DE19844252A1 - Modular unit for infusing insulin and glucose uses commercially-available computing systems to control automatic analysis and dosing, with upgradability and data exchange functions - Google Patents

Modular unit for infusing insulin and glucose uses commercially-available computing systems to control automatic analysis and dosing, with upgradability and data exchange functions

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Publication number
DE19844252A1
DE19844252A1 DE19844252A DE19844252A DE19844252A1 DE 19844252 A1 DE19844252 A1 DE 19844252A1 DE 19844252 A DE19844252 A DE 19844252A DE 19844252 A DE19844252 A DE 19844252A DE 19844252 A1 DE19844252 A1 DE 19844252A1
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glucose
insulin
operating system
upgradability
dosing
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Hendrik Lehnert
Daniel Kopf
Ralf Lobmann
Isabel Muehlen
Edgar Kanneberg
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    • 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
    • A61M5/172—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 electrical or electronic
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
    • G16H20/17—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/67—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
    • 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
    • A61M5/1413—Modular systems comprising interconnecting elements

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Biomedical Technology (AREA)
  • Medical Informatics (AREA)
  • Epidemiology (AREA)
  • Primary Health Care (AREA)
  • Anesthesiology (AREA)
  • Vascular Medicine (AREA)
  • Hematology (AREA)
  • Veterinary Medicine (AREA)
  • Business, Economics & Management (AREA)
  • General Business, Economics & Management (AREA)
  • Animal Behavior & Ethology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Chemistry (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

Modular unit for infusing insulin and glucose is based on commercially-available industrial computer equipment including a PC (2), operating system (6) and user program (7) controlling interchangeable peripherals. The unit determines blood glucose by analysis (5) and delivers appropriate quantities of insulin (4) and glucose (3) continuously.

Description

Die Erfindung betrifft eine Vorrichtung entsprechend dem Oberbegriff des Hauptanspruchs, mit der eine Regulation der Glukosekonzentration beim Menschen zu wissenschaftlichen und klinischen Fragestellungen vorgenommen werden kann und deren Ausstattungs- und Leistungsprofil der jeweiligen Aufgabenstellung und denn erreichten wissenschaftlichen Erkenntnisstand angepaßt werden kann.The invention relates to a device according to the preamble of the main claim which is a regulation of glucose concentration in humans to scientific and clinical questions can be made and their equipment and Performance profile of the respective task and then achieved scientific Level of knowledge can be adjusted.

Einrichtungen und Verfahren zur Glukoseregulation sind seit längerem bekannt. Derartige Apparaturen und Geräte bestehen im wesentlichen aus den Komponenten Infusionspumpe für Insulin, Infusionspumpe für Glukose, Messeinrichtung zur Ermittlung des Blutglukosespiegels und Rechnereinheit zur Umsetzung der Verfahren zur Glukoseregulation. Solche Geräte gibt es für den Einsatz als gesteuerte Infusionsgeräte für die Gabe von Insulin (US PN 4526569, US PN 4055175, DE PN 36 00 888) oder als kombinierte Infusionsgeräte zur Gabe von Insulin und Glukose (US PN 4464170, US PN 4526568).Devices and methods for glucose regulation have been known for a long time. Such apparatus and equipment essentially consist of the components Infusion pump for insulin, infusion pump for glucose, measuring device for determining the Blood glucose level and computer unit for implementing the methods for glucose regulation. Such devices exist for use as controlled infusion devices for the administration of insulin (US PN 4526569, US PN 4055175, DE PN 36 00 888) or as combined infusion devices for Administration of insulin and glucose (US PN 4464170, US PN 4526568).

