WO2009086817A2 - Implantable infusion pump and control device and detection device for said pump - Google Patents

Implantable infusion pump and control device and detection device for said pump Download PDF

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Publication number
WO2009086817A2
WO2009086817A2 PCT/DE2009/000009 DE2009000009W WO2009086817A2 WO 2009086817 A2 WO2009086817 A2 WO 2009086817A2 DE 2009000009 W DE2009000009 W DE 2009000009W WO 2009086817 A2 WO2009086817 A2 WO 2009086817A2
Authority
WO
WIPO (PCT)
Prior art keywords
infusion pump
valve
coil
induction coil
active substance
Prior art date
Application number
PCT/DE2009/000009
Other languages
German (de)
French (fr)
Other versions
WO2009086817A3 (en
Inventor
Jan G. TÖNNIES
Original Assignee
Tricumed Medizintechnik Gmbh
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Tricumed Medizintechnik Gmbh filed Critical Tricumed Medizintechnik Gmbh
Publication of WO2009086817A2 publication Critical patent/WO2009086817A2/en
Publication of WO2009086817A3 publication Critical patent/WO2009086817A3/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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14276—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body specially adapted for implantation
    • 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
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/148—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons flexible, e.g. independent bags
    • A61M5/1483—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons flexible, e.g. independent bags using flexible bags externally pressurised by fluid pressure
    • A61M5/1486—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons flexible, e.g. independent bags using flexible bags externally pressurised by fluid pressure the bags being substantially completely surrounded by fluid
    • 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
    • A61M2005/1401—Functional features
    • A61M2005/1405—Patient controlled analgesia [PCA]
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M2039/0036—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use characterised by a septum having particular features, e.g. having venting channels or being made from antimicrobial or self-lubricating elastomer
    • A61M2039/0081—Means for facilitating introduction of a needle in the septum, e.g. guides, special construction of septum
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/0208—Subcutaneous access sites for injecting or removing fluids
    • A61M2039/0238—Subcutaneous access sites for injecting or removing fluids having means for locating the implanted device to insure proper injection, e.g. radio-emitter, protuberances, radio-opaque markers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3331—Pressure; Flow
    • A61M2205/3337—Controlling, regulating pressure or flow by means of a valve by-passing a pump
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3507—Communication with implanted devices, e.g. external control
    • A61M2205/3515—Communication with implanted devices, e.g. external control using magnetic means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/60—General characteristics of the apparatus with identification means
    • A61M2205/6054—Magnetic identification systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/82—Internal energy supply devices
    • A61M2205/8218—Gas operated
    • 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
    • A61M5/16877—Adjusting flow; Devices for setting a flow rate
    • A61M5/16881—Regulating valves

Definitions

  • the invention relates to an implantable infusion pump having a continuously dispensing agent receiving, with an access forming septum and an optionally leading to a catheter outlet active substance space, a propellant gas receiving propellant space, a the active substance space delimiting the propellant space flexible separating element and a throttle section which determines the exit of the active substance from the active substance space through the outlet and ensures the basal basic requirement of the patient;
  • the invention further relates to a control device for controlling such an implantable infusion pump and a locating device for locating the septum of such an implantable infusion pump.
  • Such implantable infusion pumps find application in patients to whom continuously lowest amounts of an active ingredient are to be supplied, for example, for the treatment of severe pain. However, they can also be used to supply diabetics with insulin, for example.
  • the known implantable pumps are provided with a second, so-called bolus septum, via which the physician, if necessary, can supply an additional amount of the active ingredient to the patient via a cannula.
  • bolus septum via which the physician, if necessary, can supply an additional amount of the active ingredient to the patient via a cannula.
  • infusion pumps which are provided with an internal power supply via a built-in battery and with a built-in computer.
  • the invention has for its object to provide an implantable infusion pump of the type mentioned, which allows the patient himself to provide a short time with an additional amount of active ingredient without the implantable infusion pump must have a battery and / or a computer.
  • this object is achieved by a controllable valve, an induction coil and an electrical circuit which brings about the opening of the valve when electrical energy is injected into the induction coil.
  • the invention is therefore based on the basic idea to provide an infusion pump with a controllable valve, which is fed via an external control unit inductively energy to provide the patient for a short time with an additional amount of active ingredient.
  • the induction coil is preferably arranged coaxially with the septum.
  • the Implantierbaxe infusion pump can be provided with an electrical filter that supplies energy to the induction coil only when the circuit has a certain frequency.
  • control device for controlling such an implantable infusion pump with a trained for cooperation with the induction coil of the infusion pump donor coil.
  • the control unit preferably has means for detecting a parameter determining the quantity of active agent to be delivered by the infusion pump, means for calculating the duration of the opening of the valve of the infusion pump resulting from the quantity to be dispensed and means for exciting the donor coil for the calculated time duration.
  • the control unit may further comprise means for detecting the duration of the opening of the valve in the infusion pump from the electrical energy supplied to the donor coil, means for summing these periods and means for calculating the amount of active substance delivered by the throttle section or the throttle sections of the infusion pump since the last filling be provided from these accumulated periods. Further, means may be provided for limiting the frequency and duration of bolus delivery (that is, the time periods while the valve is open).
  • the control device is in a preferred embodiment with means for detecting a caused via the donor coil ⁇ ffiiens the valve in the infusion pump from the donor coil supplied electrical energy, means for totaling these times and thus the amount of active substance dispensed, means for regularly repeating subtracting itself the half-life of the drug in the human body resulting percentage of the accumulated value (or subtracting a fixed percentage of the accumulated value in from the half-life of the drug time intervals) and means for limiting the duration of a renewed excitation of the donor coil of the controller when computationally achieved permissible drug concentration.
  • a locator for locating the septum of such an implantable infusion pump provided with a donor coil adapted to cooperate with the induction coil of the infusion pump, which is different from the frequency at which the induction coil is fed to open the valve Coupling to the induction coil recognizable making, an opening of the valve but not causing frequency is fed.
