WO1999029356A1 - Method and device for monitoring a catheter unit - Google Patents

Method and device for monitoring a catheter unit Download PDF

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Publication number
WO1999029356A1
WO1999029356A1 PCT/IB1998/001881 IB9801881W WO9929356A1 WO 1999029356 A1 WO1999029356 A1 WO 1999029356A1 IB 9801881 W IB9801881 W IB 9801881W WO 9929356 A1 WO9929356 A1 WO 9929356A1
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WO
WIPO (PCT)
Prior art keywords
catheter
line
monitoring
electrode
signal
Prior art date
Application number
PCT/IB1998/001881
Other languages
German (de)
French (fr)
Inventor
Peter F. Meier
Rudolf Dünki
Michel Willemin
Rudolf Füchslin
Original Assignee
Meier Peter F
Duenki Rudolf
Michel Willemin
Fuechslin Rudolf
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 Meier Peter F, Duenki Rudolf, Michel Willemin, Fuechslin Rudolf filed Critical Meier Peter F
Priority to AU10504/99A priority Critical patent/AU1050499A/en
Priority to JP2000524025A priority patent/JP2001525229A/en
Priority to EP98952990A priority patent/EP1035885A1/en
Priority to CA002312746A priority patent/CA2312746A1/en
Publication of WO1999029356A1 publication Critical patent/WO1999029356A1/en

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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
    • 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
    • A61M5/36—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 with means for eliminating or preventing injection or infusion of air into body
    • A61M5/365—Air detectors
    • 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
    • A61M5/168—Means 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
    • A61M5/16831—Monitoring, detecting, signalling or eliminating infusion flow anomalies
    • A61M5/16836—Monitoring, detecting, signalling or eliminating infusion flow anomalies by sensing tissue properties at the infusion site, e.g. for detecting infiltration

Definitions

  • the invention relates to a method for monitoring a catheter device according to the preamble of claim 1 and a device for monitoring a catheter device according to the preamble of claim 4.
  • a catheter is a tubular instrument for insertion into hollow organs, for example for the purpose of emptying, flushing, for introducing food and / or medication.
  • the catheter is rigid or elastic, single or multiple tubes, possibly provided with length marks and radiopaque or negative. It is named according to the purpose, e.g. Bladder catheter, ureteral catheter, cardiac catheter, vascular catheter,
  • catheter forms with the means necessary for its application, e.g. with an infusion device, a functional device for the introduction or removal of liquid.
  • catheter device means all known devices with one or more catheters and the associated cannulas, connections, connections, lines, regulating valves, etc.
  • the invention thus relates to medical devices which allow a liquid to flow from a reservoir into the body of a patient via a catheter or something out of the body using a catheter.
  • the catheter can be a peripheral as well as a central venous catheter.
  • Such catheter devices should be monitored for their function because Various incidents can impair or interrupt the proper fluid supply from the reservoir to the destination or the fluid drainage, such as tears, cuts or kinks in the tube serving as a line between the reservoir and the patient, air bubbles in this tube or the tearing away of the same or the catheter from Patient.
  • tears, cuts or kinks in the tube serving as a line between the reservoir and the patient air bubbles in this tube or the tearing away of the same or the catheter from Patient.
  • Catheter monitoring in particular long-term monitoring by means of an automatic system, enables the nursing staff to be alerted to a malfunction in the fluid supply.
  • FIG. 1 shows the basic diagram of a first embodiment of the invention
  • FIG. 2 shows a circuit diagram for the circuits for resistance measurement in FIG. 1,
  • FIG. 3 shows the basic diagram of a second embodiment of the invention
  • FIG. 4 shows a circuit diagram for a circuit for resistance measurement in FIG. 3
  • FIG. 5 shows a roughly schematic representation
  • FIG. 1 schematically shows a system for monitoring a peripheral catheter designated by 1, in this example a liquid is supplied to the patient.
  • the catheter is supplied with a liquid 3 stored in a container 2 via a line 4.
  • the line 4 generally consists of an electrically insulating rubber or plastic hose which is as thin and flexible as possible for the convenience of the patient, and can therefore be relatively easily bent or torn, as a result of which the fluid supply can be impaired or interrupted.
  • the letters P, Q and R denote three electrical contact points, of which the first P is close to the entry point in the body and thus in the area of one end of the line 4, the second Q close to the reservoir and thus in the area of the other end the line lies and the third R is formed by an electrode 10 which is attached somewhere on, for example as a skin surface electrode, or in the body.
  • an impairment of the fluid supply to the patient could be determined on the basis of a single resistance measurement between the positions Q and R.
  • the resistance between P and Q is very different from that between P and R.
  • Line contained liquid, and the circuit 7 can flow a current between the electrodes 5 and 6 in a known manner, and monitor the voltage required for this, as described below in connection with Figure 2.
  • an alternating current is preferably used, wherein a constant current, that is to say an alternating current with a constant amplitude, is also preferably used, and the circuit is set up to send an alarm signal via its output 8 to be sent out when the resistance measured between the points P and Q exceeds a predetermined value or lies outside a predetermined interval.
  • the circuit 11 monitors the resistance between the electrodes 6 and 10 at the positions P and R.
  • the two circuits can be set differently, or they can be constructed in order to optimally adapt the resistances to be monitored and their changes in a manner known to the person skilled in the art adapt.
  • a second catheter could also serve as a measuring tap.
  • FIG. 2 shows an example of a circuit diagram that can be used for circuits 7 and 11 if they each have a constant current source and a voltage detector. This circuit has an oscillator 30 which feeds a stabilized alternating current source 31, the output of which is connected both to the electrode 5 of the monitoring system (see FIG.
  • a high-impedance preamplifier 32 1
  • a bandpass filter 33 the output signal of which is fed via an amplifier 34 to a unit 35 which determines the peak-to-peak value of the signal and generates a corresponding DC voltage which is applied to one input of a comparator 37.
