[go: up one dir, main page]

WO2025063019A1 - Dispositif et procédé de prélèvement de sang - Google Patents

Dispositif et procédé de prélèvement de sang Download PDF

Info

Publication number
WO2025063019A1
WO2025063019A1 PCT/JP2024/031314 JP2024031314W WO2025063019A1 WO 2025063019 A1 WO2025063019 A1 WO 2025063019A1 JP 2024031314 W JP2024031314 W JP 2024031314W WO 2025063019 A1 WO2025063019 A1 WO 2025063019A1
Authority
WO
WIPO (PCT)
Prior art keywords
blood collection
blood
collection tube
information
tube
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/JP2024/031314
Other languages
English (en)
Japanese (ja)
Inventor
美樹 滝
雅弘 加藤
隆史 入江
公一 杉山
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Hitachi High Tech Corp
Original Assignee
Hitachi High Tech Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Hitachi High Tech Corp filed Critical Hitachi High Tech Corp
Publication of WO2025063019A1 publication Critical patent/WO2025063019A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/153—Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
    • A61B5/154—Devices using pre-evacuated means
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G01N1/02—Devices for withdrawing samples
    • G01N1/10—Devices for withdrawing samples in the liquid or fluent state
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/40—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis

Definitions

  • Blood collection work involves many types of complicated tasks and work, and is one of the tasks that places a large burden on workers, so it is desirable to automate it as much as possible.
  • Blood collection devices that automatically collect blood are required to have the function of checking the prepared collection tubes and the function of collecting appropriate blood for each sample and type of collection tube. It is desirable to optimize the type of collection tube used, the amount of blood collected, the time of collection, and the order in which blood is collected.
  • the blood collection method is characterized in that it prepares a database of required blood collection volume information indicating the required blood collection volume for each type of blood collection tube to be collected from a blood collection subject into a blood collection tube, maximum blood collection time information indicating the maximum blood collection time for each type of blood collection tube, which is the upper limit of the time required from the start to the end of blood collection into a blood collection tube, blood collection tube information indicating the type of blood collection tube, and test item information indicating the test items of the blood test to be performed after blood collection, reads a specimen ID for identifying the specimen to be collected into the blood collection tube and blood collection tube information indicating the type of blood collection tube from the blood collection tube, reads the required blood collection volume information and the maximum blood collection time information corresponding to the specimen ID and the blood collection tube information read from the blood collection tube from the database and sets them as the parameters for each specimen and each type of blood collection tube, reads the test item information from the database and sets the blood collection order for multiple blood collection tubes of different types, and collects blood so as
  • FIG. 10 is a flowchart showing a process flow in a preparation operation of the blood sampling device.
  • 10 is a flowchart showing a process flow in a blood sampling operation of the blood sampling device.
  • FIG. 13 is a diagram showing an example of a matching result image showing the matching result of the sample ID read from the blood collection tube.
  • FIG. 13 is a diagram showing an example of a blood collection result image showing the result of blood collection into a blood collection tube.
  • FIG. 1 is a diagram showing an example of a blood collection system incorporating a blood collection device.
  • FIG. 1 is a diagram showing a blood collection method using a blood collection device incorporated in a blood collection system.
  • FIG. 1 is a diagram for explaining a method for calculating the required amount of blood to be collected from a subject into a blood collection tube.
  • FIG. 1 is a diagram showing a blood collection method using a blood collection device according to an embodiment of the present invention.
  • FIG. 1 shows an overview of the preparation operations performed before starting a blood collection operation.
  • Steps S101 and S102 are processes performed by the user of the blood collection device.
  • Steps S103 to S108 are processes performed automatically by the blood collection device.
  • a blood collection tube to which a sample ID and blood collection tube information have been assigned in advance is used.
  • the sample ID is information for identifying the sample to be collected in the blood collection tube.
  • the blood collection tube information is information indicating the type of blood collection tube. The blood collected in the blood collection tube as a sample is classified according to the subject and the date of collection.
  • the blood collection parameters are parameters that stipulate the blood collection conditions for each type of blood collection tube.
  • the blood collection operation is controlled according to the blood collection parameters set in the preparation operation.
  • the blood collection parameters set include the required amount of blood to be collected from the subject into a blood collection tube and the maximum blood collection time, which is the upper limit of the time required from the start to the end of blood collection into a blood collection tube.
  • the blood collected in a blood collection tube can be used for blood tests.
  • blood tests There are various types of blood tests. These include blood count tests to measure the amount and size of red blood cells, white blood cells, platelets, etc.; biochemical tests to measure the amount of protein and lipids in the blood; immunological tests to measure infections, allergies, hormones, tumor markers, etc.; blood glucose tests to measure blood sugar levels, hemoglobin A1c levels, etc.; and electrolyte tests to measure various blood ions.
  • Blood collection tubes containing an anticoagulant are used for blood counts and blood glucose tests. Blood collection tubes containing a coagulation promoter or plain tubes without an anticoagulant are used for biochemical and immunological tests. After the blood collected in a blood collection tube clots inside the tube, it is centrifuged to separate the blood cell components and serum, and then each component is subjected to analysis.
  • Anticoagulants include sodium citrate, EDTA, sodium fluoride, and heparin.
  • sodium citrate is used for coagulation and fibrinolysis tests
  • EDTA for blood count tests
  • sodium fluoride for blood glucose tests
  • heparin for electrolyte tests and pH measurements.
  • anticoagulants may have effects such as inhibiting the test drug. Therefore, it is necessary to use different anticoagulants depending on the test item.
  • the sample ID is information used to identify the sample to be collected in a blood collection tube, and is assigned to each individual blood collection tube used for blood collection.
  • Information used to identify the sample includes information used to identify the recipient of the blood collection and information used to identify the date the blood was collected.
  • the sample ID can be, for example, a combination of a code used to identify the recipient and a code used to identify the date the blood was collected.
  • the individual blood collection tube installed in the blood collection device can be matched with the pre-registered registration information for each blood collection recipient and blood collection date by reading the sample ID. This prevents mix-ups between individual blood collection tubes, making it possible to collect samples from each individual blood collection tube that correspond to the correct recipient and blood collection date.
  • the blood collection tube information is information indicating the type of blood collection tube, and is assigned to each type of blood collection tube used for blood collection.
  • the type of blood collection tube installed in the blood collection device can be compared with the parameters that stipulate the blood collection conditions for each type of blood collection tube that are registered in advance by reading the blood collection tube information. This prevents mix-ups of blood collection tube types, allowing blood to be collected under appropriate blood collection conditions for each type of blood collection tube.
  • the user of the blood collection device places a collection tube in a holder of the blood collection device (step S101).
  • the blood collection device is provided with a holder that can hold multiple collection tubes.
  • the number and type of collection tubes to be placed in the holder are determined according to the test items of the blood test to be performed after blood collection.
  • the number and type of collection tubes are specified by registration information for each blood recipient and each blood collection date.
  • the user of the blood collection device notifies the blood collection device that the collection tube has been placed and that blood collection has begun (step S102).
  • the user of the blood collection device switches the device or performs operations on the image to instruct the blood collection device to prepare for blood collection.
  • the blood collection device accepts the input of the instruction, it begins the specified preparation operations.
  • the blood collection device detects whether the cover covering the holder is closed and whether there is a blood collection tube in the holder. For example, the blood collection device can determine whether at least one blood collection tube is placed in the holder to prevent the user from forgetting to place a blood collection tube.
  • step S104 the information attached to the blood collection tube is read (step S104).
  • the blood collection device checks the operation of each device, reads the sample ID and blood collection tube information attached to the blood collection tube, and determines whether the reading was completed successfully.
  • step S104 If the information attached to the blood collection tube is read correctly (step S104; YES), the information attached to the blood collection tube is verified (step S105).
  • the blood collection device verifies the read information against the registered information, and compares the sample ID and blood collection tube information read from the blood collection tube with the registered information registered in the database.
  • step S105 If the read information matches the registered information (step S105; YES), parameters related to blood collection are set based on the information read from the blood collection tube (step S106).
  • the blood collection device reads parameters corresponding to the sample ID and blood collection tube information read from the blood collection tube from the database. The read parameters are then set as blood collection conditions for each sample and each type of blood collection tube.
  • the blood collection order for the different types of blood collection tubes is set based on the information read from the blood collection tubes (step S107).
  • the blood collection device reads out registered information corresponding to the registered test items from the database. Then, based on the registered information, the blood collection order for the different types of blood collection tubes is determined, and the result of this determination is set as the condition for the blood collection order.
  • step S108 the user of the blood collection device is warned of the abnormality.
  • the blood collection device can warn of the occurrence of an abnormality by displaying a warning image or emitting a warning sound. The preparation operation and blood collection operation can be suspended until the abnormality is corrected.
  • blood collection parameters and blood collection order are set as control conditions for the blood collection unit, which collects blood from the subject into a collection tube.
  • the blood collection unit collects blood from the subject in accordance with the settings of the control conditions for the blood collection operation so as to satisfy the set blood collection parameters and blood collection order.
  • the read information read from the blood collection tube is compared with the registered information that has been registered in advance, and blood collection parameters and the blood collection order that correspond to the read information are set. Since preparation and confirmation work is carried out automatically before blood collection, and appropriate blood collection conditions are automatically set for each sample and type of blood collection tube, the work involved in blood collection is reduced, enabling accurate blood collection.
  • FIG. 2 is a diagram showing a blood collection tube housed in an outer tube used for blood collection.
  • the left figure shows a state in which a barcode label is not attached, and the right figure shows a state in which a barcode label is attached.
  • a blood collection tube 201 can be installed in a blood collection device while being housed in an outer tube 202.
  • the outer tube 202 is used for the purpose of adjusting the size of an object to the installation location of the blood collection tube 201.
  • the blood collection tube 201 is formed in a cylindrical shape with an open top and a closed bottom.
  • a micro blood collection tube with a capacity of about several hundred ⁇ L is used as the blood collection tube 201.
  • the outer tube 202 is formed in a cylindrical shape with an open top and a closed bottom, with inner and outer diameters larger than those of the blood collection tube 201.
  • the blood collection tube 201 and the outer tube 202 can be formed from a light-transmitting material.
  • the blood collection tube 201 is supported on the inside of the opening side of the outer tube 202.
  • the opening of the outer tube 202 is covered with a cap 203 to prevent the intrusion of foreign matter and to prevent the contents from scattering and leaking.
