EP0914059A1 - Implantable measuring unit for intracorporeal measurement of patient data - Google Patents

Implantable measuring unit for intracorporeal measurement of patient data

Info

Publication number
EP0914059A1
EP0914059A1 EP98912209A EP98912209A EP0914059A1 EP 0914059 A1 EP0914059 A1 EP 0914059A1 EP 98912209 A EP98912209 A EP 98912209A EP 98912209 A EP98912209 A EP 98912209A EP 0914059 A1 EP0914059 A1 EP 0914059A1
Authority
EP
European Patent Office
Prior art keywords
unit
sensor element
implantable
measuring unit
sensor
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Withdrawn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
EP98912209A
Other languages
German (de)
French (fr)
Inventor
Christian Beck
Bernd Brehmeier-Flick
Guido Eckert
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.)
Sci Worx GmbH
Original Assignee
Sican F& e (sibet) GmbH
SICAN F&E GmbH SIBET
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
Priority claimed from DE1997105474 external-priority patent/DE19705474A1/en
Application filed by Sican F& e (sibet) GmbH, SICAN F&E GmbH SIBET filed Critical Sican F& e (sibet) GmbH
Publication of EP0914059A1 publication Critical patent/EP0914059A1/en
Withdrawn legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/03—Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs
    • A61B5/031—Intracranial pressure

Definitions

  • Implantable measuring unit for intra-orporal measurement of patient data
  • the invention relates to an implantable measuring unit for intracorporeal measurement of patient data, in particular intracranial pressure, for mobile use under everyday conditions and an additional application to DE 196 38 813.9 entitled "Intracorporeal measuring system”.
  • measuring probes are inserted into the body using a catheter, e.g. m inserted the head (mtrakramell) and directed to places where bio signals have to be measured.
  • a catheter e.g. m inserted the head (mtrakramell) and directed to places where bio signals have to be measured.
  • the probes When measuring in the skull, the probes must have a very small cross-section and are therefore preferably microsensors which are mounted and contacted in a carrier sleeve.
  • the intracranial pressure is measured with a mtra ran ⁇ ell probe.
  • the probe is then pulled out and destroyed or, in the case of reusable probes, sterilized and reused with the next patient.
  • a so-called shunt system is put in place, by means of which when the brain pressure rises above a fixed value brain water (liquor), the abdominal cavity is drained off so that overpressure i * -, goin is avoided.
  • the intracranial pressure measurement can be done both epi- and subdural.
  • Epidural means that between the hard meninges
  • the intracranial pressure is determined indirectly via the pressure exerted on the meninges by the iquor.
  • This measuring location has the advantages that the hard meninges are not pierced, thus avoiding an infection of the meninges, the procedure is much easier, no brain tissue is injured during this measurement, and the sensor can remain at its measuring location for a longer period of time.
  • a micro pressure sensor is attached to a metal housing. The sensor is connected to the strands of a cable through which 5 electrical signals are sent to an extracorporeal evaluation unit be directed.
  • Another epiduraies system is available from Spiegeibero, in which a balloon catheter is pushed under the C otte C. Depending on the pressure in the brain, the hard meninges on the Ballon transmits, the pressure is passed outside via a line and can be measured extracorporeally there.
  • the company Camino offers a mtravent ⁇ kulare intracranial pressure measurement system with an optical waveguide, in which a pressure measurement is carried out according to the reflection measurement method via a silicon oxide mirror, which changes its position and thus its reflection coefficient depending on the pressure.
  • the reflected portion is set in relation to the transmitted light portion, whereby information about the pressure in the ventricle is obtained.
  • the system offers the advantage of TÜV approval that no electrical currents or voltages occur mtracorporally.
  • the aforementioned measuring systems require a station e rs admission of the patient to perform pressure measurements because the leads are very sensitive. It is desirable tj edoch, m time intervals mtrakorporal Pres e t ⁇ i normal living conditions of the patient to be measured: and recorded.
  • CSF drage would be an implantable measuring system for
  • US Pat. No. 4,519,401 describes a telemetric, mtracramular pressure measurement implant that does not require any cable connections to extracorporeally located recording and evaluation units.
  • a first radio unit is provided, which transmits the measurement signals of a pressure and a temperature sensor to a second radio unit.
  • the first radio unit is implanted under the scalp and is connected to the intracorporeal sensors.
  • the patient carries the second radio unit with him extracorporeally.
  • Both radio units each have a transmitter and a receiver.
  • the sensors are activated with a pulse that is transmitted from the second radio unit to the first radio unit.