  • the locating device can also be formed by the control device, for this purpose with a switch for switching the frequency at which the donor coil is fed, between a first frequency, with which the valve of the infusion pump is controlled, and a second frequency, with which the septum is located, be provided. Locating may also be performed at the frequency that causes the valve to switch, but at a voltage that does not cause the valve to switch. It is further proposed to provide the infusion pump with a pressure sensor downstream of the valve, which forms the electrical load of the induction coil, and to provide means, which fall from the time at which the pressure behind the valve after its closing to a certain value is to gain a statement about the mobility of the catheter attached to the outlet.
  • Fig. 1 is a sectional view of such an implantable infusion pump
  • Fig. 2 shows an electrical schematic diagram of the controller.
  • the infusion pump consists of a housing in which an active substance space 10 and a propellant space 12 are formed, which are delimited by a flexible separating element 14 (also a bellows or a membrane formed here as a bag) Using a cannula via a septum 24 accessible access 10a and one - possibly using a catheter - in the body of the patient leading outlet 1 Ob provided.
  • a flexible separating element 14 also a bellows or a membrane formed here as a bag
  • the propellant gas space 12 consists of a storage chamber 12a with a fixed volume and a working chamber 12b with variable volume, which are connected to each other via a throttle section 16.
  • the volume of the working chamber 12b thus gradually increases, reducing the volume of the active substance space 10 and displacing active ingredient from the active substance chamber 10 through the outlet 10b into the body of the patient at a rate determined by the amount of propellant passing through the throttling path 26.
  • a cannula When infusion of the infusion pump with active ingredient, a cannula is introduced through the septum 10a, the active ingredient is introduced by applying a pressure above the propellant gas pressure in the drug compartment 10, the drug chamber 10 increases accordingly under compression of the propellant gas in the working space 12b.
  • a check valve between the working chamber 12b and the reservoir 12a allows the return of the (thereby at least partially liquefying) propellant gas into the reservoir.
  • the access 10a is provided with cannula-actuated means which provide the path between the active substance space 10 and the outlet 1b before feeding the active ingredient to the drug compartment 10 closes.
  • the implantable infusion pump further comprises an electrically controllable valve 20.
  • Dias valve 20 makes it possible to control the amount of the released active ingredient as needed from the outside.
  • an induction coil 22 is coaxially provided to the septum 10a, which operates for the duration of the inductive coupling of electrical energy through a donor coil acting on the valve 20 electrical circuit and this opens it (preferably periodically).
  • blowing agent from the storage space 12a penetrates into the working space 12b, so that the active substance is applied from the space 10 via the outlet 10b and the catheter (not shown) into the patient, the patient thus becomes constantly at one supplied basal basic needs covering drug amount.
  • the infusion pump may also be designed - in the usual way - such that the throttle sections 26 are arranged between the active substance space and the outlet 10b.
  • the separating element 14 may also be formed by a bellows or a membrane.
  • the patient can supply an additional quantity of active substance, a control unit (only shown in a broken line), which is provided with a donor coil 28, via the septum 24 of the infusion pump, which is surrounded by the induction coil 22, that the two Coils are inductively coupled to each other through the skin of the patient.
  • a control unit (only shown in a broken line)
  • the throttle section 16 upstream or downstream valve is opened, the patient supplied for the duration of the opening of the valve 20 with a drug bolus.
  • FIG. 2 shows a schematic diagram of the electrical arrangement with the parts 30, 32, 34 and 36.
  • Part 30 consists of a voltage source and the donor coil 28, both located outside the patient in the controller, and the induction coil 22 located in the implanted infusion pump. Upon actuation of the controller, the donor coil couples electrical AC voltage into the induction coil through the skin and adipose tissue of the patient.
  • Part 32 represents a rectifier (the further necessary filter in the practical realization, which ensures that the infusion pump can be operated only with its associated control unit, is not shown.)
  • Part 34 represents the electrical equivalent circuit diagram of the valve 20, part 36 the the opening and closing of the valve causing switch.
  • a circuit implementation is preferred in which the valve 20 is periodically switched on and off during the period during which energy is coupled in via the part 30.
  • valve 20 Detecting the total time during which the donor coil 28 was energized when coupled to the induction coil 22 of the infusion pump, the valve 20 was thus opened, allows a determination of the total drug release and thus a determination of the time at which the pump must be refilled with active ingredient.
  • a feedback, so detecting the frequency of opening the valve and thus the (in addition to the basal rate) delivered amount of active ingredient can be done by observing the electrical current that pulls the donor coil when a fixed voltage is applied: This current is at a switching operation of the valve briefly increase significantly.
  • the control unit may further comprise means for detecting an opening of the valve 20 in the induction pump via excitation of the donor coil 28 from the electrical energy supplied to the donor coil 28, means for shrinking these times and thus the amount of drug delivered, means for regularly subtracting one percentage of the accumulated value (or a predefined percentage with a frequency resulting from the half-life of the active substance) resulting from the half-life of the active substance in the human body and means for limiting the duration of renewed excitation of the control coil 28 of the control unit when the calculated value is reached be provided maximum permissible drug concentration in the body of the patient.
  • a locating device which makes it possible to locate the septum: This is provided with a donor coil, which is coupled in coaxial alignment with the septum inductively with the induction coil 22 of the implanted pump. With this coupling, the current drawn by the donor coil increases, as indicated by the locator. However, it is important to ensure that the locating device must not cause the opening of the valve 20, which can be accomplished by the fact that the frequency of the current with which the sensor coil of the locating device is fed, deviates from that of the controller; the infusion pump is then provided with a throttle which causes the actuator for the valve 20 is not addressed by the coupled electrical energy with the frequency of the locating device.
  • control unit can also detect the switching of the valve on the course of the current drawn by the donor coil by connecting a pressure sensor downstream of the valve, which forms an electrical load of the induction coil:
  • the current drawn by the donor coil can be seen at what time the pressure after closing the valve has risen to the value at which the pressure switch switches, which allows a statement about the connection of the catheter (if the catheter is detached from the connection, the drop will occur immediately), if the catheter is continuous (the Pressure drop then occurs properly) or if the catheter is not continuous (the pressure drop is then slow).
