WO2005048835A1 - Implant for carrying out intracorporal measurements - Google Patents

Implant for carrying out intracorporal measurements Download PDF

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Publication number
WO2005048835A1
WO2005048835A1 PCT/EP2004/012670 EP2004012670W WO2005048835A1 WO 2005048835 A1 WO2005048835 A1 WO 2005048835A1 EP 2004012670 W EP2004012670 W EP 2004012670W WO 2005048835 A1 WO2005048835 A1 WO 2005048835A1
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WO
WIPO (PCT)
Prior art keywords
implant
sensor device
telemetric
coil
implant according
Prior art date
Application number
PCT/EP2004/012670
Other languages
German (de)
French (fr)
Inventor
Volker BÖDECKER
Axel Niemeyer
Stefan Meyer
Max G. Ostermeier
Bernhard Wagner
Original Assignee
Mesotec Gmbh
Cranium Telemetrics 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 Mesotec Gmbh, Cranium Telemetrics Gmbh filed Critical Mesotec Gmbh
Priority to EP04797744A priority Critical patent/EP1694205A1/en
Publication of WO2005048835A1 publication Critical patent/WO2005048835A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B3/00—Apparatus for testing the eyes; Instruments for examining the eyes
    • A61B3/10—Objective types, i.e. instruments for examining the eyes independent of the patients' perceptions or reactions
    • A61B3/16—Objective types, i.e. instruments for examining the eyes independent of the patients' perceptions or reactions for measuring intraocular pressure, e.g. tonometers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0031—Implanted circuitry
    • 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

Definitions

  • the invention relates to an implant for performing intracorporeal measurements according to the preamble of claim 1.
  • a sensor device for pressure measurement and / or temperature measurement and a telemetry unit with an inductive coil, the windings of which are applied to the support film, are arranged on a flexible support film.
  • the sensor device and the telemetry device are electrically connected to one another.
  • the carrier film and the devices and components arranged thereon are encapsulated in a silicone covering.
  • the object of the invention is to provide an implant of the type mentioned at the outset, which can be folded or bent in a stress-free manner, in particular in the area of inductive coil turns.
  • the turns of the inductive coil which are formed by at least one metallized flexible plastic band, are arranged in the encapsulation material of the casing without a strap.
  • the encapsulation material encompasses the turns on all sides.
  • the wrapping material thus fulfills the carrier function.
  • the turns of the coil are kept at an electrically insulating distance from one another by the covering material.
  • a filling material other than the encapsulation material can also be used as a spacer filling material between the coil turns.
  • Figure 1 is a plan view of the arrangement of the inductive coil and sensor device in one embodiment.
  • FIG. 2 schematically shows a sectional, enlarged representation through parts of the implant shown in FIG. 1, only some of the coil turns and part of the sensor device being shown;
  • FIG. 3 different manufacturing steps of the implant shown in Figs. 1 and 2.
  • the implant shown in FIGS. 1 and 2 contains, in a covering 1 (shown in black in FIG. 1, shown in FIG. 2 with continuous and dotted hatching), for example made of silicone, a sensor device 2 and an electrically connected inductive coil 4.
  • Sensor device 2 contains all the components required for measurement, such as pressure sensor and / or temperature sensor, and a telemetric processing circuit to convert the measurement signals into a signal form suitable for telemetry.
  • the casing 1 is designed such that an acting pressure is passed on to the pressure sensor through the casing, which is preferably made of silicone.
  • the coil 4 consists of one or more spirally wound turns 3, each turn 3 being formed by a plastic strip 5 covered with a metallization 6.
  • the metallization 6 is preferably made of a noble metal, for example gold, and the plastic band 5 is preferably made of polyimide.
  • the turns 3 of the inductive coil 4 are encompassed on all sides by the encapsulation material of the casing 1.
  • another filler material e.g. B. a foldable acrylate or the like may be provided.
  • the envelope 1 thus forms both the carrier for the coil turns and the spacer between the individual coil turns.
  • a continuous carrier film on which the coil turns are applied is not required in the invention.
  • the coil turns 3 are passed through the encapsulation material of the casing 1 in an isolated manner. At the spiral ends of the coil turns 3 there are contacting points 9, 10 at which the coil 4 is electrically connected to the sensor device 2.
  • the thickness of the plastic band 5 can be 10 ⁇ m, for example.
  • the thickness of the metallization 6 can be 5 to 120 ⁇ m.
  • the plastic material of the film 7 is then removed between the metallizations by suitable solvents, so that turns 3 of the coil, which consist of the plastic tape 5 and the metallization 6 located thereon, remain on the base 8 (step B).
  • the coil turns 3 and the sensor device 2 likewise subsequently introduced into the casting mold (step C) are then encapsulated, for example by molding.
  • a material other than the encapsulation material can also be introduced as spacer filling material between the coil turns 3.
  • the partially encapsulated implant of FIG. 2C is then detached from the base 8 and the still free side of the implant is also encapsulated with the encapsulation material by molding, so that the implant shown in FIGS. 1 and 2 is produced.
  • the implant is preferably used for telemetric intracranial pressure measurement, in particular epidural intracranial pressure measurement as is known for example from DE 101 56 469 AI, or for telemetric intraocular pressure measurement as is known for example from DE 199 45 879 AI.
  • the implant forms the intracorporeal, telemetric measuring device.