Bei diesen Geräten muß man erkennen, daß sie für einen konkreten Einsatzfall entwickelt und gebaut worden sind und dadurch in ihrer Konfiguration und in der Verfahrensauswahl festgelegt sind. Es ist nicht einfach möglich, den Steuer- und. Regelalgorithmus zu verändern, weil damit in den internen Programmspeicher eingegriffen werden muß. Die angeschlossenen Peripheriekomponenten für die Injektionen und Blutzuckermessungen sind nicht veränderbar. Damit ist die Geräteeinheit nur so wissenschaftlich und technologisch aktuell, wie es zum Zeitpunkt der Konzipierung und Entwicklung des Gerätes möglich war. Ein weiteres Merkmal vorhandener Apparaturen besteht darin, daß im Falle eines Ausfalls einer Komponente das gesamte Gerät für den Einsatzfall nicht mehr zur Verfügung steht. In der Regel sind diese Geräte nicht mit umfangreichen Anzeige-, Diagnose- und Bedienerführungseigenschaften ausgestattet, so daß eine umfangreiche Schulung und Einarbeitungszeit für das Bedienpersonal notwendig werden. Schließlich ergeben sich aus dem Betrieb umfangreiche Datenmengen, die in annehmbarer Zeit aufbereitet werden müssen und zur Weiterverarbeitung und Dokumentation in unterschiedlichen Datenformaten zur Verfügung gestellt werden müssen.With these devices you have to recognize that they have been developed for a specific application and have been built and therefore in their configuration and in the selection of processes are set. It is not easy to control and. Change control algorithm, because it has to be accessed in the internal program memory. The connected Peripheral components for injections and blood sugar measurements cannot be changed. This means that the device unit is only as scientifically and technologically up-to-date as it is for When the device was designed and developed. Another characteristic Existing equipment is that in the event of a component failure entire device is no longer available for the application. As a rule, these are Devices not with extensive display, diagnostic and operator guidance properties equipped so that extensive training and familiarization time for the operating personnel become necessary. After all, the operation results in extensive amounts of data that must be prepared in an acceptable time and for further processing and Documentation must be made available in different data formats.

Erfindungsgemäß werden die genannten Probleme durch eine modulare Vorrichtung gemäß dem Kennzeichen des Hauptanspruchs gelöst.According to the invention, the problems mentioned are solved by a modular device solved the characteristic of the main claim.

Im Vergleich zu bekannten Lösungen erlaubt der Entwicklungsstand der PC-Technologie und deren Betriebssysteme die Verwendung eines heute handelsüblichen Industrie-PC in Kombination mit geeigneter Peripherie zur Realisierung einer Geräteeinheit, die auf den jeweiligen Anwendungsfall zur Insulin- und Glukoseregulation schnell, komfortabel und kostengünstig angepaßt werden kann. Hauptmerkmal ist der Aufbau von leicht und sicher bedienbaren Geräten, deren anfallende Daten systemübergreifend verarbeitet und analysiert werden können. Durch die Erstellung adaptiver Software für die Regelstrategien können die Ergebnisse der wissenschaftlichen Untersuchungen dem jeweiligen Kenntnisstand entsprechend in der Geräteeinheit umgesetzt verwirklicht werden. Es lassen sich auf den Anwendungsfall und auf bestimmte Anforderungen hin angepaßte Steuer- und Regelstrategien anwenden. Das betreuende Versuchspersonal wird dialoggestützt während der Messungen geführt und durch Entscheidungsunterstützung für andere Aufgaben entlastet. Die Peripheriekomponenten zur Blutglukosebestimmung und Steuerung der Injektionen werden über die allgemein üblichen Hardwareschnittstellen des Industrie-PC gesteuert. Der bidirektionale Datenaustausch mit diesen Komponenten sichert die zuverlässige Funktion und liefert zusätzliche Informationen für die Benutzerführung. Durch Softwareanpassung wird gewährleistet, daß der Anwender in der Wahl der Peripheriekomponenten nicht eingeschränkt wird. So wird es auch möglich, unvorhergesehene Störungen von Peripheriegeräten schnell zu kompensieren. Damit steht ein effizientes Analysegerät zur Untersuchung und Lösung von Aufgaben der Regulation der Glukosekonzentration beim Menschen bei wissenschaftlichen und klinischen Fragestellungen zur Verfügung.Compared to known solutions, the level of development of PC technology and whose operating systems use a commercially available industrial PC in Combination with suitable peripherals to implement a device unit that is based on the each application for insulin and glucose regulation quickly, comfortably and can be adapted inexpensively. The main feature is the construction of light and safe  operable devices, the resulting data processed and analyzed across systems can be. By creating adaptive software for the control strategies, the Results of the scientific studies according to the current level of knowledge implemented in the device unit. It can be based on the use case and Apply control strategies that are tailored to specific requirements. The supervising test personnel is led and carried out with the support of dialogues during the measurements Decision support for other tasks is relieved. The peripheral components for Blood glucose determination and control of injections are beyond the common Hardware interfaces of the industrial PC controlled. The bidirectional data exchange with These components ensure reliable operation and provide additional information for the user guidance. Software adaptation ensures that the user in the Choice of peripheral components is not restricted. So it also becomes possible to quickly compensate for unforeseen disturbances of peripheral devices. With that comes one efficient analyzer for examining and solving tasks of regulation Glucose concentration in humans for scientific and clinical questions to disposal.