  • the control unit itself can also be used as a locating device, preferably it has a switch that allows switching between a valve control frequency and a locating frequency.

Abstract

The invention relates to an implantable infusion pump comprising a septum (10a), which receives an active agent to be discharged and allows filling the pump, an active agent space (10) provided with an outlet (10b) that introduces the active agent into the body of the patient, optionally via a catheter, a propellant gas chamber (12) containing a propellant gas, a flexible separating element (14) separating the active agent space (10) from the propellant gas chamber (12), a throttle segment (26) which ensures that an amount of active agent sufficient to cover the basic needs of the patient is discharged from the outlet (10b), an electrically controllable valve (20) associated to the throttle segment (26), and an induction coil (22) and a circuit that operates the opening of the valve (20) during the injection of electrical energy into the induction coil (22). The invention also relates to a control device and a detection device for such a pump.

Description

Implantierbare Infusionspumpe sowie Steuerungsgerät und Ortungsgerät für die Pumpe Implantable infusion pump and control device and tracking device for the pump
Die Erfindung betrifft eine implantierbare Infusionspumpe mit einem einen kontinuierlich abzugebenden Wirkstoff aufnehmenden, mit einem einen Zugang bildenden Septum und einem mit einem ggf. zu einem Katheter führenden Auslass versehen Wirkstoffraum, einem ein Treibgas aufnehmenden Treibgasraum, einem den Wirkstoffraum von dem Treibmittelraum abgrenzenden flexiblen Trennelement und eine den Austritts des Wirkstoffs aus dem Wirkstoffraum durch den Auslass bestimmende, den basalen Grundbedarf des Patienten sicherstellende Drosselstrecke; die Erfindung betrifft weiter eine Steuereinrichtung zum Steuern einer solchen implantierbaren Infusionspumpe und eine Ortungseinrichtung zum Orten des Septums einer solchen implantierbaren Infusionspumpe.The invention relates to an implantable infusion pump having a continuously dispensing agent receiving, with an access forming septum and an optionally leading to a catheter outlet active substance space, a propellant gas receiving propellant space, a the active substance space delimiting the propellant space flexible separating element and a throttle section which determines the exit of the active substance from the active substance space through the outlet and ensures the basal basic requirement of the patient; The invention further relates to a control device for controlling such an implantable infusion pump and a locating device for locating the septum of such an implantable infusion pump.
Derartige implantierbare Infusionspumpen finden bei Patienten, denen kontinuierlich geringste Mengen eines Wirkstoffs zuzuführen sind, beispielsweise zur Therapie bei schwersten Schmerzen, Anwendung. Sie können aber beispielsweise auch zur Versorgung von Diabetikern mit Insulin verwendet werden.Such implantable infusion pumps find application in patients to whom continuously lowest amounts of an active ingredient are to be supplied, for example, for the treatment of severe pain. However, they can also be used to supply diabetics with insulin, for example.
Die bekannten implantierbaren Pumpen sind mit einem zweiten, sogenannten Bolus- septum versehen, über das der Arzt - wenn erforderlich — über eine Kanüle eine zusätzliche Menge des Wirkstoffs dem Patienten zufuhren kann. Es sind weiter steuerbare Infusionspumpen bekannt, die mit einer internen Spannungsversorgung über eine eingebaute Batterie und mit einem eingebauten Rechner versehen sind.The known implantable pumps are provided with a second, so-called bolus septum, via which the physician, if necessary, can supply an additional amount of the active ingredient to the patient via a cannula. There are further known infusion pumps known which are provided with an internal power supply via a built-in battery and with a built-in computer.
Der Erfindung liegt die Aufgabe zugrunde, eine implantierbare Infusionspumpe der eingangs genannten Art zu schaffen, die es dem Patienten selbst ermöglicht, sich kurzzeitig mit einer zusätzlichen Wirkstoffmenge zu versorgen, ohne dass die implantierbare Infusionspumpe über eine Batterie und/oder einen Rechner verfugen muss.The invention has for its object to provide an implantable infusion pump of the type mentioned, which allows the patient himself to provide a short time with an additional amount of active ingredient without the implantable infusion pump must have a battery and / or a computer.
Erfindungsgemäß wird diese Aufgabe durch ein steuerbares Ventil, eine Induktionsspule und eine bei Einkopplung von elektrischer Energie in die Induktionsspule die Öffnung des Ventils bewirkende elektrische Schaltung gelöst. Der Erfindung liegt also der Grundgedanke zugrunde, eine Infusionspumpe mit einem steuerbaren Ventil zu schaffen, das über ein externen Steuergerät induktiv Energie gespeist wird, um den Patienten kurzzeitig mit einer zusätzlichen Wirkstoffmenge zu versorgen.According to the invention, this object is achieved by a controllable valve, an induction coil and an electrical circuit which brings about the opening of the valve when electrical energy is injected into the induction coil. The invention is therefore based on the basic idea to provide an infusion pump with a controllable valve, which is fed via an external control unit inductively energy to provide the patient for a short time with an additional amount of active ingredient.
Die Induktionsspule ist bevorzugt koaxial zu dem Septum angeordnet.The induction coil is preferably arranged coaxially with the septum.
Die implantierbaxe Infusionspumpe kann mit einem elektrischen Filter, dass in die Induktionsspule eingespeiste Energie nur dann der Schaltung zufuhrt, wenn diese eine bestimmte Frequenz hat, versehen sein.The Implantierbaxe infusion pump can be provided with an electrical filter that supplies energy to the induction coil only when the circuit has a certain frequency.
Es wird weiter ein Steuergerät zum Steuern einer derartigen implantierbaren Infusionspumpe mit einer zum Zusammenwirken mit der Induktionsspule der Infusionspumpe ausgebildete Geberspule vorgeschlagen.It is further proposed a control device for controlling such an implantable infusion pump with a trained for cooperation with the induction coil of the infusion pump donor coil.
