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WO2025142023A1 - Dispositif de prélèvement sanguin automatisé et procédé de prélèvement sanguin automatisé - Google Patents

Dispositif de prélèvement sanguin automatisé et procédé de prélèvement sanguin automatisé Download PDF

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Publication number
WO2025142023A1
WO2025142023A1 PCT/JP2024/035959 JP2024035959W WO2025142023A1 WO 2025142023 A1 WO2025142023 A1 WO 2025142023A1 JP 2024035959 W JP2024035959 W JP 2024035959W WO 2025142023 A1 WO2025142023 A1 WO 2025142023A1
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WIPO (PCT)
Prior art keywords
puncture
suitability
blood
unit
image
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PCT/JP2024/035959
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English (en)
Japanese (ja)
Inventor
晃朗 長坂
啓 竹中
作一郎 足立
隆史 入江
雅弘 加藤
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Hitachi High Tech Corp
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Hitachi High Tech Corp
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Publication of WO2025142023A1 publication Critical patent/WO2025142023A1/fr
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/103Measuring devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/107Measuring physical dimensions, e.g. size of the entire body or parts thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/151Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/153Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes

Definitions

  • the present invention relates to a method and device for automating blood sampling from a living body using a machine, and in particular to an automatic blood sampling device and automatic blood sampling method that automatically determines a suitable needle insertion position to obtain a sufficient amount of blood.
  • Blood tests have become essential in the medical field as they provide basic information for diagnosing various diseases. They are also expected to be used for early diagnosis of disease signs in order to curb ever-increasing medical costs, and the demand for blood tests is expected to continue to increase in the future. As this demand increases, there are concerns about the increased burden on medical professionals who collect blood, and in recent years, attention has been focused on automatic blood collection devices that mechanize blood collection with as little manual effort as possible. In particular, there is a demand for small, space-saving blood collection devices that can be placed without taking up space in the limited space available at medical facilities.
  • a conventional example of this type of automatic blood sampling device is the device described in Patent Document 1.
  • a needle automatically moves to puncture the fingertip, creating a small wound, and blood is collected by being collected in a collection container.
  • the device is made smaller by using the fingertip as the part to be sampled.
  • parts of the fingertip that are suitable for blood sampling and parts that are not.
  • the above device does not determine suitability, and only discloses mechanically piercing the needle at a fixed position. Therefore, there is a possibility that a sufficient amount of blood may not be collected due to individual differences in the finger and changes in the posture and position of the presented finger.
  • Patent Document 3 discloses a method of measuring the depth of the blood vessel through stereoscopic vision using two cameras, and controlling the puncture so that the needle reaches the blood vessel in accordance with the measurement data. This makes it possible to reliably collect blood by targeting the blood vessel.
  • Patent No. 6994910 JP 2023-049080 A Japanese Patent Application Publication No. 8-168477
  • the automatic blood sampling device described in Patent Document 2 also calculates a suitability index (hereinafter referred to as puncture suitability) based on the clarity of the blood vessel, specifically the curvature rate described later, based on image analysis for the point to be punctured, making it possible to quantitatively determine whether the blood vessel is suitable for puncturing.
  • puncture suitability a suitability index
  • simply focusing on image features such as the clarity of the blood vessel may not provide a correlation with the amount of blood collected due to factors other than those that appear as features in the image.
  • one of the influencing factors is that even if the clarity of the blood vessel is sufficient, the blood vessel may be located deep.
  • the puncture suitability on that blood vessel will show a high value.
  • blood collection itself is difficult because the needle is difficult to reach, and the amount of blood collected is not as much as expected from the clarity of the blood vessel on the image.
  • the S/N ratio of the captured image may decrease due to the influence of the surrounding environment at the time of image capture, especially external light, and the original clarity of the blood vessel may not be accurately reflected in the image. For example, if ambient light is reflected on the imaging surface, such as the fingertip, the signal-to-noise ratio of blood vessels will decrease relatively.
  • the automatic blood sampling device of the present invention is an automatic blood sampling device that collects blood by inserting a needle into a body part including a finger or an arm, and is characterized by comprising: a light receiving unit that receives light in a wavelength range that can penetrate into the body to the maximum depth of the blood vessels included in the puncture target area, and light in a wavelength range that can only penetrate to near the surface; an image acquiring unit that acquires measurement images of the backscattered light in each wavelength range; an emphasis observation unit that selectively emphasizes and observes blood vessels that exist between the near the surface and the maximum depth based on the difference between the measurement images in each wavelength range; a puncture suitability calculation unit that calculates an index value of suitability for puncturing from the obtained characteristics of the blood vessel thickness and/or thickness as a puncture suitability; and a puncture suitability judgment unit that judges suitability for puncturing based on the puncture suitability.
