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WO2007105805A1 - Sonde de mesure des caracteristiques du sang, organe artificiel du systeme cardiovasculaire et poumon artificiel - Google Patents

Sonde de mesure des caracteristiques du sang, organe artificiel du systeme cardiovasculaire et poumon artificiel Download PDF

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Publication number
WO2007105805A1
WO2007105805A1 PCT/JP2007/055302 JP2007055302W WO2007105805A1 WO 2007105805 A1 WO2007105805 A1 WO 2007105805A1 JP 2007055302 W JP2007055302 W JP 2007055302W WO 2007105805 A1 WO2007105805 A1 WO 2007105805A1
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WO
WIPO (PCT)
Prior art keywords
blood
light
artificial
light receiving
wavelength
Prior art date
Application number
PCT/JP2007/055302
Other languages
English (en)
Japanese (ja)
Inventor
Toshitaka Yasuda
Akio Funakubo
Setsuo Takatani
Seishi Iyama
Toshiyasu Yuba
Original Assignee
Kawasumi Laboratories, Inc.
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 Kawasumi Laboratories, Inc. filed Critical Kawasumi Laboratories, Inc.
Priority to JP2008505210A priority Critical patent/JP4944093B2/ja
Publication of WO2007105805A1 publication Critical patent/WO2007105805A1/fr

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Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/25—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
    • G01N21/31—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
    • G01N21/35—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using infrared light
    • G01N21/359—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using infrared light using near infrared light
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • A61B5/14551—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases
    • A61B5/14552—Details of sensors specially adapted therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • A61B5/14551—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases
    • A61B5/14557—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases specially adapted to extracorporeal circuits
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/367—Circuit parts not covered by the preceding subgroups of group A61M1/3621
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3306—Optical measuring means

Definitions

  • the present invention is capable of measuring multiple blood characteristics simultaneously by projecting (irradiating) near-infrared light to blood and measuring the intensity of the reflected light of globin contained in red blood cells. : ', And the blood characteristic measurement probe, and the circulatory system artificial organ and the artificial lung in which the blood characteristic measurement probe is installed.
  • the present invention relates to circulatory system artificial organs, artificial lungs, and related devices in general that can control oxygen gas flow rate and Z or blood flow rate based on the measurement data of the blood characteristic measurement probe and can automatically optimize them.
  • Measurement and evaluation of blood characteristic values in circulatory system artificial organs such as artificial heart for example, hematocrit: oxygen value, oxygen saturation, etc., the blood flow rate that the artificial heart pumps out, oxygen consumption of living tissue ⁇ It is used as an index for automatic control according to.
  • These measurements are non-invasive methods using light, and irradiate blood (red blood cells) with a multi-wavelength light source and estimate the oxygen saturation from the reflected light intensity ratio.
  • the blood flow of the artificial heart is controlled by comparing the oxygen saturation of blood with different body circulation and pulmonary circulation, and estimating and calculating the oxygen consumption of the living body.
  • the hemoglobin concentration in the flowing blood at any site inside the artificial heart during operation is essential. All of these four blood characteristic measurement items are indispensable, and only when all of them are measurable, the practical use of circulatory prosthetic organs such as an artificial heart can be achieved completely.
  • PCPS Percutaneous Circulatory Pulmonary System
  • ECMO Extra Corporal Membrane Oxygenator
  • I VOX Extra Venous oxygenator, intravenous used for patients with severe heart failure and respiratory failure Type oxygenators
  • respiratory assist devices artificial lungs
  • the extracorporeal circulation devices such as these breathing assistance devices
  • the oxygen (air) gas flow rate and blood circulation volume are always controlled by human operations such as ME (Medical Engineering) engineers.
  • ME Medical Engineering
  • these artificial lungs are applied from environments with specialized equipment to environments closer to daily life, such as disaster areas and SARS (Severe Acute Respiratory Syndrome (Severe Acute Respiratory Syndrome) Expected to be applied to transcutaneous respiratory assistance for infectious diseases such as countermeasures.
  • SARS severe Acute Respiratory Syndrome
  • thrombus formation in artificial lungs is thought to be due to the mechanism by which small thrombus aggregates gather in hollow fiber bundles and large thrombus is formed. Therefore, in order to solve the problem related to thrombus, the thrombus formation process can be solved in detail by monitoring the blood flow in the vicinity of the hollow fiber in real time. It is essential to clarify.
  • blood flow near the hollow fiber membrane and blood oxygen saturation must be measured in order to achieve further miniaturization of the artificial lung (membrane type lung) and higher gas exchange capacity.
  • the conventional method of measuring oxygen saturation in an oxygenated lung by blood sampling does not know the distribution of oxygen saturation inside the oxygenator, so the gas exchange efficiency with respect to the hollow fiber membrane area cannot be measured correctly. Therefore, in the development and clinical application of an oxygenator, it is strongly desired that blood characteristics can be measured in real time at any site within the oxygenator.
  • the local hematocrit value that depends on the blood flow in the oxygenator during the development stage or clinical use of the artificial ⁇ ! Measurement is required.