  • the measurement data are then transmitted from the first to the second radio unit and can be stored from there and displayed on a monitor.
  • the system described switches the sensors on and off at preset intervals. Then it can happen that suddenly increasing pressures are recorded. In addition, the recording of the measurement data is constant regardless of the relevance of the data. It is not possible to obtain a continuous measurement signal because the data rate of the measured values ZL is low.
  • the use of radio signals requires relatively large transmission powers in the vicinity of the brain, which may have harmful side effects.
  • the German published patent application DE 43 41 903 AI describes an implantable telemetric endosystem, the external dimensions of which are smaller than 1.0 mm x 1.5 mm x 0.6 mm.
  • the implantable measuring system has a sensor connected to a telemetry unit which is inductively coupled to an extracorporeal receiving device.
  • the implanted system is inductively supplied with energy from the outside, so that no batteries have to be implanted.
  • Amplitude, frequency and pulse width modulation are proposed as data transmission methods. A method for arranging, fastening and wiring the pressure sensor and the telemetry unit is not described.
  • the telemetry unit should now be used for trouble-free and patient-friendly operation directly under the skin of pressure / temperature sensor and telemetry unit on a chip is not advantageous, ⁇ a dei sensor must be inserted at defined points in the body, eg in the cerebrospinal fluid under the meninges therefore a separation of sensor and telemetry unit is required.
  • the conventional systems use a cable connection between the sensor and the transmission unit, e.g. Telemetry unit.
  • the cable connections can only be implemented in a very complex and error-prone manner.
  • the implantation by the doctor requires a lot of skill, since the cables cannot be pushed under the skin and can twist and break during the implantation.
  • Invention to provide a measuring unit with an implant part for mobile use for measuring the intracranial pressure with a simple and inexpensive to attach and connect sensor and telemetry unit.
  • the measuring unit should be implantable by the doctor simply and without complications.
  • the wiring of the sensor element and the telemetry device with conductor tracks can be implemented inexpensively and reliably.
  • the flexible film is very easy to implant because it can be pushed under the skin without twisting or undesirably changing direction. This allows the ocr with a smaller diameter than usual.
  • FIG. 1 shows a top view of the implantable measuring system
  • Fig. 2 Cross section through the implantable measuring system
  • Fig. 3 Mobile measuring unit for extracorporeal data transmission and evaluation.
  • a new type of brain pressure measurement system is presented as a preferred embodiment. Likewise, the measuring system can also be used for other medical applications.
  • FIG. 1 a schematic view of the implantable part of the measuring system that is represented t Eir sensor element 1 with at least one sensor, for example, for printing, is implanted.
  • other sensors for example for temperature, can be provided as required.
  • the sensor element 1 is ver with a telemetry unit 2 b Andes, ie, implanted with an inductive coupling element, the eoen AIIS.
  • the telemetry unit 2 has supplied a power ä ußere coil through which the implanted circuit mt inductive.
  • the data measured in sensor element 1 are transmitted with an inductive coupling ar to an evaluation unit. Thereby, it is no t h r me necessary to implant a battery.
  • the sensor element 1 and the telemetry unit 2 are applied to a flexible film 3 which has conductor tracks 4 for the electrical connection of the sensor element 1 and the telemetry unit 2.
  • the flexible film 3 is very easy to implant because it can be pushed under the skin without twisting or undesirably changing direction. As a result, the hole to be drilled in the skullcap can be designed with a smaller diameter than previously customary.
  • only a very small incision is required in the skin, since the film 3 with the sensor element 1 and the telemetry unit 2 applied thereon is very narrow.
  • the implantable measuring unit is shown in cross section in FIG. It can be seen that the sensor element 1 and the telemetry unit 2 m of a special design are arranged on opposite sides of the film 3. There is provided a through-l augmentation 5 for the conductor track 4 to guide it to the opposite side.
  • the entire implant is covered with a silicone layer 6a for patient protection.
  • the sensor element 1 and the telemetry unit 2 are each covered with a layer 6b, 6c for protection.
  • the data from t he be supplied via an extracorporeal telemetry unit 7 according to the measurement over a l ä extended period of Aufolinsemheit 8 implantable measuring unit
  • the data for example, from there can be a serial section t el l e be transferred to a personal computer 9 or the like or via a data card 10, for example PCMCIA, a portable computer or mobile telephone 11.
  • the data are then evaluated in a powerful computing unit and used as an aid to medical diagnostics.