  • the automatic blood sampling method is an automatic blood sampling method for sampling blood by inserting a needle into a body part including a finger or an arm, and is characterized by having a light receiving step in which the light receiving unit receives light in a wavelength range capable of penetrating the body to the maximum depth of blood vessels included in the puncture target area and light in a wavelength range capable of penetrating only to the vicinity of the surface layer, an image acquiring step in which the image acquiring unit acquires measurement images of backscattered light in each wavelength range, an emphasis observing step in which the emphasis observing unit selectively emphasizes and observes blood vessels present between the vicinity of the surface layer and the maximum depth based on the difference between the measurement images in each wavelength range, a suitability calculating step in which the puncturing suitability calculating unit calculates an index value indicating whether or not puncturing is suitable from the obtained characteristics of the blood vessel thickness and/or width as the puncturing suitability, and a puncturing suitability determining step in which the puncturing suitability determining unit determines whether
  • an automatic blood sampling device and an automatic blood sampling method that can calculate a more accurate puncture suitability by taking into account not only the clarity of the blood vessels but also the depth by simply presenting the blood sampling site such as a finger or arm.
  • FIG. 1 is a configuration diagram of an automatic blood sampling device according to a first embodiment of the present invention.
  • FIG. 2 is a functional block diagram of a calculation unit shown in FIG. 1 .
  • FIG. 2 is a top view of the drive unit shown in FIG. 1 .
  • 1 is a diagram showing an outline of a method for selectively measuring blood vessels in a shallow layer using an automatic blood sampling device according to a first embodiment of the present invention.
  • FIG. 4 is a diagram showing an example of sensitivity characteristics of each RGB wavelength range.
  • FIG. 13 is a diagram showing an example of a difference image when a color camera is placed directly under a finger. 4 is a flowchart showing a process flow of the automatic blood sampling device according to the first embodiment of the present invention.
  • FIG. 1 is a configuration diagram of an automatic blood sampling device according to a first embodiment of the present invention.
  • FIG. 2 is a functional block diagram of a calculation unit shown in FIG. 1 .
  • FIG. 2 is a top view of the drive
  • Fig. 1 is a configuration diagram of an automatic blood sampling device according to a first embodiment of the present invention, and is a schematic diagram of a hardware configuration.
  • a calculation unit 101 built into the automatic blood sampling device 1 is further composed of a CPU 102, a memory 103, an auxiliary storage 104, and an interface (I/F) 105, which are interconnected by an internal bus. These may be interconnected by a dedicated bus for the purpose of increasing speed, etc.
  • the CPU 102 is a calculation device that executes programs.
  • the CPU 102 also executes the calculation process of the puncture suitability from an image and the reliability evaluation described below.
  • the memory 103 stores the processing program itself and data necessary for processing. Data that is to be permanently stored is written to and read from a recording medium such as a flash memory or a hard disk shown as an auxiliary memory 104.
  • the interface (I/F) 105 connects the calculation unit 101 to various other functional blocks and is used to exchange data.
  • the calculation unit 101 can perform various types of communication with the outside world.
  • the communication unit 109 makes it possible to share some or all of the processing associated with blood collection with an external device, i.e., a host calculation device, and to link with various services on the cloud.
  • a functional block for automatically collecting blood is connected to the calculation unit 101 via an interface (I/F) 105.
  • the image input unit 106 is connected to a color camera 112, captures an image of a body part 115 (a finger is shown here as an example) from which blood is to be collected, and sends the image to the calculation unit 101 as digital image data.
  • the image input unit 106 has a function of converting the output signal of the color camera 112 into a format that is easy for the calculation unit 101 to handle, but the color camera 112 may have an equivalent function built in, in which case the image input unit 106 simply functions as a data transmission relay.
  • the captured image is stored in the memory 103, and the CPU 102 processes it.
  • the calculation unit 101 has an emphasis observation unit 11, a puncture suitability calculation unit 12, a puncture suitability determination unit 13, a puncture position selection unit 14, a blood vessel evaluation unit 15, a memory 103, an auxiliary storage 104, and an interface (I/F) 105, which are connected to each other via an internal bus.
  • the emphasis observation unit 11, the puncture suitability calculation unit 12, the puncture suitability determination unit 13, the puncture position selection unit 14, and the blood vessel evaluation unit 15 are realized by the CPU 102 shown in FIG. 1 and a memory 103 storing various programs.