Das Steuergerät weist vorzugsweise Mittel zum Erfassen eines die Menge des von der Infusionspumpe abzugebenden Wirkstoffs bestimmenden Parameters, Mittel zum Berechnen der sich aus der abzugebenden Menge ergebenden Zeitdauer der Öffnung des Ventils der Infusionspumpe und Mittel zum Erregen der Geberspule für die berechnete Zeitdauer auf.The control unit preferably has means for detecting a parameter determining the quantity of active agent to be delivered by the infusion pump, means for calculating the duration of the opening of the valve of the infusion pump resulting from the quantity to be dispensed and means for exciting the donor coil for the calculated time duration.
Weiter können Mittel zum Messen des Parameters vorgesehen sein. Das Steuergerät kann weiter mit Mitteln zum Erkennen der Zeitdauer der Öffnung des Ventils in der Infusionspumpe aus der der Geberspule zugeführten elektrischen Energie, Mitteln zum Aufsummieren dieser Zeitdauern und Mitteln zum Berechnen der von der Drosselstrecke bzw. den Drosselstrecken der Infusionspumpe seit der letzen Befüllung abgegebenen Wirkstoffmenge aus diesen aufsummierten Zeitdauern versehen sein. Weiter können Mittel zum Begrenzen der Häufigkeit und der Dauer der Bolusgaben (also der Zeitdauern, während das Ventil geöffnet ist), vorgesehen sein.Furthermore, means for measuring the parameter can be provided. The control unit may further comprise means for detecting the duration of the opening of the valve in the infusion pump from the electrical energy supplied to the donor coil, means for summing these periods and means for calculating the amount of active substance delivered by the throttle section or the throttle sections of the infusion pump since the last filling be provided from these accumulated periods. Further, means may be provided for limiting the frequency and duration of bolus delivery (that is, the time periods while the valve is open).
Das Steuergerät ist bei einer bevorzugten Ausgestaltung mit Mitteln zum Erkennen eines über die Geberspule bewirkten Öffiiens des Ventils in der Infusionspumpe aus der der Geberspule zugeführten elektrischen Energie, Mitteln zum Aufsummieren dieser Zeiten und damit der abgegebenen Wirkstoffmenge, Mitteln zum sich regelmäßig wiederholenden Subtrahieren eines sich aus der Halbwertzeit des Wirkstoffs im menschlichen Körper ergebenden Prozentsatzes von den aufsummierten Wert (oder Subtrahieren eines festen Prozentsatzes von dem aufsummierten Wert in sich aus der Halbwertzeit des Wirkstoffs ergebenen Zeitabständen)und Mitteln zum Begrenzen der Dauer einer erneuten Erregung der Geberspule des Steuergeräts bei rechnerischem Erreichen der zulässigen Wirkstoffkonzentration versehen.The control device is in a preferred embodiment with means for detecting a caused via the donor coil Öffiiens the valve in the infusion pump from the donor coil supplied electrical energy, means for totaling these times and thus the amount of active substance dispensed, means for regularly repeating subtracting itself the half-life of the drug in the human body resulting percentage of the accumulated value (or subtracting a fixed percentage of the accumulated value in from the half-life of the drug time intervals) and means for limiting the duration of a renewed excitation of the donor coil of the controller when computationally achieved permissible drug concentration.
Es wird weiter einOrtungsgerät zum Orten des Septums einer solchen implantierbaren Infusionspumpe vorgeschlagen, das mit einer zum Zusammenwirken mit der Induktionsspule der Infusionspumpe ausgebildete Geberspule versehen ist, die mit einer von der Frequenz, mit der die Induktionsspule zum Öffnen des Ventils gespeist wird, unterschiedlichen, eine Ankopplung an die Induktionsspule erkennbar machenden, ein Öffnen des Ventils aber nicht bewirkenden Frequenz gespeist wird.There is further proposed a locator for locating the septum of such an implantable infusion pump provided with a donor coil adapted to cooperate with the induction coil of the infusion pump, which is different from the frequency at which the induction coil is fed to open the valve Coupling to the induction coil recognizable making, an opening of the valve but not causing frequency is fed.
Das Ortungsgerät nach kann auch durch das das Steuergerät gebildet werden, das zu diesem Zweck mit einem Schalter zum Umschalten der Frequenz, mit der die Geberspule gespeist wird, zwischen einer ersten Frequenz, mit der das Ventil der Infusionspumpe gesteuert wird, und einer zweiten Frequenz, mit der das Septum geortet wird, versehen sein. Die Ortung kann auch mit der Frequenz, die ein Schalten des Ventils bewirkt, aber einer Spannung, bei der das Schalten des Ventils nicht erfolgt, ausgeführt werden. Es wird weiter vorgeschlagen, die Infusionspumpe mit einem dem Ventil nachgeschalte- ten Drucksensor zu versehen, der die elektrische Last der Induktionsspule bildet, und Mittel vorzusehen, die aus dem Zeitpunkt, zu dem der Druck hinter dem Ventil nach dessen Schließen auf einen bestimmten Wert abgefallen ist, eine Aussage über die Gängigkeit des Katheters, der an den Auslass angesetzt ist, zu gewinnen.The locating device according to can also be formed by the control device, for this purpose with a switch for switching the frequency at which the donor coil is fed, between a first frequency, with which the valve of the infusion pump is controlled, and a second frequency, with which the septum is located, be provided. Locating may also be performed at the frequency that causes the valve to switch, but at a voltage that does not cause the valve to switch. It is further proposed to provide the infusion pump with a pressure sensor downstream of the valve, which forms the electrical load of the induction coil, and to provide means, which fall from the time at which the pressure behind the valve after its closing to a certain value is to gain a statement about the mobility of the catheter attached to the outlet.
Die Erfindung wird im folgenden anhand einer Zeichnung erläutert, in derThe invention will be explained below with reference to a drawing in which
Fig. 1 eine Schnittdarstellung einer solchen implantierbaren Infusionspumpe undFig. 1 is a sectional view of such an implantable infusion pump and
Fig. 2 ein elektrisches Prinzipschaltbild der Steuerung wiedergibt.Fig. 2 shows an electrical schematic diagram of the controller.
