DD284411A5

DD284411A5 - BIOSENSITIVE INFUSION DEVICE

Info

Publication number: DD284411A5
Application number: DD32888489A
Authority: DD
Inventors: Peter Abel; Ute Brunstein; Kerstin Rebrin
Original assignee: Zentralinstitut Fuer Diabetes "Gerhardt Katsch",Dd
Priority date: 1989-05-25
Filing date: 1989-05-25
Publication date: 1990-11-14

Abstract

Die Erfindung betrifft eine biosensitive Infusionseinrichtung zur simultanen Bestimmung biologischer Parameter, vorzugsweise der Glukose, und Infusion von in Loesung befindlichen Pharmaka, vorzugsweise des Insulins, im menschlichen und tierischen Koerper. Sie dient der Verringerung der anwendungsbedingten Belastung bei Realisierung beider Aufgaben, der Messung und der Infusion durch eine kombinierte Anordnung, deren aeuszere Abmessungen denen der herkoemmlichen Infusionseinrichtung entsprechen. Durch die geometrische Anordnung der sensitiven Katheterspitze und der Infusataustrittsoeffnungen wird einer Verduennung des Meszkompartiments am Implantationsort vorgebeugt, und es werden guenstige Resorptionsbedingungen fuer das Infusat geschaffen. Anwendungsgebiete der Erfindung sind die apparative, meszwertgeregelte Insulintherapie mit extrakorporalen und implantierbaren Insulininfusionspumpen und mit manuellen Insulindosiergeraeten in Kathetervariante. Fig. 1{Infusionseinrichtung; Biosensitivitaet; Biosensor; Kombination; meszwertgeregelte Infusion; Katheter als Sensorfuehrung; verbesserte Resorption bei subkutaner Applikation}The invention relates to a biosensitive infusion device for the simultaneous determination of biological parameters, preferably glucose, and infusion of drugs in solution, preferably of insulin, in the human and animal body. It serves to reduce the application-related burden in realizing both tasks, the measurement and the infusion by a combined arrangement, the aeuszere dimensions of which correspond to those of the conventional infusion device. Due to the geometric arrangement of the sensitive catheter tip and the Infusataustrittsoeffnungen a Verduennung the Meszkompartiments is prevented at the implantation, and there are favorable resorption conditions for the infusate created. Areas of application of the invention are the apparatus-based, metered-regulated insulin therapy with extracorporeal and implantable insulin infusion pumps and with manual insulin dosing devices in the catheter variant. Fig. 1 {infusion device; Biosensitivitaet; biosensor; Combination; value-controlled infusion; Catheter as sensor port; improved absorption with subcutaneous administration}

Description

Biosensor oder der funktionsbestimmende Teil des Biosensors, die Meßelektrode, innerhalb des Lumens in der Spitze des Infusionskatheters angeordnet ist und daß der Infusionskatheter auf der implantierten Länge des Schaftes mehrfach in unterschiedlichen Ebenen perforiert ist, um den Austritt des Pharmakons in ausreichendem Abstand vom sensitiven Teil der Anordnung zu ermöglichen.Biosensor or the function determining part of the biosensor, the measuring electrode, is disposed within the lumen in the tip of the infusion catheter and that the infusion catheter is perforated on the implanted length of the shaft several times in different planes to the outlet of the drug at a sufficient distance from the sensitive part of the To allow arrangement.

Die Kombination des Infusionskatheters mit dem Biosensor hat zur Folge, daß zur intrakorporalen Anwendung der Meß- und Infusionseinrichtung nur eine einzige Verletzung der Haut erforderlich ist. Des weiteren ermöglicht die erfindungsgemäße Anordnung im Falle der routinemäßigen subkutanen Pharmakotherapie, daß die Referenzelektrode des Biosensors nicht im Infusionskatheter untergebracht werden muß, daß sie darüber hinaus überhaupt nicht in den Körper implantiert werden muß, sondern unter Verwendung eines Elektrolyten in der Nähe des Implantationsortes der biosensitiven Infusionseinrichtung außen auf der Haut des Probanden fixiert werden kann.The combination of the infusion catheter with the biosensor has the consequence that for the intracorporeal application of the measuring and infusion device only a single injury to the skin is required. Furthermore, in the case of routine subcutaneous pharmacotherapy, the inventive arrangement allows the reference electrode of the biosensor not to be housed in the infusion catheter, nor does it need to be implanted into the body at all, but using an electrolyte near the implantation site of the biosensitive ones Infusion device can be fixed externally on the skin of the subject.