  • the other input of this comparator receives a threshold voltage from an adjustable voltage source 36 and then delivers an output signal when the DC voltage received by the unit 35 exceeds the threshold voltage.
  • This output signal is fed to a time and hold circuit 39 clocked by an oscillator 38, which can be reset by a reset signal and generates an alarm signal at its output if it receives a signal from the comparator 37 that is longer than a predetermined minimum duration of, for example, 1 second receives.
  • the detected voltage value or resistance value can thus be set or predetermined, from which it is concluded that the catheter device is malfunctioning and an alarm is generated.
  • FIG. 3 schematically shows a preferred form of a system according to the invention for monitoring the supply of a central venous catheter designated by 21, elements which perform the same function as in FIG. 1 have the same reference numbers.
  • the catheter is fed with a liquid 3 from a container 2 via a flexible line 4, and the second and third contact points designated by the letters Q and R are the same as in that figure.
  • the first contact point can be any position between a point P] _, near the point of entry of the catheter into the patient's body and one with P2 take the designated place near the end of the catheter, provided that the corresponding electrode touches the liquid flow.
  • the location, denoted by P x will depend on the intended application, inter alia whether the focus is on monitoring the insertion process of the catheter or long-term monitoring of its proper functioning.
  • the last piece of the electrical lead to the electrode will either consist of an insulated line running inside the catheter, or will be embedded in an insulating wall thereof. In both cases, the bare part of the supply line, which acts as an electrode, projects into the liquid flow at the selected contact point.
  • a further embodiment, outlined in FIG. 3, can also be used, in which the contact point between the position P2 which is advantageous during the insertion of the catheter is close to the extremity thereof and the position P- ] _ which is more favorable for permanent monitoring is close to the insertion point of the Catheter can be moved.
  • the electrode has an insulated, sufficiently flexible lead, which can be moved back and forth in the catheter, the rear end of which emerges laterally from the catheter or the line feeding it through a sealed opening.
  • the position of the electrode located at the end of the insulating supply line can then be positioned as desired in a point labeled P x , between the points P *] _ and I? 2.
  • two separate circuits are provided to monitor the resistances between the locations P x and Q and P x and R, respectively. While the circuit 7 is constructed the same as the corresponding one Circuit 7 of Figure 1, the circuit 11 'comprises only a voltage detector, the structure of which will be briefly explained with reference to Figure 4. This has the advantage that no additional currents flow near the heart; the electrical signal associated with the beating of the heart can also be used.
  • FIG. 4 outlines the circuit diagram of a voltage detector as it can be used for circuit 11 ', for example.
  • the voltage to be monitored is fed in via an adapter, the output of which feeds a unit 44 via a bandpass filter 42 and an amplifier 43 connected downstream thereof, which determines the peak-to-peak value of the incoming signal and generates a corresponding DC voltage. From then on, the construction of the circuit is basically the same as described in connection with FIG. 2.
  • Said DC voltage is applied to an input of a comparator 45, the other input of which receives a threshold voltage from an adjustable voltage source 46 and which then sends a signal when the DC voltage received by the unit 45 exceeds the threshold voltage.
  • the timing and hold circuit 49 clocked by an oscillator 48 generates an alarm signal if it receives a signal from the comparator 47 for more than a predetermined period of time.
  • a drainage catheter device which drains fluid from the body can be monitored in basically the same way as described.
  • Catheter monitoring is also carried out in accordance with the present procedure for operations on a decommissioned heart, in which the blood circulation is maintained by means of an external pump and the blood flow from the body to the pump and from the pump to the body by means of a catheter device.
  • applicable invention usable.
  • the possibility of detecting air bubbles in the liquid or. Blood flow may be useful.
  • FIG. 5 shows a corresponding intermediate piece 4 'with a smaller line diameter than the line 4. The intermediate piece is inserted into the line 4 with adapters 19 and brings about a greater change in electrical resistance in the line due to air bubbles 17 in the liquid 18 and thus a better one Detection of air bubbles by the monitoring device.
  • the illustrated embodiment is only to be understood as an example and the modification can also be carried out by a different construction, e.g. by an appropriate design or coating of the inner wall of the line 4 itself or with an element acting on the outside of the line by squeezing the same.
  • the arrangement is schematically indicated as a narrowing 4 '.
  • the monitoring of the tube 4 and thus the catheter device can also be implemented by other means instead of the preferred electrical monitoring described above.
  • a plastic tube and or the liquid can act as a light guide, so that light coupled in at point Q can be detected at point P or vice versa.
  • Corresponding coupling and detector elements are commercially available. In this way, an interruption, a kink or a leak in the hose can be identified and evaluated by evaluating the detected light Alarm will be triggered.
  • the hose and the liquid can act as sound conductors, for example for ultrasound signals, which are coupled in at Q and coupled out at P, for example, and from which a malfunction of the hose can also be determined.

Abstract

The invention relates to a method and device for monitoring proper fluid supply to an implanted catheter (1). Said method consists in monitoring the transmission of a signal between a location (Q) at the fluid source (2) or adjacent to it, and a location (P, R) downstream from the fluid flow or on the patient's skin. Preferably, propagation of an electrical current is monitored by separately measuring the electrical resistance values between the upstream location and the downstream location as well as between the latter and the area located on the skin, and comparing them to predetermined limits. An alarm is triggered when one of the limits is exceeded.

Description

Verfahren und Vorrichtung zur Überwachung einer Kathetereinrichtung Method and device for monitoring a catheter device
Technisches GebietTechnical field
Die Erfindung betrifft ein Verfahren zur Überwachung einer Kathetereinrichtung gemäss Oberbegriff des .Anspruchs 1 sowie eine Vorrichtung zur Überwachung einer Kathetereinrichtung gemäss Oberbegriff des An- spruchs 4.The invention relates to a method for monitoring a catheter device according to the preamble of claim 1 and a device for monitoring a catheter device according to the preamble of claim 4.
