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DE102015000352A1 - Controllable infusion pump - Google Patents

Controllable infusion pump Download PDF

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Publication number
DE102015000352A1
DE102015000352A1 DE102015000352.6A DE102015000352A DE102015000352A1 DE 102015000352 A1 DE102015000352 A1 DE 102015000352A1 DE 102015000352 A DE102015000352 A DE 102015000352A DE 102015000352 A1 DE102015000352 A1 DE 102015000352A1
Authority
DE
Germany
Prior art keywords
throttle section
pressure
computer
infusion pump
infusate
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
DE102015000352.6A
Other languages
German (de)
Inventor
Jan G. Tönnies
Karl-Heinz Otto
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Tricumed Medizintechnik GmbH
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
Priority to DE102015000352.6A priority Critical patent/DE102015000352A1/en
Priority to PCT/DE2015/100479 priority patent/WO2016116081A1/en
Priority to EP15817062.1A priority patent/EP3247422A1/en
Publication of DE102015000352A1 publication Critical patent/DE102015000352A1/en
Withdrawn legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/145Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/14586Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of a flexible diaphragm
    • A61M5/14593Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of a flexible diaphragm the diaphragm being actuated by fluid pressure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/14244Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14276Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body specially adapted for implantation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16877Adjusting flow; Devices for setting a flow rate
    • A61M5/16881Regulating valves

Landscapes

  • Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Veterinary Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Fluid Mechanics (AREA)
  • Physics & Mathematics (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

Implantierbare Infusionspumpe mit einem Treibmittelraum, einem von diesem über ein elastisches Element getrennten Infusatraum, einem Katheteranschluss und einer zwischen Infusatraum und Katheteranschluss liegenden Drosselstrecke, einem die Drosselstrecke freigebenden Schaltventil, einem vor der Drosselstrecke liegenden ersten Drucksensor und einem Rechner, der das Ventil mit einem sich auf Grundlage einer über ein externes Steuergerät unter Zugrundelegung eines Nenn-Treibmitteldrucks berechneten Vorgabe steuert, bei der der Rechner zum Korrigieren der Vorgabe des Steuergeräts oder des sich aus diesem ergebenden Tastverhältnisses in Abhängigkeit von dem vor der Drosselstrecke tatsächlich anliegenden Druck, vorzugsweise dem über der Drosselstrecke abfallenden Druck, eingerichtet ist.An implantable infusion pump having a propellant space, an infusate space separated therefrom by an elastic element, a catheter connection and a throttle section located between infusate space and catheter connection, a switching valve releasing the throttle section, a first pressure sensor located in front of the throttle section and a computer which supplies the valve with a based on a calculated via an external control unit on the basis of a nominal propellant pressure control, in which the computer for correcting the specification of the control unit or resulting from this duty as a function of the pressure actually applied before the throttle section, preferably the pressure above the throttle section declining pressure, is set up.

Description

Die Erfindung betrifft eine steuerbare Infusionspumpe mit den Merkmalen des Oberbegriffs des Anspruchs 1.The invention relates to a controllable infusion pump having the features of the preamble of claim 1.

Eine derartige implantierbare steuerbare Infusionspumpe ist aus einer offenkundigen Vorbenutzung der Anmelderin bekannt, auf die DE 10 2010 034 560 A1 wird hingewiesen.Such an implantable controllable infusion pump is known from an obvious prior use of the applicant, to the DE 10 2010 034 560 A1 being point out.

