JP6603836B1 - Blood leak detection device - Google Patents

Blood leak detection device Download PDF

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JP6603836B1
JP6603836B1 JP2019520769A JP2019520769A JP6603836B1 JP 6603836 B1 JP6603836 B1 JP 6603836B1 JP 2019520769 A JP2019520769 A JP 2019520769A JP 2019520769 A JP2019520769 A JP 2019520769A JP 6603836 B1 JP6603836 B1 JP 6603836B1
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receiving element
blood leakage
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JPWO2020031230A1 (en
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拓則 島崎
拓則 島崎
芳文 川久保
芳文 川久保
昭裕 森本
昭裕 森本
啓介 細谷
啓介 細谷
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CURECARE CO. LTD.
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/25Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
    • G01N21/27Colour; 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

Abstract

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、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を照らす位置に配設され、受光素子は、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いる。制御手段は、受光素子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以下の赤色光の範囲内の、予め定める第1の波長における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反射光の受光強度とを、取得可能である。これにより、ドレープ上に付着した液体が、血液であるか否かを、ドレープの裏面側から検出することができる。その結果、血液以外の他の液体による誤動作が少ない。The blood leak detection device of the present invention includes a light source, a light receiving element, and a control means connected to the light source, and the light source covers the lower surface of a cloth-like blood leak receiving member disposed below the blood leak location. The light receiving element is disposed at a position to illuminate, and the light receiving element is disposed at a position capable of receiving the reflected light emitted from the light source and reflected by the lower surface of the blood leakage receiving member. The control means includes a light receiving intensity of the reflected light at a predetermined first wavelength within a 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, among wavelengths of reflected light received by the light receiving element. , And the received light intensity of the reflected light at one or more other wavelengths less than 620 nm. Thereby, it can be detected from the back side of the drape whether the liquid adhering on the drape is blood. As a result, there are few malfunctions due to liquids other than blood.

Description

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 apparatus that monitors whether or not 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 an artificial kidney (dialyzer), an accident may occur in which blood leaks due to the indwelling needle on the side that returns blood passed through the artificial kidney to the patient. If such an accident is left unattended, it will endanger the dialysis patient's life 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。   Also, even if it is not a large amount, a small amount of blood that does not affect life or treatment leaks from the indwelling needle and its surroundings during dialysis treatment, and the arm of the dialysis patient and the sheets laid under the arm, etc. Impermeable woven fabric, or impervious puncture or puncture sheet placed and placed in advance under the arm of a dialysis patient (blood leak location), or a water-repellent nonwoven fabric (both drapes) May form a blood (leakage) reservoir.

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 blood leakage detectors or blood leakage sensors for detecting blood leakage outside this blood vessel or infusion tube are commercially available and 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, as a commercially available product, an electrically conductive type or a photoelectric type is known. As an electrical continuity type blood leak detector, it is used to detect and monitor changes in electrical continuity between electrodes placed on and around the indwelling needle, or to be placed in an absorption pad laid under the arm. There is one that monitors changes in electrical resistance between wires (electric wires) (see Patent Documents 1 and 2, etc.).

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 leakage detector, a light-emitting element such as an LED and a pair of light-receiving elements are used to transmit through a translucent or translucent blood absorption pad disposed on or around the indwelling needle. For detecting and monitoring the change in the transmittance of the transmitted light, and detecting the attenuation of light passing through the optical fiber disposed around the 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 sensitively detect and detect blood leak occurring around the indwelling needle of the patient during dialysis. However, blood leak detection devices using these conventional detection modes cannot distinguish between leakage of blood 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 due to leakage or adhesion of 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 circumstances, and an object of the present invention is to provide a blood leakage detection device that is less likely to malfunction due to liquids 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。 The blood leakage detection device of the present invention includes a light source, a light receiving element, and a control means connected to the light source, and the light source is a lower surface of a cloth-shaped blood leakage receiving member disposed below the blood leakage location. Alternatively, the light receiving element is disposed at a position that illuminates the back surface, and the light receiving element is disposed at a position capable of receiving reflected light that is emitted from the light source and reflected by the lower surface or the back surface of the blood leak receiving member, The received light intensity of the reflected light at a predetermined first wavelength 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, among wavelengths of the reflected light received by the light receiving element, , wavelength of less than 620 nm, and a light-receiving intensity of the reflected light in one or more other wavelengths, Ru obtainable der.

