DE4329229A1 - Adaptive controlled pump control, in particular for adaptive patient-controlled analgesia (APCA) - Google Patents

Adaptive controlled pump control, in particular for adaptive patient-controlled analgesia (APCA)

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Publication number
DE4329229A1
DE4329229A1 DE19934329229 DE4329229A DE4329229A1 DE 4329229 A1 DE4329229 A1 DE 4329229A1 DE 19934329229 DE19934329229 DE 19934329229 DE 4329229 A DE4329229 A DE 4329229A DE 4329229 A1 DE4329229 A1 DE 4329229A1
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DE
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Prior art keywords
pump
patient
control
adaptive
controlled
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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Withdrawn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
DE19934329229
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German (de)
Inventor
Joern Meuser
Juergen Dipl Phys Konkel
Peter Dipl Ing Meuser
Steffen Dipl Ing Koelbel
Bernd Dipl Ing Pfennighaus
Klaus Prof Dr Med Borchert
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MEUSER MEDIZINTECHNIK GMBH, 17033 NEUBRANDENBURG,
Original Assignee
Meditech Medizintechnik 17033 Neubrandenburg De GmbH
MEDITECH MEDIZINTECHNIK GmbH
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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/172Means 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 electrical or electronic
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M2005/1401Functional features
    • A61M2005/1405Patient controlled analgesia [PCA]

Abstract

The invention relates to an adaptive controlled pump control, in particular for adaptive patient-controlled analgesia (APCA). Adaptive patient-controlled controls are required in medicine for administration of highly active medicaments. Administration of a medicament is worthwhile only to the extent that it is required. This adjustment can only be done optimally by the patient himself/herself. Preliminary technical implementations are to be found in patient-controlled analgesia (PCA) which permits minimum involvement of the patient. In this case, rigid specifications such as inertia periods and constant bolus sizes make adaptation to the constantly changing needs possible to only a limited extent. A significant improvement is brought about by the adaptive patient-controlled pump control, in particular for adaptive patient-controlled analgesia (APCA). The APCA control operates in an open-control loop utilising a biological two-compartment model by means of variable boli and without inertia periods. It permits the patient to adapt the administration of analgesics continuously to his/her need without overdosing the drug. For easy handling, a fully graphic operator unit with parameter-minimised input dialog and display of the course of therapy is used.

Description

Die Erfindung betrifft eine adaptive kontrollierte Pumpensteuerung insbesondere für die Adaptive Patientenkontrollierte Analgesie (APCA) nach dem Oberbegriff des Anspruchs 1. The invention relates to an adaptive controlled pump control especially for the Adaptive Patient Controlled Analgesia (APCA) according to the preamble of claim 1.

Adaptive Patientenkontrollierte Pumpensteuerungen werden in der Medizin im klinischen Bereich und in der Forschung benötigt, um hochwirksame Medikamente zu verabreichen. Adaptive Patient Controlled pump controls are needed in medicine in the clinic and in research to deliver potent drugs. Die Verabreichung sehr hochwirksamer Medikamente besonders in der Analgesie ist mit erhöhten Risiken und mit erweiterten Sicherheitsanforderungen verbunden. The administration of very highly effective drugs, especially in the analgesia is associated with increased risks and with enhanced security requirements. Eine Medikamentengabe ist nur sinnvoll, wenn Schmerzen auftreten und zwar nur soviel, um diese zu beseitigen. A medication is useful only when pain occurs and only so much to eliminate them. Hier liegt das Problem der Über- bzw.- Unterdosierung. Here's the problem of over- bzw.- underdosing. Es ist eine Adaptation an den Schmerzverlauf sinnvoll. It is an adaptation of the pain course useful. Da der Patient seine eigenen Schmerzen nur selbst kennt, überläßt man ihm in einem patientenkontrollierten Tee der Analgesie die Entscheidung zur Medikamenteneinnahme mittels Pumpen. Since the patient knows his own pain only themselves, are left to him in a patient-controlled analgesia tea the decision to medication by means of pumps. Technisch realisiert wird dies bisher in Form der bekannten Patientenkontrollierten Analgesie in Anaesthesist 39 (1990), 513-520; this is technically realized so far in the form of the known patient-controlled analgesia in Anaesthesist 39 (1990), 513-520; Anaesthesia 44 (1989), 2-4. Anesthesia 44 (1989), 2-4. Derartige PCA-Steuerungen ermöglichen dem Patienten erstmals eine minimale aktive Beteiligung an der Verabreichung von Medikamenten zur eigenen Schmerzlinderung bzw. Beseitigung. Such PCA controls allow the patient for the first time a minimum active participation in the administration of medicaments for the own pain relief or disposal.