Bei der bekannten implantierbaren steuerbaren Infusionspumpe hängt der Druck, mit dem das aus dem Infusatraum ausgetriebene Infusat in die Drosselstrecke eintritt, von der Federrate des den Infusatraum von dem Treibmittelraum trennenden elastischen Element und dem mit der Temperatur des Treibmittels schwankenden Druck des Treibmittels ab. Dies hat zur Folge, dass die Rate, mit der das Infusat von der Infusionspumpe über den Katheteranschluss dem Patienten zugeführt wird, nicht konstant ist: Bei einer den Druck des Treibmittels unterstützenden Federrate des elastischen Elements, also bei dessen Dehnung, und/oder bei einer über dem Treibmittel-Nenndruck (etwa dem bei 37°C erreichten Druck) liegenden Treibmittel-Istdruck wird pro Zeiteinheit relativ viel, bei einer dem Druck des Treibmittelraums entgegen wirkenden Federrate des elastischen Elements und/oder einem (bei einer Temperatur unter 37°C erreichten) unter dem Treibmittel-Nenndruck liegenden Treibmittel-Istdruck wird pro Zeiteinheit relativ wenig Infusat abgegeben.In the known implantable, controllable infusion pump, the pressure with which the infusate expelled from the infusate space enters the throttle section depends on the spring rate of the elastic element separating the infusate space from the propellant space and the pressure of the propellant fluctuating with the temperature of the propellant. This has the consequence that the rate at which the infusate is supplied from the infusion pump via the catheter connection to the patient is not constant: at a spring rate of the elastic element which supports the pressure of the propellant, ie during its elongation, and / or at one Above the nominal blowing agent pressure (approximately the pressure reached at 37 ° C) actual blowing agent pressure per unit time is relatively high, at a pressure of the propellant space counteracting spring rate of the elastic element and / or reached (at a temperature below 37 ° C. ) Under the propellant nominal pressure blowing agent actual pressure is given per unit time relatively little infusate.

Der Erfindung liegt damit die Aufgabe zugrunde, eine steuerbare implantierbare Infusionspumpe zu schaffen, bei der die genannten Infusatdruckschwankungen kompensiert werden.The invention is therefore based on the object to provide a controllable implantable infusion pump, in which the said Infusatdruckschwankungen be compensated.

Erfindungsgemäß wird diese Aufgabe durch die Merkmale des Anspruchs 1 gelöst, wobei sich der Begriff Tastverhältnis als Verhältnis der Zeit, zu der das Ventil geöffnet ist, zu der Gesamtzeit versteht.According to the invention, this object is achieved by the features of claim 1, wherein the term duty cycle as the ratio of the time at which the valve is open to understand the total time.

Um den nicht immer zu vernachlässigenden Gegendruck des an den Katheteranschluss angeschlossenen, zu dem Patienten führenden Katheter die Ist-Infusionsrate zu korrigieren, wird auch dieser mit den Merkmalen des Anspruchs 2 kompensiert. Anspruch 3 gibt ein bevorzugte Ausbildung mit einer Pulsweitenmodulation an, auch eine Impulsabstandsmodulation ist aber möglich.In order to correct the not always negligible back pressure of the connected to the catheter connection, leading to the patient catheter, the actual infusion rate, this is compensated with the features of claim 2. Claim 3 indicates a preferred embodiment with a pulse width modulation, but a pulse spacing modulation is possible.

Die Erfindung wird im Folgenden anhand eines Ausführungsbeispiels erläutert.The invention will be explained below with reference to an embodiment.

Das Steuergerät berechnet anhand der Vorgaben des Arztes die Soll-Infusionsrate, also die Menge an Infusat, die pro Zeiteinheit über die erste Drosselstrecke dem Patienten appliziert werden soll. Bei einer Übermittlung der Soll-Infusionsrate von dem Steuergerät an die Pumpe berechnet diese die einzuhaltende Pulsweite durch Division der vorgegebenen Infusionsrate durch die jeweilige Druckdifferenz über der Drossel und der Multiplikation des Ergebnisses mit einem festen, sich aus dem Produkt der Pulsdauer mit dem der jeweiligen Pumpe eigenen Strömungswiderstand der Drossel ergebenden Wert. Pulsweite = Soll-Infusionsrate/Druckdifferenz × (Drosselwiderstand × Periodendauer) Based on the specifications of the physician, the control unit calculates the desired infusion rate, that is to say the amount of infusate which is to be administered to the patient per unit time via the first throttle section. When transmitting the desired infusion rate from the control unit to the pump, this calculates the pulse width to be maintained by dividing the predetermined infusion rate by the respective pressure difference across the throttle and multiplying the result by a fixed, from the product of the pulse duration with that of the respective pump own flow resistance of the throttle resulting value. Pulse width = target infusion rate / pressure difference × (throttle resistance × period duration)

Schwankungen des Infusatdrucks vor (oder ggf. über) der Drossel werden so durch ein umgekehrt proportionale Anpassung der Pulsweite kompensiert.Variations of the infusate pressure before (or possibly over) the throttle are thus compensated by an inversely proportional adjustment of the pulse width.

