the blood collection tube during blood collection. This is a diagram showing the positional relationship between the patient's finger and the blood collection tube during blood collection. This is a timing chart showing the relationship between the height of the blood collection tube and the size of the blood on the lifting trajectory during blood collection. This is a timing chart showing the relationship between the height of the blood collection tube and the size of the blood on the lifting trajectory during blood collection. This is a flowchart showing the operation of the blood collection process in the blood collection device. This is a timing chart showing the relationship between the height of the blood collection tube and the size of the blood on the lifting trajectory during blood collection. This is a flowchart showing the operation of the bleeding mode performed in the blood collection process in the blood collection device. This is a diagram showing the positional relationship between the patient's finger and the hemostatic material during hemostasis. This is a diagram showing the positional relationship between the patient's finger and the hemostatic material during hemostasis. This is a diagram showing the positional relationship between the patient's finger and the hemostatic material during hemostasis. This is a diagram showing the positional relationship between the patient's finger and the hemostatic material during hemostasis. This is a flowchart showing the operation of the hemostasis process and the protection process in the blood collection device.

[0021] The following describes a blood collection device and blood collection method according to one embodiment of the present invention. In the following figures, common components are denoted by the same reference numerals, and redundant explanations are omitted.

[0022] Figure 1 is a diagram showing the configuration of the equipment built into a blood collection device according to an embodiment of the present invention. As shown in Figure 1, the blood collection device 1 according to this embodiment is detachably equipped with a lancing device holder 101 that holds a lancing device, a plurality of blood collection tube holders 102, 103 that hold blood collection tubes for biochemical immunoassays and complete blood counts, a hemostatic material holder 104 that holds a hemostatic material such as gauze, and a protective material holder 105 that holds a protective material such as an adhesive bandage.

[0023] Furthermore, the blood collection device 1 according to this embodiment includes a turntable 106 on which each holder is installed, a drive mechanism (107, 115) for driving the movement of each holder, a vascular image acquisition mechanism (108, 116) for acquiring a vascular image showing the course of blood vessels in the fingertip, a fingertip image acquisition mechanism (109, 117) for acquiring a fingertip image showing the appearance of the fingertip, a compression mechanism 112 for compressing the fingers, a display mechanism 113, a control mechanism 114, a blood collection volume measurement mechanism 118 for measuring the amount of blood collected in the blood collection tube, and a finger rest 119.

[0024] The blood collection device 1 according to this embodiment is a finger blood collection device that automatically collects blood from the fingers of a person to be collected. The blood collection device 1 includes a housing (not shown) that incorporates a turntable 106, drive mechanisms (107, 115), vascular image acquisition mechanisms (108, 116), fingertip image acquisition mechanisms (109, 117), control mechanism 114, etc. The top surface of the housing is provided with a hand rest where the person to be collected can be placed, and a finger rest 119 where the person to be collected can be placed.

[0025] The finger rest 119 is equipped with a compression mechanism 112 that compresses the finger 10 of the person being collected for blood collection. In Figure 1, the compression mechanism 112 is supported in a position that contacts the finger 10 of the person being collected for blood collection, which is placed on the finger rest 119. The compression mechanism 112 is composed of a bag or the like that which contains a working fluid, such as an airbag or cuff. The finger 10 of the person being collected for blood collection is placed on the finger rest 119 and compressed by the compression mechanism 112 so that the fingertip becomes congested with blood, and then blood is collected by the operation of a mechanism built into the housing. By compressing the area around the finger, the fingertip becomes more prone to bleeding when the puncture needle is inserted.

[0026] The fingertip of the blood recipient's finger 10 is placed on the finger rest 119. For example, the finger rest 119 can have an opening that penetrates it vertically. The blood recipient's finger 10 can be placed on the finger rest 119 so that the ventral side of the fingertip faces downwards through the opening. The finger rest 119 may be formed from disposable parts, or it may be formed by covering a structural material for finger resting with disposable parts.

[0027] Figure 1 shows an example of a holder installed on a turntable 106. In Figure 1, a lancing device holder 101 holding a lancing device, multiple blood collection tube holders 102 and 103 holding blood collection tubes, a hemostatic material holder 104 holding hemostatic materials such as gauze, and a protective material holder 105 holding protective materials such as adhesive bandages are installed on the turntable 106. As for the blood collection tubes, blood collection tubes for biochemical and immunological tests are installed in blood collection tube holder 102, and blood collection tubes for complete blood count tests are installed in blood collection tube holder 103.

[0028] Each holder 101-105 is driven to move relative to the finger rest 119 by the rotation of the turntable 106 or by its movement up and down relative to the turntable 106. By driving the relative movement of each holder 101-105 relative to the fingertip placed on the finger rest 119, the actions related to blood collection are executed sequentially. Actions related to blood collection include the puncture action of inserting a lancet into the fingertip, the blood collection action of collecting blood from the puncture site into a blood collection tube, and the treatment action of treating the puncture site. Treatment actions include the hemostatic action of stopping bleeding at the puncture site with a hemostatic agent and the protective action of protecting the puncture site with a protective material.

[0029] The turntable 106 is formed, for example, in the shape of a disc. The turntable 106 is rotatably supported inside the housing so that its main surface faces up and down. The turntable 106 has a plurality of holding holes for holding each of the holders 101 to 105. The holding holes can be formed as through holes that penetrate the turntable 106 vertically.

[0030] Multiple holding holes are arranged on a circumference concentric with the turntable 106. The holding holes can be formed on a circumference passing directly beneath the finger rest 119, spaced apart from each other along the circumferential direction of the turntable 106. Each holding hole is distinguished from the others by a predetermined position. By placing each holder 101 to 105 in the designated position, the movement of each holder is driven in accordance with the blood collection operation.

[0031] Holders 101 to 105 are detachably mounted on the turntable 106. Each holder 101 to 105 has a portion on its side that has an outer diameter larger than the diameter of the holding hole. Each holder 101 to 105 is inserted into the holding hole, and the portion with the larger outer diameter is supported from below. With this structure, each holder 101 to 105 is detachably held on the turntable 106 in a state where it can move up and down by being pushed up from below.

[0032] Various types of blood collection tubes can be installed in the blood collection tube holders 102 and 103, depending on the blood test items to be performed after blood collection. The number of blood collection tube holders 102 and 103 installed on the turntable 106 is not particularly limited. Outer tubes containing blood collection tubes may also be installed in the blood collection tube holders 102 and 103. As blood collection tubes, micro-volume blood collection tubes with a capacity on the order of several hundred μL can be used. The outer tubes are used for purposes such as matching the size of the installed object to the installation location of the blood collection tubes.

[0033] A blood collection tube is a container from which blood is collected from the puncture site where a puncture needle is inserted. Blood collection tubes for biochemical and immunological tests are containers from which blood is collected for biochemical and immunological tests, and contain a separating agent to separate the serum. When the collected blood is centrifuged, it can be separated into blood clot and serum due to the difference in specific gravity. If the blood collection tube contains a separating agent, the blood clot phase and the serum phase can be accurately separated. Blood collection tubes for complete blood count tests are containers from which blood is collected for complete blood count tests, and contain an anticoagulant such as EDTA-2K.

[0034] The lancing device comprises a lancet and a holder that houses the lancet. A single-use skin puncture device can be attached to the lancing device holder 101. When the lancing device is pressed against the finger 10 of the person receiving blood collection, the lancet is extended and punctures the skin or capillaries of the person's finger. The blood that bleeds from the puncture site is collected in a blood collection tube that is transported below the fingertip of the person receiving blood collection 10.

[0035] The hemostatic material is an absorbent cloth such as gauze, which is pressed against the puncture site to absorb blood and stop bleeding. The protective material is an adhesive sheet such as a bandage with an absorbent cloth attached, which is pressed against the puncture site to stop bleeding or protect the puncture site. The protective material is attached to the protective material holder 105 so that the absorbent cloth and adhesive surface face upwards.

[0036] The turntable 106 may be protected by a protective sheet. The protective sheet can be installed so as to cover the top surface of the turntable 106 by forming through holes at positions corresponding to the holding holes. The protective sheet can prevent contamination of the turntable 106 by blood. The protective sheet can be made of an inexpensive and lightweight disposable material, such as paper, cloth, or resin film.

[0037] As shown in Figure 1, the turntable 106 is installed below the finger rest 119. Below the turntable 106, a drive mechanism (107, 115) is installed to drive the rotation of the turntable 106 and the raising and lowering of the holders 101-105. To the side of the turntable 106, a blood collection volume measurement mechanism 118 is installed facing the sides of the holders 101-105 installed on the turntable 106. Around the finger rest 119, a vascular image acquisition mechanism (108, 116), a fingertip image acquisition mechanism (109, 117), and a compression mechanism 112 are installed. A pressure adjustment mechanism (not shown) is connected to the bag of the compression mechanism 112 via a tube (not shown).

[0038] The drive mechanisms (107, 115) drive the movement of the holders 101-105 to change the relative position of the lancing device, blood collection tube, hemostatic material, and protective material with respect to the fingertip of the blood recipient's finger 10. The drive mechanisms (107, 115) consist of a lifting drive mechanism 107 that drives the lifting and lowering of the holders 101-105 on the turntable 106, and a rotation drive mechanism 115 that drives the rotational movement of the turntable 106.

[0039] The lifting drive mechanism 107 is installed directly below the fingertips of the blood recipient's fingers 10 placed on the finger rest 119, and below the turntable 106. The rotation drive mechanism 115 is installed below the turntable 106. An external power supply or an internal battery can be used as the power source for the drive mechanisms (107, 115). Alternatively, a mechanical power source such as a spring may be used. If a spring is used as the power source, the blood collection device 1 can be used in locations where it is difficult to supply electricity.

[0040] The rotational drive mechanism 115 is formed by a shaft connected to the center of the turntable 106, and a motor connected to the shaft. The turntable 106 is driven to rotate by the rotational drive mechanism 115 in predetermined step angles. The rotation of the turntable 106 transports and unloads the holders 101 to 105 to a position directly below the fingertip. At the position directly below the fingertip, the lifting drive mechanism 107 raises and lowers the holders 101 to 105.

[0041] The lifting drive mechanism 107 is an electric actuator, formed by a combination of a solenoid, a motor, and a conversion mechanism that converts the motor's rotational motion into linear motion. Push rods that drive the lifting and lowering of holders 101 to 105 are connected to the lifting drive mechanism 107. The lifting drive mechanism 107 drives the up and down movement of the push rods.

[0042] When the push rod is driven to rise, it pushes up and raises the holders 101 to 105 installed on the turntable 106 from below. The puncture devices, blood collection tubes, hemostatic materials, and protective materials held by the holders 101 to 105 are raised by the pushing up of the push rod to a position where they are pressed against the fingertip of the finger 10 of the blood donor or a position close to the fingertip. On the other hand, when the push rod is driven to lower, it lowers the holders 101 to 105 located directly below the fingertip to the position supported on the turntable 106.

