WO2003068061A1 - Device that is used for delivering and/or intracorporeal sampling of substances - Google Patents

Device that is used for delivering and/or intracorporeal sampling of substances Download PDF

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Publication number
WO2003068061A1
WO2003068061A1 PCT/FR2003/000437 FR0300437W WO03068061A1 WO 2003068061 A1 WO2003068061 A1 WO 2003068061A1 FR 0300437 W FR0300437 W FR 0300437W WO 03068061 A1 WO03068061 A1 WO 03068061A1
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WO
WIPO (PCT)
Prior art keywords
substances
intracorporeal
delivery
sampling
capsule
Prior art date
Application number
PCT/FR2003/000437
Other languages
French (fr)
Inventor
Roland Duffait
Bernard Rognon
Alain Lambert
Jean-Jacques Baertschi
Original Assignee
C.T.M. (Centre De Transfert Des Microtechniques)
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 C.T.M. (Centre De Transfert Des Microtechniques) filed Critical C.T.M. (Centre De Transfert Des Microtechniques)
Priority to AU2003226877A priority Critical patent/AU2003226877A1/en
Publication of WO2003068061A1 publication Critical patent/WO2003068061A1/en

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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
    • A61B5/0002—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
    • A61B5/07—Endoradiosondes
    • A61B5/073—Intestinal transmitters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • A61M31/002—Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time

Definitions

  • the present invention relates to a device for delivering substances and intracorporeal sampling by ingestion of a capsule. It applies in particular, but not exclusively, to the delivery of drugs and the removal of intestinal contents using an intestinal exploration capsule.
  • a capsule intended for dropping substances, for taking samples and for physical and / or chemical type measurements, is called an intestinal exploration capsule.
  • This capsule made of specific material and from high technology, is unmanageable and disposable, which makes its operating cost particularly high. It conventionally comprises different compartments: a compartment for the energy reserve, a compartment comprising the electronic management and processing of data as well as a transmission device, generally by radio, as well as a compartment reserved for the carrying out predetermined functions, such as dropping substances, for example drugs, or intracorporeal sampling.
  • a certain number of sensors allow the capsule to deliver in real time a certain amount of information on its environment.
  • patent application WO 9221307 is already known, which describes a capsule which can be administered orally.
  • This indigestible capsule contains an electrical energy transmitter, a radio signal transmitter, a drug storage device and a remote drug delivery device.
  • the capsule sends signals to a receiver, located at a distance from the capsule, as it passes through the digestive tract following a path defined by the intestine, and when it reaches a specific site, an operator, or an automatic control system, activates it so that it releases a dose of drug.
  • a miniature capsule used for administering medicaments.
  • This capsule comprises one or more aggregates of semiconductors in the form of a ball ensuring the release of a medicament stored in a reservoir.
  • a first aggregate is used for detection and memory functions, while a second aggregate is used for control aspects, such as pumping and dispensing of the drug.
  • This system can communicate with a remote control system, or operate independently over a long period of time using local power for drug administration based on patient demand.
  • the device according to the invention makes it possible to carry out one or more deliveries of substances as well as one or more intracorporeal samples.
  • the invention therefore aims to remedy the drawbacks of the systems of the prior art by providing a device performing the same operations but at a much lower cost because it allows their repetitions during the same exploration or the same transfer , and to guarantee perfect safety for the patient thanks in particular to perfectly reliable operation.
  • a device for the delivery of substances and the intracorporeal sampling by ingestion in particular intended for the intestine of a patient or an animal, of a capsule formed by a body comprising a source of energy, a transceiver, means for physical measurement of the environment as well as of the position of said body, a module for delivering substances and / or a module for taking samples, all of which are controlled by control means characterized in that the means for deliverance of substances and of withdrawal consist of a plurality of rigid sealed reservoirs, each comprising an ejection or injection means and a sealed closure means capable, after the release or aspiration of a substance, of automatically closing The reservoir.
  • the device according to the invention may further comprise display means capable of displaying and / or storing images or data by optical means.
  • the sealing means will consist of a plug, of shape and diameter adapted to the opening of a reservoir, kept closed by an elastic band while the ejection means will consist of a piston actuated by a mechanical and / or electrical mechanism, for example a cam device actuated by the geared motor module.
  • the ejection means will consist of a piston, or an elastic membrane, actuated by a mechanical and / or electrical mechanism, for example a cam device actuated by the geared motor module.
  • the closure means can recover, when it returns to close the reservoir, part of the intestinal contents, for example thanks to its particular shape, so that the device operates an intestinal sampling in this way.
  • the reservoirs will be able to be placed in depression relative to the pressure external to the capsule and the body will then comprise at least one orifice which can be closed in leaktight manner opening into at least one tanks of so that the intestinal contents are sucked into said reservoirs
  • the device according to the invention will comprise an external control means, for example a conventional computer, as well as a means of communication with said capsule, located remotely.