  • artificial lungs that are considered for implantation and carrying are different from fast-flowing artificial organs such as an artificial heart, so there is a high probability that thrombus will be formed. Therefore, it is necessary to constantly monitor the stagnation part of the flow inside the oxygenator and to have a function that enables self-diagnosis such as forcible flow when a condition that facilitates thrombus formation occurs.
  • This method does not have the trouble of processing for transmitting light as in the past, that is, destroying red blood cells or diluting it several hundred times with distilled water, and the measurer only measures the reflected light intensity. According to the above formula, it is assumed that the hemoglobin concentration can be easily measured.
  • Patent Document 2 Japanese Examined Patent Publication No. 0 7-1 1 3 6 0 4 (Patent Document 2) relates to an apparatus for measuring hemoglobin relating to the improvement of the above method, and the extinction coefficient depends on the oxygen saturation of hemoglobin in blood.
  • Patent Document 2 a specific example of a sensor probe having a light irradiation part of a light irradiation means and a light detection part of a light detection means is described in FIG. 1 and FIG.
  • the distance between the centers of the first and second light irradiating parts formed by the end faces of the first and second optical fibers and the light detecting part formed by the end faces of the receiving optical fibers is 0.25 respectively. mm and 0.5 0 mm, so that the distance between them is different, so that hemoglobin concentration can be measured accurately and easily continuously without the need to hemolyze the blood to be measured.
  • Patent Document 3 Japanese Patent Publication No. 0 6-2 9 8 50 (Patent Document 3) relates to an oxygen saturation measuring apparatus, which has a first light irradiation function for irradiating blood with light having a first wavelength. And a second light irradiation function for irradiating light of the second wavelength in which the absorption coefficients of oxygenated hemoglobin and reduced hemoglobin are approximately equal, and a third light irradiation for irradiating light of the same wavelength as the second wavelength
  • a light irradiating means having a function, a detecting means for detecting reflected light intensity provided at a specific distance therefrom, and a third reflected light intensity signal to reduce measurement errors caused by hemoglobin concentration, etc.
  • the correction value (I 1 – C 1) and the second reflected light intensity of the first reflected light intensity signal (II) Calculate the correction value (I 2— C 1) of the signal (I 2) and use the correction value (I 1— C 1) and (1 2— C 1)
  • Patent Document 3 a specific example of a sensor probe having the light irradiation part of the light irradiation means and the light detection part of the light detection means and having the same form as that of Patent Document 2 is described in FIG. 1 and FIG. Yes.
  • First and second light sources formed by the end face of the optical fiber Similarly, the distances between the centers of the light emitting portion and the light detecting portion formed by the end face of the light receiving fiber are 0.25 mm and 0.50 mm, respectively.
  • the distance is set to 0.9 mm or more as defined by the present invention. This is essential, and if it is less than 0.9 mm, the reliability of the data is significantly reduced.
  • Non-patent document 1 can measure the thrombus formation process of blood passing through the flow cell from the intensity of reflected light and the amplitude of the optical sensor (probe). It is shown.
  • This means for detecting the thrombus formation process is to detect the thrombus formation process by frequency analysis of the intensity of scattered light that changes due to changes in the shape and concentration of red blood cells flowing on the sensor surface.
  • the light emission / light reception distance of the optical sensor (the interval between the light irradiation part at the front end of the light emitting part and the light detection part at the front end of the light receiving part in the present invention: equivalent to SD) is 0.25. Because of the mm, the reflected light has a characteristic that maximizes when the hematocrit value H et is 50%. In other words, when Het fluctuates around 50%, it is difficult to determine whether Het is increasing or decreasing in the detection range of the optical sensor.
  • the light source uses a peak wavelength of 6 3 2 nm, the value of the scattered light intensity measured by the oxygen saturation greatly changes.
  • the probe of this optical sensor is a light source with a single wavelength of incident light, it can qualitatively measure the movement of red blood cells, but it cannot measure physical properties such as oxygen saturation and hematocrit. There was also.
  • the blood characteristic measurement device is provided with a separate flow cell in the blood circulation circuit depending on the sensor structure and measurement method, or a method for measuring the characteristics of blood flowing in the flow cell, or a sensor directly in the blood circuit. It is done by the method of incorporation. For this reason, an increase in the blood filling amount of the blood circulation circuit and an increase in electrical wiring for measuring blood characteristics increase the complexity of the periphery of the blood circulation circuit. Furthermore, conventional blood characteristic measurement systems are not suitable for measuring multiple pieces of information at the same time because they have introduced a single design and signal analysis algorithm according to the measurement target item.
  • circulatory prosthetic organs that are assumed to be implanted or portable are required to have a blood flow rate suitable for the amount of biological activity and oxygen supply to the blood.
  • the oxygen saturation which is a basic blood characteristic, is not greatly affected by changes in hemoglobin concentration, as described below.
  • a blood characteristic measurement probe that can be optically measured is provided. 1. Irradiate blood with near-infrared light of the first wavelength ⁇ 1 (805 ⁇ 30 (775 to 835) nm) and Z or the second wavelength ⁇ 2 (660 earth 60 (600 to 720) nm) A light irradiation part (3), and a light receiving part (4) for reflected light of near-infrared light irradiated on the blood,
  • the light irradiation part (3) and the light receiving part (4) are arranged substantially in parallel,
  • a blood characteristic measuring probe (1) comprising at least 9 to 3.0 mm as an optical transceiver (2).