Stand der TechnikState of the art
Ein Katheter ist bekannterweise ein röhrenförmiges Instrument zur Einführung in Hohlorgane und zwar zum Beispiel zwecks Entleerung, Spülung, für das Einbringen von Nahrung und/oder Medikamenten. Der Katheter ist starr oder elastisch, ein- oder mehrläufig, evtl. mit Längenmarken versehen und röntgendicht oder -negativ. Er wird nach Verwendungszweck bezeichnet, z.B. Blasenkathe- ter, Harnleiterkatheter, Herzkatheter, Gefässkatheter,As is known, a catheter is a tubular instrument for insertion into hollow organs, for example for the purpose of emptying, flushing, for introducing food and / or medication. The catheter is rigid or elastic, single or multiple tubes, possibly provided with length marks and radiopaque or negative. It is named according to the purpose, e.g. Bladder catheter, ureteral catheter, cardiac catheter, vascular catheter,
Trachialkatheter, Bronchialkatheter. Der Katheter bildet mit den zu seiner Anwendung notwendigen Mitteln, z.B. mit einem Infusionsgerät, eine funktionsfähige Einrichtung zur Einbringung oder Entnahme von Flüssigkeit. Vorliegend sind mit dem Begriff Kathetereinrichtung alle bekannten Einrichtungen mit einem oder mehreren Kathetern und den zugehörigen Kanülen, .Anschlüssen, Verbindungen, Leitungen, Regulierventilen usw. gemeint.Trachial catheter, bronchial catheter. The catheter forms with the means necessary for its application, e.g. with an infusion device, a functional device for the introduction or removal of liquid. In the present case, the term catheter device means all known devices with one or more catheters and the associated cannulas, connections, connections, lines, regulating valves, etc.
Darstellung der ErfindungPresentation of the invention
Die Erfindung betrifft also medizinische Einrichtungen, die eine Flüssigkeit von einem Reservoir über einen Katheter in den Körper eines Patienten oder etwas unter Verwendung eines Katheters aus dem Körper strömen lassen. Dabei kann der Katheter ebenso ein peripherer, wie ein Zentralvenenkatheter sein. Solche Kathetereinrichtungen sollten auf ihre Funktion überwacht werden, da verschiedene Zwischenfälle die ordnungsgemässe Flüssigkeitszufuhr vom Reservoir zum Zielort oder die Flüssigkeitsabfuhr beeinträchtigen oder unterbrechen können, wie etwa Risse, Schnitte oder Knicke des als Leitung dienen- den Schlauches zwischen dem Reservoir und dem Patienten, Luftblasen in diesem Schlauch oder das Wegreissen desselben oder des Katheters vom Patienten. Bis jetzt wird die nötige Überwachung im Rahmen der üblichen Pflege durch das Spitalpersonal gewährleistet; es gibt aber Situatio- nen in denen es zu Störungen der Katheterfunktion kommen kann, welche zu spät entdeckt werden.The invention thus relates to medical devices which allow a liquid to flow from a reservoir into the body of a patient via a catheter or something out of the body using a catheter. The catheter can be a peripheral as well as a central venous catheter. Such catheter devices should be monitored for their function because Various incidents can impair or interrupt the proper fluid supply from the reservoir to the destination or the fluid drainage, such as tears, cuts or kinks in the tube serving as a line between the reservoir and the patient, air bubbles in this tube or the tearing away of the same or the catheter from Patient. Up to now, the necessary monitoring within the framework of normal care has been guaranteed by the hospital staff; however, there are situations in which disorders of the catheter function can occur which are discovered too late.
Es ist daher Aufgabe der Erfindung diesen Nachteil zu vermeiden und die rechtzeitige Behebung einer Katheterfehlfunktion durch das Personal zu ermöglichen, bzw. das Personal zu entlasten und die Kontrolle der Kathetereinrichtung insbesonders nachts zu vereinfachen.It is therefore an object of the invention to avoid this disadvantage and to enable the staff to correct a catheter malfunction in good time, or to relieve the staff and to simplify the control of the catheter device, in particular at night.
Zu diesem Zweck ist die Erfindung wie in den Hauptansprüchen beschrieben, definiert. Eine Katheterüberwachung, insbesondere Langzeitüberwachung mittels ei- ner Automatik erlaubt es, das Pflegepersonal bei einer Störung der Flüssigkeitszufuhr zu alarmieren.To this end, the invention is defined as described in the main claims. Catheter monitoring, in particular long-term monitoring by means of an automatic system, enables the nursing staff to be alerted to a malfunction in the fluid supply.
