EP1762148A1 - Telemetry equipment for communicating with an active system implanted in the thorax of a patient - Google Patents

Telemetry equipment for communicating with an active system implanted in the thorax of a patient Download PDF

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Publication number
EP1762148A1
EP1762148A1 EP06291377A EP06291377A EP1762148A1 EP 1762148 A1 EP1762148 A1 EP 1762148A1 EP 06291377 A EP06291377 A EP 06291377A EP 06291377 A EP06291377 A EP 06291377A EP 1762148 A1 EP1762148 A1 EP 1762148A1
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Prior art keywords
garment
equipment
patient
wave collector
support
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EP06291377A
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German (de)
French (fr)
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EP1762148B1 (en
Inventor
Renzo Dal Molin
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Sorin CRM SAS
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Ela Medical SAS
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    • A—HUMAN NECESSITIES
    • A41—WEARING APPAREL
    • A41D—OUTERWEAR; PROTECTIVE GARMENTS; ACCESSORIES
    • A41D13/00—Professional, industrial or sporting protective garments, e.g. surgeons' gowns or garments protecting against blows or punches
    • A41D13/12—Surgeons' or patients' gowns or dresses
    • A41D13/1236—Patients' garments
    • A41D13/1281—Patients' garments with incorporated means for medical monitoring