  • the external control means may also include storage means for storing all of the information collected by the measurement means and / or the display means.
  • the means for measuring the position will consist of a toothed wheel comprising at least one magnet distributed, or located, on the teeth of the wheel.
  • the device according to the invention will comprise at least one Reed relay, the magnets of the toothed wheel causing it to close; each pulse, corresponding to a closure, equivalent to a distance predetermined by the construction of said wheel so that the distance is immediately calculated by recording the number of pulses from the Reed relay.
  • Figure 1 is a block diagram showing the different elements constituting the device for the delivery of substances and intracorporeal sampling by ingestion according to the invention
  • FIG. 2 is a perspective side view of the device according to the invention
  • FIG. 3 illustrates a plurality of reservoirs containing pulverulent substances
  • Figure 4 schematically illustrates the ejection systems of said substance fitted to each of the tanks shown in Figure 3;
  • FIG. 5 is a schematic view of the system for triggering the removal of intestinal contents according to the invention.
  • FIG. 6 illustrates the various elements constituting the device according to the invention in the case of sampling.
  • the capsule 1 consists of the following elements: a basic module 2, comprising all the electronics common to all the functions: transceiver, microprocessor, sensors for measuring the characteristics physical environment of the capsule and its location, connection interface, a compartment 3 for the energy source, constituted for example by one or more batteries, - functional modules 4, 5, and 6 such as the delivery of substances 4, sampling and biopsy 5 as well as for imaging via visualization means 6.
  • a basic module 2 comprising all the electronics common to all the functions: transceiver, microprocessor, sensors for measuring the characteristics physical environment of the capsule and its location, connection interface, a compartment 3 for the energy source, constituted for example by one or more batteries, - functional modules 4, 5, and 6 such as the delivery of substances 4, sampling and biopsy 5 as well as for imaging via visualization means 6.
  • the device for delivering substances and intracorporeal sampling by ingestion also requires external installations, located at a distance from the body of the patient or the animal in which the capsule 1 is located, in order to obtain perfect control. of capsule 1.
  • these installations include means of communication with said capsule 1 serving for the transmission of orders and data, connected to a control means by wire connection, for example via an RS 232 bus.
  • the control means serves to provide the operator-capsule interface for all orders, in particularly the delivery of substances and / or the collection, as well as for all processing operations, data storage and presentation of results.
  • the operator-capsule communication environment conventionally comprises a transceiver for the transmission of data, information and orders and a PC-type computer for processing, presenting the data and the indications concerning handling, storage and printing of results.
  • the device according to the invention will also be able to function autonomously, thanks to its energy source (s) and to its position sensor (s) 7.
  • the capsule will be programmed beforehand to carry out measurements, releases of substances and / or samples, either continuously or according to a predetermined duration or for example each time a certain distance of movement is noted by the position sensor 7; it being understood that this position sensor is capable of determining the distances traveled.
  • the position sensor 7 consists of a toothed wheel 8, retained by a gelatin strip, not shown in the figures, which dissolves in the stomach, under the effect of stomach acids.
  • one or more permanent magnets are distributed over the teeth of this wheel 8, causing the closure of at least one Reed relay 9, located fixed on one of the sides of the capsule 1.
  • Each pulse, corresponding to a closing of said relay 9, corresponds to a distance traveled determined beforehand by construction of the toothed wheel 8.
  • the substance release module 10 consists of a plurality of reservoirs 11 having the same size and the same shape, four according to FIG. 3, of cylindrical shape and arranged symmetrically inside a cylinder 12 of much larger diameter.
  • the tanks 11 may have different dimensions and shapes.
  • Each reservoir 11 has a piston set 13, called the ejection piston, and has at one of its ends a closure means 14, for example a plug or a cover, capable of closing automatically after partial release or total of the substance contained in each reservoir 11.
  • a plug 14 of suitable shape and material, for example plastic, silicone or any other biocompatible material, kept closed by an elastic, not shown in the figures, held integral at the base of each reservoir 11.
  • the piston 13 - spring 16 system can advantageously be replaced by an elastic membrane acting as a reservoir .
  • the release of the substances contained in the rigid reservoirs 11 is triggered by a cam device actuated by a conventional geared motor module.
  • the release trigger system consists of a latch 15 holding a compressed push spring 16.
  • the cam mounted on the central axis of the geared motor drive module, pushes the latch 15, which has the effect of release the spring 16.
  • the spring 16 acting on the bottom of the end opposite to the opening of the reservoir 11, expels the contents of the reservoir 11, partially or entirely, towards the outside.
  • the content of the reservoir 11 pushes the plug 14, or the chosen sealing means, then spreads in the intestine, or any other targeted organ.
  • the closure means 14 closes the reservoir 11 under the effect of the traction of the elastic.