  • the light irradiator (3) in the optical transceiver (2) is composed of one or two or more irradiation optical fibers (5), and the light receiver (4) is at least one or more.
  • the irradiation optical fiber (5) is connected to the light emitting element (13), the light receiving optical fiber (6) is connected to the light receiving element (14),
  • the optical transmitting / receiving unit (2) including the irradiation optical fiber (5) and the light receiving optical fiber (6) includes an electronic circuit unit (3 0) including the light emitting element (13) and the light receiving element (14). 3.
  • the optical transmission / reception unit (2) including the irradiation optical fiber (5) and the light receiving optical fiber (6) is liquid-tightly covered with a sheath (21).
  • the blood characteristic measuring probe according to any one of 1 force, et al. (1).
  • the blood characteristic measuring probe according to any one of 1 to 4 above, wherein the oxygen saturation level in the blood can be measured by measuring (1).
  • an artificial organ in particular, an artificial lung, an artificial lung including a portable / implantable type that can be mounted with the blood characteristic measurement probe of the present invention and can monitor blood characteristics flowing in the artificial organ by the measurement probe is provided.
  • the blood characteristic measurement probe according to any one of 1 to 5 described above is disposed at a plurality of locations in the artificial organ at the same time.
  • the above-mentioned circulatory system artificial organ characterized in that it can measure blood characteristics of blood.
  • a circulatory system artificial organ provided with a hollow fiber membrane, wherein the blood characteristic measurement probe according to any one of 1 to 5 is knitted in the hollow fiber membrane.
  • the circulatory system artificial organ as described in Crab.
  • the circulatory system artificial organ according to any one of 6 to 9 above, which is an implantable type or a portable type.
  • a cardiovascular prosthetic organ that is transferred by wire or wirelessly and can optimize the gas flow rate and Z or blood flow rate to the circulatory prosthetic organ by constructing an algorithm based on this information.
  • FIG. 1 is a schematic explanatory view of a blood characteristic measuring probe of the present invention
  • FIG. 2 is a schematic view of a blood characteristic measuring probe of the present invention
  • (A) is a perspective view
  • (B) is a side view
  • (C) is a front view
  • FIG. 3 is a schematic explanatory diagram of an artificial lung equipped with the blood characteristic measurement probe of the present invention
  • FIG. 4 is a correlation between the wavelength of light irradiated on blood and the light absorption coefficient.
  • the is a graph showing the case of a blood oxygen saturation 1 0 0% (H b0 2 (oxygenated hemoglobin)) If the oxygen saturation of 0% (11 (reduced hemoglobin)).
  • Figure 5 shows the hematocrit value and reflected light intensity (relative reflectance) when the distance (SD) between the center (7 C) of the light irradiation tip and the center (8 C) of the light detector (8) is changed.
  • Fig. 6 is a graph showing the correlation between the reflected light intensity and the hematocrit value
  • Fig. 7 is a graph showing two wavelengths (830/730 nm and 830/730 nm). It is a graph which shows the correlation of the measurement result of reflected light ratio (Reflected light intensity) in 830/660 nm) and OS (oxygen saturation: Oxygen Saturation).
  • Fig. 6 is a graph showing the correlation between the reflected light intensity and the hematocrit value
  • Fig. 7 is a graph showing two wavelengths (830/730 nm and 830/730 nm). It is a graph which shows the correlation of the measurement result of reflected light ratio (Reflected light intensity) in 830/660 n
  • FIG. 8 is an explanatory diagram of an experimental device with a closed circuit including a magpie for experimenting with the thrombus formation process and the correlation between peeling and reflected light intensity.
  • Fig. 9 shows the inside of the flow cell used in Fig. 8.
  • Figure 10 shows the position of the blood flow analysis and blood characteristic probe, and Fig. 10 shows the backscattered light intensity in each process from the thrombus formation process to separation in the experimental apparatus shown in Fig. 9. ) (Wavelength 810 nm), and
  • Fig. 11 is a graph showing the measurement results of the reflected light intensity and oxygen saturation of the blood characteristic measurement probe to be attached to the artificial lung. The figure shows the measurement results when oxygen saturation is measured with a blood property measurement probe attached to an artificial lung.
  • 1, 1 A, 1 B, 1 C, 1 1 are blood characteristic measurement probes
  • 2 is optical transmission Receiving unit
  • 3 is a light irradiation unit
  • 4 is a light receiving unit
  • 5 is an optical fiber for irradiation
  • 6 is a light receiving optical fiber
  • 7 is a light irradiation tip
  • 7 C is the center of the light irradiation tip
  • 8 is light Detection unit
  • 8C is the center of the light detection unit
  • 13 is a light emitting device (light emitting diode, etc.)
  • 14 is a light receiving device (photodiode, etc.)