Abstract

The invention relates to an implant which is used to carry out intracorporal, telemetric measurements, especially pressure measurements. Said implant comprises a covering (1) wherein at least one sensor device (2) and coil windings of an inductive spool (4) are arranged, said coil winding being connected to the sensor arrangement (2). Each of the coil windings (3), which are formed from at least one flexible plastic strip (5) provided with metallisation (6), is encompassed by covering material on all sides, without a carrier.

Description

[Patentanmeldung] Implantat zur Durchführung intrakorporaler Messungen [Patent application] implant for performing intracorporeal measurements
[Besehreibung][Besehreibung]
Die Erfindung betrifft ein Implantat zur Durchführung intrakorporaler Messungen nach dem Oberbegriff des Patentanspruches 1.The invention relates to an implant for performing intracorporeal measurements according to the preamble of claim 1.
Bei einem derartigen, beispielsweise aus US 6,083,174 bekannten Implantat sind auf einer flexiblen Trägerfolie eine Sensoreinrichtung zur Druckmessung und/oder Temperaturmessung sowie eine Telemetrieeinheit mit einer induktiven Spule, deren Windungen auf der Trägerfolie aufgebracht sind, angeordnet. Die Sensoreinrichtung und die Telemetrieeinrich- tung sind elektrisch miteinander verbunden. Die Trägerfolie und die darauf angeordneten Einrichtungen und Bauteile sind in einer Umhüllung aus Silikon verkapselt. Beim Implantieren oder der intrakorporalen Positionierung am Zielort im Körper ist es erforderlich, das Implantat zu falten oder zu biegen. Dabei können Spannungen an der Grenzfläche zwischen deztr Trägerfolie und den Windungen der induktiven Spule, welche in der Umhüllung den größten Raum einnimmt, entstehen.In such an implant, for example known from US Pat. No. 6,083,174, a sensor device for pressure measurement and / or temperature measurement and a telemetry unit with an inductive coil, the windings of which are applied to the support film, are arranged on a flexible support film. The sensor device and the telemetry device are electrically connected to one another. The carrier film and the devices and components arranged thereon are encapsulated in a silicone covering. When implanting or intracorporeal positioning at the target site in the body, it is necessary to fold or bend the implant. This can result in tensions at the interface between the carrier film and the turns of the inductive coil, which occupies the largest space in the sheath.
Aufgabe der Erfindung ist es, ein Implantat der eingangs genannten Art zu schaffen, welches insbesondere im Bereich der induktiven Spulenwindungen spannungsfrei gefaltet oder gebogen werden kann.The object of the invention is to provide an implant of the type mentioned at the outset, which can be folded or bent in a stress-free manner, in particular in the area of inductive coil turns.
Diese Aufgabe wird durch die kennzeichnenden Merkmale des Patentanspruches 1 gelöst.This object is achieved by the characterizing features of patent claim 1.
Die Unteransprüche beinhalten vorteilhafte Weiterbildungen der Erfindung. Bei der Erfindung werden die Windungen der induktiven Spule, die von wenigstens einem metallisierten flexiblen Kunststoffband gebildet sind, trägerlos im Verkapselungsmaterial der Umhüllung angeordnet. Das Verkapselungsmaterial umfasst allseitig die Windungen. Die Trägerfunktion wird somit vom Umhüllungsmaterial erfüllt. Ferner werden die Windungen der Spule durch das Umhüllungsmaterial in elektrisch isolierendem Abstand voneinander gehalten. Zwischen den Spulenwindungen kann auch ein anderes Füllmaterial als das Verkapselungsmaterial als Distanzfüllmaterial sein.The subclaims contain advantageous developments of the invention. In the invention, the turns of the inductive coil, which are formed by at least one metallized flexible plastic band, are arranged in the encapsulation material of the casing without a strap. The encapsulation material encompasses the turns on all sides. The wrapping material thus fulfills the carrier function. Furthermore, the turns of the coil are kept at an electrically insulating distance from one another by the covering material. A filling material other than the encapsulation material can also be used as a spacer filling material between the coil turns.