Definitions

  • the invention relates to "active implantable medical devices" as defined by Council Directive 90/385 / EC of June 20, 1990.
  • This definition includes cardiac pacemakers, defibrillators, cardiovers and / or multisite devices, but also neurological devices, medical substance delivery pumps, cochlear implants, implanted biological sensors, etc., as well as pH measuring devices. or intracorporeal impedance (such as measurement of transpulmonary impedance or intracardiac impedance).
  • These devices can be placed in a particular configuration intended to ensure data exchange with an external apparatus making it possible to check the parameterization of the implanted device, to read information recorded by the latter, in particular "Holter” type information intended for a given device. after a long period of statistical analysis, or to enter information therein, in particular for purposes of reprogramming or updating the internal software of the implant.
  • Holter type information intended for a given device.
  • the invention is more specifically the case where the exchange of information between the implant and the external equipment is operated by varying the magnetic field produced by an induction coil, a technique known as the "induction method ".
  • the electromagnetic coupling between the implant and the external equipment is thus essentially a magnetic coupling, the wave collector of the implant and that of the external equipment therefore being in the form of homologous coils to be positioned in position. vis-à-vis one another to achieve this coupling.
  • the coupling of the external equipment with the implant is generally performed by the user practitioner of the external equipment, which has a "programming head” or “telemetry head” in the form of a housing containing the winding of the device. external device (programmer) as well as associated electronic circuits, this telemetry head being connected by a cable to the programmer itself.
  • the practitioner moves the telemetry head above the patient's body in the region where the active device has been implanted, until finding the location producing the maximum signal level: this means that the telemetry head is positioned at the right of the implant, position that ensures optimal coupling.
  • the practitioner can then continue the operations and proceed to the exchange of data between implant and programmer, keeping the telemetry head at the position thus found.
  • the implementation of the external device involves the participation of the patient.
  • a problem lies in the need to correctly position the wave collector of the external device relative to the implant, to ensure the optimal coupling between these two elements of the telemetry system. It is not desirable for the patient to seek the optimal position for each interrogation of the implant: in addition to trial and error and the difficulty for an inexperienced person to find the optimal coupling, the patient may have a loss of autonomy. which does not allow him to perform this manipulation himself.
  • the wave collector of the external apparatus is an antenna whose diameter is of the order of 5 cm, which must be centered vis-à-vis the implant, whose collector has a diameter of about 2 cm, and this with an accuracy of the order of one centimeter to ensure a satisfactory coupling.
  • telemetry equipment for communicating with an active device implanted in a region of the thorax of a patient, this equipment comprising a wave collector essentially sensitive to the magnetic field to enable the exchange of inductive signals with the implanted device, and means for connecting the wave collector to an electronic transmitter / receiver and signal processing unit.
  • the equipment comprises a vest-shaped garment adapted to cover at least a portion of the patient's torso, a support for the wave collector, and adjustable means for fixing the support at a location. chosen garment.
  • the equipment thus allows, after initial positioning of the wave collector to the right of the region where the device is implanted, the placement and maintenance of the wave collector in this position each threading of the garment by the patient.
  • the practitioner positions once and for all the telemetry wave collector on the garment looking for the optimal position, and sets the support of the wave collector at this location.
  • the patient will not have to worry about starting again each time this operation, he will then have only the minimum of gestures to carry out, the optimal position being already planned and regulated (the clothing is clean to each patient, as well as adjusting the position of the wave collector).
  • the adjustable means for fixing the support may in particular comprise gripping strips disposed on the support and cooperating with the material on the surface of the garment, or conversely gripping strips disposed on the garment and cooperating with the material on the surface of the support.
  • reference numeral 10 denotes a garment, for example in the form of a vest, worn by the patient 12.
  • the shape of the vest is however not limiting, and other forms of clothing or clothing accessories may be envisaged, such as a chasuble, harness, harness, etc., as long as it is sufficiently easy to put on by the patient and provides a precise and durable positioning of the wave collector.
  • the patient is a patient carrying an active device 14, for example a pacemaker or defibrillator, whose housing ("implant") has been placed in a region of the body whose position may vary quite substantially depending on the surgeon and the patients. Implantation constraints, which can be on the right side as well as on the left side of the patient's body.
  • an external apparatus comprises a coil-shaped waveguide 16, preferably flat and circular, made in printed or wired technology.
  • This coil 16 is fixed to a support 18, for example a piece of fabric slightly larger than the size of the wave collector and provided with fastening means to the garment 18, for example provided with gripping strips 20 which will hold firmly the support 18 at a specific point after finding the optimal coupling position.
  • gripping strips 20 comprise, for example, a multitude of flexible hooks capable of gripping the surface of the textile constituting the garment 10.
  • This method of attachment makes it possible to very finely adjust the position of the wave collector 16 with respect to the implant, with an accuracy of the order of one centimeter. Reduced movements of the patient do not disturb the functioning of the system.
  • the support 18 can be placed indifferently inside or outside the garment 10.
  • a wire 22 connects the wave collector 16 to an electronic box 24 comprising the transmission / reception circuits (including the tuning capacitor of the resonant circuit associated with the coil 16) and processing transmitted and received signals.
  • the garment 10 comprises means for supporting the housing 24, for example an internal or external pocket 26, or any other appropriate means (strap, ).
  • the telemetry equipment may also include an additional coil called "compensation coil" 28, associated with the wave collector 16 and connected to the electronic box 24 by a specific connecting wire 30.
  • This compensation coil is to capture the noise components from external parasitic sources in order to subtract these parasitic components from the signal picked up by the wave collector 16 when extracting the useful signal, thereby improving the signal-to-noise ratio. (more details on the role of these compensation antennas can be found in EP-A-1,481,708 (ELA Medical)). Since the position of the compensation coil 28 relative to the implant 14 is much less critical than that of the wave collector 16, the compensation coil may be incorporated into the garment in a fixed location, preferably approximately central, so that the practitioner and the user do not have to worry about this compensation coil 28.
  • Accurate positioning, with good repeatability, of the wave collector 16 implies that the garment 10 is worn fitted close to the body.
  • various means are provided for adapting this garment to the morphology of the patient, for example elastic regions 32 and / or a strap system and clamping loop 34, or any other means to avoid wearing too loose, detrimental to proper positioning relative to the implant.
  • the material of the garment is chosen so that it can be worn for a long time, without hindering breathing or thermal comfort.
  • the garment is washable after removing the electronic box 24, which does not support immersion.
  • the wave collector 16 and the compensation antenna 28 and their connecting means can be made on the other hand rendered insensitive to immersion, which avoids having to remove them for a wash and keeps the initial positioning without preventing the washing of the garment.
  • the signal-to-noise ratio can be tainted by components of essentially electrical nature transmitted in particular capacitively.
  • the wave collector used which is essentially sensitive to the magnetic field, is also sensitive to the electric field, although to a lesser extent, which has the effect of degrading the signal / noise ratio significantly in certain situations.
  • This non-magnetic conductive material may be a non-ferrous metal material, for example zinc, copper or silver / copper, made either in the form of an insert or by incorporating threads of these materials to the fabric of the textile constituting the garment 10 Carbon can also be used to achieve this shielding, a material that has the advantage of being both very good conductor and totally transparent to the magnetic field.
  • the electronic box 24 includes its own power supply 36, and also makes it possible to connect to sensors 38, 40 capable of supplying the electronic unit with a certain number of information or measurements: tensiometer, ECG device, scale , means of therapeutic compliance of the "electronic pill” type, etc.
  • sensors 38, 40, ... can be connected to the control unit 24 by a wired connection, or advantageously a wireless connection of Bluetooth type .
  • the sensors are ECG sensors, the intervention of competent personnel is necessary to place the electrodes and to implement the specific ECG acquisition box; the data processed by this ECG box are, here again, advantageously transmitted to the control unit 24 by a wireless link.
  • the telemetry data collected locally by the housing 24 are transmitted, as well as other data possibly collected by the sensors 38, 40, ..., to a data communication means, which may advantageously be a mobile telephone 42 connected to the housing 24 by a wired connection or, advantageously, a wireless link for example Bluetooth type (trademark of the Bluetooth SIG).
  • the data can thus be exchanged between a remote site and the housing 24, thus between the site and the implant via the wave collector 16, by any known appropriate data transmission means such as GSM, GPRS, UMTS, etc.
  • the patient is equipped with the garment 10 provided with its accessories, possibly with outside help, depending on its degree of autonomy.
  • the end of transmission can be signaled to the patient by the housing and / or electronic modules that go out. automatically when a preprogrammed time expires. The patient can then remove the garment 10.
  • This operation can be performed daily; it implies a typical communication time of the order of 5 minutes for the transmission of 3 KB by GPRS. It should be noted that this operation, thanks to the GSM / GPRS transmission, is independent of the location of the patient, who can very well be at home or outside. The operation can of course be performed at more spaced intervals, depending on the data to monitor and / or the clinical condition of the patient.
  • the data is collected by the housing 24 for example by Bluetooth short-range radio link .
  • the housing 24 retains these data.
  • the patient may not wear the garment 10, or have not lit the housing 24, which nevertheless remains still in standby waiting for a communication from a sensor.
  • the box When the box is activated by the patient, it triggers the transmission to the remote site, via the mobile phone 42, data that had been stored in memory. After receiving an acknowledgment from the remote site, this data is erased from the memory of the housing 24.

Abstract

The equipment has a wave collector (16) sensitive to a magnetic field to exchange signals via an inductive channel with an active implantable medical device (14). A connection unit (22) connects the collector to a signal processing and transmitting and receiving electronic unit (24). An adjusting unit fixes a wave collector support (18) in a location of a garment (10) such that, after initial positioning of the collector to a right of a thorax region, the collector is positioned and maintained in the former position at each threading of the garment by the patient.

Description

L'invention concerne les "dispositifs médicaux implantables actifs" tels que définis par la Directive 90/385/CE du 20 juin 1990 du Conseil des communautés européennes. Cette définition inclut les stimulateurs cardiaques, défibrillateurs, cardioverteurs et/ou dispositifs multisite, mais aussi les appareils neurologiques, les pompes de diffusion de substances médicales, les implants cochléaires, les capteurs biologiques implantés, etc., ainsi que les dispositifs de mesure de pH ou encore d'impédance intracorporelle (telle que mesure d'impédance transpulmonaire ou d'impédance intracardiaque).The invention relates to "active implantable medical devices" as defined by Council Directive 90/385 / EC of June 20, 1990. This definition includes cardiac pacemakers, defibrillators, cardiovers and / or multisite devices, but also neurological devices, medical substance delivery pumps, cochlear implants, implanted biological sensors, etc., as well as pH measuring devices. or intracorporeal impedance (such as measurement of transpulmonary impedance or intracardiac impedance).