  • the cap 203 is removed when the outer tube 202 is installed in the blood collection device.
  • a barcode label 204 can be attached to the outer tube 202.
  • the sample ID and blood collection tube information can be recorded as a barcode on the barcode label 204.
  • the barcode label 204 may be attached to the outer tube 202 or to the blood collection tube 201 as long as it can be read from the outside.
  • a code of about 10 digits can be recorded.
  • a barcode for example, a combination of a sample ID code that identifies the sample and a blood collection tube information code that identifies the type of blood collection tube can be recorded.
  • a sample ID code a combination of a code that identifies the recipient and a code that identifies the blood collection date can be recorded.
  • the specimen ID and blood collection tube information can be attached by any suitable method, such as printing a barcode, attaching a two-dimensional code label, printing a two-dimensional code, attaching a data matrix code label, printing a data matrix code, embedding an IC chip, etc.
  • the specimen ID and blood collection tube information may be attached to the outer tube 202 or the blood collection tube 201, as long as they can be read from the outside.
  • FIG. 3 is a top view of the inside of an example of a blood collection device according to an embodiment of the present invention.
  • FIG. 4 is a side view of the inside of an example of a blood collection device according to an embodiment of the present invention.
  • FIGS. 3 and 4 show, as an example of a blood collection device, a finger blood collection device that collects blood from the fingers of a subject.
  • the blood collection device includes a plurality of holders 302, a turntable 303, a puncture module 304, hemostasis modules 305 and 306, a reader 307, a blood collection tube sensor 308 that detects the presence or absence of a blood collection tube, a rotation drive mechanism 309, a lifting mechanism (not shown) that raises and lowers the holder 302 and modules 304, 305, and 306, a blood collection amount sensor 316 that measures the amount of blood collected into the blood collection tube during blood collection, a cuff mechanism (not shown) that applies pressure to the fingers of the person to be blood-collected, and a pressure adjustment mechanism (not shown) that drives the cuff mechanism.
  • the holder 302 is provided in a structure in which the blood collection tube 301 is inserted and supports the blood collection tube 301 from the periphery.
  • a total of three holders 302A, 302B, and 302C are provided.
  • the multiple holders 302 are arranged at intervals from each other along the circumferential direction of the turntable 303.
  • blood collection tubes 301 are placed in each holder 302 depending on the test items specified by the test order.
  • outer tubes containing blood collection tubes can be placed as blood collection tubes 301.
  • Blood collection tubes can include blood count test blood collection tubes and biochemistry/immunology test blood collection tubes.
  • the blood collection tubes 301 can be placed in any arrangement in the multiple holders 302, regardless of the recommended blood collection order.
  • the turntable 303 supports multiple holders 302 and modules 304, 305, and 306, and is configured to be freely rotatable around a vertical axis of rotation.
  • the turntable 303 is formed roughly in a disk shape, and is supported inside the blood collection device with its main surface facing up and down.
  • the turntable 303 has multiple sections where parts of the outer periphery are cut out facing inward.
  • the turntable 303 has multiple holding holes that penetrate from top to bottom.
  • the cutouts and holding holes of the turntable 303 are regularly spaced apart along the circumferential direction of the turntable 303.
  • the holder 302 is placed in the cutouts of the turntable 303 so that it can be inserted from above and below.
  • the puncture module 304 and hemostasis modules 305 and 306 are held in the holding holes of the turntable 303 so that they can be inserted from above and below.
  • the upper part of the holder 302 is supported by support parts 310 (310A, 310B, 310C) provided on the upper and central side of the turntable 303.
  • a rotation axis parallel to the diameter line of the turntable 303 is formed on the support parts 310.
  • the holder 302 is provided so as to be freely rotatable around the rotation axis formed on the support parts 310.
  • the holder 302 can be tilted so that the lower side opens outward by rotating relative to the support parts 310.
  • the puncture module 304 and the multiple hemostatic modules 305, 306 are detachably attached to the turntable 303.
  • Each module 304, 305, 306 is formed with a flange-like portion whose diameter is larger than the inner diameter of the holding hole.
  • Each module 304, 305, 306 is inserted into the holding hole and the flange-like portion is supported from below, so that the module is held in a state in which it can be raised and lowered within the holding hole.
  • a puncture device is attached to the puncture module 304.
  • the puncture device has a built-in puncture needle (lancet).
  • a hemostatic material such as gauze and a protective material such as bandage are attached to each of the multiple hemostatic modules 305, 306.
  • the puncture needle When the puncture device is pressed against the subject's finger, the puncture needle extends and punctures the subject.
  • the hemostatic material such as gauze is pressed against the puncture site of the subject and absorbs blood that has bled from the puncture site to stop the bleeding.
  • a protective material such as bandage is pressed and attached against the puncture site of the subject to stop the bleeding and protect the puncture site.
  • the turntable 303 is supported for free rotation by a rotation drive mechanism 309.
  • the turntable 303 can rotate in both clockwise and counterclockwise directions around a rotation axis passing through the center of the main surface.
  • the turntable 303 is controlled to rotate a predetermined step angle in accordance with the blood collection operation or treatment operation.
  • the movement of the multiple holders 302, the puncture module 304, and the multiple hemostasis modules 305 and 306 to predetermined stopping positions is controlled by the rotation of the turntable 303.
  • the holder 302A is stopped at the blood sampling position.
  • the holder 302B is stopped at the standby position.
  • the holder 302C is stopped at the measurement position.
  • a finger rest (not shown) is provided above the blood collection position.
  • a disposable finger rest part is attached to the finger rest.
  • the finger of the person to be blood-collected is placed on the finger rest part, which has a window-like opening in the center.
  • the puncture needle by the puncture module 304, hemostasis using a hemostatic material by the hemostatic module 305, and application of a protective material by the hemostatic module 306 are performed in this order by the rotation of the turntable 303.
  • the blood that flows out of the finger after puncturing is collected in a blood collection tube that has been moved to the blood collection position.
  • the holder 302 supported by the turntable 303 can include a rotation mechanism (not shown) that rotates the blood collection tube 301 placed in the holder 302, a tilt mechanism (not shown) that tilts the holder 302, and a lifting mechanism (not shown) that raises and lowers the blood collection tube 301 placed in the holder 302.
  • the rotation mechanism is placed at the measurement position.
  • the tilt mechanism and the lifting mechanism are placed at the blood collection position.
  • the holder 302 is provided in a structure that exposes the side of the blood collection tube 301 to the side.
  • a rotation mechanism (not shown) equipped with a roller-type pad or the like can be installed to the side of the measurement position. The rotation mechanism is driven to move so as to come into contact with the exposed side of the blood collection tube 301. Then, a rotational motion is driven to rotate the pad or the like in contact with the side. The frictional force generated by the rotational motion causes the blood collection tube 301 to rotate around its central axis.
  • the blood collection tube may be one that has a protrusion 311 formed at the top opening.
  • the protrusion 311 protrudes upward from a portion of the circumference of the top opening of the blood collection tube.
  • the protrusion 311 forms a receptacle-like scoop on one side of the opening.
  • the protrusion 311 becomes receptacle-like so as to easily receive droplets.
  • the orientation around the central axis of the blood collection tube 301 can be adjusted by a rotation mechanism so that the protrusion 311 faces a specified direction.
  • a guide 315 that constitutes a tilting mechanism for tilting the holder 302 is provided below the blood collection position.
  • the guide 315 is tilted from the inside and upper side of the turntable 303 toward the outside and lower side.
  • the guide 315 is located closer to the center than the outer periphery of the turntable 303, and extends in an arc like the turntable 303.
  • holder 302 moves to the blood collection position by rotating turntable 303, it moves along guide 315 and tilts so that the lower side opens outward.
  • blood collection tube 301 placed in holder 302 also tilts, and the opening of the blood collection tube is tilted inward and upward.
  • blood that has been punctured is more likely to be received by protrusion 311 and to flow down the inner surface of the tilted blood collection tube. Blood droplets are less likely to remain at the puncture site, improving blood collection.
  • a lifting mechanism (not shown) that raises and lowers the blood collection tube 301 and modules 304, 305, and 306 placed in the holder 302.
  • the lifting mechanism is provided with a movable support member below the turntable 303 at the blood collection position for supporting the blood collection tube 301 and modules 304, 305, and 306 placed in the holder 302 from below.
  • the vertical movement of the movable support member is controlled according to the blood collection operation and the treatment operation related to blood collection.
  • the blood collection tube 301 and modules 304, 305, and 306 mounted on the holder 302 are moved to the blood collection position by the rotation of the turntable 303, they can move up and down relative to the finger placement area by being pushed up from below by the rise of the movable support member, and pulled down by the fall of the movable support member.
  • the blood collection tube is pressed against the puncture site, the puncture needle is inserted into the subject's finger, and a hemostatic material or protective material is pressed against the puncture site.
  • a reader 307 is installed to the side of the measurement position.
  • the reader 307 is a device that reads information attached to the blood collection tube from the blood collection tube.
  • the reader 307 targets the blood collection tube 301 that has been moved to the measurement position, and performs operations such as reading barcode information and IC information depending on the format in which the information is written.
  • the reader 307 can be an optical reader such as a CCD image sensor or a laser scanner, or an RFID reader that receives electromagnetic waves.
  • the reader 307 may also have the function of a detection means that detects the presence or absence of a blood collection tube in the holder.
  • a blood collection tube sensor 308 is installed to the side of the turntable 303.
  • the blood collection tube sensor 308 is a sensor that detects the presence or absence of a blood collection tube in the holder 302. By detecting the presence or absence of a blood collection tube in the holder 302 with the blood collection tube sensor 308, it is possible to prevent forgetting to place a blood collection tube in the blood collection device.
  • a blood collection amount sensor 316 is installed near the blood collection position.
  • the blood collection amount sensor 316 is a sensor that measures the amount of blood collected into the blood collection tube.
  • the blood collection amount sensor 316 measures the light intensity of reflected light, scattered light, and transmitted light from the blood collected in the blood collection tube 301 during blood collection, and measures the amount of blood collected in the blood collection tube.
  • the blood collection volume sensor 316 can be composed of a light source that irradiates light toward the blood collection tube 301, and an optical sensor that detects reflected light, scattered light, and transmitted light from the irradiated light.
  • the light source can be of any suitable type, such as a laser light source or an LED.
  • the optical sensor can be a photodiode or a photodiode array. The light source and the optical sensor can be integrally disposed in the same location, or can be disposed separately in different locations.
  • the blood collection volume sensor 316 can be positioned to irradiate light from the side of the blood collection tube 301A stopped at the blood collection position.
  • the light intensity of the reflected light, scattered light, or transmitted light changes depending on whether blood is present or not. Therefore, by measuring the light intensity of the reflected light, scattered light, or transmitted light, a signal correlating to the level or volume of the blood collected in the blood collection tube can be obtained.
  • the volume of blood collected in the blood collection tube can be calculated based on the measurement result of the level of the blood collected in the blood collection tube and blood collection tube information indicating the shape and inner diameter of the blood collection tube. Alternatively, it can be calculated by measuring a calibration curve with a known volume of liquid in advance.
