DE102014010406B3 - Defibrillationsinfusionspumpe - Google Patents

Defibrillationsinfusionspumpe Download PDF

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Publication number
DE102014010406B3
DE102014010406B3 DE102014010406.0A DE102014010406A DE102014010406B3 DE 102014010406 B3 DE102014010406 B3 DE 102014010406B3 DE 102014010406 A DE102014010406 A DE 102014010406A DE 102014010406 B3 DE102014010406 B3 DE 102014010406B3
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Germany
Prior art keywords
drug
atrial fibrillation
pressure sensor
catheter
infusion pump
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Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Fee Related
Application number
DE102014010406.0A
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German (de)
Inventor
Karl-Heinz Otto
Jan G. Tönnies
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Tricumed Medizintechnik GmbH
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Tricumed Medizintechnik GmbH
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Priority to DE102014010406.0A priority Critical patent/DE102014010406B3/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
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/172—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic
    • A61M5/1723—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic using feedback of body parameters, e.g. blood-sugar, pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A61B5/346—Analysis of electrocardiograms
    • A61B5/349—Detecting specific parameters of the electrocardiograph cycle
    • A61B5/361—Detecting fibrillation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/172—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic
    • A61M5/1723—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic using feedback of body parameters, e.g. blood-sugar, pressure
    • A61M2005/1726—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic using feedback of body parameters, e.g. blood-sugar, pressure the body parameters being measured at, or proximate to, the infusion site
    • 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
    • A61M2205/3344—Measuring or controlling pressure at the body treatment site
    • 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
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/12—Blood circulatory system
    • A61M2210/125—Heart
    • 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
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/005—Parameter used as control input for the apparatus
    • 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
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/04—Heartbeat characteristics, e.g. ECG, blood pressure modulation

Abstract

Implantierbare Infusionspumpe zum Applizieren eines dem Herzvorhofflimmern entgegen wirkenden Medikaments in ein Blutgefäß des menschlichen Körpers, mit einem Medikamentenraum, einer zu einem Katheteranschluss führenden Kammer, einem bei der Implantation in das Blutgefäß des Patienten einzuführenden Katheter, einem das Medikament von dem Medikamentenraum zu dem Katheter fördernden Antrieb, einem die Förderrate des zu applizierenden Medikaments beeinflussenden Mittels, einem Sensor zum Erkennen des Auftretens eines Vorhofflimmerns und einem Mittel zum Steuern der jeweiligen Förderrate in Abhängigkeit von dem Erkennen eines Vorhofflimmerns, bei der der Sensor ein den Druck in der Kammer erfassender Drucksensor ist und das Mittel mit einem Rechner zum Analysieren des Ausgangssignals des Drucksensors in Hinblick auf das Vorliegen eines Vorhofflimmerns versehen ist.An implantable infusion pump for applying a cardiac atrial fibrillation drug to a blood vessel of the human body, having a drug compartment, a catheter port leading chamber, a catheter to be inserted into the patient's blood vessel during implantation, delivering the drug from the drug compartment to the catheter Drive, a means influencing the delivery rate of the drug to be administered, a sensor for detecting the occurrence of atrial fibrillation and means for controlling the respective delivery rate in response to the detection of atrial fibrillation, wherein the sensor is a pressure sensor in the chamber detecting pressure sensor and the means is provided with a computer for analyzing the output signal of the pressure sensor with regard to the presence of atrial fibrillation.

