WO2015086384A1 - Dispositif et procédé permettant de surveiller l'accès vasculaire veineux lors d'un traitement sanguin extracorporel - Google Patents

Dispositif et procédé permettant de surveiller l'accès vasculaire veineux lors d'un traitement sanguin extracorporel Download PDF

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Publication number
WO2015086384A1
WO2015086384A1 PCT/EP2014/076309 EP2014076309W WO2015086384A1 WO 2015086384 A1 WO2015086384 A1 WO 2015086384A1 EP 2014076309 W EP2014076309 W EP 2014076309W WO 2015086384 A1 WO2015086384 A1 WO 2015086384A1
Authority
WO
WIPO (PCT)
Prior art keywords
venous
blood
limit
flow rate
blood flow
Prior art date
Application number
PCT/EP2014/076309
Other languages
German (de)
English (en)
Inventor
Johann BREDE
Pascal Kopperschmidt
Original Assignee
Fresenius Medical Care Deutschland 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 Fresenius Medical Care Deutschland Gmbh filed Critical Fresenius Medical Care Deutschland Gmbh
Publication of WO2015086384A1 publication Critical patent/WO2015086384A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3653—Interfaces between patient blood circulation and extra-corporal blood circuit
    • A61M1/3656—Monitoring patency or flow at connection sites; Detecting disconnections
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3639—Blood pressure control, pressure transducers specially adapted therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/18—General characteristics of the apparatus with alarm