Ces dispositifs peuvent être placés dans une configuration particulière destinée à assurer un échange de données avec un appareillage externe permettant de vérifier le paramétrage du dispositif implanté, de lire des informations enregistrées par celui-ci, notamment des informations de type « Holter » destinées à une analyse statistique a posteriori sur une longue durée, ou encore d'y inscrire des informations, notamment à des fins de reprogrammation ou de mise à jour du logiciel interne de l'implant.These devices can be placed in a particular configuration intended to ensure data exchange with an external apparatus making it possible to check the parameterization of the implanted device, to read information recorded by the latter, in particular "Holter" type information intended for a given device. after a long period of statistical analysis, or to enter information therein, in particular for purposes of reprogramming or updating the internal software of the implant.

L'invention vise plus précisément le cas où l'échange d'informations entre l'implant et l'appareillage externe est opéré en faisant varier le champ magnétique produit par une bobine d'induction, technique connue sous le nom de "procédé par induction". Le couplage électromagnétique entre l'implant et l'appareillage externe est donc essentiellement un couplage magnétique, le collecteur d'ondes de l'implant et celui de l'appareillage externe se présentant donc sous la forme de bobines homologues devant être positionnées en vis-à-vis l'une de l'autre pour réaliser ce couplage.The invention is more specifically the case where the exchange of information between the implant and the external equipment is operated by varying the magnetic field produced by an induction coil, a technique known as the "induction method ". The electromagnetic coupling between the implant and the external equipment is thus essentially a magnetic coupling, the wave collector of the implant and that of the external equipment therefore being in the form of homologous coils to be positioned in position. vis-à-vis one another to achieve this coupling.

Le couplage de l'appareillage externe avec l'implant est généralement réalisé par le praticien utilisateur de l'appareillage externe, qui dispose d'une « tête de programmation » ou « tête de télémétrie » en forme de boîtier contenant le bobinage de l'appareil externe (programmateur) ainsi que des circuits électroniques associés, cette tête de télémétrie étant reliée par un câble au programmateur proprement dit. Le praticien déplace la tête de télémétrie au-dessus du corps du patient dans la région où le dispositif actif a été implanté, jusqu'à trouver l'endroit produisant le niveau de signal maximal : ceci signifie que la tête de télémétrie se trouve positionnée au droit de l'implant, position qui assure le couplage optimal. Le praticien peut alors poursuivre les opérations et procéder à l'échange de données entre implant et programmateur, en maintenant la tête de télémétrie à la position ainsi trouvée.The coupling of the external equipment with the implant is generally performed by the user practitioner of the external equipment, which has a "programming head" or "telemetry head" in the form of a housing containing the winding of the device. external device (programmer) as well as associated electronic circuits, this telemetry head being connected by a cable to the programmer itself. The practitioner moves the telemetry head above the patient's body in the region where the active device has been implanted, until finding the location producing the maximum signal level: this means that the telemetry head is positioned at the right of the implant, position that ensures optimal coupling. The practitioner can then continue the operations and proceed to the exchange of data between implant and programmer, keeping the telemetry head at the position thus found.

La recherche d'un couplage optimal est un facteur important, non seulement pour la qualité et la fiabilité de l'échange de signaux entre implant et appareillage externe, mais également pour réduire la consommation des circuits d'émission de l'implant, et donc accroître la durée de vie de ce dernier : un couplage imparfait requiert en effet une puissance d'émission plus importante, et induit donc une plus forte consommation d'énergie par l'implant.The search for an optimal coupling is an important factor, not only for the quality and the reliability of the signal exchange between implant and external device, but also for reducing the consumption of the emission circuits of the implant, and therefore increase the service life of the latter: imperfect coupling requires a higher transmission power, and therefore induces a higher energy consumption by the implant.

Le mode opératoire que l'on vient de décrire est couramment pratiqué par tous les praticiens lors d'une consultation.The procedure that has just been described is commonly practiced by all practitioners during a consultation.

Il peut être cependant intéressant, notamment grâce aux nouveaux moyens de communication (Internet, GPRS, UMTS, ...) d'assurer un suivi des patients à distance et à domicile, sans intervention d'un praticien. Il peut être également avantageux d'effectuer ce suivi à intervalles réguliers, par exemple avec relevé et télétransmission quotidiens des données vers un serveur distant de télésurveillance, de manière à assurer une surveillance beaucoup plus étroite de l'état de santé du patient, tout en évitant de multiplier les consultations par le praticien.However, it may be interesting, especially thanks to the new means of communication (Internet, GPRS, UMTS, ...) to monitor patients remotely and at home without the intervention of a practitioner. It may also be advantageous to carry out this monitoring at regular intervals, for example with daily reading and transmission of the data to a remote remote monitoring server, in order to ensure a much closer monitoring of the patient's state of health, while avoiding multiple consultations by the practitioner.

Le praticien n'étant pas présent, la mise en oeuvre du dispositif externe implique la participation du patient.The practitioner is not present, the implementation of the external device involves the participation of the patient.

Un problème réside dans la nécessité de positionner correctement le collecteur d'ondes du dispositif externe par rapport à l'implant, afin d'assurer le couplage optimal entre ces deux éléments du système de télémétrie. Il n'est pas souhaitable que le patient cherche lui-même la position optimale à chaque interrogation de l'implant : outre les tâtonnements et la difficulté pour une personne non expérimentée à trouver le couplage optimal, le patient peut présenter une perte d'autonomie qui ne lui permet pas d'exécuter lui-même cette manipulation.A problem lies in the need to correctly position the wave collector of the external device relative to the implant, to ensure the optimal coupling between these two elements of the telemetry system. It is not desirable for the patient to seek the optimal position for each interrogation of the implant: in addition to trial and error and the difficulty for an inexperienced person to find the optimal coupling, the patient may have a loss of autonomy. which does not allow him to perform this manipulation himself.

