DE102015004177A1 - Implantable sensor technology for integration in cardiac assist systems, heart assist systems and methods for controlling and controlling a sensor system - Google Patents
Implantable sensor technology for integration in cardiac assist systems, heart assist systems and methods for controlling and controlling a sensor system Download PDFInfo
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Abstract
Die Erfindung beschreibt eine implantierbare Sensorik und eine dazugehörige Elektronik zur Integration in Herzunterstützungssysteme, zur Messung von unter anderem Temperatur und Durchfluss sowie Blutparametern und Blutdruck.The invention describes an implantable sensor system and associated electronics for integration in cardiac assist systems, for measuring, inter alia, temperature and flow, and blood parameters and blood pressure.
Description
Die Erfindung betrifft eine implantierbare Sensorik zur Integration in Herzunterstützungssysteme, ein Herzunterstützungssystem und ein Verfahren zur Kontrolle und Steuerung einer derartigen Sensorik.The invention relates to an implantable sensor system for integration in cardiac assist systems, a cardiac assist system and a method for controlling and controlling such a sensor system.
Heutige implantierbare Herzunterstützungssysteme sind nicht mit Sensoren zur direkten gleichzeitigen Messung von mehreren (physiologischen) Parametern wie Durchfluss, Druck und Temperatur ausgestattet. Sie bestehen im Wesentlichen aus einem Pumpengehäuse mit integriertem pneumatischen oder elektrischen Antrieb und Kanülen zum Anschluss an das Herz-Kreislaufsystem. Die Energieversorgung jetziger implantierbarer Herzunterstützungssysteme geschieht über ein mehradriges Kabel, das die Pumpe mit einer externen Energiequelle und in der Regel einem Steuergerät verbindet. An der Austrittstelle des Kabels aus dem Körper besteht eine erhöhte Infektionsgefahr für den Patienten. Dies ist besonders problematisch bei Systemen zur dauerhaften Therapie.Today's implantable cardiac assist systems are not equipped with sensors for direct simultaneous measurement of multiple (physiological) parameters such as flow, pressure and temperature. They consist essentially of a pump housing with integrated pneumatic or electric drive and cannulas for connection to the cardiovascular system. The power supply of current implantable cardiac assist systems is via a multi-core cable that connects the pump to an external power source and usually a controller. At the exit point of the cable from the body there is an increased risk of infection for the patient. This is particularly problematic in systems for permanent therapy.
Bei heutigen Systemen kann man höchstens über die Auswertung der Stromaufnahme und/oder Drehzahl indirekt auf die Druck- bzw. Strömungsverhältnisse in der Pumpe schließen. Da es sich hierbei um eine indirekte Methode handelt, können mögliche Quereinflüsse wie z. B. Lagerschäden, Ablagerungen innerhalb der Pumpe (z. B. Thromben) sowie der variable Gegendruck des Kreislaussystems zu Fehlinterpretationen der Ergebnisse führen.In today's systems, it is possible at most indirectly to conclude the pressure and flow conditions in the pump via the evaluation of the current consumption and / or speed. Since this is an indirect method, possible cross influences such. As bearing damage, deposits within the pump (eg thrombi) and the variable counter-pressure of the circular louse system lead to misinterpretation of the results.
Der Erfindung liegt daher die Aufgabe zu Grunde, eine implantierbare Sensorik und Herzunterstützungssysteme mit einer derartigen Sensorik weiterzuentwickeln, sowie ein Verfahren zur Kontrolle und Steuerung einer derartigen Sensorik bereitzustellen.The invention is therefore based on the object to further develop an implantable sensor and cardiac assistance systems with such sensors, as well as to provide a method for controlling and controlling such a sensor.
Diese Aufgabe wird mit den Merkmalen der unabhängigen Ansprüche gelöst. Vorteilhafte Weiterbildungen werden in den Unteransprüchen beschrieben.This object is achieved with the features of the independent claims. Advantageous developments are described in the subclaims.