  • the height of the blood level collected in the blood collection tube can be determined, for example, by measuring the change in light intensity over time at a specified height in the blood collection tube and deriving the time when the blood level passes the specified height. Alternatively, it can be determined by detecting the blood level collected in the blood collection tube from the horizontal direction and deriving the detection height when the blood level is detected.
  • the blood collection tube 301 can be raised and lowered relative to the blood collection volume sensor 316 by a mechanism similar to the lifting mechanism that raises and lowers each of the modules 304, 305, and 306.
  • the blood collection volume sensor 316 can be supported on a stand that can move up and down and raised and lowered relative to the blood collection tube 301.
  • the level of the blood collected in the blood collection tube may be detected from a horizontal direction, or from a direction inclined relative to the liquid level.
  • the height of the blood level in the blood collection tube can be found by detecting both ends of the liquid level along the tilt direction from above or below the liquid level, and deriving the time when both ends of the liquid level pass from the change in light intensity.
  • FIG. 5 shows an example of blood collection tube information and operational parameters related to blood collection.
  • FIG. 5 shows an example of blood collection tube information provided to a blood collection tube used in a blood collection device, and an example of operational parameters related to blood collection, such as required blood collection volume information and maximum blood collection time information linked to the blood collection tube information.
  • a blood collection tube container code can be assigned to each type of blood collection tube to identify the type of blood collection tube.
  • the blood collection tube container code is A01
  • the blood collection tube is used for a blood count test
  • the manufacturer of the blood collection tube is Company A
  • the required blood collection volume is 230 ⁇ L
  • the maximum blood collection time is 60 seconds.
  • the type of blood collection tube used for blood collection will differ, and the required blood collection volume and maximum blood collection time will also differ. This is because the required blood volume differs depending on the test item, and the time it takes for blood to clot differs depending on the type of blood collection tube.
  • the shape of the bottom of the blood collection tube and the size of the inner diameter of the blood collection tube vary depending on the manufacturer and model number.
  • the blood collection operation of collecting blood from the subject into a blood collection tube is controlled so as to satisfy the blood collection parameters.
  • the blood collection parameters are set for each specimen to be collected into a blood collection tube and for each type of blood collection tube.
  • the blood collection parameters set include the required blood collection volume for each type of blood collection tube to be collected from the subject into a blood collection tube, and the maximum blood collection time for each type of blood collection tube, which is the upper limit of the time required from the start to the end of blood collection into a blood collection tube.
  • FIG. 6 is a diagram showing an example of blood collection order information.
  • FIG. 6 shows an example of blood collection order information indicating the order in which blood should be collected into multiple different types of blood collection tubes when blood is designated to be collected from the same blood subject into multiple blood collection tubes.
  • tissue fluids are more likely to be mixed into the drawn blood due to cell damage caused by the puncture, which makes it easier for blood clotting to progress.
  • tissue fluids are more likely to be mixed into the drawn blood due to cell damage caused by the puncture, which makes it easier for blood clotting to progress.
  • the amount of bleeding and bleeding pressure will decrease, so it will take longer to draw blood and blood clotting will be more likely to progress.
  • the first blood collection tube from which blood is collected for applications in which blood clotting is acceptable, such as biochemical tests and immunological tests that use serum. Also, blood count tests and the like require non-clotted blood, so it is preferable to use the second or subsequent blood collection tubes early on.
  • the blood collection device controls the blood collection operation of collecting blood from the subject into collection tubes so as to fulfill a predetermined blood collection order.
  • the blood collection order is set for each sample to be collected into the collection tube.
  • the blood collection order is determined according to predetermined blood collection guidelines depending on the type of test item. Examples of blood collection guidelines include the Standard Blood Collection Guideline GP4-A3 (issued by the Japan Committee for Clinical Laboratory Standards).
  • blood collection device 100 includes a reader 307, a detection unit (collection tube sensor) 308, a measurement unit (collected blood amount sensor) 316, a control unit 10, an input unit 20, a display unit 30, a communication unit 40, a processing unit 50, a storage unit 60, a blood collection unit 70, and a turntable unit 80.
  • the control unit 10, the input unit 20, the display unit 30, the communication unit 40, the processing unit 50, and the storage unit 60 may be built into the main body of the blood collection device, or may be provided in an external computer.
  • a reader 307 reads the sample ID and blood collection tube information.
  • a blood collection tube sensor 308 constitutes a detection unit 308 that detects the installation status of the blood collection tube.
  • a blood collection amount sensor 316 constitutes a measurement unit 316.
  • a lifting mechanism equipped with a finger placement area, a cuff mechanism, a pressure adjustment mechanism, and a movable support member that raises and lowers the puncture module 304 and holder 302 constitutes a blood collection unit 70 that collects blood from a subject into a blood collection tube installed in a holder.
  • a turntable 303 and a rotation drive mechanism 309 constitute a turntable unit 80.
  • the control unit 10 executes processes according to programs, reads programs and data, etc., and controls operations related to blood collection, such as preparation operations of the blood collection device and blood collection operations.
  • the control unit 10 is composed of, for example, an arithmetic unit such as a CPU (Central Processing Unit) and storage devices such as a RAM (Random Access Memory) and a ROM (Read Only Memory).
  • the input unit 20 accepts input from a user of the blood collection device.
  • the input unit 20 is configured, for example, with a touch panel, various switches, etc.
  • the display unit 30 displays information related to blood collection and information related to the operation of the blood collection device.
  • Information related to blood collection includes information on the blood collection subject, blood collection conditions, blood collection progress, blood collection results, warnings, etc.
  • the display unit is composed of, for example, a touch panel, a liquid crystal display, an organic EL display, etc.
  • the communication unit 40 transmits and receives data to and from an external system. However, if the data necessary for blood collection is built into the blood collection device and data transmission and reception is not necessary, or if the data necessary for blood collection is input to the blood collection device by an external device, the communication unit 40 can be omitted.
  • the processing unit 50 performs various processes related to the preparation operation and blood collection operation.
  • the functions of the processing unit 50 are realized by the control unit 10 executing processes according to a program.
  • the processing unit 50 is configured with a matching unit 51 that matches data related to blood collection, a setting unit 52 that sets parameters related to blood collection, an order specifying unit 53 that specifies the blood collection order, a blood collection management unit 54 that manages the time required to collect blood into a collection tube and the amount of blood collected, etc.
  • the storage unit 60 stores various data and programs.
  • the storage unit 60 is configured, for example, with a storage device such as a semiconductor memory or a hard disk.
  • the storage unit 60 stores a blood collection subject registration information database 61 and a blood collection tube registration information database 62.
  • the blood recipient registration information database 61 is a collection of data on multiple blood recipient registration information. Blood recipient registration information is registered in advance for each blood recipient and for each blood collection date. Blood recipient registration information is information indicating the content of the blood collection, and includes a blood recipient ID that identifies the blood recipient, blood type information that indicates the blood type of the blood recipient, blood collection date information that indicates the date of blood collection, blood collection location information that indicates the location of blood collection, and test item information that indicates the type of test item of the blood test performed after blood collection.
  • the blood recipient ID is associated with blood type information, blood collection date information, blood collection location information, and test item information. The type of test item is specified by a test order. Test orders are input by doctors and medical staff.
  • the blood collection tube registration information database 62 is a collection of data for multiple blood collection tube registration information. Blood collection tube registration information is registered in advance for each type of blood collection tube.
  • the blood collection tube registration information includes blood collection tube information indicating the type of blood collection tube, required blood collection volume information indicating the required amount of blood that should be collected from the subject into the blood collection tube, and maximum blood collection time information indicating the maximum blood collection time, which is the upper limit of the time required from the start to the end of blood collection into the blood collection tube.
  • Required blood collection volume information and maximum blood collection time information are associated with the blood collection tube information.
  • the test item information and the blood collection tube information are associated with each other.
  • the type of blood collection tube from which blood should be collected and the number of blood collection tubes from which blood should be collected can be specified by the test item information associated with the blood collection tube information.
  • the blood collection tube information can also be stored in association with an order score or the like as blood collection order information that indicates the order in which blood should be collected from multiple blood collection tubes of different types.
  • a preparation operation is performed before the blood collection operation.
  • the processing in the preparation operation is performed by the reader 307, the detection unit 308, the processing unit 50, etc.
  • a blood collection subject registration information database 61 and a blood collection tube registration information database 62 are prepared in advance in the memory unit 60. These data can be input via the communication unit 40 or an external device.
  • FIG. 8 is a flow chart showing a process flow in the preparation operation of the blood sampling apparatus. As shown in FIG. 8, the reading and collation of information attached to the blood collection tube in the preparation operation (steps S104 and S105) and the management of the blood collection time and amount in the blood collection operation are performed in the following procedure.
  • step S103 when it is confirmed that the blood collection tubes have been properly placed (step S103; YES), the blood collection tubes placed in each holder 302 are moved sequentially to the measurement position by the rotation of the turntable 303. At the measurement position, the sample ID and blood collection tube information for each blood collection tube are read by the reader 307 (step S201).
  • the matching unit 51 matches the sample ID with the blood recipient ID for each blood collection tube placed in the holder (step S202).
  • the matching unit 51 compares the sample ID read from the blood collection tube with the blood collection recipient ID registered in the blood collection recipient registration information database 61 to determine whether the sample ID and the blood collection recipient ID correspond to each other.
  • Each holder in which a blood collection tube is placed can be given information that identifies its position. Reading of information and detection of the presence or absence of a blood collection tube are performed for each holder position.
  • step S202 If the sample ID corresponds to the blood recipient ID (step S202; YES), the process proceeds to step S203. On the other hand, if the sample ID does not correspond to the blood recipient ID (step S202; NO), the process proceeds to step S209.
  • the matching unit 51 then identifies the number and type of blood collection tubes (step S203). Based on the blood collection subject registration information database 61, the matching unit 51 identifies test item information associated with the matched blood collection subject ID, and based on the test item information, identifies the number of blood collection tubes from which blood should be collected and the type of blood collection tube from which blood should be collected. Matching result information showing the matching result between the sample ID and the blood collection subject ID can be displayed on the display unit 30 for confirmation by the user of the blood collection device.
  • the matching unit 51 matches the number of blood collection tubes placed in the holder (step S204).