On notera que la recherche d'un couplage optimal est une opération relativement délicate pour une personne non expérimentée : le collecteur d'ondes de l'appareillage externe est une antenne dont le diamètre est de l'ordre de 5 cm, qui doit être centrée en vis-à-vis de l'implant, dont le collecteur présente un diamètre de l'ordre de 2 cm, et ceci avec une précision de l'ordre du centimètre pour assurer un couplage satisfaisant.It should be noted that the search for an optimal coupling is a relatively delicate operation for an inexperienced person: the wave collector of the external apparatus is an antenna whose diameter is of the order of 5 cm, which must be centered vis-à-vis the implant, whose collector has a diameter of about 2 cm, and this with an accuracy of the order of one centimeter to ensure a satisfactory coupling.

De plus, ce positionnement précis doit être maintenu pendant toute la durée de l'opération (l'interrogation d'un implant peut durer plusieurs minutes), un défaut de couplage risquant d'entraîner une perte d'informations obligeant à réitérer certaines séquences d'interrogation.In addition, this precise positioning must be maintained throughout the duration of the operation (the interrogation of an implant may last several minutes), a coupling fault may result in a loss of information requiring the reiteration of certain sequences. interrogation.

Ce problème résolu, selon l'invention, par un équipement de télémétrie pour communiquer avec un dispositif actif implanté dans une région du thorax d'un patient, cet équipement comprenant un collecteur d'ondes essentiellement sensible au champ magnétique pour permettre l'échange de signaux par voie inductive avec le dispositif implanté, et des moyens de liaison du collecteur d'ondes à un boîtier électronique d'émission/réception et de traitement des signaux.This problem solved, according to the invention, by telemetry equipment for communicating with an active device implanted in a region of the thorax of a patient, this equipment comprising a wave collector essentially sensitive to the magnetic field to enable the exchange of inductive signals with the implanted device, and means for connecting the wave collector to an electronic transmitter / receiver and signal processing unit.

De façon caractéristique de l'invention, l'équipement comprend un vêtement en forme de gilet, apte à couvrir au moins une partie du torse du patient, un support du collecteur d'ondes, et des moyens ajustables de fixation du support en un emplacement choisi du vêtement.Characteristically, the equipment comprises a vest-shaped garment adapted to cover at least a portion of the patient's torso, a support for the wave collector, and adjustable means for fixing the support at a location. chosen garment.

L'équipement permet ainsi, après positionnement initial du collecteur d'ondes au droit de la région où le dispositif est implanté, le placement et le maintien du collecteur d'ondes en cette position à chaque enfilage du vêtement par le patient.The equipment thus allows, after initial positioning of the wave collector to the right of the region where the device is implanted, the placement and maintenance of the wave collector in this position each threading of the garment by the patient.

De la sorte, le praticien positionne une fois pour toutes le collecteur d'ondes de télémétrie sur le vêtement en recherchant la position optimale, et fixe le support du collecteur d'ondes en cet emplacement. Le patient n'aura pas à se préoccuper de recommencer à chaque fois cette opération, il n'aura ensuite que le minimum de gestes à effectuer, la position optimale étant déjà prévue et réglée (le vêtement est propre à chaque patient, de même que le réglage de la position du collecteur d'ondes).In this way, the practitioner positions once and for all the telemetry wave collector on the garment looking for the optimal position, and sets the support of the wave collector at this location. The patient will not have to worry about starting again each time this operation, he will then have only the minimum of gestures to carry out, the optimal position being already planned and regulated (the clothing is clean to each patient, as well as adjusting the position of the wave collector).

On connaît certes des vêtements incorporant des antennes : voir par exemple les US-A-6 590 540 , US-A-6 483 469 ou US-A-6 680 707 .We certainly know clothes incorporating antennas: see for example the US-A-6,590,540 , US-A-6,483,469 or US-A-6,680,707 .

Il s'agit néanmoins d'antennes radiofréquence pour communiquer avec un équipement distinct, par exemple avec un émetteur de radiodiffusion ou une station de base de radiocommunication. Dans la mesure où il ne s'agit pas de télémétrie mettant en oeuvre un procédé par induction, le positionnement précis de l'antenne sur le corps n'est pas déterminant. Ces documents n'abordent donc pas le problème spécifique de la présente invention, tenant à la proximité très étroite entre les collecteurs d'ondes respectifs de l'implant et de l'appareillage externe.However, these are radiofrequency antennas for communicating with separate equipment, for example with a broadcasting transmitter or a radio base station. Insofar as it is not a question of telemetry using an induction method, the precise positioning of the antenna on the body is not decisive. These documents do not address the specific problem of the present invention, due to the very close proximity between the respective wave collectors of the implant and the external equipment.

Les moyens ajustables de fixation du support peuvent notamment comprendre des bandes agrippantes disposées sur le support et coopérant avec la matière en surface du vêtement, ou inversement des bandes agrippantes disposées sur le vêtement et coopérant avec la matière en surface du support.The adjustable means for fixing the support may in particular comprise gripping strips disposed on the support and cooperating with the material on the surface of the garment, or conversely gripping strips disposed on the garment and cooperating with the material on the surface of the support.