Die bisher bekannten PCA-Realisierungen z. The previously known PCA realizations z. B. aus Neue Technologien in der Infusionstherapie und Monitoring, B. Melsungen AG Melsungen 1990; B. from New technologies in infusion therapy and monitoring, as Melsungen AG Melsungen 1990; Infusionstherapie und klinische Ernährung 17. Aufl. Fresenius Bad Homburg 1990 haben jedoch eine Reihe von Nachteilen, die zwar eine Anpassung an die individuell sehr unterschiedlich verlaufenden Schmerzhäufigkeiten und Schmerzintensitäten nicht erlauben, aber eine Verbesserung gegenüber der allgemein bekannten kontinuierlichen Medikamentengabe oder der Spritzenapplikation darstellen. Infusion therapy and clinical nutrition 17th ed. However, Fresenius Bad Homburg 1990 have a number of disadvantages, while not allowing an adjustment to the highly individual running pain frequency and pain intensity, but represent an improvement over the generally known continuous medication or syringe application. PCA-Steuerungen sind im klinischen Betrieb kompliziert zu bedienen, da sie wegen des patientenkontrollierten Teils eine Reihe von technisch bedingten Zwangseinstellungen benötigt. PCA controls are in clinical operation complicated to use because it requires a number of technical reasons forced settings because of patient-controlled part. Die wesentlichsten Merkmale hierbei sind die Vorgabe von festen Bolusgrößen und Refraktärzeiten. The main features here are the specifications of solid Bolusgrößen and refractory periods.

Nachteile beim PCA-Einsatz liegen in der durch die starre Steuerung bedingten Unter- bzw. Überversorgung mit hochwirksamen Medikamenten und deren Nebenwirkungen. Disadvantages of the PCA are used in the conditional by the rigid control excessive or insufficient with highly effective drugs and their side effects. Praktisch bekommt ein Patient mittels PCA in der Refraktärzeit, bei plötzlich auftretendem Schmerz mittels Eigenanforderung kein Schmerzmittel. Virtually gets a patient using PCA in the refractory period, when suddenly occurring pain by own request no painkillers. Treten derartige Schmerzen unregelmäßig, wiederholt auf, ist durch die limitierte Momentanabgabe (fester Bolus) mit der nachfolgenden Refraktärzeit keine dem Schmerzzustand angepaßte Medikamentenabforderung möglich. If such pain, irregular, repeated by the limited instantaneous output (fixed bolus) not adapted to the pain state Medikamentenabforderung is possible with the following refractory period. Derartigen Zuständen wird gegenwärtig durch einen überhöhten Schmerzmitteleinsatz begegnet. Such conditions is currently met by an excessive use of analgesics.

