EP2375984A1 - Dispositif de mesure d'au moins un paramètre d'un échantillon sanguin artériel - Google Patents

Dispositif de mesure d'au moins un paramètre d'un échantillon sanguin artériel

Info

Publication number
EP2375984A1
EP2375984A1 EP10700321A EP10700321A EP2375984A1 EP 2375984 A1 EP2375984 A1 EP 2375984A1 EP 10700321 A EP10700321 A EP 10700321A EP 10700321 A EP10700321 A EP 10700321A EP 2375984 A1 EP2375984 A1 EP 2375984A1
Authority
EP
European Patent Office
Prior art keywords
flow sensor
measuring
blood sample
measuring cell
sensor
Prior art date
Legal status (The legal status 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 status listed.)
Withdrawn
Application number
EP10700321A
Other languages
German (de)
English (en)
Inventor
Hans Köhler
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Smart Medical Solutions GmbH
Original Assignee
Smart Medical Solutions GmbH
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 Smart Medical Solutions GmbH filed Critical Smart Medical Solutions GmbH
Priority to EP15183257.3A priority Critical patent/EP2997896A1/fr
Publication of EP2375984A1 publication Critical patent/EP2375984A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
    • G01N21/77—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/14—Devices for taking samples of blood ; Measuring characteristics of blood in vivo, e.g. gas concentration within the blood, pH-value of blood
    • A61B5/1405—Devices for taking blood samples
    • A61B5/1427—Multiple blood sampling, e.g. at periodic or pre-established intervals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14546—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring analytes not otherwise provided for, e.g. ions, cytochromes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150015—Source of blood
    • A61B5/15003—Source of blood for venous or arterial blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150389—Hollow piercing elements, e.g. canulas, needles, for piercing the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150992—Blood sampling from a fluid line external to a patient, such as a catheter line, combined with an infusion line; blood sampling from indwelling needle sets, e.g. sealable ports, luer couplings, valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/153—Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • A61B5/14551—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases
    • A61B5/14557—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases specially adapted to extracorporeal circuits
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150503—Single-ended needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/15074—Needle sets comprising wings, e.g. butterfly type, for ease of handling
    • 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
    • G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
    • G01N21/77—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
    • G01N2021/7756—Sensor type
    • G01N2021/7763—Sample through flow
    • 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
    • G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
    • G01N21/77—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
    • G01N21/7703—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator using reagent-clad optical fibres or optical waveguides
    • 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
    • G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
    • G01N21/77—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
    • G01N21/78—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator producing a change of colour
    • G01N21/80—Indicating pH value