Anhand der Figuren wird an einem Ausführungsbeispiel die Erfindung noch näher erläutert .Based on the figures, the invention is explained in more detail using an exemplary embodiment.
Es zeigtIt shows
Fig. 1 eine Draufsicht auf die Anordnung von induktiver Spule und Sensoreinrichtung bei einem Ausführungsbeispiel;Figure 1 is a plan view of the arrangement of the inductive coil and sensor device in one embodiment.
Fig. 2 schematisch eine schnittbildliche, vergrößerte Darstellung durch Teile des in Fig. 1 dargestellten Implantats, wobei nur einige der Spulenwindungen und ein Teil der Sensoreinrichtung dargestellt sind; undFIG. 2 schematically shows a sectional, enlarged representation through parts of the implant shown in FIG. 1, only some of the coil turns and part of the sensor device being shown; and
Fig. 3 verschiedene Herstellungsschritte des in Fig. 1 und 2 dargestellten Implantats.Fig. 3 different manufacturing steps of the implant shown in Figs. 1 and 2.
Das in den Fig. 1 und 2 dargestellte Implantat beinhaltet in einer Umhüllung 1 (in Fig. 1 mit schwarzer Farbe dargestellt, in Fig. 2 mit durchgehender und punktierter Schraf- fur dargestellt) , beispielsweise aus Silikon, eine Sensor- einrichtung 2 sowie eine elektrisch daran angeschlossene induktive Spule 4. Die Sensoreinrichtung 2 beinhaltet alle zur Messung erforderlichen Bauelemente, wie beispielsweise Drucksensor und/oder Temperatursensor, und eine telemetri- sche Aufbereitungsschaltung, um die Messsignale in eine für die Telemetrie geeignete Signalform umzuwandeln. Im Bereich der Sensoreinrichtung 2 ist die Umhüllung 1 so ausgebildet, dass ein einwirkender Druck durch die vorzugsweise aus Silikon bestehende Umhüllung auf den Drucksensor weitergeleitet wird.The implant shown in FIGS. 1 and 2 contains, in a covering 1 (shown in black in FIG. 1, shown in FIG. 2 with continuous and dotted hatching), for example made of silicone, a sensor device 2 and an electrically connected inductive coil 4. Sensor device 2 contains all the components required for measurement, such as pressure sensor and / or temperature sensor, and a telemetric processing circuit to convert the measurement signals into a signal form suitable for telemetry. In the area of the sensor device 2, the casing 1 is designed such that an acting pressure is passed on to the pressure sensor through the casing, which is preferably made of silicone.
Die Spule 4 besteht aus einer oder mehreren spiralförmig gewundenen Windungen 3, wobei jede Windung 3 von einem mit einer Metallisierung 6 belegten Kunststoffband 5 gebildet wird. Die Metallisierung 6 besteht vorzugsweise aus einem Edelmetall, beispielsweise Gold, und das Kunststoffband 5 besteht vorzugsweise aus Polyimid.The coil 4 consists of one or more spirally wound turns 3, each turn 3 being formed by a plastic strip 5 covered with a metallization 6. The metallization 6 is preferably made of a noble metal, for example gold, and the plastic band 5 is preferably made of polyimide.
Wie aus den Fig. 1 und 2 zu ersehen ist, werden die Windungen 3 der induktiven Spule 4 allseitig vom Verkapselungsmaterial der Umhüllung 1 umfasst. Anstelle des Umhüllungsmaterials kann als Abstandhalter zwischen den Spulenwindungen auch ein anderes Füllmaterial, z. B. ein faltbares Acrylat oder dergleichen vorgesehen sein. Die Umhüllung 1 bildet somit sowohl den Träger für die Spulenwindungen als auch den Abstandhalter zwischen den einzelnen Spulenwindungen. Eine durchgehende Trägerfolie, auf welcher die Spulenwindungen aufgebracht sind, ist bei der Erfindung nicht erforderlich.As can be seen from FIGS. 1 and 2, the turns 3 of the inductive coil 4 are encompassed on all sides by the encapsulation material of the casing 1. Instead of the wrapping material, another filler material, e.g. B. a foldable acrylate or the like may be provided. The envelope 1 thus forms both the carrier for the coil turns and the spacer between the individual coil turns. A continuous carrier film on which the coil turns are applied is not required in the invention.