  • 21 is a sheath
  • 30 is an electronic circuit unit
  • 50 is an artificial lung
  • 53 is the blood outlet
  • 54 is the hollow fiber membrane (bundle)
  • 5 is the blood pump
  • 56 is the (electromagnetic) valve
  • 57 is the gas cylinder
  • USCPU is a storage device
  • 63 is a display means such as a display
  • 64 is a wireless receiver
  • 70 is a closed circuit
  • 71 is a flow cell
  • 72 is a roller pump
  • the blood characteristic measurement probe 1 of the present invention can be schematically described as follows. As illustrated in FIG. 1, the blood has a first wavelength ⁇ 1 (805 ⁇ 30 nm (600 to 720 nm)) and Z or second. A light irradiator 3 that emits near-infrared light having a wavelength ⁇ 2 (660 ⁇ 60 nm (775 to 835 nm)) and a light-receiving unit 4 that reflects reflected light of near-infrared light irradiated on blood.
  • the transmitter / receiver 2 includes at least the transmitter / receiver 2, and the optical transmitter / receiver 2 is characterized by being provided separately from the light emitting element 13 and the electronic circuit unit 30 including the light receiving element 14.
  • the light irradiating unit 3 in the optical transmitting / receiving unit 2 is composed of one or two or more irradiation optical fibers 5, and the light receiving unit 4 includes at least one light receiving optical fiber 6.
  • the irradiating optical fiber 5 is connected to the light emitting element 13, and the light receiving optical fiber 6 is connected to the light receiving element 14.
  • the blood characteristic measurement probe 1 of the present invention includes an arrangement of the light irradiation unit 3 and the light receiving unit 4 in the optical transmission / reception unit 2.
  • the light irradiation unit 3 and the light receiving unit 4 are arranged substantially in parallel, and the center of the light irradiation tip 7 at the tip of the light irradiation unit 3 and the light detection of the tip of the light receiving unit 4 are detected.
  • the feature is that the distance of the center 8 C of the part 8 (SD, Separate Distance) (hereinafter simply referred to as “light irradiation part 3—light receiving part 4 distance”) is set to 0.9 to 3.0 mm. .
  • a plurality of light emitting units 3 are arranged around the light receiving unit 4, but a plurality of light receiving units 4 may be arranged around the light emitting unit 3 ′.
  • the Figure 4 is a correlation relationship between the wavelength and the light absorption coefficient of the light irradiated on the blood, from FIG. 4 is a graph showing Hb0 2 and (oxygenated hemoglobin) for Hb (reduced hemoglobin), to correctly measure the hemoglobin concentration
  • ⁇ ⁇ 805 ⁇ 30 (775 to 835) nm
  • ⁇ 1 a wavelength in the vicinity of the so-called “isobestic wavelength” is selected as ⁇ 1.
  • the second wavelength ( ⁇ 2) (660 ⁇ 60 (600 to 720) nm) is used to measure the oxygen saturation level of blood. Since the absorbance of near-infrared light having a wavelength of ⁇ 2 is extremely high when hemoglobin is in an oxidized state, the intensity of reflected light of the near-infrared light of ⁇ 2 (660 ⁇ 60 nm) is measured. The oxygen saturation concentration can be measured accurately.
  • the light emitting element 1 3 in the electronic circuit section 30 has an LED (Light Emitting Diode) LD (Laser Diode) is preferably used, and a photodiode (also referred to as a phototransistor) is preferably used for the light receiving element 14.
  • LED Light Emitting Diode
  • a photodiode also referred to as a phototransistor
  • the wavelength of the LED or the like which is the light emitting element 1 3 is appropriately selected and used depending on the blood characteristics to be measured.
  • the reflected light captured by the light receiving element 14 is converted into a signal voltage and amplified by an amplifier system (not shown).
  • the amplified signal is sent to an arithmetic control unit and subjected to arithmetic processing by the CPU (central processing unit) to measure a blood characteristic value, and the result is displayed on a display such as an LCD. Can be displayed.
  • the light irradiating unit 3 in the optical transmitting / receiving unit 2 includes one or two or more irradiation optical fibers 5, and the light receiving unit 4 includes at least one or more light receiving optical fibers 6. It is configured.
  • the optical transmission / reception unit 2 including the irradiation optical fiber 5 and the light receiving optical fiber 6 is liquid-tightly coated with the sheath 21 as shown in FIGS. 1 and 2. . '
  • the sheath 21 is flexible, sterilizable and disposable. It is preferable to form with a material.
  • the disposable material is not particularly limited, but an appropriate polymer material is usually selected and used.
  • polymer material for example, polyolefins such as polyethylene and polypropylene, polyurethane, polyamide, polyethylene terephthalate, vinyl chloride resin, fluororesin, PMMA, etc. are preferable. Materials with less are desirable.
  • the number of the irradiation optical fibers 5 in the light irradiation section 3 to be coated is as follows.
  • One irradiation optical fiber 5 has a first wavelength ⁇ 1 (80 5 ⁇ 30 nm) and a second in the blood.
  • a function of irradiating near-infrared light having a wavelength of ⁇ 2 (6 60 ⁇ 60 nm) may be added, or two or more optical fibers for irradiation 5 may be arranged, and each of the first wavelengths A function of irradiating ⁇ 1 and the second wavelength ⁇ 2 may be added.
  • the blood characteristic measurement probe 1 of the present invention irradiates blood with the above-mentioned specific wavelengths ⁇ 1 and ⁇ 2, and measures the reflected light intensity, thereby measuring hemoglobin in blood.
