EP2247272A2 - Dispositif et procédé de contrôle d'un accès à un patient, en particulier d'un accès vasculaire lors d'un traitement extracorporel du sang - Google Patents

Dispositif et procédé de contrôle d'un accès à un patient, en particulier d'un accès vasculaire lors d'un traitement extracorporel du sang

Info

Publication number
EP2247272A2
EP2247272A2 EP09717252A EP09717252A EP2247272A2 EP 2247272 A2 EP2247272 A2 EP 2247272A2 EP 09717252 A EP09717252 A EP 09717252A EP 09717252 A EP09717252 A EP 09717252A EP 2247272 A2 EP2247272 A2 EP 2247272A2
Authority
EP
European Patent Office
Prior art keywords
patient
blood
monitoring
blood treatment
arterial
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Withdrawn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
EP09717252A
Other languages
German (de)
English (en)
Inventor
Malte Gross
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.)
Fresenius Medical Care Deutschland GmbH
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 EP2247272A2 publication Critical patent/EP2247272A2/fr
Withdrawn legal-status Critical Current

Links

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
    • A61M1/367—Circuit parts not covered by the preceding subgroups of group A61M1/3621
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A61M2005/1588—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body having means for monitoring, controlling or visual inspection, e.g. for patency check, avoiding extravasation
    • 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
    • A61M2205/15—Detection of leaks
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body