Selon diverses caractéristiques subsidiaires avantageuses, le vêtement comprend :

  • des moyens pour supporter et loger le boîtier électronique d'émission/réception et de traitement des signaux ;
  • des moyens d'adaptation à la morphologie du patient, de manière à permettre après adaptation un port ajusté du vêtement, par exemple des régions élastiques et/ou des moyens de réglage dimensionnel du vêtement ;
  • des moyens pour loger au moins un capteur de données physiologiques ou thérapeutiques, ainsi que des moyens de liaison de ce(s) capteur(s) au boîtier électronique d'émission/réception et de traitement des signaux ;
  • une bobine de compensation associée au collecteur d'ondes, qui peut être disposée en un emplacement fixe prédéterminé du vêtement ;
  • au moins une surface de blindage à l'encontre de champs électriques parasites, cette surface de blindage étant en un matériau conducteur amagnétique essentiellement transparent au champ magnétique dans le domaine des fréquences utilisées pour ledit échange des signaux par voie inductive.
According to various advantageous subsidiary characteristics, the garment comprises:
  • means for supporting and housing the electronic transmitter / receiver and signal processing unit;
  • means for adapting to the morphology of the patient, so as to allow, after adaptation, an adjusted wearing of the garment, for example elastic regions and / or dimensional adjustment means of the garment;
  • means for housing at least one physiological or therapeutic data sensor, as well as means for connecting this sensor (s) to the electronic transmission / reception and signal processing unit;
  • a compensation coil associated with the wave collector, which may be disposed at a predetermined fixed location of the garment;
  • at least one shielding surface against parasitic electric fields, said shielding surface being of a non-magnetic conductive material substantially transparent to the magnetic field in the frequency range used for said inductive signal exchange.

On va maintenant décrire un exemple de mise en oeuvre du dispositif de l'invention, en référence aux dessins annexés où les mêmes références désignent d'une figure à l'autre des éléments identiques ou fonctionnellement semblables.

  • La figure 1 montre l'équipement de télémétrie de l'invention, avec le vêtement équipé de ses divers éléments associés.
  • La figure 2 est un schéma par blocs montrant les différents organes électroniques mis en oeuvre par cet équipement.
An embodiment of the device of the invention will now be described with reference to the appended drawings in which the same references designate identical or functionally similar elements from one figure to another.
  • Figure 1 shows the telemetry equipment of the invention, with the garment equipped with its various associated elements.
  • Figure 2 is a block diagram showing the various electronic devices implemented by this equipment.

Sur la figure 1, la référence 10 désigne un vêtement, par exemple en forme de gilet, porté par le patient 12. La forme de gilet n'est cependant pas limitative, et d'autres formes de vêtement ou accessoire vestimentaire peuvent être envisagées, tels que chasuble, harnais, baudrier, etc., dès lors qu'il est suffisamment facile à enfiler par le patient et procure un positionnement précis et durable du collecteur d'ondes.In FIG. 1, reference numeral 10 denotes a garment, for example in the form of a vest, worn by the patient 12. The shape of the vest is however not limiting, and other forms of clothing or clothing accessories may be envisaged, such as a chasuble, harness, harness, etc., as long as it is sufficiently easy to put on by the patient and provides a precise and durable positioning of the wave collector.

Le patient est un patient porteur d'un dispositif actif 14, par exemple un stimulateur cardiaque ou défibrillateur, dont le boîtier (« implant ») a été placé en une région du corps dont la position peut varier assez sensiblement en fonction du chirurgien et des contraintes d'implantation, et qui peut se trouver aussi bien du côté droit que du côté gauche du corps du patient.The patient is a patient carrying an active device 14, for example a pacemaker or defibrillator, whose housing ("implant") has been placed in a region of the body whose position may vary quite substantially depending on the surgeon and the patients. Implantation constraints, which can be on the right side as well as on the left side of the patient's body.

Pour permettre l'interrogation de cet implant 14, un appareillage externe comprend un collecteur d'ondes 16 en forme de bobine, de préférence plate et circulaire, réalisée en technologie imprimée ou filaire. Cette bobine 16 est fixée à un support 18, par exemple une pièce de tissu de dimension légèrement supérieure à celle du collecteur d'ondes et pourvue de moyens de fixation au vêtement 18, par exemple pourvue de bandes agrippantes 20 qui permettront de maintenir fermement le support 18 en un point précis après avoir trouvé la position de couplage optimale. Ces bandes agrippantes 20 comprennent par exemple une multitude de crochets souples susceptibles de s'agripper à la surface du textile constituant le vêtement 10.To allow interrogation of this implant 14, an external apparatus comprises a coil-shaped waveguide 16, preferably flat and circular, made in printed or wired technology. This coil 16 is fixed to a support 18, for example a piece of fabric slightly larger than the size of the wave collector and provided with fastening means to the garment 18, for example provided with gripping strips 20 which will hold firmly the support 18 at a specific point after finding the optimal coupling position. These gripping strips 20 comprise, for example, a multitude of flexible hooks capable of gripping the surface of the textile constituting the garment 10.

Ce mode de fixation permet d'ajuster de manière très fine la position du collecteur d'ondes 16 par rapport à l'implant, avec une précision de l'ordre du centimètre. Des mouvements réduits du patient ne perturbent pas le fonctionnement du système.This method of attachment makes it possible to very finely adjust the position of the wave collector 16 with respect to the implant, with an accuracy of the order of one centimeter. Reduced movements of the patient do not disturb the functioning of the system.

Le support 18 peut être placé indifféremment à l'intérieur ou à l'extérieur du vêtement 10.The support 18 can be placed indifferently inside or outside the garment 10.

Un fil 22 relie le collecteur d'ondes 16 à un boîtier électronique 24 comprenant les circuits d'émission/réception (y compris le condensateur d'accord du circuit résonnant associé à la bobine 16) et de traitement des signaux émis et reçus. Avantageusement, le vêtement 10 comporte des moyens pour supporter ce boîtier 24, par exemple une poche 26 interne ou externe, ou tout autre moyen approprié (sangle, ...).A wire 22 connects the wave collector 16 to an electronic box 24 comprising the transmission / reception circuits (including the tuning capacitor of the resonant circuit associated with the coil 16) and processing transmitted and received signals. Advantageously, the garment 10 comprises means for supporting the housing 24, for example an internal or external pocket 26, or any other appropriate means (strap, ...).