  • Various blood properties such as bottle concentration, hematocrit, thrombus formation, and oxygen saturation can be measured simultaneously.
  • the hematocrit value is measured by irradiating blood with near-infrared light and measuring the intensity of the reflected light.
  • a wavelength ⁇ 1 80 5 ⁇ 30 ⁇ m is preferably used in which the absorbance is not affected by the oxidation state of hemoglobin.
  • the hematocrit value and reflected light intensity differ slightly depending on the wavelength
  • the intensity has a strong linear correlation. Therefore, by using the relational expression, the hematocrit value can be easily measured from the reflected light intensity.
  • Fig. 6 shows an example of blood characteristics measurement results when the oxygen saturation is 0 to 100% and the hematocrit value is 20 to 50%.
  • the figure shows the relationship between the hemoglobin concentration and the reflected light intensity when the light irradiation part 3—light receiving part 4 distance (SD) is 2.1 mm.
  • a thrombus is an abnormal increase in local hematocrit. When a thrombus grows, it interferes with the normal blood flow in the blood vessel, causing various symptoms.
  • blood clots can be generated even in blood circuits of artificial organs such as heart-lung machines at sites where blood flow stagnate (for example, hollow fiber membranes in the case of artificial lungs) when operated for a long time. Formation and growth can be a major cause of malfunction of the organ. Thus, for example, it is important to continuously monitor and confirm the thrombus formation status in the bloodstream even during the operation of the artificial organ.
  • a measurement method for enabling confirmation of the thrombus formation status it is preferable to irradiate blood with near infrared light and measure the intensity of the reflected light.
  • the thrombus is recognized as a local increase in hematocrit, the absorbance of red blood cells increases and the intensity of reflected light decreases as thrombus formation * growth occurs.
  • the near-infrared wavelength for measuring the hematocrit value near-infrared light having a wavelength ⁇ 1 (8 0 5 ⁇ 30 nm) in which the absorbance is not affected by the oxidation state of hemoglobin is preferably used.
  • the measurement method that measures the oxygen saturation level of blood is possible to irradiate blood with near infrared light of two or more wavelengths and measure the intensity of the reflected light.
  • the absorbance (light absorption coefficient) when blood is irradiated with near-infrared light having a wavelength of about 2 (660 nm) is extremely high if hemoglobin is in an oxidized state. Become. Therefore, it is possible to measure the oxygen saturation concentration of blood by measuring the reflected light intensity of near-infrared light around 66 nm.
  • the absorbance when blood is irradiated with near-infrared light varies greatly depending on its hemoglobin concentration and hematocrit value.
  • Fig. 7 shows the results of Example 3 to be described later.
  • the relationship between oxygen saturation and reflected light intensity can generally be predicted by linear linearity, but here a higher degree of correlation is obtained by arranging it as a second-order linear as shown in the figure. Was confirmed.
  • the blood characteristic measurement probe of the present invention was created by applying a three-dimensional diffusion theory.
  • the blood characteristic measurement probe 1 of the present invention in a circulatory system artificial organ, particularly an artificial lung, the blood characteristic measurement probe 1 of the present invention described above is installed inside, and the hemoglobin concentration of blood flowing in the artificial organ by the measurement probe, hematocrit All blood properties can be measured, including value, thrombus formation, and oxygen saturation.
  • the blood characteristics measurement probe 1 of the present invention is arranged at a plurality of locations of the artificial organ, so that blood characteristics at a plurality of locations can be measured simultaneously.
  • the blood characteristic measurement probe of the present invention can be knitted into the hollow fiber membrane.
  • the circulatory system artificial organ is preferably implantable or portable.
  • the arithmetic and control unit includes a storage device composed of ROM and RAM, and stores the data in the RAM.
  • the ROM also stores the OS program and the reflected light intensity data described above into the moglobin concentration, A program that calculates all blood characteristics of the matocrit value, thrombus formation status, and oxygen saturation concentration is stored, and accordingly, these blood characteristic values are immediately calculated from the transmitted measurement data. Calculated.
  • a construction algorithm that controls the oxygen gas flow rate and / or blood flow rate to the circulatory prosthetic organ is added to the ROM.
  • the arithmetic and control unit builds a control system that automatically controls and optimizes the gas and blood flow to the artificial organ within the optimal range. be able to.
  • an oxygenator equipped with the blood characteristic measurement probe of the present invention by constructing the control system as described above, percutaneous breathing assistance in a disaster-stricken area, etc., and rehabilitation with a portable oxygenator are possible. It becomes. It also contributes to reducing the workload of ME engineers and improving the patient's quality of life (QOL) when used in hospitals. Furthermore, it will enable early use of implantable oxygenators or portable oxygenators.
  • a single blood characteristic measurement probe may be used so that all of the above items can be measured, or a plurality of blood characteristic probes are provided, each of which is divided into roles, You may make it measure with another independent blood characteristic measurement probe.
  • the blood characteristic measurement probe 1 of the present invention is disposed at a plurality of locations of the artificial organ, respectively, so that blood characteristics of a plurality of sites can be simultaneously measured. It can be measured.
  • a blood characteristic measurement probe is attached to a plurality of locations in the oxygenator, particularly where the blood flow changes or where a specific blood characteristic value is required to be maintained in a specific part. It is preferable to measure blood characteristics at a plurality of sites simultaneously.