Bevorzugt werden mit der implantierbaren Sensorik die Parameter Durchfluss und Temperatur gemessen. Zusätzlich kann eine gleichzeitige Messung von Blutparametern, welche die Schallgeschwindigkeit des Blutes beeinflussen (z. B. Hämatokrit) sowie eine Messung des System- bzw. Blutdruckes möglich sein.The parameters flow and temperature are preferably measured with the implantable sensor system. In addition, a simultaneous measurement of blood parameters which influence the speed of sound of the blood (eg hematocrit) as well as a measurement of the system or blood pressure may be possible.
Die Sensorik besteht aus der Kombination eines Temperatursensors zur Messung der Bluttemperatur und zur Kompensation von Temperatureffekten, welche die Schallgeschwindigkeit des Blutes beeinflussen, und einem Sensor basierend auf Ultraschall, welcher gleichzeitig den Durchfluss und die Schallgeschwindigkeit im Blut ermitteln kann. Als Nebeneffekt können unerwünschte Blutinhaltsstoffe wie Partikel (z. B. sich ablösende Verkalkungen), Gasblasen oder Thromben akustisch detektiert werden.The sensor system consists of the combination of a temperature sensor to measure the blood temperature and to compensate for temperature effects that influence the speed of sound of the blood, and a sensor based on ultrasound, which can simultaneously determine the flow and the speed of sound in the blood. As a side effect, unwanted blood components such as particles (eg, detaching calcifications), gas bubbles or thrombi can be detected acoustically.
Als weiterer Nebeneffekt können die zur Ultraschallerzeugung eingesetzten Schallwandler durch ihre Mikrophoneigenschaften eventuelle Schäden am Antrieb bzw. Betriebsverhalten des Herzunterstützungssystems über Veränderungen am akustischen Verhalten erkennen. Dabei ist hervorzuheben, dass diese Schallwandler gleichzeitig zur Messung des Durchflusses und der Schallgeschwindigkeit eingesetzt werden.As a further side effect, the sound transducers used for ultrasound generation can detect possible damage to the drive or operating behavior of the heart support system via changes in the acoustic behavior due to its microphone characteristics. It should be emphasized that these sound transducers are used simultaneously for measuring the flow rate and the speed of sound.
Zur Anzeige des Messwertes oder eines vom Messwert abgeleiteten Signals kann der Ultraschallsensor eine Verbindung zu einer nicht implantierbaren Anzeige aufweisen. Damit können beispielsweise Veränderungen am Akustischen Verhalten des Antriebs angezeigt werden.To display the measured value or a signal derived from the measured value, the ultrasonic sensor can have a connection to a non-implantable display. This allows, for example, changes in the acoustic behavior of the drive to be displayed.
Vorteilhaft ist es, wenn die integrierte Sensorik eine Druckmesseinrichtung aufweist. Dies ermöglicht es, beispielsweise den Druck in einer Herzpumpe oder in Kanülen einer Herzpumpe zu messen. Die Druckmesseinrichtung muss sich in der Regel bis zu einem Flüssigkeitsraum der Herzpumpe oder von daran angeschlossenen Systemen erstrecken, um einerseits dort den Druck zu messen und andererseits die Informationen aus diesem Flüssigkeitsraum weiterzuleiten.It is advantageous if the integrated sensor system has a pressure measuring device. This makes it possible, for example, to measure the pressure in a heart pump or in cannulae of a heart pump. As a rule, the pressure measuring device must extend to a fluid space of the heart pump or of systems connected to it in order, on the one hand, to measure the pressure there and, on the other hand, to pass on the information from this fluid space.
Die implantierbare Sensorik ermöglicht es somit unterschiedliche Messwerte wie beispielsweise Temperatur und Durchfluss sowie Blutparameter und Blutdruck aufzunehmen und an eine Anzeige- und/oder Auswerteeinrichtung weiterzuleiten.The implantable sensor thus makes it possible to record different measured values such as, for example, temperature and flow as well as blood parameters and blood pressure and to forward them to a display and / or evaluation device.