  • the matching unit 51 compares the detection result of the presence or absence of blood collection tubes in the holder with the registered information indicating the number of blood collection tubes specified based on the test item information in the blood collection subject registration information database 61, and determines whether the detection result matches the registered number.
  • step S204 If the result of the determination regarding the number of blood collection tubes indicates that the detection result matches the registered number (step S204; YES), the process proceeds to step S205. On the other hand, if the detection result does not match the registered number (step S204; NO), the process proceeds to step S209.
  • the matching unit 51 matches the type of blood collection tube placed in the holder (step S205).
  • the matching unit 51 compares the blood collection tube information read by the reader 307 with the registered information indicating the type of blood collection tube specified based on the test item information in the blood collection subject registration information database 61, and determines whether the detection result matches the registered type. Matching of the blood collection tube type is performed for each holder position.
  • step S205 If the result of the determination regarding the type of blood collection tube is that the detection result matches the registered type (step S205; YES), the process proceeds to step S206. On the other hand, if the detection result does not match the registered type (step S205; NO), the process proceeds to step S209.
  • the setting unit 52 sets parameters related to blood collection as blood collection conditions for the blood collection unit 70 (step S206).
  • the setting unit 52 acquires blood collection tube registration information corresponding to the test item information, and reads out required blood collection volume information and maximum blood collection time information corresponding to the matched number and type of blood collection tubes from the database. Then, the setting unit 52 sets the required blood collection volume for each sample and type of blood collection tube and the maximum blood collection time for each sample and type of blood collection tube as parameters related to blood collection.
  • the order determination unit 53 determines the blood collection order into the multiple different types of blood collection tubes (step S207).
  • the blood collection order can be set by any appropriate method, such as a method of specifying an order in advance for each type of blood collection item, or a method of assigning an order score in advance to each type of blood collection tube and using the calculation results of the order score.
  • the order determination unit 53 sets the blood collection order corresponding to the number and type of blood collection tubes that have been matched, based on the test item information corresponding to the specimen ID read from the blood collection tube.
  • control unit 10 controls the blood collection unit 70, turntable unit 80, etc. to perform the blood collection operation into the blood collection tube according to the test item (step S208).
  • the control unit 10 collects blood so as to satisfy the required blood collection amount preset for each sample and each type of blood collection tube, and the maximum blood collection time preset for each sample and each type of blood collection tube. Furthermore, when blood collection into multiple blood collection tubes is specified, blood is collected so as to satisfy the blood collection order preset for each sample.
  • control unit 10 can cause the display unit 30 to display that the blood collection tubes installed in the blood collection device are appropriate.
  • step S202 if the sample ID and the recipient ID do not correspond (step S202; NO), if the detection result does not match the registered number (step S204; NO), or if the detection result does not match the registered type (step S205; NO), the control unit 10 displays a warning on the display unit 30 that the blood collection tube installed in the blood collection device is not appropriate, and stops blood collection into the blood collection tube held in the blood collection position (step S209).
  • the user of the blood collection device can follow the warning display to reinstall the appropriate blood collection tube and then resume preparation operations.
  • FIG. 9 is a flow chart showing a process flow in the blood sampling operation of the blood sampling device.
  • the blood collection operation in which a puncture needle is inserted into a subject to collect blood from the subject into a collection tube can be performed under controlled conditions of the amount of blood collected into the collection tube and the blood collection time.
  • the control unit 10 controls the movement of the puncture module 304 to puncture the finger of the person to be sampled with the puncture needle (step S301).
  • the control unit 10 controls the rotational operation of the turntable 303 to move the puncture module 304 to the blood sampling position, and then controls the blood sampling unit 70 to raise the puncture module 304.
  • the raising of the puncture module 304 causes the puncture needle to puncture the finger of the person to be sampled.
  • control unit 10 controls the movement of the blood collection tube 301 to collect blood from the puncture site of the subject's finger (step S302).
  • the control unit 10 controls the rotational operation of the turntable 303 to move the holder 302 in which the blood collection tube 301 containing the blood collection tube is placed to the blood collection position, and then controls the blood collection unit 70 to lift the blood collection tube 301.
  • the blood collection tube 301 rises, the blood collection tube is pressed against the puncture site.
  • blood is collected into the collection tube (step S303).
  • the collection tube is pressed against the puncture site, starting the collection of blood from the puncture site into the collection tube.
  • the blood collection time which is the time required from the start to the end of blood collection into the collection tube, needs to be limited for each type of collection tube.
  • the time elapsed from the start of blood collection can be counted, for example, from the time the blood collection tube 301 rises.
  • the blood collection management unit 54 compares the time elapsed since the start of blood collection, counted by the built-in timer, with the maximum blood collection time set as a blood collection parameter for each sample and each type of blood collection tube, and determines whether the time elapsed since the start of blood collection into the blood collection tube has reached the maximum blood collection time (step S304).
  • the determination of the maximum blood collection time can be performed continuously at any time interval.
  • step S304 When the result of the determination regarding the blood collection time is that the elapsed time has not reached the maximum blood collection time (step S304; NO), the process proceeds to step S305. On the other hand, when the result of the determination regarding the blood collection time is that the elapsed time has reached the maximum blood collection time (step S304; YES), the process proceeds to step S306. When the elapsed time has reached the maximum blood collection time, the control unit 10 can cause the display unit 30 to display a warning that the blood collection time is inappropriate.
  • the blood collection management unit 54 compares the amount of blood collected measured by the blood collection amount sensor 316 with the required amount of blood collected set for each sample and each type of blood collection tube, and determines whether the amount of blood collected into the blood collection tube has reached the required amount (step S305).
  • the determination of the required amount of blood can be performed continuously at any time interval.
  • step S305 When the result of the judgment regarding the amount of blood collected is that the amount of blood collected into the collection tube has not reached the required amount (step S305; NO), the process returns to step S303. Then, from step S303 onwards, blood collection into the same collection tube continues.
  • the control unit 10 causes the display unit 30 to display a warning that the amount of blood collected is inappropriate.
  • step S305; YES when the result of the judgment regarding the amount of blood collected is that the amount of blood collected into the collection tube has reached the required amount (step S305; YES), the process proceeds to step S306.
  • the control unit 10 causes the display unit 30 to display a warning that the amount of blood collected is appropriate.
  • the control unit 10 then controls the movement of the blood collection tube 301 to stop blood collection into the blood collection tube held at the blood collection position (step S306).
  • the control unit 10 controls the blood collection unit 70 to lower the blood collection tube 301 held at the blood collection position.
  • the lowering of the blood collection tube 301 forcibly ends the collection of blood into the blood collection tube.
  • the blood collection management unit 54 determines whether there are other blood collection tubes from which blood should be collected on the turntable 303 (step S307).
  • the blood collection management unit 54 refers to the test item information and the detection result by the blood collection tube sensor 308 to check whether there are other blood collection tubes from which blood should be collected from the subject placed in other holders 302 on the turntable 303.
  • step S307 If the result of the determination regarding the blood collection tube is that there is another blood collection tube from which blood should be collected (step S307; YES), the process returns to step S302. Then, the movement of the blood collection tube 301 is controlled to switch the blood collection tube used for blood collection at the blood collection position. After that, the timer is reset and blood collection from the other blood collection tube continues. On the other hand, if the result of the determination regarding the blood collection tube is that there is no other blood collection tube from which blood should be collected (step S307; NO), the process proceeds to step S308.
  • the control unit 10 then controls the movement of the hemostatic module 305 to treat the puncture site on the subject's finger with a hemostatic material (step S308).
  • the control unit 10 controls the rotational operation of the turntable 303 to move the hemostatic module 305, to which a hemostatic material such as gauze is attached, to the blood collection position, and controls the blood collection unit 70 to raise and then lower the hemostatic module 305.
  • the hemostatic module 305 rises, the hemostatic material is pressed against the puncture site, stopping the bleeding at the puncture site.
  • the control unit 10 then controls the movement of the hemostasis module 306 to treat the puncture site on the subject's finger with a protective material (step S309).
  • the control unit 10 controls the rotational movement of the turntable 303 to move the hemostasis module 306, to which a protective material such as a bandage is attached, to the blood collection position, and controls the blood collection unit 70 to raise and then lower the hemostasis module 306.
  • the hemostasis module 306 rises, the protective material is pressed against the puncture site, protecting the puncture site.
  • the blood collection amount sensor 316 measures the amount of blood collected from the blood collection tube held at the blood collection position. More preferably, the amount of blood collected can be measured again at the measurement position after the blood collection operation is completed to improve accuracy.
  • the turntable unit 80 can move the blood collection tube from which blood has been collected to the measurement position from the blood collection position. At the measurement position, the amount of blood collected into the blood collection tube is measured by a blood collection amount sensor separate from that at the blood collection position.
  • a blood collection amount sensor can be provided only at the measurement position, and no blood collection amount sensor can be provided at the blood collection position.
  • the blood collection tube 301 is moved to the measurement position in a time shorter than the maximum blood collection time to measure the amount of blood collected, and if the amount of blood collected exceeds the required amount of blood, blood collection is terminated. If not, the blood collection is returned to the blood collection position and blood collection is continued within the range not exceeding the maximum blood collection time.
  • each holder When moving the blood collection tubes, the position of the holder can be identified, and each holder can be controlled to move to a specified stop position.
  • the detection results of the blood collection tubes in each holder can be stored in the memory unit 60 in association with information identifying the holder position.
  • a specified type of blood collection tube can be moved to a blood collection position that satisfies the set blood collection sequence. Even if the blood collection tubes are placed in multiple holders in any order, the movement is controlled so that the blood collection tubes are in the specified blood collection sequence, reducing the work of placing and checking the blood collection tubes.
  • step S307 when the result of the judgment regarding the blood collection tube is that there is no other blood collection tube from which blood should be collected (step S307; NO), blood collection into the blood collection tube ends.
  • the amount of blood collected into the blood collection tube can be measured at a measurement position or the like.
  • the control unit 10 can compare the measurement result of the blood collection amount by the blood collection amount sensor with the required blood collection amount set as a parameter regarding blood collection, and determine whether the amount of blood collected into the blood collection tube has reached the required blood collection amount.