Kurze Beschreibung der ZeichnungenBrief description of the drawings
Im folgenden soll die Erfindung durch die Be- Schreibung bevorzugter Ausführungsbeispiele und anhand der Zeichnung näher erläutert werden. Es zeigtThe invention is to be explained in more detail below by describing preferred exemplary embodiments and with reference to the drawing. It shows
Figur 1 das Prinzipschema einer ersten Aus- führungsform der Erfindung,FIG. 1 shows the basic diagram of a first embodiment of the invention,
Figur 2 ein Schaltungsdiagramm für die Schal- tungen zur Widerstandsmessung in Figur 1,FIG. 2 shows a circuit diagram for the circuits for resistance measurement in FIG. 1,
Figur 3 das Prinzipschema einer zweiten Ausführungsform der Erfindung,FIG. 3 shows the basic diagram of a second embodiment of the invention,
Figur 4 ein Schaltungsdiagramm für eine Schaltung zur Widerstandsmessung in Figur 3, und Figur 5 eine grob schematisch dargestellteFIG. 4 shows a circuit diagram for a circuit for resistance measurement in FIG. 3, and FIG. 5 shows a roughly schematic representation
Ausführungsform eines Teils der Leitung einer Kathetereinrichtung. Bester Weg zur Ausführung der Erfindung Die Figur 1 zeigt schematisch eine Anlage zur Überwachung eines mit 1 bezeichneten peripheren Kathe- ters , wobei in diesem Beispiel eine Flüssigkeitszufuhr zum Patienten erfolgt. Der Katheter wird über eine Leitung 4 mit einer in einem Behälter 2 aufbewahrten Flüssigkeit 3 gespiesen. Die Leitung 4 besteht in der Regel aus einem elektrisch isolierenden Gummi- oder Kunststoff- Schlauch der für die Bequemlichkeit des Patienten möglichst dünn und biegsam ist, und daher relativ leicht knicken oder einreissen kann, wodurch die Flüssigkeitszufuhr beeinträchtigt oder unterbrochen werden kann. Es bezeichnen die Buchstaben P, Q und R drei elektrische Kon- taktstellen, von denen die erste P nahe der Eintrittsstelle im Körper und somit im Bereich des einen Endes der Leitung 4 liegt, die zweite Q nahe beim Reservoir und damit im Bereich des anderen Endes der Leitung liegt und die Dritte R von einer Elektrode 10 gebildet wird, die irgendwo am, z.B. als Hautoberflächenelektrode, oder im Körper angebracht ist. Prinzipiell könnte eine Beeinträchtigung der Flüssigkeitszufuhr zum Patienten anhand einer einzigen Widerstandsmessung zwischen den Stellen Q und R festgestellt werden. Es ist jedoch in der Regel, insbesondere beim Einträufeln einer physiologischen Salzlösung, der Widerstand zwischen P und Q sehr verschieden von demjenigen zwischen P und R. Ausserdem ist die Wirkung der zu erwartenden Störungen in beiden Fällen verschieden: ein Herausreissen des Katheters 1 oder seiner Zuführung bringt den Widerstand zwischen P und R praktisch auf unendlich, während ein Knick in der Leitung 4 oder die Anwesenheit von Luftblasen in dieser nur eine endliche Änderung des Widerstandes zwischen P und Q bewirkt. Wie praktische Versuche bestätigt haben, ist es daher vorteilhafter, den Widerstand über jede der beiden Strecken P-Q und P-R durch eine eigene, den elektrischen Parametern der Strecke angepasste Schaltung zu überwa- chen. Zu diesem Zweck sind die Schaltungen 7 und 11 vorgesehen. Erstere ist mit einer in der Nähe der Stelle Q befindlichen Elektrode 5 sowie mit einer in der Nähe der Stelle P dieser Leitung befindlichen Elektrode 6 verbun- den. Beide Elektroden stehen in Kontakt mit der in derEmbodiment of part of the conduit of a catheter device. BEST WAY OF IMPLEMENTING THE INVENTION FIG. 1 schematically shows a system for monitoring a peripheral catheter designated by 1, in this example a liquid is supplied to the patient. The catheter is supplied with a liquid 3 stored in a container 2 via a line 4. The line 4 generally consists of an electrically insulating rubber or plastic hose which is as thin and flexible as possible for the convenience of the patient, and can therefore be relatively easily bent or torn, as a result of which the fluid supply can be impaired or interrupted. The letters P, Q and R denote three electrical contact points, of which the first P is close to the entry point in the body and thus in the area of one end of the line 4, the second Q close to the reservoir and thus in the area of the other end the line lies and the third R is formed by an electrode 10 which is attached somewhere on, for example as a skin surface electrode, or in the body. In principle, an impairment of the fluid supply to the patient could be determined on the basis of a single resistance measurement between the positions Q and R. However, as a rule, especially when instilling a physiological saline solution, the resistance between P and Q is very different from that between P and R. In addition, the effect of the disturbances to be expected is different in both cases: tearing out the catheter 1 or its delivery brings the resistance between P and R practically infinite, while a kink in line 4 or the presence of air bubbles in it only causes a finite change in the resistance between P and Q. As practical tests have confirmed, it is therefore more advantageous to monitor the resistance over each of the two paths PQ and PR by means of a separate circuit adapted to the electrical parameters of the path. chen. The circuits 7 and 11 are provided for this purpose. The former is connected to an electrode 5 located near the point Q and to an electrode 6 located near the point P of this line. Both electrodes are in contact with the one in the
Leitung enthaltenen Flüssigkeit, und es kann in bekannter Weise die Schaltung 7 einen Strom zwischen den Elektroden 5 und 6 fliessen lassen, und die dafür erforderliche Spannung überwachen, wie weiter unten im Zusammenhang mit der Figur 2 beschrieben. Um auch über längere Zeiträume einen Elektrolyse-Effekt zu vermeiden, wird man vorzugsweise Wechselstrom verwenden, wobei ebenfalls bevorzugt ein konstanter Strom, also ein Wechselstrom mit konstanter .Amplitude, verwendet wird, und es ist die Schaltung eingerichtet, um über ihrem Ausgang 8 ein Alarmsignal auszusenden, wenn der zwischen den Stellen P und Q gemessene Widerstand einen vorbestimmten Wert übersteigt oder ausserhalb eines vorbestimmten Intervalles liegt. In analoger Weise überwacht die Schaltung 11 den Widerstand zwischen den Elektroden 6 und 10 an den Stellen P und R. Es können die beiden Schaltungen verschieden eingestellt, respektive aufgebaut sein, um sie in einer dem Fachmann bekannten Weise den zu überwachenden Widerständen und ihren Änderungen optimal anzupassen. Anstelle einer Haute- lektrode 10 könnte auch ein zweiter Katheter als Messabgriff dienen.Line contained liquid, and the circuit 7 can flow a current between the electrodes 5 and 6 in a known manner, and monitor the voltage required for this, as described below in connection with Figure 2. In order to avoid an electrolysis effect even over longer periods of time, an alternating current is preferably used, wherein a constant current, that is to say an alternating current with a constant amplitude, is also preferably used, and the circuit is set up to send an alarm signal via its output 8 to be sent out when the resistance measured between the points P and Q exceeds a predetermined value or lies outside a predetermined interval. In an analogous manner, the circuit 11 monitors the resistance between the electrodes 6 and 10 at the positions P and R. The two circuits can be set differently, or they can be constructed in order to optimally adapt the resistances to be monitored and their changes in a manner known to the person skilled in the art adapt. Instead of an upper electrode 10, a second catheter could also serve as a measuring tap.