Definitions

  • the invention relates to a device for monitoring the venous vascular access in an extracorporeal blood treatment with an extracorporeal
  • Blood treatment device and an extracorporeal blood treatment device with a device for monitoring the venous vascular access relate to a method for monitoring venous vascular access in an extracorporeal blood treatment.
  • Hemofiltration and hemodiafiltration streams the patient's blood into one
  • Extracorporeal blood circulation Access to the patient's vasculature is made with an arterial and venous cannula or needle that punctures the patient.
  • the patient's blood flows from the arterial puncture site via an arterial blood line into the blood chamber of a dialyzer or filter and from the blood chamber via a venous blood line back to the venous puncture site of the patient.
  • Dialyzer is from a semipermeable membrane in the blood chamber and
  • EP 0 995 451 B 1 describes a device for monitoring the venous and arterial vascular access, in which for the state of the venous and arterial
  • Vascular access characteristic values are calculated from the sum and difference of the arterial and venous pressure measured in successive measurements. Consequently, the monitoring of venous vascular access is not based solely on the evaluation of venous pressure in the venous blood line.
  • EP 1 399 204 B1 describes a method for detecting the dislodgement of the venous needle, which is also based on the monitoring of arterial and venous pressure.
  • the blood flow is detected to determine if the blood flow is constant in the time interval in which a decrease in arterial and venous pressure has occurred.
  • the method known from EP 1 815 878 B1 is based on the monitoring of the venous pressure, which is compared with a predetermined limit value. It is proposed to increase the limit value after a certain time interval
  • EP 1 829 570 B1 describes a device in which the amplitude of pressure pulses is monitored in order to detect a stenosis in the extracorporeal blood circulation.
  • the invention has for its object to provide a device that allows the monitoring of venous vascular access with a higher security than the known protection systems in a relatively simple structure, in which after
  • Another object of the invention is an extracorporeal
  • the invention has the object, a method for
  • Tubing system is dependent on the Theological conditions in the system and especially the blood flow rate is a particularly important rheological size, which must be considered in the determination of the critical limit.
  • Monitoring of venous vascular access in extracorporeal blood treatment with an extracorporeal blood treatment device is based on detecting the blood flow rate and the venous pressure limit alone depending on the level of blood flow rate according to a fixed relationship between the threshold value and the blood flow rate is determined.
  • the fixed relationship between the amount of the limit value and the level of the blood flow rate with increasing blood flow rate provides for an increase in the limit value for the venous pressure.
  • the device has means for measuring the pressure in the venous blood line and a computing and evaluation unit evaluating the measurement signal of the venous pressure sensor, which is configured such that the venous pressure is compared with the limit dependent on the blood flow rate, with a faulty Vascular access is closed when the venous pressure is less than the predetermined limit.
  • the relationship between the magnitude of the threshold and the level of blood flow rate is described by a mathematical function that calculates the threshold for each blood flow rate.
  • the relationship between the magnitude of the threshold and the level of blood flow rate may be a linear or non-linear function.
  • the dependency can be described, for example, by a non-continuous, step-shaped function.
  • a control or alarm signal is generated, so that a Intervention in the machine control of the blood treatment device made or an acoustic and / or visual and / or tactile alarm can be given.
  • an intervention in the machine control provided on the venous blood line obturator can be closed and / or the blood pump can be stopped.
  • the device according to the invention for monitoring the venous vascular access may form a separate assembly or component of an extracorporeal
  • the device according to the invention can make use of components which are present in the blood treatment device anyway.
  • the computing and evaluation unit of the device according to the invention can be part of the central control and processing unit of the device according to the invention, for example.
  • the extracorporeal blood treatment device according to the invention is characterized in that it has the device according to the invention for monitoring venous vascular access.
  • 1 shows a dialysis machine with a device for monitoring the
  • Fig. 2B the limit for the venous pressure monitoring as a function of
  • FIG. 1 shows a simplified schematic representation of a dialysis machine 1 with a device 2 for monitoring the venous vascular access.
  • the dialysis apparatus has a dialyzer 3, which is separated by a semipermeable membrane 4 into a blood chamber 5 and a dialysis fluid chamber 6.
  • a venous blood line 8 is connected.
  • an arterial cannula 9 At the end of the arterial blood line is an arterial cannula 9 and at the end of the venous blood line 8 there is provided a venous cannula 10 for puncturing the patient to provide arterial and venous patient access so that the patient's blood in the patient extracorporeal blood circulation can flow.
  • the blood lines 7, 8 are part of a disposable, which is inserted into the blood treatment device.
  • a blood pump 11 provided on the arterial blood line 7 conveys the blood at a predetermined blood flow rate Q t,.
  • a venous obturator 16 is provided on the venous blood line 8, which is an electromagnetically actuated
  • Hose clamp can be.
  • a dialysis fluid source 12 fresh dialysis fluid is provided. From the dialysis fluid 12, a dialysis fluid supply line 13 leads to the inlet of the dialysis fluid chamber 6 of the dialyzer 3, while a
  • Dialysis fluid removal 14 leads from the output of Dialysier remplikeitshunt 3 to a drain 15.
  • the dialysis device 1 has a central control and computing unit 17, which via a control line 18 to the blood pump 11 and a control line 19 with the
  • Shut-off 16 is connected to the blood pump 11 and the obturator 16 to be able to control.
  • the dialysis machine may still have other components, but they are not shown for the sake of clarity.
  • the device 2 for monitoring the venous vascular access has a pressure sensor 20, which measures the venous pressure p ven in the venous blood line 8.
  • the monitoring device has a computing and evaluation unit 21, which via a data line 26 is connected to the central control and computing unit 17 of the blood treatment device. But it can also be part of the central control and processing unit 17.
  • the computing and evaluation unit 21 of the monitoring device receives that
  • a signal unit 23 is provided, which via a data line 24 with the arithmetic and
  • Evaluation unit 21 is connected.
  • Blood treatment device has a signal generator 23 A, to give an optical and / or acoustic and / or tactile alarm signal.
  • the signal unit 23 generates in addition to the alarm signal and a control signal, which receives the central control and processing unit 17 via the data line 25, after which the control and
  • Arithmetic unit 17 the venous valve 16 closes and the blood pump 11 stops.
  • the computing and evaluation unit 21 which has a data processing unit (microprocessor) on which a data processing program runs, is configured such that the method steps described below are carried out.
  • the arithmetic and evaluation unit 21 receives the measurement signal of the venous pressure sensor 20. Furthermore, the arithmetic and evaluation unit 21 detects the current blood flow rate Qb. The blood flow rate Qb, on an operating unit, not shown, the
  • Dialysis device can be adjusted from the central control and
  • Arithmetic unit 17 of the dialysis device are read out via the data line 26. It is also possible, for the detection of the blood flow rate, to evaluate a signal proportional to the flow rate, for example a signal proportional to the rotational speed of the blood pump. The blood flow rate can also be measured with a sensor.
  • the arithmetic and evaluation unit 21 calculates with a predetermined function from the current blood flow rate Qb the limit value LIMIT for monitoring the venous pressure.
  • the computing and evaluation unit 21 has a comparator 21B, with which the pressure p ven in the venous blood line 8, which is measured with the venous pressure sensor 20, with the limit LIMIT (Q b ) is compared. When the difference ⁇ between the venous pressure p ven and the limit LIMIT (Q b ) is greater than zero, proper venous access to the vascular system is concluded.
  • the signal unit 23 determines whether the difference ⁇ is equal to or less than zero, ie the venous pressure p ven has dropped below the limit value LIMIT (Q b ).
  • the signal unit 23 generates a control signal which the central control and arithmetic unit 17 receives. Thereupon, an intervention in the machine control is made, whereby the venous hose clamp 16 is closed and the blood pump 1 1 is stopped. In addition, an alarm signal is generated, so that alarm is given.
  • Fig. 2B shows an alternative embodiment in which the function describing the relationship between the limit LIMIT (Q b ) and the blood flow rate Q b is a non-linear function.
  • individual value ranges for the blood flow rate Q b are assigned specific limit values LIMIT (Q b ).
  • the individual limit values LIMIT (Q b ) need not be calculated according to a function, but may also be stored in the memory 21 A of the arithmetic and evaluation unit 21 in the form of a table.
  • the limit value LIMIT (Q b ) is preferably between 22.5 and 27.5 mmHg, in particular 25 mmHg, at a blood flow rate Q b [ml / min] 100 ⁇ Q b ⁇ 200 the limit LIMIT (Qb) is preferably between 27.5 and 32.5 mmHg, in particular 30 mmHg, with a blood flow rate Qb [ml / min] 200 ⁇ Qb ⁇ 300 the limit value LIMIT (Qb) is preferably between 32.5 and 37.5 mmHg, in particular 35 mmHg, with a blood flow rate Qb [ml / min] 300 ⁇ Qb ⁇ 400 the limit value LIMIT (Qb) is preferably between 37.5 and 42.5 mmHg, in particular 40 mmHg, with a blood flow rate Qb [ml / min] 400 ⁇ Qb ⁇ 500, the limit