Definitions

  • the invention relates to a device for detecting fluid for a device for monitoring access to a patient, in particular for monitoring the arterial and / or venous vascular access in an extracorporeal blood treatment device. Moreover, the invention relates to a device for monitoring access to a patient, in particular for monitoring a vascular access in an extracorporeal blood treatment, wherein the monitoring device has a device for detecting blood. Furthermore, the invention relates to an extracorporeal blood treatment device with a device for monitoring the arterial and / or venous vascular access and a method for monitoring access to a patient, in particular for monitoring the arterial and / or venous vascular access in an extracorporeal blood treatment.
  • Devices are known in the field of medical technology with which liquids can be taken from a patient via a hose line or liquids can be supplied to patients. Access to the patient is generally with a catheter for insertion into body organs or a cannula or needle for puncturing vessels. During the examination or treatment, proper access to the patient must be ensured. Therefore, it is necessary to monitor patient access.
  • An application with particularly high demands on the safety of the monitoring of vascular access is the extracorporeal blood treatment in which an arterial tubing, which has an arterial puncture cannula (needle), blood drained from the patient, the blood is passed through a dialyzer and over a venous blood line comprising a venous puncture cannula (needle), which is returned to the patient. It exists despite regular monitoring of the Patient access by the hospital staff in principle the risk that a puncture cannula unnoticed slip out of the patient's blood vessel or even slip out both puncture cannulas from the patient's blood vessel.
  • US-A-5 578 003 discloses a safety device for a blood, wound secretion or infiltrating tubing that responds to a relative change in position of the tubing.
  • a mechanical safety device which can be attached to the blood line of a dialysis machine.
  • the known safety device has elastically biased jaws which are held in the open position by a locking bar fixed to the patient's body. In a change in position of the blood line tear the locking latch, so that the jaws disconnect the hose.
  • devices for monitoring vascular access are known, which are based on monitoring the venous and / or arterial pressure in the extracorporeal blood circulation.
  • WO 97/10013 describes a monitoring device based on monitoring the pressure in the extracorporeal circuit.
  • monitoring devices are known which detect the blood emerging at the puncture site.
  • WO 2006/8866 A1 and WO 99/24145 A1 describe devices for monitoring access to a patient which have a moisture-sensitive sensor which detects the blood exiting at the puncture site.
  • US Pat. No. 6,445,304 also discloses a moisture sensor for detecting bleeding.
  • US 2002/198483 A1 describes a moisture sensor for detecting blood at a puncture site in extracorporeal blood treatment.
  • the sensor is a conductive sensor that is electrically connected to a DC or AC voltage source, measuring the voltage drop between the two conductive electrodes.
  • a capacitive sensor is proposed.
  • it is proposed to cover the puncture site for reasons of sterility with a sterile barrier, for example, a sterile Päd on which the conductive or capacitive moisture sensor is placed.
  • the invention is based on the object to monitor a Gefforgedzugang to a patient, in particular an arterial and / or venous Gefforgedzugang in a simple manner with high reliability, whereby not only the slipping out, but also an improper fit of the puncture cannula can be reliably detected.
  • the device according to the invention for detecting fluid for a device for monitoring access to the patient is designed as a magneto-elastic moisture sensor embedded in an absorbent material which is placed on the puncture site.
  • the improper fit of the puncturing cannula can be reliably detected with the device according to the invention.
  • the absorbent material with the embedded magneto-elastic moisture sensor can be placed on the puncture site like conventional dressings or a gauze bandage. It is advantageous that with the use of the device according to the invention as it meets the requirements of hospital hygiene in dialysis, which are made by the Commission for Hospital Hygiene and Infection Prevention, since the puncture site is covered with the laying of the device according to the invention sterile. It is to be assumed that the absorbent material of the device according to the invention is sterile.
  • the device according to the invention can be provided cost-effectively as a single-use article in large numbers and can be handled as conventional dressing material to avoid infections at puncture sites. In this respect, the monitoring of patient access requires no additional measures.
  • the device according to the invention for detecting liquid preferably has means for attaching the absorbent material to the patient.
  • the fastening means are designed as means by which the absorbent material can be adhered to the skin of the patient.
  • conventional patches or the like can be used for this purpose.
  • the device according to the invention has an adhesive strip or the like which is attached to the side of the absorbent material with which the device according to the invention is placed on the skin of the patient at the puncture site.
  • the pad has an annular or U-shaped shape, so that the puncture site is partially or completely edged by the pedestrian, but not obscured and thus remains visible. It may additionally be provided a sterile transparent cover to cover the visible puncture site.
  • one magneto-elastic moisture sensor may be present in one or both legs.
  • An annular ped may be interrupted at one point by a narrow slit, so that the pedicle can be placed around the puncture site even after the puncture has already been performed.
  • An annular ped may be equipped with one or more sensors.