In einer vorteilhaften Ausführungsform der Erfindung befindet sich die Steuer- und Verfahrensablaufsoftware in einem handelsüblichen Industrie-PC. Die notwendigen Peripheriegeräte werden durch die Software eigenständig eingebunden. Das Meßgerät zur Blutzuckermessung und die Injektionspumpen werden über serielle Schnittstellen des Industrie- PC in ihrer Funktion gesteuert und gleichzeitig werden Daten über ihren Betiebszustand an den PC geliefert. Diese Daten werden durch die Steuersoftware analysiert und die ermittelten Informationen werden dem Bedienpersonal auf dem Monitor des PC signalisiert. Das gesamte Programmsystem erlaubt die Einbindung neuer Softwaremodule, um neue wissenschaftliche Methoden zur Glukoseregulation anwenden zu können und um neue Peripheriegeräte anschließen zu können, ohne daß eine gesamte neue Geräteeinheit erworben werden muß.In an advantageous embodiment of the invention, the control and Process software in a standard industrial PC. The necessary Peripheral devices are integrated independently by the software. The measuring device for Blood sugar measurement and the injection pumps are carried out via serial interfaces of the industrial PC controlled in its function and at the same time data about its operating status are sent to the PC delivered. This data is analyzed by the control software and the determined Information is signaled to the operating personnel on the PC monitor. The entire Program system allows the integration of new software modules to new scientific To be able to apply methods for glucose regulation and to new peripheral devices to be able to connect without having to purchase an entire new unit.

Diese Ausführungsform ist für den Einsatz in der experimentellen Anwendung zur präzisen Regulation des Insulin- und Blutzuckerspiegels auf voreinstellbarem Niveau zu wissenschaftlichen Untersuchungen (euglykämischer und hypoglykämischer Clamp) und nach Etablierung des Systems in wissenschaftlichen Anwendungen vorgesehen. Ein weiterer Einsatzbereich ist die klinische Anwendung zur Beantwortung spezieller diagnostischer Fragestellungen (Untersuchungen zur Hypoglykämiewarnehmung, Insulinbedarf bei schwer einstellbaren Diabetikern) und zur Therapie in Notfallsituationen bei Diabetikern (diabetisches Koma).This embodiment is for use in experimental application for precise Regulation of insulin and blood sugar levels at a pre-adjustable level scientific studies (euglycemic and hypoglycemic clamp) and after The system is to be established in scientific applications. Another Area of application is the clinical application for answering special diagnostic Questions (examinations for hypoglycaemia warning, insulin requirement for severe adjustable diabetics) and for therapy in emergency situations in diabetics (diabetic Coma).

AusführungsbeispielEmbodiment

Die erfindungsgemäße Lösung wird nachstehend an einem Ausführungsbeispiel näher erläutert. In der zugehörigen Zeichnung zeigtThe solution according to the invention is explained in more detail below using an exemplary embodiment. In the accompanying drawing shows

Fig. 1 eine Schematische Darstellung der Komponenten zur Insulin- und Glukoseinfusion in einer modularen Geräteeinheit. Fig. 1 is a schematic representation of the components for insulin and glucose infusion in a modular device unit.