L'équipement de télémétrie peut également comprendre une bobine additionnelle dite « bobine de compensation » 28, associée au collecteur d'ondes 16 et reliée au boîtier électronique 24 par un fil de liaison spécifique 30. Le rôle de cette bobine de compensation est de capter les composantes de bruit en provenance de sources parasites externes afin de soustraire ces composantes parasites du signal capté par le collecteur d'ondes 16 au moment d'en extraire le signal utile, améliorant ainsi le rapport signal/bruit. (on pourra trouver de plus amples détails sur le rôle de ces antennes de compensation dans le EP-A-1 481 708 (ELA Medical)). La position de la bobine de compensation 28 par rapport à l'implant 14 étant beaucoup moins critique que celle du collecteur d'ondes 16, la bobine de compensation pourra être incorporée au vêtement en un emplacement fixe, de préférence approximativement central, de manière que le praticien et l'utilisateur n'aient pas à se soucier de cette bobine de compensation 28.The telemetry equipment may also include an additional coil called "compensation coil" 28, associated with the wave collector 16 and connected to the electronic box 24 by a specific connecting wire 30. The role of this compensation coil is to capture the noise components from external parasitic sources in order to subtract these parasitic components from the signal picked up by the wave collector 16 when extracting the useful signal, thereby improving the signal-to-noise ratio. (more details on the role of these compensation antennas can be found in EP-A-1,481,708 (ELA Medical)). Since the position of the compensation coil 28 relative to the implant 14 is much less critical than that of the wave collector 16, the compensation coil may be incorporated into the garment in a fixed location, preferably approximately central, so that the practitioner and the user do not have to worry about this compensation coil 28.

Un positionnement précis, avec une bonne répétabilité, du collecteur d'ondes 16 implique que le vêtement 10 soit porté ajusté, près du corps. A cet effet, divers moyens sont prévus pour adapter ce vêtement à la morphologie du patient, par exemple des régions élastiques 32 et/ou un système de sangle et boucle de serrage 34, ou tout autre moyen permettant d'éviter un port trop lâche, préjudiciable à un bon positionnement par rapport à l'implant.Accurate positioning, with good repeatability, of the wave collector 16 implies that the garment 10 is worn fitted close to the body. For this purpose, various means are provided for adapting this garment to the morphology of the patient, for example elastic regions 32 and / or a strap system and clamping loop 34, or any other means to avoid wearing too loose, detrimental to proper positioning relative to the implant.

De la sorte, le réglage de la position du collecteur d'ondes sera retrouvé sans difficulté lors de chaque enfilage du vêtement.In this way, the adjustment of the position of the wave collector will be found without difficulty during each threading of the garment.

Le matériau du vêtement est choisi pour que celui-ci puisse être porté pendant une longue durée, sans gêne à la respiration ni au confort thermique.The material of the garment is chosen so that it can be worn for a long time, without hindering breathing or thermal comfort.

Le vêtement est lavable après avoir retiré le boîtier électronique 24, qui ne supporte pas l'immersion. Le collecteur d'ondes 16 et l'antenne de compensation 28 ainsi que leurs moyens de liaison peuvent être en revanche rendus insensibles à l'immersion, ce qui évite d'avoir à les retirer pour un lavage et permet de conserver le positionnement initial sans empêcher le lavage du vêtement.The garment is washable after removing the electronic box 24, which does not support immersion. The wave collector 16 and the compensation antenna 28 and their connecting means can be made on the other hand rendered insensitive to immersion, which avoids having to remove them for a wash and keeps the initial positioning without preventing the washing of the garment.

Par ailleurs, outre les perturbations de nature magnétique (inductions parasites) qui peuvent être efficacement éliminées grâce à la bobine de compensation 28, le rapport signal/bruit peut être entaché par des composantes de nature essentiellement électrique transmises en particulier par voie capacitive. Le collecteur d'ondes utilisé, qui est essentiellement sensible au champ magnétique, l'est également au champ électrique, bien qu'à un moindre degré, ce qui a pour effet de dégrader le rapport signal/bruit de manière sensible dans certaines situations.Furthermore, in addition to magnetic disturbances (parasitic inductions) which can be effectively eliminated by the compensation coil 28, the signal-to-noise ratio can be tainted by components of essentially electrical nature transmitted in particular capacitively. The wave collector used, which is essentially sensitive to the magnetic field, is also sensitive to the electric field, although to a lesser extent, which has the effect of degrading the signal / noise ratio significantly in certain situations.

Il est possible pour pallier ce phénomène de prévoir sur le vêtement 10 des surfaces de blindage à l'encontre des champs électriques parasites, par exemple des surfaces en un matériau conducteur amagnétique, essentiellement transparent au champ magnétique dans le domaine des fréquences utilisées pour la télémétrie (typiquement quelques dizaines de kilohertz) et essentiellement opaque au champ électrique dans le domaine des fréquences où se situent des parasites susceptibles de perturber le fonctionnement du programmateur (typiquement quelques kilohertz à quelques mégahertz). Ce matériau conducteur amagnétique peut être un matériau métallique non ferreux, par exemple zinc, cuivre ou argent/cuivre, réalisé soit sous la forme d'un élément rapporté, soit en incorporant des fils de ces matériaux à la trame du textile constituant le vêtement 10. Le carbone peut également être utilisé pour réaliser ce blindage, matériau qui présente l'avantage d'être à la fois très bon conducteur et totalement transparent au champ magnétique.It is possible to overcome this phenomenon of providing on the garment 10 shielding surfaces against parasitic electric fields, for example surfaces made of a nonmagnetic conductive material, essentially transparent to the magnetic field in the range of frequencies used for telemetry (typically a few tens of kilohertz) and essentially opaque to the electric field in the frequency range where are located parasites likely to disturb the operation of the programmer (typically a few kilohertz a few megahertz). This non-magnetic conductive material may be a non-ferrous metal material, for example zinc, copper or silver / copper, made either in the form of an insert or by incorporating threads of these materials to the fabric of the textile constituting the garment 10 Carbon can also be used to achieve this shielding, a material that has the advantage of being both very good conductor and totally transparent to the magnetic field.