Abstract

The invention relates to an implantable measuring unit for the intracorporeal measurement of patient data, in particular intracranial pressures and is for mobile, everyday use. The invention is an application of addition to DE 196 38 813.9. Implantable measuring units usually have a cable connection between the sensor and the transmission unit. These cable connections are however very complex to create and susceptible to error. The implantation also demands great skill from the doctor since the cables cannot be slid under the skin and can twist and break during implantation. The sensor element (1) and telemetry unit (2) are set on a flexible film (3) which has conductor paths to electrically connect the sensor element (1) and the telemetry unit (2) .The measuring unit is intended to be used for medical purposes, mainly for measuring intracranial pressure.

Description

Implantierbare Meßeinheit zur intra orporalen Messung von PatientendatenImplantable measuring unit for intra-orporal measurement of patient data
Die Erfindung betrifft eine implantierbare Meßeinheit zur intrakorporalen Messung von Patientendaten, insbesondere von Hirndrücken, für den mobilen Einsatz unter Alltagsbedingungen und st eine Zusatzanmeldung zur DE 196 38 813.9 mit dem Titel „Intrakorporal einsetzbares Meßsystem".The invention relates to an implantable measuring unit for intracorporeal measurement of patient data, in particular intracranial pressure, for mobile use under everyday conditions and an additional application to DE 196 38 813.9 entitled "Intracorporeal measuring system".
In medizinischen Anwendungen werden Meßsonden mit Hilfe eines Katheters in den Körper, z.B. m den Kopf (mtrakramell) eingeführt und an Stellen geleitet, an denen Biosignale gemessen werden müssen. Die Sonden müssen bei Messungen im Schädel einen sehr kleinen Querschnitt aufweisen und sind daher bevorzugt Mikrosensoren, die in eine Trägerhülse montiert und kontaktiert sind.In medical applications, measuring probes are inserted into the body using a catheter, e.g. m inserted the head (mtrakramell) and directed to places where bio signals have to be measured. When measuring in the skull, the probes must have a very small cross-section and are therefore preferably microsensors which are mounted and contacted in a carrier sleeve.
Zum Beispiel wird zur Diagnose der Symptomatik eines Wasserkopfes (Hydrozephalus) m der Klinik auf der Intensivstation der Hirndruck mit einer Sonde mtra ranιell gemessen. Anschließend wird die Sonde herausgezogen und vernichtet bzw. bei mehrfach verwendbaren Sonden sterilisiert und beim nächsten Patienten wiederverwendet.For example, to diagnose the symptoms of a water head (hydrocephalus) in the clinic in the intensive care unit, the intracranial pressure is measured with a mtra ranιell probe. The probe is then pulled out and destroyed or, in the case of reusable probes, sterilized and reused with the next patient.
Wenn z.B. ein Hydrozephalus diagnostiziert wurde, wirc ein sog. Shunt -System gelegt, durch das bei Ansteigen αes Hirndrucks über einen festgelegten Wert Gehirnwasser (Liquor) m die Bauchhöhle ableitet, damit ein Überdruck i*-, Gehin vermieden wird. Die Hirndruckmessung kann sowohl epi- als auch subdural erfolgen. Epidural bedeutet, daß zwischen der harten HirnhautIf, for example, a hydrocephalus has been diagnosed, a so-called shunt system is put in place, by means of which when the brain pressure rises above a fixed value brain water (liquor), the abdominal cavity is drained off so that overpressure i * -, goin is avoided. The intracranial pressure measurement can be done both epi- and subdural. Epidural means that between the hard meninges
(Dura mater) und der Schädeldecke (Kalotte) der Hirndruck indirekt über den vom iquor auf die Hirnhaut ausgeübten Druck bestimmt wird.(Dura mater) and the skull cap (calotte) the intracranial pressure is determined indirectly via the pressure exerted on the meninges by the iquor.
Dieser Meßort hat die Vorteile, daß die harte Hirnhaut nicht durchstoßen wird, somit eine Infektion der Hirnhaut vermieden wird, der Eingriff wesentlich einfacher ist, kein Hirngewebe bei dieser Messung verletzt wird, und der Sensor einen längeren Zeitraum an seinem Meßort verweilen kann.This measuring location has the advantages that the hard meninges are not pierced, thus avoiding an infection of the meninges, the procedure is much easier, no brain tissue is injured during this measurement, and the sensor can remain at its measuring location for a longer period of time.