[0043] The blood vessel image acquisition mechanism (108, 116) is a mechanism for acquiring a blood vessel image of the finger 10 of the blood donor. The blood vessel image acquisition mechanism (108, 116) is composed of an infrared light imaging device 108 and a near-infrared light source 116. The infrared light imaging device 108 and the near-infrared light source 116 are arranged so as to sandwich the fingertip of the finger 10 of the blood donor placed in the finger placement area 119. The infrared light imaging device 108 is arranged to face the ventral side of the fingertip. The near-infrared light source 116 is arranged to face the nail side of the fingertip.

[0044] The infrared light imaging device 108 detects the near-infrared light transmitted through the finger 10 of the blood donor placed in the finger placement area 119, photographs the blood vessels of the finger 10 of the blood donor, and acquires a blood vessel image of the finger 10 of the blood donor. As the infrared light imaging device 108, an infrared camera capable of detecting infrared light and near-infrared light, a near-infrared camera capable of detecting near-infrared light with high sensitivity, etc. can be used.

[0045] The near-infrared light source 116 is a light source for projection that emits near-infrared light, and irradiates the finger 10 of the blood donor placed in the finger placement area 119 with near-infrared light. As the near-infrared light source 116, an LED (Light Emitting Diode) whose emission wavelength includes the near-infrared light region, etc. can be used. Examples of the near-infrared light include light with a wavelength of 700 nm or more and 2500 nm or less, for example, light of about 940 nm.

[0046] The blood vessel image is an image obtained by photographing the fingertip of the finger 10 of the blood donor, and is an image representing the course of blood vessels at the fingertip with the contrast of pixels. Since hemoglobin in the blood absorbs near-infrared light, the near-infrared light transmitted through the finger 10 of the blood donor is attenuated. Therefore, when near-infrared light is projected onto the finger 10 of the blood donor and the distribution of the light intensity of the transmitted light of the near-infrared light transmitted through the finger 10 of the blood donor is measured, the blood vessel network running through the fingertip can be imaged.

[0047] In the blood vessel image, the course of the blood vessels is represented by the contrast due to the shading of the pixels. The attenuation of the light intensity of the transmitted light by hemoglobin can be displayed as the difference in gradation for each pixel, for example, the difference in luminance for each pixel. With such a blood vessel image, the blood vessels running under the skin of the fingertip can be visualized as dark lines in the image. The blood vessels are visualized as a series of low-luminance pixels with a low light intensity of the transmitted light among the surrounding pixels with a high light intensity of the transmitted light. Based on the blood vessel image, the target puncture position for puncturing the puncture needle can be determined.

[0048] The fingertip image acquisition mechanism (109, 117) is a mechanism for acquiring a fingertip image showing the appearance of the fingertip of the finger 10 of the blood donor. The fingertip image acquisition mechanism (109, 117) is composed of a fingertip appearance imaging device 109 and a fingertip imaging light source 117. The fingertip appearance imaging device 109 is arranged on the side of the fingertip of the finger 10 of the blood donor placed on the finger placement site 119 so that the puncture site can be photographed. The fingertip imaging light source 117 is arranged on the side of the fingertip of the finger 10 of the blood donor placed on the finger placement site 119 so that the puncture site can be illuminated.

[0049] The fingertip appearance imaging device 109 photographs the periphery of the puncture site of the finger 10 of the blood donor placed on the finger placement site 119 to acquire a fingertip image of the finger 10 of the blood donor. As the fingertip appearance imaging device 109, an RGB camera, an infrared camera capable of detecting infrared light and near-infrared light, a near-infrared camera capable of detecting near-infrared light with high sensitivity, etc. can be used. The fingertip appearance imaging device 109 may be provided with optical elements such as an optical filter for attenuating wavelengths other than the emission wavelength of the light source and a lens for changing the detection range by focusing or diverging light.

[0050] The light source 117 for fingertip imaging is a light source that provides illumination for imaging, and illuminates the area around the fingertip of the blood subject's finger 10, which is placed on the finger rest 119. An LED (Light Emitting Diode), fluorescent lamp, etc., can be used as the light source 117 for fingertip imaging. From the viewpoint of detecting blood with high sensitivity, white light, blue light, near-infrared light, etc., can be used as the illumination light.

[0051] The fingertip image acquisition mechanism (109, 117) functions as a blood loss measurement mechanism that measures the amount of blood bled from the puncture site where the puncture needle was inserted. In order to measure the amount of blood bled from the puncture site, the fingertip image acquisition mechanism (109, 117) acquires a fingertip image showing the appearance of the fingertip in a bleeding state from the puncture site, as an image of the blood bled from the puncture site.

[0052] The fingertip image is a photograph of the fingertip of the person receiving blood. When a puncture needle is inserted into the fingertip of the person receiving blood, blood bleeds from the puncture site and forms blood droplets on the surface of the skin. Therefore, by detecting pixels containing blood on the fingertip image and measuring the area, length, width, etc., of the region containing blood, it is possible to measure the size of the blood bled from the puncture site, for example, the size of the blood droplets formed by the blood.

[0053] In fingertip images, the size of the blood indirectly represents the amount of blood bled from the puncture site. Pixels containing blood can be detected based on the chromaticity of each pixel or the absorption intensity at a predetermined wavelength. Based on such fingertip images, the temporal change in the size of the blood on the fingertip image can be measured. Based on the temporal change in the size of the blood, it is possible to estimate the amount of blood bled from the puncture site, calculate the bleeding rate (the temporal change in the amount of blood bled from the puncture site), and detect the fall of blood droplets formed at the puncture site.

[0054] The fingertip external imaging device 109 may be installed in a position to photograph the surface of the skin on the ventral side of the fingertip from below, or from an oblique angle below, but it is preferable to install it in a position to photograph the surface of the skin on the ventral side of the fingertip from the side. With this arrangement, blood bleeding from the puncture site can be photographed with high sensitivity against a background of space where there is no blood.

[0055] A pressure adjustment mechanism is connected to the compression mechanism 112 to adjust the pressure inside the bag. The pressure adjustment mechanism consists of a tube connecting the bag and the source of the working fluid, a pressure sensor for measuring the internal pressure of the bag, a valve for opening and closing the tube to adjust the amount of working fluid, and a pump for supplying working fluid to the bag. The compression pressure applied to the finger 10 of the person receiving blood is adjusted by discharging the working fluid through the valve and supplying it through the pump. For example, air or water can be used as the working fluid.

[0056] The blood volume measurement mechanism 118 is a mechanism for measuring the amount of blood collected in a blood collection tube. The blood volume measurement mechanism 118 consists of a light source for projection and a photodetector. The light source and the photodetector are positioned opposite each other, with the blood collection tube to be measured in the transported position directly below the fingertip. The 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 102 and 103. The photodetector detects the transmitted light emitted from the light source that has passed through the blood collection tube.

[0057] Because the light emitted from the light source is scattered, reflected, and absorbed by the blood, the intensity of the transmitted light decreases when blood is collected in a blood collection tube. By detecting the transmitted light that has passed through the blood collection tube and measuring its intensity, a reduction in the intensity of the transmitted light due to the blood is observed according to the liquid level of the blood collected in the tube. Therefore, the amount of blood collected in the blood collection tube can be determined based on the correlation between the liquid level of the blood collected in the blood collection tube and the amount of blood in the 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 tube.

[0058] The correlation between the liquid level of blood collected in a blood collection tube and the volume of blood in the tube, and the correlation between the amount of light transmitted through the blood collection tube and the volume of blood in the tube, can be determined by measurements using samples with a known blood volume. Measurements using samples with a known blood volume are performed for each type of blood collection tube according to the test items of the blood test performed after blood collection. The liquid level of blood collected in the blood collection tube and the amount of light transmitted through the blood collection tube can be determined by recording the operation of the lifting drive mechanism 107, in accordance with the vertical displacement of the blood collection tube.

[0059] The blood level can be measured as the distance from the bottom of the blood collection tube to the blood level in the tube. If the blood collection tube contains a separating agent, the average height of the top of the separating agent can be used as the zero reference point for the blood level. The amount of transmitted light can be measured as the integral over a predetermined range.

[0060] As the light source for the blood volume measurement mechanism 118, LEDs (Light Emitting Diodes), COB (Chip On Board) LEDs, OLEDs (Organic Light Emitting Diodes), etc., can be used. The light emitted by the light source is preferably visible light or near-infrared light with a wavelength of 300 to 1000 nm. With such wavelengths, attenuation of light intensity due to scattering and reflection by blood, and attenuation of light intensity due to absorption by hemoglobin can be detected with high sensitivity.

[0061] A photodiode array or the like can be used as the photodetector. The photodiode array can measure the two-dimensional distribution of the amount or intensity of light transmitted through the blood collection tube. The photodetector may also be equipped with optical elements such as an optical filter that attenuates wavelengths other than the emission wavelength of the light source, a lens that changes the detection range by focusing or diverging light, or a mirror that changes the optical path.

[0062] Image sensors such as CCDs (Charge Coupled Devices) and CMOSs ​​(Complementary Metal-Oxide-Semiconductors) can be used as photodetectors. The image sensor detects the transmitted light that passes through the blood collection tube, and an image of the blood collection tube can be captured that contains information equivalent to the amount of transmitted light and the two-dimensional distribution of light intensity. By analyzing the captured image, the liquid level of the blood collected in the blood collection tube and the amount of transmitted light that passed through a predetermined area of ​​the blood collection tube can be determined.

[0063] The blood volume measurement mechanism 118 functions as a blood loss measurement mechanism that measures the amount of blood bled from the puncture site where the puncture needle was inserted when the fingertip image acquisition mechanism (109, 117), which functions as a blood loss measurement mechanism, cannot capture images of the area around the puncture site. The blood volume measurement mechanism 118 measures the amount of blood collected in the blood collection tube in order to determine the amount of blood bled from the puncture site.

[0064] The display mechanism 113 displays information related to blood collection, information related to the operation of the blood collection device 1, and information related to the results of the blood collection. Information related to blood collection includes information representing the blood collection target, blood collection conditions, blood collection progress, and blood collection results, as well as information representing warnings to the operator of the blood collection device 1 and the person being collected. The display mechanism 113 is composed of, for example, a liquid crystal display, an organic EL display, a touch panel, etc.

[0065] The drive mechanisms (107, 115), vascular image acquisition mechanisms (108, 116), fingertip image acquisition mechanisms (109, 117), display mechanism 113, and blood sampling volume measurement mechanism 118 are connected to the control mechanism 114 via signal lines. The control mechanism 114 performs processing according to the program, reads programs and data, controls the operation of each mechanism, processes signals transmitted to and from each mechanism, and performs image analysis of images acquired by the vascular image acquisition mechanisms (108, 116) and fingertip image acquisition mechanisms (109, 117).

[0066] An input / output device (not shown) is connected to the control mechanism 114 via wired or wireless signal lines. The input / output device performs tasks such as inputting instructions regarding the operation of each mechanism, inputting instructions regarding image analysis, inputting settings regarding blood collection conditions, outputting results regarding the operation of each mechanism, outputting measurement results of the blood collection volume, and processing corresponding to judgments. The input / output device may be built into the blood collection device 1 or connected to the blood collection device 1 as an external device. A personal computer, tablet, etc., can be used as an external input / output device.