  • the plug and the elastic closure device can advantageously be produced by molding in one piece. Another embodiment provides a single elastic for closing and holding all the plugs. In another embodiment, the plugs can be replaced by a membrane, pre-cut or not, which tears under the combined effect of the pushing of the piston and the particular shape of the end plate of the capsule.
  • this sampling system is particularly advantageous and suitable for carrying out intracorporeal samples.
  • the sampling module 17 also consists of a plurality of reservoirs, not shown in these figures, but these sealed reservoirs must be able to be placed in depression relative to the body pressure, external to the capsule 1.
  • each reservoir includes an electromechanical triggering device releasing an axis which is pushed longitudinally by a spring maintained in compression.
  • the axis comprises a plate 18 whose diameter relative to that of the chamber in which it slides, that is to say one of the tanks, is in a determined ratio.
  • the chamber, or the reservoir is here filled with a substance of determined viscosity. Typically, this substance is silicone. This device makes it possible to regulate the advance speed of the piston 19 present in each tank.
  • the central outlet axis is equipped with a cam 20 cooperating with a trigger lever 21 per reservoir, the lever 21 releasing a thrust spring from the axis.
  • the body of the capsule 1 has at least one sealable orifice opening into at least one of the reservoirs so that the intestinal contents are sucked into said reservoirs from the opening of said orifice, when the reservoir has a pressure below that of the medium outside the capsule 1.
  • the channel has a diameter greater than that of the axis, which is guided by a number of O-rings in its translational movement.
  • the axis has a circular groove which, before triggering, is placed between two seals so that the intrusion of intestinal fluid into the storage chamber is impossible.
  • the axis moves longitudinally and arrives at a given moment in a position such that the groove of the axis is at the same level as the last joint, thus putting the storage tank in contact with the outside.
  • the intestinal fluid is then sucked by the depression of the storage chamber, here called reservoir. Subsequently, the axis then continues its course and the groove passes beyond the last joint, the sealing of the chamber is thus again ensured.

Abstract

The invention relates to a device that is used for the delivery of substances and for intracorporeal sampling through the ingestion of a capsule (1) which is intended, in particular, for the intestine of a patient or animal. Said capsule consists of: a body comprising an energy source; an emitter/receiver; physical measurement means which are used to take measurements in relation to the environment and the position (7) of the body; a module for delivering (4) substances; and/or a sampling module (5, 17), all of the aforementioned components being controlled by control means. The invention is characterised in that the substance delivery and sampling means consist of numerous hermetic containers (11), each comprising a release or injection means and a hermetic sealing means (14) which, after the release or suction of a substance, can automatically close the container (11) again.

Description

DISPOSITIF POUR LA DELIVRANCE ET/OU LE PRELEVEMENT INTRACORPOREL DE SUBSTANCES DEVICE FOR DELIVERY AND / OR INTRACORPOREAL SAMPLING OF SUBSTANCES
La présente invention concerne un dispositif pour la délivrance de substances et le prélèvement intracorporel par ingestion d'une capsule. Elle s'applique notamment, mais non exclusivement, à la délivrance de médicaments et au prélèvement de contenu intestinal grâce à d'une capsule d'exploration intestinale.The present invention relates to a device for delivering substances and intracorporeal sampling by ingestion of a capsule. It applies in particular, but not exclusively, to the delivery of drugs and the removal of intestinal contents using an intestinal exploration capsule.
D'une manière générale, une capsule, destinée au largage de substances, aux prélèvements et aux mesures de type physique et/ou chimique, est dénommée une capsule d'exploration intestinale. Cette capsule, réalisée en matériau spécifique et issue des hautes technologies, est ingérable et à usage unique, ce qui rend son coût d'exploitation particulièrement élevée. Elle comprend classiquement différents compartiments : un compartiment pour la réserve d'énergie, un compartiment comportant l'électronique de gestion et de traitement des données ainsi qu'un dispositif de transmission, en général par voie hertzienne, ainsi qu'un compartiment réservé à la réalisation de fonctions prédéterminées, comme le largage de substances, par exemple des médicaments, ou le prélèvement intracorporel. En outre, un certain nombre de capteurs permettent à la capsule de délivrer en temps réels un certain nombre d ' informations sur son environnement .In general, a capsule, intended for dropping substances, for taking samples and for physical and / or chemical type measurements, is called an intestinal exploration capsule. This capsule, made of specific material and from high technology, is unmanageable and disposable, which makes its operating cost particularly high. It conventionally comprises different compartments: a compartment for the energy reserve, a compartment comprising the electronic management and processing of data as well as a transmission device, generally by radio, as well as a compartment reserved for the carrying out predetermined functions, such as dropping substances, for example drugs, or intracorporeal sampling. In addition, a certain number of sensors allow the capsule to deliver in real time a certain amount of information on its environment.
