WO2020031230A1 - Blood leakage detection device - Google Patents

Blood leakage detection device Download PDF

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Publication number
WO2020031230A1
WO2020031230A1 PCT/JP2018/029402 JP2018029402W WO2020031230A1 WO 2020031230 A1 WO2020031230 A1 WO 2020031230A1 JP 2018029402 W JP2018029402 W JP 2018029402W WO 2020031230 A1 WO2020031230 A1 WO 2020031230A1
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WIPO (PCT)
Prior art keywords
light
blood
wavelength
blood leak
detection device
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PCT/JP2018/029402
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French (fr)
Japanese (ja)
Inventor
拓則 島崎
芳文 川久保
昭裕 森本
啓介 細谷
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株式会社キュアケア
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Priority to JP2019520769A priority Critical patent/JP6603836B1/en
Priority to PCT/JP2018/029402 priority patent/WO2020031230A1/en
Publication of WO2020031230A1 publication Critical patent/WO2020031230A1/en

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    • 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
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • 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
    • 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
    • G01N21/27—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands using photo-electric detection ; circuits for computing concentration

Definitions

  • the present invention relates to a blood leak detection device that monitors whether blood leaks from a living body at a puncture site, a suture site, a drain site, or the like.
  • An electrical conduction type blood leak detector detects and monitors changes in electrical conduction between electrodes placed on and around the indwelling needle, and is placed in an absorbent pad laid under the arm.
  • There is a device that monitors a change in electrical resistance between wirings (electric wires) see Patent Documents 1 and 2).
  • a light-emitting element such as an LED and a light-receiving element forming a pair are used to transmit light through a translucent or translucent blood absorption pad disposed on or around an indwelling needle.
  • a type that detects and monitors a change in the transmittance of transmitted light and a type that detects attenuation of light passing through an optical fiber disposed around an indwelling needle due to blood contact (see Patent Document 3, etc.).
  • the conventional blood leak detection device as described above can immediately and sharply detect and detect blood leak occurring around the indwelling needle of a patient during dialysis.
  • blood leak detection devices using these conventional detection modes cannot distinguish between blood leakage and leakage of other liquids such as bodily fluids such as sweat and urine and infusions. There is a problem that there are many malfunctions caused by leakage or adhesion of the liquid.
  • the present invention has been made in view of the above-described circumstances, and has as its object to provide a blood leak detection device that is less likely to malfunction due to a liquid other than blood.
  • the blood leak detection device of the present invention includes a light source, a light receiving element, and control means connected thereto,
  • the light source is disposed at a position illuminating the lower surface or the back surface of the cloth-shaped blood leakage receiving member disposed below the blood leakage site
  • the light receiving element is disposed at a position capable of receiving reflected light emitted from the light source and reflected on the lower surface or the back surface of the blood leakage receiving member
  • the control means may include, among wavelengths of the reflected light received by the light receiving element, Within the range of red light having a wavelength of 620 nm or more and 750 nm or less, which is a light reflection band of blood, the light receiving intensity of the reflected light at a predetermined first wavelength, The received light intensity of the reflected light at one or more other wavelengths having a wavelength of less than 620 nm can be obtained.
  • control unit may be configured such that the value of the light reception intensity of the reflected light at the first wavelength, measured by the light receiving element, is equal to the light reception intensity of the reflected light at the other wavelength.
  • a configuration including blood leakage warning means for issuing a blood leakage warning to the outside is preferably employed.
  • the control means may include a value of a light receiving intensity of the reflected light at the first wavelength measured by the light receiving element, and a light receiving intensity of the reflected light at the other wavelength.
  • the control unit is configured to perform the leakage based on a difference between the amount of change in the received light intensity at the first wavelength and the amount of change in the received light intensity at the other wavelength before and after the same time interval recorded in the recording unit. It may be configured to have a blood leakage determining unit that indirectly determines whether or not blood has leaked above the blood receiving member.
  • the blood leak determining means issues an alarm for blood leakage to the outside when the variation in the received light intensity at the first wavelength is smaller than the variation in the received light intensity at the other wavelength.
  • a blood leak warning means may be included.
  • the blood leak detection device of the present invention may further include, as the other wavelength, a second wavelength within a range of green light having a wavelength of 500 nm or more and 560 nm or less, and a blue light having a wavelength of 445 nm or more and 485 nm or less. May be configured to include at least one wavelength among the third wavelengths within the range.
  • the light source and the light receiving element are arranged in plurals in a horizontal direction around the position immediately below the blood leak location as a base point. Is desirable.
  • the blood leak detection device of the present invention is capable of receiving a blood leak occurring around an indwelling needle placed in the arm of a dialysis patient while eliminating the influence and malfunction due to liquids other than blood, and receiving a cloth-like blood leak such as drape. Detection can be quickly and reliably performed from the lower surface side of the member.
  • FIG. 1A is a perspective view illustrating a basic configuration of a blood leak detection device according to an embodiment
  • FIG. 2B is a side view illustrating an arrangement of a light source and a light receiving element.
  • (A), (b) is a top view explaining the example of arrangement of the light source and the light receiving element in the blood leak detection device of the embodiment.
  • It is a graph figure which shows an example of the change of the light receiving intensity of three primary colors RGB of light measured by the blood leak detection apparatus, (a), (b) is a chart when blood adheres, (c) is a chart other than blood. 3 shows a chart using liquid.
  • FIGS. 1A and 1B are diagrams illustrating a basic configuration of a blood leak detection device according to the embodiment.
  • the blood leak detection device mainly includes a light source L, a light receiving element P, and control means (controller C) connected thereto.
  • the light source may be indicated as LED and the light receiving element may be indicated as PD.
  • components of the blood leak detection device other than the light source L, the light receiving element P, and the control unit such as a storage unit built in the control unit, a blood leakage warning unit, a blood leakage determination unit, an input unit,
  • the illustration of a display device, a recording device, an alarm device for notifying the occurrence of blood leakage, a power supply, wiring, a communication device, and the like is omitted.
  • the blood leak detection device of the present embodiment is disposed at a position where the light source L illuminates the lower surface of a cloth-shaped blood leakage receiving member such as a drape D, which is disposed below a place where blood leakage is assumed to occur.
  • the light receiving element P is disposed at a position where it can receive the reflected light emitted from the light source L and reflected on the lower surface or the back surface of the drape D or the like.
  • the controller C which is a control means of the blood leak detection device, which is composed of a computer or the like, outputs a wavelength of 620 nm or more and 750 nm or less (red light), which is a light reflection band of blood, of the wavelength of the reflected light received by the light receiving element P. And the received light intensity of the reflected light at a predetermined first wavelength and the received light intensity of the reflected light at one or more other wavelengths less than 620 nm.
  • FIG. 1B shows an example of the arrangement of the light source L and the light receiving element P below the blood leakage receiving member.
  • This figure is a side view of a portion of a drape D which is a cloth-shaped blood leakage receiving member laid under the arm of a dialysis patient or the like in FIG. 1A.
  • a transparent plate E on which the drape D can be placed or laid is disposed below the drape D, and a plate member F for arranging the light source L and the light receiving element P is disposed below the transparent plate E. It is arranged.
  • the drape D, the transparent plate E, the plate-like member F, and the like in this figure are drawn with their thickness emphasized for the sake of explanation.
  • the actual thickness is about 0.5 to 5.0 mm for drape D, about 0.5 to 2.0 mm for transparent plate E made of plastic or the like, wood, paper (cardboard), metal or plastic (sponge, styrene).
  • the plate-like member F made of, for example, has a thickness of about 5 to 30 mm.
  • the transparent plate E may not be provided and may be omitted.
  • the plate member F for arranging the light source L and the light receiving element P is provided with a plurality of hollow cylindrical recesses (circular in top view), and the light sources L (LED) are respectively provided in the recesses. And the light receiving element P (PD) are arranged in pairs.
  • the reflected light from the lower surface of the cloth-shaped blood leakage receiving member such as drape D laid under the arm of the dialysis patient is converted into a plurality of light. It can be measured evenly at the position.
  • each light source L may be disposed at that portion.