[0067] Figures 2A and 2B illustrate fingertip images taken during blood collection. Figures 2A and 2B show examples of fingertip images taken by the fingertip appearance imaging device 109 during blood collection, specifically images of a fingertip with blood adhering to it from the puncture site. Figure 2A shows the state of the fingertip at time t, when a blood droplet was formed at the puncture site. Figure 2B shows the state of the fingertip at time t+Δt, after a small time interval Δt has elapsed from the state in Figure 2A.

[0068] In Figures 2A and 2B, reference numeral 201 denotes a fingertip image taken around the puncture site of the patient's finger 10, reference numeral 202 denotes a fingertip image representing the fingertip of the patient's finger 10, reference numeral 203 denotes a blood image representing the blood bled from the puncture site of the patient's finger 10, and reference numeral 204 denotes a scale added to explain the pixel values ​​of the pixels constituting the fingertip image. Reference numeral Rth denotes an example of a threshold used to detect pixels representing blood. Reference numeral Pr denotes the number of pixels constituting the blood image 203 at time t, and reference numeral Prb denotes the number of pixels constituting the blood image 203 at time t + Δt.

[0069] The fingertip imaging device 109 photographs the area around the puncture site on the fingertip 10 of the person being blood collected after the puncture needle has been inserted. By photographing the fingertip, a fingertip image 201 is obtained that captures a blood smear 203 representing the blood that has bled from the puncture site. The fingertip image 201 may be obtained as a still image or as a moving image.

[0070] The control mechanism 114 receives image data captured by the fingertip external appearance imaging device 109 and performs image analysis processing to measure the size of the blood bled from the puncture site. The image analysis processing to measure the size of the blood includes image preprocessing, detection processing to detect pixels representing blood on the image, and measurement processing to determine the size of the blood bled from the puncture site based on the pixels representing blood.

[0071] In the preprocessing step, the image captured by the fingertip external imaging device 109 is processed before image analysis to enable the identification of pixels representing blood and to remove noise from the image. In the preprocessing step, a grayscale image may be generated that displays blood and other substances using only luminosity as an indicator, or a binarized image may be generated that displays blood and other substances or space by binarizing them.

[0072] Preprocessing can include converting images to grayscale, converting images to binarized images, scaling images, changing the chromaticity of images, adjusting image contrast, normalizing pixel values, performing calculations between images to remove noise and extract differences, and removing noise from images using filters such as averaging filters, median filters, and Gaussian filters.

[0073] In the detection process, pixels representing blood bleeding from the puncture site are detected on the pre-processed image. Detecting pixels representing blood is done by comparing the pixel values ​​of the pixels that make up the image with a preset threshold. The comparison between pixel values ​​and thresholds may be performed on the entire area of ​​the image, or on a portion of the image, including the area around the puncture site. Pixels representing blood can be detected by determining whether or not the pixel value falls within a predetermined range of chromaticity coordinates in a predetermined color space.

[0074] For example, L ＊ a ＊ b ＊In a color space of a color system such as XYZ, the range of chromaticity coordinates on the red side can be set as the range that represents the color of blood. As thresholds that define such a range, thresholds indicating the upper limit and lower limit of the range can be set for each of lightness, hue, and saturation. By comparing each pixel value with each threshold, it is possible to determine whether the pixel value of each pixel constituting the fingertip image falls within the predetermined range of chromaticity coordinates. Therefore, it is possible to determine whether each pixel constituting the fingertip image 201 is a pixel that displays blood.

[0075] In Figures 2A and 2B, the chromaticity of the fingertip image 201 has been converted to RGB, and the pixel values ​​of each pixel constituting the fingertip image 201 have been sampled to contain only information about the intensity of red. A threshold Rth is set in the scale 204 to detect pixels representing blood. The threshold Rth can be set to a value that can distinguish between the color of venous blood or the color of blood when oxygen is bound, and the color of the skin on the fingertip or the colors of other objects or space within the field of view.

[0076] The process of measuring blood size can also be performed on blood droplets formed by blood bleeding from the puncture site. When detecting blood droplets, the comparison between pixel values ​​and thresholds may be performed as edge extraction to extract the outline of the blood droplet. The outline of the blood droplet can be determined by first finding the relationship between the pixel values ​​and pixel coordinates of the pixels that make up the image, and then performing calculations for local maximums and minimums using the first derivative, or calculations for the point of change between positive and negative values ​​using the second derivative.

[0077] In the measurement process, the dimensions and area of ​​pixels representing blood detected on the image are measured to determine the size of the blood bled from the puncture site. The size of the blood can also be determined as the amount of blood bled from the puncture site. The amount of blood bled from the puncture site can be determined by using the correlation between the area of ​​the pixels representing blood detected on the image and the measured amount of blood bled from the puncture site. Alternatively, it may be determined by assuming that the blood droplet has a predetermined three-dimensional shape and converting the dimensions of the pixels representing blood into the volume of that three-dimensional shape.

[0078] In Figures 2A and 2B, pixels whose pixel values ​​exceed the threshold Rth constitute the blood image 203. In such cases, the measurement process can count the number of pixels Pr that constitute the blood image 203 at time t, and the number of pixels Prb that constitute the blood image 203 at time t + Δt. For example, by multiplying the area of ​​one pixel by the number of pixels Pr and Prb that exceed the threshold Rth, the area of ​​the blood image 203 can be calculated. Assuming that the blood droplet formed at the puncture site has a three-dimensional shape such as a sphere or ellipsoid, the area of ​​the blood image 203 can be converted into the volume of blood.

[0079] The calculation result of the amount of blood bled from the puncture site can be used to calculate the bleeding rate, which is the change in the amount of blood bled from the puncture site over time. The calculation result of the bleeding rate can be used to switch the raising and lowering of the blood collection tube holders 102 and 103 during blood collection, and to detect the fall of blood droplets formed at the puncture site. The bleeding rate may be calculated for each frame of the fingertip image 201, or for multiple frames of the fingertip image 201.

[0080] In Figures 2A and 2B, the number of pixels Pr constituting the blood image 203 at time t changes to the number of pixels Prb at time t+Δt over a small time interval Δt. In such a case, the rate of change per unit time of the number of pixels constituting the blood image 203 is calculated as (Pr - Prb) / Δt. Therefore, the bleeding rate can be calculated as Q × (Pr - Prb) / Δt, provided that the blood volume Q corresponding to one pixel is determined.

[0081] In the blood collection device 1, when collecting blood from the puncture site into the blood collection tube, the device repeatedly drives an action to bring the blood in contact with the puncture site and the inner surface of the blood collection tube into contact with each other and then separate them a predetermined number of times. The number of times this action is repeated is passively changed by switching modes according to the bleeding rate.

[0082] When collecting blood from a puncture site into a blood collection tube, if the bleeding rate is less than a preset threshold Rb, the system operates in normal mode. On the other hand, if the bleeding rate is greater than a preset threshold Rb, the system operates in bleeding mode. The operation of normal mode and bleeding mode is switched by the control mechanism 114 and executed by the lifting drive mechanism 107.

[0083] The normal mode is a mode in which the blood collection tube holders 102 and 103, which have been raised toward the finger rest 119, are lowered onto the turntable 106 after a predetermined time has elapsed. In normal mode, the blood collection tube holders 102 and 103, which have been raised, are lowered onto the turntable 106 in a short time. Therefore, the amount of blood bled from the puncture site can be measured on the turntable 106 by the blood collection volume measurement mechanism 118.

[0084] The bleeding mode is a mode in which the blood collection tube holders 102 and 103, which have been raised toward the finger rest 119, are positioned to be pressed against the puncture site or to be close to the puncture site, and the blood bleeding from the puncture site is collected in the blood collection tube. The bleeding mode is executed when the blood bleeding from the puncture site is forceful and there is a risk that the blood bleeding from the puncture site will fall to a location other than the blood collection tube.

[0085] Furthermore, the blood collection device 1 can detect the fall of blood droplets formed at the puncture site during blood collection, when blood is collected from the puncture site into the blood collection tube. When the bleeding rate decreases to below a preset threshold, it can be determined that the blood droplets formed at the puncture site have fallen from the surface of the skin. On the other hand, when the bleeding rate does not decrease to below a preset threshold, it can be determined that the blood droplets formed at the puncture site have not fallen from the surface of the skin. Detecting the fall of blood droplets during transport of the blood collection tube allows for the detection of blood adhering to locations other than the blood collection tube and the scattering of blood that contaminates the surrounding area.

[0086] The process of measuring blood size may be performed using machine learning. Machine learning models such as convolutional neural networks (CNNs) and artificial neural networks (ANNs) can be used. A training phase is performed using a dataset of multiple fingertip images, and a prediction phase is performed using the trained machine learning model to detect blood using image recognition or object detection. Features such as area and circumference can be extracted. For region classification, any segmentation method, such as semantic or instance-based segmentation, may be used.

[0087] Figure 3 is a flowchart illustrating the operation of a blood collection device according to an embodiment of the present invention. As shown in Figure 3, finger blood collection by the blood collection device 1 is performed by sequentially executing a puncture operation, a blood collection operation, and a treatment operation. The blood collection device 1 uses a vascular image to determine the target puncture position for inserting the puncture needle. In addition, when collecting blood from the puncture site into the blood collection tube, the finger 10 of the person to be blood collected is compressed by the compression mechanism 112.

[0088] The blood collection method performed using the blood collection device 1 is a blood collection method for collecting blood from the fingers of a person to be collected, and includes a puncture step of inserting a puncture needle into the fingers of the person to be collected, a compression step of applying pressure to the fingers of the person to be collected, a blood collection step of collecting blood bled from the puncture site where the puncture needle was inserted into a container, a hemostatic step of stopping the bleeding from the puncture site where the puncture needle was inserted with a hemostatic material such as gauze, and a protective step of protecting the puncture site where the puncture needle was inserted with a protective material such as an adhesive bandage.

[0089] When performing blood collection using the blood collection device 1, first, the fingertip of the person to be collected (finger 10) is placed on the finger rest 119 (step S301). On the turntable 106, a lancing device holder 101 with a lancing device attached, blood collection tube holders 102 and 103 with blood collection tubes attached, a hemostatic material holder 104 with gauze or other hemostatic material attached, and a protective material holder 105 with adhesive bandages or other protective materials attached are placed.

[0090] Next, the start button is pressed to begin blood collection (step S302). The start button is pressed by the person receiving the blood or the operator of the blood collection device 1. When blood collection begins, the various mechanisms built into the housing are reset, and the operation of each mechanism and device is checked. Also, when blood collection begins, an ID to identify the person receiving the blood, as well as information specifying the type of blood collection tube and the blood test items, are input into the blood collection device 1.