  • the device according to the invention for detecting fluid is intended for a device for monitoring a patient access, in particular arterial and / or venous vascular access in an extracorporeal blood treatment device.
  • the device for monitoring the vascular access with which the device for detecting fluid interacts, has a measuring unit for measuring the resonance frequency of the magneto-elastic sensor and an evaluation unit for comparing the measured resonance frequency with a predetermined reference value. In the event that the difference between the measured resonance frequency and the predetermined reference value is greater than a predetermined limit value, the evaluation unit generates a control and / or alarm signal, which signals a faulty patient access.
  • the device according to the invention for monitoring arterial and / or venous vascular access can form a separate assembly.
  • the device according to the invention is preferably part of the extracorporeal blood treatment device.
  • the monitoring device can make use of the components that are already present in the blood treatment device.
  • these include in particular the central control and processing unit of the blood treatment device, which has, for example, a microprocessor.
  • a preferred embodiment of the invention provides that in the generation of a control and / or alarm signal, the blood treatment is interrupted and / or an alarm is given.
  • the blood pump provided in the blood treatment device for delivering blood through the extracorporeal blood circulation.
  • the obturator is preferably closed, which is also arranged in the blood treatment device in extracorporeal blood circulation.
  • the arterial and / or venous clamps of the extracorporeal blood circulation can be closed.
  • an alternating magnetic field is generated by means of an exciter coil at the puncture site, wherein the response of the magneto-elastic sensor is received on the alternating magnetic field with a detector coil. Since the signal transmission for evaluation is wireless, lines can be omitted, which would be provided within the absorbent material. Thereby, the manufacture of the unit consisting of the magneto-elastic moisture sensor and the absorbent material, which may be formed as ped or the like, is substantially simplified.
  • FIG. 1 shows the essential components of a hemodialysis apparatus together with the device according to the invention for monitoring patient access in a highly simplified schematic representation
  • FIG. 2 shows a section through the device according to the invention for detecting fluid for the device according to the invention for monitoring patient access
  • FIG. 3 is a view of the device according to the invention for detecting liquid from below
  • Fig. 4 shows the essential components of the device according to the invention for monitoring the patient access
  • FIG. 5 shows the device according to the invention for detecting liquid located on a puncture site.
  • Fig. 1 shows the essential components of a hemodialysis apparatus, which has a device for monitoring the venous and / or arterial Gefrawzugangs.
  • the hemodialysis apparatus has a dialyzer 1, which is subdivided by a semipermeable membrane 2 into a blood chamber 3 and a dialysis fluid chamber 4.
  • an arterial tubing 6 is connected by means of an arterial puncture cannula 5, which leads to the inlet of the blood chamber 3 of the dialyzer.
  • a venous tubing 7 which is connected by means of a venous puncture cannula 8 to a vein of the patient.
  • the arterial tube 6 is inserted into an occluding blood pump 9, which promotes the blood in extracorporeal blood circulation I.
  • the dialysis fluid circuit II of the hemodialysis apparatus comprises a dialysis fluid source 10, to which a dialysis fluid supply line 11 is connected, which leads to the inlet of the dialysis fluid chamber 4 of the dialyzer. From the outlet of the dialysis fluid chamber 4 of the dialyzer 1, a dialysis fluid discharge line 12 departs, which leads to an outlet 13. In the dialysis fluid removal 12 a dialysis fluid pump 14 is connected.
  • the control of the dialysis device takes over a central control unit 15 which controls the blood and Dialysiersammlungspumpe 9, 14 via control lines 16, 17.
  • the central control unit 15 is connected via a data line 18 to an alarm unit 19, which gives an optical and / or audible alarm in the event of a malfunction.
  • an electromagnetically actuated venous hose clamp 20 which is closed by a further control line 21 from the central control unit 15, if a faulty Gefbuszugang is detected, for example, after complete dislodgement of the cannula from the vessel or a partial dislocation of the cannula, which leads to blood leakage.
  • An electro-magnetically actuated arterial tube clamp 40 which is closed by a further control line 41 from the central control unit 15 when a faulty Gefbuszugang is detected is located upstream of the blood chamber 3 of the dialyzer on the arterial tube 6.
  • the device 22 for monitoring the vascular access may be part of the blood treatment device or form a separate assembly.
  • the monitoring device 22 is part of the dialysis apparatus insofar as the monitoring device makes use of various components which are present in the dialysis apparatus anyway, for example parts of the central control unit 15 (microprocessor) or the alarm unit 19.
  • the device 22 for monitoring the vascular access has a device 23 for the detection of fluid, which is placed on the puncture site.
  • the liquid detection device 23 will be described in detail with reference to FIGS. 2 and 3.
  • the liquid detection device 23 comprises a magneto-elastic humidity sensor 24 which is formed as a flexible flat strip.
  • the magneto-elastic moisture sensor 24 is completely embedded in an absorbent material 25.
  • the absorbent material 25 consists of a substantially rectangular upper layer 25 A and a substantially rectangular lower layer 25 B of the same dimensions. Between the upper and lower layers 25A, 25B, which form a unit, the humidity sensor 24 is completely enclosed.
  • the figures Figures 2 and 3 show a section through the absorbent material with the moisture sensor and a bottom view of the absorbent material with the sensor.