  • the blood characteristic measurement probe of the present invention that can constantly monitor (monitor) the thrombus formation status at a site where the flow rate is slow and thrombus formation is predicted, or blood oxygen saturation before and after the gas exchange section It is possible to comprehensively manage the cardiopulmonary bypass by installing a blood characteristic measurement probe to measure the concentration and check whether the oxygen saturation concentration has reached the reference value.
  • the blood characteristic measurement probe of the present invention in the circulatory organ prosthesis provided with the hollow fiber membrane as described above, the blood characteristic measurement probe of the present invention can be knitted into the hollow fiber membrane.
  • the light irradiating part and the light receiving part are formed of an optical fiber and have a very thin and flexible tip end covered with a flexible sheath. Therefore, the probe can be knitted together in the hollow fiber of the artificial lung.
  • the organ is filled with a fluid and flowed
  • the blood characteristic measurement probe of the present invention is inserted into the organ
  • light is irradiated from the light irradiation unit 3 at that position
  • the reflected light is received by the light receiving unit.
  • the reflected light received by the light-receiving unit 4 absorbs, shields, and scatters substances that have some effect (may be liquid or fine particles) as tracers upstream of the flow path.
  • At least one shot (ie as a pulse) flows through the liquid and downstream of the flow path.
  • FIG. 3 is a schematic diagram of a circulatory system artificial organ (artificial lung) 50 in which the blood characteristic measurement probe 1 is disposed and attached.
  • a method for attaching a probe and measuring blood characteristics for an example of an artificial lung 50 will be described.
  • 51 is a housing
  • 52 is a blood inlet to the oxygenator
  • 53 is a blood outlet
  • 54 is a hollow fiber membrane (bundle)
  • 55 is a roller pump or a centrifugal pump, etc.
  • Blood pump 5 6 (electromagnetic) valve
  • 5 7 gas cylinder
  • the blood with low oxygen saturation (reduced hemoglobin: H b) flowing in from the inlet 52 is brought into contact with the hollow fiber membrane 54, thereby supplying the air supplied from the gas cylinder connecting pipe 57 to the valve 56.
  • Or oxygen and blood with high oxygen saturation (oxygenated globin: H b 0 2 ) flows out from 53.
  • a low-speed part where the blood flow is slow in the artificial lung 50 (for example, in FIG. 3, the part opposite to the blood outlet 53 in the upper right of the housing 51 (Part) is expected to be prone to blood clots.
  • the value of oxygen saturation is measured as the most important factor in the human lung, and the oxygen saturation exceeds a predetermined value. It is necessary to always monitor and manage what is secured. For example, three measurement probes 1 A, 1 B, and 1 C are attached to these parts as shown in the figure.
  • 58 is a wireless transmission unit
  • 60 is an arithmetic processing control device equipped with a receiver
  • 61 is a CPU
  • 62 is a storage device
  • 63 is a display means such as a display.
  • 6 4 is a wireless receiver.
  • the information (measurement data) from each probe 1A, 1B, and 1C is sent to the embedded or wearable wireless transmitter 5 8 for data processing and computation processing. Therefore, it is preferable to use a system that transmits to the radio receiving unit 64 (embedded type or wearable type) of the arithmetic processing control device 60 having a receiver.
  • the arithmetic processing control device 60 includes a central processing unit (C PU) 6 1, a storage device 6 2, display means 6 3, a wireless receiver 6 ′ 4, and the like.
  • the storage device 62 is composed of ROM and RAM, and the measurement data from each probe is stored and recorded in the RAM, and the OS program and the reflected light intensity data described above are stored in R 0 M.
  • a program that calculates all blood characteristics of moglobin concentration, hematocrit value, thrombus formation status, and oxygen saturation concentration is stored, and various blood characteristic values are calculated by this program.
  • each probe 1 A, 1 B, 1 C blood characteristic data in each part 1 A, 1 B, 1 C transferred by radio is stored in the arithmetic processing control device.
  • the result is processed, and the result is displayed in real time on display means 63, for example, an LED display.
  • control program for controlling the Z or blood flow rate is stored in the ROM, and the arithmetic processing control device uses the control program to determine the gas flow rate to the artificial organ 50 based on the measurement data. It is possible to construct a control system that automatically controls the blood flow to the optimum range and optimizes it.
  • the blood characteristic measurement probe of the present invention has the following advantageous features or effects.
  • the blood characteristic measurement site at the tip thereof (the optical transmission / reception unit including the light irradiation unit 3 and the light receiving unit 4) is separated from the light emitting element and the electronic circuit unit including the light receiving element. It is not a mechanism or shape that causes a change in the blood flow.
  • the optical transmission / reception unit including the light irradiation unit 3 and the light receiving unit 4 is composed of the light emitting optical fiber 5 and the light receiving optical fiber 6, so that it can be easily installed at an arbitrary position. It can be easily installed at the manufacturing stage of the circulatory prosthetic organ to be measured.
  • the light emitting optical fiber 5 and the light receiving optical fiber 6 are connected to the light emitting element 13 and the light receiving element 14, respectively, and the optical transmission / reception unit 2 and the electric circuit unit 30 can be separated.