Die Adaptive und kontrollierte Pumpensteuerung, insbesondere zur Adaptiven Patientenkontrollierten Analgesie nachfolgend als APCA-Steuerung bezeichnet ( Fig. 1), die Flüssigkeit durch einen Schlauch in den menschlichen oder tierischen Körper fördert, stellt eine wesentliche Verbesserung der bisher bekannten PCA dar. Die APCA-Steuerung (S) sieht vor, daß die Einstellung der Förderrate der Pumpe mit einer Tastatur (TA) und einem Display (DP) so betrieben wird, daß jederzeit durch eine externer Anforderung (EA) oder interner Ansteuerung (IA) ein Volumen abgegeben werden kann. The Adaptive and controlled pump control, in particular for adaptive patient-controlled analgesia hereinafter referred to as APCA control (Fig. 1), conveys the liquid through a tube into the human or animal body, constitutes a substantial improvement of the previously known PCA. The APCA control (S) provides that the adjustment of the delivery rate of the pump with a keyboard (TA) and a display (DP) is operated so that at any time by external demand (EA) or internal control (IA), a volume can be delivered. Hierbei wird die Pumpe in den energetischen Aktivzustand (Volumenstromabgabe) versetzt, wenn eine interne oder externe Anforderung erfolgt. Here, the pump energy into the active state (flow discharge) is set when an internal or external request is made. Die APCA-Steuerung ist ständig aktiv. The APCA control is always active. In der Inaktivphase der Pumpe befindet sich die Steuerung in einem energetisch minimierten, überwachten Schlafzustand. In the Inaktivphase the pump, the control system is in an energetically minimized, monitored sleep state. Dabei kann zu jeder Zeit eine Fördermenge, extern oder intern ausgelöst, mit der adaptiven und kontrollierten APCA-Steuerung abgegeben werden. Here, a flow rate at any time, triggered externally or internally, are submitted to the adaptive and controlled APCA control. Die Volumenabgabe erfolgt unter Berücksichtigung vorgegebener Verfahrensschemen. The volume delivery is carried out taking into account a predetermined process schemes. Diese liegen in der APCA-Steuerung vor und können mittels Tastatur aufgerufen, modifiziert und über Display kontrolliert werden. These are in the APCA control and can be accessed via keyboard, modified and controlled via the display. Dabei werden die vor dem Startzyklus verabreichte Sockelmengen berücksichtigt. The administered before the start cycle base amounts are taken into account. Um zu gewährleisten, daß eine vom Arzt maximal vorgegebene virtuelle Arzneimittelkonzentration ständig in kurzer Zeit erreichbar, nicht überschreitbar, jeder beliebige Teil des Maximums, begrenzt durch die jeweiligen Leistungsparameter der eingesetzten an sich bekannten Pumpe einstellbar ist, wird mit der APCA- Steuerung ohne Refraktärzeiten und mit variablen Boli gearbeitet. In order to ensure that a maximum prescribed by the physician virtual drug concentration can always be reached in a short time, not passable, any portion of the maximum is limited by the respective performance parameters of the employed known pump is adjustable, is with the APCA- control without refractory and worked with variable boluses. Die Ansteuerung der Pumpe kann wahlweise zeitvariabel oder -antriebsvariabel erfolgen. The control of the pump may optionally be time-variable or -antriebsvariabel. Die APCA-Steuerung ermöglicht einer Pumpe zu jedem Zeitpunkt eine flexibel steuerbare Förderung, dh in kürzester Zeit durch den Patienten angefordert (EA) ist eine beliebige Menge eines Schmerzmittels, bis hin zum durch den Arzt zugelassenen Maximum abrufbar. The APCA control enables a pump at any time a flexibly controllable promotion, that is required in a short time by the patient (EA) is any amount of an analgesic, to the approved by the physician maximum available. Bei Fehlfunktion der APCA-Steuerung, der Energieversorgung und der Pumpe wird die Infusion dV/dt durch eine Überwachungseinheit (U) gestoppt. In case of malfunction of APCA control, the power supply and the pump, the infusion dV / dt through a monitoring unit (U) is stopped. Hierzu werden die Energieversorgung (EU), die Steuereinheit (SU) und die Pumpe (PU) ständig kontrolliert. For this, the energy supply (EU), the control unit (SU) and the pump (PU) constantly monitored. Gleichzeitig wird mit der Überwachungseinheit eine Biofeedback-Funktion realisiert, mit deren Hilfe der Patient eine aktive Einhaltung eines durch den Arzt vorgegebenen Therapieregiemes durchführen kann, mit der z. Simultaneously, a biofeedback function can perform an active adherence to a predetermined by the doctor Therapieregiemes with the help of the patient, with the z is realized by the monitoring unit. B. eine Suchtprävention, Medikamentenverbrauchsoptimierung oder ein Abtrainieren möglich wird. As is possible addiction, drug use optimization or detraining. Die Rückkopplung erfolgt dabei optisch über das Display und zeigt die Überschreitung von Vorgaben an. The feedback is effected optically via the display and shows the exceeding of specifications to. Die adaptive und kontrollierte APCA-Steuerung ist universell als eigenständiges Zusatzgerät über eine Schnittstelle oder in einer Pumpe integriert betreibbar. The adaptive and controlled APCA control is universal integrated operable as an independent additional device via an interface, or in a pump. Dabei befindet sich die Pumpe in einem offenen System eines pharmakologischen Mehrkompartimentmodells in dem die Sollwerte des an sich bekannten Regelkreises ständig schwanken und dessen Verhalten bekannt ist. In this case, the pump is in an open system of a pharmacological Mehrkompartimentmodells in which the target values ​​of the known per se control circuit constantly fluctuate and its behavior is known.