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Cardiology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • External Artificial Organs (AREA)

Abstract

L'invention concerne un dispositif permettant de surveiller l'accès vasculaire veineux lors d'un traitement sanguin extracorporel au moyen d'un dispositif de traitement sanguin extracorporel, et un dispositif de traitement sanguin extracorporel muni dudit dispositif. L'invention concerne par ailleurs un procédé permettant de surveiller l'accès vasculaire veineux lors d'un traitement sanguin extracorporel. Le dispositif selon l'invention est muni de moyens (20) servant à mesurer la pression dans la ligne veineuse (8), et d'une unité de calcul et d'analyse (21) qui analyse le signal de mesure des moyens (20) servant à mesurer la pression, et qui est configurée de manière que la pression veineuse (pven) est comparée à une valeur limite (LIMIT(Qb)) dépendant du débit sanguin Q(b) et, si la pression veineuse (pven) est inférieure à la valeur limite prescrite (LIMIT(Qb)), on en conclut que l'accès vasculaire est défectueux. Selon l'invention, la valeur limite (LIMIT(Qb)) de la pression veineuse (pven) est déterminée en fonction de la hauteur du débit sanguin selon un rapport fixe prédéfini entre le montant de la valeur limite et la hauteur du débit sanguin. Ce rapport fixe prédéfini entre le montant de la valeur limite et le niveau de débit sanguin prévoit une augmentation de la valeur limite de la pression veineuse lorsque le débit sanguin augmente.
PCT/EP2014/076309 2013-12-10 2014-12-02 Dispositif et procédé permettant de surveiller l'accès vasculaire veineux lors d'un traitement sanguin extracorporel WO2015086384A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102013020747.9A DE102013020747A1 (de) 2013-12-10 2013-12-10 Vorrichtung und Verfahren zur Überwachung des venösen Gefäßzugangs bei einer extrakorporalen Blutbehandlung
DE102013020747.9 2013-12-10

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Publication Number Publication Date
WO2015086384A1 true WO2015086384A1 (fr) 2015-06-18