[0091] Next, the blood vessels running through the fingertip of the blood recipient's finger 10 are photographed to determine the target puncture position for inserting the needle into the blood recipient's finger 10 (step S303). The control mechanism 114 controls the infrared light imaging device 108 to acquire images of the blood vessels in the blood recipient's finger 10. The data from the imaging results is transmitted from the infrared light imaging device 108 to the control mechanism 114. The control mechanism 114 visualizes the blood vessels based on the imaging results and determines a target puncture position suitable for securing a sufficient blood volume based on the blood vessel images.

[0092] Next, a puncture operation is performed in which the lancing device is pressed against the finger 10 of the person from whom blood is drawn and the puncture needle is inserted (step S304). The control mechanism 114 controls the rotation drive mechanism 115 to rotate the turntable 106 so that the position of the puncture needle in a plan view coincides with the target puncture location. Then, the lifting drive mechanism 107 is controlled to raise the lancing device holder 101 to a height where the lancing device is pressed against the pad of the fingertip. When the lancing device is pressed against the pad of the fingertip, the puncture needle is extended to puncture the skin or capillaries at the target puncture location. After that, the lifting drive mechanism 107 is controlled to lower the lancing device holder 101 back onto the turntable 106.

[0093] Next, a blood collection operation is performed in which blood is collected into blood collection tubes from the puncture site where the puncture needle was inserted (step S305). The control mechanism 114 controls the rotation drive mechanism 115 to rotate the turntable 106 so that the blood collection tube holders 102 and 103 are sequentially transported to a position directly below the fingertips of the blood recipient's fingers 10 placed on the finger rest 119. After rotation, the control mechanism 114 controls the lifting drive mechanism 107 to raise the blood collection tube holders 102 and 103 to a height where the blood in contact with the puncture site and the inner surface of the blood collection tubes come into contact with each other. The blood flowing out of the puncture site is sequentially collected into each blood collection tube. Once the blood has been collected, the control mechanism 114 controls the lifting drive mechanism 107 to lower the blood collection tube holders 102 and 103 back onto the turntable 106.

[0094] Next, a hemostatic operation is performed to stop bleeding at the puncture site where the puncture needle has inserted (step S306). The control mechanism 114 controls the rotation drive mechanism 115 to rotate the turntable 106 so that the hemostatic material holder 104 is transported to a position directly below the fingertip of the blood recipient's finger 10 placed on the finger rest 119. Then, the control mechanism 114 controls the lifting drive mechanism 107 to raise the hemostatic material holder 104 to a height where the hemostatic material such as gauze is pressed against the puncture site. The puncture site is stopped from bleeding by the pressure of the hemostatic material. After that, the control mechanism 114 controls the lifting drive mechanism 107 to lower the hemostatic material holder 104 back onto the turntable 106.

[0095] Next, a protective action is performed to protect the puncture site where the puncture needle has been inserted (step S307). The control mechanism 114 controls the rotation drive mechanism 115 to rotate the turntable 106 so that the protective material holder 105 is transported to a position directly below the fingertip of the blood sampler's finger 10 placed on the finger rest 119. Then, the control mechanism 114 controls the lifting drive mechanism 107 to raise the protective material holder 105 to a height where a protective material such as an adhesive bandage is pressed against the puncture site. The puncture site is protected by the adhesion of the protective material. After that, the control mechanism 114 controls the lifting drive mechanism 107 to lower the protective material holder 105 back onto the turntable 106.

[0096] These actions complete the blood collection from the patient's finger 10. The blood collection tube containing the blood is removed from the blood collection device 1, mixed by inversion as necessary, and then transported to an automated analyzer or similar device for blood testing. The lancet and hemostatic agent are removed from the blood collection device 1 and replaced for each patient. Protective material can be replenished in the protective material holder 105 after each blood collection.

[0097] Figures 4A, 4B, 4C, 4D, and 4E show the positional relationship between the patient's finger and the lancing device during puncture. Figures 4A, 4B, 4C, 4D, and 4 show the lancing device holder 101 and blood collection tube holder 102 installed on the turntable 106, and the area around the fingertip of the patient's finger 10 placed on the finger rest 119, viewed from the opposite side of the turntable 106's central axis. In the figures, the dashed line represents the central axis of the turntable 106.

[0098] Figure 4A shows the lancing device holder 101 and blood collection tube holder 102 in standby positions on the turntable 106. The blood collection tube holder 103, hemostatic material holder 104, and protective material holder 105 are not shown. The lancing device holder 101, blood collection tube holder 102, and the blood collection tube holder 103, hemostatic material holder 104, and protective material holder 105 (not shown) are prepared in predetermined positions on the turntable 106.

[0099] Figure 4B shows the state in which the lancing device holder 101 has been transported to the starting position for upward movement. Before the puncture in which the puncture needle is inserted into the finger 10 of the person from whom blood is drawn, the lancing device holder 101 is transported to the lower end position 401 of the lancing device lifting track by the rotation of the turntable 106 by the rotation of the rotary drive mechanism 115.

[0100] The lower end position 401 of the lancing device's lifting trajectory is the lower end position of the lifting trajectory of the lancing device holder 101. The lower end position 401 of the lancing device's lifting trajectory is the position where the lancing device holder 101 begins to rise and where the lancing device holder 101 ends to descend, and is located on the turntable 106 directly below the fingertip of the blood recipient's finger 10 placed on the finger rest 119. The lower end position 401 of the lancing device's lifting trajectory is set so that, in a plan view, the position of the puncture needle built into the lancing device coincides with the target puncture position on the fingertip. The lower end position 401 of the lancing device's lifting trajectory can be determined using vascular images or fingertip images.

[0101] Figure 4C shows the state in which the lancing device holder 101 has been raised from the starting position to the ending position. When the lancing device holder 101 is inserted into the finger 10 of the person from whom blood is drawn, it is pushed up by the lifting drive mechanism 107, raising it from the lower end position 401 of the lancing device lifting track to the upper end position 402 of the lancing device lifting track.

[0102] The upper end position 402 of the lancing device's vertical trajectory is the upper end position of the vertical trajectory of the lancing device holder 101. The upper end position 402 of the lancing device's vertical trajectory is the position where the lancing device holder 101 finishes rising and where the lancing device holder 101 begins to descend, and is the execution position where the puncture needle is inserted into the fingertip. The upper end position 402 of the lancing device's vertical trajectory is set to a height where the tip of the lancing device held in the lancing device holder 101 is pressed against the surface of the ventral side of the fingertip. When the lancing device holder 101 rises to the upper end position 402 of the lancing device's vertical trajectory, the lancing device is pressed against the ventral side of the fingertip of the person whose blood is being collected (finger 10), and the puncture needle built into the lancing device protrudes to puncture the skin and capillaries.

[0103] Figure 4D shows the lancing device holder 101 in the lowered position from the starting position to the ending position. After the puncture in the finger 10 of the person from whom blood is drawn, the lancing device holder 101 is lowered from the upper end position 402 of the lancing device lifting trajectory to the lower end position 401 of the lancing device lifting trajectory by the downward movement of the lifting drive mechanism 107.

[0104] Figure 4E shows the state after the lancing device holder 101 has been removed from its lowered end position. After the lancing device holder 101 has been lowered onto the turntable 106, it is removed from directly below the fingertip by the rotation of the turntable 106 by the rotation drive mechanism 115. Directly below the fingertip, the blood collection tube holder 102, which is installed at an adjacent position on the turntable 106, is transported. The blood collection tube holder 102 is transported to the lower end position 403 of the blood collection tube lifting track.

[0105] Figure 5 is a flowchart showing the operation of the blood collection device from the puncture step to the blood collection step. As shown in Figure 5, the puncture operation by the blood collection device 1 is performed after compressing the patient's finger 10 with the compression mechanism 112. The target puncture position for inserting the puncture needle is determined based on the vascular image captured by the infrared light imaging device 108.

[0106] When inserting the lancet into the patient's finger 10, the patient's finger 10, which is placed on the finger rest 119, is first compressed by the compression mechanism 112 (step S501). Compressing the fingers causes blood to gather at the fingertips, resulting in congestion of the fingertips, which makes bleeding easier when the lancet is inserted.

[0107] Next, a vascular image of the fingertip of the person receiving blood is taken to determine the target puncture site (step S502). Blood vessels running through the fingertip can be visualized as dark lines, which are sequences of low-luminance pixels, on the vascular image. The target puncture site can be specified as the intersection of the arc-shaped trajectory of the puncture needle, caused by the rotation of the turntable 106, and a representative blood vessel running through the fingertip on the vascular image. Representative blood vessels include those that run shallowly from the surface of the fingers, are large in diameter, or have high blood flow. Selecting such blood vessels ensures a stable supply of the blood volume necessary for blood tests.

[0108] Next, the lancing device holder 101 is moved to the lower end position 401 of the lancing device lifting track (step S503). The control mechanism 114 controls the rotation drive mechanism 115 to rotate the turntable 106 by a predetermined rotation angle so that the position of the puncture needle in a plan view coincides with the target puncture position.

[0109] Next, the lancing device holder 101 is moved to the upper end position 402 of the lancing device lifting track (step S504). The control mechanism 114 controls the lifting drive mechanism 107 to raise the lancing device holder 101 to a height where the lancing device is pressed against the pad of the fingertip. When the lancing device is pressed against the pad of the fingertip, the puncture needle is extended to puncture the skin or capillaries at the target puncture site.

[0110] Next, the lancing device holder 101 is moved to the lower end position 401 of the lancing device lifting track (step S505). The control mechanism 114 controls the lifting drive mechanism 107 to lower the lancing device holder 101 onto the turntable 106.

[0111] Next, the blood collection tube holder 102 is moved to the lower end position 403 of the blood collection tube lifting track (step S506). The control mechanism 114 controls the rotation drive mechanism 115 to rotate the turntable 106 at a predetermined rotation angle so that the puncture position in plan view is inside the inner surface of the blood collection tube and close to the inner surface of the blood collection tube.

[0112] Next, it is determined whether or not the blood that bled from the puncture site has fallen off the surface of the skin (step S507). The control mechanism 114 can determine whether or not the blood has fallen based on the bleeding rate calculated using the fingertip image acquisition mechanism (109, 117). The fingertip image acquisition mechanism (109, 117) can, for example, start imaging the fingertip from the moment the puncture needle is inserted into the finger 10 of the person from whom blood is collected.

[0113] Whether or not blood has dripped is determined by checking whether the bleeding rate has decreased to a preset threshold after puncturing the patient's finger 10 with the lancet and before moving the blood collection tube to the lower end position 403 of the blood collection tube's lifting trajectory. If the bleeding rate decreases to a threshold or below, it can be determined that blood has dripped. On the other hand, if the bleeding rate does not decrease to a threshold or below, it can be determined that blood has not dripped. The threshold can be set to a zero point where the bleeding rate turns negative, or to a threshold that corresponds to a negative value indicating a decrease in the bleeding rate.