Ainsi, on connaît déjà la demande de brevet WO 9221307, qui décrit une capsule administrable par voie orale. Cette capsule non digestible contient un émetteur électrique d'énergie, un émetteur de signaux radio, un dispositif de stockage d'un médicament et un dispositif télécommandé de libération du médicament. La capsule envoie des signaux à un récepteur, situé à distance de la capsule, à mesure qu'elle passe dans le tube digestif en suivant un trajet défini par l'intestin, et lorsqu'elle atteint un site spécifique, un opérateur, ou un système de commande automatique, l'actionne afin qu'elle libère une dose du médicament.Thus, patent application WO 9221307 is already known, which describes a capsule which can be administered orally. This indigestible capsule contains an electrical energy transmitter, a radio signal transmitter, a drug storage device and a remote drug delivery device. The capsule sends signals to a receiver, located at a distance from the capsule, as it passes through the digestive tract following a path defined by the intestine, and when it reaches a specific site, an operator, or an automatic control system, activates it so that it releases a dose of drug.
On connaît également par la demande de brevet WO 0053243 une capsule miniature servant à administrer des médicaments. Cette capsule comprend un ou plusieurs agrégats de semi-conducteurs en forme de boule assurant la libération d'un médicament stocké dans un réservoir. Un premier agrégat est utilisé pour les fonctions de détection et de mémoire, alors qu'un second agrégat est utilisé pour les aspects de commande, tels que le pompage et la distribution du médicament. Ce système peut communiquer avec un système de télécommande, ou fonctionner indépendamment sur une longue période grâce à une alimentation locale en vue d'une administration des médicaments basée sur la demande du patient.Also known from patent application WO 0053243 is a miniature capsule used for administering medicaments. This capsule comprises one or more aggregates of semiconductors in the form of a ball ensuring the release of a medicament stored in a reservoir. A first aggregate is used for detection and memory functions, while a second aggregate is used for control aspects, such as pumping and dispensing of the drug. This system can communicate with a remote control system, or operate independently over a long period of time using local power for drug administration based on patient demand.
Enfin, on connaît le brevet Français FR 2794654, au nom de la demanderesse, qui décrit un dispositif ingérable pour le largage de substances liquides dans le système digestif dans lequel le moyen de stockage des substances consiste en des enveloppes souples permettant l'expulsion des substances sous l'effet de forces de pression s 'exerçant sur la poche de stockage.Finally, we know the French patent FR 2794654, in the name of the plaintiff, which describes an ingestible device for dropping liquid substances in the digestive system in which the means for storing the substances consists of flexible envelopes allowing the expulsion of the substances under the effect of pressure forces exerted on the storage bag.
Mais tous ces systèmes de l'art antérieur ne permettent pas de combiner à la fois la possibilité de délivrer différentes substances, en général des médicaments, à différents instants déclenchés selon les souhaits du médecin. Par ailleurs, le dispositif selon l'invention permet d'effectuer à la fois une ou plusieurs délivrances de substances ainsi qu'un ou plusieurs prélèvements intracorporels .However, all of these systems of the prior art do not make it possible to combine the possibility of delivering different substances, generally drugs, at different times triggered according to the wishes of the doctor. Furthermore, the device according to the invention makes it possible to carry out one or more deliveries of substances as well as one or more intracorporeal samples.
En outre, une étanchéité parfaite de la capsule vis-à- vis de l'environnement extérieur ainsi qu'une étanchéité parfaite des réservoirs recevant chacun des substances différentes doit être atteinte. D'une manière générale, les impératifs de construction doivent être respectés afin de garantir la sécurité du patient, ou de l'animal, tout en assurant le bon fonctionnement du dispositif. En effet, aucune pièce ou sous-ensemble du dispositif ne doit être désolidarisé du corps de la capsule après la fonction de libération, ou de largage. Ainsi, par exemple, les couvercles d'obturation des réservoirs ne doivent pas rester ouverts. De la même manière, des substances gélatineuses, telles que des résidus de gélules ne doivent pas être utilisées, car elles pourraient empêcher le fonctionnement de certains organes.In addition, a perfect seal of the capsule vis-à-vis the external environment as well as a perfect seal of the tanks each receiving different substances must be achieved. In general, the construction requirements must be respected in order to guarantee the safety of the patient, or of the animal, while ensuring the proper functioning of the device. In fact, no part or sub-assembly of the device must be detached from the body of the capsule after the release or release function. Thus, for example, the closure covers of the tanks must not remain open. Likewise, gelatinous substances such as capsule residues should not be used as they could prevent the functioning of certain organs.