Die erfindungsgemäße Anordnung gestattet es, bei Verwendung eines Biosensors in Form einer Mikroelektrode, die Funktionen Parameterbestimmung und Infusion mit einem Infusionskatheter zu realisieren, dessen Durchmesser gegenüber den bisher verwendeten Kathetern für die Infusion von in Lösung befindlichen Pharmaka unverändert ist. Die gleiche Aussage gilt für die implantierte Länge des biosensitiven Infusionskatheters. Durch die räumliche Trennung des sensitiven Teils und der Infusataustrittsöffnungen ist gesichert, daß das austretende Pharmakon nicht das Meßkompartiment beeinflußt. Hierzu trägt zusätzlich die Anordnung mehrerer Austrittsöffnungen in unterschiedlichen Ebenen bei, die darüber hinaus dafür sorgen, daß sich während der Infusion kein größeres Pharmakodepot ausbildet, sondern a priori eine feine Verteilung und damit günstigere Resorptionsbedingungen für das infundierte Pharmakon gewährleistet sind.The arrangement according to the invention makes it possible, when using a biosensor in the form of a microelectrode, to realize the functions of parameter determination and infusion with an infusion catheter whose diameter is unchanged from the catheters used to infuse in-solution pharmaceuticals. The same statement applies to the implanted length of the biosensitive infusion catheter. The spatial separation of the sensitive part and the infusate outlet openings ensures that the exiting drug does not affect the measuring compartment. In addition, the arrangement of several outlet openings in different planes contributes to this, which moreover ensure that no larger Pharmakodepot forms during the infusion, but a priori fine distribution and thus more favorable absorption conditions for the infused drug are guaranteed.

Ausführungsbeispielembodiment

Die Erfindung soll nachstehend anhand von Ausführungsbeispielen für eine biosensitive Infusionseinrichtung zur simultanen Bestimmung der Glukosekonzentration und einer meßwertgeregelten oder gesteuerten Infusion von Insulin näher erläutert werden.The invention will be explained in more detail below with reference to exemplary embodiments of a biosensitive infusion device for the simultaneous determination of the glucose concentration and a measured-value or controlled infusion of insulin.

In den dazugehörigen Zeichnungen ist dargestellt:The accompanying drawings show:

Fig. 1: erfindungsgemäße biosensitive Infusionseinrichtung mit Enzymelektrode Fig.2: erfindungsgemäße biosensitive Infusionseinrichtung mit Infusionskanüle1: biosensitive infusion device according to the invention with enzyme electrode FIG. 2: biosensitive infusion device according to the invention with infusion cannula

Fig.3: erfindungsgemäße biosensitive Infusionseinrichtung mit interner Meßelektrode und externer Referenzelektrode des Biosensors.3 shows a biosensitive infusion device according to the invention with internal measuring electrode and external reference electrode of the biosensor.

Die erfindungsgemäße biosensitive Infusionseinrichtung beinhaltet gemäß Fig. 1 die Kombination von Meßeinrichtung zur Bestimmung der Glukosekonzentration und Infusionseinrichtung zursimultanen Insulinapplikation, die in einer Körperhöhe oder einem anderen geeigneten Ort beim Probanden implantiert ist. Sie arbeitet in der Weise, daß im Falle der meßwertgeregelten Insulinapplikation das Signal des Biosensors 1, der in Form einer Enzymelektrode im Lumen der Spitze des Infusionskatheters 2 angeordnet ist, über die Signalleitung 3 am anderen Ende des Infusionskatheters 2 herausgeführt und in einen adäquaten Insulininfusionsbefehl umgewandelt wird. Die Signalleitung 3 ist hierzu außerhalb des Körpers des Probanden aus dem Infusionskatheter 2 ausgekoppelt und der Meßwertverarbeitungs- und Speichereinheit 4 zugeführt.According to the invention, the biosensitive infusion device according to the invention comprises the combination of measuring device for determining the glucose concentration and infusion device for simulant insulin application, which is implanted at a body height or another suitable location in the subject. It operates in such a way that in the case of metered insulin application the signal of the biosensor 1, which is arranged in the form of an enzyme electrode in the lumen of the tip of the infusion catheter 2, led out via the signal line 3 at the other end of the infusion catheter 2 and converted into an adequate insulin infusion command becomes. For this purpose, the signal line 3 is decoupled from the infusion catheter 2 outside the body of the subject and fed to the measured value processing and storage unit 4.

Die Insulininfusion erfolgt durch die gesteuerte Infusatpumpe 5 unter Nutzung des selben Infusionskatheters 2, aus dem der Insulinaustritt durch die auf dem Umfang verteilten und auf unterschiedliche Ebenen der implantierten Katheterlänge untergebrachten Offnungen 6 realisiert ist. Der Abstand zwischen der biosensitiven Spitze des Infusionskatheters 2 und den Infusataustrittsöffnungen 6 und deren räumliche Anordnung garantieren, daß keine Verdünnung der Glukosekonzentration durch das in den Probanden infundierte Medikament auftritt.The insulin infusion is effected by the controlled infusate pump 5 using the same infusion catheter 2, from which the insulin outlet is realized by the openings 6 distributed on the circumference and accommodated on different levels of the implanted catheter length. The distance between the biosensitive tip of the infusion catheter 2 and the infusate outlets 6 and their spatial arrangement ensure that no dilution of the glucose concentration by the drug infused into the subject occurs.