Daher ist es vorteilhaft, wenn die integrierte Sensorik eine implantierbare Elektronik aufweist, mit der beispielsweise die Sensoren angesteuert oder die Messwerte bzw. die Sensorsignale ausgewertet werden können. Die Elektronik kann die Messwerte aber auch aufbereiten, um sie als Signal weiterzuleiten.Therefore, it is advantageous if the integrated sensor system has implantable electronics with which, for example, the sensors can be controlled or the measured values or the sensor signals can be evaluated. The electronics can also process the measured values in order to pass them on as a signal.
Die Sensoren werden bevorzugt in das bestehende oder modifizierte Gehäuse des Herzunterstützungssystems integriert, z. B. durch Aufkleben, Umgießen, Ausfräsungen oder eine spezifische Erweiterung. Eine mögliche Variante ist die Integration der Sensoren in die Anschlusskanülen des Herzunterstützungssystems.The sensors are preferably integrated into the existing or modified housing of the cardiac assist system, e.g. B. by gluing, pouring, milled or a specific extension. One possible variant is the integration of the sensors into the connecting cannulas of the cardiac assist system.
Die miniaturisierte Elektronik ist bevorzugt in das bestehende oder modifizierte Gehäuse des Herzunterstützungssystems integriert, z. B. durch Aufkleben, Umgießen, Ausfräsungen oder spezifische Erweiterung. Eine Variante ist die Integration der Elektronik in ein eigenes Gehäuse mit direkter Verbindung nur zur Sensorik. Dazu ist eine gesonderte Energieversorgung und eine Datenübertragung per Funk vorgesehen. Eine weitere Variante ist die Integration der Elektronik in ein eigenes Gehäuse mit direkter Verbindung zu Sensorik und Herzunterstützungssystem.The miniaturized electronics are preferably integrated into the existing or modified case of the cardiac assist system, e.g. B. by gluing, pouring, milled or specific Extension. A variant is the integration of the electronics in a separate housing with direct connection only to the sensor. For this purpose, a separate power supply and data transmission by radio is provided. Another variant is the integration of the electronics in a separate housing with direct connection to sensors and cardiac assistance system.
Die Energieversorgung der Elektronik erfolgt bevorzugt über die bestehenden Pumpen-Versorgungsleitungen. Von diesen wird die notwendige Energie über eine direkte Verbindung zur Messelektronik oder durch eine induktive Einkopplung bereitgestellt. Für den Fall einer unterbrochenen Energieversorgung über die bestehenden Versorgungsleitungen (z. B. Kabelbruch, Abschalten der Pumpe ausgelöst durch das Alarmsystem oder sonstige Störfälle) soll die Sensorik über einen integrierten Zwischenspeicher (z. B. Kondensator) noch für einen bestimmten Zeitraum mit Energie versorgt werden.The power supply of the electronics preferably takes place via the existing pump supply lines. Of these, the necessary energy is provided via a direct connection to the measuring electronics or by inductive coupling. In the event of an interrupted power supply via the existing supply lines (eg cable break, switching off of the pump triggered by the alarm system or other incidents), the sensor system is to be supplied with energy for a certain period of time by means of an integrated temporary storage device (eg capacitor) become.
Weitere Varianten der Energieversorgung der Elektronik sind:
- – über zusätzliche Leitungen in dem bestehenden Kabel,
- – über ein gesondertes Kabel,
- – über die Nutzung des magnetischen Wechselfeldes der implantierten Pumpe,
- – über die Versorgung der Messelektronik über ein System zum transkutanen Energietransfer (TET),
- – über Methoden des Energy Harvesting d. h. das Ausnutzen bzw. Wandeln von im Körper vorhandenen Temperaturdifferenzen oder Bewegungen von Organen wie Lunge oder des Herzens oder der Muskeln oder der Pumpe.