L'invention a donc pour but de remédier aux inconvénients des systèmes de 1 ' art antérieur en offrant un dispositif réalisant les mêmes opérations mais pour un coût bien moindre car il permet leurs répétitions au cours d'une même exploration ou d'un même transfert, et de garantir une parfaite sécurité pour le patient grâce notamment à un fonctionnement parfaitement fiable. Elle propose à cet effet un dispositif pour la délivrance de substances et le prélèvement intracorporel par ingestion, en particulier à destination de l'intestin d'un patient ou d'un animal, d'une capsule formé par un corps comportant une source d'énergie, un émetteur-récepteur, des moyens de mesure physique de l'environnement ainsi que de la position dudit corps, un module pour la délivrance de substances et/ou un module pour le prélèvement, le tout étant commandé par des moyens de commande caractérisé en ce que les moyens pour la délivrance de substances et de prélèvement consistent en une pluralité de réservoirs rigides étanches, comprenant chacun un moyen d'éjection ou d'injection et un moyen d'obturation étanche apte, après la libération ou l'aspiration d'une substance, à venir refermer automatiquement le réservoir.The invention therefore aims to remedy the drawbacks of the systems of the prior art by providing a device performing the same operations but at a much lower cost because it allows their repetitions during the same exploration or the same transfer , and to guarantee perfect safety for the patient thanks in particular to perfectly reliable operation. To this end, it proposes a device for the delivery of substances and the intracorporeal sampling by ingestion, in particular intended for the intestine of a patient or an animal, of a capsule formed by a body comprising a source of energy, a transceiver, means for physical measurement of the environment as well as of the position of said body, a module for delivering substances and / or a module for taking samples, all of which are controlled by control means characterized in that the means for deliverance of substances and of withdrawal consist of a plurality of rigid sealed reservoirs, each comprising an ejection or injection means and a sealed closure means capable, after the release or aspiration of a substance, of automatically closing The reservoir.
Avantageusement, le dispositif selon l'invention pourra comprendre en outre des moyens de visualisation apte à visualiser et/ou à stocker des images ou des données par voie optique.Advantageously, the device according to the invention may further comprise display means capable of displaying and / or storing images or data by optical means.
Selon un mode d'exécution de l'invention, le moyen d'obturation consistera en un bouchon, de forme et de diamètre adapté à l'ouverture d'un réservoir, maintenu fermé par un élastique tandis que le moyen d'éjection consistera en un piston actionné par un mécanisme mécanique et/ou électrique, par exemple un dispositif à came actionné par le module moto-réducteur.According to one embodiment of the invention, the sealing means will consist of a plug, of shape and diameter adapted to the opening of a reservoir, kept closed by an elastic band while the ejection means will consist of a piston actuated by a mechanical and / or electrical mechanism, for example a cam device actuated by the geared motor module.
Par ailleurs, le moyen d'éjection consistera en un piston, ou une membrane élastique, actionné par un mécanisme mécanique et/ou électrique, par exemple un dispositif à came actionné par le module moto-réducteur.Furthermore, the ejection means will consist of a piston, or an elastic membrane, actuated by a mechanical and / or electrical mechanism, for example a cam device actuated by the geared motor module.
Avantageusement, le moyen d'obturation pourra récupérer, lors de son retour pour la fermeture du réservoir, une partie du contenu intestinal grâce par exemple à sa forme particulière, de sorte que le dispositif opère un prélèvement intestinal de cette façon.Advantageously, the closure means can recover, when it returns to close the reservoir, part of the intestinal contents, for example thanks to its particular shape, so that the device operates an intestinal sampling in this way.
Selon un autre mode d'exécution de l'invention, les réservoirs seront aptes à être placés en dépression par rapport à la pression extérieure à la capsule et le corps comportera alors au moins un orifice obturable de façon étanche débouchant dans l'un au moins des réservoirs de sorte que le contenu intestinal est aspiré dans lesdits réservoirsAccording to another embodiment of the invention, the reservoirs will be able to be placed in depression relative to the pressure external to the capsule and the body will then comprise at least one orifice which can be closed in leaktight manner opening into at least one tanks of so that the intestinal contents are sucked into said reservoirs
De préférence, le dispositif selon l'invention comprendra un moyen de commande extérieur, par exemple un ordinateur classique, ainsi qu'un moyen de communication avec ladite capsule, situés à distance. Le moyen de commande extérieur pourra en outre comprendre des moyens de stockage pour stocker l'ensemble des informations collectées par les moyens de mesure et/ou les moyens de visualisation.Preferably, the device according to the invention will comprise an external control means, for example a conventional computer, as well as a means of communication with said capsule, located remotely. The external control means may also include storage means for storing all of the information collected by the measurement means and / or the display means.