  • the number of light sources L to be arranged can be reduced, and the initial cost of the blood leak detection device can be reduced.
  • the transparent plate E can be omitted as described above, if the transparent plate E is not omitted and is arranged as shown in FIG. Can be prevented from entering. That is, even if blood or the like adheres to the drape D, it is sufficient to replace only the attached drape D, and the running cost of blood leak detection as a whole can be reduced.
  • the light source L used in the blood leak detection device of the embodiment has at least one peak in a wavelength band including at least red light (wavelength 620 nm to 750 nm), and can emit green light and blue light as evenly as possible.
  • Light sources are preferred.
  • a white LED or an LED of each color may be used in combination with a normal halogen light source (lamp), a bulb light source, or a fluorescent light source.
  • the light source L be capable of distributing light in all directions (omnidirectional) of 360 ° above. Above all, a white LED that does not emit heat rays and can be configured to be small and lightweight is preferable.
  • the light emission of the light source L is controlled by the controller C.
  • the light emission may be either continuous light emission or intermittent (discontinuous) light emission.
  • a simple photodiode may be used alone or in combination, or a color sensor, a CCD, an image sensor or the like in which a charge element is integrated may be used.
  • a color sensor, a CCD, an image sensor or the like in which a charge element is integrated may be used.
  • the color sensor emits green light (Green among the three primary colors of light) in addition to reflected light (first wavelength) having a wavelength of 620 nm to 750 nm, which is red light (Red among the three primary colors of light).
  • the received light intensity which is the amount of reflected light (second wavelength) having a wavelength of 500 nm or more and 560 nm or less, and the amount of reflected light (third wavelength) having a wavelength of 445 nm or more and 485 nm or less, which is blue light (Blue among the three primary colors of light). Since it is possible to simultaneously measure each color separately, it is suitably used in the present embodiment.
  • the above-described first, second, and third wavelengths are not limited to a single specific wavelength but also include a light reception wavelength including the surroundings. It is displayed as the peak value (maximum value) of the range.
  • the sensitive peak frequency of the red (R) sensor is around 625 nm
  • the sensitive peak frequency of the green (G) sensor is around 530 nm
  • the sensitive peak frequency of the blue (B) sensor is Is around 460 nm.
  • the blood leak detection device receives the above-described received light intensity of the reflected light (first wavelength) having a wavelength of 620 nm to 750 nm, that is, the received light intensity of the red light (Red) in the color sensor (hereinafter, “R value”) ),
  • Two operation modes capable of detecting a blood leak occurring around an indwelling needle indwelled in the arm of a dialysis patient are provided.
  • these two operation modes do not erroneously recognize that liquid other than blood is "blood” even if liquid other than blood adheres to the upper side of the drape D. "Malfunction" due to adhesion to the drape D is prevented.
  • the blood leak detection device of the present embodiment has the following two uses. That is, (A) Focusing on the increase in the reflectance of red light when blood adheres to drapes, etc., and comparing the “reflected light intensity (received light intensity)” of each color obtained in real time at that time. ⁇ Absolute reflection amount mode '' that directly detects the presence or absence of blood leakage without performing calculations, etc. (B) Since blood does not absorb red light and reflects it, attention is paid to the fact that the reflectance of red light is less reduced than blood of other colors even if blood adheres.
  • the “change amount” of the received light intensity) from the initial (initial) value or the past value stored in the storage means is obtained by calculation, and from the comparison of the "change amount” of each color, it is found that the amount of light received on the upper surface of the blood leakage receiving member.
  • the “relative reflectance mode” determines and determines whether or not the thing is blood.
  • the controller C determines the value of the received light intensity of the reflected light in the red light (Red) measured by the light receiving element P (see above). Is the value of the received light intensity of the reflected light at another wavelength [(in the embodiment, both the “G value” of the green light (Green) and the “B value” of the blue light (Blue))] ) Is provided with blood leakage warning means for issuing an alarm to the outside when blood leakage is exceeded.
  • the controller C of the blood leak detection device performs initial reflection on the lower surface of the blood leak receiving member, such as installation in a new environment or replacement of a cloth-shaped blood leak receiving member such as drape D.
  • the rate blank or control
  • the rate is changed
  • the received light intensity of red light (Red), green light (Green) and blue light (Blue) that is, R value
  • Each of the G value and the B value is set so as to become “0 (zero)” which is the light receiving intensity reference when the button is pressed.
  • the blood leak detection device can calibrate errors due to environmental factors such as the change of the installation location, the exchange of the drape D, or the replacement of the dialysis patient.
  • a liquid having a red reflected color (appearance) such as blood leakage or blood adheres to an upper surface of a drape D or the like located above a light receiving element P such as a color sensor.
  • a light receiving element P such as a color sensor.
  • the change in the intensity of the reflected light incident on the light receiving element P located below the attached matter is as shown in the chart of FIG. 3A or 3B.
  • the controller C of the blood leak detection device is determined in advance.
  • a warning that blood leakage has been detected is transmitted (reported) to a staff member, a medical worker, or the like by light or sound of a warning lamp or the like (blood leakage warning means).
  • the alarm may be simply displayed on a display device or the like in addition to light and sound.
  • the connection between these means may be either wired or wireless.
  • the light receiving intensity of the color sensor or the like is as shown in the chart of FIG.
  • the R value is lower than at least one of the G value and the B value, so that the controller C does not generate the above-described alarm. That is, in the blood leak detection device of the present embodiment, malfunctions due to these liquids other than blood are prevented.
  • the controller C adjusts the R value (the received light intensity of red light) in these figures to the G value and the B value carelessly due to a measurement error or fluctuation of voltage or the like.
  • the R value is set to a negative value slightly lower than 0 (zero) so as not to exceed.
  • liquids that may adhere to this site include, for example, alcohol, disinfectant, physiological saline, various infusions, and the like. All of these are substances having a light absorption band in the wavelength range of 620 nm to 750 nm, which is red light, or in the vicinity of 625 to 615 nm, which is the sensitive peak frequency of the red (R) sensor of the color sensor.
  • the controller C of the blood leak detection device performs the same calibration so as to eliminate the above-mentioned error due to environmental factors and the like.
  • the calibration in the relative reflectance mode does not set the R value (reception intensity of red light) to a negative value, but always sets the blank value (or control) of the R value, G value, and B value to the negative value. It is not necessary to match all 0 (zero).
  • FIG. 4A is a chart showing a change in the intensity of reflected light when a red liquid such as blood adheres to the upper surface of the drape D or the like.
  • FIG. 4B shows a chart when a liquid other than blood adheres to the upper surface of the drape D or the like.
  • the blood leak detection device is configured such that the controller C detects the value (R value) of the received light intensity of the reflected light in the red light (Red) measured by the light receiving element P; It includes a recording unit that measures the values of the received light intensity of the reflected light at other wavelengths (the G value and the B value in the embodiment) at the same timing and records them in chronological order. Further, the controller C may use a cloth-like material such as a drape D based on a difference between the change amount of the R value and the change amounts of the G value and the B value before and after the same time interval recorded in the recording unit.
  • a blood leak determining unit is provided for determining whether the liquid adhering to the upper side of the blood leak receiving member is blood.
  • the blood leak determination means issues an alarm indicating that blood leak has been detected by a predetermined light or sound of an alarm lamp or the like, as in the case of the above-described absolute reflection amount mode, by a staff member, a medical worker, or the like. May be provided.
  • the R value decreases, but the decrease width (change amount or change rate) is as follows. It becomes smaller than the change amount of the G value and the B value. Thereby, it can be determined that red liquid such as blood or blood leak has adhered to the upper surface of the drape D or the like (blood leak determining means).
  • the controller C determines that the attached liquid is not blood. And it does not emit the alarm as described above. That is, in the blood leak detection device of the present embodiment, malfunctions due to these liquids other than blood are prevented.
  • the blood leak detection device of the present embodiment uses the indwelling needle indwelled on the dialysis patient's arm from the lower surface side of the cloth-shaped blood leak receiving member such as drape. Blood leakage occurring in the surroundings can be quickly and reliably detected without malfunction due to adhesion of liquid other than blood.