Eine subdurale Messung bedeutet, daß der Sensor unter dieA subdural measurement means that the sensor is under the
Hirnhaut geschoben wird und diese hierbei durchstoßen werden muß. Des weiteren kann nun auch der Druck im HirngewebeMeninges is pushed and this must be pierced. Furthermore, the pressure in the brain tissue can now
(parenchymal) gemessen werden und es wird häufig das Hirngewebe durchstoßen, um eine Messung im Ventrikel(parenchymal) and it is often pierced through the brain tissue to measure in the ventricle
(intraventrikulär) zu ermöglichen.(intraventricular).
C Es sind verschiedene mtrakraniale Meßsyste e oeRanπ; . Zur- Beispiel bietet die Firma B.Braun Melsungen AG ein epiduraies Meßsystem unter dem Namen „Epidyn" an. Hier ist ein Mikrodrucksensor m einem metallischen Gehäuse befestigt. Der Sensor ist mit Litzen eines Kabels verbunden, durch die 5 elektrische Signale an eine extrakorporaie Auswerteeinheit geleitet werden.C There are various mtracranial measuring systems e oeRanπ; . For example, B.Braun Melsungen AG offers an epidural measuring system under the name "Epidyn". A micro pressure sensor is attached to a metal housing. The sensor is connected to the strands of a cable through which 5 electrical signals are sent to an extracorporeal evaluation unit be directed.
Ein weiteres epiduraies System ist von der Firma Spiegeibero erhältlich, bei dem ein Ballonkatheter unter die Ka otte C geschoben wird. Je nach Hirndruck, die harte Hirnhaut auf den Ballon überträgt, wird der Druck über eine Leitung nach außen geleitet und kann dort extrakorporal gemessen werden.Another epiduraies system is available from Spiegeibero, in which a balloon catheter is pushed under the C otte C. Depending on the pressure in the brain, the hard meninges on the Ballon transmits, the pressure is passed outside via a line and can be measured extracorporeally there.
Die Firma Camino bietet ein mtraventπkuläres Hirndruckmeßsystem mit einem Lichtwellenleiter an, bei dem über einen Siliziumoxidspiegel, der je nach Druck seine Lage und damit seinen Reflexionskoefflzienten verändert, eine Druckmessung nach dem Reflexionsmeßverfahren durchgeführt wird. Der reflektierte Anteil wird in Verhältnis zum gesendeten Lichtanteil gesetzt, wodurch eine Information über den Druck im Ventrikel gewonnen wird. Das System bietet den Vorteil bei der TÜV-Zulassung, daß keine elektrischen Strome bzw. Spannungen mtrakorporal auftreten.The company Camino offers a mtraventπkulare intracranial pressure measurement system with an optical waveguide, in which a pressure measurement is carried out according to the reflection measurement method via a silicon oxide mirror, which changes its position and thus its reflection coefficient depending on the pressure. The reflected portion is set in relation to the transmitted light portion, whereby information about the pressure in the ventricle is obtained. The system offers the advantage of TÜV approval that no electrical currents or voltages occur mtracorporally.
Zudem sind einmalverwendbare, mtraventrikuare und parenchymale „Low-cost" HirndrucKsensoren verfugbar. Die Firma Codman (Johnson & Johnson) bietet seit Früh ahr '95 einen Hirndrucksensor mit piezoresistiver Technik an, der durch eine Schaltung mit Trimmpotentiometern 1 StecKer aogeglichen wird.In addition, single-use, mtraventrikuare and parenchymal "low-cost" intracranial pressure sensors are translated. The company Codman (Johnson & Johnson) has been providing Fri ü h ahr '95 an intracranial pressure sensor with piezoresistive technology on which through a circuit with trimmer potentiometers 1 S t ec K he is equalized.
Die vorgenannten Meßsysteme erfordern eine stationäre Aufnahme des Patienten zur Durchführung von Druckmessungen, da die Zuleitungen sehr empfindlich sind. Es ist jedoch erwünscht, m zeitlichen Abstanden mtrakorporal Drucke antεi normalen Lebensbedingungen des Patienten zu messe: und aufzuzeichnen .The aforementioned measuring systems require a station e rs admission of the patient to perform pressure measurements because the leads are very sensitive. It is desirable tj edoch, m time intervals mtrakorporal Pres e t εi normal living conditions of the patient to be measured: and recorded.
Des weiteren wird durch die Katheteranbindung des Patienten an die Monitore seine Bewegungsfreiheit eingeschränkt Dadurch ist die Pflege des Patienten sehr aufwendig, obwohl sich dieser psychisch und physisch selbst versorgen könnte. Zudem besteht die Gefahr von Fehlmessungen und Geräteausfall bei Bewegung des Patienten.Furthermore, through the catheter connection of Pa t ia t s to the monitors his movements Restricted ä nk t Thus the patient's care is very expensive, even though he could take care of himself mentally and physically. There is also the risk of incorrect measurements and device failure when the patient is moving.