Die Infusionspumpe besteht aus einem Gehäuse, in dem ein Wirkstoffraum 10 und ein Treibmittelraum 12 ausgebildet sind, die durch ein - hier als Beutel ausgebildetes flexibles Trennelement 14 (auch ein Balg oder eine Membran kommen in Betrachfjvoneinander abgegrenzt sind. Der Wirkstoffraum 10 ist mit einem unter Verwendung einer Kanüle über ein Septum 24 zugänglichen Zugang 10a und einem - ggf. unter Verwendung eines Katheters - in den Körper des Patienten führenden Auslass 1 Ob versehen.The infusion pump consists of a housing in which an active substance space 10 and a propellant space 12 are formed, which are delimited by a flexible separating element 14 (also a bellows or a membrane formed here as a bag) Using a cannula via a septum 24 accessible access 10a and one - possibly using a catheter - in the body of the patient leading outlet 1 Ob provided.
Der Treibgasraum 12 besteht aus einer Vorratskammer 12a mit festem Volumen und einer Arbeitskammer 12b mit veränderlichem Volumen, die über eine Drosselstrecke 16 miteinander verbunden sind. Das bei vollständig gefüllter Infusionspumpe flüssige, unter dem Treibgasdruck stehende Treibgas in der Vorratskammer 12a tritt in die Drosselstrecke 16 ein, verdampft an deren Eingang und tritt allmählich durch die Drosselstrecke 16 hindurch in die Arbeitskammer 12b ein, die - wegen ihrer direkten Kommunikation mit dem Körper des Patienten - im wesentlichen lediglich unter dem Körperdruck steht. Das Volumen der Arbeitskammer 12b vergrößert sich so allmählich unter Verringerung des Volumens des Wirkstoffraums 10 und Verdrängung von Wirkstoff aus der Wirkstoffkammer 10 durch den Auslass 10b in den Körper des Patienten mit einer durch die Menge des die Drosselstrecke 26 passierenden Treibmittels bestimmten Rate. Bei einem Befallen der Infusionspumpe mit Wirkstoff wird eine Kanüle durch das Septum 10a eingebracht, der Wirkstoff wird unter Aufbringen eines über dem Treibgasdruck liegenden Druck in den Wirkstoffraum 10 eingeführt, der Wirkstoffraum 10 vergrößert sich entsprechend unter Komprimierung des Treibgases in dem Arbeitsraum 12b. Ein Rückschlagventil zwischen dem Arbeitsraum 12b und dem Vorratsraum 12a ermöglicht die Rückkehr des (sich dabei wenigstens teilweise verflüssigenden) Treibgases in den Vorratsraum.The propellant gas space 12 consists of a storage chamber 12a with a fixed volume and a working chamber 12b with variable volume, which are connected to each other via a throttle section 16. The fully filled infusion pump, under the propellant pressure propellant gas in the storage chamber 12a enters the throttle section 16, evaporates at the inlet and gradually enters through the throttle section 16 into the working chamber 12b, which - because of their direct communication with the body of the patient - is essentially only under the body pressure. The volume of the working chamber 12b thus gradually increases, reducing the volume of the active substance space 10 and displacing active ingredient from the active substance chamber 10 through the outlet 10b into the body of the patient at a rate determined by the amount of propellant passing through the throttling path 26. When infusion of the infusion pump with active ingredient, a cannula is introduced through the septum 10a, the active ingredient is introduced by applying a pressure above the propellant gas pressure in the drug compartment 10, the drug chamber 10 increases accordingly under compression of the propellant gas in the working space 12b. A check valve between the working chamber 12b and the reservoir 12a allows the return of the (thereby at least partially liquefying) propellant gas into the reservoir.
Um während des (unter hohem Druck erfolgenden) BeMlens des Wirkstoffraums 10 einen Austritt des Wirkstoffs aus dem Auslass 10b zu verhindern, ist der Zugang 10a mit einem von der Kanüle betätigten Mittel versehen, das den Weg zwischen Wirkstoffraum 10 und Auslass 1 Ob vor dem Zuführen des Wirkstoffs zum Wirkstoffraum 10 verschließt.In order to prevent leakage of the active substance from the outlet 10b during the (high pressure) agitation of the active substance space 10, the access 10a is provided with cannula-actuated means which provide the path between the active substance space 10 and the outlet 1b before feeding the active ingredient to the drug compartment 10 closes.
Die implantierbare Infusionspumpe weist weiter ein elektrisch steuerbares Ventil 20 auf.The implantable infusion pump further comprises an electrically controllable valve 20.
Dias Ventil 20 ermöglicht es, die Menge des abgegebenen Wirkstoffs bedarfsgerecht von außen zu steuern. Zu diesem Zweck ist koaxial zu dem Septum 10a eine Induktionsspule 22 vorgesehen, die für die Dauer der induktiven Einkopplung elektrischer Energie durch eine Geberspule eine auf das Ventil 20 wirkende elektrische Schaltung betreibt und dieses damit (vorzugsweise periodisch) öffnet.Dias valve 20 makes it possible to control the amount of the released active ingredient as needed from the outside. For this purpose, an induction coil 22 is coaxially provided to the septum 10a, which operates for the duration of the inductive coupling of electrical energy through a donor coil acting on the valve 20 electrical circuit and this opens it (preferably periodically).
Über die Drosselstrecke 26, dringt Treibmittel aus dem Vorratsraum 12a in den Arbeitsraum 12b ein, so dass der Wirkstoff aus dem Raum 10 über den Auslass 10b und den - nicht dargestellten - Katheter in den Patienten appliziert wird, der Patient wird so ständig mit einer dessen basalen Grundbedarf deckenden Wirkstoffmenge versorgt.Via the throttle section 26, blowing agent from the storage space 12a penetrates into the working space 12b, so that the active substance is applied from the space 10 via the outlet 10b and the catheter (not shown) into the patient, the patient thus becomes constantly at one supplied basal basic needs covering drug amount.