  • the light receiving element P receives reflected light reflected on the back surface (in this case, the upper surface or side surface) of a blood leakage receiving member or a blood leakage absorbing member member such as a gauze, which is placed on or around a puncture portion of an indwelling needle. It may be arranged at a possible position and configured to detect blood that has permeated into the gauze or the like or has oozed from the gauze.
  • the blood leak detection device of the present invention is used for monitoring whether or not blood has leaked around the arm of a person having an indwelling needle placed in a blood vessel during artificial dialysis treatment or dialysis. . Further, the present invention can be used not only for detecting blood oozing from the drape laid on the arm but also for detecting blood oozing from or from a gauze placed on the puncture part. In addition, the present invention can be used for monitoring blood leakage at any place where a conventional blood leakage detector or blood leakage sensor is used and where blood may leak from a living body.

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Abstract

This blood leakage detection device comprises a light source, a light reception element, and a control means connected to the light source and light reception element. The light source is disposed at a position where the same illuminates the lower surface of a cloth-like leaked-blood-reception member disposed below a blood leakage location. The light reception element is disposed at a position where the same can receive reflected light that has been emitted from the light source and reflected by the lower surface of the leaked-blood-reception member. From among the wavelengths of reflected light received by the light reception element, the control means is capable of acquiring the reception intensities for reflected light of a predetermined first wavelength that is within the range of red light between the wavelengths of 620-750 nm, which is the light reflection band for blood, and reflected light of one or more other wavelengths below 620 nm. As a result, it is possible to detect, from the back surface side of a drape, whether liquid adhered to the top of the drape is blood. Consequently, erroneous operation caused by a liquid other than blood is uncommon.

Description

血液漏出検知装置Blood leak detection device
　本発明は、穿刺部位や縫合部位、ドレーン部位等において、生体からの血液の漏出がないか否かを監視する血液漏出検知装置に関する。 The present invention relates to a blood leak detection device that monitors whether blood leaks from a living body at a puncture site, a suture site, a drain site, or the like.
　例えば、人工腎臓（ダイアライザー）においては、人工腎臓を経た血液を患者に戻す側の留置針が抜けて血液が漏れる事故が起こる場合がある。このような事故は、放置しておくと、失血により透析患者の命を危険に晒すことになる。 For example, in the case of an artificial kidney (dialyzer), an accident may occur in which the indwelling needle on the side that returns the blood that has passed through the artificial kidney to the patient comes off and blood leaks. Such accidents, if left unchecked, could jeopardize the lives of dialysis patients due to blood loss.
　また、大量でなくても、透析治療中に、留置針やその周辺から、生命や治療に影響しない程度の少量の血液が漏れ、透析患者の腕や、その腕の下に敷かれたシーツ等の吸水性の織布に滲み込んだり、透析患者の腕等（漏血箇所）の下に予め載置・配設された不透水性の穿刺用または穿刺シートや、撥水性の不織布（ドレープとも言う）の上に、血液（漏血）溜まりを形成したりする場合がある。 In addition, even if the amount is not large, during dialysis treatment, a small amount of blood leaks from the indwelling needle and its surroundings that does not affect life or treatment, and the dialysis patient's arm or sheets laid under the arm Impervious puncture or puncture sheet that has sunk into the water-absorbent woven fabric of the dialysis patient, placed or placed under the dialysis patient's arm, etc. ) May form a blood (leakage) pool.
　この種の、血管または輸液管外への漏血を検出するための漏血検出器または漏血センサが種々市販され、また提案されている。 Various types of blood leak detectors or sensors for detecting blood leak outside blood vessels or infusion tubes of this type are commercially available or proposed.
　例えば、市販されているものとしては、電気導通式や光電式のもの等が知られている。電気導通式の漏血検出器としては、留置針の上や周囲に配設された電極間の電気導通の変化を検出・監視するものや、腕の下に敷かれた吸収パッド内に配置された配線（電線）間の電気抵抗変化を監視するもの等がある（特許文献１，２等を参照）。 For example, commercially available ones such as an electrical conduction type and a photoelectric type are known. An electrical conduction type blood leak detector detects and monitors changes in electrical conduction between electrodes placed on and around the indwelling needle, and is placed in an absorbent pad laid under the arm. There is a device that monitors a change in electrical resistance between wirings (electric wires) (see Patent Documents 1 and 2).
　光電式の漏血検出器としては、ＬＥＤ等の発光素子と、対になる受光素子とを用いて、留置針の上や周囲に配設された透光性または半透明の血液吸収パッドを透過した光の透過率の変化を検出・監視するものや、留置針の周囲に配設した光ファイバ内を透る光の、血液接触による減衰を検出するもの等がある（特許文献３等を参照）。 As a photoelectric blood leak detector, a light-emitting element such as an LED and a light-receiving element forming a pair are used to transmit light through a translucent or translucent blood absorption pad disposed on or around an indwelling needle. There is a type that detects and monitors a change in the transmittance of transmitted light, and a type that detects attenuation of light passing through an optical fiber disposed around an indwelling needle due to blood contact (see Patent Document 3, etc.). ).
実開平５－７９４６８号公報Japanese Utility Model Publication No. 5-79468 特開２００６－１１０１１９号公報JP 2006-110119 A 特開２０１０－５２３１９７号公報JP 2010-523197 A
　上述のような従来の血液漏出検知装置は、透析中の患者の留置針の周辺で発生する漏血を、即座にかつ鋭敏に検知・検出することができる。しかしながら、これら従来の検知様式を用いた血液漏出検知装置は、血液の漏出と、汗や尿等の体液や輸液等の他の液体の漏出とを、区別することができないため、血液以外の他の液体の漏出や付着等に起因する誤動作が多いという問題がある。 The conventional blood leak detection device as described above can immediately and sharply detect and detect blood leak occurring around the indwelling needle of a patient during dialysis. However, blood leak detection devices using these conventional detection modes cannot distinguish between blood leakage and leakage of other liquids such as bodily fluids such as sweat and urine and infusions. There is a problem that there are many malfunctions caused by leakage or adhesion of the liquid.
　本発明は、上記のような実情を鑑みてなされたものであり、血液以外の他の液体による誤動作の少ない、血液漏出検知装置を提供することを目的とする。 The present invention has been made in view of the above-described circumstances, and has as its object to provide a blood leak detection device that is less likely to malfunction due to a liquid other than blood.
　本発明の血液漏出検知装置は、光源と、受光素子と、これらと接続される制御手段と、を備え、
　前記光源は、漏血箇所の下方に配置された布状の漏血受け部材の下面または裏面を照らす位置に配設され、
　前記受光素子は、前記光源から出射され前記漏血受け部材の下面または裏面で反射した反射光を受光可能な位置に配設されており、
　前記制御手段は、前記受光素子により受光された前記反射光の波長のうち、
　　血液の光反射帯である波長６２０ｎｍ以上７５０ｎｍ以下の赤色光の範囲内の、予め定める第１の波長における前記反射光の受光強度と、
　　波長６２０ｎｍ未満の、１つ以上の他の波長における前記反射光の受光強度とを、取得可能であることを特徴とする。 The blood leak detection device of the present invention includes a light source, a light receiving element, and control means connected thereto,
The light source is disposed at a position illuminating the lower surface or the back surface of the cloth-shaped blood leakage receiving member disposed below the blood leakage site,
The light receiving element is disposed at a position capable of receiving reflected light emitted from the light source and reflected on the lower surface or the back surface of the blood leakage receiving member,
The control means may include, among wavelengths of the reflected light received by the light receiving element,
Within the range of red light having a wavelength of 620 nm or more and 750 nm or less, which is a light reflection band of blood, the light receiving intensity of the reflected light at a predetermined first wavelength,
The received light intensity of the reflected light at one or more other wavelengths having a wavelength of less than 620 nm can be obtained.