Insbesondere für eine Implantation eines Shuntsystems zurIn particular for an implantation of a shunt system
Liquordramage wäre ein implantierbares Meßsystem zurCSF drage would be an implantable measuring system for
Steuerung des Katheterquerschnitts und des Ventilöffnungsdrucks sehr wünschenswert.Control of catheter cross-section and valve opening pressure is very desirable.
In der US-PS 4,519,401 ist ein telemetπsches , mtrakramelles Druckmeßimplantat beschrieben, das keine KabelVerbindungen zu extrakorporal gelegenen Aufzeichnungs- und Auswerteeinheiten benötigt. Hierzu ist eine erste Funkeinheit vorgesehen, die die Meßsignale eines Druck- und eines Temperatursensors an eine zweite Funkeinheit übertragt. Die erste Funkeinheit wird unter der Kopfhaut implantiert und ist mit den intrakorporalen Sensoren verbunden. Der Patient trägt die zweite Funkeinheit extrakorporal bei sich. Beide Funkeinheiten verfügen jeweils über einen Sender und einen Empfanger. Zu festgelegten Zeiten werden die Sensoren m_t einem Impuls aktiviert, der von der zweiten Funkeinheit zur ersten Funkeinheit übertragen wird. Die Meßdaten werden dann von der ersten zur zweiten Funkeinheit übertragen und können von dort an gespeichert und an einem Monitor angezeigt werden. Das beschriebene System schaltet die Sensorer ir voreingestellten Intervallen ein und aus. Dann Kann es ιeαocr passieren, daß plötzlich ansteigende Drücke mcnt aufgezeichnet werden. Außerder ist die Aufzeichnungsαicnte der Meßdaten unabhängig von der Relevanz der Dater gleichbleibend. Es ist nicht möglich, ein kontinuierliches Meßsignal zu erhalten, da die Datenrate der Meßwerte Z L gering ist. Durch die Verwendung von Funksignalen sind relativ große Sendeleistungen m der Gehirnnähe erforderlich, die unter Umständen schädliche Nebenwirkungen haben.US Pat. No. 4,519,401 describes a telemetric, mtracramular pressure measurement implant that does not require any cable connections to extracorporeally located recording and evaluation units. For this purpose, a first radio unit is provided, which transmits the measurement signals of a pressure and a temperature sensor to a second radio unit. The first radio unit is implanted under the scalp and is connected to the intracorporeal sensors. The patient carries the second radio unit with him extracorporeally. Both radio units each have a transmitter and a receiver. At defined times, the sensors are activated with a pulse that is transmitted from the second radio unit to the first radio unit. The measurement data are then transmitted from the first to the second radio unit and can be stored from there and displayed on a monitor. The system described switches the sensors on and off at preset intervals. Then it can happen that suddenly increasing pressures are recorded. In addition, the recording of the measurement data is constant regardless of the relevance of the data. It is not possible to obtain a continuous measurement signal because the data rate of the measured values ZL is low. The use of radio signals requires relatively large transmission powers in the vicinity of the brain, which may have harmful side effects.
In der deutschen Offenlegungsschrift DE 43 41 903 AI wird ein implantierbares telemetπsche Endosystem beschrieben, dessen Außenmaße kleiner als 1,0 mm x 1,5 mm x 0,6 mm sind. Das implantierbare Meßsystem weist einen Sensor m Verbindung mit einer Telemetrieeinheit auf, die induktiv an ein extrakorporales Empfangsgerät gekoppelt wird. Das implantierte System wird induktiv von außen mit Energie versorgt, so daß keine Batterien implantiert werden müssen. Als Datenübertragungsverfahren werden Amplituden- , Frequenz- und Pulsweitenmodulation vorgeschlagen. Eine Methode zur Anordnung, Befestigung und Verkabelung des Drucksensors und der Telemetrieeinheit wird nicht beschrieben.The German published patent application DE 43 41 903 AI describes an implantable telemetric endosystem, the external dimensions of which are smaller than 1.0 mm x 1.5 mm x 0.6 mm. The implantable measuring system has a sensor connected to a telemetry unit which is inductively coupled to an extracorporeal receiving device. The implanted system is inductively supplied with energy from the outside, so that no batteries have to be implanted. Amplitude, frequency and pulse width modulation are proposed as data transmission methods. A method for arranging, fastening and wiring the pressure sensor and the telemetry unit is not described.