In Fig. 1 ist die modulare Geräteeinheit (1) zur geregelten Insulin- und Glukoseinfusion, bestehend aus einem Personalcomputer (2) mit üblichem Betriebssystem (6) und darauf laufender Anwendersoftware (7) sowie dem Peripheriegerät zur Bestimmung des Blutglukosewertes (5) und den Peripheriegeräten zur Injektion von Insulin (4) und Glukose (3) dargestellt. Die Anwendersoftware (7) enthält die einzelnen Module, die die Verfahrensregelung und Steuerung mit den Peripheriegeräten über die standardmäßig installierten Hardwareschnittstellen (9) des Computers verbindet. Der PC (2) und die Komponenten zur Injektion von Insulin (4) und Glukose (3) stellen eigenständige Geräte dar, die über Interfacekabel (10) miteinander verbunden werden. Über ein Display (8), in der Regel ein Computermonitor, werden Daten und Informationen sichtbar, und das Bedienpersonal wird im Verfahrensablauf geführt. Die Geräte zur Injektion von Insulin (4) und Glukose (3) und Glukosewertbestimmung stellen über ihre Schnittstellen (11) die Verbindung zum jeweiligen Untersuchungsobjekt her.In Fig. 1, the modular device unit ( 1 ) for regulated insulin and glucose infusion, consisting of a personal computer ( 2 ) with a conventional operating system ( 6 ) and user software running thereon ( 7 ) and the peripheral device for determining the blood glucose value ( 5 ) and Peripheral devices for the injection of insulin ( 4 ) and glucose ( 3 ) are shown. The user software ( 7 ) contains the individual modules that connect the process control and control with the peripheral devices via the standard hardware interfaces ( 9 ) of the computer. The PC ( 2 ) and the components for the injection of insulin ( 4 ) and glucose ( 3 ) are independent devices that are connected to each other via interface cables ( 10 ). Data and information become visible on a display ( 8 ), usually a computer monitor, and the operating personnel are guided in the process sequence. The devices for the injection of insulin ( 4 ) and glucose ( 3 ) and glucose value determination establish the connection to the respective examination object via their interfaces ( 11 ).

Dieses Ausführungsbeispiel wird angewendet zur präzisen Einstellung des Blutzuckerspiegels auf voreinstellbarem Niveau zu wissenschaftlichen Untersuchungen im euglykämischen Clamp. Dabei wird durch die Verfahrenssoftware (7) aus den Bedienereingaben ermittelt, welche Insulinmenge über den Versuchszeitraum gegeben werden muß und steuert dann die notwendige variable Glukosezufuhr, um den gewünschten Wert zu erreichen und einzuhalten. Bei diesem Ausführungsbeispiel erfolgt die Blutzuckerwertbestimmung in einem vorher festgelegten äquidistanten Zeitintervall.This exemplary embodiment is used for the precise setting of the blood sugar level at a presettable level for scientific studies in the euglycemic clamp. The process software ( 7 ) uses the operator input to determine the amount of insulin that has to be given over the test period and then controls the necessary variable glucose supply in order to achieve and maintain the desired value. In this exemplary embodiment, the blood sugar value is determined in a predetermined equidistant time interval.

An den Personalcomputer werden bezüglich der Geschwindigkeit keine großen Forderungen gestellt, da es sich hier um langsame Prozesse mit relativ großen Zeitkonstanten handelt. Die Daten werden auf dem Rechner gespeichert und es können Berichte ausgedruckt werden. Wird beabsichtigt, ein anderes Meßgerät für die Blutzuckerbestimmung einzusetzen, dann wird über eine Sofwarekonfiguration eine Modulanpassung vorgenommen und das neue Gerät in den Verfahrensablauf implementiert.No great demands are made on the personal computer in terms of speed because these are slow processes with relatively large time constants. The data is saved on the computer and reports can be printed out. If it is intended to use another blood glucose meter, then Modification of the module was carried out via a software configuration and the new device was installed in the Procedure implemented.

Durch weitere Miniaturisierung der Mikrorechentechnik und Gerätetechnik und die Kombination mit moderner Sensorik zur Glukosebestimmung kann an einen portablen Einsatz gedacht und innovative Anwendungsfelder erschlossen werden.Through further miniaturization of micro computing and device technology and the Combination with modern sensors for glucose determination can be carried out in a portable manner thought and innovative fields of application are opened up.