- Via additional lines in the existing cable,
- - via a separate cable,
- - the use of the alternating magnetic field of the implanted pump,
- - via the supply of the measuring electronics via a system for transcutaneous energy transfer (TET),
- - through methods of energy harvesting, ie the exploitation or conversion of temperature differences in the body or movements of organs such as the lungs or the heart or the muscles or the pump.
Die Übertagung der Messergebnisse erfolgt bevorzugt über die bestehenden Versorgungsleitungen z. B. durch Aufmodulation der Messsignale oder durch Übertragung mittels elektromagnetischer Wellen (Funk).The transmission of the measurement results is preferably via the existing supply lines z. B. by modulating the measurement signals or by transmission by means of electromagnetic waves (radio).
Weitere Varianten der Übertragung der Messsignale sind:
- – die akustische Übertagung der Messergebnisse (z. B. Ultraschall),
- – die Übertagung der Messergebnisse über zusätzliche, in das bestehende Versorgungskabel integrierte Übertragungsleitungen oder durch Aufmodulation auf die in das bestehende Versorgungskabel zusätzlichen integrierten Versorgungsleitungen für die Elektronik,
- – die Übertagung der Messergebnisse über zusätzliche, in das gesonderte Versorgungskabel integrierte Übertragungsleitungen oder durch Aufmodulation auf die Kabel der gesonderten Versorgungsleitung.
- - the acoustic transmission of the measurement results (eg ultrasound),
- The transmission of the measurement results via additional transmission lines integrated in the existing supply cable or by modulation on the additional supply lines for the electronics present in the existing supply cable,
- - The transmission of the measurement results via additional, integrated in the separate supply cable transmission lines or by modulating on the cables of the separate supply line.
Die vorliegende Erfindung ermöglicht erstmals die gleichzeitige Erfassung von physiologisch relevanten Parametern wie Bluttemperatur, Durchfluss, System bzw. Blutdruck und Bluteigenschaften wie Hämatokrit mittels implantierter und in das Herz-Unterstützungssystem integrierter Sensorik und Elektronik. Dies ermöglicht die Erfassung von physiologischen Herz-Kreislaufdaten und schafft die Grundlage für eine Autoregulation des Herz-Unterstützungssystems sowie für eventuelle medizinische Maßnahmen. Unerwünschte Zustände wie zu geringer Durchfluss (verursacht z. B. durch Thrombenbildung innerhalb des Systems) können zuverlässig erkannt werden.For the first time, the present invention enables the simultaneous detection of physiologically relevant parameters such as blood temperature, flow rate, system or blood pressure and blood properties such as hematocrit by means of implanted sensors and electronics integrated in the cardiac support system. This allows the collection of physiological cardiovascular data and provides the basis for autoregulation of the cardiac support system as well as for any medical intervention. Undesirable conditions such as low flow (caused, for example, by thrombus formation within the system) can be reliably detected.
Dabei stehen die Messwerte auch bei abgeschalteter Pumpe für einen gewissen Zeitraum (beispielsweise bis zu wenigen Minuten) zur Verfügung. Dies liefert Hinweise zur Diagnose des Pumpenstillstands und zur Entscheidung über ein mögliches wiederanfahren. Auch bei der Implantation des Herzunterstützungssystems können die Messwerte bei nicht laufender Pumpe zur korrekten Implantation beitragen (z. B. Kanülenanschluss, Rückfluss...). In der bevorzugten Variante sind keine zusätzlichen Leitungen notwendig, d. h. es besteht keine Notwendigkeit ein neues perkutanes Kabel zu entwickeln und es entsteht kein neues Risiko für den Patienten durch ein zusätzliches perkutanes Kabel.The measured values are available even when the pump is switched off for a certain period of time (for example up to a few minutes). This provides information on the diagnosis of the pump standstill and the decision on a possible restart. Even when implanting the cardiac assist system, readings may contribute to correct implantation when the pump is not running (eg, cannula connection, reflux ...). In the preferred variant, no additional lines are necessary, i. H. there is no need to develop a new percutaneous cable and there is no new risk to the patient due to an extra percutaneous cable.
