WO2011087059A1 - Unité et système de détection de fuite - Google Patents

Unité et système de détection de fuite Download PDF

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Publication number
WO2011087059A1
WO2011087059A1 PCT/JP2011/050445 JP2011050445W WO2011087059A1 WO 2011087059 A1 WO2011087059 A1 WO 2011087059A1 JP 2011050445 W JP2011050445 W JP 2011050445W WO 2011087059 A1 WO2011087059 A1 WO 2011087059A1
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WO
WIPO (PCT)
Prior art keywords
leakage detection
detection unit
sensor
unit
sensor units
Prior art date
Application number
PCT/JP2011/050445
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English (en)
Japanese (ja)
Inventor
茂 根本
世一 小野
Original Assignee
株式会社根本杏林堂
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 株式会社根本杏林堂 filed Critical 株式会社根本杏林堂
Priority to JP2011550003A priority Critical patent/JPWO2011087059A1/ja
Publication of WO2011087059A1 publication Critical patent/WO2011087059A1/fr

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Classifications

    • 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16831Monitoring, detecting, signalling or eliminating infusion flow anomalies
    • A61M5/16836Monitoring, detecting, signalling or eliminating infusion flow anomalies by sensing tissue properties at the infusion site, e.g. for detecting infiltration
    • 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/3306Optical measuring means
    • 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/007Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests for contrast media