そして、本発明の血液漏出検知装置前記制御手段は、
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、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と、
該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と、を含む。
And the control means of the blood leak detection device of the present invention comprises:
Recording means for recording the received light intensity value of the reflected light at the first wavelength and the received light intensity value of the reflected light at the other wavelength in time series measured by the light receiving element at the same timing. When,
Based on the difference between the amount of change in received light intensity at the first wavelength and the amount of change in received light intensity at the other wavelengths before and after the same time interval recorded in the recording means, the upper side of the blood leakage receiving member in indirectly determining blood leakage judging means whether a blood leakage occurs, the including.

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。
Upper Symbol blood leakage determining means, the amount of change in the received light intensity of the first wavelength, when it falls below the amount of change in the received light intensity in the other wavelength, leakage to alarm toward an alarm of the blood leaking out A blood 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。   Furthermore, in the blood leakage detection device of the present invention, as the other wavelength, a second wavelength within a range of green light having a wavelength of 500 nm to 560 nm and a blue light having a wavelength of 445 nm to 485 nm that is less than 620 nm. It is good also as a structure containing at least one wavelength among the 3rd wavelengths in 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。   From the viewpoint of improving detection / detection sensitivity, a plurality of the light sources and the light receiving elements are distributed in the horizontal direction around the light leakage site and the periphery thereof. 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 eliminates the influence and malfunction caused by liquids other than blood, and is configured to receive blood leakage occurring around an indwelling needle placed on the arm of a dialysis patient in the form of a cloth-like blood leak such as a drape. It can be detected quickly and reliably 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。(A) is a perspective view explaining the basic composition of the blood leak detection device of an embodiment, and (b) is a side view explaining 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 both the top views explaining the example of arrangement | positioning of the light source and light receiving element in the blood leak detection apparatus of 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 which shows an example of the change of the light reception intensity | strength of three primary colors RGB of light measured in the blood leak detection apparatus, (a), (b) is a chart when blood adheres, (c) is other than blood The chart by liquid is shown. 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 which shows an example of the change of the light reception intensity | strength of three primary colors RGB of light measured in 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.
FIG. 1A and FIG. 1B are diagrams illustrating the basic configuration of a blood leak detection device according to an 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 of the present embodiment is mainly composed of a light source L, a light receiving element P, and control means (controller C) connected thereto. In the figure, the light source may be displayed as LED and the light receiving element may be displayed as PD. In each figure, the components of the blood leakage detection device other than the light source L, the light receiving element P, and the control means, for example, storage means built in the control means, blood leakage warning means, blood leakage determination means, input means, Illustrations of a display device, a recording device, an alarm device for notifying the occurrence of blood leakage, a power source, wiring, a communication device, and the like are 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 leakage detection device according to 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 drape D, which is disposed below a portion 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 by 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 leakage detection device, including a computer or the like, among the wavelengths of reflected light received by the light receiving element P, has a wavelength of 620 nm or more and 750 nm or less (red light) that is a light reflection band of blood. 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 are obtained.

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。   An example of the arrangement of the light source L and the light receiving element P on the lower side of the blood leakage receiving member is shown in FIG. This figure is a side view of the portion of drape D, which is a cloth-like blood leakage receiving member laid under the arm of a dialysis patient or the like in FIG. A transparent plate E on which the drape D can be placed or placed is disposed below the drape D, and a plate-like 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。   In addition, the drape D, the transparent plate E, the plate-like member F, etc. in this figure are drawn with emphasis on the thickness for 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, etc., wood, paper (corrugated cardboard), metal or plastic (sponge, polystyrene) The plate-like member F made of etc. has a thickness of about 5 to 30 mm. Further, the transparent plate E may be omitted without being provided.