Im Fall einer akustischen Schadenserkennung kann frühzeitig reagiert werden, z. B. durch Schadensbeurteilung oder einen kontrollierten Pumpenaustausch.In the case of acoustic damage detection can be reacted early, z. B. by damage assessment or a controlled pump replacement.
Durch die räumliche Nähe von Sensorik und Auswerteelektronik wird der Einfluss elektrischer Störfelder minimiert.The proximity of sensors and evaluation electronics minimizes the influence of electrical interference fields.
Neben den oben beschriebenen indirekten Messmethoden über Drehzahl und Stromaufnahme leistet die zusätzliche Sensorik einen wichtigen Beitrag zur funktionalen Sicherheit (Redundanz) von kritischen Produkten wie Herzunterstützungssystemen.In addition to the above-described indirect measurement methods for speed and current consumption, the additional sensor technology makes an important contribution to the functional safety (redundancy) of critical products such as cardiac assist systems.
Ein Ausführungsbeispiel ist in der Figur dargestellt. Es zeigt schematisch ein Herzunterstützungssystem mit externer Energieversorgung.An embodiment is shown in the figure. It schematically shows a cardiac assist system with external power supply.
Der Blutfluss
Ein implantierbarer Stecker
Passend ansetzbar an die Antriebseinheit ist eine miniaturisierte, implantierbare Sensorik mit Messelektronik
Die Funkwellen
Claims (14)
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DE102015004177.0A DE102015004177A1 (en) | 2014-04-02 | 2015-04-02 | Implantable sensor technology for integration in cardiac assist systems, heart assist systems and methods for controlling and controlling a sensor system |
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DE102014004746 | 2014-04-02 | ||
DE102015004177.0A DE102015004177A1 (en) | 2014-04-02 | 2015-04-02 | Implantable sensor technology for integration in cardiac assist systems, heart assist systems and methods for controlling and controlling a sensor system |
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Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2019036198A1 (en) * | 2017-08-18 | 2019-02-21 | Heartware, Inc. | Thrombus detection and removal using a flexible electronic sensor and emitter |
WO2019234166A1 (en) * | 2018-06-06 | 2019-12-12 | Kardion Gmbh | Method for determining a flow speed of a fluid flowing through an implanted, vascular assistance system and implantable, vascular assistance system |
CN112533660A (en) * | 2018-06-06 | 2021-03-19 | 开迪恩有限公司 | Method for determining a fluid volume flow through an implantable vascular support system and vascular support system |
CN112839588A (en) * | 2018-09-25 | 2021-05-25 | 开迪恩有限公司 | Method and system for determining a flow rate of a fluid flowing through an implantable vascular assistance system |
-
2015
- 2015-04-02 DE DE102015004177.0A patent/DE102015004177A1/en active Pending
Cited By (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2019036198A1 (en) * | 2017-08-18 | 2019-02-21 | Heartware, Inc. | Thrombus detection and removal using a flexible electronic sensor and emitter |
WO2019234166A1 (en) * | 2018-06-06 | 2019-12-12 | Kardion Gmbh | Method for determining a flow speed of a fluid flowing through an implanted, vascular assistance system and implantable, vascular assistance system |
CN112533660A (en) * | 2018-06-06 | 2021-03-19 | 开迪恩有限公司 | Method for determining a fluid volume flow through an implantable vascular support system and vascular support system |
CN112566687A (en) * | 2018-06-06 | 2021-03-26 | 开迪恩有限公司 | Method for determining a flow rate of a fluid flowing through an implantable vascular assistance system and implantable vascular assistance system |
CN112839588A (en) * | 2018-09-25 | 2021-05-25 | 开迪恩有限公司 | Method and system for determining a flow rate of a fluid flowing through an implantable vascular assistance system |
CN112839588B (en) * | 2018-09-25 | 2023-09-26 | 开迪恩有限公司 | Method and system for determining a flow rate of a fluid flowing through an implantable vascular assistance system |
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