  • the other short-wavelength component image 404 is in the blue visible light wavelength range of about 470 nm, and has the property of relatively emphasizing the skin surface patterns such as fingerprints and wrinkles compared to the long-wavelength component image 402 (Fig. 4). This is because light in the short-wavelength range does not penetrate deep layers, but returns as backscattered light from the epidermis to the upper dermis, and is less susceptible to absorption by blood vessels inside the body.
  • the skin surface patterns are also reflected in the long-wavelength component image 402 (Fig. 4), and if you pay attention to observing the blood vessels, you can say that they are buried in noise and have low contrast. Therefore, by subtracting the short-wavelength component image 404 (Fig.
  • a difference image 406 (Fig. 4) in which only the blood vessels are emphasized is obtained.
  • This difference image (blood vessel image) 406 is adjusted so that only the superficial blood vessels are displayed darkly, and is suitable as a base image for calculating the puncture suitability.
  • the subsequent calculation process for the puncture suitability can be basically performed according to the procedure described in Patent Document 2.
  • FIG. 6 is a diagram showing an example of a difference image 406 when the color camera 112 is placed directly under the finger.
  • the fingertip which is the biological part 115, is captured in the center of the difference image (blood vessel image) 406, and a blood vessel pattern 301 appears within the finger area. Points on this blood vessel pattern indicate areas with a relatively large amount of blood. Also, blood vessels located deep within the area, which are determined by the wavelength set for the long-wavelength light source 110, are not clearly captured.
  • the arc trajectory 300 in FIG. 6 indicates the movable range of the puncture needle 117 in the structure shown in FIG. 3.
  • the optimal puncture point needs to be extracted from each point on this arc trajectory 300, and among them, the intersection point with the blood vessel estimated to have a large amount of blood is selected.
  • the blood vessel pattern 301 is formed in a mesh-like shape, the arc trajectory 300 and the blood vessel pattern 301 often intersect at multiple points. Therefore, among these intersection points, the point with the highest puncture suitability is extracted, and the point where the puncture needle 117 should actually be inserted is determined.
  • the movable range of the puncture needle 117 is limited to the arc trajectory 300, but the method of realizing the movement of the puncture needle 117 is not limited to the mechanism shown in FIG. 3, and the movable range changes depending on the realization method.
  • the movable range will also be wider, and it is possible to make it a band-like range with width rather than a line as described above.
  • it does not have to be an arc shape, and it can be a straight line, a rectangle, or even a sector shape.
  • FIG. 7 is a flowchart showing the process flow of the automatic blood sampling device 1 according to the present embodiment.
  • the process starts in step S501, and includes various processes to be executed from now on, initialization of hardware, and the like.
  • the color camera 112 is started and starts taking images, and the taken images are taken into a memory area accessible by the CPU 102.
  • a detection process of a body part 115 such as a finger is executed. Specifically, image recognition is performed on the input image, and in particular, a large image change caused by a finger or an arm being presented to the device is detected.
  • step S504 if the image change detected in step S503 is large, it is determined that a body part 115 has been presented, and the process proceeds to step S505.
  • step S504 blood sampling preparation is started, and the user is notified as necessary.
  • a dedicated sensor can be used to detect the body part.
  • the method most suitable for the application environment is selected from among display of text or an icon on a display or the like, or an audio announcement, an alarm sound, etc.
  • the process returns to step S502 and the subsequent processes are repeated.
  • the light intensity of each of the long wavelength light source 110 and short wavelength light source 111 (FIG. 1) is controlled so that the amount of information of the difference image (blood vessel image) 406 is increased.
  • the amount of information can be easily determined from the average luminance of the difference image (blood vessel image) 406.
  • the light amount adjustment is performed by returning to step S502 and checking that both the light amount and balance are satisfied.
  • FIG. 8 is a schematic diagram of an automatic adjustment method of the ⁇ value.
  • the upper diagram of FIG. 8 illustrates the above formula (1).
  • the lower diagram vertically shows three examples of difference images when the value of ⁇ in formula (1) is changed.
  • Image 412 shows a state in which an appropriate ⁇ value m is found, the image components of the skin surface are removed, and only the image components of the blood vessels are emphasized.
  • the image components of the skin surface are never smooth and uniform, and the presence of a fingerprint or the like causes fine changes in brightness.
  • a profile curve 420 with high and low brightness in the figure is obtained, which is a profile curve that is inverted from the top to bottom of the profile curve 416. This inversion occurs because the value of ⁇ is too large, and the concave parts are filled in excessively to become convex parts.
  • the optimal value m is the value of ⁇ when it becomes zero.
  • the inflection rate represents the rate of change in brightness at each point of the cross-sectional profile, and takes a maximum positive value at the bottom of the concave part where the brightness is lowest, and conversely takes a minimum negative value at the top of the convex part where the brightness is highest. The higher the inflection rate, the sharper the image change, and the clearer the fingerprint or blood vessels are.