  • the electric circuit part including the element and the light receiving element can be used repeatedly, and only the optical transmission / reception part 2 made of an optical fiber can be used as a disposable.
  • An artificial lung including a circulatory system artificial organ, a portable type, and an implantable type equipped with a blood characteristic measurement probe according to the present invention has the following advantageous effects.
  • the first wavelength ⁇ 1 (805 ⁇ 30 (775 to 835) ⁇ m is used to measure blood characteristics at sites with relatively slow flow, such as blood inlet and outlet in the oxygenator.
  • a light emitting unit 3 that emits near-infrared light having a second wavelength ⁇ 2 (660 ⁇ 60 (600 to 720) nm) and a light-receiving unit 4 that reflects this near-infrared light are directly connected to an artificial lung.
  • Blood characteristics can be measured by embedding it in the wall of the internal blood channel or by attaching it from the outside.
  • the tip of the probe is mainly composed of an optical fiber.
  • a hollow fiber bundle that forms an artificial lung (membrane-type artificial lung) by covering an optical fiber having such a small diameter and a relatively flexible structure with a flexible grease 21.
  • Yarn membrane where blood and oxygen come into contact with each other through the hollow fiber membrane, and oxygen moves to the blood
  • the blood characteristic measurement probe placed in the hollow fiber bundle has two diameters, a light-emitting optical fiber 5 and a light-receiving optical fiber 6, each of which has a diameter and does not disturb the blood flow.
  • a flow cell 71 was connected to a living body (rabbit), and a closed circuit 70 that circulated blood 7 3 (oxygen saturation 99 ⁇ 0.5%) by a roller pump 72 was produced.
  • a closed circuit 70 that circulated blood 7 3 (oxygen saturation 99 ⁇ 0.5%) by a roller pump 72 was produced.
  • the closed circuit 70 when blood circulation was continued, as the circulation time became longer, a thrombus occurred in a portion where the flow velocity in the circuit was slow.
  • Fig. 9 shows the flow velocity analysis in the flow cell used in Fig. 8 and the location of the blood characteristics probe.
  • the flow cell 71 has a low flow velocity region 1 ⁇ and a high flow velocity.
  • Site L 2 is present and a thrombus is usually formed at this low flow rate site 1 ⁇ .
  • a blood characteristic measurement probe 1 having a light emitting part 3 and a light receiving part 4 of wavelength ⁇ 1 (8 1 0 nm) (measuring the thrombus formation state) was attached to the low flow velocity part 1 ⁇ .
  • FIG. 10 shows an example of the experimental results.
  • the roller The reflected light intensity varies periodically according to the period of the pump 72.
  • a thrombus is formed at the low flow rate 1 ⁇ ( ⁇ ), and the amplitude and average value of the reflected light intensity decrease (C).
  • red blood cells coagulate, and finally a red blood cell group (thrombus mass) in a region where blood characteristic measurement probe 1 can detect is detected, but the thrombus mass is not affected by the flow and remains as it is. This is because it maintains the shape.
  • bovine blood has a hematocrit value of 10 to 80% and oxygen saturation of 0 to 100%. It adjusted so that it might become.
  • the near-infrared light irradiation part 3 (luminance 1 2 0 0) with a wavelength ⁇ 1 (8 3 0 nm) where the absorbance of oxyhemoglobin (H b 0 2 ) is low 111, 1, forward current 2 O mA) 6 in a circular shape, and the blood characteristic measuring probe of the present invention is arranged so that there is one light receiving portion 4 in the center thereof. 1 was installed.
  • the correlation between the hematocrit value and the reflected light intensity was measured with the above-adjusted sample using the blood characteristic measurement probe 1 designed with an SD of 2.1 mm.
  • the measurement results are shown in Fig. 6. From the experimental results, it was found that there is a strong correlation between the hematocrit value and the intensity of the reflected light. From the above results, it was confirmed that it is possible to accurately obtain a hematocrit value of 20% or more by measuring the reflected light intensity.
  • the reflected light intensity was measured for blood characteristics similar to Example 2 using a blood characteristic measurement probe 1 (with built-in light source wavelengths: 830, 730, and 660 nm) designed to have an SD of 2.1 mm.
  • the results are shown in Fig. 7.
  • the figure shows the correlation between reflected light archivities i R (Reflected light intensity) and OS (Oxygen Saturation) at two wavelengths ( ⁇ 1 / ⁇ 2) (830/730 nm and 830/660 nm) It is expressed as a graph. From each experimental result, it was confirmed that the oxygen saturation OS with respect to the reflected light intensity ratio R obtained a high correlation of 0.95 or higher by the second-order linear approximation.
  • 'A blood cell and a flow cell equipped with a blood characteristic measurement probe are connected by an artificial cardiopulmonary circuit (made by Kawasumi Chemical Industry Co., Ltd.), and a closed circuit (not shown) that circulates blood by a roller pump is created. 37 heparinized blood was circulated. A blood characteristic measurement probe was installed in the circuit, and blood characteristics were measured. Blood characteristics measurement The probe has the same shape as that used in Example 1, and measurement probes with irradiation wavelengths of ⁇ ⁇ (81 0 nm) and ⁇ 2 (645 nm) are installed in the flow cell for measurement. did. As shown in Fig. 11, it is confirmed that the oxygen saturation OS and the reflected light intensity ratio R (81 0/645 nm) have a high correlation coefficient of 0.97 or higher.