Während die Meßelektrode 1.1 als funktionsbestimmender Teil des Biosensors 1 erfindungsgemäß stets im Lumen der Spitze des Infusionskatheters 2 anzuordnen ist, kann gemäß Fig.2 die Referenzelektrode 1.2 des Biosensors 1 als Kanüle des Infusionskatheters 2 realisiert werden.While the measuring electrode 1.1 as a function-determining part of the biosensor 1 according to the invention is always to be arranged in the lumen of the tip of the infusion catheter 2, according to Figure 2, the reference electrode 1.2 of the biosensor 1 can be realized as a cannula of the infusion catheter 2.

Die Referenzelektrode 1.2 des Biosensors 1 kann sich gemäß Fig.3 außerhalb des Infusionskatheters 2 parallel zur Meßelektrode 1.1 des Biosensors 1 befinden.The reference electrode 1.2 of the biosensor 1 can be located parallel to the measuring electrode 1.1 of the biosensor 1 according to FIG. 3 outside the infusion catheter 2.

Darüber hinaus ist vorgesehen, die Referenzelektrode 1.2 des Biosensors 1 extrakorporal unter Verwendung eines Elektrolyten in der Nähe des Implationsortes der biosensitiven Infusionseinrichtung auf der Haut des Probanden zu fixieren.In addition, it is provided to fix the reference electrode 1.2 of the biosensor 1 extracorporeally using an electrolyte in the vicinity of the place of implantation of the biosensitive infusion device on the subject's skin.

Die biosensitive Infusionseinrichtung ist in der erfindungsgemäßen Anordnung auch für die Überwachung der kontinuierlichen und der diskontinuierlichen Infusionstherapie geeignet.In the arrangement according to the invention, the biosensitive infusion device is also suitable for monitoring continuous and discontinuous infusion therapy.

Claims

1. Biosensitive infusion device for the simultaneous realization of continuous or discontinuous pharmaceutical applications, preferably insulin, and continuous detection of biochemical parameters, preferably of glucose, in the human and animal body, consisting of an infusion catheter, the stem wall radially and longitudinally in one or more levels outlet openings for the liquid Pharmakon has, characterized in that in the lumen of the tip of the infusion catheter and at a distance from the first infusion holes, a biosensor is arranged.

2. Biosensitive infusion devices according to claim 1, characterized in that when using an electrochemical sensor only one measuring electrode (1.1) is arranged in the lumen of the infusion catheter tip and the infusion cannula of the infusion catheter is designed as a reference electrode (1.2) of the sensor.

For this 1 page drawings

Field of application of the invention

The invention relates to an easily applied, combined with a biosensor, preferably for glucose, infusion and Meßwerterfassungsanordnung, which is for the long-term continuous application of in-solution drugs, preferably insulin, with simultaneous continuous measurement of biological parameters, preferably the glucose concentration in the human and animal body and therefore for use in the device system of the measured-value pharmaceutical application, preferably the insulin application in the artificial beta cell, and for use in open-loop systems for drug application, preferably in extracorporeal portable and implantable infusion pumps and manually operated dosing with Catheter connection is suitable.

Characteristic of the known state of the art

In "Artificial Organs", Raven Press, 1988, Pfeiffer and others and in "Diabetes", American Diabetes Association, 1984, Shichiri and others describe bed-side and portable configurations for metered insulin application. In the case of the bedside arrangement, blood is continuously withdrawn from the patient via a catheter which has been inserted into a peripheral vein, in which the determination of the glucose concentration is carried out extracorporeally by means of a biosensor. The measured signal is converted into a proper insulin dosing command after measurement processing. By means of an infusion pump is applied via a second catheter system, which was also introduced into a peripheral vein, the calculated dose of the insulin in solution. In principle, the same arrangement, which is characterized by the separate application of the transducer and infusion system, is applied to the portable variant of the measurement-dependent insulin application. Only the measuring compartment and the place of infusion are varied. Furthermore, such arrangements are known in which biosensors for the purpose of therapy monitoring extracorporeal or implanted, but without direct (on-line) coupling to Pharmakainfusionseinrichtung used. In the simplest case, these are discontinuously performed measurements, realized by well-known laboratory analysis devices, test strips for visual or photometric evaluation or strip electrodes in connection with a corresponding electronic evaluation device for retrospective evaluation. In any case, for the use of such apparatus for closed-loop, metered-dose pharmacotherapy and for continuous or discontinuous infusion therapy, at least two catheters are to be placed in the human or animal body, or in the case of discontinuous measurement, the skin and peripheral blood vessels must be used Blood sampling for extracorporeal analysis is often violated. The separate application of sensor and infusion catheter is also synonymous with the permanent penetration of the skin in at least two places. This also applies to continuous extracorporeal data acquisition due to the constantly necessary blood collection.

Object of the invention

The object of the invention is a cost-effective biosensitive infusion device, which is particularly suitable for the long-term continuous detection of biological parameters, preferably glucose, with simultaneous measured or controlled infusion of drugs, preferably insulin, and by simple applicability in the human and animal body as well as minimized psychological Stress on the patient.

Explanation of the essence of the invention

The object of the invention is therefore to provide an implantable, biosensitive infusion device whose design principle is characterized in terms of miniaturization by the appropriate combination of a biosensor with an infusion catheter over the prior art in single application of both functional elements and in which all mentioned deficiencies are largely eliminated , According to the invention, this object is achieved in that the