Im Bereich des Sensoreinrichtung 2 werden die Spulenwindungen 3 durch das Verkapselungsmaterial der Umhüllung 1 isoliert hindurchgeführt. An Spiralenden der Spulenwindungen 3 befinden sich Kontaktierungsstellen 9, 10, an denen die Spule 4 mit der Sensoreinrichtung 2 elektrisch verbunden ist. Die Dicke des Kunststoffbandes 5 kann beispielsweise 10 μm betragen. Die Dicke der Metallisierung 6 kann 5 bis 120 μm betragen. Bei der Herstellung des Implantats werden, wie aus Fig. 3 zu ersehen ist, auf einer Kunststofffolie 7, die lösbar auf einer Unterlage 8 aufliegt, in spiralförmigen Windungen die Metallisierungen 6, beispielsweise aus Gold, aufgebracht (Schritt A) . Anschließend wird das Kunststoffmaterial der Folie 7 zwischen den Metallisierungen durch geeignete Lösungsmittel entfernt, so dass auf der Unterlage 8 Windungen 3 der Spule, die aus dem Kunststoffband 5 und der darauf befindlichen Metallisierung 6 bestehen, verbleiben (Schritt B) . Anschließend erfolgt beispielsweise durch Formgießen die Verkapselung der Spulenwindungen 3 und der ebenfalls anschließend in die Gießform eingebrachten Sensoreinrichtung 2 (Schritt C) . Als Distanzfüllmaterial kann zwischen die Spulenwindungen 3 auch ein anderes Material als das Verkapselungsmaterial eingebracht werden. Anschließend wird das teilweise verkapselte Implantat der Fig. 2C von der Unterlage 8 gelöst und die noch freie Seite des Implantats ebenfalls durch Formgießen mit dem Verkapselungsmaterial umhüllt, so dass das in den Fig. 1 und 2 dargestellte Implantat entsteht.In the area of the sensor device 2, the coil turns 3 are passed through the encapsulation material of the casing 1 in an isolated manner. At the spiral ends of the coil turns 3 there are contacting points 9, 10 at which the coil 4 is electrically connected to the sensor device 2. The thickness of the plastic band 5 can be 10 μm, for example. The thickness of the metallization 6 can be 5 to 120 μm. During the manufacture of the implant, as can be seen from FIG. 3, the metallizations 6, for example made of gold, are applied to a plastic film 7, which rests releasably on a base 8 (step A). The plastic material of the film 7 is then removed between the metallizations by suitable solvents, so that turns 3 of the coil, which consist of the plastic tape 5 and the metallization 6 located thereon, remain on the base 8 (step B). The coil turns 3 and the sensor device 2 likewise subsequently introduced into the casting mold (step C) are then encapsulated, for example by molding. A material other than the encapsulation material can also be introduced as spacer filling material between the coil turns 3. The partially encapsulated implant of FIG. 2C is then detached from the base 8 and the still free side of the implant is also encapsulated with the encapsulation material by molding, so that the implant shown in FIGS. 1 and 2 is produced.
Das Implantat wird vorzugsweise zur telemetrischen Hirndruckmessung, insbesondere epiduralen Hirndruckmessung wie es beispielsweise aus DE 101 56 469 AI bekannt ist, oder zur telemetrischen Augeninnendruckmessung, wie es beispielsweise aus DE 199 45 879 AI bekannt ist, verwendet. Dabei bildet das Implantat die intrakorporale, telemetrische Messeinrichtung . [Bezugszeichenliste]The implant is preferably used for telemetric intracranial pressure measurement, in particular epidural intracranial pressure measurement as is known for example from DE 101 56 469 AI, or for telemetric intraocular pressure measurement as is known for example from DE 199 45 879 AI. The implant forms the intracorporeal, telemetric measuring device. [REFERENCE LIST]
1 Umhüllung1 serving
2 Sensoreinrichtung2 sensor device
3 Spulenwindungen3 coil turns
4 induktive Spule4 inductive coil
5 Kunststoffband5 plastic straps
6 Metallisierung6 metallization
7. Folie7. Slide
8 Unterlage8 pad
9 Kontaktierungsstelle9 contact point
10 Kontaktierungsstelle 10 contact point