  • the control unit 10 causes the display unit 30 to display a warning that the amount of blood collected is inappropriate as blood collection result information showing the result of blood collection into the collection tube.
  • the control unit 10 causes the display unit 30 to display a determination result that the amount of blood collected is appropriate as blood collection result information showing the result of blood collection into the collection tube. For confirmation by the user of the blood collection device, blood collection result information showing the result of blood collection into the collection tube can be displayed on the display unit 30.
  • the user of the blood collection device can decide to redo the collection or change the blood collection site. On the other hand, if the amount of blood collected into the collection tube reaches the required amount, the collection tube can be removed from the holder and post-processing such as mixing by inversion can be performed as necessary.
  • Fig. 10 shows an example of a matching result image showing the matching result of the sample ID read from the blood collection tube.
  • Fig. 10 shows an example of a matching result image that is an image of matching result information showing the matching result between the sample ID and the recipient ID, which is a confirmation image displayed on the touch panel display unit of the blood collection device for the user of the blood collection device to check before blood collection.
  • the display unit of the blood collection device can display matching result information showing the result of matching the sample ID with the recipient ID.
  • the user of the blood collection device can check the content of the blood collection performed by the blood collection device through an image before collecting blood.
  • the matching result information can display recipient information (patient name, etc.) associated with the recipient ID, the sample ID read from the blood collection tube, test item information, blood collection tube information read from the blood collection tube, blood collection order information, information on the amount of blood required for each blood collection item, etc.
  • the display unit of the blood collection device can also display detection result information indicating the detection result of the presence or absence of a blood collection tube in the holder.
  • the detection result information can display information identifying the position of the holder, the presence or absence of a blood collection tube in each position, the type of blood collection tube detected in each position, the appropriate type of blood collection tube for each position, etc.
  • the presence or absence of a blood collection tube in the holder can be detected by a reader having a detection function or a blood collection tube sensor during the preparation operation of the blood collection device.
  • the user of the blood collection device can press a touch-panel confirmation completion button to instruct the blood collection device to begin blood collection for the current recipient. If a problem is found with the comparison results, the user can reposition the blood collection tube and then instruct the blood collection device to resume preparation operations.
  • the comparison results and detection results as images and warning the user of the blood collection device, it is possible to prevent mixing up blood collection tubes or forgetting to place them.
  • FIG. 11 is a diagram showing an example of a blood collection result image showing the results of blood collection into a blood collection tube.
  • FIG. 11 shows an example of a blood collection result image that is displayed on a touch panel display unit of a blood collection device for a user of the blood collection device to check after blood collection, and is an image of blood collection result information showing the results of blood collection into a blood collection tube.
  • the user of the blood collection device can press the confirmation completion button on the touch panel to instruct the blood collection device to end the blood collection operation for the current recipient.
  • the confirmation completion button on the touch panel to instruct the blood collection device to end the blood collection operation for the current recipient.
  • the maximum blood collection time which is the upper limit of the time required from the start to the end of blood collection into a blood collection tube, is limited, so unnecessary blood collection operations are shortened or skipped, unlike conventional blood collection devices in which the blood collection operation is performed in a fixed time.
  • Blood is collected into a blood collection tube in the appropriate time required for each test item, depending on the maximum blood collection time according to the type of blood collection tube.
  • the blood collection tube can be quickly removed from the blood collection device, and post-processing such as mixing by inversion can be performed quickly. A decrease in the amount of bleeding due to the passage of blood collection time and contamination with tissue fluid can be avoided, allowing accurate testing.
  • Fig. 12 is a diagram showing an example of a blood collection system incorporating a blood collection device.
  • Fig. 12 shows an example of a blood collection system incorporating a blood collection device that automatically collects blood from a subject, the blood collection system being configured by the blood collection device and a system higher up than the blood collection device.
  • the blood collection device can be incorporated into a blood collection system 400 together with a higher-level system.
  • the blood collection system 400 includes an electronic medical record system 401, a blood collection support system 402, and a test information system 403. These devices are connected to each other by a communication line such as a LAN. These devices can send and receive data to each other via the communication line.
  • the blood collection system 400 may be constructed, for example, within a hospital, or may be constructed both inside and outside the hospital.
  • the electronic medical record system 401, blood collection support system 402, and test information system 403 each function as a server. These systems manage data, transfer data, share data, etc. These systems are connected to each other via communication lines such as a LAN. These systems may be installed, for example, inside a hospital or outside a hospital.
  • one each of an electronic medical record system 401, a blood collection support system 402, and a test information system 403 are connected to the blood collection system 400, but any number of these systems, one or more, can be connected. Also, one or more of these systems may be omitted.
  • a management server can be installed.
  • the electronic medical record system 401 is a system that manages electronic medical records, and writes information to the electronic medical records, reads information from the electronic medical records, edits the electronic medical records, etc.
  • a plurality of input terminals 411 are connected to the electronic medical record system 401 via communication lines.
  • the input terminal 411 is a terminal for performing operations on the electronic medical record, and is used to input information into the electronic medical record, output information from the electronic medical record, view the electronic medical record, etc.
  • the input terminal 411 is composed of a computer, a tablet, etc.
  • the input terminal 411 is operated by a doctor or medical staff.
  • the input terminal 411 can be used to input blood sample recipient registration information into the electronic medical record and output blood sample recipient registration information from the electronic medical record.
  • the blood collection support system 402 is a system that provides support regarding blood collection, and performs operations such as registering data related to blood collection, updating data, managing data, and issuing sample IDs.
  • a blood collection reception machine 412, a blood collection preparation device 413, a blood collector terminal 414, and a blood collection device 415 are connected to the blood collection support system 402 via communication lines.
  • the blood collection support system 402 manages, as registration information related to specimens and collection tubes, a blood collection subject registration information database, which is a collection of data on multiple blood collection subject registration information, a blood collection tube registration information database, which is a collection of data on multiple blood collection tube registration information, and a specimen ID database, which is a collection of data on multiple specimen IDs.
  • the blood collection subject registration information database, blood collection tube registration information database, and specimen ID database are stored in a storage device associated with the blood collection system 400.
  • the storage device may be installed, for example, inside or outside the hospital.
  • the blood collection reception machine 412 is a device that receives blood samples from people who wish to have their blood collected, and performs tasks such as verifying the blood collection subject's ID and issuing a blood collection ticket.
  • the blood collection reception machine 412 is operated, for example, by the person who wishes to have their blood collected, a doctor, or medical staff. Information such as the name of the person who wishes to have their blood collected and the blood collection subject's ID is added to the blood collection ticket by printing a barcode or the like.
  • the blood collection preparation device 413 is a device that performs preparations related to blood collection, such as stocking blood collection tubes, preparing blood collection tubes for each blood collection subject, assigning sample IDs and blood collection tube information to blood collection tubes, attaching barcode labels, printing barcodes, and registering blood collection tube information.
  • the blood collector terminal 414 is a terminal for performing operations related to blood collection, and inputs, reads, and outputs data related to blood collection.
  • the blood collector terminal 414 is composed of a computer, tablet, etc.
  • the blood collector terminal 414 is operated by a doctor or medical staff.
  • the blood collector terminal 414 can be used to register the recipient's ID, input the date of blood collection, check the blood collection schedule and blood collection items for each recipient, and assist in processing abnormalities in the blood collection device 415, for example, reading barcodes using a manual reader.
  • the blood collection device 415 is the blood collection device that automatically collects blood from a subject.
  • the blood collection device 415 is equipped with a communication unit that communicates with a host system, and can obtain sample IDs and collection tube information from the blood collection support system 402.
  • the blood collection device 415 can match the collection tubes placed in the holders by referring to the subject registration information input from the host system.
  • parameters related to blood collection can be set by referring to the collection tube registration information input from the host system. Any number of blood collection devices 415 can be connected to the blood collection support system 402.
  • the test information system 403 is a system that manages information related to blood tests, and performs tasks such as entering data related to blood tests, registering data, updating data, and managing data related to blood collection results.
  • a test terminal 416 and multiple analyzers 417A, 417B, and 417C are connected to the test information system 403 via communication lines.
  • the testing terminal 416 is a terminal for performing operations related to blood tests, and is used to operate the analysis device 417, input data, output data, check the analysis status and analysis results, etc.
  • the testing terminal 416 is composed of a computer, etc.
  • the testing terminal 416 is operated by the person performing the blood test. Using the testing terminal 416, it is possible to check the analysis status and analysis results for each blood collection tube from which blood was collected, and input data for reporting the test results to the requester.
  • Analyzers 417A, 417B, and 417C are devices that perform analyses related to blood tests, and perform analyses according to the blood test items using blood collected in blood collection tubes as samples.
  • Analyzers 417A, 417B, and 417C are composed of various types of automatic biochemical analyzers that analyze blood components. Any number of analyzers 417 can be connected to the test information system 403.
  • a blood collection subject ID is issued to each blood collection subject who receives blood collection.
  • the blood collection subject ID is associated with the test item information specified by the test order and is registered in advance in the blood collection subject registration information database. If an electronic medical record has been created for the blood collection subject, the ID in the electronic medical record can be used as the blood collection subject ID.
  • the blood collection reception machine 412 After matching the blood collection subject with the blood collection subject ID, the blood collection reception machine 412 transmits the blood collection subject ID to the blood collection support system 402.
  • the blood collection support system 402 When the blood collection support system 402 receives the blood collection recipient ID, it identifies the blood collection recipient registration information corresponding to the blood collection recipient ID from the blood collection recipient registration information database. Based on the test item information associated with the blood collection recipient ID, the number of blood collection tubes from which blood should be collected and the type of blood collection tube from which blood should be collected are identified. Information on the number and type of blood collection tubes is associated with the sample ID registered in the sample ID database. Furthermore, if blood collection into multiple blood collection tubes is specified, the order in which blood should be collected into the multiple different types of blood collection tubes is identified based on the test item information associated with the blood collection recipient ID.