Comme illustré figure 2, le boîtier électronique 24 inclut sa propre alimentation électrique 36, et permet également le raccordement à des capteurs 38, 40 susceptibles de fournir au boîtier électronique un certain nombre d'informations ou mesures : tensiomètre, dispositif ECG, pèse-personne, moyen d'observance thérapeutique du type « pilulier électronique », etc. Ces capteurs 38, 40, ... peuvent être reliés au boîtier électronique 24 par une liaison filaire, ou bien avantageusement une liaison sans fil de type Bluetooth. Dans le cas particulier où les capteurs sont des capteurs ECG, l'intervention d'un personnel compétent est nécessaire pour poser les électrodes et mettre en oeuvre le boîtier d'acquisition ECG spécifique ; les données traitées par ce boîtier ECG sont, ici encore, avantageusement transmises au boîtier électronique 24 par une liaison sans fil.As illustrated in FIG. 2, the electronic box 24 includes its own power supply 36, and also makes it possible to connect to sensors 38, 40 capable of supplying the electronic unit with a certain number of information or measurements: tensiometer, ECG device, scale , means of therapeutic compliance of the "electronic pill" type, etc. These sensors 38, 40, ... can be connected to the control unit 24 by a wired connection, or advantageously a wireless connection of Bluetooth type . In the particular case where the sensors are ECG sensors, the intervention of competent personnel is necessary to place the electrodes and to implement the specific ECG acquisition box; the data processed by this ECG box are, here again, advantageously transmitted to the control unit 24 by a wireless link.

Les données de télémétrie collectées localement par le boîtier 24 sont transmises, ainsi que d'autres données éventuellement recueillies par les capteurs 38, 40, ..., à un moyen de communication de données, qui peut être avantageusement un téléphone mobile 42 relié au boîtier 24 par une liaison filaire ou, avantageusement, une liaison sans fil par exemple de type Bluetooth (marque déposée du SIG Bluetooth). Les données pourront être ainsi échangées entre un site distant et le boîtier 24, donc entre le site et l'implant via le collecteur d'ondes 16, par tout moyen de transmission de données approprié connu tel que GSM, GPRS, UMTS ...The telemetry data collected locally by the housing 24 are transmitted, as well as other data possibly collected by the sensors 38, 40, ..., to a data communication means, which may advantageously be a mobile telephone 42 connected to the housing 24 by a wired connection or, advantageously, a wireless link for example Bluetooth type (trademark of the Bluetooth SIG). The data can thus be exchanged between a remote site and the housing 24, thus between the site and the implant via the wave collector 16, by any known appropriate data transmission means such as GSM, GPRS, UMTS, etc.

Le mode opératoire de ce vêtement, équipé de ses différents accessoires, est le suivant.The procedure of this garment, equipped with its various accessories, is as follows.

À la demande du médecin ou d'un personnel soignant, ou spontanément à un horaire convenu, le patient s'équipe du vêtement 10 pourvu de ses accessoires, éventuellement avec une aide extérieure, selon son degré d'autonomie.At the request of the doctor or a caregiver, or spontaneously at an agreed time, the patient is equipped with the garment 10 provided with its accessories, possibly with outside help, depending on its degree of autonomy.

Il déclenche alors le téléchargement des données en allumant le boîtier électronique 24, qui établit la communication avec le site distant via le téléphone mobile 42. La fin de transmission peut être signalée au patient par le boîtier et/ou des modules électroniques qui s'éteignent automatiquement à l'expiration d'une durée préprogrammée. Le patient peut alors retirer le vêtement 10.It then triggers the downloading of the data by switching on the electronic control unit 24, which establishes the communication with the remote site via the mobile phone 42. The end of transmission can be signaled to the patient by the housing and / or electronic modules that go out. automatically when a preprogrammed time expires. The patient can then remove the garment 10.

Cette opération peut être réalisée quotidiennement ; elle implique une durée de communication typique de l'ordre de 5 minutes pour la transmission de 3 Ko par GPRS. On notera que cette opération, grâce à la transmission par GSM/GPRS, est indépendante de la localisation du patient, qui peut très bien se trouver à son domicile ou en dehors. L'opération peut bien entendu être réalisée à intervalles plus espacés, en fonction des données à surveiller et/ou de l'état clinique du patient.This operation can be performed daily; it implies a typical communication time of the order of 5 minutes for the transmission of 3 KB by GPRS. It should be noted that this operation, thanks to the GSM / GPRS transmission, is independent of the location of the patient, who can very well be at home or outside. The operation can of course be performed at more spaced intervals, depending on the data to monitor and / or the clinical condition of the patient.

Dans le cas où le boîtier 24 est relié à des capteurs tels que 38, 40, ... les données sont recueillies par le boîtier 24 par exemple par liaison radio de courte portée de type Bluetooth. Entre deux sessions de connexion au site distant, le boîtier 24 conserve ces données. Dans cette phase, le patient peut ne pas porter le vêtement 10, ou ne pas avoir allumé le boîtier 24, qui reste néanmoins toujours en veille en attente d'une communication émanant d'un capteur. Lorsque le boîtier est activé par le patient, celui-ci déclenche la transmission vers le site distant, via le téléphone mobile 42, des données qui avaient été conservées en mémoire. Après réception d'un acquittement en provenance du site distant, ces données sont effacées de la mémoire du boîtier 24.In the case where the housing 24 is connected to sensors such as 38, 40, ... the data is collected by the housing 24 for example by Bluetooth short-range radio link . Between two login sessions at remote site, the housing 24 retains these data. In this phase, the patient may not wear the garment 10, or have not lit the housing 24, which nevertheless remains still in standby waiting for a communication from a sensor. When the box is activated by the patient, it triggers the transmission to the remote site, via the mobile phone 42, data that had been stored in memory. After receiving an acknowledgment from the remote site, this data is erased from the memory of the housing 24.