[0114] If the determination results in the blood being dropped (step S507; Yes), a warning indicating that an abnormality has occurred during blood collection is displayed by the display mechanism 113 (step S508). By displaying a warning to the person being collected for blood collection and the operator of the blood collection device 1, infections transmitted through the dropped blood can be prevented. In addition, if the blood being dropped is confirmed by visual inspection or other means, a warning indicating that an abnormality has occurred during blood collection can also be displayed by the display mechanism 113. After displaying the warning, the puncture process is terminated, and blood collection is interrupted or stopped.

[0115] On the other hand, if the judgment determines that no blood has fallen (step S507; No), the puncture process is terminated. If the puncture process is completed successfully, the hemostasis process is started by the operation of the hemostatic material holder 104.

[0116] Figures 6A, 6B, 6C, 6D, and 6E show the positional relationship between the patient's finger and the blood collection tube during blood collection. Figures 6A, 6B, 6C, 6D, and 6E show the area around the fingertip of the patient's finger 10, which is placed on the turntable 106 and the finger rest 119, as viewed from the opposite side of the turntable 106's central axis. In the figures, the dashed line represents the central axis of the turntable 106. Figures 6A, 6B, 6C, 6D, and 6E show the normal mode of blood collection, which is performed when the bleeding rate is less than the threshold Rb.

[0117] Figure 6A shows the blood collection tube holder 102 in a standby position on the turntable 106. The lancing device holder 101, blood collection tube holder 103, hemostatic material holder 104, and protective material holder 105 are not shown. Immediately after the puncture needle is inserted into the target puncture site on the patient's finger 10, the blood collection tube holder 102 is in a standby position different from directly below the fingertip.

[0118] Figure 6B shows the state in which the blood collection tube holder 102 has been transported to the starting position for upward movement. When blood is collected from the puncture site, the blood collection tube holder 102 is transported to the lower end position 403 of the blood collection tube lifting track by the rotation of the turntable 106 by the rotation drive mechanism 115.

[0119] The lower end position 403 of the blood collection tube lifting trajectory is the lower end position of the lifting trajectory of the blood collection tube holders 102 and 103. The lower end position 403 of the blood collection tube lifting trajectory is the position where the blood collection tube holders 102 and 103 begin to rise and where they end to descend, and is located on the turntable 106 directly below the fingertip of the blood recipient's finger 10 placed on the finger rest 119. In a plan view, the lower end position 403 of the blood collection tube lifting trajectory is set so that the puncture position is located inside the inner surface of the blood collection tube, and the inner surface of the blood collection tube is close to the puncture position. The lower end position 403 of the blood collection tube lifting trajectory can be determined using vascular images or fingertip images.

[0120] In each figure, the blood collection tube held in the blood collection tube holder 102 is provided with a structure in which a projection 121 is formed at the upper opening. The projection 121 protrudes upward from a part of the outer circumference of the upper opening and forms a receiving-shaped scoop on one side of the opening. The projection 121 functions as a receiving surface for receiving blood flowing out from the puncture site or as a part for wiping away blood. In this specification, the inner surface of the blood collection tube includes the inner surface of the container portion of the blood collection tube as well as the inner surface facing the opening side of the projection 121.

[0121] Figure 6C shows the blood collection tube holder 102 in a waiting position at the starting position for upward movement. In Figure 6C, the blood 601 bleeding from the puncture site on the patient's finger 10 has grown to a predetermined size Vfb. After being transported to the lower end position 403 of the blood collection tube lifting track, the blood collection tube holder 102 is kept waiting at the lower end position 403 of the blood collection tube lifting track until the blood 601 bleeding from the puncture site reaches a predetermined size Vfb, or until a predetermined waiting time has elapsed. The blood 601 bleeding from the puncture site is continuously photographed by the fingertip appearance imaging device 109 from the time of puncture. The size of the blood 601 is measured on the captured fingertip image.

[0122] Figure 6D shows the blood collection tube holder 102 raised from the starting position to the ending position. When blood is collected from the puncture site, the blood collection tube holder 102 is pushed up by the lifting drive mechanism 107 from the lower end position 403 of the blood collection tube lifting trajectory to the upper end position 404 of the blood collection tube lifting trajectory.

[0123] The upper end position 404 of the blood collection tube lifting trajectory is the upper end position of the lifting trajectory of the blood collection tube holders 102 and 103. The upper end position 404 of the blood collection tube lifting trajectory is the position where the blood collection tube holders 102 and 103 finish rising and where the blood collection tube holders 102 and 103 begin to descend, and is the execution position where blood bled from the puncture site is collected into the blood collection tube. The upper end position 404 of the blood collection tube lifting trajectory is set at a height where the blood in contact with the puncture site and the inner surface of the blood collection tube held by the blood collection tube holders 102 and 103 come into contact with each other. When the blood collection tube holders 102 and 103 rise to the upper end position 404 of the blood collection tube lifting trajectory, the inner surface of the blood collection tube comes into contact with the blood in contact with the puncture site, and blood is collected into the blood collection tube.

[0124] The upward movement of the blood collection tube from the lower end position 403 of the lifting trajectory to the upper end position 404 can be performed when the size of the blood bled from the puncture site of the patient's finger 10, as measured on the fingertip image captured by the fingertip appearance imaging device 109, exceeds a preset threshold Vfb. Alternatively, it can be performed when a preset waiting time has elapsed while the blood collection tube holders 102 and 103 are transported to the lower end position 403 of the lifting trajectory.

[0125] By limiting the timing of the upward movement of the blood collection tube holders 102 and 103 in this way, the contact time between the blood bled from the puncture site and the blood collection tube can be shortened, thus preventing the blood from drying out. Furthermore, since the upward movement of the blood collection tube holders 102 and 103 is activated when the blood bled from the puncture site reaches a certain size, the blood droplets formed at the puncture site can be transferred from the puncture site to the blood collection tube in a short time after puncture. Because the puncture site and the bled blood can be separated from each other in a short time, blood coagulation can be avoided. In addition, because blood droplets of a certain size come into contact with the blood collection tube, the blood droplets flow down more easily, allowing for efficient blood collection.

[0126] Figure 6E shows the blood collection tube holder 102 in the lowered position from the starting position to the ending position. After blood is collected from the puncture site, the blood collection tube holder 102 is lowered from the upper end position 404 of the blood collection tube lifting trajectory to the lower end position 403 by the lowering of the lifting drive mechanism 107.

[0127] The descent from the upper end position 404 of the blood collection tube lifting track to the lower end position 403 can be performed immediately after the blood collection tube holders 102 and 103 have risen to the upper end position 404 of the blood collection tube lifting track, or after a preset waiting time has elapsed after they have risen to the upper end position 404 of the blood collection tube lifting track. After blood is collected from the puncture site, the blood collection tube holders 102 and 103 are removed from directly below the fingertips of the blood recipient's fingers 10 placed on the finger rest 119 by the rotation of the turntable 106 by the rotation drive mechanism 115.

[0128] By limiting the timing of the descent of the blood collection tube holders 102 and 103 in this way, the blood collection tube holders 102 and 103, which have risen to the upper end position 404 of the blood collection tube lifting trajectory, descend to the lower end position 403 of the blood collection tube lifting trajectory in a short time. This reduces the time that the blood in contact with the puncture site and the inner surface of the blood collection tube are in contact with each other. Since the spreading of the blood in contact with the puncture site is suppressed, drying of the bleeding blood can be avoided.

[0129] Furthermore, the blood collection procedures shown in Figures 6A, 6B, 6C, 6D, and 6E can be performed in the same manner regardless of the type of blood collection tube, whether it is a blood collection tube holder 102 holding a blood collection tube for biochemical / immunological testing, or a blood collection tube holder 103 holding a blood collection tube for complete blood count testing.

[0130] Furthermore, the blood collection procedure shown in Figures 6A, 6B, 6C, 6D, and 6E may be performed with the blood collection tube held upright along the vertical direction, or with the blood collection tube tilted relative to the vertical direction. Methods for tilting the blood collection tube include, for example, installing an outer tube in the blood collection tube holders 102 and 103 and accommodating the blood collection tube in an inclined state within the outer tube, or providing a mechanism on the turntable 106 to tilt the blood collection tube holders 102 and 103. By tilting the blood collection tube, the projection 121 can be positioned in a tray-like shape below the puncture site, allowing for efficient blood collection.

[0131] Furthermore, with the blood collection tube holders 102 and 103 raised to the upper end position 404 of the blood collection tube lifting track, the blood collection tube holders 102 and 103 may be moved horizontally. By moving them horizontally, it is possible to bring the blood in contact with the puncture site and the inner surface of the blood collection tube into contact with each other, and to separate the blood in contact with the puncture site and the inner surface of the blood collection tube from each other, once or multiple times. By performing such actions, the blood in contact with the puncture site can be efficiently collected by wiping it away. Since the blood bled from the puncture site can be quickly transferred to the blood collection tube, blood coagulation can be avoided.

[0132] Figures 7 and 8 are timing charts showing the relationship between the height of the blood collection tube on the lifting trajectory during blood collection and the size of the blood. Figures 7 and 8 show the operation of the blood collection device 1 in normal mode. In Figures 7 and 8, the upper figure shows the height of the blood collection tube between the lower end position 403 and the upper end position 404 of the blood collection tube lifting trajectory. The lower figure shows the size of the blood bled from the puncture site as captured by the fingertip image acquisition mechanism (109, 117).

[0133] Figure 7 is a timing chart showing the case where the waiting time Tp before the blood collection tube holders 102 and 103 rise at the lower end position 403 of the blood collection tube lifting trajectory elapses before the size of the blood bled from the puncture site, as captured by the fingertip external appearance imaging device 109, exceeds the threshold Vfb.

[0134] As shown in Figure 7, the blood collection tube holders 102 and 103 are driven to rise toward the upper end position 404 of the blood collection tube lifting trajectory when a predetermined waiting time Tp has elapsed before the size of the blood bled from the puncture site exceeds the threshold Vfb. With this operation, even if the size of the blood bled from the puncture site is small, the blood and the blood collection tube can be brought into contact after a predetermined time has elapsed. Therefore, drying and coagulation of the blood bled from the puncture site can be avoided.

[0135] Figure 8 is a timing chart showing the case where the size of blood bled from the puncture site exceeds the threshold Vfb before the waiting time elapses before the blood collection tube holders 102 and 103 rise at the lower end position 403 of the blood collection tube lifting trajectory has elapsed.

[0136] As shown in Figure 8, the blood collection tube holders 102 and 103 are driven to rise toward the upper end position 404 of the blood collection tube lifting trajectory when the size of the blood bled from the puncture site exceeds the threshold Vfb before a predetermined waiting time Tp has elapsed. This operation allows the blood collection tube to come into contact with the blood, which is large in size and flows easily. Therefore, the blood bleeding from the puncture site can be collected in a short time before the blood dries or coagulates.

[0137] When the blood collection tube holders 102 and 103 rise, the blood in contact with the puncture site comes into contact with the inner surface of the blood collection tube. In this state, the blood droplet formed at the puncture site flows down into the blood collection tube, making it impossible to photograph the size of the blood using the fingertip external imaging device 109. Therefore, when measuring the amount of blood bled from the puncture site, the blood collection volume measurement mechanism 118 is used.