  • the blood collection support system 402 registers the number of identified blood collection tubes, the type of blood collection tube, and the blood collection order information in association with the blood collection subject ID.
  • the blood collection subject ID matched with the blood collection subject who will receive blood collection, the test item information associated with the blood collection subject ID, and the blood collection tube information associated with the test item information are transmitted to the blood collection preparation device 413.
  • the blood collection support system 402 when the blood collection support system 402 receives the recipient ID, it specifies the device number of the blood collection device 415 that will collect the blood and the order in which the blood will be collected for each recipient. The device number of the specified blood collection device 415 and information on the order in which the blood will be collected are associated with the recipient ID. The device number and information on the order in which the blood will be collected are transmitted to the blood collection reception machine 412.
  • the blood collection preparation device 413 When the blood collection preparation device 413 receives the subject's ID, test item information, and blood collection tube information, it issues a sample ID for each individual blood collection tube. It also extracts the type of blood collection tube required for blood collection from its stock. It then assigns a sample ID and blood collection tube information to the collected blood collection tube, and provides a set of blood collection tubes for one person on a tray or the like.
  • the blood collection reception machine 412 When the blood collection reception machine 412 receives information on the blood recipient from a patient's appointment card or the like, it issues a blood collection slip associated with the recipient's ID for each blood recipient.
  • the blood collection slip records the recipient's ID and other information as a barcode or the like.
  • the blood recipient takes the issued blood collection slip with them to have their blood collected by the designated blood collection device 415.
  • the information on the blood collection slip can be read by a reader or the like connected to the blood collector's terminal 414 and compared with the sample ID, test item information, and the like.
  • the designated blood collection device 415 uses a set of blood collection tubes provided by the blood collection preparation device 413.
  • FIG. 13 is a diagram showing a blood collection method using a blood collection device incorporated in a blood collection system.
  • FIG. 13 shows an overview of the preparation operations that are performed before starting the blood collection operation.
  • Steps S401 and S402 are processes that are performed by the user of the blood collection device.
  • Steps S403 to S409 are processes that are automatically performed by the blood collection device.
  • a blood collection device 415 incorporated in a blood collection system automatically collects blood from a subject using a blood collection tube to which a sample ID and blood collection tube information have been assigned in advance.
  • the blood collection device 415 can input the subject registration information and blood collection tube registration information from a higher-level system.
  • step S401 placing the blood collection tube (step S401), notifying completion of the placement of the blood collection tube and start of blood collection (step S402), detecting proper placement of the blood collection tube (step S403), and reading the information attached to the blood collection tube (step S404).
  • the read information is used as a key to query the blood collection support system 402 for registration information (step S405).
  • the blood collection device 415 requests the registration information corresponding to the sample ID read from the blood collection tube from the blood collection support system 402, which is a higher-level system.
  • the blood collection support system 402 When the blood collection support system 402 receives a request for registration information, it identifies test item information associated with the blood collection subject ID corresponding to the read sample ID based on the blood collection subject registration information database. Then, based on the test item information, it identifies the number of blood collection tubes from which blood should be collected and the type of blood collection tube from which blood should be collected. It also determines the blood collection order corresponding to the number and type of blood collection tubes based on the test item information. The blood collection support system 402 transmits the test item information, the number of blood collection tubes associated with the blood collection subject ID corresponding to the sample ID, the type of blood collection tube, and information on the blood collection order to the blood collection device 415.
  • the blood collection device 415 performs the same steps as the blood collection method shown in FIG. 1, such as verifying the information attached to the blood collection tubes (step S406), setting parameters related to blood collection (step S407), and setting the blood collection order for the blood collection tubes (step S408).
  • the blood collection device 415 can display verification result information showing the verification result of the specimen ID and blood collection tube information against the registration information received from the blood collection support system 402.
  • step S403 If the blood collection tube is not properly installed (step S403; NO), if the information attached to the blood collection tube is not read correctly (step S404; NO), or if the read information does not match the registered information (step S406; NO), the user of the blood collection device 415 is warned of the abnormality (step S409).
  • step S404 If the information attached to the blood collection tube is not read correctly (step S404; NO), the information attached to the blood collection tube can be read manually by a reader connected to the blood collector terminal 414. Also, if the read information does not match the registered information (step S406; NO), the read information can be input and verified manually using the blood collector terminal 414.
  • blood collection parameters and blood collection order are set as control conditions for the blood collection unit 70, which collects blood from the subject into a collection tube.
  • the blood collection unit 70 collects blood from the subject so as to satisfy the set blood collection parameters and blood collection order.
  • the blood collection device 415 can transmit information on the amount of blood collected from each collection tube, information on the blood collection time for each collection tube, etc., to the testing information system 403 as blood collection result information associated with the sample ID.
  • the read information read from the collection tube is compared with the registered information registered in advance in the higher-level system, and blood collection parameters and the blood collection order corresponding to the read information are set.
  • the registered information required for the comparison is registered in real time in response to the reception of the blood recipient.
  • preparation and confirmation work is carried out automatically, and appropriate blood collection conditions are automatically set for each sample and type of collection tube based on the registered information registered in the higher-level system. This reduces the work involved in blood collection and enables accurate blood collection.
  • FIG. 14 is a diagram for explaining a method for calculating the required amount of blood to be collected from a subject into a blood collection tube.
  • the amount of blood required to be collected from a subject into a blood collection tube can be calculated by adding up the amount required for each test item, the biochemical dummy amount, and the dead volume.
  • the amount of serum components required for each test item is converted into the amount of whole blood required for calculation.
  • the biochemistry dummy volume indicates the amount of sample that should be collected in addition to the required volume for proper analysis of the sample.
  • Analytical devices used in blood tests may use a sampling probe to aspirate and discharge the sample. When the sample is aspirated into the probe, it may come into contact with the working medium and be diluted. For this reason, it is necessary to collect more blood than is needed to serve as the dummy volume.
  • Dead volume refers to the volume of a blood collection tube that cannot be used to analyze a sample. Blood collection tubes have dead volume that cannot be sucked up by the analytical equipment used in blood tests. Due to the performance of the analytical equipment, it is not possible to analyze all of the blood collected in a blood collection tube, so a margin must be secured in advance.
  • CRP C-reactive protein
  • TP total protein
  • ALB albumin
  • AST aminotransferase
  • ALT alanine aminotransferase
  • LD lactate dehydrogenase
  • the amount of blood required to be collected from the subject into a blood collection tube can be calculated based on the required serum volume and hematocrit value. For example, if the subject is an adult male, the hematocrit value can be assumed to be 50%, which is the upper limit for adult males. If the hematocrit value is set at 50%, and the required serum volume is 73.2 ⁇ L, the required blood volume is calculated to be 146.4 ⁇ L.
  • the target amount of blood to be collected into the collection tube can be controlled to match this required amount.
  • a parameter for converting to an equivalent amount of whole blood such as the hematocrit value, can be read, and the required amount of blood converted to an equivalent amount of whole blood can be set as a parameter related to blood collection.
  • the initial value for the required blood volume for each type of blood collection tube is usually 400 to 420 ⁇ L.
  • the required blood volume converted to an equivalent volume of whole blood is 146.4 ⁇ L, which is less than half of the initial value. Therefore, if the target value for the blood volume to be collected into the blood collection tube is controlled to be the required blood volume, the overall time required for blood collection can be shortened and the effects of the coagulation state can be avoided.
  • the blood collection device 415 can update the required blood collection volume, which differs depending on the test item, to the blood collection volume appropriate to the test item based on the test item information transmitted from the higher-level system, the blood collection support system 402.
  • the blood collection support system 402 When the blood collection support system 402 receives a request for registration information from the blood collection device 415 (step S405), it identifies test item information associated with the blood collection subject ID corresponding to the read sample ID based on the blood collection subject registration information database. Then, based on the test item information, it identifies the number of blood collection tubes from which blood should be collected and the type of blood collection tube from which blood should be collected. The blood collection support system 402 can transmit this information and the test item information to the blood collection device 415.
  • the blood collection device 415 calculates the amount of blood required to be collected per collection tube based on the test item information and collection tube information, and stores the calculated amount in the memory unit 60.
  • the setting unit 52 which sets parameters related to blood collection, reads required blood collection amount information indicating the amount of blood required to be collected per collection tube from a database, and updates the required blood collection amount information corresponding to the sample ID and collection tube information read from the collection tube with required blood collection amount information based on the test item information received from the higher-level system.
  • the blood collection unit 70 can collect blood so as to satisfy the required blood collection amount updated according to the test item.
  • the amount of blood required to be drawn per collection tube can be changed based on the test item information collected in real time by the higher-level system. Even if blood collected in one collection tube is used for multiple types of tests, there is no need to collect an excessive amount of blood in advance, and the amount of blood drawn from the subject and the time required for blood collection can be kept to a minimum.
  • the present invention is not limited to the above-described embodiments, and various modifications are possible without departing from the spirit of the present invention.
  • the present invention is not necessarily limited to having all of the configurations of the above-described embodiments. It is possible to replace part of the configuration of an embodiment with another configuration, add part of the configuration of an embodiment to another form, or omit part of the configuration of an embodiment.
  • 201 blood collection tube
  • 202 outer tube
  • 203 cap
  • 204 barcode label
  • 301 blood collection tube
  • 302 holder
  • 303 turntable
  • 304 puncture module
  • 305 hemostasis module
  • 306 hemostasis module
  • 307 reader
  • 308 blood collection tube sensor (detection unit)
  • 309 rotation drive mechanism
  • 316 blood collection volume sensor
  • 401 electronic medical record system
  • 402 blood collection support system
  • 403 test information system
  • 411 input terminal
  • 412 blood collection reception machine
  • 413 blood collection preparation device
  • 414 blood collector terminal
  • 415 blood collection device
  • 416 test terminal
  • 417A, 417B, 417C analysis device