Eine Korrektur der Pulsweite braucht nur bei einer Änderung der Soll-Infusionsrate und einer erheblichen Änderung der Druckdifferenz (was vorzugsweise mit einem durch die Pulsperiode vorgegebenen Zeitabstand geprüft wird) zu erfolgen. Auf diese Weise wird von dem von einer Batterie betriebenen Rechner benötige Energie gespart.A correction of the pulse width needs to be done only with a change in the target infusion rate and a significant change in the pressure difference (which is preferably checked with a predetermined by the pulse period time interval). In this way, the energy required by the battery-operated computer is saved.

Die Pumpe kann weiter mit einer zweiten Drosselstrecke versehen sein, die das Infusat dauerhaft abgibt. Die erste, mit einem gesteuerten Ventil versehene Drosselstrecke dient dabei zum Titrieren, also zur Festlegung der Medikamentkonzentration in dem Infusat und/oder zur zeitweisen Gabe einer zusätzlichen Menge an Infusat. Das – bezüglich der Genauigkeit kritische – Titrieren und die Bolusgabe können bei der vorgeschlagenen Ausbildung der Infusionspumpe exakter erfolgen.The pump may further be provided with a second throttle section, which releases the infusate permanently. The first, provided with a controlled valve throttle section is used for titration, ie to determine the drug concentration in the infusate and / or for temporary administration of an additional amount of infusate. The titration and the bolus administration, which are critical with regard to accuracy, can be carried out more accurately in the case of the proposed design of the infusion pump.

ZITATE ENTHALTEN IN DER BESCHREIBUNG QUOTES INCLUDE IN THE DESCRIPTION

Diese Liste der vom Anmelder aufgeführten Dokumente wurde automatisiert erzeugt und ist ausschließlich zur besseren Information des Lesers aufgenommen. Die Liste ist nicht Bestandteil der deutschen Patent- bzw. Gebrauchsmusteranmeldung. Das DPMA übernimmt keinerlei Haftung für etwaige Fehler oder Auslassungen.This list of the documents listed by the applicant has been generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Zitierte PatentliteraturCited patent literature

  • DE 102010034560 A1 [0002] DE 102010034560 A1 [0002]

Claims (3)

Implantierbare Infusionspumpe mit einem Treibmittelraum, einem von diesem über ein elastisches Element getrennten Infusatraum, einem Katheteranschluss und einer zwischen Infusatraum und Katheteranschluss liegenden Drosselstrecke, einem die Drosselstrecke freigebenden Schaltventil, einem vor der Drosselstrecke liegenden ersten Drucksensor und einem Rechner, der das Ventil mit einem sich auf Grundlage einer über ein externes Steuergerät unter Zugrundelegung eines Nenn-Treibmitteldrucks berechneten Vorgabe steuert, dadurch gekennzeichnet, dass der Rechner zum Korrigieren der Vorgabe des Steuergeräts oder des sich aus diesem ergebenden Tastverhältnisses in Abhängigkeit von dem vor der Drosselstrecke tatsächlich anliegenden Druck eingerichtet ist.An implantable infusion pump having a propellant space, an infusate space separated therefrom by an elastic element, a catheter connection and a throttle section lying between infusate space and catheter connection, a switching valve releasing the throttle section, a first pressure sensor located in front of the throttle section and a computer which supplies the valve with a on the basis of a calculated via an external control unit on the basis of a nominal propellant pressure control specified, characterized in that the computer for correcting the specification of the control device or the duty cycle resulting from this depending on the pressure actually applied before the throttle section is established. Infusionspumpe nach Anspruch 1, gekennzeichnet durch einen hinter der Drosselstrecke liegenden zweiten Drucksensor, wobei der Rechner zum Korrigieren des Tastverhältnisses in Abhängigkeit von dem über der Drosselstrecke abfallenden Druck eingerichtet ist.Infusion pump according to claim 1, characterized by a second pressure sensor located behind the throttle section, wherein the computer is adapted to correct the duty cycle as a function of the falling over the throttle section pressure. Infusionspumpe nach Anspruch 1 oder 2, dadurch gekennzeichnet, dass der Rechner bei mit einem gleichbleibenden Zeitabstand für eine sich aus der Abgaberate ergebende Zeitdauer erfolgenden Öffnungen des Ventils (Pulslängenmodulation) die Zeitdauer der Öffnungen korrigiert.Infusion pump according to claim 1 or 2, characterized in that the computer corrects the duration of the openings at a constant time interval for a time resulting from the delivery rate period of the valve openings (pulse length modulation).
DE102015000352.6A 2015-01-19 2015-01-19 Controllable infusion pump Withdrawn DE102015000352A1 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
DE102015000352.6A DE102015000352A1 (en) 2015-01-19 2015-01-19 Controllable infusion pump
PCT/DE2015/100479 WO2016116081A1 (en) 2015-01-19 2015-11-10 Controllable infusion pump
EP15817062.1A EP3247422A1 (en) 2015-01-19 2015-11-10 Controllable infusion pump