[0138] The waiting time Tp before the blood collection tube holders 102 and 103 rise at the lower end position 403 of the blood collection tube lifting trajectory can be set to any desired time. The waiting time Tp can also be changed based on the calculation result of the bleeding rate. For example, if the bleeding rate is greater than the standard value, the waiting time Tp can be shortened from the initial value. If the bleeding rate is excessive, setting the waiting time Tp to a short time can prevent the blood bleeding from the puncture site from falling off the skin surface, thereby preventing contamination of the surrounding area by blood.

[0139] Figure 9 is a flowchart showing the operation of the blood collection process in the blood collection device. As shown in Figure 9, the blood collection operation by the blood collection device 1 is performed under conditions corresponding to the bleeding rate, after the finger 10 of the person from whom blood is collected is compressed by the compression mechanism 112. Blood is collected from the puncture site of the person from whom blood is collected so as to satisfy predetermined conditions regarding the amount of blood collected and the blood collection time.

[0140] In blood collection using the blood collection device 1, when blood is collected from the puncture site into the blood collection tube (step S305), the fingertip image acquisition mechanism (109, 117) continuously monitors the area around the puncture site on the blood subject's finger 10 and acquires a fingertip image of the blood bleeding from the puncture site. The fingertip image is used for measuring the size of the blood bleeding from the puncture site and calculating the bleeding rate of the blood bleeding from the puncture site, etc.

[0141] The lifting drive mechanism 107, during blood collection from the puncture site into the blood collection tube (step S305), repeatedly drives the mechanism to bring the blood in contact with the puncture site and the inner surface of the blood collection tube into contact with each other and then separate them a predetermined number of times. That is, it repeatedly moves the blood collection tube holders 102 and 103 up and down between the lower end position 403 of the blood collection tube lifting trajectory and the upper end position 404 of the blood collection tube lifting trajectory. The number of times this operation is repeated increases when the bleeding rate is high and decreases when the bleeding rate is low.

[0142] When collecting blood from the puncture site into a blood collection tube, imaging of the patient's fingertip is started (step S901). By imaging the area around the puncture site with the fingertip imaging device 109, fingertip images are acquired at predetermined intervals, and the size of the blood bled from the puncture site is measured.

[0143] Next, it is determined whether the size of the blood droplets bled from the puncture site is greater than or equal to a preset threshold Vfb (step S902). The control mechanism 114 can determine the size of the blood droplets based on the fingertip images acquired by the fingertip image acquisition mechanisms (109, 117). The fingertip image acquisition mechanisms (109, 117) can, for example, continue to image the area around the puncture site from the moment the puncture needle is inserted into the finger 10 of the person receiving the blood sample. The threshold Vfb can be preset to be a size that allows the blood droplets formed at the puncture site to flow down naturally.

[0144] If the determination results in the blood size being greater than or equal to the threshold Vfb (step S902; Yes), then the amount of blood in the fingertip of the person from whom the blood was collected is sufficient, and the process proceeds to step S904.

[0145] On the other hand, if the determination is found to be that the blood size is less than the threshold Vfb (step S902; No), the amount of blood in the fingertip of the person being treated is insufficient, and the process proceeds to step S903.

[0146] Next, it is determined whether the time taken to photograph the fingertip of the person from whom blood is collected has reached the pre-set waiting time Tp before the blood collection tube holders 102 and 103 rise (step S903). The time taken to photograph the fingertip of the person from whom blood is collected is calculated, for example, from the time the puncture needle is inserted into the finger 10 of the person from whom blood is collected.

[0147] If the determination results in the imaging time not reaching the waiting time Tp (step S903; No), the process returns to step S902. In this case, the blood collection tube holders 102 and 103 are kept in standby position 403 at the lower end of the blood collection tube lifting track, and imaging of the fingertip by the fingertip appearance imaging device 109 continues.

[0148] On the other hand, if the determination results in a judgment that the shooting time has reached the waiting time Tp (step S903; Yes), the process proceeds to step S904.

[0149] If it is determined that the blood size is greater than or equal to the threshold Vfb (step S902; Yes), or if it is determined that the imaging time has reached the waiting time Tp (step S903; Yes), the imaging of the fingertip is terminated (step S904).

[0150] Next, the blood collection tube holder 102 is moved to the upper end position 404 of the blood collection tube lifting track (step S905). The control mechanism 114 controls the lifting drive mechanism 107 to raise the blood collection tube holder 102 to a height where the blood in contact with the puncture site and the inner surface of the blood collection tube come into contact with each other. The contact between the blood in contact with the puncture site and the inner surface of the blood collection tube causes the blood to flow down into the blood collection tube, and blood collection begins.

[0151] Next, the bleeding rate, which is the change in the amount of blood bleeding from the puncture site over time, is calculated (step S906). The bleeding rate can be calculated as the time derivative of the amount of blood bleeding from the puncture site, based on the size of the blood in the fingertip image acquired by the fingertip image acquisition mechanism (109, 117).

[0152] Next, it is determined whether the bleeding rate is equal to or greater than a preset threshold Rb (step S907). The bleeding rate can be determined by the control mechanism 114 by comparing the measured bleeding rate with the threshold Rb. The threshold Rb for bleeding rate can be set as the lower limit of the bleeding rate at which there is a high probability that the blood bled from the puncture site will fall off the skin surface within the time it takes for the blood collection tube holders 102 and 103 to move to the upper end position 404 of the blood collection tube lifting trajectory.

[0153] If the result of the assessment determines that the bleeding rate is greater than or equal to the threshold Rb (step S907; Yes), the process proceeds to step S908. In this case, the blood collection operation by the blood collection device 1 is switched to bleeding mode (step S908). In bleeding mode, the raised blood collection tube holders 102 and 103 are placed in standby position 404 at the upper end of the blood collection tube lifting trajectory. The transition to bleeding mode prevents the blood bled from the puncture site from falling to a location other than the blood collection tube.

[0154] On the other hand, if the determination is found to be that the bleeding rate is less than the threshold Rb (step S907; No), the process proceeds to step S909. In this case, since the blood bled from the puncture site is less likely to fall to a location other than the blood collection tube, the blood collection operation by the blood collection device 1 is maintained in normal mode.

[0155] Next, the blood collection tube holder 102 is moved to the lower end position 403 of the blood collection tube lifting track (step S909). The control mechanism 114 controls the lifting drive mechanism 107 to lower the blood collection tube holder 102 onto the turntable 106.

[0156] Next, it is determined whether the amount of blood collected from the puncture site into the blood collection tube has reached or exceeded the preset target blood collection amount Vcb (step S910). The determination of the blood collection amount can be performed by the control mechanism 114 by comparing the measured blood collection amount with the preset target blood collection amount Vcb for each type of blood collection tube. The amount of blood collected from the puncture site into the blood collection tube can be measured by calculating the time integral of the bleeding rate or by the blood collection volume measurement mechanism 118. The target blood collection amount is specified for each type of blood collection tube according to the test items of the blood test performed after blood collection.

[0157] If the determination results in a blood volume reaching the target blood volume Vcb (step S910; Yes), the blood collection operation is terminated because the necessary blood volume for the blood test has been secured.

[0158] On the other hand, if the determination is made that the amount of blood collected has not reached the target amount Vcb (step S910; No), the process proceeds to step S911 because the amount of blood necessary for the blood test has not been secured.

[0159] Next, it is determined whether the elapsed time since the start of blood collection into the blood collection tube has reached a preset blood collection completion limit Tfin (step S911). The determination of the blood collection time can be performed by the control mechanism 114 by comparing the counted blood collection time with a preset blood collection completion limit Tfin for each type of blood collection tube. The elapsed time since the start of blood collection into the blood collection tube is counted by a built-in timer. The blood collection time affects the time it takes for the blood to coagulate and the composition of the components that flow out from the puncture site. Therefore, the blood collection completion limit, which is the upper limit of the blood collection time, is limited for each type of blood collection tube, according to the test items of the blood test to be performed after blood collection.

[0160] If the determination is made that the blood collection time has reached the blood collection completion limit time Tfin (step S911; Yes), the process proceeds to step S914. In this case, blood collection into the blood collection tube is stopped because there is a possibility that tissue fluid has mixed with the blood or that blood coagulation is progressing.

[0161] On the other hand, if the determination is made that the blood collection time has not reached the blood collection completion limit time Tfin (step S911; No), the process proceeds to step S912.

[0162] Next, it is determined whether the bleeding rate, which is the change in the amount of blood bleeding from the puncture site over time, is less than a preset threshold Rbs (step S912). The bleeding rate can be determined by the control mechanism 114 by comparing the measured bleeding rate with the threshold Rbs. The bleeding rate determination confirms the tendency to stop bleeding at the puncture site. The threshold Rbs for the bleeding rate can be set as an upper limit of the bleeding rate at which the tendency to stop bleeding is strong and additional blood collection into another blood collection tube is not possible.

[0163] If the result of the assessment indicates that the bleeding rate is below the threshold Rbs (step S912; Yes), the process proceeds to step S914 because there is little blood bleeding from the puncture site. In this case, it is highly likely that it will be difficult to obtain the amount of blood required for the blood test, so blood collection into the blood collection tube is stopped.

[0164] On the other hand, if the result of the assessment indicates that the bleeding rate is greater than or equal to the threshold Rbs (step S912; No), a large amount of blood is bleeding from the puncture site, and additional blood collection into another blood collection tube is possible, so the process proceeds to step S913.

[0165] Next, the waiting time Tp before the blood collection tube holders 102 and 103 rise is updated (step S913). The waiting time Tp can be changed according to the latest bleeding rate calculated in step S906. For example, if the bleeding rate is above the standard value, the waiting time Tp can be changed to be smaller than the initial value. If the bleeding rate is below the standard value, the waiting time Tp can be kept at the initial value.

[0166] If it is determined that the blood collection time has reached the blood collection completion limit time Tfin (step S911; Yes), or if the bleeding rate is less than the threshold Rbs (step S912; Yes), a warning indicating that an abnormality has occurred in blood collection is displayed by the display mechanism 113 (step S914). For example, the display mechanism 113 can display an image indicating that normal blood collection, in which the target blood collection volume Vcb is collected before the blood collection completion limit time Tfin has elapsed, could not be achieved, and that additional blood collection into another blood collection tube is also not possible. After displaying the warning, the blood collection process is terminated, and blood collection is interrupted or stopped.

[0167] The blood collection process shown in Figure 9 can be performed in the same manner regardless of the type of blood collection tube, whether it is a blood collection tube holder 102 holding a blood collection tube for biochemical / immunological testing, or a blood collection tube holder 103 holding a blood collection tube for complete blood count testing. The control mechanism 114 controls the rotational drive mechanism 115 to transport the blood collection tube holder from the position directly below the puncture site after blood collection. If there are any blood collection tubes remaining that have not yet been used to collect blood, the remaining blood collection tube holders are transported to the position directly below the puncture site.