Description

Die Erfindung betrifft eine implantierbare Infusionspumpe zum Applizieren eines dem Auftreten von Herzvorhofflimmern entgegen wirkenden Medikaments in ein Blutgefäß des menschlichen Körpers, mit einem Medikamentenraum, einer zu einem Katheteranschluss führenden Kammer, einem bei der Implantation in das Blutgefäß des Patienten einzuführenden Katheter, einem das Medikament von dem Medikamentenraum zu dem Katheter fördernden Antrieb, einem die Förderrate des zu applizierenden Medikaments beeinflussenden Mittels, einem Sensor zum Erkennen des Auftretens eines Vorhofflimmerns und einem Mittel zum Steuern der jeweiligen Förderrate in Abhängigkeit von dem Erkennen eines Vorhofflimmerns.The invention relates to an implantable infusion pump for applying a counter to the occurrence of atrial fibrillation drug in a blood vessel of the human body, with a drug compartment, leading to a catheter port chamber, a to be inserted in the implantation in the blood vessel of the patient, the drug of the medicament space to the catheter-promoting drive, a means influencing the delivery rate of the medicament to be administered, a sensor for detecting the occurrence of atrial fibrillation, and means for controlling the respective delivery rate in response to the detection of atrial fibrillation.

Derartige Infusionspumpen sind in unterschiedlicher Ausgestaltung bekannt, insbesondere auch solche, bei denen die Förderrate durch einen motorisch angetriebenes Element und solche, bei denen die Förderrate durch eine Drosselstrecke, die über ein Ventil schaltbar ist, bestimmt wird. Aus der DE 100 20 688 A1 ist eine implantierbare Infusionspumpe bekannt, die ein Flimmern der Vorhöfe des Herzens erkennt und ggf. die Applikation eines diesem entgegen wirkenden Anti-Arrhythmikums in die Blutbahn bewirkt. Dabei erfolgt das Erkennen durch Erfassen der mit dem Fibrillation einhergehenden elektrischen Signale. Dieses Vorgehen setzt die Plazierung wenigstens einer Elektrode an einer Vorhofwandung und damit einen operativen Eingriff voraus.Such infusion pumps are known in different embodiments, especially those in which the delivery rate by a motor-driven element and those in which the delivery rate through a throttle path, which is switchable via a valve, is determined. From the DE 100 20 688 A1 an implantable infusion pump is known, which detects a flicker of the atria of the heart and possibly causes the application of this counteracting anti-arrhythmic agent in the bloodstream. In this case, the detection takes place by detecting the electrical signals associated with the fibrillation. This procedure requires the placement of at least one electrode on a Vorhofwandung and thus an operative intervention.

In der DE 10 2013 006 437 wird eine implantierbare Infusionspumpe vorgeschlagen, die mit einem benachbart zu dem Katheteranschluss angeordneten Sensor und einem Rechner versehen ist.In the DE 10 2013 006 437 An implantable infusion pump is proposed, which is provided with a sensor arranged adjacent to the catheter connection and a computer.

Aus der US 2003/0199813A1 und der US 2005/0043616 sind implantierbare Infusionspumpen bekannt, die über einen besonderen, in das Herz einzubringenden Draht verfügen, an deren distalen Ende ein Drucksensor angeordnet ist, wobei die zu applizierende Menge des Medikaments aus dem Druckverlauf berechnet wird.From the US 2003 / 0199813A1 and the US 2005/0043616 implantable infusion pumps are known, which have a special, to be introduced into the heart wire, at the distal end of a pressure sensor is arranged, wherein the amount of drug to be administered is calculated from the pressure profile.

Der Erfindung liegt die Aufgabe zugrunde, eine implantierbare Infusionspumpe der eingangs genannten Art zu schaffen, bei der auf die Vorsehung eines an einem in das Herz vorzuschiebenden Drahtes, an dessen distalem Ende ein Drucksensor angeordnet ist verzichtet werden kann.The invention has for its object to provide an implantable infusion pump of the type mentioned, in which can be dispensed with the providence of a vorziebenden in a heart of the heart wire, at the distal end of a pressure sensor.

Erfindungsgemäß wird diese Aufgabe dadurch gelöst, dass der Drucksensor den Druck in der Kammer erfasst und das Mittel mit einem Rechner zum Analysieren des Ausgangssignals versehen ist. Bei der Erfindung wird das Vorhofflimmern damit durch Auswertung des Druckverlaufs in dem Katheter erkannt.According to the invention, this object is achieved in that the pressure sensor detects the pressure in the chamber and the means is provided with a computer for analyzing the output signal. In the invention, the atrial fibrillation is thus recognized by evaluating the pressure curve in the catheter.