Claims (8)

  1. 1. Adaptive kontrollierte Pumpensteuerung, insbesondere zur Adaptiven Patientenkontrollierten Analgesie (APCA), die mit einer Pumpe (P), Infusionsflüssigkeit von einem Vorratsbehälter in einen menschlichen oder tierischen Körper fördert, die in einem Gehäuse extern oder integriert in einer Pumpe untergebracht ist, die externe Steuerimpulsauslösungen (EA) zuläßt und interne (IA) erzeugen kann, dabei ein vorgegebenes virtuelles Maximum nicht überschreitet, geht von einer einstellbaren Ausgangssituation ohne Refraktärzeiten und mit variablen Boli aus und kann in kurzer Zeit eine gewünschte Fördermenge (dV/dt) mittels externer Anforderung derart erreichen, daß Parametereinstellungen, durch eine prognostisch wirkende Regelgrößenempfehlung der im Hintergrund geladenen Modelle über einen in seinem Verhalten bekannten offenen Regelkreis (APCA) wirken, dadurch gekennzeichnet, 1. Adaptive controlled pump control, in particular for adaptive patient-controlled analgesia (APCA) connected to a pump (P), promotes infusion fluid from a reservoir into a human or animal body, which is housed externally or integrated in a pump in a housing, the external control pulse triggers (EA) permits and internal (IA) can produce, thereby not exceed a predetermined virtual maximum, goes from an adjustable initial situation without refractory periods and with variable boluses and a desired flow rate in a short time (dV / dt) by means of external request such reach that parameter settings by a prognostic acting control parameter recommendation of the charged in the background models via a known in its behavior open loop (APCA) act, characterized in that
    • a) daß die Steuerung (S) in drei Arbeitsstufen, dem stabilen Ausgangszustand als energetische Minimalfunktion der Boluserwartung und Sicherheitsüberwachung (Schlafzustand), dem aktiven Ansteuerungszustand als energetischen Maximalfunktion und dem unterbrochenen Schlafzustand zur Aktualisierung und Berechnung Parameter zur Pumpenansteuerung (Durchgangs- oder Halbschlafzustand) arbeitet und a) that the control (S) in three stages of operation, (the stable output condition as an energetic minimum function of Boluserwartung and security monitoring sleep state), the active control state works as energy maximum function and the interrupted sleep state to update and calculation parameters for pump control (through or half-sleep state) and
    • b) daß das im Hintergrund geladene Simulationsmodell ein Mehrkompartimentmodell ist, zu dem keine starre Kopplung besteht und b) that the charged in the background simulation model is a Mehrkompartimentmodell to which no rigid coupling exists and
    • c) daß bei jeder externen (EA) oder internen Anforderung (IA) eine Volumengabe erfolgt und c) that (for each outside (EA) or internal request IA), a volume rendering is performed and
    • d) daß die ärztliche Vorgabe einer virtuellen Obergrenze nicht überschritten wird. d) that the medical setting a virtual upper limit is not exceeded.
  2. 2. Pumpensteuerung nach Anspruch 1, dadurch gekennzeichnet, daß die interne Überwachungsfunktionen (U) die Pumpe (P), die zentrale Steuereinheit (S) und die Energieversorgung (E) derart mit einbezieht, daß eine prognostisch wirksame Vorwarnung realisiert wird, bei der 2. Pump controller according to claim 1, characterized in that the internal monitoring functions (U), the pump (P), the central control unit (S) and the energy supply (E) in such a manner involving that a prognostically effective warning is realized in which
    • - ein Leistungsabfall der Batterie durch die Energieüberwachung (EU) so erkannt wird, daß mehrere Stunden Betrieb noch möglich sind und darüber hinaus eine ständige Aussage über den Entladezustand vorliegt, - is detected a drop in performance of the battery by the power monitoring (EU) such that several hours of operation are possible and, moreover, there is a continuous indication of the unloading state,
    • - Fehlfunktionen der zentralen Steuereinheit zum direkten Stoppzustand der Pumpe führen, durch die Steuerungsüberwachung (SU) erkannt, korrigiert bzw. zum manifesten Abschalten der Pumpe (P) führen, - malfunction of the central control unit for directly stopping state of the pump lead, by the controller monitor (SU) is detected, corrected or (P) for switching off the pump manifest lead,
    • - Pumpenfunktionsstörungen und Übermittlungsfehler im Stoppzustand der Pumpe mehrfach wiederholt und erst bei manifesten Defekten zum Abschalten durch die Pumpenüberwachung führen. - repeated several times while stopped the pump and only when manifest defects for switching off by the pump monitoring lead pump malfunctions and errors in transmission.