Definitions

  • the invention relates to a device for measuring at least one parameter of an arterial blood sample.
  • blood is aspirated manually with an aspiration flask of the infusion set and removed via the septum of the infusion set with the aid of a disposable syringe.
  • the blood sample is then analyzed by an external blood gas analyzer or sent to a laboratory for analysis after transfer to collection tubes. Removal via the septum presents a certain risk of infection and injury to the patient and personnel, which can result in errors during transport to the external blood gas analyzer or when sending it to the laboratory analysis, e.g. by incorrectly labeled or confused blood samples.
  • US Pat. No. 4,989,606 A discloses an intravascular blood gas measuring system in which a hose line which communicates with the patient's vascular system is connected directly to a sensor unit.
  • the sensor unit has a flow sensor with fluorescence-optical sensors, for example for measuring the O 2 - and the C0 2 concentration, and the pH of the blood.
  • a hose is fixed, which is in communication with a pressure bag containing a heparinized salt solution.
  • an adjustable drip valve and a manually operated flush valve is arranged in the hose to the pressure vessel.
  • the flow sensor of US 4,989,606 A is attached to a transmission unit which contains a Thermostatisier adopted for the blood sample, as well as a plurality of optical fibers, with which the optical sensors are supplied with excitation radiation and the measuring radiation is removed.
  • the fixed on the arm of the patient sensor unit is relatively bulky and heavy and is therefore usually felt in use as disturbing. Furthermore, the measuring system can not be integrated into conventional infusion sets.
  • EP 0 994 669 B1 discloses a system for measuring blood parameters which can be used in surgical procedures in the extracorporeal circulation (heart-lung machine).
  • the device has a A flow cassette having a chamber for receiving the blood sample, wherein in the cassette at least one optical sensor is arranged.
  • a device is provided with which the cassette can be detachably connected, wherein the device comprises a light source, is applied to the sensor, further comprising a light detector for detecting light emanating from the sensor, and at least one signal converter, with the Light detector is connected.
  • the signal converter provides a digital output that changes in response to the amount of light detected by at least one light detector.
  • US Pat. No. 4,830,013 A discloses an intravascular measuring system for blood parameters which has a catheter unit in whose distal end region optical sensors for measuring the blood gases (C 1 concentration, CO 2 concentration and pH value) are provided the tip of a light guide are arranged.
  • the object of the invention is to provide a device for measuring at least one parameter of an arterial blood sample, which is as small volume and easy to handle used in conventional arterial access systems.
  • a device having the following components: a flow sensor with standardized connection elements which are connected to the inlet and outlet sides of the measuring cell of the flow sensor, the measuring cell having at least one optochemical sensor element which can be brought into contact with the blood sample removable on the flow sensor, attachable connector with at least one light source for exciting the optochemical sensor element and at least one photodetector for receiving the measuring radiation of the optochemical sensor element, an electronic module having an electrical connection line to the connector and the at least one light source and the at least one photodetector contacted , wherein the flow sensor with the inlet-side connection element to the standardized connection of an arterial catheter and with the outlet-side connection to the standardized connection an arterial infusion set is connectable.
  • the device according to the invention can be optimally inserted into the clinical workflow, wherein for the application of the measuring device, only the standardized connection between the arterial catheter and the arterial infusion set needs to be separated and the system according to the invention inserted.
  • the electronic module which supplies the light sources and the photodetectors in the connector, is connected via a flexible electrical connection line with an evaluation and display unit, or may also have a wireless radio connection, so that without further cable connection contact to the evaluation and display unit can be produced.
  • the flow sensor and connector can be fixed to the patient's arm, whereby the electronic module can also be fixed to the arm or integrated into the evaluation and display unit.
  • a preferably optical measuring device can be arranged in the measuring cell of the flow sensor, which emits a start signal for activation of the parameter measurement on contact with the blood sample.
  • FIG. 1 shows an arterial access system including catheter and infusion set according to the prior art
  • FIG. 2 shows a variant embodiment of the device according to the invention for measuring at least one parameter of an arterial blood sample, integrated into an arterial access system according to FIG. 1;
  • FIG. 3 and Fig. 4 different embodiment details of the device according to the invention shown in FIG. 2; such as
  • FIG. 5 shows a preferred embodiment of the device according to the invention according to FIG. 2.
  • An arterial access according to the prior art, with which a blood sample can be taken for blood analysis, has an arterial catheter 1 and a directly attachable arterial infusion set 16.
  • An arterial blood sample is removed via a disposable syringe (not shown) via the septum 24 (disadvantages: risk of infection for patients and staff, risk of injury).
  • the blood sample is measured by an external analyzer or transferred to collection tubes and sent to a laboratory for analysis. (Disadvantages: increased manipulation effort, risk of contamination)
  • the check valve 23 is opened and the aspirated blood reinfused by aspiration piston 22 into the artery.
  • the check valve 21 is opened and the arterial line is cleaned via the flush valve 26.
  • the manually adjustable drip valve of the infusion set is designated 25.
  • the arterial catheter 1 and the infusion set 16 have standardized connections 14, 15, for example, Luer adapters, with which the two components 1 and 16 are connected in a known manner liquid and gas tight.
  • the measuring system according to the invention according to FIG. 2 has significant advantages, since the measurement of the desired blood parameters takes place directly on the patient with a flow sensor 2 between the commercially available components of an arterial access, namely an arterial catheter 1 and an arterial infusion set 16 is inserted.
  • the flow sensor 2 of the device according to the invention has for this purpose standardized connection elements 3 and 4, for example Luer adapters, which are in communication with the inlet and outlet sides 5, 6 of the measuring cell 7 of the flow sensor 2.
  • the optochemical sensor elements 8 which can be brought into contact with the blood sample are arranged in the measuring cell 7, wherein only such a sensor element is shown schematically in FIG.
  • the device has a connector 9, which can be detachably attached to the flow sensor 2, and which is connected to at least one light source 10 for exciting the optochemical sensor element 8 and a photodetector 11 for mounting. would be equipped with the measuring radiation emitted by the sensor element 8.
  • the measuring system can therefore be operated very inexpensively, since the flow sensor for a new measuring insert of the device can be easily replaced.
  • the connector 9 is connected via an electrical connection line 13 to an electronic module 12 which serves to supply the light source 10 (e.g., LED) and to relay the signals of the photodetector 11 (e.g., photodiode).
  • the flow sensor 2 is connected to the inlet-side connection element 3, to the standardized connection 14 of the arterial catheter 1 and to the outlet-side connection 4 with the standardized connection 15 of the arterial infusion set 16. The entire measuring system can thus be inserted in a simple manner by separating the Luer connection into a commercially available arterial system according to FIG. 1.
  • the electronic module 12 which serves for the electrical contacting of the light sources 10 and the photodetectors 11 in the connector 9, is connected to an evaluation and display unit 18 via an electrical connecting line 17 or a wireless radio link. As shown schematically in FIG. 4, the electronic module 12 can also be integrated directly into an evaluation and display unit 18 '.
  • the connector 9 has a flow sensor 2 mechanically stably comprehensive terminal 27 through which a correct position fixation of the optical elements takes place.
  • a flexible piece of tubing 19 is provided for the mechanical relief of the arterial catheter 1 between the inlet-side connecting element 3 of the flow sensor 2 and the actual measuring cell 7.
  • Such a flexible relief can also be provided between the outlet-side connection element 4 and the measuring cell 7.
  • a preferably optical measuring device can be arranged in the measuring cell 7 of the flow sensor 2, which emits a start signal for activating the parameter measurement on contact with the blood sample.
  • This device can also unintentionally detected in the withdrawal system blood rapidly detected and the evaluation and display unit 18, 18 ', a corresponding visual or audible warning signal and possibly a flushing of the catheter can be activated.
  • a sensor for temperature measurement can additionally be arranged in the measuring cell 7 of the flow sensor 2.
  • the measurement is started only when the blood sample has come to a standstill.
  • the automatic start of the measurement can thus be coupled with a temperature measurement.
  • the flow rate or the standstill of the blood sample can be determined, for example, by the measured temperature gradient. The principle: As long as the aspirated blood is in motion, the temperature will rise. As soon as the blood is in the measuring cell, the temperature will start to drop. Thus, the optimal start time of the measurement can be better determined and controlled, which improves the measurement accuracy.
  • the measuring cell 7 of the flow sensor 2 at least one sensor for measuring a parameter from the group O 2 , CO 2 , pH, sodium, potassium, glucose, lactate and temperature.
  • the metering system can be easily inserted into a commercially available system of arterial catheter and arterial infusion set using standardized connectors (e.g., Luer).
  • standardized connectors e.g., Luer
  • the device according to the invention can thus be used with any conventional blood sampling system.
  • the arterial catheter may remain in use for all intended applications.