Selon une possibilité offerte par l'invention, le moyen de mesure de la position consistera en une roue dentée comportant au moins un aimant réparti, ou situé, sur les dents de la roue. Ainsi, le dispositif selon l'invention comprendra au moins un relais Reed, les aimants de la roue dentée provoquant sa fermeture ; chaque impulsion, correspondant à une fermeture, équivalent à une distance prédéterminée par la construction de ladite roue de sorte que la distance est immédiatement calculée en relevant le nombre d'impulsions du relais Reed.According to a possibility offered by the invention, the means for measuring the position will consist of a toothed wheel comprising at least one magnet distributed, or located, on the teeth of the wheel. Thus, the device according to the invention will comprise at least one Reed relay, the magnets of the toothed wheel causing it to close; each pulse, corresponding to a closure, equivalent to a distance predetermined by the construction of said wheel so that the distance is immediately calculated by recording the number of pulses from the Reed relay.
Un mode d'exécution de l'invention sera décrit ci- après, à titre d'exemple non limitatif, avec référence aux figures annexées dans lesquelles :An embodiment of the invention will be described below, by way of nonlimiting example, with reference to the appended figures in which:
la figure 1 est un schéma bloc représentant les différents éléments constituant le dispositif pour la délivrance de substances et le prélèvement intracorporel par ingestion selon l'invention ;Figure 1 is a block diagram showing the different elements constituting the device for the delivery of substances and intracorporeal sampling by ingestion according to the invention;
la figure 2 est une vue en perspective, de côté, du dispositif selon l'invention ; la figure 3 illustre une pluralité de réservoirs contenant des substances pulvérulentes ;Figure 2 is a perspective side view of the device according to the invention; FIG. 3 illustrates a plurality of reservoirs containing pulverulent substances;
la figure 4 illustre schématiquement les systèmes d'éjection de ladite substance équipant chacun des réservoirs représentés sur la figure 3 ;Figure 4 schematically illustrates the ejection systems of said substance fitted to each of the tanks shown in Figure 3;
la figure 5 est une vue schématique du système de déclenchement du prélèvement de contenu intestinal selon l'invention ;FIG. 5 is a schematic view of the system for triggering the removal of intestinal contents according to the invention;
la figure 6 illustre les différents éléments constituant le dispositif selon 1 ' invention dans le cas du prélèvement.FIG. 6 illustrates the various elements constituting the device according to the invention in the case of sampling.
Comme cela est visible sur la figure 1, la capsule 1 selon l'invention se compose des éléments suivants : un module de base 2 , comprenant toute l'électronique commune à toutes les fonctions : émetteur- récepteur, microprocesseur, capteurs de mesure des caractéristiques physique de l'environnement de la capsule et de sa localisation, interface de connexions, un compartiment 3 pour la source d'énergie, constitué par exemple par une ou plusieurs piles, - des modules fonctionnels 4, 5, et 6 comme la délivrance de substances 4, le prélèvement et la biopsie 5 ainsi que pour l'imagerie via des moyens de visualisation 6.As can be seen in FIG. 1, the capsule 1 according to the invention consists of the following elements: a basic module 2, comprising all the electronics common to all the functions: transceiver, microprocessor, sensors for measuring the characteristics physical environment of the capsule and its location, connection interface, a compartment 3 for the energy source, constituted for example by one or more batteries, - functional modules 4, 5, and 6 such as the delivery of substances 4, sampling and biopsy 5 as well as for imaging via visualization means 6.
Le dispositif pour la délivrance de substances et le prélèvement intracorporel par ingestion selon l'invention nécessite également des installations externes, situées à distance du corps du patient ou de l'animal dans lequel la capsule 1 se trouve, afin d'obtenir une parfaite maîtrise de la capsule 1. Ainsi, ces installations, non représentées sur les figures, comprennent des moyens de communication avec ladite capsule 1 servant pour la transmission des ordres et des données, reliés à un moyen de commande par liaison filaire, par exemple via un bus RS 232. Le moyen de commande sert à assurer l'interface opérateur-capsule pour toutes les commandes, en particulier la délivrance de substances et/ou le prélèvement, ainsi que pour toutes les opérations de traitements, de stockage des données et de présentation des résultats.The device for delivering substances and intracorporeal sampling by ingestion according to the invention also requires external installations, located at a distance from the body of the patient or the animal in which the capsule 1 is located, in order to obtain perfect control. of capsule 1. Thus, these installations, not shown in the figures, include means of communication with said capsule 1 serving for the transmission of orders and data, connected to a control means by wire connection, for example via an RS 232 bus. The control means serves to provide the operator-capsule interface for all orders, in particularly the delivery of substances and / or the collection, as well as for all processing operations, data storage and presentation of results.
Ainsi, l'environnement de communication opérateur- capsule comprend classiquement un émetteur-récepteur pour la transmission des données, des informations et des ordres et un ordinateur, de type PC pour le traitement, la présentation des données et les indications concernant la manipulation, le stockage et l'impression des résultats.Thus, the operator-capsule communication environment conventionally comprises a transceiver for the transmission of data, information and orders and a PC-type computer for processing, presenting the data and the indications concerning handling, storage and printing of results.