　また、本発明の血液漏出検知装置は、前記制御手段が、前記受光素子により計測された、前記第１の波長における前記反射光の受光強度の値が、前記他の波長における前記反射光の受光強度の値を上回った場合に、血液漏出の警報を外部に向けて発報する漏血警告手段を含む構成を、好適に採用する。 Further, in the blood leak detection device according to the present invention, the control unit may be configured such that the value of the light reception intensity of the reflected light at the first wavelength, measured by the light receiving element, is equal to the light reception intensity of the reflected light at the other wavelength. When the strength value is exceeded, a configuration including blood leakage warning means for issuing a blood leakage warning to the outside is preferably employed.
　また、本発明の血液漏出検知装置は、前記制御手段は、前記受光素子により計測された、前記第１の波長における前記反射光の受光強度の値と、前記他の波長における前記反射光の受光強度の値とを、同じタイミングで時系列に記録する記録手段を含み、
　該制御手段は、前記記録手段に記録された同じ時間間隔の前後における、前記第１の波長の受光強度の変化量と前記他の波長における受光強度の変化量との差に基づいて、前記漏血受け部材の上側で発生する血液漏出の有無を間接的に判定する漏血判定手段を有する構成としてもよい。なお、上記漏血判定手段は、前記第１の波長の受光強度の変化量が、前記他の波長における受光強度の変化量を下回った場合に、血液漏出の警報を外部に向けて発報する漏血警告手段を包含していてもよい。 Further, in the blood leak detection device according to the present invention, the control means may include a value of a light receiving intensity of the reflected light at the first wavelength measured by the light receiving element, and a light receiving intensity of the reflected light at the other wavelength. Including recording means for recording the value of the intensity in time series at the same timing,
The control unit is configured to perform the leakage based on a difference between the amount of change in the received light intensity at the first wavelength and the amount of change in the received light intensity at the other wavelength before and after the same time interval recorded in the recording unit. It may be configured to have a blood leakage determining unit that indirectly determines whether or not blood has leaked above the blood receiving member. The blood leak determining means issues an alarm for blood leakage to the outside when the variation in the received light intensity at the first wavelength is smaller than the variation in the received light intensity at the other wavelength. A blood leak warning means may be included.
　さらに、本発明の血液漏出検知装置は、前記他の波長として、波長６２０ｎｍ未満である、波長５００ｎｍ以上５６０ｎｍ以下の緑色光の範囲内の第２の波長、および、波長４４５ｎｍ以上４８５ｎｍ以下の青色光の範囲内の第３の波長のうち、少なくとも一方の波長を含む構成としてもよい。 Further, the blood leak detection device of the present invention may further include, as the other wavelength, a second wavelength within a range of green light having a wavelength of 500 nm or more and 560 nm or less, and a blue light having a wavelength of 445 nm or more and 485 nm or less. May be configured to include at least one wavelength among the third wavelengths within the range.
　なお、検知・検出感度の向上の観点から、前記光源および前記受光素子は、前記漏血箇所の直下の位置を基点とするその周囲に、水平方向に分散して、複数個ずつ配設することが望ましい。 In addition, from the viewpoint of improvement of detection / detection sensitivity, the light source and the light receiving element are arranged in plurals in a horizontal direction around the position immediately below the blood leak location as a base point. Is desirable.
　本発明の血液漏出検知装置は、血液以外の液体による影響や誤動作を排除しつつ、透析患者の腕に留置された留置針の周囲で発生する漏血を、ドレープ等の布状の漏血受け部材の下面側から、素早く確実に検出することができる。 The blood leak detection device of the present invention is capable of receiving a blood leak occurring around an indwelling needle placed in the arm of a dialysis patient while eliminating the influence and malfunction due to liquids other than blood, and receiving a cloth-like blood leak such as drape. Detection can be quickly and reliably performed from the lower surface side of the member.
（ａ）は実施形態の血液漏出検知装置の基本構成を説明する斜視図であり、（ｂ）は光源および受光素子の配置を説明する側方図である。1A is a perspective view illustrating a basic configuration of a blood leak detection device according to an embodiment, and FIG. 2B is a side view illustrating an arrangement of a light source and a light receiving element. （ａ），（ｂ）はともに、実施形態の血液漏出検知装置における光源および受光素子の配置例を説明する上面図である。(A), (b) is a top view explaining the example of arrangement of the light source and the light receiving element in the blood leak detection device of the embodiment. 血液漏出検知装置において計測された、光の三原色ＲＧＢの受光強度の変化の一例を示すグラフ図であり、（ａ），（ｂ）は血液が付着した際のチャート、（ｃ）は血液以外の液体によるチャートを示す。It is a graph figure which shows an example of the change of the light receiving intensity of three primary colors RGB of light measured by the blood leak detection apparatus, (a), (b) is a chart when blood adheres, (c) is a chart other than blood. 3 shows a chart using liquid. 血液漏出検知装置において計測された、光の三原色ＲＧＢの受光強度の変化の一例を示すグラフ図であり、（ａ）は血液が付着した際のチャート、（ｂ）は血液以外の液体によるチャートを示す。It is a graph figure which shows an example of the change of the received light intensity of three primary colors RGB of light measured by the blood leak detection apparatus, (a) is a chart when blood adheres, (b) is a chart by liquids other than blood. Show.
　以下、本発明の実施形態について図を用いて説明する。
　図１（ａ），（ｂ）は、実施形態明における血液漏出検知装置の基本構成を説明する図である。 Hereinafter, embodiments of the present invention will be described with reference to the drawings.
1A and 1B are diagrams illustrating a basic configuration of a blood leak detection device according to the embodiment.
　本実施形態の血液漏出検知装置は、図１（ａ）に示すように、光源Ｌと、受光素子Ｐと、これらと接続される制御手段（コントローラＣ）とを、主体として構成されている。なお、図中では、光源はＬＥＤと、受光素子はＰＤと表示する場合がある。また、各図では、光源Ｌ，受光素子Ｐ，制御手段以外の血液漏出検知装置の構成要素、例えば、制御手段に内蔵される記憶手段，漏血警告手段，漏血判定手段や、入力手段、表示装置、記録装置、漏血の発生を知らせる警報装置等と、電源や配線および通信装置等の図示を省略している。 As shown in FIG. 1A, the blood leak detection device according to the present embodiment mainly includes a light source L, a light receiving element P, and control means (controller C) connected thereto. In the drawings, the light source may be indicated as LED and the light receiving element may be indicated as PD. In each of the drawings, components of the blood leak detection device other than the light source L, the light receiving element P, and the control unit, such as a storage unit built in the control unit, a blood leakage warning unit, a blood leakage determination unit, an input unit, The illustration of a display device, a recording device, an alarm device for notifying the occurrence of blood leakage, a power supply, wiring, a communication device, and the like is omitted.
　本実施形態の血液漏出検知装置は、光源Ｌが漏血が発生すると想定される箇所の下方に配置された、例えばドレープＤ等の布状の漏血受け部材の下面を照らす位置に配設され、受光素子Ｐは、光源Ｌから出射され前記ドレープＤ等の下面または裏面で反射した反射光を受光可能な位置に配設される。そして、コンピュータ等からなる、血液漏出検知装置の制御手段であるコントローラＣは、受光素子Ｐにより受光された反射光の波長のうち、血液の光反射帯である波長６２０ｎｍ以上７５０ｎｍ以下（赤色光）の範囲内の、予め定める第１の波長における前記反射光の受光強度と、波長６２０ｎｍ未満の、１つ以上の他の波長における前記反射光の受光強度とを、取得するよう構成されている。 The blood leak detection device of the present embodiment is disposed at a position where the light source L illuminates the lower surface of a cloth-shaped blood leakage receiving member such as a drape D, which is disposed below a place where blood leakage is assumed to occur. The light receiving element P is disposed at a position where it can receive the reflected light emitted from the light source L and reflected on the lower surface or the back surface of the drape D or the like. Then, the controller C, which is a control means of the blood leak detection device, which is composed of a computer or the like, outputs a wavelength of 620 nm or more and 750 nm or less (red light), which is a light reflection band of blood, of the wavelength of the reflected light received by the light receiving element P. And the received light intensity of the reflected light at a predetermined first wavelength and the received light intensity of the reflected light at one or more other wavelengths less than 620 nm.