Abstract

L'invention concerne un dispositif de mesure d'au moins un paramètre d'un échantillon sanguin artériel, comportant un capteur de débit (2) pourvu d'éléments de connexion standardisés (3, 4) connectés au côté d'entrée et au côté de sortie (5, 6) de la cellule de mesure (7) du capteur de débit (2), la cellule de mesure (7) présentant au moins un élément de détection optochimique (8) pouvant être mis en contact avec l'échantillon sanguin. Un connecteur (9) pouvant être enfiché de façon amovible sur le capteur de débit (2) est pourvu d'au moins une source de lumière (10) pour exciter l'élément de détection optochimique (8), et d'au moins un photodétecteur (11) pour détecter le rayonnement de mesure de l'élément de détection optochimique (8). Un module électronique (12) présentant une ligne de connexion électrique (13) vers le connecteur (9) met en contact la ou les sources de lumière (10) et le ou les photodétecteurs (11). Le capteur de débit (2) peut être connecté au moyen de l'élément de connexion côté entrée (3) à la connexion standardisée (14) d'un cathéter artériel (1) et au moyen de l'élément de connexion côté sortie (4) à la connexion standardisée (15) d'organes de perfusion artériels (16).
EP10700321A 2009-01-13 2010-01-12 Dispositif de mesure d'au moins un paramètre d'un échantillon sanguin artériel Withdrawn EP2375984A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP15183257.3A EP2997896A1 (fr) 2009-01-13 2010-01-12 Dispositif de mesure d'au moins un paramètre d'un échantillon sanguin artériel