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。   The plate-like member F for arranging the light source L and the light receiving element P is provided with a plurality of hollow cylindrical (circular in top view) recesses as shown in the figure, and the light sources L (LEDs) 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 on the lower surface of the cloth-like blood leakage receiving member such as drape D laid under the arm of the dialysis patient It can be measured evenly by 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。   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 planar (horizontal cross-sectional) shape of the plurality of recesses formed in the plate-like member F is a square shape, the light from one light source L (LED) May be cut out at the corners or corners where the four concave portions are common, and the light source L may be disposed at the cut-out 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。   Also, for example, as shown in the top view of FIG. 2B, when the planar (horizontal cross-sectional) shape of the plurality of recesses formed in the plate-like member F is hexagonal, one light source L (LED) The light source L may be disposed at a portion where a corner or a corner common to the three recesses is cut out so that the light can be distributed into the three recesses. With these arrangements, the number of light sources L to be arranged can be reduced, and the initial cost of the blood leakage 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。   The transparent plate E can be omitted as described above. However, if the transparent plate E is not omitted and is arranged as shown in the figure, a liquid such as blood enters each recess of the plate-like member F. Can be prevented. 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 the whole blood leak detection 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 leakage detection device of the embodiment has at least one peak in a wavelength band including at least red light (wavelength of 620 nm or more and 750 nm or less), and can emit green light and blue light as uniformly as possible. A light source is desirable. For example, in addition to a normal halogen light source (lamp), a light bulb light source, and a fluorescent light source, a white LED or each color LED may be used in combination. In addition, as the performance of the light source L, it is desirable that the light source L can distribute light in all upper 360 ° directions (omnidirectional). Among these, white LEDs that do not emit heat rays and can be configured to be small and light are suitable. 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。   As the light receiving element P, a simple photodiode may be used alone or in combination, and a color sensor, a CCD, an image sensor, or the like in which charge elements are integrated may be used. In the blood leak detection device of this embodiment, it is desirable that light having a wavelength in the range of 620 nm to 750 nm (red light) and light of other wavelengths (out of range) can be received simultaneously. For this reason, a color sensor, an image sensor, or the like on which a plurality of color filters having 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。   Among them, the color sensor is red light (Red among the three primary colors of light), reflected light (first wavelength) having a wavelength of 620 nm or more and 750 nm or less, and green light (Green among the three primary colors of light). The received light intensity of reflected light (second wavelength) having a wavelength of 500 nm to 560 nm and reflected light (third wavelength) of wavelength 445 nm to 485 nm, which is blue light (Blue among the three primary colors of light). Since each color can be separated and measured simultaneously, it is preferably used in this 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 wide wavelength band (region), the first, second, and third wavelengths described above are not only a single specific wavelength but also a light reception wavelength including the periphery thereof. It is displayed as the peak value (maximum value) of the range. For example, in the color sensor used in the following embodiments, the sensitivity peak frequency of the red (R) sensor is around 625 nm, the sensitivity peak frequency of the green (G) sensor is around 530 nm, and the sensitivity peak frequency of the blue (B) sensor. 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 leakage detection device according to the embodiment has a light reception intensity of the reflected light (first wavelength) having a wavelength of 620 nm or more and 750 nm or less, that is, a light reception intensity (hereinafter referred to as “R value”) of red light (Red) in the color sensor. 2), there are two operation modes (operation modes) capable of detecting blood leakage occurring around the indwelling needle placed in the arm of the dialysis patient. Moreover, in these two operation modes, even if a liquid other than blood adheres to the upper side of the drape D, the liquid other than blood will not be mistakenly recognized as “blood”. “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。   Detection of blood leakage and prevention of malfunction in the blood leakage detection device of the embodiment will be described.