Die Ausgangssignale der Schaltungen 7 und 11 werden über ein Oder Tor 15 einer (nicht gezeigten) Alarmanlage zugeführt, um ein Alarmsignal auszulösen so- bald der Widerstand über eine der beiden Strecken P-Q und P-R unerlaubte Werte annimm . Um Fehlalarme zu vermeiden kann eine oder können beide Schaltungen eingerichtet sein, um nur dann ein Ausgangssignal zu erzeugen, wenn der Widerstandswert bzw. das zugelassene Widerstandsin- tervall während mehr als einer einstellbaren minimalen Zeitdauer (im Bereich von Sekunden) überschritten bzw. verlassen wird. Figur 2 zeigt als Beispiel ein Schaltungsschema das für die Schaltungen 7 und 11 verwendet werden kann, wenn diese je eine Konstantstromquelle und einen Spannungsdetektor aufweisen. Diese Schaltung weist einen Oszillator 30 auf, der eine stabilisierte Wechselstromquelle 31 speist, deren Ausgang sowohl mit der Elektrode 5 der Überwachungsanlage (siehe Figur 1) , wie mit dem Eingang eines hochohmigen Vorverstärkers 32 verbunden ist. Diesem ist ein Bandpassfilter 33 nachgeschaltet, dessen Ausgangssignal über einen Verstärker 34 einer Einheit 35 zugeführt wird, die den Spitze-zu-Spitze Wert des Signales bestimmt und eine entsprechende Gleichspannung erzeugt, die an den einen Eingang eines Comparators 37 angelegt wird. Der andere Eingang dieses Comparators er- hält eine Schwellwertspannung von einer einstellbaren Spannungsquelle 36 und liefert dann ein Ausgangssignal, wenn die von der Einheit 35 erhaltene Gleichspannung die Schwellwert-Spannung übersteigt. Dieses Ausgangssignal wird einer von einem Oszillator 38 getakteten Zeit- und Halte-Schaltung 39 zugeführt, welche durch ein Rücksetzsignal zurückgesetzt werden kann und an ihrem Ausgang ein Alarmsignal erzeugt, wenn sie vom Comparator 37 ein länger als eine vorbestimmte Minimaldauer von beispielsweise 1 Sekunde dauerndes Signal erhält. Mit der einstellbaren Spannungsquelle 36 ist somit der detektierte Spannungswert bzw. Widerstandswert einstellbar bzw. vorbestimmbar, ab welchem auf eine Funktionsstörung der Kathetereinrichtung geschlossen wird und ein Alarm erzeugt wird.The output signals of the circuits 7 and 11 are fed via an OR gate 15 to an alarm system (not shown) in order to trigger an alarm signal as soon as the resistance over one of the two paths PQ and PR assumes illegal values. In order to avoid false alarms, one or both circuits can be set up to only generate an output signal if the resistance value or the permitted resistance interval is exceeded or left for more than an adjustable minimum time period (in the range of seconds). FIG. 2 shows an example of a circuit diagram that can be used for circuits 7 and 11 if they each have a constant current source and a voltage detector. This circuit has an oscillator 30 which feeds a stabilized alternating current source 31, the output of which is connected both to the electrode 5 of the monitoring system (see FIG. 1) and to the input of a high-impedance preamplifier 32. This is followed by a bandpass filter 33, the output signal of which is fed via an amplifier 34 to a unit 35 which determines the peak-to-peak value of the signal and generates a corresponding DC voltage which is applied to one input of a comparator 37. The other input of this comparator receives a threshold voltage from an adjustable voltage source 36 and then delivers an output signal when the DC voltage received by the unit 35 exceeds the threshold voltage. This output signal is fed to a time and hold circuit 39 clocked by an oscillator 38, which can be reset by a reset signal and generates an alarm signal at its output if it receives a signal from the comparator 37 that is longer than a predetermined minimum duration of, for example, 1 second receives. With the adjustable voltage source 36, the detected voltage value or resistance value can thus be set or predetermined, from which it is concluded that the catheter device is malfunctioning and an alarm is generated.