Die Infusionspumpe kann alternativ aber auch — in üblicher Weise — so ausgebildet sein, dass die Drosselstrecken 26 zwischen dem Wirkstoffraum und dem Auslass 10b angeordnet ist. Weiter kann das Trennelement 14 statt wie dargestellt durch einen Beutel auch durch einen Balg oder eine Membran gebildet sein.Alternatively, however, the infusion pump may also be designed - in the usual way - such that the throttle sections 26 are arranged between the active substance space and the outlet 10b. Furthermore, instead of being represented by a bag, the separating element 14 may also be formed by a bellows or a membrane.
Der Patient kann bei Bedarf an einer zusätzlichen Wirkstoffmenge, ein (nur gebrochen dargestelltes) Steuergerät, das mit einer Geberspule 28 versehen ist, so über das von der Induktionsspule 22 umgebene Septum 24 der Infusionspumpe führen, dass die beiden Spulen durch die Haut des Patienten hindurch miteinander induktiv gekoppelt sind. Bei Erregung der Geberspule in dem Steuergerät wird das der Drosselstrecke 16 vor- oder nachgeschaltete Ventil geöffnet, der Patient für die Dauer der Öffnung des Ventils 20 mit einem Wirkstoffbolus versorgt.If necessary, the patient can supply an additional quantity of active substance, a control unit (only shown in a broken line), which is provided with a donor coil 28, via the septum 24 of the infusion pump, which is surrounded by the induction coil 22, that the two Coils are inductively coupled to each other through the skin of the patient. Upon excitation of the donor coil in the control unit, the throttle section 16 upstream or downstream valve is opened, the patient supplied for the duration of the opening of the valve 20 with a drug bolus.
Fig. 2 zeigt ein Prinzipschaltbild der elektrischen Anordnung mit den Teilen 30, 32, 34 und 36.2 shows a schematic diagram of the electrical arrangement with the parts 30, 32, 34 and 36.
Teil 30 besteht aus einer Spannungsquelle und der Geberspule 28, die beide außerhalb des Patienten in dem Steuergerät angeordnet sind, sowie der Induktionsspule 22, die sich in der implantierten Infusionspumpe befindet. Bei Betätigung des Steuergeräts koppelt die Geberspule elektrische Wechselspannung in die Induktionsspule durch Haut und Fettgewebe des Patienten hindurch ein. Teil 32 stellt einen Gleichrichter dar (der bei der praktischen Verwirklichung weiter erforderliche Filter, der sicherstellt, dass die Infusionspumpe nur mit dem ihm zugehörigen Steuergerät bedient werden kann, ist nicht dargestellt. Teil 34 gibt das elektrische Ersatzschaltbild des Ventils 20 wieder, Teil 36 das des das Öffnen und Schließen des Ventils bewirkenden Schalters.Part 30 consists of a voltage source and the donor coil 28, both located outside the patient in the controller, and the induction coil 22 located in the implanted infusion pump. Upon actuation of the controller, the donor coil couples electrical AC voltage into the induction coil through the skin and adipose tissue of the patient. Part 32 represents a rectifier (the further necessary filter in the practical realization, which ensures that the infusion pump can be operated only with its associated control unit, is not shown.) Part 34 represents the electrical equivalent circuit diagram of the valve 20, part 36 the the opening and closing of the valve causing switch.
Bevorzugt ist eine schaltungstechnische Verwirklichung, bei der das Ventil 20 während der Zeitdauer, während der Energie über das Teil 30 eingekoppelt wird, periodisch ein- und ausgeschaltet wird.A circuit implementation is preferred in which the valve 20 is periodically switched on and off during the period during which energy is coupled in via the part 30.
Ein Erfassen der Gesamtzeitdauer, während der die Geberspule 28 bei Kopplung mit der Induktionsspule 22 der Infusionspumpe erregt, deren Ventil 20 also geöffnet, war, erlaubt eine Ermittlung der Wirkstoffgesamtabgabe und damit eine Ermittlung des Zeitpunkts, zu dem die Pumpe mit Wirkstoff nachgefüllt werden muss.Detecting the total time during which the donor coil 28 was energized when coupled to the induction coil 22 of the infusion pump, the valve 20 was thus opened, allows a determination of the total drug release and thus a determination of the time at which the pump must be refilled with active ingredient.
Eine Rückkopplung, also ein Erfassen der Häufigkeit des Öffnens des Ventils und damit der (neben der Basalrate) abgegebenen Wirkstoffmenge kann durch Beobachten des elektrischen Stroms erfolgen, den die Geberspule zieht, wenn eine feste Spannung angelegt ist: Dieser Strom wird bei einem Schaltvorgang des Ventils kurzzeitig deutlich ansteigen. Das Steuergerät kann weiter mit Mitteln zum Erkennen einer über die Erregung der Geberspule 28 bewirkten Öffnens des Ventils 20 in derlnfüsionspumpe aus der der Geberspule 28 zugeführten elektrischen Energie, Mitteln zum Aufsurnrnieren dieser Zeiten und damit der abgegebenen Wirkstoffmenge, Mitteln zum sich regelmäßig wiederholenden Subtrahieren eines sich aus der Halbwertzeit des Wirkstoffs im menschlichen Körper ergebenden Prozentsatzes von den aufsummierten Wert (oder eines vorgebenen Prozentsatz mit einer Häufigkeit, die sich aus der Halbwertzeit des Wirkstoffs ergibt) und Mitteln zum Begrenzen der Dauer einer erneuten Erregung der Geberspule 28 des Steuergeräts bei rechnerischen Erreichen der maximal zulässigen Wirkstoffkonzentration im Körper des Patienten versehen sein.A feedback, so detecting the frequency of opening the valve and thus the (in addition to the basal rate) delivered amount of active ingredient can be done by observing the electrical current that pulls the donor coil when a fixed voltage is applied: This current is at a switching operation of the valve briefly increase significantly. The control unit may further comprise means for detecting an opening of the valve 20 in the induction pump via excitation of the donor coil 28 from the electrical energy supplied to the donor coil 28, means for shrinking these times and thus the amount of drug delivered, means for regularly subtracting one percentage of the accumulated value (or a predefined percentage with a frequency resulting from the half-life of the active substance) resulting from the half-life of the active substance in the human body and means for limiting the duration of renewed excitation of the control coil 28 of the control unit when the calculated value is reached be provided maximum permissible drug concentration in the body of the patient.