　前述の光源Ｌおよび受光素子Ｐの、漏血受け部材の下側への配設例を、図１（ｂ）に示す。この図は、図１（ａ）における、透析患者等の腕の下に敷かれた布状の漏血受け部材であるドレープＤの部分を、側面から見たものである。ドレープＤの下側には、該ドレープＤを載置または置き敷きできる透明板Ｅが配設され、さらにその透明板Ｅの下側に、光源Ｌおよび受光素子Ｐ配置用の板状部材Ｆが配設されている。 FIG. 1B shows an example of the arrangement of the light source L and the light receiving element P below the blood leakage receiving member. This figure is a side view of a portion of a drape D which is a cloth-shaped blood leakage receiving member laid under the arm of a dialysis patient or the like in FIG. 1A. A transparent plate E on which the drape D can be placed or laid is disposed below the drape D, and a plate member F for arranging the light source L and the light receiving element P is disposed below the transparent plate E. It is arranged.
　なお、この図におけるドレープＤ，透明板Ｅ，板状部材Ｆ等は、説明のため、厚みを強調して描いている。実際の厚みは、ドレープＤは０．５～５．０ｍｍ程度、ブラスチック等からなる透明板Ｅは０．５～２．０ｍｍ程度、木，紙（ダンボール），金属あるいはプラスチック（スポンジ、スチロール）等からなる板状部材Ｆは５～３０ｍｍ程度の厚さになっている。また、透明板Ｅは配設せず、省略してもよい。 Note that the drape D, the transparent plate E, the plate-like member F, and the like in this figure are drawn with their thickness emphasized for the sake of explanation. The actual thickness is about 0.5 to 5.0 mm for drape D, about 0.5 to 2.0 mm for transparent plate E made of plastic or the like, wood, paper (cardboard), metal or plastic (sponge, styrene). The plate-like member F made of, for example, has a thickness of about 5 to 30 mm. Further, the transparent plate E may not be provided and may be omitted.
　光源Ｌおよび受光素子Ｐ配置用の板状部材Ｆには、図のように、中空円筒状（上面視円状）の凹部が複数設けられており、その凹部内にそれぞれ、光源Ｌ（ＬＥＤ）と受光素子Ｐ（ＰＤ）とが、対になるように配設されている。この構成により、図１（ａ）の概念図に示したような、透析患者の腕の下に敷かれたドレープＤ等のような布状の漏血受け部材の下面の反射光を、複数の位置で満遍なく計測することができる。 As shown in the figure, the plate member F for arranging the light source L and the light receiving element P is provided with a plurality of hollow cylindrical recesses (circular in top view), and the light sources L (LED) are respectively provided in the recesses. And the light receiving element P (PD) are arranged in pairs. With this configuration, as shown in the conceptual diagram of FIG. 1A, the reflected light from the lower surface of the cloth-shaped blood leakage receiving member such as drape D laid under the arm of the dialysis patient is converted into a plurality of light. It can be measured evenly at the position.
　なお、光源Ｌと受光素子Ｐとは、各複数個ずつ必要ではあるものの、図１（ｂ）のように、それぞれを必ずしも対として配設する必要はない。例えば、図２（ａ）の上面図に示すように、前述の板状部材Ｆに形成された複数の凹部の平面（水平断面）形状が四角状の場合、１つの光源Ｌ（ＬＥＤ）の光を４つの凹部内に配光できるように、４つの凹部が共通する角部または隅部を切り欠き、その切欠き部位に光源Ｌを配設してもよい。 光源 Although a plurality of light sources L and a plurality of light receiving elements P are required, it is not always necessary to arrange each of them as a pair as shown in FIG. For example, as shown in the top view of FIG. 2A, when the plane (horizontal cross section) shape of the plurality of recesses formed in the above-mentioned plate-shaped member F is square, the light of one light source L (LED) May be cut out at a common corner or corner of the four concave portions so that the light can be distributed into the four concave portions, and the light source L is disposed at the cutout portion.
　また、例えば、図２（ｂ）の上面図に示すように、前述の板状部材Ｆに形成された複数の凹部の平面（水平断面）形状が六角形状の場合、１つの光源Ｌ（ＬＥＤ）の光を３つの凹部内に配光できるように、３つの凹部が共通する角部または隅部を切り欠いて、その部位に各光源Ｌを配設してもよい。これらの配置により、配設する光源Ｌの個数を減らして、血液漏出検知装置のイニシャルコストを低減することができる。 Further, for example, as shown in the top view of FIG. 2B, when the plane (horizontal section) shape of the plurality of recesses formed in the above-mentioned plate-shaped member F is hexagonal, one light source L (LED) In order to distribute the light into the three concave portions, the corners or corners common to the three concave portions may be cut out, and each light source L may be disposed at that portion. With these arrangements, the number of light sources L to be arranged can be reduced, and the initial cost of the blood leak detection device can be reduced.
　なお、前述のように透明板Ｅも省略可能であるが、透明板Ｅを省略せず、図のように配設しておけば、血液等の液体の、板状部材Ｆの各凹部内への浸入を防止することができる。すなわち、仮に血液等がドレープＤに付着した場合でも、この付着したドレープＤのみを交換するだけで事足りるようになり、漏血検知全体のランニングコストを低減できる。 Although the transparent plate E can be omitted as described above, if the transparent plate E is not omitted and is arranged as shown in FIG. Can be prevented from entering. That is, even if blood or the like adheres to the drape D, it is sufficient to replace only the attached drape D, and the running cost of blood leak detection as a whole can be reduced.
　実施形態の血液漏出検知装置に用いる光源Ｌとしては、少なくとも赤色光（波長６２０ｎｍ以上７５０ｎｍ以下）を含む波長帯に少なくとも１つのピークを有し、なるべく万遍なく、緑色光や青色光まで発射できる光源が望ましい。例えば、通常のハロゲン光源（ランプ）や電球光源、蛍光灯光源に加え、白色のＬＥＤや、各色のＬＥＤを組み合わせて使用してもよい。なお、光源Ｌの性能としては、上方の３６０°全方向（無指向）に光を配光できるものが望ましい。なかでも、熱線を発せず、小型軽量に構成できる白色ＬＥＤが好適である。また、光源Ｌの発光はコントローラＣにより制御されるが、発光は、連続発光でも、間欠（不連続）発光でも、どちらでもよい。 The light source L used in the blood leak detection device of the embodiment has at least one peak in a wavelength band including at least red light (wavelength 620 nm to 750 nm), and can emit green light and blue light as evenly as possible. Light sources are preferred. For example, a white LED or an LED of each color may be used in combination with a normal halogen light source (lamp), a bulb light source, or a fluorescent light source. It is desirable that the light source L be capable of distributing light in all directions (omnidirectional) of 360 ° above. Above all, a white LED that does not emit heat rays and can be configured to be small and lightweight is preferable. The light emission of the light source L is controlled by the controller C. The light emission may be either continuous light emission or intermittent (discontinuous) light emission.
　受光素子Ｐとしては、シンプルなフォトダイオードを単独であるいは組み合わせて使用してもよく、電荷素子が集積されたカラーセンサ，ＣＣＤ，イメージセンサ等を用いてもよい。なお、本実施形態の血液漏出検知装置においては、波長６２０ｎｍ以上７５０ｎｍ以下（赤色光）の範囲内の波長の光と、それ以外（範囲外）の波長の光を同時に受光できることが望ましい。そのため、これらの光波長のカラーフィルタが複数個同時に搭載する、カラーセンサやイメージセンサ等が、好適に使用される。 (4) As the light receiving element P, a simple photodiode may be used alone or in combination, or a color sensor, a CCD, an image sensor or the like in which a charge element is integrated may be used. In the blood leak detection device of the present embodiment, it is desirable that light having a wavelength within the range of 620 nm to 750 nm (red light) and light having a wavelength other than that (outside the range) can be simultaneously received. Therefore, a color sensor, an image sensor, or the like, in which a plurality of color filters of these light wavelengths are simultaneously mounted, is preferably used.