Claims (10)

Un équipement de télémétrie pour communiquer avec un dispositif actif implanté dans une région du thorax d'un patient, tel qu'un dispositif de stimulation, resynchronisation, défibrillation et/ou cardioversion ou un dispositif à visée diagnostique,
cet équipement de télémétrie comprenant : - un collecteur d'ondes (16) essentiellement sensible au champ magnétique pour permettre l'échange de signaux par voie inductive avec le dispositif implanté (14), et - des moyens (22) de liaison du collecteur d'ondes à un boîtier électronique (24) d'émission/réception et de traitement des signaux, équipement caractérisé en ce qu'il comprend : - un vêtement (10) en forme de gilet, apte à couvrir au moins une partie du torse du patient, - un support (18) du collecteur d'ondes, et - des moyens ajustables de fixation du support en un emplacement choisi du vêtement, de manière à permettre, après positionnement initial du collecteur d'ondes au droit de la région où le dispositif est implanté, le placement et le maintien du collecteur d'ondes en cette position à chaque enfilage du vêtement par le patient.Telemetry equipment for communicating with an active device implanted in a region of a patient's thorax, such as a device for stimulation, resynchronization, defibrillation and / or cardioversion or a device for diagnostic purposes,
this telemetry equipment including: a wave collector (16) substantially sensitive to the magnetic field for enabling inductive signal exchange with the implanted device (14), and means (22) for connecting the wave collector to an electronic box (24) for transmitting / receiving and processing the signals, equipment characterized in that it comprises: a garment (10) in the form of a vest, able to cover at least a portion of the patient's torso, a support (18) of the wave collector, and - Adjustable means for fixing the support at a chosen location of the garment, so as to allow, after initial positioning of the wave collector to the right of the region where the device is implanted, the placement and maintenance of the wave collector in this position each threading of the garment by the patient. L'équipement de la revendication 1, où les moyens ajustables de fixation du support comprennent des bandes agrippantes (20) disposées sur le support (18) et coopérant avec la matière en surface du vêtement, ou inversement des bandes agrippantes disposées sur le vêtement et coopérant avec la matière en surface du support.The equipment of claim 1, wherein the adjustable means for fixing the support comprise gripping strips (20) disposed on the support (18) and cooperating with the surface material of the garment, or conversely gripping strips disposed on the garment and cooperating with the surface material of the support. L'équipement de la revendication 1, où le vêtement comprend en outre des moyens (26) pour supporter et loger ledit boîtier électronique d'émission/réception et de traitement des signaux.The equipment of claim 1, wherein the garment further comprises means (26) for supporting and housing said transmit / receive and signal processing electronics. L'équipement de la revendication 1, où le vêtement comprend en outre des moyens d'adaptation à la morphologie du patient, de manière à permettre après adaptation un port ajusté du vêtement.The equipment of claim 1, wherein the garment further comprises means for adapting to the morphology of the patient, so as to allow after adjustment an adjusted wearing of the garment. L'équipement de la revendication 4, où les moyens d'adaptation à la morphologie du patient comprennent des régions élastiques (32) du vêtement.The equipment of claim 4, wherein the means for adapting to the morphology of the patient comprises elastic regions (32) of the garment. L'équipement de la revendication 4, où les moyens d'adaptation à la morphologie du patient comprennent des moyens de réglage dimensionnel (34) du vêtement.The equipment of claim 4, wherein the means for adapting to the morphology of the patient comprises dimensional adjustment means (34) of the garment. L'équipement de la revendication 1, où le vêtement comprend en outre des moyens pour loger au moins un capteur (38, 40) de données physiologiques ou thérapeutiques, ainsi que des moyens de liaison de ce(s) capteur(s) au boîtier électronique (24) d'émission/réception et de traitement des signaux.The equipment of claim 1, wherein the garment further comprises means for housing at least one sensor (38, 40) of physiological or therapeutic data, and means for connecting the sensor (s) to the housing electronic (24) transmission / reception and signal processing. L'équipement de la revendication 1, où le vêtement comprend en outre une bobine de compensation (28) associée au collecteur d'ondes (16).The equipment of claim 1, wherein the garment further comprises a compensation coil (28) associated with the wave collector (16). L'équipement de la revendication 8, où la bobine de compensation est disposée en un emplacement fixe prédéterminé du vêtement.The equipment of claim 8, wherein the compensation coil is disposed at a predetermined fixed location of the garment. L'équipement de la revendication 1, où le vêtement comprend en outre au moins une surface de blindage à l'encontre de champs électriques parasites, cette surface de blindage étant en un matériau conducteur amagnétique essentiellement transparent au champ magnétique dans le domaine des fréquences utilisées pour ledit échange des signaux par voie inductive.The equipment of claim 1, wherein the garment further comprises at least one shielding surface against parasitic electric fields, said shielding surface being of a non-magnetic conductive material substantially transparent to the magnetic field in the frequency range used for said inductive signal exchange.
EP06291377A 2005-09-01 2006-08-31 Telemetry equipment for communicating with an active system implanted in the thorax of a patient Active EP1762148B1 (en)

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FR0508944A FR2889917A1 (en) 2005-09-01 2005-09-01 Telemetry equipment for use with e.g. cardiac simulator, has adjusting unit fixing collector support in location of garment such that collector is positioned and maintained in one position at each threading of garment by patient

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US8214044B2 (en) 2012-07-03
DE602006001909D1 (en) 2008-09-04
ATE401804T1 (en) 2008-08-15
EP1762148B1 (en) 2008-07-23
US20070123948A1 (en) 2007-05-31
FR2889917A1 (en) 2007-03-02

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