Figur 3 zeigt schematisch eine bevorzugte Form einer erfindungsgemässen .Anlage zur Überwachung der Speisung eines mit 21 bezeichneten Zentralvenenkatheters, wobei Elemente, welche dieselbe Funktion wie in Figur 1 ausführen, dieselben Bezugsziffern tragen. Wie in Figur 1 wird der Katheter über eine biegsame Leitung 4 mit einer Flüssigkeit 3 aus einem Behälter 2 gespiesen, und die mit den Buchstaben Q und R bezeichneten zweite und dritte Kontaktstellen liegen gleich wie in jener Figur. Da je- doch der Katheter 21 tief in den mit 22 bezeichneten (nur sehr schematisch angedeuteten) Körper des Patienten eindringt, kann die erste Kontaktstelle irgendeine Lage zwischen einer Stelle P]_, nahe dem Eintrittsort des Kathe- ters in den Körper des Patienten und einer mit P2 bezeichneten Stelle nahe dem Ende des Katheters einnehmen, sofern die entsprechende Elektrode jeweils den Flüssigkeitsstrom berührt. Die, mit Px bezeichnete, Lage wird von der beabsichtigten Anwendung abhängen, unter anderem davon, ob die Überwachung des Einsetzvorganges des Katheters oder eine langzeitige Überwachung seines ordnungsge- mässen Funktionierens im Vordergrund steht. In der Regel wird das letzte Stück der elektrischen Zuleitung zur Elektrode entweder aus einer im Inneren des Katheters verlaufenden, isolierten Leitung bestehen, oder in einer isolierenden Wandung desselben eingebettet sein. In beiden Fällen ragt das als Elektrode wirkende, blanke Teil der Zuleitung an der gewählten Kontaktstelle in den Flüssigkeitsstrom hinein. Es kann aber auch eine weitere, in Figur 3 skizzierte Ausführungsform verwendet werden, bei der sich die Kontaktstelle zwischen der während des Einsetzens des Katheters vorteilhaften Position P2 nahe der Extremität desselben, und der für die Dauerüberwachung günstigeren Position P-]_ nahe des Einführungsortes des Ka- theters verschieben lässt. Zu diesem Zweck besitzt die Elektrode, wie in Fig. 3 angedeutet, eine isolierte, im Katheter hin und her verschiebbare, hinreichend biegsame Zuleitung, deren rückwärtiges Ende durch eine abgedichtete Oeffnung seitlich aus dem Katheter oder die ihn spei- sende Leitung austritt. Die Lage der am Ende der isolierenden Zuleitung befindlichen Elektrode kann dann wunsch- gemäss in einem mit Px bezeichneten, zwischen den Stellen P*]_ und l?2 liegenden Punkt positioniert werden. Wie im vorangehenden Beispiel sind zwei getrennte Schaltungen vorgesehen, um die Widerstände zwischen den Stellen Px und Q respektive Px und R zu überwachen. Während die Schaltung 7 gleich aufgebaut ist, wie die entsprechende Schaltung 7 der Figur 1, umfasst die Schaltung 11' nur einen Spannungsdetektor, dessen Aufbau anhand der Figur 4 kurz erläutert werden soll. Dies bietet den Vorteil, dass keine zusätzlichen Ströme in Herznähe fliessen; zudem kann das mit dem Schlagen des Herzens verknüpfte elektrische Signal verwendet werden.FIG. 3 schematically shows a preferred form of a system according to the invention for monitoring the supply of a central venous catheter designated by 21, elements which perform the same function as in FIG. 1 have the same reference numbers. As in FIG. 1, the catheter is fed with a liquid 3 from a container 2 via a flexible line 4, and the second and third contact points designated by the letters Q and R are the same as in that figure. Since However, if the catheter 21 penetrates deeply into the patient's body, which is denoted by 22 (only indicated very schematically), the first contact point can be any position between a point P] _, near the point of entry of the catheter into the patient's body and one with P2 take the designated place near the end of the catheter, provided that the corresponding electrode touches the liquid flow. The location, denoted by P x , will depend on the intended application, inter alia whether the focus is on monitoring the insertion process of the catheter or long-term monitoring of its proper functioning. As a rule, the last piece of the electrical lead to the electrode will either consist of an insulated line running inside the catheter, or will be embedded in an insulating wall thereof. In both cases, the bare part of the supply line, which acts as an electrode, projects into the liquid flow at the selected contact point. However, a further embodiment, outlined in FIG. 3, can also be used, in which the contact point between the position P2 which is advantageous during the insertion of the catheter is close to the extremity thereof and the position P- ] _ which is more favorable for permanent monitoring is close to the insertion point of the Catheter can be moved. For this purpose, as indicated in FIG. 3, the electrode has an insulated, sufficiently flexible lead, which can be moved back and forth in the catheter, the rear end of which emerges laterally from the catheter or the line feeding it through a sealed opening. The position of the electrode located at the end of the insulating supply line can then be positioned as desired in a point labeled P x , between the points P *] _ and I? 2. As in the previous example, two separate circuits are provided to monitor the resistances between the locations P x and Q and P x and R, respectively. While the circuit 7 is constructed the same as the corresponding one Circuit 7 of Figure 1, the circuit 11 'comprises only a voltage detector, the structure of which will be briefly explained with reference to Figure 4. This has the advantage that no additional currents flow near the heart; the electrical signal associated with the beating of the heart can also be used.
In Figur 4 ist das Schaltschema eines Spannungsdetektors skizziert, wie er etwa für die Schaltung 11' verwendet werden kann. Die zu überwachende Spannung wird über einen Adapter eingespiesen, dessen Ausgang über einen Bandpassfilter 42 und einem diesen nachgeschalteten Verstärker 43 eine Einheit 44 speist, die den Spitze-zu- Spitze Wert des eingehenden Signales bestimmt und eine entsprechende Gleichspannung erzeugt. Von da an ist der Aufbau der Schaltung im Prinzip derselbe, wie im Zusammenhang mit Figur 2 beschrieben. Besagte Gleichspannung wird an einem Eingang eines Comparators 45 angelegt, dessen anderer Eingang eine Schwellwert-Spannung von einer einstellbaren Spannungsquelle 46 erhält und einer dann ein Signal sendet, wenn die von der Einheit 45 erhaltene Gleichspannung die Schwellwert-Spannung übersteigt. Wie im vorangehenden Beispiel erzeugt die durch einen Oszillator 48 getaktete Zeit- und Halteschaltung 49 ein Alarmsignal, wenn sie während mehr als einer vorbestimmten Zeitdauer ein Signal vom Comparator 47 erhält.FIG. 4 outlines the circuit diagram of a voltage detector as it can be used for circuit 11 ', for example. The voltage to be monitored is fed in via an adapter, the output of which feeds a unit 44 via a bandpass filter 42 and an amplifier 43 connected downstream thereof, which determines the peak-to-peak value of the incoming signal and generates a corresponding DC voltage. From then on, the construction of the circuit is basically the same as described in connection with FIG. 2. Said DC voltage is applied to an input of a comparator 45, the other input of which receives a threshold voltage from an adjustable voltage source 46 and which then sends a signal when the DC voltage received by the unit 45 exceeds the threshold voltage. As in the previous example, the timing and hold circuit 49 clocked by an oscillator 48 generates an alarm signal if it receives a signal from the comparator 47 for more than a predetermined period of time.