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Medical Informatics (AREA)
  • Public Health (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Analytical Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Biochemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Primary Health Care (AREA)
  • Epidemiology (AREA)
  • Hematology (AREA)
  • Biophysics (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Hydrology & Water Resources (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

La présente invention concerne un dispositif de prélèvement de sang et un procédé de prélèvement de sang avec lesquels il est possible d'effectuer un prélèvement de sang précis dans lequel la quantité de sang prélevée dans un tube de prélèvement de sang, le temps de prélèvement de sang et la séquence de prélèvement de sang sont optimisés, et avec lesquels il est possible de réduire la quantité de travail impliquée dans le prélèvement de sang. Le dispositif de prélèvement de sang comprend : un lecteur qui lit, à partir d'un tube de prélèvement de sang, un identifiant d'échantillon pour identifier un échantillon, et des informations de tube de prélèvement de sang indiquant le type du tube de prélèvement de sang ; des supports dans lesquels des tubes de prélèvement de sang sont placés ; un plateau tournant qui supporte une pluralité des supports ; une unité de prélèvement de sang qui prélève le sang dans chaque tube de prélèvement de sang ; une unité de mesure qui mesure la quantité de sang prélevée dans chaque tube de prélèvement de sang ; une unité de stockage qui stocke des informations de quantité de prélèvement de sang requises, des informations de temps de prélèvement de sang maximal, les informations de tube de prélèvement de sang et des informations d'élément de test ; une unité de réglage qui règle des paramètres relatifs au prélèvement de sang ; et une unité de commande. Le procédé de prélèvement de sang comprend : la lecture de l'ID d'échantillon, et des informations de quantité de prélèvement de sang requises et des informations de temps de prélèvement de sang maximal correspondant aux informations de tube de prélèvement de sang, et le réglage de ceux-ci en tant que paramètres ; la lecture des informations d'élément de test et le réglage de la séquence de prélèvement de sang pour la pluralité de tubes de prélèvement de sang ; et la réalisation d'un prélèvement de sang de façon à satisfaire la quantité de prélèvement de sang requise, le temps de prélèvement de sang maximal et la séquence de prélèvement de sang.
PCT/JP2024/031314 2023-09-21 2024-08-30 Dispositif et procédé de prélèvement de sang Pending WO2025063019A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2023-156507 2023-09-21
JP2023156507 2023-09-21