Das Blutgefäß, in den das distale Ende des Katheters einzubringen ist, ist vorzugsweise der linke Vorhof oder ein diesem benachbarter Ort. Der Rechner ermittelt vorzugsweise die Rate, mit der das ggf. geglättete Ausgangssignal des Drucksensors einen vorgegebenen Schwellenwert übersteigt.The blood vessel into which the distal end of the catheter is to be inserted is preferably the left atrium or a neighboring site. The computer preferably determines the rate at which the possibly smoothed output signal of the pressure sensor exceeds a predetermined threshold value.

Die Erfindung schlägt also vor, eine steuerbare Infusionspumpe mit einem benachbart dem Katheteranschluss (also hinter dem Antrieb und ggf. einer Drosselstrecke) angeordneten Drucksensor und einem Rechner zu versehen. Der Rechner ist geeignet, aus dem Druckverlauf an dem proximalen Ende des Katheters, der dem im Vorhof entspricht, ein Vorhofflimmern zu erkennen und ggf. über eine vorgegebene Zeitdauer die Abgabe des von der Pumpe bevorrateten Anti-Arrhythmikums zu bewirken. Die Erfindung nutzt damit den Umstand, dass ein Vorhofflimmern durch Schwankungen des Drucks im oder nahe dem linken Vorhof kleiner und häufiger sind, nämlich unter 5 mm Hg bleiben und mit einer Häufigkeit von mehr als 120/min auftreten, erkennbar ist.The invention therefore proposes providing a controllable infusion pump with a pressure sensor arranged adjacent to the catheter connection (that is to say behind the drive and optionally a throttle section) and a computer. The computer is capable of detecting atrial fibrillation from the pressure course at the proximal end of the catheter, which corresponds to that in the atrium, and if necessary to effect the delivery of the anti-arrhythmic agent stored by the pump over a predetermined period of time. The invention thus exploits the fact that atrial fibrillation due to variations in pressure in or near the left atrium are smaller and more frequent, namely, remain below 5 mm Hg and occur at a frequency of more than 120 / min, can be seen.

Die Gabe des Anti-Arrhythmikums nur bei Bedarf und nahe an dessen Wirkungsort ermöglicht die Applikation nur geringer Mengen, die Nebenwirkungen des Medikaments werden so begrenzt. Bei erfolgreicher Terminierung des Vorhofflimmerns kann die Gabe des Medikaments sofort unterbrochen werden.The application of the anti-arrhythmic drug only when needed and close to its site of action allows the application of only small amounts, the side effects of the drug are so limited. With successful termination of atrial fibrillation, the administration of the drug can be interrupted immediately.

Claims (3)