Es können die Schaltungen 7 und 11, respektive 11' natürlich durch andere, dem Fachmann bekannte Vorrichtungen ersetzt werden, welche die betreffenden Widerstände in passender Weise messen. Grundsätzlich auf dieselbe Weise wie geschildert kann eine Drainagekathetereinrichtung überwacht werden, welche Flüssigkeit aus dem Körper abführt. Auch bei Operationen am stillgelegten Herzen, bei welchen der Blutkreislauf über eine körperexterne Pumpe aufrechter- halten wird und der Blutstrom vom Körper zur Pumpe und von der Pumpe zum Körper über eine Kathetereinrichtung erfolgt, ist die Katheterüberwachung gemäss der vorlie- genden Erfindung einsetzbar. Dabei wird insbesonders die Möglichkeit der Erkennung von Luftblasen im Flüssigkeitsbzw. Blutstrom nützlich sein.The circuits 7 and 11 or 11 'can of course be replaced by other devices known to the person skilled in the art which measure the relevant resistances in an appropriate manner. A drainage catheter device which drains fluid from the body can be monitored in basically the same way as described. Catheter monitoring is also carried out in accordance with the present procedure for operations on a decommissioned heart, in which the blood circulation is maintained by means of an external pump and the blood flow from the body to the pump and from the pump to the body by means of a catheter device. applicable invention usable. In particular, the possibility of detecting air bubbles in the liquid or. Blood flow may be useful.
Bei der Verwendung von Leitungen 4 mit rela- tiv grossem Durchmesser von z.B. 5 mm und je nach der Art der Flüssigkeit ist es für die Detektion von kleinen Luftblasen vorteilhaft, wenn die Überwachungsvorrichtung so ausgeführt wird, dass ein Teil der gesamten Leitung 4, z.B. des Infusionsschlauches oder eines Schlauches der bereits erwähnten Pumpe, mit einer Verengung geringeren Durchmessers, von z.B. 1-3 mm, versehen wird. Figur 5 zeigt ein entsprechendes Zwischenstück 4' mit geringerem Leitungsdurchmesser als die Leitung 4. Das Zwischenstück ist mit Adaptern 19 in die Leitung 4 eingesetzt und be- wirkt eine grössere elektrische Widerstandsänderung in der Leitung aufgrund von Luftblasen 17 in der Flüssigkeit 18 und damit eine bessere Erkennung der Luftblasen durch die ÜberwachungsVorrichtung. Natürlich ist die dargestellte Ausführungsform nur als Beispiel zu verstehen und die Modifikation kann auch durch eine andere Konstruktionsweise, z.B. durch eine entsprechende Ausgestaltung oder Beschichtung der Leitungsinnenwand der Leitung 4 selber oder mit einem von aussen auf die Leitung wirkenden Element durch Quetschung derselben erzeugt werden. In den Figuren 1 und 3 ist die Anordnung als Verengung 4' schematisch angedeutet.When using lines 4 with a relatively large diameter of e.g. 5 mm and depending on the type of liquid, it is advantageous for the detection of small air bubbles if the monitoring device is designed so that a part of the entire line 4, e.g. of the infusion tube or a tube of the pump already mentioned, with a narrowing of smaller diameter, e.g. 1-3 mm. FIG. 5 shows a corresponding intermediate piece 4 'with a smaller line diameter than the line 4. The intermediate piece is inserted into the line 4 with adapters 19 and brings about a greater change in electrical resistance in the line due to air bubbles 17 in the liquid 18 and thus a better one Detection of air bubbles by the monitoring device. Of course, the illustrated embodiment is only to be understood as an example and the modification can also be carried out by a different construction, e.g. by an appropriate design or coating of the inner wall of the line 4 itself or with an element acting on the outside of the line by squeezing the same. In FIGS. 1 and 3, the arrangement is schematically indicated as a narrowing 4 '.
Die Überwachung des Schlauches 4 und damit der Kathetereinrichtung kann anstelle der bevorzugten vorstehend beschriebenen elektrischen Überwachung auch mit anderen Mitteln realisiert werden. So kann z.B. ein Kunststoffschlauch und oder die Flüssigkeit als Lichtleiter wirken, so dass an der Stelle Q eingekoppeltes Licht an der Stelle P detektierbar ist oder umgekehrt. Entsprechende Einkopplungs- und Detektorelemente sind handelsüb- lieh. Auf diese Weise kann durch Auswertung des detek- tierten Lichtes ein Unterbruch, ein Knick oder auch eine undichte Stelle des Schlauches erkannt werden und ein Alarm ausgelöst werden. Ferner kann der Schlauch und die Flüssigkeit als Schall-Leiter z.B. für Ultraschall-Signale wirken, welche z.B. bei Q eingekoppelt und bei P ausgekoppelt werden und aus welchen ebenfalls eine Fehlfunk- tion des Schlauches ermittelbar ist. The monitoring of the tube 4 and thus the catheter device can also be implemented by other means instead of the preferred electrical monitoring described above. For example, a plastic tube and or the liquid can act as a light guide, so that light coupled in at point Q can be detected at point P or vice versa. Corresponding coupling and detector elements are commercially available. In this way, an interruption, a kink or a leak in the hose can be identified and evaluated by evaluating the detected light Alarm will be triggered. Furthermore, the hose and the liquid can act as sound conductors, for example for ultrasound signals, which are coupled in at Q and coupled out at P, for example, and from which a malfunction of the hose can also be determined.