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
DE102015000352.6A DE102015000352A1 (en) 2015-01-19 2015-01-19 Controllable infusion pump

Publications (1)

Publication Number Publication Date
DE102015000352A1 true DE102015000352A1 (en) 2016-07-21

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ID=55066259

Family Applications (1)

Application Number Title Priority Date Filing Date
DE102015000352.6A Withdrawn DE102015000352A1 (en) 2015-01-19 2015-01-19 Controllable infusion pump

Country Status (3)

Country Link
EP (1) EP3247422A1 (en)
DE (1) DE102015000352A1 (en)
WO (1) WO2016116081A1 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102018130655A1 (en) * 2018-12-03 2020-06-04 Tricumed Medizintechnik Gmbh Method for operating an implantable gas pressure-operated infusion pump with a throttle section

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050267413A1 (en) * 2004-05-26 2005-12-01 Wang Jong H Flow monitoring devices and methods of use
US20110034872A1 (en) * 2008-01-02 2011-02-10 The Regents Of The University Of Michigan Dual Drug Delivery Device
DE102010034560A1 (en) 2010-08-17 2012-02-23 Tricumed Medizintechnik Gmbh Implantable infusion pump for applying medicament into body of patient, has chamber with volume changed against pressure that is smaller than pressure in space, where controllable valve is arranged in path between space and chamber

Family Cites Families (7)

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US6620151B2 (en) * 2001-03-01 2003-09-16 Advanced Neuromodulation Systems, Inc. Non-constant pressure infusion pump
US7291126B2 (en) * 2001-11-26 2007-11-06 Nilimedix Ltd. Drug delivery device and method
US7725272B2 (en) * 2006-03-30 2010-05-25 Codman Neuro Sciences, Sarl Methods and devices for monitoring fluid of an implantable infusion pump
WO2007123764A2 (en) * 2006-04-06 2007-11-01 Medtronic, Inc. Systems and methods of identifying catheter malfunctions using pressure sensing
US8535280B2 (en) * 2007-09-26 2013-09-17 Medtronic, In Pressure based refill status monitor for implantable pumps
DE102009018024A1 (en) * 2009-04-18 2010-10-28 Tricumed Medizintechnik Gmbh Implantable infusion pump for use by physician, has propellant area receiving propellant, and valve formed such that it is switched in closed/opened condition if pressure of substance exceeds/falls below counter-pressure around preset value
DE102009034013A1 (en) * 2009-07-21 2011-02-10 Tricumed Medizintechnik Gmbh Implantable infusion pump, has valve electrically actuated and arranged in path lying parallel to another path that is restricted by restrictor passage, and valve control unit operating valve after program is read from outside

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050267413A1 (en) * 2004-05-26 2005-12-01 Wang Jong H Flow monitoring devices and methods of use
US20110034872A1 (en) * 2008-01-02 2011-02-10 The Regents Of The University Of Michigan Dual Drug Delivery Device
DE102010034560A1 (en) 2010-08-17 2012-02-23 Tricumed Medizintechnik Gmbh Implantable infusion pump for applying medicament into body of patient, has chamber with volume changed against pressure that is smaller than pressure in space, where controllable valve is arranged in path between space and chamber

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102018130655A1 (en) * 2018-12-03 2020-06-04 Tricumed Medizintechnik Gmbh Method for operating an implantable gas pressure-operated infusion pump with a throttle section

Also Published As

Publication number Publication date
EP3247422A1 (en) 2017-11-29
WO2016116081A1 (en) 2016-07-28

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Representative=s name: LOBEMEIER, MARTIN LANDOLF, DR., DE

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