Bien entendu, le dispositif selon l'invention pourra également fonctionner de façon autonome, grâce à sa ou ses sources d'énergie et à son ou ses capteurs de position 7. Ainsi, la capsule sera préalablement programmée pour effectuer des mesures, des libérations de substances et/ou des prélèvements, soit de façon continue ou selon une durée prédéterminée soit par exemple à chaque fois qu'une certaine distance de déplacement est constatée par le capteur de position 7 ; étant entendu que ce capteur de position est apte à déterminer les distances parcourues.Of course, the device according to the invention will also be able to function autonomously, thanks to its energy source (s) and to its position sensor (s) 7. Thus, the capsule will be programmed beforehand to carry out measurements, releases of substances and / or samples, either continuously or according to a predetermined duration or for example each time a certain distance of movement is noted by the position sensor 7; it being understood that this position sensor is capable of determining the distances traveled.
En effet, dans l'exemple choisi pour illustrer l'invention et visible sur la figure 2, le capteur de position 7 se compose d'une roue dentée 8, retenue par un bandeau de gélatine, non représenté sur les figures, qui se dissout dans l'estomac, sous l'effet des acides gastriques. Ainsi, un ou plusieurs aimants permanents sont répartis sur les dents de cette roue 8, provoquant la fermeture d'au moins un relais Reed 9, situé fixe sur l'un des côtés de la capsule 1. Chaque impulsion, correspondant à une fermeture dudit relais 9, correspond à une distance parcourue déterminée au préalable par construction de la roue dentée 8.Indeed, in the example chosen to illustrate the invention and visible in Figure 2, the position sensor 7 consists of a toothed wheel 8, retained by a gelatin strip, not shown in the figures, which dissolves in the stomach, under the effect of stomach acids. Thus, one or more permanent magnets are distributed over the teeth of this wheel 8, causing the closure of at least one Reed relay 9, located fixed on one of the sides of the capsule 1. Each pulse, corresponding to a closing of said relay 9, corresponds to a distance traveled determined beforehand by construction of the toothed wheel 8.
Dans l'exemple choisi pour illustrer l'invention sur les figures 3 et 4, le module de libération 10 de substances consiste en une pluralité de réservoirs 11 présentant une même taille et une même forme, quatre selon la figure 3, de forme cylindrique et disposés de façon symétrique à l'intérieur d'un cylindre 12 de diamètre beaucoup plus grand. Bien entendu, les réservoirs 11 pourront présenter des dimensions et des formes différentes. Chaque réservoir 11 possède un jeu de piston 13, dit piston d'éjection, et présente à l'une de ses extrémités un moyen d'obturation 14, par exemple un bouchon ou un couvercle, apte à se refermer automatiquement après une libération partielle ou totale de la substance contenue dans chaque réservoir 11. Selon les figures 3 et 4, Chaque réservoir 11 est fermé par un bouchon 14, de forme et de matière adaptées, par exemple en plastique, silicone ou tout autre matériau bio-compatible, maintenu fermé par un élastique, non représenté sur les figures, maintenu solidaire à la base de chaque réservoir 11. Selon une autre version du dispositif de l'invention, le système piston 13 — ressort 16 peut être avantageusement remplacé par une membrane élastique faisant office de réservoir.In the example chosen to illustrate the invention in FIGS. 3 and 4, the substance release module 10 consists of a plurality of reservoirs 11 having the same size and the same shape, four according to FIG. 3, of cylindrical shape and arranged symmetrically inside a cylinder 12 of much larger diameter. Of course, the tanks 11 may have different dimensions and shapes. Each reservoir 11 has a piston set 13, called the ejection piston, and has at one of its ends a closure means 14, for example a plug or a cover, capable of closing automatically after partial release or total of the substance contained in each reservoir 11. According to Figures 3 and 4, Each reservoir 11 is closed by a plug 14, of suitable shape and material, for example plastic, silicone or any other biocompatible material, kept closed by an elastic, not shown in the figures, held integral at the base of each reservoir 11. According to another version of the device of the invention, the piston 13 - spring 16 system can advantageously be replaced by an elastic membrane acting as a reservoir .