Implantierbare Infusionspumpe zum Applizieren eines dem Herzvorhofflimmern entgegen wirkenden Medikaments in ein Blutgefäß des menschlichen Körpers, mit einem Medikamentenraum, einer zu einem Katheteranschluss führenden Kammer, einem bei der Implantation in das Blutgefäß des Patienten einzuführenden Katheter, einem das Medikament von dem Medikamentenraum zu dem Katheter fördernden Antrieb, einem die Förderrate des zu applizierenden Medikaments beeinflussenden Mittels, einem Drucksensor zum Erkennen des Auftretens eines Vorhofflimmerns und einem Mittel zum Steuern der jeweiligen Förderrate in Abhängigkeit von dem Erkennen eines Vorhofflimmerns, dadurch gekennzeichnet, dass – der Drucksensor den Druck in der Kammer der Infusionspumpe erfasst und – das Mittel mit einem Rechner zum Analysieren des Ausgangssignals des Drucksensors in Hinblick auf das Vorliegen eines Vorhofflimmerns versehen ist.An implantable infusion pump for applying a cardiac atrial fibrillation drug to a blood vessel of the human body, having a drug compartment, a catheter port leading chamber, a catheter to be inserted into the patient's blood vessel during implantation, delivering the drug from the drug compartment to the catheter Drive, a means influencing the delivery rate of the drug to be administered, a pressure sensor for detecting the occurrence of atrial fibrillation and a means for controlling the respective delivery rate in response to the detection of atrial fibrillation, characterized in that - the pressure sensor, the pressure in the chamber of the infusion pump and - the means is provided with a computer for analyzing the output signal of the pressure sensor with regard to the presence of atrial fibrillation. Implantierbare Infusionspumpe nach Anspruch 1, dadurch gekennzeichnet, dass das Blutgefäß der linke Vorhof ist. An implantable infusion pump according to claim 1, characterized in that the blood vessel is the left atrium. Implantierbare Infusionspumpe nach Anspruch 1, dadurch gekennzeichnet, dass der Rechner die Rate, mit der das ggf. geglättete Ausgangssignal einen vorgegebenen Schwellenwert übersteigt, ermittelt.An implantable infusion pump according to claim 1, characterized in that the computer determines the rate at which the possibly smoothed output signal exceeds a predetermined threshold value.
DE102014010406.0A 2014-07-15 2014-07-15 Defibrillationsinfusionspumpe Expired - Fee Related DE102014010406B3 (en)

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Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030199813A1 (en) * 2002-04-22 2003-10-23 Struble Chester L. Implantable drug delivery system responsive to intra-cardiac pressure
US20050043616A1 (en) * 2003-08-07 2005-02-24 Medtronic, Inc. Diastolic coronary perfusion detection for timed delivery of therapeutic and/or diagnostic agents
US20060224190A1 (en) * 2005-04-05 2006-10-05 Jong Gill System and method for detecting heart failure and pulmonary edema based on ventricular end-diastolic pressure using an implantable medical device
EP2020248A1 (en) * 2004-11-18 2009-02-04 Japan Health Sciences Foundation Cardiac disease treatment system
US20100179609A1 (en) * 2004-07-14 2010-07-15 Girouard Steven D Method for preparing an implantable controlled gene or protein delivery device
US20110077616A1 (en) * 2009-09-30 2011-03-31 Medtronic, Inc. Methods for guiding heart failure decompensation therapy
US20120035587A1 (en) * 1999-10-29 2012-02-09 Medtronic, Inc. Methods and systems for providing therapies into the pericardial space
WO2013048977A1 (en) * 2011-09-30 2013-04-04 Medtronic, Inc. Therapy control based on nighttime cardiovascular pressure

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120035587A1 (en) * 1999-10-29 2012-02-09 Medtronic, Inc. Methods and systems for providing therapies into the pericardial space
US20030199813A1 (en) * 2002-04-22 2003-10-23 Struble Chester L. Implantable drug delivery system responsive to intra-cardiac pressure
US20050043616A1 (en) * 2003-08-07 2005-02-24 Medtronic, Inc. Diastolic coronary perfusion detection for timed delivery of therapeutic and/or diagnostic agents
US20100179609A1 (en) * 2004-07-14 2010-07-15 Girouard Steven D Method for preparing an implantable controlled gene or protein delivery device
EP2020248A1 (en) * 2004-11-18 2009-02-04 Japan Health Sciences Foundation Cardiac disease treatment system
US20060224190A1 (en) * 2005-04-05 2006-10-05 Jong Gill System and method for detecting heart failure and pulmonary edema based on ventricular end-diastolic pressure using an implantable medical device
US20110077616A1 (en) * 2009-09-30 2011-03-31 Medtronic, Inc. Methods for guiding heart failure decompensation therapy
WO2013048977A1 (en) * 2011-09-30 2013-04-04 Medtronic, Inc. Therapy control based on nighttime cardiovascular pressure

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