[0168] In this blood collection process, when the size of the blood bled from the puncture site exceeds a preset threshold Vfb, the lifting drive mechanism 107 is activated to raise the blood collection tube holders 102 and 103. Furthermore, depending on the bleeding rate, the lifting drive mechanism 107 is activated to lower the blood collection tube holders 102 and 103. The lifting and lowering of the blood collection tube holders 102 and 103 is then repeated according to the target blood collection volume Vcb, the blood collection completion time Tfin, and the bleeding rate threshold Rbs. This control allows for the repeated lifting and lowering of the blood collection tube holders 102 and 103 in a short period of time, thus preventing blood coagulation and drying from the puncture site and ensuring that all blood bled from the puncture site is collected into the blood collection tube without leakage. Additionally, by repeatedly performing this operation, the contact time between the blood at the puncture site and the blood collection tube is shortened, while the total amount of blood collected from the puncture site into the blood collection tube can be secured. Therefore, it is possible to stably perform normal blood collection by collecting the target blood volume Vcb before the blood collection completion limit time Tfin has elapsed.

[0169] Figure 10 is a timing chart showing the relationship between the height of the blood collection tube on the lifting trajectory during blood collection and the size of the blood. Figure 10 shows the operation of the bleeding mode of the blood collection device 1, which is executed when the bleeding rate is greater than or equal to the threshold Rb. In Figure 10, the upper figure shows the height of the blood collection tube between the lower end position 403 of the blood collection tube lifting trajectory and the upper end position 404 of the blood collection tube lifting trajectory. The lower figure shows the size of the blood bled from the puncture site as captured by the fingertip image acquisition mechanism (109, 117).

[0170] As shown in Figure 10, in bleeding mode, the blood collection tube holders 102 and 103 are held at the upper end position 404 of the blood collection tube lifting trajectory without being lowered to the lower end position 403 of the blood collection tube lifting trajectory. This control prevents blood bleeding from the puncture site from falling to locations other than the blood collection tube, thereby preventing bloodborne infections and other complications.

[0171] Figure 11 is a flowchart illustrating the operation of the bleeding mode performed during the blood collection process in a blood collection device. As shown in Figure 11, the bleeding mode is performed under conditions corresponding to the bleeding rate. The bleeding mode is started when the bleeding rate is high and is released when the bleeding rate decreases or when a predetermined amount of blood has been collected.

[0172] In bleeding mode, while the blood bleeding from the puncture site is being collected into the blood collection tube, it is determined whether the amount of blood collected from the puncture site into the blood collection tube has reached or exceeded a preset target blood collection amount Vcb (step S1101). The determination of the blood collection amount can be performed by the control mechanism 114 by comparing the measured blood collection amount with the preset target blood collection amount Vcb for each type of blood collection tube. The amount of blood collected from the puncture site into the blood collection tube is measured by the blood collection amount measurement mechanism 118.

[0173] If the determination is made that the amount of blood collected has reached the target amount Vcb (step S1101; Yes), the blood collection operation is terminated because the amount of blood required for the blood test has been secured.

[0174] On the other hand, if the determination is made that the amount of blood collected has not reached the target amount Vcb (step S1101; No), the process proceeds to step S1102 because the amount of blood necessary for the blood test has not been secured.

[0175] Next, it is determined whether the bleeding rate is equal to or greater than a preset threshold Rb (step S1102). The bleeding rate can be determined by the control mechanism 114 by comparing the measured bleeding rate with the threshold Rb. In bleeding mode, the blood collection tube holders 102 and 103 are held at the upper end position 404 of the blood collection tube lifting trajectory, and the bleeding blood flows down into the blood collection tube without remaining at the puncture site. Therefore, when determining the bleeding rate, the fingertip image acquired by the fingertip image acquisition mechanism (109, 117) cannot be used. For this reason, in bleeding mode, the bleeding rate is calculated as the time derivative of the amount of blood collected in the blood collection tube measured by the blood collection volume measurement mechanism 118.

[0176] If the assessment determines that the bleeding rate is above the threshold Rb (step S1102; Yes), the process returns to step S1101. In this case, the bleeding mode is continued because the blood bleeding from the puncture site is likely to fall to a location other than the blood collection tube.

[0177] On the other hand, if the result of the assessment determines that the bleeding rate is less than the threshold Rb (step S1102; No), the process proceeds to step S1103. In this case, since the blood bleeding from the puncture site is less likely to fall to a location other than the blood collection tube, the process switches to normal mode.

[0178] Next, the blood collection tube holder 102 is moved to the lower end position 403 of the blood collection tube lifting track (step S1103). The control mechanism 114 controls the lifting drive mechanism 107 to lower the blood collection tube holder 102 onto the turntable 106. After that, as shown in Figure 9, the operation in normal mode is resumed (step S901).

[0179] Figures 12A, 12B, 12C, and 12D show the positional relationship between the patient's finger and the hemostatic material during hemostasis. Figures 12A, 12B, 12C, and 12D show the area around the fingertip of the patient's finger 10, which is placed on the turntable 106 and on the finger rest 119, as viewed from the opposite side of the turntable 106's central axis. In the figures, the dashed line represents the central axis of the turntable 106.

[0180] Figure 12A shows the hemostatic material holder 104 in a standby position on the turntable 106. The lancing device holder 101, blood collection tube holders 102 and 103, and protective material holder 105 are not shown. Immediately after the blood bled from the puncture site is collected in the blood collection tube, the hemostatic material holder 104 is in a standby position different from directly below the fingertip.

[0181] Figure 12B shows the state in which the hemostatic material holder 104 has been transported to the upward starting position. When hemostasis is performed to stop bleeding at the puncture site, the hemostatic material holder 104 is transported to the lower end position 405 of the hemostatic material lifting track by the rotation of the turntable 106 by the rotation drive mechanism 115.

[0182] The lower end position 405 of the hemostatic material lifting trajectory is the lower end position of the lifting trajectory of the hemostatic material holder 104. The lower end position 405 of the hemostatic material lifting trajectory is the position where the hemostatic material holder 104 begins to rise and where the hemostatic material holder 104 ends to descend, and is located on the turntable 106 directly below the fingertip of the blood recipient's finger 10 placed on the finger rest 119. The lower end position 405 of the hemostatic material lifting trajectory is set so that, in a plan view, the puncture site is located inside the contour line of the hemostatic material, and the center of the hemostatic material is close to the puncture site. The lower end position 405 of the hemostatic material lifting trajectory can be determined using vascular images or fingertip images.

[0183] Figure 12C shows the state in which the hemostatic material holder 104 has been raised from the starting position to the ending position. When hemostasis is performed to stop bleeding at a puncture site, the hemostatic material holder 104 is raised from the lower end position 405 of the hemostatic material lifting track to the upper end position 406 of the hemostatic material lifting track by the lifting drive mechanism 107.

[0184] The upper end position 406 of the hemostatic material lifting track is the upper end position of the hemostatic material holder 104's lifting track. The upper end position 406 of the hemostatic material lifting track is the position where the hemostatic material holder 104 finishes rising and where the hemostatic material holder 104 begins to descend, and is the execution position where bleeding at the puncture site is stopped by the hemostatic material. The upper end position 406 of the hemostatic material lifting track is set at a height where the puncture site on the surface of the fingertip and the hemostatic material held in the hemostatic material holder 104 come into contact with each other. When the hemostatic material holder 104 rises to the upper end position 406 of the hemostatic material lifting track, the hemostatic material comes into contact with the blood flowing out of the puncture site, the blood is absorbed by the hemostatic material and bleeding at the puncture site is stopped.

[0185] The hemostatic material can be raised from the lower end position 405 of the hemostatic material lifting track to the upper end position 406 when the size of the blood bled from the puncture site on the patient's finger 10, as measured on the fingertip image captured by the fingertip appearance imaging device 109, exceeds a preset threshold. Alternatively, it can be performed regardless of the size of the blood bled from the puncture site, after a preset time has elapsed since blood collection into the blood collection tube.

[0186] By limiting the timing of the rise of the hemostatic material holder 104 in this way, blood bleeding from the puncture site can be absorbed by the hemostatic material before it falls from the puncture site, thus avoiding contamination of the turntable 106 and other components with blood. Furthermore, hemostasis at the puncture site can be performed only when necessary due to a large amount of bleeding. Since unnecessary hemostasis actions can be omitted when the amount of bleeding is small, blood collection by the blood collection device 1 can be completed in a shorter time.

[0187] Figure 12D shows the state in which the hemostatic material holder 104 has been lowered from the starting position to the ending position. After hemostasis has been achieved at the puncture site, the hemostatic material holder 104 is lowered from the upper end position 406 of the hemostatic material lifting track to the lower end position 405 of the hemostatic material lifting track by the downward movement of the lifting drive mechanism 107.

[0188] The descent from the upper end position 406 of the hemostatic material lifting track to the lower end position 405 can be performed immediately after the hemostatic material holder 104 rises to the upper end position 406 of the hemostatic material lifting track, or after a preset time has elapsed since rising to the upper end position 406 of the hemostatic material lifting track. After hemostasis is achieved at the puncture site, the hemostatic material holder 104 is removed from directly below the fingertip of the blood sampler's finger 10, which is placed in the finger rest 119, by the rotation of the turntable 106 by the rotation drive mechanism 115.

[0189] By limiting the timing of the descent of the hemostatic material holder 104 in this way, blood bleeding from the puncture site can be absorbed by the hemostatic material without falling from the puncture site, thus avoiding contamination of the turntable 106 and other components with blood. Furthermore, hemostasis at the puncture site can be performed over a longer period of time only when necessary due to a large amount of bleeding. Since unnecessary stopping periods can be shortened when the amount of bleeding is small, blood collection by the blood collection device 1 can be completed in a shorter time.

[0190] Furthermore, the procedures shown in Figures 12A, 12B, 12C, and 12D can be performed in the same manner not only for hemostasis using the hemostatic material holder 104, but also for protection using the protective material holder 105. The lower end position of the protective material lifting track can be set so that, in a plan view, the puncture site is located inside the contour line of the absorbent cloth of the protective material, and the center of the absorbent cloth is close to the puncture site. The upper end position of the protective material lifting track can be set to a height where the puncture site on the surface of the fingertip and the protective material held in the protective material holder 105 come into contact with each other.

[0191] Figure 13 is a flowchart illustrating the operation of the hemostasis and protection processes in the blood collection device. As shown in Figure 13, the hemostasis operation by the blood collection device 1 can be performed under conditions corresponding to the bleeding rate. The hemostatic material holder 104 constitutes a hemostatic mechanism that presses a hemostatic material to the puncture site to stop bleeding. The protective material holder 105 constitutes a protective mechanism that presses a protective material to the puncture site to protect it.

[0192] In blood collection using the blood collection device 1, when blood is collected from the puncture site into the blood collection tube (step S305), the fingertip image acquisition mechanism (109, 117) may be used to continuously monitor the area around the puncture site on the blood subject's finger 10 and acquire a fingertip image of the blood bleeding from the puncture site. The fingertip image can be used to measure the amount of blood bleeding from the puncture site, etc.