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DE (1) DE102013020747A1 (fr)
WO (1) WO2015086384A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9551625B2 (en) 2011-05-31 2017-01-24 Nxstage Medical, Inc. Pressure measurement devices, methods, and systems
WO2017186354A1 (fr) * 2016-04-28 2017-11-02 Fresenius Medical Care Deutschland Gmbh Machine de traitement du sang
US10864312B2 (en) 2005-11-09 2020-12-15 B. Braun Medical Inc. Diaphragm pressure pod for medical fluids

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1110566A2 (fr) * 1999-12-22 2001-06-27 Gambro, Inc. Méthode et appareil pour traitement extracorporel du sang
US20030152482A1 (en) * 2002-02-14 2003-08-14 O'mahony John J. Method and apparatus for an extracorporeal treatment device to control blood withdrawal and infusion
EP0995451B1 (fr) 1998-10-20 2005-12-07 Fresenius Medical Care Deutschland GmbH Dispositif de surveillance d'un accès à un vaisseau sanguin
EP1399204B1 (fr) 2001-06-29 2007-02-28 Gambro Lundia AB Procédé et dispositif permettant de détecter le détachement de l'aiguille veineuse d'un patient pendant une dialyse
EP1815878B1 (fr) 2004-10-06 2010-10-13 Nikkiso Company, Ltd. Dispositif de purification du sang
US20130012861A1 (en) * 2010-02-12 2013-01-10 Fresenius Medical Care Deutschland Gmbh Device and method for monitoring a vascular access for an extracorporeal blood treatment
EP1829570B1 (fr) 1999-01-14 2013-09-11 Fresenius Medical Care Deutschland GmbH Dispositif destinés à la détection de sténoses pour le traitement sanguin extracorporel et utilisation

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0995451B1 (fr) 1998-10-20 2005-12-07 Fresenius Medical Care Deutschland GmbH Dispositif de surveillance d'un accès à un vaisseau sanguin
EP1829570B1 (fr) 1999-01-14 2013-09-11 Fresenius Medical Care Deutschland GmbH Dispositif destinés à la détection de sténoses pour le traitement sanguin extracorporel et utilisation
EP1110566A2 (fr) * 1999-12-22 2001-06-27 Gambro, Inc. Méthode et appareil pour traitement extracorporel du sang
EP1399204B1 (fr) 2001-06-29 2007-02-28 Gambro Lundia AB Procédé et dispositif permettant de détecter le détachement de l'aiguille veineuse d'un patient pendant une dialyse
US20030152482A1 (en) * 2002-02-14 2003-08-14 O'mahony John J. Method and apparatus for an extracorporeal treatment device to control blood withdrawal and infusion
EP1815878B1 (fr) 2004-10-06 2010-10-13 Nikkiso Company, Ltd. Dispositif de purification du sang
US20130012861A1 (en) * 2010-02-12 2013-01-10 Fresenius Medical Care Deutschland Gmbh Device and method for monitoring a vascular access for an extracorporeal blood treatment

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10864312B2 (en) 2005-11-09 2020-12-15 B. Braun Medical Inc. Diaphragm pressure pod for medical fluids
US9551625B2 (en) 2011-05-31 2017-01-24 Nxstage Medical, Inc. Pressure measurement devices, methods, and systems
US9835509B2 (en) 2011-05-31 2017-12-05 Nxstage Medical, Inc. Pressure measurement devices, methods, and systems
US10345175B2 (en) 2011-05-31 2019-07-09 Nxstage Medical, Inc. Pressure measurement devices, methods, and systems
US11529448B2 (en) 2011-05-31 2022-12-20 Nxstage Medical, Inc. Pressure measurement devices, methods, and systems
WO2017186354A1 (fr) * 2016-04-28 2017-11-02 Fresenius Medical Care Deutschland Gmbh Machine de traitement du sang
CN109310812A (zh) * 2016-04-28 2019-02-05 费森尤斯医疗护理德国有限责任公司 血液处理机
US11324871B2 (en) 2016-04-28 2022-05-10 Fresenius Medical Care Deutschland Gmbh Blood treatment machine

Also Published As

Publication number Publication date
DE102013020747A1 (de) 2015-06-25

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