Nicht dargestellt ist ein Ortungsgerät, das es ermöglicht, das Septum zu orten: Dieses ist mit einer Geberspule versehen, die bei koaxialer Ausrichtung mit dem Septum induktiv mit der Induktionsspule 22 der implantierten Pumpe gekoppelt ist. Bei dieser Kopplung nimmt der Strom, den die Geberspule zieht, zu, was von dem Ortungsgerät angezeigt wird. Es ist dabei jedoch darauf zu achten, dass das Ortungsgerät nicht die Öffnung des Ventils 20 bewirken darf, was dadurch bewerkstelligt werden kann, dass die Frequenz des Stromes, mit der die Geberspule des Ortungsgeräts gespeist wird, von der des Steuergeräts abweicht; die Infusionspumpe ist dann mit einer Drossel zu versehen, die bewirkt, dass die Stelleinrichtung für das Ventil 20 von der eingekoppelten elektrischen Energie mit der Frequenz des Ortungsgerätes nicht angesprochen wird.Not shown is a locating device, which makes it possible to locate the septum: This is provided with a donor coil, which is coupled in coaxial alignment with the septum inductively with the induction coil 22 of the implanted pump. With this coupling, the current drawn by the donor coil increases, as indicated by the locator. However, it is important to ensure that the locating device must not cause the opening of the valve 20, which can be accomplished by the fact that the frequency of the current with which the sensor coil of the locating device is fed, deviates from that of the controller; the infusion pump is then provided with a throttle which causes the actuator for the valve 20 is not addressed by the coupled electrical energy with the frequency of the locating device.
Alternativ oder zusätzlich kann das Steuergerät das Schalten des Ventils auch an dem Verlauf des von der Geberspule gezogenen Stroms erkennen, indem dem Ventil ein Drucksensor nachgeschaltet wird, der eine elektrische Last der Induktionsspule bildet: Der von der Geberspule gezogene Strom lässt erkennen, zu welchem Zeitpunkt der Druck nach dem Schließen des Ventils auf den Wert, bei dem der Druckschalter schaltet, angefallen ist, was eine Aussage über die Anbindung des Katheters erlaubt (bei Lösung des Katheters von dem Anschluss erfolgt der Abfall unverzüglich), ob der Katheter durchgängig ist (der Druckabfall erfolgt dann regelgerecht) oder ob der Katheter nicht durchgängig ist (der Druckabfall erfolgt dann langsam). Das Steuergerät selbst kann auch als Ortungsgerät verwendet werden, vorzugsweise weist es dazu einen Schalter auf, der ein Umschalten zwischen einer Ventilsteuerfrequenz und einer Ortungsfrequenz erlaubt. Alternatively or additionally, the control unit can also detect the switching of the valve on the course of the current drawn by the donor coil by connecting a pressure sensor downstream of the valve, which forms an electrical load of the induction coil: The current drawn by the donor coil can be seen at what time the pressure after closing the valve has risen to the value at which the pressure switch switches, which allows a statement about the connection of the catheter (if the catheter is detached from the connection, the drop will occur immediately), if the catheter is continuous (the Pressure drop then occurs properly) or if the catheter is not continuous (the pressure drop is then slow). The control unit itself can also be used as a locating device, preferably it has a switch that allows switching between a valve control frequency and a locating frequency.

Claims

Ansprüche claims
1. Implantierbare Infosionspumpe mit1. Implantable infusion pump with
einem einen kontinuierlich abzugebenden Wirkstoff aufnehmenden, mit einem ein Befüllen der Pumpe erlaubenden Septum (10a) und mit einem - ggf. über ein Katheter - den Wirkstoff in den Körper des Patienten einbringenden Auslass (10b) versehenen Wirkstoffraum (10),an active substance space (10) which receives a substance to be dispensed continuously, with a septum (10a) permitting the pump to be filled, and with an outlet (10b), possibly via a catheter, which introduces the active substance into the patient's body;
einem ein Treibgas aufnehmenden Treibgasraum (12),a propellant gas receiving propellant gas space (12),
einem den Wirkstoffraum (10) von dem Treibmittelraum (12) abgrenzenden flexiblen Trennelement (14) unda flexible separating element (14) delimiting the active substance space (10) from the propellant space (12) and
einer den Austritt einer den basalen Grundbedarf des Patienten sicherstellenden Menge des Wirkstoffs aus dem Auslass (10b) bestimmenden Drosselstrecke (26),a leakage path (26) which determines the exit of an amount of the active substance from the outlet (10b) which ensures the basal basic requirement of the patient
gekennzeichnet durch ein parallel zu der Drosselstrecke (26) liegendes elektrisch steuerbares Ventil (20), eine Induktionsspule (22) und eine bei Einkopplung von elektrischer Energie in die Induktionsspule (22) die Öffnung des Ventils (20) bewirkende Schaltung.characterized by a parallel to the throttle section (26) lying electrically controllable valve (20), an induction coil (22) and a coupling of electrical energy into the induction coil (22) opening the valve (20) causing circuit.
2. Implantierbare Infusionspumpe nach Anspruch 1, gekennzeichnet durch eine dem steuerbaren Ventil (20) vor- oder nachgeschaltete Drosselstrecke (16).2. An implantable infusion pump according to claim 1, characterized by a controllable valve (20) upstream or downstream throttle section (16).
3. Implantierbare Infusionspumpe nach einem der vorangehenden Ansprüche, gekennzeichnet durch ein elektrisches Filter, dass die in die Induktionsspule (22) eingespeiste elektrische Energie nur dann der Schaltung zufuhrt, wenn diese eine bestimmte Frequenz hat.3. Implantable infusion pump according to one of the preceding claims, characterized by an electrical filter that in the induction coil (22) fed electrical energy to the circuit only if this has a certain frequency.