[0193] The lifting drive mechanism 107 may repeatedly perform an action to bring the blood in contact with the puncture site and the hemostatic material into contact with each other and then separate them a predetermined number of times when hemostasis is performed at the puncture site (step S306). The number of times such an action is repeated can be changed according to the bleeding rate calculated based on the measurement result of the amount of blood bled from the puncture site.

[0194] When stopping bleeding at a puncture site, first, the hemostatic material holder 104 is moved to the lower end position 405 of the hemostatic material lifting track (step S1301). The control mechanism 114 controls the rotation drive mechanism 115 to rotate the turntable 106 by a predetermined rotation angle so that the position of the hemostatic material in a plan view coincides with the puncture position.

[0195] Next, the hemostatic material holder 104 is moved to the upper end position 406 of the hemostatic material lifting track (step S1302). The control mechanism 114 controls the lifting drive mechanism 107 to raise the hemostatic material holder 104 to a height where the hemostatic material is pressed against the puncture site on the fingertip. When the hemostatic material is pressed against the puncture site on the fingertip, it absorbs the blood bleeding from the puncture site and stops the bleeding.

[0196] Next, the hemostatic material holder 104 is moved to the lower end position 405 of the hemostatic material lifting track (step S1303). The control mechanism 114 controls the lifting drive mechanism 107 to lower the hemostatic material holder 104 onto the turntable 106.

[0197] Next, it is determined whether the bleeding rate is below a preset threshold Rh (step S1304). The bleeding rate can be determined by the control mechanism 114 by comparing the measured bleeding rate with the threshold Rh. The bleeding rate determination confirms the tendency for hemostasis at the puncture site. By comparing the bleeding rate with the threshold Rh, it is possible to determine whether hemostasis at the puncture site has been completed. The threshold Rh for the bleeding rate can be set to an upper limit of the bleeding rate at which hemostasis is classified as strong and hemostatic material such as gauze is not required.

[0198] If the judgment determines that the bleeding rate is above the threshold Rh (step S1304; No), it can be determined that hemostasis at the puncture site is not complete, and the process is returned to step S1302. In this case, a large amount of blood is bleeding from the puncture site, and the blood that has bled from the puncture site is likely to fall off the surface of the skin, so hemostasis at the puncture site is repeated with hemostatic material. In this case, a warning that hemostasis at the puncture site is insufficient can be displayed by the display mechanism 113.

[0199] On the other hand, if the result of the assessment determines that the bleeding rate is less than the threshold Rb (step S1304; Yes), it can be determined that hemostasis at the puncture site is complete, and the process proceeds to step S1305. In this case, since there is little blood bleeding from the puncture site and the blood that does bleed from the puncture site is unlikely to fall off the surface of the skin, the process moves to a protective action to protect the puncture site with a protective material. In this case, the display mechanism 113 can indicate that hemostasis at the puncture site is complete.

[0200] Next, the protective material holder 105 is moved to the lower end position of the protective material lifting track (step S1305). The control mechanism 114 controls the rotation drive mechanism 115 to rotate the turntable 106 by a predetermined rotation angle so that the position of the protective material in a plan view coincides with the puncture position.

[0201] Next, the protective material holder 105 is moved to the upper end position of the protective material lifting track (step S1306). The control mechanism 114 controls the lifting drive mechanism 107 to raise the protective material holder 105 to a height where the protective material can be pressed against the puncture site on the fingertip. When the protective material is pressed against the puncture site on the fingertip, it adheres to cover the puncture site and protects it.

[0202] Next, the protective material holder 104 is moved to the lower end position of the protective material lifting track (step S1307). The control mechanism 114 controls the lifting drive mechanism 107 to lower the protective material holder 105 onto the turntable 106. After lowering onto the turntable 106, the protective material holder 104 is discharged from directly below the fingertip by the rotation of the turntable 106 by the rotation drive mechanism 115.

[0203] In this hemostasis process, when the bleeding rate, which is the change in the amount of blood bleeding from the puncture site over time, exceeds a preset threshold Rh, the hemostatic action by the hemostatic material holder 104 is re-executed. By repeatedly raising and lowering the hemostatic material holder 104, the surface area of ​​the blood that has come into contact with the puncture site and the blood adhering to the hemostatic material can be increased, thereby promoting drying. Because the blood can be wiped away in a state where drying has been promoted, the blood bleeding from the puncture site can be coagulated or dried, and bleeding at the puncture site can be stopped quickly.

[0204] According to the blood collection device and method described above, the elevation of the blood collection tube holders 102 and 103 is performed when the size of the blood bled from the puncture site exceeds a preset threshold. The blood droplet formed at the puncture site is transferred from the puncture site to the blood collection tube in a short time after puncture, and the puncture site and the bled blood are separated from each other in a short time, thus preventing the blood from coagulating.

[0205] Furthermore, with the blood collection device and method described above, the descent of the blood collection tube holders 102 and 103 is performed within a short time after they rise. This minimizes the time that the blood in contact with the puncture site and the inner surface of the blood collection tube are in contact with each other, thereby preventing the blood in contact with the puncture site from spreading thinly and thus preventing the bleeding blood from drying out.

[0206] Furthermore, with the above blood collection device and method, the blood collection operation switches to bleeding mode according to the bleeding rate, thus preventing blood bleeding from the puncture site from falling off the skin surface to a location other than the blood collection tube, or from splattering into the surrounding area. By indirectly detecting when blood bleeding from the puncture site falls off the skin surface, a warning can be issued to the person being collected for blood collection and the operator of the blood collection device 1, thereby preventing infections transmitted through the fallen blood.

[0207] Furthermore, with the blood collection device and method described above, the hemostatic material holder 104 rises when the bleeding rate, which is the change in the amount of blood bleeding from the puncture site over time, exceeds a preset threshold. Because the blood bleeding from the puncture site can be reliably wiped away, bleeding at the puncture site can be stopped quickly. Therefore, infections transmitted through blood adhering to the surrounding area can be prevented.

[0208] Although embodiments of the present invention have been described above, the present invention is not limited to the embodiments described above, and various modifications are possible without departing from the spirit of the invention. For example, the present invention is not necessarily limited to having all the configurations of the embodiments described above. Some configurations of one embodiment may be replaced with other configurations, some configurations of one embodiment may be added to other forms, or some configurations of one embodiment may be omitted.

[0209] For example, in the bleeding mode described above, the bleeding rate is determined using the blood volume measurement mechanism 118, but the bleeding rate may also be determined using fingertip images acquired by the fingertip image acquisition mechanisms (109, 117). In this case, it is preferable to install the fingertip external appearance imaging device 109 in a location where blood bleeding from the puncture site and blood flowing into the blood collection tube can be reliably photographed.

[0210] Furthermore, although the aforementioned fingertip image acquisition mechanism (109, 117) is composed of a fingertip appearance imaging device 109 and a fingertip imaging light source 117, the installation of the fingertip imaging light source 117 may be omitted if external light or the like can be used.

[0211] Furthermore, although the aforementioned blood loss measurement mechanism is composed of a fingertip image acquisition mechanism (109, 117) and a blood collection volume measurement mechanism 118, an optical sensor that detects transmitted light that has passed through the blood or reflected light that has been reflected by the blood may also be used as the blood loss measurement mechanism that measures the amount of blood that has bled from the puncture site where the puncture needle has been inserted. The amount of blood can also be measured based on the two-dimensional distribution of light intensity detected by the optical sensor or the amount of light which is the integral amount within a predetermined range.

[0212] 1. Blood collection device 10. Finger of the person receiving blood 106. Turntable 107. Lifting and lowering drive mechanism (drive mechanism) 108. Infrared light imaging device (vascular image acquisition mechanism) 109. Fingertip appearance imaging device (fingertip image acquisition mechanism) 112. Compression mechanism 113. Display mechanism 114. Control mechanism 115. Rotation drive mechanism (drive mechanism) 116. Near-infrared light source (vascular image acquisition mechanism) 117. Light source for fingertip imaging (fingertip image acquisition mechanism) 118. Blood volume measurement mechanism 119. Finger rest

Claims

1. A blood collection device comprising: a lancing device for puncturing the finger of a person to be given blood; a container for collecting blood bled from the puncture site where the lancing device was inserted; a blood volume measurement mechanism for measuring the amount of blood bled from the puncture site; and a drive mechanism for changing the relative position of the lancing device and the container with respect to the puncture site, wherein the drive mechanism repeatedly drives an operation to bring the blood in contact with the puncture site and the inner surface of the container into contact with each other and then separate them a predetermined number of times when collecting blood, and the number of times the operation is repeated is changed according to the bleeding rate calculated based on the measurement result measured by the blood volume measurement mechanism.

2. A blood collection device according to claim 1, wherein the bleeding volume measurement mechanism is an image acquisition mechanism that acquires an image of the blood bleeding from the puncture site, and the bleeding rate is calculated based on the size of the blood in the image acquired by the image acquisition mechanism.

3. A blood collection device according to claim 1, wherein the bleeding volume measurement mechanism is a blood collection volume measurement mechanism that measures the amount of blood collected in the container from the puncture site, and the bleeding rate is calculated based on the measurement result measured by the blood collection volume measurement mechanism.

4. A blood collection device according to claim 1, comprising a control mechanism for determining abnormalities in blood collection, wherein the control mechanism determines, based on the bleeding rate, whether or not the blood bled from the puncture site has fallen off the surface of the skin.

5. A blood collection device according to claim 4, comprising a display mechanism for displaying information relating to blood collection, wherein the display mechanism displays a warning indicating that an abnormality in blood collection has occurred when it is determined that blood bleeding from the puncture site has fallen from the surface of the skin.

6. A blood collection device according to claim 1, comprising: a hemostatic mechanism for pressing a hemostatic material for stopping bleeding at a puncture site against the puncture site; and a drive mechanism for changing the relative position of the hemostatic mechanism with respect to the puncture site, wherein the drive mechanism repeatedly drives an operation to bring the blood in contact with the puncture site and the hemostatic material into contact with each other and then separate them for a predetermined number of times when stopping bleeding at the puncture site.

7. A blood collection device according to claim 6, comprising a control mechanism for determining abnormalities in blood collection, wherein the control mechanism determines whether or not hemostasis at the puncture site has been completed based on the measurement results measured by the blood loss measurement mechanism.

8. A blood collection device according to claim 7, comprising a display mechanism for displaying information relating to blood collection, wherein the display mechanism displays a warning indicating that hemostasis is insufficient when it is determined that hemostasis at the puncture site has not been completed.

9. A blood collection method comprising: a puncture step of inserting a puncture needle into the finger of a person to be blood collected; a compression step of applying pressure to the finger; and a blood collection step of collecting blood bled from the puncture site into a container, wherein in the blood collection step, the action of bringing the blood in contact with the puncture site and the inner surface of the container into contact with each other and then separating them is repeatedly performed a predetermined number of times, and the number of times the action is repeated is changed according to the bleeding rate calculated based on the measurement result of the amount of blood bleeding from the puncture site.

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