Definitions

  • the present invention relates to a technique for detecting extravasation when a medical solution is being injected into a subject.
  • the present invention relates to a leak detection unit capable of detecting extravasation with higher accuracy and a system including the leak detection unit.
  • CT Computer Tomography
  • MRI Magnetic Resonance Imaging
  • PET PET
  • ultrasound diagnostic devices etc.
  • medical devices for imaging include an angio device and an MRA (MR ANGIO) device.
  • a medical solution such as a contrast medium or physiological saline may be injected into the subject.
  • a chemical injection device that automatically executes this injection has also been put into practical use.
  • a chemical syringe in which a piston member is slidably inserted into a cylinder member is loaded, and a piston driving mechanism pushes the piston member of the syringe.
  • medical solution in a syringe is inject
  • the leak detection unit described in this document has a light emitting element that emits light of a predetermined wavelength toward a part of the body and a light receiving element that receives the reflected light.
  • the leakage detection unit has been used by being attached to a position that covers the tip of the injection needle.
  • the skin swells at that position, but it has been difficult to confirm the occurrence of leakage by palpation with the conventional unit. This is because the leak occurrence position is covered by the unit, and the portion cannot be palpated.
  • the present invention has been made in view of the above problems, and an object of the present invention is to provide a leakage detection unit capable of detecting the occurrence of extravascular leakage with higher accuracy and a system including the leakage detection unit.
  • the leak detection unit of the present invention comprises: A plurality of sensor units, each sensor unit having a light emitting element that emits light of a wavelength toward a part of the body of the subject and a light receiving element that receives the reflected light
  • a support that supports the plurality of sensor units
  • a leakage detection unit for detecting extravasation at the tip of the injection needle, When the leakage detection unit is viewed from above, a plurality of the sensor parts are arranged so as to surround the tip of the injection needle, and The support is characterized in that a portion above the tip of the injection needle is cut out.
  • “Arranged so as to surround” includes a configuration in which one sensor portion is disposed on each side of the tip of the injection needle.
  • the term “cut out” is not intended to limit the manufacturing method of the support in any way and is intended to be an opening or a recess.
  • the present invention since a plurality of sensor units are arranged so as to surround the tip of the injection needle, the occurrence of leakage is detected in a wider range as compared with the conventional configuration in which detection is performed by one sensor unit. be able to. Moreover, since the portion above the tip of the injection needle is cut out with respect to the support body, the doctor can perform direct contact diagnosis of the subject's body and can confirm the occurrence of leakage by palpation.
  • the leak detection system of the present invention includes the leak detection unit and a control unit that controls the operation of the leak detection unit.
  • the present invention it is possible to provide a leak detection unit capable of detecting the occurrence of extravasation with higher accuracy and a system including the leak detection unit.
  • FIG. 3 is a cross-sectional view taken along line AA of the unit of FIG.
  • FIG. 3 is a cross-sectional view taken along line BB of the unit of FIG.
  • the other example of the leak detection unit is shown, (a) is a longitudinal cross-sectional view, (b) is a bottom view.
  • the medicinal solution injection system 1 shown in FIG. 1 includes an injection head 10 for injecting a medicinal solution in a syringe 200 toward a subject, a display 50 on which various information is displayed, and a subject's in order to detect the occurrence of extravasation.
  • a leakage detection unit 60 attached to the arm 100 (one example) and a control unit 30 that controls the operation of the head 10 and the unit 60 are provided.
  • a conventionally known injection head 10 can be used.
  • the head 10 includes a syringe holding unit (not shown) on which a syringe is mounted, and a piston drive mechanism 15 that slides a piston member of the syringe.
  • the injection head 10 may be a one-cylinder type to which only one syringe is attached, or a two-cylinder type to which two syringes (for example, contrast medium and physiological saline) are attached. There may be.
  • the piston drive mechanism 15 has a motor (not shown) as a drive source and a drive rod configured to move forward and backward to press the piston member of the syringe.
  • the injection head 10 operates the piston drive mechanism 15 in response to a command from the control unit 30. Thereby, the chemical solution is pushed out in a predetermined injection pattern (for example, a pattern in which the horizontal axis is time and the vertical axis is the injection speed).
  • the control unit 30 may be incorporated in the injection head 10 or may be provided separately from the injection head 10. Moreover, the piston drive mechanism may have an empty sensor for detecting the completion of the chemical liquid injection, for example, by detecting the slide position of the piston member.
  • the display 50 is not particularly limited as long as it can display information to the operator.
  • the display 50 may be provided integrally with the injection head 10 or may be provided separately from the injection head 10.
  • this display may be a touch panel display so that the operator can perform an input operation through the screen.
  • the system 1 may have a speaker for outputting information by voice.
  • leakage detection unit in this specification corresponds to the leak detection unit 60 in the example of FIG.
  • Leakage detection system corresponds to a part of the functions of the leak detection unit 60 and the control unit 30.
  • the leakage detection unit 60 includes a plurality of sensor units 61 ⁇ / b> A, 61 ⁇ / b> B, 61 ⁇ / b> C (hereinafter also simply referred to as “sensor unit 61”) and a support sheet 63 that supports the sensor unit 61. ing.
  • the support sheet 63 has flexibility to cope with the curvature of the human body.
  • the support sheet 63 is U-shaped as a whole, and has a shape in which a portion of the leakage occurrence position P1 that the leakage detection unit 60 is to detect is cut out.
  • the three sensor parts 61A, 61B, 61C are arranged so as to surround the leakage occurrence position P1.
  • the leakage occurrence position P1 is located at the tip of the injection needle 201.
  • a cord 67 extends from the edge of the support sheet 63, and the cord 67 is connected to the control unit 30 described above.
  • An adhesive tape (one example) is provided on the back surface of the support sheet 63, whereby the support sheet 63 can be attached to the body of the subject. Note that the communication is not limited to the code 67 but may be performed by a wireless method.
  • FIG. 3 is a cross-sectional view taken along the line AA in FIG. 2 and schematically shows the configuration of the sensor unit 61.
  • the sensor unit 61 has a light emitting element 65 that emits light of a predetermined wavelength toward a part of the body of the subject, and a light receiving element 66 that receives the reflected light.
  • the light emitting element 65 may be a light emitting diode.
  • the light receiving element 66 may be a phototransistor.
  • the light from the light emitting element 65 is irradiated onto a part of the subject's body, and the reflected light is received by the light receiving element (for example, the phototransistor 66).
  • the light receiving element for example, the phototransistor 66.
  • the specific wavelength of the irradiated light is absorbed by the contrast medium.
  • the intensity of the specific wavelength of the reflected light is reduced as compared with the normal time.
  • the presence or absence of extravasation can be determined by looking at the change in the reflection intensity.
  • FIG. 4 is a cross-sectional view taken along the line BB in FIG. 2 and schematically shows the arrangement of the sensor unit 61.
  • the light emitting elements 65 of the sensor unit are arranged obliquely so that the emission direction thereof faces the leakage occurrence position P1.
  • disposed obliquely means that the sensor unit is inclined with respect to the normal direction of the support sheet 63.