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
AT0004609A AT506798B1 (de) 2009-01-13 2009-01-13 Vorrichtung zur messung zumindest eines parameters einer arteriellen blutprobe
PCT/EP2010/050237 WO2010081789A1 (fr) 2009-01-13 2010-01-12 Dispositif de mesure d'au moins un paramètre d'un échantillon sanguin artériel

Related Child Applications (1)

Application Number Title Priority Date Filing Date
EP15183257.3A Division EP2997896A1 (fr) 2009-01-13 2010-01-12 Dispositif de mesure d'au moins un paramètre d'un échantillon sanguin artériel

Publications (1)

Publication Number Publication Date
EP2375984A1 true EP2375984A1 (fr) 2011-10-19

Family

ID=41402026

Family Applications (2)

Application Number Title Priority Date Filing Date
EP10700321A Withdrawn EP2375984A1 (fr) 2009-01-13 2010-01-12 Dispositif de mesure d'au moins un paramètre d'un échantillon sanguin artériel
EP15183257.3A Withdrawn EP2997896A1 (fr) 2009-01-13 2010-01-12 Dispositif de mesure d'au moins un paramètre d'un échantillon sanguin artériel

Family Applications After (1)

Application Number Title Priority Date Filing Date
EP15183257.3A Withdrawn EP2997896A1 (fr) 2009-01-13 2010-01-12 Dispositif de mesure d'au moins un paramètre d'un échantillon sanguin artériel

Country Status (13)

Country Link
US (1) US9091660B2 (fr)
EP (2) EP2375984A1 (fr)
JP (1) JP2012515027A (fr)
CN (1) CN102271582B (fr)
AT (1) AT506798B1 (fr)
AU (1) AU2010205740B2 (fr)
BR (1) BRPI1007289B8 (fr)
CA (1) CA2748952C (fr)
IL (1) IL213758A (fr)
MY (1) MY159414A (fr)
RU (1) RU2482796C2 (fr)
SG (1) SG172305A1 (fr)
WO (1) WO2010081789A1 (fr)

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CN109983341B (zh) * 2016-12-07 2020-09-08 雷迪奥米特医学公司 用于估计液体样本的温度的系统和方法
CN109357959B (zh) * 2018-09-21 2021-05-28 深圳普博腾迈医疗科技有限公司 一种输液管疲劳度检测装置

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Also Published As

Publication number Publication date
RU2011134089A (ru) 2013-02-20
SG172305A1 (en) 2011-07-28
US9091660B2 (en) 2015-07-28
BRPI1007289A2 (pt) 2010-07-22
EP2997896A1 (fr) 2016-03-23
WO2010081789A1 (fr) 2010-07-22
MY159414A (en) 2017-01-13
BRPI1007289B8 (pt) 2021-06-22
CN102271582B (zh) 2014-12-03
CN102271582A (zh) 2011-12-07
CA2748952C (fr) 2015-12-22
AU2010205740A1 (en) 2011-07-07
US20110275913A1 (en) 2011-11-10
IL213758A (en) 2015-01-29
RU2482796C2 (ru) 2013-05-27
CA2748952A1 (fr) 2010-07-22
BRPI1007289B1 (pt) 2020-10-20
AU2010205740B2 (en) 2013-03-07
JP2012515027A (ja) 2012-07-05
AT506798A4 (de) 2009-12-15
AT506798B1 (de) 2009-12-15
IL213758A0 (en) 2011-07-31

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