  • the purpose is not only to find the optimal puncture point in the captured image, but also to estimate the expected blood collection amount and determine whether or not puncture can be performed.
  • the puncture suitability is found from the image immediately before puncture, and a correspondence with the blood collection amount obtained by puncturing is obtained in pairs. From this correspondence data, a regression equation between the puncture suitability and the blood collection amount is found, and this equation is used to estimate the blood collection amount from the puncture suitability.
  • the correlation coefficient is not high enough, the estimated value will be uncertain, so the internal parameters in the calculation of the puncture suitability are adjusted to increase the correlation coefficient. For example, by changing the weighting of features such as the density, width, length, and depth of the blood vessels, the characteristics of the puncture suitability can be flexibly changed, and a combination parameter of characteristics that is highly correlated with the blood collection amount is finally selected. If the puncturing suitability determination unit 13 determines that the amount of blood to be collected estimated from the puncturing suitability thus obtained does not reach a preset amount, it quantitatively determines whether to refrain from collecting blood or to change the target area to another area.
  • the long wavelength light source 110 and the short wavelength light source 111 are irradiated simultaneously to separate the components from the color image.
  • the present invention is not limited to simultaneous irradiation.
  • the long wavelength light source 110 and the short wavelength light source 111 can be irradiated alternately to obtain two types of captured images, which can be used as the long wavelength component image 402 and the short wavelength component image 404.
  • the target biological part 115 may move or fluctuate between the two captures, and it is necessary to correct the fluctuation before using the two long wavelength component images 402 and the short wavelength component images 404.
  • the long wavelength light source 110 and the short wavelength light source 111 it is also possible to use a white light source that can irradiate light with a wider wavelength range. Only one light source is required, and conditions such as the spread of the light beam can be matched for the long and short wavelengths.
  • the wavelength range of the white light source is too wide in the long wavelength range, the penetration depth into the subcutaneous tissue will be large, which is contrary to the purpose of the present invention, which is to selectively measure only shallow blood vessels. Therefore, in the case of a white light source, the characteristics of the long wavelength range must be carefully examined.
  • the light flux conditions are to be uniform, it is possible to use a light source component that incorporates multiple light emitting elements of long and short wavelengths in the same package. Furthermore, a multi-wavelength light source that further increases the number of light emitting elements in the long wavelength range can be used. By making the emission wavelength in the long wavelength range variable according to the blood vessel depth to be measured, the optimal wavelength according to the depth that the puncture needle can reach can be selected.
  • the puncture suitability is calculated for each point on the image by the vascular evaluation unit 15, which is designed to show a higher or lower value the more prominent the thickness and darkness of the blood vessel and the shallower the blood vessel is, if that point is located on a blood vessel. Furthermore, a more stable and accurate calculation of the puncture suitability is performed by using the total output value of the vascular evaluation unit 15 for each point in the entire neighborhood centered on the point to be calculated. In addition, when calculating the total value of the neighborhood, the vascular evaluation unit output value is weighted by the distance from the center of the area, so that the more points with high vascular evaluation unit output values are concentrated near the center, the higher the suitability is.
  • an automatic blood sampling device and an automatic blood sampling method that can calculate a more accurate puncture suitability by taking into account not only the clarity of the blood vessels but also the depth by simply presenting the blood sampling site such as a finger or arm. Furthermore, according to this embodiment, it is possible to determine whether or not puncturing is appropriate with a higher correlation to the amount of blood to be collected.
  • FIG. 9 is a functional block diagram of the calculation unit 101a constituting the automatic blood sampling device according to this embodiment.
  • the calculation unit 101a according to this embodiment differs from the above-mentioned embodiment 1 in that it further includes a reliability evaluation unit 16, a usage restriction unit 17, and a puncture suitability correction unit 18.
  • the same components as those in embodiment 1 are given the same reference numerals, and duplicated explanations are omitted.
  • this embodiment in order to obtain a puncture suitability that has a high correlation with the blood sampling volume, it is focused on the fact that one of the issues is to suppress the influence of image quality degradation.
  • the cause of the discontinuity is the three-dimensional running of the blood vessel under the skin, and the discontinuity occurs simply because the blood vessel has sunk deep.
  • the cause of the discontinuity is not necessarily appropriate to perform interpolation, so interpolation of the puncture suitability should not be performed either.
  • the luminance change caused by the discontinuity is not abrupt, and tends to fade in stages and become invisible. Therefore, by focusing on the steepness of the luminance change in the discontinuous part, interpolation is performed only in the case of a steep change.