  • the sensor unit 61 is not disposed immediately above the leakage occurrence position P1, but the occurrence of leakage can be detected well. All of the three sensor units 61A to 61C may have such an inclined arrangement, or only a part thereof may have such an arrangement. Of the light emitting element and the light receiving element, only the light emitting element may be inclined, or both the light emitting element and the light receiving element may be inclined.
  • FIG. 4 shows a configuration in which the light emitting element itself is slanted, this is merely an example, and other configurations may be used.
  • an element configured to emit light in an oblique direction by changing the shape of the light guide member of the light emitting element may be used.
  • the plurality of sensor units 61A to 61C are arranged so as to surround the leak occurrence position P1. Therefore, it is possible to detect the occurrence of leakage in a wider range as compared with the conventional configuration in which detection is performed by one sensor unit.
  • the support sheet 63 in the portion above the leakage occurrence position P1 is cut out, and the doctor can visually or palpate the body surface of the subject in this portion. Therefore, the presence or absence of leakage detection can also be confirmed by palpation or the like. Furthermore, when the support sheet 63 is cut out as described above, there is an advantage that positioning is easy when the unit is attached to the body of the subject.
  • this invention is not limited to the said form, A various change is possible.
  • only two sensor units 61 or four or more sensor units 61 may be provided.
  • a support sheet 163 that is not U-shaped may be used.
  • the support sheet 163 is rectangular as an example, and one opening is provided in the center. Even if it is such a shape, the effect by hollowing out the part above the leak occurrence position can be obtained similarly to the above embodiment.
  • four sensor portions 161 are provided in the vicinity of each corner portion of the support sheet 163.
  • the directivity of the light emitting element 65 of one sensor part differs from the directivity of the light emitting element 65 of another sensor part (for example, sensor part 61B). It may be. According to such a configuration, detection with higher accuracy is possible. This is because, even if the extravasation cannot be detected by one sensor unit, the extravasation can be detected by another sensor unit having different directivity.
  • the wavelength of the light emitting element 65 of one sensor unit may be different from the wavelength of the light emitting element 65 of another sensor unit. Even with such a configuration, detection with higher accuracy is possible. This is because even if extravasation cannot be detected by one sensor unit, the extravasation can be detected by another sensor unit having a different wavelength.
  • the detection depth may be changed by changing the current value applied to the light emitting element of the sensor unit.
  • Such a method is advantageous in that it is not necessary to separately provide sensor units 61 having different structures and characteristics. This is because even if the light emitting elements of the sensor units are the same, the detection characteristics can be changed by simply changing the current value.
  • a plurality of leakage detection units 260 may be provided.
  • the three leak detection units 260 are arranged in a triangular shape so as to surround the leak occurrence position p1.
  • the units are connected by a wiring 261, and a cord 267 is connected to one of the three units.
  • the four leak detection units 260 are arranged in a square shape so as to surround the leak occurrence position p1.
  • the units are connected by a wiring 261, and a cord 267 is connected to one of the four units.
  • the unit as shown in FIG. 2 or the unit as shown in FIG. 5 may be used instead of the leak detection unit 260 shown in the figure.
  • the communication is not limited to the code 267 but may be performed by a wireless method.
  • the detection by each of the sensor units 61A to 61C may be performed in a predetermined order. Such an operation can be preferably applied when the detection ranges of the sensor units overlap each other, thereby preventing erroneous detection due to interference.
  • the “predetermined order” there are a method in which the sensor units 61A to 61C are operated in order, a method in which the sensor units 61B, 61A, 61B, and 61C are operated in order (an example), for example. Further, after the detection by a certain sensor unit is completed, the detection by the subsequent sensor unit may be started after a certain period of time.
  • the sensor units are not limited to operate one by one, but a plurality of sensor units (61A to 61C in the example of FIG. 2) are divided into two or more groups (for example, 61A and 61C pairs and 61B). The detection by the group may be performed in a predetermined order.
  • the distance between each sensor unit 61 and the position P1 is short.
  • the distance between the sensor units is also reduced, and erroneous detection due to mutual interference is likely to occur.
  • detection by each of the sensor units 61A to 61C is performed in a predetermined order, good detection can be performed while preventing erroneous detection due to mutual interference.
  • a warning may be issued through the display 50 or a speaker (not shown), for example. Or the injection
  • medical solution may be stopped automatically.
  • FIG. 9 is a diagram for explaining an example in which the directivity of the leakage detection unit is adjusted by changing the size of the opening of the housing of the unit.
  • the leakage detection unit 360 includes a flat circular housing 361, and a light emitting element (light emitting diode) 365 and a light receiving element 366 that are provided downward on a substrate disposed therein.
  • an opening 368a is formed at a position facing the light emitting element 365
  • an opening 368b is formed at a position facing the light receiving element 366.
  • Light from the light emitting element 365 is emitted toward the body of the subject through the opening 368a.
  • the reflected light is received by the light receiving element 366 through the opening 368b.
  • the distance d1 from the light emitting diode chip to the housing opening 368a is, for example, 1.2 mm to 1.5 mm (more specifically 1.3 mm). As shown in FIG. 9B, the distance between the centers of the openings 368a and 368b is, for example, 5.2 mm.
  • Opening 368a is a square, the longitudinal dimension d 2a is 2.0 mm, the lateral dimension d 2b is 2.0 mm.
  • the opening 368b is rectangular and has a vertical dimension d3a of 2.0 mm and a horizontal dimension d3b of 3.0 mm.
  • the lateral dimension d 2b of the opening 368a may be 1.0 mm to 3.0 mm, preferably 1.5 mm to 2.5 mm.
  • Lateral dimension d3b of the opening 368b is preferably greater than the transverse dimension d 2b of the opening portion 368a.
  • the directivity of light emitted to the outside of the housing can be adjusted by appropriately changing the size of the opening 368a on the light emitting element 365 side. Specifically, the light emitted to the outside can be narrowed by making the size of the opening 368a relatively small (the emission angle ⁇ in FIG. 9A). By narrowing the emission angle ⁇ in this way, the influence of the reflected light on the skin surface is reduced, and as a result, the detection accuracy of the entire unit can be improved.
  • the opening 368b on the light receiving element side when the opening is enlarged, the amount of received light increases, but the influence of noise due to the surface condition of the human body also increases, so when determining the size of the opening, It is preferable to determine appropriately considering the influence and the like.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention porte sur une unité de détection de fuite qui permet de détecter la survenance d'une extravasation avec une plus grande précision, et sur un système équipé de l'unité de détection de fuite. L'unité de détection de fuite (60) est munie : d'une pluralité d'unités de capteur (61A-61C), chacune d'entre elles comportant un élément d'émission de lumière qui irradie une longueur d'onde prédéterminée de lumière sur une partie du corps d'un sujet testé et un élément de réception de lumière qui reçoit la lumière réfléchie, et d'un corps de support (63) qui porte la pluralité de capteurs. Les unités de capteurs (61A-61C) de la pluralité sont disposées sur le corps de support (63) afin d'être situées autour d'une pointe d'aiguille d'injection (P1) en vue de dessus. L'emplacement sur le corps de support (63) au niveau de la partie supérieure de la pointe (P1) est creux, permettant la palpation.
PCT/JP2011/050445 2010-01-15 2011-01-13 Unité et système de détection de fuite WO2011087059A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2011550003A JPWO2011087059A1 (ja) 2010-01-15 2011-01-13 漏出検出ユニットおよび漏出検出システム