  • the absorbent material is provided with a circumferential adhesive strip 26, with which the absorbent material with the moisture sensor, which is also referred to as Päd hereinafter, is adhered to the skin of the patient at the puncture site.
  • the adhesive strip 26 should adhere firmly to the skin of the patient, but can be easily removed. It can also be provided several adhesive strips instead of a circumferential adhesive strip.
  • the pedestrian is an article intended for single use, which can be provided in a film package 26 sterile packaged.
  • Fig. 4 shows the essential components of the device for monitoring the vascular access.
  • the device for monitoring the vascular access 22 has a measuring unit 27 for measuring the resonance frequency of the magneto-elastic moisture sensor 24, which is embedded in the sterile absorbent material 25.
  • the frequency / fundamental of the magneto-elastic sensor in the form of a cuboid strip of length L is:
  • the measuring unit 27 for detecting the frequency change has an exciter coil 28 and a detector coil 29 and a function generator 30, a lock-in amplifier
  • the evaluation unit 32 may be a conventional computer (microprocessor), which may also be part of the central control unit 15 of the dialysis machine.
  • the function generator 30 generates an AC voltage having a constant amplitude and frequency, whereby the exciting coil generates an alternating magnetic field which penetrates the humidity sensor 24.
  • the detector coil 29 measures the response of the humidity sensor to the alternating magnetic field.
  • the frequency of the AC voltage generated by the function generator is now changed, whereby the response of the humidity sensor with the excitation coil and the lock-in amplifier is measured and amplified. While the frequency of the AC signal is changed, the evaluation unit 32 determines the frequency at which the amplitude of the signal detected by the detector coil 29 is largest. This frequency corresponds to the resonance frequency of the humidity sensor 24.
  • the measured resonance frequency of the humidity sensor 24 is in the evaluation unit
  • the reference value can be calculated in known manner from the given sensor data according to equation (1). However, manufacturing-related fluctuations in the sensor properties are not taken into account. It may therefore be useful to measure the reference value by means of a test measurement, eg when commissioning the sensor, and to store the measured value as a reference value.
  • the detection of blood at the puncture site is based on the fact that the wetting of the magneto-elastic moisture sensor 24 with moisture (liquid), the resonance frequency of the magneto-elastic moisture sensor 24 changes. The resonance frequency decreases with increasing humidity.
  • the predetermined reference value for the resonance frequency is a value that is assumed when the humidity sensor is dry or exposed to only low humidity.
  • the moisture sensor is embedded in the absorbent material, the effect of changing the frequency due to the change in humidity is greatly enhanced, so that the signal evaluation is even easier and safer.
  • FIG. 5 shows the area of the puncture site 37 at which the skin 38 of the patient has been punctured by a puncture cannula 39.
  • the pedestal 23 is placed so that the puncture site is covered sterile.
  • the peder 23 adheres to the skin of the patient by means of the adhesive strip 26.
  • the pedicle is withdrawn and the cannula is withdrawn from the vessel.
  • the evaluation unit 32 of the device 22 for monitoring the Gefforgedzugangs is connected via a line 36 to the central control unit 15 of the dialysis machine. If the monitor detects a faulty vascular access, i. detects the leakage of blood at the puncture site, the central control unit 15 of the dialysis device receives the control and / or alarm signal of the monitoring device. Then, the control unit 15 closes the electro-magnetically actuable obturator 20 in the venous tubing 7 and stops the blood pump 9 in the arterial tubing 6 at. Thus, the extracorporeal blood treatment is interrupted, so that a further free flow of blood from the venous needle is not possible.
  • FIG. 1 shows an exemplary embodiment in which the monitoring device 22, which is shown only by way of an indication, is connected via a venous and an arterial device 23, 23 'to the Detection of blood has been provided to monitor both venous and arterial vascular access.
  • the moisture sensor 24 is coated. It may be provided a coating that reacts with blood, so that change the properties of the blood. Preferably, a coating is provided which coagulates the blood.
  • the coating may contain an enzyme that coagulates blood.
  • an acid or a base may also be included in the coating containing blood proteins, e.g. Albumin denatured.
  • two or more than two magneto-elastic moisture sensors are embedded in their electrical properties, in particular the dependence of the resonance frequency of the moisture, different.
  • two magneto-elastic sensors with different surface roughness may be provided to determine the density and viscosity of the liquid from the difference between the respective resonance frequencies of the two sensors for distinguishing between different events.
  • the excitation coil 28 and the detector coil 29 is integrated in a dialysis table or in a dialysis chair.
  • a dialysis table are the Exciter coil 28 and the detector coil 29 or the combined excitation and detector coil preferably integrated in the lying surface of the dialysis table.
  • the exciter coil and the detector coil or the combined exciter and detector coil are preferably integrated in the armrest.
  • the function of the exciter coil and the detector coil is realized with only one coil, which fulfills the function of both coils.
  • excitation coil 28 and detector coil 29 on the one hand and the blood treatment machine on the other hand can be done by cable.
  • a wireless connection e.g. to provide a radio link between the coils on the one hand and the blood treatment machine on the other.
  • the unit of exciter coil and detector coil has its own power supply, e.g. a battery, so that electrical lines to a power supply can be omitted.