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Abstract

La présente invention concerne un dispositif de prélèvement sanguin automatisé et un procédé de prélèvement sanguin automatisé grâce auxquels une valeur d'aptitude à la ponction plus précise qui tient compte de la profondeur ainsi que de la visibilité de vaisseaux sanguins peut être calculée lorsqu'un site de prélèvement sanguin tel qu'un doigt ou un bras est présenté. L'invention concerne un dispositif de prélèvement sanguin automatisé destiné à prélever du sang au moyen d'une perforation par aiguille d'un site biologique comprenant un doigt ou un bras, ledit dispositif comprenant : une unité de réception de lumière qui reçoit de la lumière dans une plage de longueurs d'onde qui peut pénétrer dans un corps vivant à la profondeur maximale de vaisseaux sanguins inclus dans une plage de ponction cible et de la lumière dans une plage de longueurs d'onde qui peut pénétrer uniquement au voisinage de la couche de surface ; une unité d'acquisition d'image qui acquiert des images de mesure, dont chacune est une image de mesure de lumière rétrodiffusée dans une plage de longueurs d'onde respective ; une unité d'observation accentuée qui souligne et observe sélectivement des vaisseaux sanguins qui existent de manière intermédiaire entre le voisinage de la couche de surface et la profondeur maximale sur la base de la différence entre les images de mesure pour les plages de longueurs d'onde respectives ; une unité de calcul de valeur d'aptitude à la ponction qui calcule une valeur d'aptitude à la ponction sous la forme d'une valeur indiquant l'aptitude ou la non-aptitude à la ponction sur la base de caractéristiques obtenues de densité et/ou d'épaisseur de vaisseau sanguin ; et une unité de détermination d'aptitude à la ponction qui effectue une détermination d'aptitude à la ponction sur la base de la valeur d'aptitude à la ponction.
PCT/JP2024/035959 2023-12-25 2024-10-08 Dispositif de prélèvement sanguin automatisé et procédé de prélèvement sanguin automatisé Pending WO2025142023A1 (fr)

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JP2023217553A JP2025101014A (ja) 2023-12-25 2023-12-25 自動採血装置及び自動採血方法

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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH08164123A (ja) * 1994-12-15 1996-06-25 Nikon Corp 採血装置
JPH11509748A (ja) * 1995-06-07 1999-08-31 ユニバーシティ・オブ・アーカンソー 生物学的組織からの電磁反射波の検出方法と装置
JP2008539932A (ja) * 2005-05-10 2008-11-20 コーニンクレッカ フィリップス エレクトロニクス エヌ ヴィ カニューレ挿入システム
JP2017174342A (ja) * 2016-03-25 2017-09-28 富士通株式会社 生体画像処理装置及び生体画像処理方法
JP2019088391A (ja) * 2017-11-13 2019-06-13 株式会社日立ハイテクノロジーズ 採血装置および採血方法
JP2021006250A (ja) * 2019-06-27 2021-01-21 国立大学法人岩手大学 3次元血管認識方法及び3次元血管認識装置
CN113017625A (zh) * 2021-02-26 2021-06-25 北京伟浩君智能技术有限公司 采血机器人的控制方法及装置

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH08164123A (ja) * 1994-12-15 1996-06-25 Nikon Corp 採血装置
JPH11509748A (ja) * 1995-06-07 1999-08-31 ユニバーシティ・オブ・アーカンソー 生物学的組織からの電磁反射波の検出方法と装置
JP2008539932A (ja) * 2005-05-10 2008-11-20 コーニンクレッカ フィリップス エレクトロニクス エヌ ヴィ カニューレ挿入システム
JP2017174342A (ja) * 2016-03-25 2017-09-28 富士通株式会社 生体画像処理装置及び生体画像処理方法
JP2019088391A (ja) * 2017-11-13 2019-06-13 株式会社日立ハイテクノロジーズ 採血装置および採血方法
JP2021006250A (ja) * 2019-06-27 2021-01-21 国立大学法人岩手大学 3次元血管認識方法及び3次元血管認識装置
CN113017625A (zh) * 2021-02-26 2021-06-25 北京伟浩君智能技术有限公司 采血机器人的控制方法及装置

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