Claims

Patentansprüche claims
1. Verfahren zur Überwachung einer Katheter- einrichtung mit mindestens einem Katheter (1) und mindestens einer an diesen angeschlossenen Leitung (4), bei welchem Verfahren die Uebertragung eines optischen, akustischen oder elektrischen Signales zwischen einer ersten Stelle (Q) in oder an der Leitung und mindestens einer zweiten Stelle (P; P]_, Px, P2 ) in oder an der Leitung und/oder einer am Patienten befindlichen Stelle (R) überwacht wird, um durch Störungen der Kathetereinrichtung bewirkte Aenderungen der Signalübertragung festzustellen und im Störfall einen Alarm zu erzeugen. 1. A method for monitoring a catheter device with at least one catheter (1) and at least one line (4) connected to it, in which method the transmission of an optical, acoustic or electrical signal between a first point (Q) in or at the Line and at least one second point (P; P] _, P x , P2) is monitored in or on the line and / or a point (R) located on the patient in order to determine changes in the signal transmission caused by disturbances in the catheter device and in the event of a fault to generate an alarm.
2. Verfahren nach Anspruch 1, dadurch gekennzeichnet, dass man die Uebertragung des Signales über verschiedene Strecken von der ersten Stelle zur zweiten Stelle einerseits, und von dieser zu einer am Patienten befindlichen Stelle andererseits, überwacht. 2. The method according to claim 1, characterized in that one monitors the transmission of the signal over different distances from the first location to the second location on the one hand, and from this to a location on the patient on the other hand.
3. Verfahren nach Anspruch 2, dadurch gekennzeichnet, dass man ein elektrisches Signal verwendet, und ein Alarmsignal erzeugt, wenn der elektrische Widerstand über eine oder beide Strecken einen einstellbaren vorbestimmten Wert übersteigt oder einen Wertebereich ver- lässt.3. The method according to claim 2, characterized in that one uses an electrical signal, and generates an alarm signal when the electrical resistance over one or both distances exceeds an adjustable predetermined value or leaves a range of values.
4. Vorrichtung zur Überwachung einer Kathetereinrichtung mit einer Leitung (4) für Flüssigkeit, dadurch gekennzeichnet, dass mindestens ein Überwachungsmittel (5,6,7) vorgesehen ist, durch welches eine Funkti- onsstörung der Leitung oder in der Leitung oder des Katheters feststellbar und ein Alarmsignal auslösbar ist.4. Device for monitoring a catheter device with a line (4) for liquid, characterized in that at least one monitoring means (5, 6, 7) is provided, by means of which a malfunction of the line or in the line or the catheter can be determined and an alarm signal can be triggered.
5. Vorrichtung nach Anspruch 4 zur Ausführung des Verfahrens nach Anspruch 3, dadurch gekennzeichnet, dass sie eine erste Schaltung (7) u fasst, um den elek- trischen Widerstand zwischen einer ersten, nahe dem Eingang des Katheters oder in demselben befindlichen Elektrode (6) und einer in der Leitung oder einem diese spei- senden Behälter befindlichen zweiten Elektrode (5) zu messen, und um ein Alarmsignal zu erzeugen, wenn dieser Widerstand einen vorbestimmten Wert übersteigt oder einen Wertebereich verlässt. 5. The device according to claim 4 for carrying out the method according to claim 3, characterized in that it comprises a first circuit (7) u to the electrical resistance between a first, near the entrance of the catheter or in the same electrode (6th ) and one in the line or one of these Send container located second electrode (5) to measure, and to generate an alarm signal when this resistance exceeds a predetermined value or leaves a value range.
6. Vorrichtung nach Anspruch 4 oder 5 , dadurch gekennzeichnet, dass sie eine Schaltung (11,11') umfasst, um den Widerstand zwischen einer ersten, nahe dem Eingang des Katheters oder in demselben befindlichen Elektrode (6) und einer auf oder in der Haut des Patien- ten befindlichen Elektrode (10) zu messen, und um ein Alarmsignal zu erzeugen, wenn dieser Widerstand einen vorbestimmten Wert übersteigt oder einen vorbestimmten Wertebereich verlässt.6. The device according to claim 4 or 5, characterized in that it comprises a circuit (11,11 ') to the resistance between a first, near the entrance of the catheter or in the same electrode (6) and one on or in the To measure the patient's skin electrode (10) and to generate an alarm signal if this resistance exceeds a predetermined value or leaves a predetermined value range.
7. Vorrichtung nach den .Ansprüchen 5 und 6, gekennzeichnet durch ein das erste und das zweite Alarmsignal empfangende ODER Tor (15) , an dessen Ausgang eine Alarmvorrichtung angeschlossen ist.7. Device according to. Claims 5 and 6, characterized by an OR gate (15) receiving the first and the second alarm signal, to the output of which an alarm device is connected.
8. Vorrichtung nach einem der Ansprüche 4 bis8. Device according to one of claims 4 to
7, dadurch gekennzeichnet, dass die erste Elektrode (6) bezüglich des Katheters in Längsrichtung verschiebbar ist.7, characterized in that the first electrode (6) is displaceable in the longitudinal direction with respect to the catheter.
9. Vorrichtung nach einem der Ansprüche 4 bis9. Device according to one of claims 4 to
8, gekennzeichnet durch eine in der Leitung wirksame Verengung oder Modifikation der Leitungsinnenwand für den Flüssigkeitsdurchgang.8, characterized by an effective narrowing or modification of the inner wall of the line for the passage of liquid.
10. Vorrichtung nach einem der aAnsprüche 4 bis 9, gekennzeichnet durch eine Elektrode, welche in einer Wandung des Katheters angeordnet ist. 10. Device according to one of the claims 4 to 9, characterized by an electrode which is arranged in a wall of the catheter.
PCT/IB1998/001881 1997-12-05 1998-11-26 Method and device for monitoring a catheter unit WO1999029356A1 (en)

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EP98952990A EP1035885A1 (en) 1997-12-05 1998-11-26 Method and device for monitoring a catheter unit
CA002312746A CA2312746A1 (en) 1997-12-05 1998-11-26 Method and device for monitoring a catheter unit

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CH281497A CH692570A5 (en) 1997-12-05 1997-12-05 Apparatus for monitoring a catheter device.
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