　なかでも、カラーセンサは、赤色光（光の三原色のうちのＲｅｄ）である波長６２０ｎｍ以上７５０ｎｍ以下の反射光（第１の波長）に加え、緑色光（光の三原色のうちのＧｒｅｅｎ）である波長５００ｎｍ以上５６０ｎｍ以下の反射光（第２の波長）と、青色光（光の三原色のうちのＢｌｕｅ）である波長４４５ｎｍ以上４８５ｎｍ以下の反射光（第３の波長）の光量である受光強度を、各色分離して同時に計測可能であることから、本実施形態において好適に使用される。 Above all, the color sensor emits green light (Green among the three primary colors of light) in addition to reflected light (first wavelength) having a wavelength of 620 nm to 750 nm, which is red light (Red among the three primary colors of light). The received light intensity, which is the amount of reflected light (second wavelength) having a wavelength of 500 nm or more and 560 nm or less, and the amount of reflected light (third wavelength) having a wavelength of 445 nm or more and 485 nm or less, which is blue light (Blue among the three primary colors of light). Since it is possible to simultaneously measure each color separately, it is suitably used in the present embodiment.
　なお、実際の受光は、幅を持った波長帯域（領域）で行われるため、前述の第１，第２，第３の波長も、単一の特定波長だけではなく、その周囲を含む受光波長範囲のピーク値（極大値）として表示される。例えば、以降の実施形態で使用したカラーセンサで言えば、赤色（Ｒ）センサの感応ピーク周波数が６２５ｎｍ付近、緑色（Ｇ）センサの感応ピーク周波数が５３０ｎｍ付近、青色（Ｂ）センサの感応ピーク周波数が４６０ｎｍ付近にある。 Since the actual light reception is performed in a wavelength band (area) having a width, the above-described first, second, and third wavelengths are not limited to a single specific wavelength but also include a light reception wavelength including the surroundings. It is displayed as the peak value (maximum value) of the range. For example, in the color sensor used in the following embodiments, the sensitive peak frequency of the red (R) sensor is around 625 nm, the sensitive peak frequency of the green (G) sensor is around 530 nm, and the sensitive peak frequency of the blue (B) sensor is Is around 460 nm.
　そして、実施形態の血液漏出検知装置は、前述の波長６２０ｎｍ以上７５０ｎｍ以下の反射光（第１の波長）の受光強度、すなわち上記カラーセンサにおける赤色光（Ｒｅｄ）の受光強度（以下「Ｒ値」という）に関連して、透析患者の腕に留置された留置針の周囲で発生する漏血を検出可能な、２つの動作モード（動作態様）を備えている。しかも、これら２つの動作モードは、血液以外の液体がドレープＤの上側に付着しても、その血液以外の液体が「血液」であると誤認識することがないため、これら血液以外の液体のドレープＤへの付着による「誤動作」が防止されている。 The blood leak detection device according to the embodiment receives the above-described received light intensity of the reflected light (first wavelength) having a wavelength of 620 nm to 750 nm, that is, the received light intensity of the red light (Red) in the color sensor (hereinafter, “R value”) ), Two operation modes (operation modes) capable of detecting a blood leak occurring around an indwelling needle indwelled in the arm of a dialysis patient are provided. In addition, these two operation modes do not erroneously recognize that liquid other than blood is "blood" even if liquid other than blood adheres to the upper side of the drape D. "Malfunction" due to adhesion to the drape D is prevented.
　実施形態の血液漏出検知装置における、漏血の検知と誤動作の防止について説明する。 A description will be given of blood leak detection and prevention of malfunction in the blood leak detection device according to the embodiment.
　本実施形態の血液漏出検知装置は、以下の二種の使い方がある。すなわち、
（Ａ）ドレープ等に血液が付着した場合に、赤色光の反射率が上昇することに着目して、その時点時点でリアルタイムに得られる、各色の「反射光強度（受光強度）」どうしの比較から、演算等することなくダイレクトに漏血の有無を検知する「絶対反射量モード」と、
（Ｂ）血液は赤色を吸収せず反射するため、血液が付着しても赤色光の反射率の低下が他色光に比べて少ない点に着目して、各色毎に、現時点の反射光強度（受光強度）の、記憶手段に記憶した初期（イニシャル）値または過去の値からの「変化量」を、演算により求め、各色の「変化量」の比較から、漏血受け部材の上面に付着したものが血液であるか否か判断・判定する「相対反射率モード」と、である。 The blood leak detection device of the present embodiment has the following two uses. That is,
(A) Focusing on the increase in the reflectance of red light when blood adheres to drapes, etc., and comparing the “reflected light intensity (received light intensity)” of each color obtained in real time at that time. `` Absolute reflection amount mode '' that directly detects the presence or absence of blood leakage without performing calculations, etc.
(B) Since blood does not absorb red light and reflects it, attention is paid to the fact that the reflectance of red light is less reduced than blood of other colors even if blood adheres. The "change amount" of the received light intensity) from the initial (initial) value or the past value stored in the storage means is obtained by calculation, and from the comparison of the "change amount" of each color, it is found that the amount of light received on the upper surface of the blood leakage receiving member. The “relative reflectance mode” determines and determines whether or not the thing is blood.
　（Ａ）絶対反射量モードの場合、本実施形態の血液漏出検知装置は、前述のコントローラＣが、受光素子Ｐにより計測された、赤色光（Ｒｅｄ）における反射光の受光強度の値（前出の「Ｒ値」）が、他の波長における反射光の受光強度の値〔（実施形態においては、緑色光（Ｇｒｅｅｎ）における「Ｇ値」と青色光（Ｂｌｕｅ）における「Ｂ値」の両者〕）を上回った際に、血液漏出の警報を、外部に向けて発報する漏血警告手段を備えている。 (A) In the case of the absolute reflection amount mode, in the blood leak detection device of the present embodiment, the controller C determines the value of the received light intensity of the reflected light in the red light (Red) measured by the light receiving element P (see above). Is the value of the received light intensity of the reflected light at another wavelength [(in the embodiment, both the “G value” of the green light (Green) and the “B value” of the blue light (Blue))] ) Is provided with blood leakage warning means for issuing an alarm to the outside when blood leakage is exceeded.
　なお、絶対反射量モードの場合、血液漏出検知装置のコントローラＣは、新たな環境への設置や、ドレープＤなどの布状の漏血受け部材の交換等、漏血受け部材の下面の初期反射率（ブランクあるいはコントロール）が変わった場合、予め用意されたキャリブレーションボタン等を押下することにより、赤色光（Ｒｅｄ），緑色光（Ｇｒｅｅｎ）および青色光（Ｂｌｕｅ）の受光強度、すなわちＲ値，Ｇ値およびＢ値がそれぞれ、ボタン押下時に、受光強度基準である「０（ゼロ）」になるように設定されている。これにより、血液漏出検知装置は、前述の設置場所の変更やドレープＤの交換、あるいは透析患者の交代等の環境要因による誤差を、校正できるようになっている。 In the case of the absolute reflection amount mode, the controller C of the blood leak detection device performs initial reflection on the lower surface of the blood leak receiving member, such as installation in a new environment or replacement of a cloth-shaped blood leak receiving member such as drape D. When the rate (blank or control) is changed, the received light intensity of red light (Red), green light (Green) and blue light (Blue), that is, R value, is depressed by pressing a prepared calibration button or the like. Each of the G value and the B value is set so as to become “0 (zero)” which is the light receiving intensity reference when the button is pressed. Thus, the blood leak detection device can calibrate errors due to environmental factors such as the change of the installation location, the exchange of the drape D, or the replacement of the dialysis patient.
　例えば、図１（ａ）に例示したように、漏血あるいは血液等、反射色（見た目）が赤色の液体が、カラーセンサ等の受光素子Ｐの上方に位置するドレープＤ等の上面に付着した場合、この付着物の下側に位置する受光素子Ｐに入射した反射光の強度の変化は、図３（ａ）または図３（ｂ）に示すチャートのようになる。 For example, as illustrated in FIG. 1A, a liquid having a red reflected color (appearance) such as blood leakage or blood adheres to an upper surface of a drape D or the like located above a light receiving element P such as a color sensor. In this case, the change in the intensity of the reflected light incident on the light receiving element P located below the attached matter is as shown in the chart of FIG. 3A or 3B.