In „Contacless Inductive-Operation Microcircuits for Medical Applications", von L. Talamonti, G. Porroveccio, G. Marotta, IEEE Engineering m Medicme & Biology Society, Proc. of tne lOth Annual Intern. Conference, New Orleans, Nov. 4-7, 1988, Seiten 818-819, wird eine implantierbare Telemetrieeinheit vorgestellt, die mit Druck- bzw. Temperatursensoren auf einem Chip integrierbar ist. Die Telemetrieeinheit sollte jεdocn für einen storungssicheren und patientenverträglichen Betriet αirekt unter der Haut eingesetzt werden. Dann ist die Descnriebene Aufbautechnik von Druck- /Temperatursenscr unα Telemetrieeinheit auf einem Chip nicht vorteilhaft, αa dei Sensor an definierte Stellen im Korper, z.B. im Liquor oαei unter die Hirnhaut eingebracht werden muß. In der Praxis ist somit eine Trennung von Sensor und Telemetrieeinheit erforderlich.In "Contacless Inductive-Operation Microcircuits for Medical Applications", by L. Talamonti, G. Porroveccio, G. Marotta, IEEE Engineering m Medicme & Biology Society, Proc. Of tne lOth Annual Intern. Conference, New Orleans, Nov. 4- 7, 1988, pages 818-819, an implantable telemetry unit is presented, which can be integrated on a chip with pressure or temperature sensors. The telemetry unit should now be used for trouble-free and patient-friendly operation directly under the skin of pressure / temperature sensor and telemetry unit on a chip is not advantageous, αa dei sensor must be inserted at defined points in the body, eg in the cerebrospinal fluid under the meninges therefore a separation of sensor and telemetry unit is required.
Die herkömmlichen Systeme verwenden eine KabelVerbindung zwischen Sensor und Übertragungseinheit, z.B. Telemetrieeinheit. Die KabelVerbindungen sind nur sehr aufwendig und fehleranfallig realisierbar. Zudem erfordert die Implantation durch den Arzt sehr viel Geschick, da sich die Kabel nicht unter die Haut schieben lassen und bei der Implantation verdrehen und brechen können.The conventional systems use a cable connection between the sensor and the transmission unit, e.g. Telemetry unit. The cable connections can only be implemented in a very complex and error-prone manner. In addition, the implantation by the doctor requires a lot of skill, since the cables cannot be pushed under the skin and can twist and break during the implantation.
Aufgabetask
Ausgehend von diesem Stand der Technik war es Aufgabe derBased on this state of the art, it was the task of
Erfindung, eine Meßeinheit mit Implantatteil für den mobilen Einsatz zur Messung des Hirndrucks mit einer einfach und kostengünstig herstellbaren Befestigung und Verbindung von Sensor und Telemetrieeinheit zu schaffen. Die Meßeinheit sollte einfach und komplikationslos vom Arzt implantierbar sein.Invention to provide a measuring unit with an implant part for mobile use for measuring the intracranial pressure with a simple and inexpensive to attach and connect sensor and telemetry unit. The measuring unit should be implantable by the doctor simply and without complications.
Die Aufgabe wird durch die Meßeinheit mit den Merkmalen des Anspruchs 1 gelöst. Vorteilhafte Ausgestaltungen sind m der Unteransprüchen beschrieben.The object is achieved by the measuring unit with the features of claim 1. Advantageous refinements are described in the subclaims.
Die Verdrahtung des Sensorelements und der Telemetrieemneit mit Leiterbahnen ist kostengünstig und zuverlässig realisierbar. Zudem ist die flexible Folie sehr leicht implantierbar, da sie unter die Haut geschoben werden Kann, ohne daß sie sich verdreht oder unerwünscht die Richtung ändert. Dadurch kann das m die Schädeldecke zu bohrende ocr mit einem kleineren Durchmesser als bisher üblich ausgeführt werden.The wiring of the sensor element and the telemetry device with conductor tracks can be implemented inexpensively and reliably. In addition, the flexible film is very easy to implant because it can be pushed under the skin without twisting or undesirably changing direction. This allows the ocr with a smaller diameter than usual.
Zeichnungen Die Erfindung wird mit der beigefügten Zeichnung erläutert. Es zeigen: Fig. 1: Draufsicht auf das implantierbare Meßsystem mitDRAWINGS The invention is explained with the attached drawing. 1 shows a top view of the implantable measuring system
Sensorelement und Telemetrieeinheit auf einer Folie; Fig. 2: Querschnitt durch das implantierbare Meßsystem: Fig. 3: Mobile Meßeinheit zur extrakorporalen Datenübertragung und -auswertung.Sensor element and telemetry unit on a film ; Fig. 2: Cross section through the implantable measuring system : Fig. 3: Mobile measuring unit for extracorporeal data transmission and evaluation.