Claims (7)

1. Modulare Vorrichtung zur computergesteuerten Insulin- und Glukoseinfusion, dadurch gekennzeichnet, daß die Geräteeinheit gebildet wird aus einem handelsüblichen Industrie- Personalcomputer mit einem auf dem ebenso handelsüblichen Betriebssystem ablaufenden Anwenderprogramm und frei austauschbaren und steuerbaren Peripheriekomponenten zur Blutglukosebestimmung und zur kontinuierlichen Gabe von Insulin und Glukose.1. Modular device for computer-controlled insulin and glucose infusion, characterized in that the device unit is formed from a commercially available industrial personal computer with a user program running on the likewise commercially available operating system and freely exchangeable and controllable peripheral components for determining blood glucose and for the continuous administration of insulin and glucose . 2. Vorrichtung nach Anspruch 1, dadurch gekennzeichnet, daß das auf dem Betriebssystem ablaufende Anwenderprogramm in Softwaremodule unterteilt ist, die die Aufgaben übernehmen zur Analyse und zur selbständigen Einbindung sowie zur Steuerung und Überwachung der Peripheriekomponenten.2. Device according to claim 1, characterized in that on the operating system running user program is divided into software modules that take over the tasks for analysis and independent integration as well as for controlling and monitoring the Peripheral components. 3. Vorrichtung nach Anspruch 1 oder 2, dadurch gekennzeichnet, daß das auf dem Betriebssystem ablaufende Anwenderprogramm in erweiterbare Softwaremodule unterteilt ist, die die Verfahrenssteuerung und Regelung zur Insulin- und Glukoseinjektion realisieren und die nach den neuesten wissenschaftlichen Erkenntnissen und Erfahrungen erneuert und erweitert werden können.3. Apparatus according to claim 1 or 2, characterized in that that on the Operating program running operating system is divided into expandable software modules, who implement the process control and regulation for insulin and glucose injection and which is renewed according to the latest scientific knowledge and experience and can be expanded. 4. Vorrichtung nach Anspruch 1, 2 oder 3, dadurch gekennzeichnet, daß die Peripheriegeräte sowohl in ihren Aktionen durch die Anwendersoftware nach validierten Regeln gesteuert werden als auch Daten und Informationen bidirektional austauschen, durch das Anwenderprogramm analysiert werden und dem Bedienpersonal aufbereitet zur Entscheidungsfindung angezeigt werden.4. Apparatus according to claim 1, 2 or 3, characterized in that the peripheral devices both controlled in their actions by the user software according to validated rules will also exchange data and information bidirectionally, through the User program are analyzed and prepared for the operating personnel Decision making are displayed. 5. Vorrichtung nach Anspruch 1, 2, 3 oder 4, dadurch gekennzeichnet, daß die anfallenden Daten auf den internen Speichermedien oder Wechselspeichermedien des Personalcomputers so abgelegt werden, daß sie auf für eine Verarbeitung mit anderen Auswerteprogrammen zur Verfügung stehen.5. Apparatus according to claim 1, 2, 3 or 4, characterized in that the accruing Data on the internal storage media or removable storage media of the personal computer that they are stored for processing with other evaluation programs To be available. 6. Vorrichtung nach Anspruch 1, 2, 3, 4 oder 5, dadurch gekennzeichnet, daß die anfallenden und gespeicherten Daten über ein Netzwerk online verarbeitet werden können.6. The device according to claim 1, 2, 3, 4 or 5, characterized in that the accruing and stored data can be processed online via a network. 7. Vorrichtung nach Anspruch 1, 2, 3, 4, 5 oder 6, dadurch gekennzeichnet, daß über ein Netzwerk Überwachungs-, Steuerungs- und Diagnosefunktionen durchgeführt werden können.7. The device according to claim 1, 2, 3, 4, 5 or 6, characterized in that over a Network monitoring, control and diagnostic functions can be performed.
DE19844252A 1998-09-26 1998-09-26 Modular unit for infusing insulin and glucose uses commercially-available computing systems to control automatic analysis and dosing, with upgradability and data exchange functions Withdrawn DE19844252A1 (en)

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