  3. 3. Pumpensteuerung nach Anspruch 1 und 2, dadurch gekennzeichnet, daß die rückgeführte Kommunikation zu Überwachungseinheit (PU) von der Pumpe (P) nur Informationen über Funktionszustände der Pumpe (P) beinhaltet. 3. Pump controller according to claim 1 and 2, characterized in that the recirculated to communication monitoring unit (PU) from the pump (P) includes only information about operating states of the pump (P).
  4. 4. Pumpensteuerung nach den vorhergehenden Ansprüchen, dadurch gekennzeichnet, daß sie adaptiv und kontrolliert in zwei Ebenen arbeitet, bei der durch externe Anforderungen (EA) ausgelöst, die erste Ebene als Arbeitsebene und ein im Hintergrund geladenes Mehrkompartimentmodell als zweite Ebene existiert, zwischen denen eine definierte Interaktion besteht. 4. pump control according to the preceding claims, characterized in that it is adaptive and controlled in two planes in which, by external requests (EA) is triggered, the first level as the working level and a charged in the background Mehrkompartimentmodell as the second level exists between which a defined interaction exists.
  5. 5. Pumpensteuerung nach vorhergehend genannten Ansprüchen mit Anforderungsmöglichkeit durch einen Patienten ohne Refraktärzeit mit variablen Boli derart, daß ein Patient bei jeder Anforderung (EA) unterhalb der ärztlich vorgegebenen Obergrenze eine Medikamentenverabreichung realisieren kann und eine akustische und optische Rückinformation bei Erreichen der Obergrenze erhält und in Form eines Biofeedback zur ärztlich vorgeplanten Therapiekonzeption optisch (DP) die Unterschreitung einer vorgegebenen Therapieschwelle signalisiert wird, um eine aktive Suchtprävention bzw. ein Abtrainieren zu unterstützen. 5. pump control according to above mentioned claims with request opportunity by a patient without refractory variable boluses such that a patient on each request (EA) can realize a drug administration and below the medically prescribed upper limit receives an acoustic and visual feedback information on reaching the upper limit and in form of a biofeedback medical preplanned therapy conception optically (DP) falling below a predetermined threshold therapy is indicated to support an active addiction or a detraining.
  6. 6. Pumpensteuerung nach den vorhergehenden Ansprüchen, dadurch gekennzeichnet, daß über die Tastatur (TA) die Ausgangswerte des adaptiven Teils vor dem Start und bei laufendem Steuerzyklus derart verändert werden können, daß ein bereits vorhandener Sockelbetrag eines vor dem Start der Steuerung (S) verabreichten Volumens bzw. im laufenden Steuerzyklus zusätzlich verabreichten Volumens berücksichtigt werden können. 6. pump control according to the preceding claims, characterized in that from the keyboard (TA), the output values ​​of the adaptive part can be changed before the start and during running control cycle such that an already existing base amount of a before the start of the control (S) administered volume or coadministered in the current control cycle volume can be considered.
  7. 7. Pumpensteuerung nach den vorhergehenden Ansprüchen, dadurch gekennzeichnet, daß die Steuerung ohne Refraktärzeiten mit variablen Bolusgrößen (dV/dt) jedes beliebige Konzentrationsniveau zwischen Null und der maximal vorgegebenen virtuellen oberen Grenze derart einnehmen kann, daß ein sich ständig ändernden Bedarf extern angefordert (EA) wird, oder ein zu haltender linearer bzw. nichtlinearer Niveauverlauf intern (IA) vom Arzt angeordnet durch ein Modell erzeugt wird. 7. pump control according to the preceding claims, characterized in that may take any concentration level between zero and the maximum predetermined virtual upper limit such control without refractory variable Bolusgrößen (dV / dt) that a constantly changing demand externally requested (EA ) is, or to be held linear and non-linear level course internally (IA) is placed by the physician generated by a model.
  8. 8. Pumpensteuerung nach den vorgegebenen Ansprüchen, dadurch gekennzeichnet, daß sie als eigenständiges Handstück mit einer Pumpen betrieben, oder als fester Teil in einer Pumpe integriert werden kann, wobei patientenseitig über die externe Anforderung (EA) nur eine ja/nein Entscheidung zugelassen wird. 8. pump control according to the specified claims, characterized in that it is operated as a separate handpiece having a pump, or can be integrated as a fixed part in a pump, wherein the patient side via the external request (EA) only a yes / no decision is allowed.
DE19934329229 1993-08-25 1993-08-25 Adaptive controlled pump control, in particular for adaptive patient-controlled analgesia (APCA) Withdrawn DE4329229A1 (en)

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