　これらの場合、ドレープＤ等の上面に血液等の赤色の液体が付着して、Ｒ値が、Ｇ値およびＢ値をともに上回った際に、血液漏出検知装置のコントローラＣは、予め決められた警報ランプ等の光や音等で、漏血が検知されたという警報を、係員や医療従事者等に伝達（発報）するようになっている（漏血警告手段）。なお、警報は、光や音のほか、単に表示装置等に表示するだけでもよい。また、これらの手段間の接続も、有線、無線のいずれでもよい。 In these cases, when a red liquid such as blood adheres to the upper surface of the drape D and the like, and the R value exceeds both the G value and the B value, the controller C of the blood leak detection device is determined in advance. A warning that blood leakage has been detected is transmitted (reported) to a staff member, a medical worker, or the like by light or sound of a warning lamp or the like (blood leakage warning means). The alarm may be simply displayed on a display device or the like in addition to light and sound. The connection between these means may be either wired or wireless.
　ここで、ドレープＤ等の上面に、血液以外の液体が付着した場合、カラーセンサ等による受光強度は、図３（ｃ）のチャートのようになる。このように、付着したものが血液以外の液体の場合、Ｒ値が、Ｇ値およびＢ値の少なくとも一方を下回るため、コントローラＣは、先に述べたような警報を発することはない。すなわち、本実施形態の血液漏出検知装置は、これら血液以外の液体による誤動作が、防止されている。 Here, when a liquid other than blood adheres to the upper surface of the drape D or the like, the light receiving intensity of the color sensor or the like is as shown in the chart of FIG. As described above, when the adhered substance is a liquid other than blood, the R value is lower than at least one of the G value and the B value, so that the controller C does not generate the above-described alarm. That is, in the blood leak detection device of the present embodiment, malfunctions due to these liquids other than blood are prevented.
　なお、絶対反射量モードの場合、コントローラＣは、これらの図におけるＲ値（赤色光の受光強度）が、計測の誤差や電圧等の揺らぎにより、Ｒ値が不用意にＧ値，Ｂ値を超えてしまわないように、前述のキャリブレーション時に、Ｒ値を、０（ゼロ）を若干下回るマイナス値に設定するようになっている。 In the case of the absolute reflection amount mode, the controller C adjusts the R value (the received light intensity of red light) in these figures to the G value and the B value carelessly due to a measurement error or fluctuation of voltage or the like. At the time of the above-mentioned calibration, the R value is set to a negative value slightly lower than 0 (zero) so as not to exceed.
　また、血液以外に、この部位に付着するおそれのある液体としては、例えばアルコール，消毒液，生理食塩水，各種輸液等が想定される。これらはいずれも、赤色光である波長６２０ｎｍ以上７５０ｎｍ以下の範囲、あるいは、カラーセンサの赤色（Ｒ）センサの感応ピーク周波数である６２５～６１５ｎｍ付近に、光吸収帯を有する物質である。 液体 In addition to blood, liquids that may adhere to this site include, for example, alcohol, disinfectant, physiological saline, various infusions, and the like. All of these are substances having a light absorption band in the wavelength range of 620 nm to 750 nm, which is red light, or in the vicinity of 625 to 615 nm, which is the sensitive peak frequency of the red (R) sensor of the color sensor.
　つぎに、（Ｂ）相対反射率モードの場合も、血液漏出検知装置のコントローラＣは、前述の環境要因等による誤差を排除できるように、同様のキャリブレーションを行う。なお、相対反射率モードのキャリブレーションは、Ｒ値（赤色光の受光強度）をマイナス値に設定することはせず、Ｒ値，Ｇ値，Ｂ値のブランク（またはコントロール）の値を、必ずしも全て０（ゼロ）に一致させる必要はない。 Next, in the case of (B) the relative reflectance mode, the controller C of the blood leak detection device performs the same calibration so as to eliminate the above-mentioned error due to environmental factors and the like. Note that the calibration in the relative reflectance mode does not set the R value (reception intensity of red light) to a negative value, but always sets the blank value (or control) of the R value, G value, and B value to the negative value. It is not necessary to match all 0 (zero).
　図４（ａ）は、ドレープＤ等の上面に血液等の赤色の液体が付着した場合の、反射光の強度の変化を示すチャートである。また、図４（ｂ）は、血液以外の液体が、ドレープＤ等の上面に付着した場合のチャートを示す。 FIG. 4A is a chart showing a change in the intensity of reflected light when a red liquid such as blood adheres to the upper surface of the drape D or the like. FIG. 4B shows a chart when a liquid other than blood adheres to the upper surface of the drape D or the like.
　相対反射率モードの場合、本実施形態の血液漏出検知装置は、前述のコントローラＣが、受光素子Ｐにより計測された、赤色光（Ｒｅｄ）における反射光の受光強度の値（Ｒ値）と、他の波長における反射光の受光強度の値（実施形態では、Ｇ値とＢ値）とを、同じタイミングで計測して時系列に記録する記録手段を含んでいる。また、コントローラＣは、記録手段に記録された同じ時間間隔の前後における、前記Ｒ値の変化量と、前記Ｇ値およびＢ値の変化量との差に基づいて、ドレープＤなどの布状の漏血受け部材の上側に付着した液体が、血液か否かを判定する、漏血判定手段を備えている。 In the case of the relative reflectance mode, the blood leak detection device according to the present embodiment is configured such that the controller C detects the value (R value) of the received light intensity of the reflected light in the red light (Red) measured by the light receiving element P; It includes a recording unit that measures the values of the received light intensity of the reflected light at other wavelengths (the G value and the B value in the embodiment) at the same timing and records them in chronological order. Further, the controller C may use a cloth-like material such as a drape D based on a difference between the change amount of the R value and the change amounts of the G value and the B value before and after the same time interval recorded in the recording unit. A blood leak determining unit is provided for determining whether the liquid adhering to the upper side of the blood leak receiving member is blood.
　なお、上記漏血判定手段は、前述の絶対反射量モードの場合と同様、予め決められた警報ランプ等の光や音等で、漏血が検知されたという警報を、係員や医療従事者等に伝達（発報）する漏血警告手段を備えていてもよい。 In addition, the blood leak determination means issues an alarm indicating that blood leak has been detected by a predetermined light or sound of an alarm lamp or the like, as in the case of the above-described absolute reflection amount mode, by a staff member, a medical worker, or the like. May be provided.
　例えば、血液等の反射色が赤色の液体が、カラーセンサ等の受光素子Ｐの上方に位置するドレープＤ等の上面に付着した場合、この付着物の下側に位置する受光素子Ｐに入射した反射光の強度の変化は、図４（ａ）に示すチャートのようになる。 For example, when a liquid having a red reflection color such as blood adheres to the upper surface of a drape D or the like located above the light receiving element P such as a color sensor, the liquid enters the light receiving element P located below the attached matter. The change in the intensity of the reflected light is as shown in the chart of FIG.
　このように、反射色が赤色の液体、すなわち、赤色以外の緑色，青色等の光吸収が大きな液体が付着した場合、Ｒ値は低下するものの、その低下幅（変化量または変化率）は、Ｇ値およびＢ値の変化量より小さくなる。これにより、ドレープＤ等の上面に、血液あるいは漏血等の赤色の液体が付着したことを、判定することができる（漏血判定手段）。 As described above, when a liquid whose reflection color is red, that is, a liquid having a large light absorption such as green and blue other than red adheres, the R value decreases, but the decrease width (change amount or change rate) is as follows. It becomes smaller than the change amount of the G value and the B value. Thereby, it can be determined that red liquid such as blood or blood leak has adhered to the upper surface of the drape D or the like (blood leak determining means).
　また、ドレープＤ等の上面に、血液等以外の液体が付着した場合は、図４（ｂ）に示すように、赤色の光吸収が大きいため、Ｒ値の変化量が、Ｇ値およびＢ値の少なくとも一方の変化量を上回る。これにより、コントローラＣは、付着した液体が血液ではないと判断する。そして、先に述べたような警報を発することはない。すなわち、本実施形態の血液漏出検知装置は、これら血液以外の液体による誤動作が、防止されている。 Further, when a liquid other than blood or the like adheres to the upper surface of the drape D or the like, as shown in FIG. 4B, since the red light absorption is large, the change amount of the R value is changed to the G value and the B value. Exceeds at least one change amount. Thus, the controller C determines that the attached liquid is not blood. And it does not emit the alarm as described above. That is, in the blood leak detection device of the present embodiment, malfunctions due to these liquids other than blood are prevented.