  • blood characteristic measurement probes irradiation light wavelength ⁇ 1 (810 nm), ⁇ 2 (64 5 nm)
  • ⁇ 1 810 nm
  • ⁇ 2 64 5 nm
  • An experiment was conducted to measure the correlation between oxygen saturation and reflected light intensity.
  • a blood reservoir and an artificial lung model are connected by an artificial cardiopulmonary circuit, a closed circuit that circulates blood by a roller pump is created, and heparinized cow blood is circulated in the closed circuit. It was.
  • the oxygen saturation in the circulation circuit was adjusted by flowing oxygen gas and carbon dioxide gas through the artificial lung model. The results are shown in Figure 12. From the figure, it is confirmed that the oxygen saturation OS and the reflected light intensity ratio (810 645 nm) are 0.68 or more.
  • the figure shows the correlation between this ratio (R810 / R645), its square root “sqrt”, and the natural logarithm “In (R810 / R645)” and oxygen saturation (OS). It is a thing. From the figure, it is estimated that the correlation between oxygen saturation (OS) and natural logarithm “In (R810ZR645)” is the least error based on the slope.
  • the blood property measurement probe of the present invention has a structure in which a blood property measurement site (near infrared light irradiation part or the like) at the tip is separated from an electronic circuit part including a light emitting element and a light receiving element. It does not have a shape that disturbs the flow, and because it is composed of optical fibers, it can be easily installed at any position, and only the optical transmission / reception unit made of optical fibers is disposable (disposable). Can be used as
  • the light transmitting / receiving unit is placed on the wall surface of the blood flow path at a site where the flow is slow and a blood clot easily occurs.
  • the thrombus can be easily woven into the raw membrane so that it becomes a measurement target.
  • the measurement position in the hollow fiber bundle can be determined arbitrarily. That is, the industrial applicability is very large.

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Abstract

L'invention concerne une sonde de mesure des caractéristiques du sang (1) revêtue de manière étanche aux liquides d'une gaine (21) comprenant une unité d'application de la lumière (3) destinée à appliquer des lumières proche infrarouge d'une première longueur d'onde λ1 (805±30 nm) et d'une seconde longueur d'onde λ2 (660±60 nm) dans le sang et une unité de réception de la lumière (4) destinée à recevoir la lumière réfléchie de la lumière proche infrarouge appliquée dans le sang, l'unité d'application de la lumière (3) et l'unité de réception de la lumière (4) étant disposées sensiblement en parallèle, l'intervalle (SD) entre le centre (7C) à l'extrémité distale (7) de l'unité d'application de la lumière (3) et le centre (8C) à l'extrémité distale (8) de l'unité de réception de la lumière (4) étant réglé à une distance de 0,9 à 3,0 mm afin de constituer une unité de transmission/réception de la lumière (2) séparée d'une unité de circuit électronique (30) comprenant un élément d'émission de la lumière (13) et un élément de réception de la lumière (14), l'unité d'application de la lumière (3) et l'unité de réception de la lumière (4) étant respectivement constituées d'une fibre optique irradiante (5) et d'une fibre optique receveuse (6).
PCT/JP2007/055302 2006-03-10 2007-03-09 Sonde de mesure des caracteristiques du sang, organe artificiel du systeme cardiovasculaire et poumon artificiel WO2007105805A1 (fr)

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JP2017150966A (ja) * 2016-02-25 2017-08-31 国立研究開発法人産業技術総合研究所 血液のフィブリン量変化の計測方法
JP2017525503A (ja) * 2014-08-29 2017-09-07 フレゼニウス カービ ドイチュラント ゲーエムベーハー 血液処理装置において用いるチューブセット
JP2017526441A (ja) * 2014-08-29 2017-09-14 フレゼニウス カービ ドイチュラント ゲーエムベーハー 測定器用のホルダー器具を備える血液処理装置
JP2017529150A (ja) * 2014-08-29 2017-10-05 フレゼニウス カービ ドイチュラント ゲーエムベーハー 測定器を備える血液処理装置
CN110554087A (zh) * 2019-09-18 2019-12-10 哈尔滨工业大学 一种检测血凝块的装置
WO2023058732A1 (fr) * 2021-10-08 2023-04-13 日機装株式会社 Dispositif de purification du sang

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JP2017525503A (ja) * 2014-08-29 2017-09-07 フレゼニウス カービ ドイチュラント ゲーエムベーハー 血液処理装置において用いるチューブセット
JP2017526441A (ja) * 2014-08-29 2017-09-14 フレゼニウス カービ ドイチュラント ゲーエムベーハー 測定器用のホルダー器具を備える血液処理装置
JP2017529150A (ja) * 2014-08-29 2017-10-05 フレゼニウス カービ ドイチュラント ゲーエムベーハー 測定器を備える血液処理装置
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CN110554087A (zh) * 2019-09-18 2019-12-10 哈尔滨工业大学 一种检测血凝块的装置
WO2023058732A1 (fr) * 2021-10-08 2023-04-13 日機装株式会社 Dispositif de purification du sang

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