AusführungsbeispielEmbodiment
Als bevorzugtes Ausführungsbeispiel wird ein neuartiges Hirndruckmeßsystem vorgestellt . Gleichermaßen kann das Meßsystem aber auch für andere medizinische Anwendungen verwendet werden.A new type of brain pressure measurement system is presented as a preferred embodiment. Likewise, the measuring system can also be used for other medical applications.
In der Figur 1 ist eine schematische Ansicht des implantierbaren Teils des Meßsystems dargestellt Eir Sensorelement 1 mit mindestens einem Sensor, z.B. f r DrucK, wird implantiert. Zusätzlich können je nach Bedarf auch weitere Sensoren, z.B. für Temperatur, vorgesehen werden. Das Sensorelement 1 ist mit einer Telemetrieeinheit 2 verbanden, d.h. mit einem induktiven Koppelelement, das eoen aiis implantiert ist. Die Telemetrieeinheit 2 hat eine äußere Spule, über die die implantierte Schaltung induktiv m t Energie versorgt wird. Außerdem werden die im Sensorelement 1 gemessenen Daten mit einer induktiven Kopplung ar eine Auswerteeinheit übertragen. Dadurch ist es nicht mehr erforderlich, eine Batterie zu implantieren. Das Sensorelement 1 und die Telemetrieeinheit 2 sind auf einer flexiblen Folie 3 aufgebracht, die Leiterbahnen 4 zur elektrischen Verbindung des Sensorelements 1 und der Telemetrieeinheit 2 aufweist. Dadurch entfällt die herkömmliche aufwendige Verdrahtung mit verdrillten Kabeln. Zudem ist die flexible Folie 3 sehr leicht implantierbar, da sie unter die Haut geschoben werden kann, ohne daß sie sich verdreht oder unerwünscht die Richtung ändert . Dadurch kann das m die Schädeldecke zu bohrende Loch mit einem kleineren Durchmesser als bisher üblich ausgeführt werden. Außerdem ist nur ein sehr kleiner Schnitt m die Haut erforderlich, da die Folie 3 mit dem darauf aufgebrachten Sensorelement 1 und der Telemetrieeinheit 2 sehr schmal ist.In the figure 1 a schematic view of the implantable part of the measuring system that is represented t Eir sensor element 1 with at least one sensor, for example, for printing, is implanted. In addition, other sensors, for example for temperature, can be provided as required. The sensor element 1 is ver with a telemetry unit 2 b Andes, ie, implanted with an inductive coupling element, the eoen AIIS. The telemetry unit 2 has supplied a power ä ußere coil through which the implanted circuit mt inductive. In addition, the data measured in sensor element 1 are transmitted with an inductive coupling ar to an evaluation unit. Thereby, it is no t h r me necessary to implant a battery. The sensor element 1 and the telemetry unit 2 are applied to a flexible film 3 which has conductor tracks 4 for the electrical connection of the sensor element 1 and the telemetry unit 2. This eliminates the need for conventional, complex wiring with twisted cables. In addition, the flexible film 3 is very easy to implant because it can be pushed under the skin without twisting or undesirably changing direction. As a result, the hole to be drilled in the skullcap can be designed with a smaller diameter than previously customary. In addition, only a very small incision is required in the skin, since the film 3 with the sensor element 1 and the telemetry unit 2 applied thereon is very narrow.
In der Figur 2 ist die implantierbare Meßeinheit im Querschnitt dargestellt. Es ist zu erkennen, daß das Sensorelement 1 und die Telemetrieeinheit 2 m einer besonderen Ausführung auf jeweils gegenüberliegenden Seiten der Folie 3 angeordnet sind. Es ist eine Durchkontaktlerung 5 für die Leiterbahn 4 vorgesehen, um diese auf die gegenüberliegende Seite zu führen. Das gesamte Implantat ist mit einer Silikonschicht 6a zum Patientenschutz überzogen. Außerdem ist das Sensorelement 1 und die Telemetrieeinheit 2 jeweils zum Schutz mit einer Schicht 6b, 6c überzogen.The implantable measuring unit is shown in cross section in FIG. It can be seen that the sensor element 1 and the telemetry unit 2 m of a special design are arranged on opposite sides of the film 3. There is provided a through-l augmentation 5 for the conductor track 4 to guide it to the opposite side. The entire implant is covered with a silicone layer 6a for patient protection. In addition, the sensor element 1 and the telemetry unit 2 are each covered with a layer 6b, 6c for protection.