4. Steuergerät zum Steuern einer implantierbaren Infusionspumpe nach einem der Ansprüche 1 bis 3, gekennzeichnet durch eine zum Zusammenwirken mit der Induktionsspule (22) der Infusionspumpe ausgebildete Geberspule (28).4. Control device for controlling an implantable infusion pump according to one of claims 1 to 3, characterized by a for cooperation with the induction coil (22) of the infusion pump trained donor coil (28).
5. Steuergerät nach Anspruch 4, gekennzeichnet durch5. Control device according to claim 4, characterized by
Mittel zum Ermitteln eines die Menge des von der Infusionspumpe über das Ventil (20) abzugebenden Wirkstoffs bestimmenden Parameters,Means for determining a parameter determining the amount of active substance to be delivered by the infusion pump via the valve (20),
Mittel zum Berechnen der sich aus der abzugebenden Menge ergebenden Zeitdauer oder Häufigkeit der Öffnung des Ventils (20) der Infusionspumpe undMeans for calculating the amount of time or frequency of opening of the valve (20) of the infusion pump resulting from the amount to be dispensed;
Mittel zum Erregen der Geberspule (28) für die berechnete Zeitdauer oder Häufigkeit..Means for energizing the donor coil (28) for the calculated duration or frequency.
6. Steuergerät nach Anspruch 4, gekennzeichnet durch Mittel zum Messen des Parameters.6. Control device according to claim 4, characterized by means for measuring the parameter.
7.. Steuergerät nach Anspruch 4, gekennzeichnet durch7 .. Control device according to claim 4, characterized by
Mittel zum Erkennen der Zeitdauer der Öffnung des Ventils (20) seit der letzten Befüllung der Infusionspumpe,Means for detecting the duration of the opening of the valve (20) since the last filling of the infusion pump,
Mittel zum Aufsummieren dieser Zeitdauern oder Häufigkeit, undMeans for summing these durations or frequencies, and
Mittel zum Berechnen der von der Drosselstrecke (16) bzw. den Drosselstrecken (16, 26) der Infusionspumpe seit der letzen Befüllung abgegebenen Wirkstoffrnenge aus diesen aufsummierten Zeitdauern,Means for calculating the amount of active substance delivered by the throttle section (16) or the throttle sections (16, 26) of the infusion pump since the last filling from these accumulated time periods,
ERSATZBLATT (REGEL 26) Replacement Blade (RULE 26)
8. Steuergerät nach einem der Ansprüche 4 bis 7, gekennzeichnet durch8. Control device according to one of claims 4 to 7, characterized by
Mittel zum Erkennen der Zeitdauern der Öffnung des Ventils (20) in der Infusionspumpe,Means for detecting the time periods of the opening of the valve (20) in the infusion pump,
Mittel zum Aufsummieren dieser Zeiten und damit der abgegebenen Wirkstoffmenge zuzüglich einer ggf. über die Drosselstrecke (26) abgegebenen Wirkstoffmenge,Means for summing up these times and thus the quantity of active substance delivered plus a quantity of active substance optionally delivered via the throttle path (26),
Mittel zum sich regelmäßig wiederholenden Subtrahieren eines sich aus der Halbwertzeit des Wirkstoffs im menschlichen Körper ergebenden Prozentsatzes von der aufsummierten abgegebenen Wirkstoffmenge (oder Subtrahieren eines bestimmten Prozentsatzes von der abgegebenen Wirkstoffmenge mit einer sich aus der Halbwertzeit des Wirkstoffs ergebenden Häufigkeit) undMeans for regularly subtracting a percentage of the cumulative delivered amount of active ingredient resulting from the half-life of the active ingredient in the human body (or subtracting a certain percentage of the delivered amount of active ingredient with a frequency resulting from the half-life of the active ingredient);
Mittel zum Begrenzen der Dauer einer erneuten Erregung der Geberspule (28) des Steuergeräts bei rechnerischen Erreichen der zulässigen Wirkstoffkonzentration.Means for limiting the duration of a renewed excitation of the encoder coil (28) of the control unit at mathematical reaching the permissible active ingredient concentration.
9. Steuergerät nach einem der Ansprüche 4 bis 8, gekennzeichnet durch ein dem Ventil (20) nachgeschalteten, eine elektrische Last der Induktionsspule (22) darstellenden Drucksensor und Mittel zum Analysieren des im Verlauf des von der Geberspule in Abhängigkeit des Druckverlaufs von der Gerberspule gezogenen Stroms9. Control device according to one of claims 4 to 8, characterized by a valve (20) downstream, an electrical load of the induction coil (22) performing pressure sensor and means for analyzing the drawn in the course of the donor coil in response to the pressure curve of the gerber coil current
10.. Ortungsgerät zum Orten des Septums einer Infusionspumpe nach einem der10 .. locating device for locating the septum of an infusion pump according to one of
Ansprüche 1 - 3, gekennzeichnet durch eine zum Zusammenwirken mit der Induktionsspule (22) der Infusionspumpe ausgebildete Geberspule (28), die entweder mit einer von der Frequenz, mit der die Induktionsspule (22) zum Öffnen des Ventils (20) gespeist wird, unterschiedlichen, eine Ankopplung an die Induktionsspule (22) erkennbar machenden, ein Öffnen des Ventils (20) aber nicht bewirkenden Frequenz gespeist wird, oder mit einer Spannung, die unterhalb derjenigen liegt, bei der ein Öffnen des Ventils bewirkt wird, und Mittel zum Erkennen der Kopplung zwischen Geberspule (28) und Induktionsspule (22) anhand des von der Geberspule (28) gezogenen Stroms. Claims 1-3, characterized by a donor coil (28) adapted to cooperate with the induction coil (22) of the infusion pump, which is different from either one of the frequency at which the induction coil (22) is opened to open the valve (20) , a coupling to the induction coil (22) is made detectable, an opening of the valve (20) but not causing frequency is fed, or with a voltage which is lower than that at which opening of the valve is effected, and means for detecting the Coupling between encoder coil (28) and induction coil (22) based on the current drawn by the encoder coil (28).
PCT/DE2009/000009 2008-01-05 2009-01-03 Implantable infusion pump and control device and detection device for said pump WO2009086817A2 (en)

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