Claims

[ atentansprüche] [claims]
1. Implantat zur Durchführung intrakorporaler, telemetri- scher Messungen mit einer Umhüllung, in welcher wenigstens eine telemetrische Sensoreinrichtung und an die Sensoreinrichtung angeschlossene Windungen einer induktiven Spule angeordnet sind, dadurch gekennzeichnet, dass jede der Spulenwindungen (3), die von wenigstens einem metallisierten flexiblen Kunststoffband gebildet sind, trägerlos allseitig vom Umhüllungsmaterial umfasst ist.1. Implant for carrying out intracorporeal, telemetric measurements with a sheath in which at least one telemetric sensor device and windings of an inductive coil connected to the sensor device are arranged, characterized in that each of the coil windings (3) has at least one metallized flexible Plastic tape are formed, is encased on all sides by the wrapping material.
2. Implantat nach Anspruch 1, dadurch gekennzeichnet, dass zwischen den Spulenwindungen (3) ein anderes abstandhaltendes Füllmaterial als das Umhüllungsmaterial vorgesehen ist.2. Implant according to claim 1, characterized in that between the coil turns (3) a different spacing filling material is provided as the wrapping material.
3. Implantat nach Anspruch 1 oder 2, dadurch gekennzeichnet, dass das Kunststoffband (5) aus Polyimid und die Metallisierung (6) aus einem Edelmetall, insbesondere Gold, bestehen.3. Implant according to claim 1 or 2, characterized in that the plastic band (5) made of polyimide and the metallization (6) consist of a noble metal, in particular gold.
4. Implantat nach einem der Ansprüche 1 bis 3, dadurch gekennzeichnet, dass das Verkapselungsmaterial der Umhüllung (1) oder das Füllmaterial zwischen den Spulenwindungen (3) aus Silikon besteht.4. Implant according to one of claims 1 to 3, characterized in that the encapsulation material of the sheath (1) or the filling material between the coil turns (3) consists of silicone.
5. Implantat nach einem der Ansprüche 1 bis 3, dadurch gekennzeichnet, dass die Sensoreinrichtung (2) wenigstens einen Drucksensor aufweist.5. Implant according to one of claims 1 to 3, characterized in that the sensor device (2) has at least one pressure sensor.
6. Implantat nach einem der Ansprüche 1 bis 5, dadurch gekennzeichnet, dass die Sensoreinrichtung (2) als Messchip mit Aufbereitungsfunktion zur Telemetrie- übertragung der Messsignale ausgebildet ist. 6. Implant according to one of claims 1 to 5, characterized in that the sensor device (2) is designed as a measuring chip with a processing function for telemetry transmission of the measurement signals.
7. Verwendung einer Vorrichtung nach einem der Ansprüche 1 bis 6 bei der telemetrischen Hirndruckmessung.7. Use of a device according to one of claims 1 to 6 in the telemetric brain pressure measurement.
8. Verwendung einer Vorrichtung nach einem der Ansprüche 1 bis 6 bei der telemetrischen Augeninnendruckmessung. 8. Use of a device according to one of claims 1 to 6 in the telemetric intraocular pressure measurement.
PCT/EP2004/012670 2003-11-14 2004-11-09 Implant for carrying out intracorporal measurements WO2005048835A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP04797744A EP1694205A1 (en) 2003-11-14 2004-11-09 Implant for carrying out intracorporal measurements

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE10353144.0 2003-11-14
DE2003153144 DE10353144A1 (en) 2003-11-14 2003-11-14 Implant for performing intracorpolar measurements

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DE (1) DE10353144A1 (en)
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WO2009146492A1 (en) * 2008-06-03 2009-12-10 Cochlear Limited Expandable structures
EP2182841A1 (en) 2007-08-23 2010-05-12 Purdue Research Foundation Intra-occular pressure sensor
US7931597B2 (en) 2005-11-23 2011-04-26 Vital Sensors Holding Company, Inc. Anchored implantable pressure monitor
US7931598B2 (en) 2005-11-23 2011-04-26 Vital Sensors Holding Company, Inc. Implantable pressure monitor
WO2012137067A2 (en) 2011-04-07 2012-10-11 Oculox Technology Intraocular pressure monitoring device and methods

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EP3463044A4 (en) 2016-05-31 2020-07-29 Qura, Inc. Implantable intraocular pressure sensors and methods of use

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US20020198573A1 (en) * 1999-05-07 2002-12-26 Wilfried Nisch Retina implant assembly and methods for manufacturing the same
DE19945879A1 (en) * 1999-09-24 2001-05-10 Acritec Gmbh Device for measuring physical quantities, in particular for measuring pressure in the eye
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US7931597B2 (en) 2005-11-23 2011-04-26 Vital Sensors Holding Company, Inc. Anchored implantable pressure monitor
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WO2012137067A2 (en) 2011-04-07 2012-10-11 Oculox Technology Intraocular pressure monitoring device and methods

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EP1694205A1 (en) 2006-08-30
DE10353144A1 (en) 2005-06-02

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