Aus der Figur 3 ist ersichtlich, daß die Daten von der implantierbaren Meßeinheit über eine extrakorporale Telemetrieeinheit 7 nach der Messung über einen längeren Zeitraum einer Aufzeichnungsemheit 8 zugeführt werden Von dort können die Daten z.B. über eine serielle Schnittstelle einem Personalcomputer 9 o.a. oder über eine Datenkarte 10, z.B. PCMCIA, einem tragbaren Computer oder Mobiltelefon 11 übergeben werden. Die Daten werden dann in einer leistungsfähigen Recheneinheit ausgewertet und als Hilfestellung zur medizinischen Diagnostik benutzt. From the figure 3 it can be seen that the data from t he be supplied via an extracorporeal telemetry unit 7 according to the measurement over a l ä extended period of Aufzeichnungsemheit 8 implantable measuring unit the data, for example, from there can be a serial section t el l e be transferred to a personal computer 9 or the like or via a data card 10, for example PCMCIA, a portable computer or mobile telephone 11. The data are then evaluated in a powerful computing unit and used as an aid to medical diagnostics.

Claims

Patentansprüche claims
1. Implantierbare Meßeinheit zur intrakorporalen Messung von Patientendaten, insbesondere von Hirndrücken, für den mobilen Einsatz unter Alltagsbedingungen mit:1. Implantable measuring unit for intracorporeal measurement of patient data, in particular intracranial pressure, for mobile use under everyday conditions with:
- mindestens einem mtrakorporal einsetzbaren Sensorelement (1) und- At least one mtracorporal sensor element (1) and
- einer damit verbundenen Telemetrieeinheit (2) zur induktiven Energieübertragung und Datenübermittlung dadurch gekennzeichnet, daß a) das mindestens ein Sensorelement (1) und die Telemetrieeinheit (2) auf einer flexiblen Folie (3) aufgebracht sind und b) die flexible Folie (3) Leiterbahnen (4) zur elektrischen Verbindung des mindestens einen Sensorelements (1) und der Telemetrieeinheit (2) aufweist .- An associated telemetry unit (2) for inductive energy transmission and data transmission, characterized in that a) the at least one sensor element (1) and the telemetry unit (2) are applied to a flexible film (3) and b) the flexible film (3) Has conductor tracks (4) for the electrical connection of the at least one sensor element (1) and the telemetry unit (2).
2. Implantierbare Meßeinheit nach Anspruch 1, dadurch gekennzeichnet, daß ein Sensorelement (1) ein Drucksensor2. Implantable measuring unit according to claim 1, characterized in that a sensor element (1) is a pressure sensor
3. Implantierbare Meßeinheit nach Anspruch 2, dadurch gekennzeichnet, daß als zweites Sensorelement ein Temperatursensor zur Erfassung der Hirntemperatur vorgesehen ist .3. Implantable measuring unit according to claim 2, characterized in that a temperature sensor for detecting the brain temperature is provided as the second sensor element.
4. Implantierbare Meßeinheit nach einem der vorhergenenden Ansprüche, gekennzeichnet durch eine extrakorporal^ Telemetrieeinheit (7), die mit der Telemetrieeinheit (2) der implantierten Meßeinrichtung kommuniziert. 4. Implantable measuring unit according to one of the preceding claims, characterized by an extracorporeal ^ telemetry unit (7) which communicates with the telemetry unit (2) of the implanted measuring device.
5. Implantierbare Meßeinheit nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, daß das Sensorelement (1) und die Telemetrieeinheit (2) auf jeweils gegenüberliegenden Seiten der Folie (3) angeordnet sind. 5. Implantable measuring unit according to one of the preceding claims, characterized in that the sensor element ( 1 ) and the telemetry unit (2) are arranged on opposite sides of the film (3).
EP98912209A 1997-02-13 1998-02-12 Implantable measuring unit for intracorporeal measurement of patient data Withdrawn EP0914059A1 (en)

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DE1997105474 DE19705474A1 (en) 1996-09-20 1997-02-13 Implantable measuring unit for intracranial pressures, etc.
DE19705474 1997-02-13
PCT/DE1998/000406 WO1998035610A1 (en) 1997-02-13 1998-02-12 Implantable measuring unit for intracorporeal measurement of patient data

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