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JP2010006983 2010-01-15
JP2010-006983 2010-01-15

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WO2011087059A1 true WO2011087059A1 (fr) 2011-07-21

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9326686B2 (en) 2012-03-12 2016-05-03 Ivwatch, Llc System and method for mitigating the effects of tissue blood volume changes to aid in diagnosing infiltration or extravasation in animalia tissue
KR101680580B1 (ko) 2015-10-01 2016-11-29 신한대학교 산학협력단 혈관외유출 감지장치
JP2018020141A (ja) * 2012-09-27 2018-02-08 イブウォッチ,リミティド ライアビリティ カンパニー 組織血液量の変化の影響を緩和して動物組織における浸潤又は遊出の診断を支援するシステム
CN111249572A (zh) * 2020-02-05 2020-06-09 翔安生医科技股份有限公司 生命体征监测系统
KR20240037728A (ko) 2022-09-15 2024-03-22 서울대학교병원 혈관외유출 감지 시스템 및 혈관외유출 감지 장치

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6408204B1 (en) * 1999-07-28 2002-06-18 Medrad, Inc. Apparatuses and methods for extravasation detection
WO2006030764A1 (fr) * 2004-09-14 2006-03-23 Nemoto Kyorindo Co., Ltd. Détecteur de fuite

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6408204B1 (en) * 1999-07-28 2002-06-18 Medrad, Inc. Apparatuses and methods for extravasation detection
WO2006030764A1 (fr) * 2004-09-14 2006-03-23 Nemoto Kyorindo Co., Ltd. Détecteur de fuite

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9326686B2 (en) 2012-03-12 2016-05-03 Ivwatch, Llc System and method for mitigating the effects of tissue blood volume changes to aid in diagnosing infiltration or extravasation in animalia tissue
JP2018020141A (ja) * 2012-09-27 2018-02-08 イブウォッチ,リミティド ライアビリティ カンパニー 組織血液量の変化の影響を緩和して動物組織における浸潤又は遊出の診断を支援するシステム
KR101680580B1 (ko) 2015-10-01 2016-11-29 신한대학교 산학협력단 혈관외유출 감지장치
CN111249572A (zh) * 2020-02-05 2020-06-09 翔安生医科技股份有限公司 生命体征监测系统
CN111249572B (zh) * 2020-02-05 2022-06-28 翔安生医科技股份有限公司 生命体征监测系统
KR20240037728A (ko) 2022-09-15 2024-03-22 서울대학교병원 혈관외유출 감지 시스템 및 혈관외유출 감지 장치

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