Publications (1)

Publication Number Publication Date
WO2025063019A1 true WO2025063019A1 (fr) 2025-03-27

Family

ID=95072831

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2024/031314 Pending WO2025063019A1 (fr) 2023-09-21 2024-08-30 Dispositif et procédé de prélèvement de sang

Country Status (1)

Country Link
WO (1) WO2025063019A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2012132932A (ja) * 2012-03-08 2012-07-12 Sysmex Corp 血液分析装置および血液分析システム
WO2012157085A1 (fr) * 2011-05-18 2012-11-22 株式会社テクノメデイカ Système de préparation automatique pour tube de prélèvement de sang
JP2019518974A (ja) * 2016-06-27 2019-07-04 ベックマン コールター、インク． 生体材料サンプルのヒストリロギング
CN112205983A (zh) * 2020-09-10 2021-01-12 赖力 一种结合网络技术的智能生物识别自动化采血系统
JP2021016581A (ja) * 2019-07-19 2021-02-15 株式会社日立ハイテク 採血装置

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012157085A1 (fr) * 2011-05-18 2012-11-22 株式会社テクノメデイカ Système de préparation automatique pour tube de prélèvement de sang
JP2012132932A (ja) * 2012-03-08 2012-07-12 Sysmex Corp 血液分析装置および血液分析システム
JP2019518974A (ja) * 2016-06-27 2019-07-04 ベックマン コールター、インク． 生体材料サンプルのヒストリロギング
JP2021016581A (ja) * 2019-07-19 2021-02-15 株式会社日立ハイテク 採血装置
CN112205983A (zh) * 2020-09-10 2021-01-12 赖力 一种结合网络技术的智能生物识别自动化采血系统

Similar Documents

Publication Publication Date Title
US10768187B2 (en) Automatic analysis device and specimen inspection automation system
US20240192234A1 (en) Automatic analysis device and automatic analysis method
JP5377866B2 (ja) 検体分析装置
US9244086B2 (en) Sample analyzing system, sample analyzer, and management method of sample analyzing system
EP2116852B1 (fr) Analyseur automatique
CN106233308B (zh) 用于样品完整性验证的系统、装置和方法
KR101912952B1 (ko) 진단 기기 및 유동 공정
CN108700603A (zh) 自动分析装置
US20070143035A1 (en) Diagnostic test reader with disabling unit
US12115531B2 (en) Test chip in a portable digital diagnostic device
JP6400312B2 (ja) 臨床検査装置
JP2020534522A (ja) 有害汚染物質を高いピックアップ効率及び分離効率で収集するサンプリングシステム及び技術
EP3833982B1 (fr) Contrôle qualité automatique pour instruments de laboratoire
WO2016056571A1 (fr) Système de gestion d'urine
JP2011038918A (ja) 検体検査装置およびそれに用いる情報管理装置
JP4805709B2 (ja) 尿分析装置
WO2025063019A1 (fr) Dispositif et procédé de prélèvement de sang
JP7527900B2 (ja) 自動分析装置および検体情報作成方法
KR20180039965A (ko) 동물 혈액 검사기 및 그 제어 방법
CN107850609B (zh) 自动分析装置
WO2025013579A1 (fr) Dispositif de prélèvement sanguin, procédé de prélèvement sanguin et système de prélèvement sanguin
CN114324922A (zh) 自动分析装置
JPH03223629A (ja) 検体量測定装置
KR20230166509A (ko) 의료용 검체 추적시스템
KR20230166510A (ko) 의료용 검체 추적장치

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 24868099

Country of ref document: EP

Kind code of ref document: A1

ENP Entry into the national phase

Ref document number: 2025547303

Country of ref document: JP

Kind code of ref document: A