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 this embodiment has the following two types of usage. That is,
(A) Focusing on the fact that the reflectivity of red light increases when blood adheres to drapes, etc., comparing the “reflected light intensity (light receiving intensity)” of each color obtained in real time at that time From `` absolute reflection amount mode '' to detect the presence or absence of blood leakage directly without calculation etc.,
(B) Since blood reflects without absorbing red, paying attention to the fact that the decrease in reflectance of red light is less than that of other colors even when blood adheres, the current reflected light intensity (for each color) (Change amount) from the initial (initial) value or the past value stored in the storage means of the received light intensity) is obtained by calculation, and from the comparison of the "change amount" of each color, it adheres to the upper surface of the blood leakage receiving member “Relative reflectance mode” for determining / determining whether or not an object 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, the blood leak detection device of the present embodiment is configured such that the controller C described above measures the light reception intensity value 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 other wavelengths (in the embodiment, both the “G value” for green light (Green) and the “B value” for blue light (Blue)). ) Is provided, a blood leakage warning means for issuing a warning of blood leakage to the outside when exceeding the above.

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 leakage detection device performs initial reflection on the lower surface of the blood leakage receiving member such as installation in a new environment or replacement of a cloth-shaped blood leakage receiving member such as drape D. When the rate (blank or control) changes, by pressing a prepared calibration button or the like, the received light intensity of red light (Red), green light (Green), and blue light (Blue), that is, the R value, Each of the G value and the B value is set to be “0 (zero)” that is a light reception intensity reference when the button is pressed. As a result, the blood leak detection apparatus can calibrate errors due to environmental factors such as the above-described change of installation location, replacement of drape D, or replacement of dialysis patients.

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 reflection color (appearance) such as blood leakage or blood adhered to the upper surface of a drape D or the like positioned 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 on the lower side of the deposit 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 or 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 by light or sound from an alarm lamp or the like is transmitted (reported) to a staff member or a medical worker (blood leakage warning means). In addition to light and sound, the alarm may be simply displayed on a display device or the like. 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 intensity of light received by the color sensor or the like is as shown in the chart of FIG. As described above, when the attached substance is a liquid other than blood, the R value is lower than at least one of the G value and the B value, and therefore the controller C does not issue an alarm as described above. That is, the blood leak detection device of this embodiment is prevented from malfunctioning due to liquids other than these blood.

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 causes the R value (red light received intensity) in these figures to inadvertently change the G value and the B value due to measurement errors and fluctuations in voltage, etc. The R value is set to a negative value slightly below 0 (zero) during the above-described calibration 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。   In addition to blood, examples of liquids that may adhere to this region include alcohol, disinfectant, physiological saline, and various infusions. Each of these is a substance having a light absorption band in the wavelength range of 620 nm or more and 750 nm or less, 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, also in the (B) relative reflectance mode, the controller C of the blood leakage detection device performs the same calibration so that the error due to the environmental factors described above can be eliminated. In the relative reflectance mode calibration, the R value (red light intensity) is not set to a negative value, and the blank (or control) values of the R value, G value, and B value are not necessarily set. It is not necessary to match all zeros.

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 changes 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 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 of the present embodiment is configured such that the controller C described above measures the received light intensity (R value) of reflected light in red light (Red) measured by the light receiving element P, and It includes recording means for measuring the received light intensity values of reflected light at other wavelengths (in the embodiment, G value and B value) at the same timing and recording them in time series. Further, the controller C has a cloth-like shape such as a drape D based on the difference between the change amount of the R value and the change amounts of the G value and B value before and after the same time interval recorded in the recording means. A blood leakage determining means for determining whether or not the liquid attached to the upper side of the blood leakage receiving member is blood is provided.

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。   As in the case of the absolute reflection mode described above, the blood leak determination means provides a warning that a blood leak has been detected with a predetermined light or sound from an alarm lamp, etc. There may be provided a blood leak warning means for transmitting (reporting).