Landscapes

  • 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 le contrôle d'un accès vasculaire en un point de ponction, en particulier, le contrôle de l'accès vasculaire artériel et/ou veineux lors d'un traitement extracorporel du sang. Le dispositif selon l'invention, au moyen duquel la sortie du sang peut être détectée au point de ponction, est constitué par un détecteur d'humidité magnéto-élastique (24) qui est inséré dans un matériau absorbant (25) qui est appliqué sur le point de ponction (37). Au cas où une solution de perfusion et/ou du sang devrait s'écouler au point de ponction (37), la position non conforme de la canule de ponction (39) peut être détectée de manière sûre au moyen du dispositif selon l'invention. Le matériau absorbant (25) avec le détecteur d'humidité magnéto-élastique inséré (24) peut être appliqué sur le point de ponction, en tant que matériau de pansement ou bande de gaze conventionnel. L'avantage est qu'en utilisant le dispositif selon l'invention, les exigences en matière d'hygiène hospitalière sont satisfaites pour la dialyse, du fait que le point de ponction est recouvert de façon stérile par application du dispositif selon l'invention. En outre, le dispositif selon l'invention peut être mis à disposition à peu de frais, en grand nombre de pièces, pour l'utilisation unique d'articles déterminés, et manipulé comme un matériau de pansement conventionnel, en vue d'éviter des infections aux points de ponction. Le contrôle d'accès au patient ne nécessite aucune disposition supplémentaire.
EP09717252A 2008-03-07 2009-03-03 Dispositif et procédé de contrôle d'un accès à un patient, en particulier d'un accès vasculaire lors d'un traitement extracorporel du sang Withdrawn EP2247272A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102008013090A DE102008013090A1 (de) 2008-03-07 2008-03-07 Vorrichtung und Verfahren zur Überwachung eines Zugangs zu einem Patienten, insbesondere eines Gefäßzugangs bei einer extrakorporalen Blutbehandlung
PCT/EP2009/001473 WO2009109351A2 (fr) 2008-03-07 2009-03-03 Dispositif et procédé de contrôle d'un accès à un patient, en particulier d'un accès vasculaire lors d'un traitement extracorporel du sang

Publications (1)

Publication Number Publication Date
EP2247272A2 true EP2247272A2 (fr) 2010-11-10

Family

ID=40936313

Family Applications (1)

Application Number Title Priority Date Filing Date
EP09717252A Withdrawn EP2247272A2 (fr) 2008-03-07 2009-03-03 Dispositif et procédé de contrôle d'un accès à un patient, en particulier d'un accès vasculaire lors d'un traitement extracorporel du sang

Country Status (6)

Country Link
US (1) US20110046534A1 (fr)
EP (1) EP2247272A2 (fr)
JP (1) JP2011512971A (fr)
CN (1) CN101959485A (fr)
DE (1) DE102008013090A1 (fr)
WO (1) WO2009109351A2 (fr)

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Publication number Publication date
US20110046534A1 (en) 2011-02-24
WO2009109351A2 (fr) 2009-09-11
WO2009109351A3 (fr) 2010-07-01
DE102008013090A1 (de) 2009-09-10
CN101959485A (zh) 2011-01-26
JP2011512971A (ja) 2011-04-28

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