　以上詳述した２つのモードの場合のいずれにおいても、本実施形態の血液漏出検知装置は、ドレープ等の布状の漏血受け部材の下面側から、透析患者の腕に留置された留置針の周囲で発生する漏血を、血液以外の液体の付着により誤動作することなく、素早くかつ確実に検出することができる。 In any of the two modes described above in detail, the blood leak detection device of the present embodiment uses the indwelling needle indwelled on the dialysis patient's arm from the lower surface side of the cloth-shaped blood leak receiving member such as drape. Blood leakage occurring in the surroundings can be quickly and reliably detected without malfunction due to adhesion of liquid other than blood.
　本発明およびその開示は、その精神または主要な特徴から逸脱することなく、他のいろいろな形態で実施できる。したがって、前述の実施形態はあらゆる点で単なる例示に過ぎず、本発明の範囲は請求の範囲に示すものであって、明細書本文には何ら拘束されない。さらに、請求の範囲に属する変形や変更は全て本発明の範囲内のものである。 The present invention and its disclosure may be embodied in various other forms without departing from its spirit or essential characteristics. Therefore, the above-described embodiment is merely an example in every aspect, and the scope of the present invention is set forth in the appended claims, and is not limited by the specification. Further, all modifications and changes belonging to the claims are within the scope of the present invention.
　例えば、受光素子Ｐを、留置針の穿刺部の上または周囲に置いた、ガーゼ等の漏血受け部材もしくは漏血吸収部材部材の裏面（この場合は上面または側面）で反射した反射光を受光可能な位置に配置し、このガーゼ等に滲み込んだ、または、ガーゼから染み出た血液を検知するように構成してもよい。 For example, the light receiving element P receives reflected light reflected on the back surface (in this case, the upper surface or side surface) of a blood leakage receiving member or a blood leakage absorbing member member such as a gauze, which is placed on or around a puncture portion of an indwelling needle. It may be arranged at a possible position and configured to detect blood that has permeated into the gauze or the like or has oozed from the gauze.
　本発明の血液漏出検知装置は、人工透析の施術中または透析中に、血管に留置針が留置された人の腕の周囲で、血液の漏出がないか否かを監視するために利用される。また、腕に敷いているドレープから染み出した血液を検知させるだけでなく、穿刺部の上に置いたガーゼにまたはガーゼから染み出た血液を検知させることにも利用できる。その他、従来の漏血検出器または漏血センサ等が使用されている、生体から血液が漏出する可能性のある場所のいずれにおいても、漏血の監視に利用することができる。 The blood leak detection device of the present invention is used for monitoring whether or not blood has leaked around the arm of a person having an indwelling needle placed in a blood vessel during artificial dialysis treatment or dialysis. . Further, the present invention can be used not only for detecting blood oozing from the drape laid on the arm but also for detecting blood oozing from or from a gauze placed on the puncture part. In addition, the present invention can be used for monitoring blood leakage at any place where a conventional blood leakage detector or blood leakage sensor is used and where blood may leak from a living body.
　Ｃ　コントローラ
　Ｄ　ドレープ
　Ｅ　透明板
　Ｆ　板状部材
　Ｌ　光源
　Ｐ　受光素子 C Controller D Drape E Transparent plate F Plate member L Light source P Light receiving element

Claims (6)

  1. 　光源と、受光素子と、これらと接続される制御手段と、を備え、
    　前記光源は、漏血箇所の下方に配置された漏血受け部材の下面を照らす位置に配設され、
    　前記受光素子は、前記光源から出射され前記漏血受け部材の下面で反射した反射光を受光可能な位置に配設されており、
    　前記制御手段は、前記受光素子により受光された前記反射光の波長のうち、
    　　血液の光反射帯である波長６２０ｎｍ以上７５０ｎｍ以下の範囲内の、予め定める第１の波長における前記反射光の受光強度と、
    　　波長６２０ｎｍ未満の、１つ以上の他の波長における前記反射光の受光強度とを、取得可能であることを特徴とする血液漏出検知装置。     A light source, a light receiving element, and control means connected to these,
    The light source is disposed at a position illuminating the lower surface of the blood leak receiving member disposed below the blood leak location,
    The light receiving element is disposed at a position capable of receiving reflected light emitted from the light source and reflected on the lower surface of the blood leakage receiving member,
    The control means may include, among wavelengths of the reflected light received by the light receiving element,
    Light receiving intensity of the reflected light at a predetermined first wavelength within a wavelength range of 620 nm to 750 nm, which is a light reflection band of blood,
    A blood leak detection device, wherein a light receiving intensity of the reflected light at one or more other wavelengths having a wavelength of less than 620 nm can be obtained.
  2. 　前記制御手段は、前記受光素子により計測された、前記第１の波長における前記反射光の受光強度の値が、前記他の波長における前記反射光の受光強度の値を上回った場合に、血液漏出の警報を外部に向けて発報する漏血警告手段を含む、請求項１に記載の血液漏出検知装置。 When the value of the received light intensity of the reflected light at the first wavelength measured by the light receiving element exceeds the value of the received light intensity of the reflected light at the other wavelength, The blood leak detection device according to claim 1, further comprising blood leak warning means for issuing a warning to the outside.
  3. 　前記制御手段は、前記受光素子により計測された、前記第１の波長における前記反射光の受光強度の値と、前記他の波長における前記反射光の受光強度の値とを、時系列に記録する記録手段を含み、
    　該制御手段は、前記記録手段に記録された同じ時間間隔の前後における、前記第１の波長の受光強度の変化量と前記他の波長における受光強度の変化量との差に基づいて、前記漏血受け部材の上側で発生する血液漏出の有無を判定する漏血判定手段を有する、請求項１に記載の血液漏出検知装置。     The control unit records the value of the received light intensity of the reflected light at the first wavelength and the value of the received light intensity of the reflected light at the other wavelength measured in time series by the light receiving element. Including recording means,
    The control unit is configured to perform the leakage based on a difference between the amount of change in the received light intensity at the first wavelength and the amount of change in the received light intensity at the other wavelength before and after the same time interval recorded in the recording unit. The blood leak detection device according to claim 1, further comprising a blood leak determination unit configured to determine whether or not blood has leaked above the blood receiving member.
  4. 　前記他の波長は、波長５００ｎｍ以上５６０ｎｍ以下の範囲内の第２の波長、および、波長４４５ｎｍ以上４８５ｎｍ以下の範囲内の第３の波長のうち、少なくとも一方の波長を含む、請求項１～３のいずれか１つに記載の血液漏出検知装置。 4. The other wavelength according to claim 1, wherein the other wavelength includes at least one of a second wavelength within a range of 500 nm to 560 nm and a third wavelength within a range of 445 nm to 485 nm. The blood leak detection device according to any one of the above.
  5. 　前記光源を複数個有し、各光源は、前記漏血箇所の直下の位置を基点とするその周囲に、水平方向に分散して配置される、請求項１から４のいずれか１つに記載の血液漏出検知装置。 The light source according to any one of claims 1 to 4, wherein the light source includes a plurality of light sources, and the light sources are distributed in a horizontal direction around a position immediately below the blood leak location. Blood leak detection device.
  6. 　前記受光素子を複数個有し、各受光素子は、前記漏血箇所の直下の位置を基点とするその周囲に、水平方向に分散して配置される、請求項１から４のいずれか１つに記載の血液漏出検知装置。 5. The light-receiving element according to claim 1, wherein the light-receiving element has a plurality of light-receiving elements, and each of the light-receiving elements is arranged in a horizontal direction around the position immediately below the blood leak location. A blood leak detection device according to claim 1.
PCT/JP2018/029402 2018-08-06 2018-08-06 Blood leakage detection device WO2020031230A1 (en)

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