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 positioned above the light receiving element P such as a color sensor, the liquid enters the light receiving element P positioned below the deposit. The change in the intensity of the reflected light is as shown in the chart in 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 having a reflection color of red, that is, a liquid having a large light absorption such as green or blue other than red adheres, the R value decreases, but the decrease width (change amount or change rate) is It becomes smaller than the change amount of G value and B value. Thereby, it can be determined that a red liquid such as blood or blood leakage has adhered to the upper surface of the drape D or the like (blood leakage determination 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 the G value and the B value. Exceeds at least one of the changes. Thereby, the controller C determines that the attached liquid is not blood. And the alarm as mentioned above is not issued. That is, the blood leak detection device of this embodiment is prevented from malfunctioning due to liquids other than these blood.

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 in detail above, the blood leak detection device of the present embodiment is provided with an indwelling needle placed on the arm of a dialysis patient from the lower surface side of a cloth-like blood leak receiving member such as drape. Blood leakage occurring in the surroundings can be detected quickly and reliably without malfunctioning due to adhesion of liquids 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 the disclosure thereof can be implemented in various other forms without departing from the spirit or main features thereof. Therefore, the above-described embodiment is merely an example in all points, and the scope of the present invention is shown in the scope of claims, and is not restricted by the text of 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 reflected light reflected from the back surface (in this case, the top surface or the side surface) of the blood leakage receiving member such as gauze or the blood leakage absorbing member member placed on or around the puncture portion of the indwelling needle is received. You may arrange | position in the position which can be, and may comprise so that the blood which oozed in this gauze etc. or oozed out from gauze may be detected.

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 there is a blood leak around a person's arm where an indwelling needle is placed in a blood vessel during artificial dialysis or during dialysis. . Moreover, it can be used not only to detect blood exuding from a drape laid on the arm but also to detect gauze placed on the puncture part or blood exuding from the gauze. In addition, the present invention can be used for monitoring blood leakage in any place where a conventional blood leakage detector or blood leakage sensor is used and where blood may leak from the 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 (4)

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、取得可能であり、
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と、
該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と、を含むことを特徴とする血液漏出検知装置。
A light source, a light receiving element, and a control means connected to these,
The light source is disposed at a position that illuminates the lower surface of the blood leakage receiving member disposed below the blood leakage location,
The light receiving element is disposed at a position capable of receiving reflected light emitted from the light source and reflected by the lower surface of the blood leakage receiving member,
The control means receives light 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, among wavelengths of the reflected light received by the light receiving element. When, less than the wavelength 620 nm, and a light-receiving intensity of the reflected light in one or more other wavelengths, Ri obtainable der,
The control means includes
A recording means for recording the received light intensity value of the reflected light at the first wavelength and the received light intensity value of the reflected light at the other wavelength, measured by the light receiving element, in time series;
Based on the difference between the change amount of the received light intensity at the first wavelength and the change amount of the received light intensity at the other wavelength before and after the same time interval recorded in the recording means, the upper side of the blood leakage receiving member And a blood leakage determining means for determining the presence or absence of blood leakage occurring in the blood leakage detecting device.
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に記載の血液漏出検知装置。 The other wavelengths, the second wavelength in a range of less than a wavelength of 500 nm 560 nm, and, among the third wavelength in the range of less than the wavelength 445 nm 485 nm, comprising at least one wavelength, according to claim 1 Blood leak detection device. 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または2に記載の血液漏出検知装置。 A plurality of the light sources, each light source has at its periphery to the base point position immediately below the blood leakage locations, are distributed in the horizontal direction, the blood leak detector according to claim 1 or 2 . 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からのいずれか1に記載の血液漏出検知装置。 A plurality of said light receiving element, the light receiving element has on its periphery to the base point position immediately below the blood leakage locations, are distributed in the horizontal direction, any one of claims 1 3 The blood leakage detection device according to 1.
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