La libération des substances contenues dans les réservoirs 11 rigides est déclenchée par un dispositif à came actionné par un module moto-réducteur classique. Le système de déclenchement de la libération est constitué d'un loquet 15 maintenant un ressort de poussé 16 comprimé. La came, monté sur l'axe central du module moto-réducteur d'entraînement, pousse le loquet 15, ce qui a pour effet de libérer le ressort 16. Le ressort 16, agissant sur le fond de l'extrémité opposée à l'ouverture du réservoir 11, expulse le contenu du réservoir 11, partiellement ou en totalité, vers l'extérieur. Ainsi, le contenu du réservoir 11 pousse le bouchon 14, ou le moyen d'obturation choisi, puis se répand dans l'intestin, ou tout autre organe ciblé. Lorsque la quantité désirée du contenu d'un réservoir 11 a été éjectée, le moyen d'obturation 14 referme le réservoir 11 sous l'effet de la traction de l'élastique.The release of the substances contained in the rigid reservoirs 11 is triggered by a cam device actuated by a conventional geared motor module. The release trigger system consists of a latch 15 holding a compressed push spring 16. The cam, mounted on the central axis of the geared motor drive module, pushes the latch 15, which has the effect of release the spring 16. The spring 16, acting on the bottom of the end opposite to the opening of the reservoir 11, expels the contents of the reservoir 11, partially or entirely, towards the outside. Thus, the content of the reservoir 11 pushes the plug 14, or the chosen sealing means, then spreads in the intestine, or any other targeted organ. When the desired quantity of the contents of a reservoir 11 has been ejected, the closure means 14 closes the reservoir 11 under the effect of the traction of the elastic.
Le bouchon et le dispositif élastique de fermeture peuvent être avantageusement réalisés par moulage en une seule pièce. Une autre forme de réalisation prévoit un seul élastique pour la fermeture et le maintien de tous les bouchons. Dans une autre forme d'exécution, les bouchons peuvent être remplacés par une membrane, prédécoupée ou non, qui se déchire sous l'effet combiné de la poussée du piston et de la forme particulière de la plaque d'extrémité de la capsule.The plug and the elastic closure device can advantageously be produced by molding in one piece. Another embodiment provides a single elastic for closing and holding all the plugs. In another embodiment, the plugs can be replaced by a membrane, pre-cut or not, which tears under the combined effect of the pushing of the piston and the particular shape of the end plate of the capsule.
Idéalement, grâce à une forme particulière du bouchon 14, lors de la fermeture du réservoir 11 par le moyen d'obturation 14, ce dernier peut emprisonner une partie du contenu intestinal dans le réservoir 11. Bien entendu, ce système de prélèvement est particulièrement intéressant et adapté pour effectuer des prélèvements intracorporels.Ideally, thanks to a particular shape of the cap 14, when the reservoir 11 is closed by the closure means 14, the latter can trap part of the intestinal contents in the reservoir 11. Of course, this sampling system is particularly advantageous and suitable for carrying out intracorporeal samples.
Selon les figures 5 et 6, le module de prélèvement 17 consiste également en une pluralité de réservoirs, non représentés sur ces figures, mais ces réservoirs étanches doivent pouvoir être placé en dépression par rapport à la pression corporelle, extérieure à la capsule 1.According to FIGS. 5 and 6, the sampling module 17 also consists of a plurality of reservoirs, not shown in these figures, but these sealed reservoirs must be able to be placed in depression relative to the body pressure, external to the capsule 1.
Dans le module de prélèvement 17, chaque réservoir comprend un dispositif de déclenchement électromécanique libérant un axe qui est poussé longitudinalement par un ressort maintenu en compression. L'axe comporte un plateau 18 dont le diamètre par rapport à celui de la chambre dans laquelle il coulisse, c'est-à-dire un des réservoirs, est dans un rapport déterminé. La chambre, ou le réservoir, est ici remplie d'une substance de viscosité déterminée. Typiquement, cette substance est du silicone. Ce dispositif permet de réguler la vitesse d'avance du piston 19 présent dans chaque réservoir.In the sampling module 17, each reservoir includes an electromechanical triggering device releasing an axis which is pushed longitudinally by a spring maintained in compression. The axis comprises a plate 18 whose diameter relative to that of the chamber in which it slides, that is to say one of the tanks, is in a determined ratio. The chamber, or the reservoir, is here filled with a substance of determined viscosity. Typically, this substance is silicone. This device makes it possible to regulate the advance speed of the piston 19 present in each tank.
De la même manière que dans le module de libération 10, l'axe de sortie central est équipé d'une came 20 coopérant avec un levier de déclenchement 21 par réservoir, le levier 21 libérant un ressort de poussée de l'axe.In the same way as in the release module 10, the central outlet axis is equipped with a cam 20 cooperating with a trigger lever 21 per reservoir, the lever 21 releasing a thrust spring from the axis.
Le corps de la capsule 1 comporte au moins un orifice obturable de façon étanche débouchant dans l'un au moins des réservoirs de sorte que le contenu intestinal est aspiré dans lesdits réservoirs dès l'ouverture dudit orifice, quand le réservoir présente une pression inférieure à celle du milieu extérieur à la capsule 1.The body of the capsule 1 has at least one sealable orifice opening into at least one of the reservoirs so that the intestinal contents are sucked into said reservoirs from the opening of said orifice, when the reservoir has a pressure below that of the medium outside the capsule 1.
Selon une possibilité de réalisation de la capsule et du module de prélèvement selon l'invention, non représentée sur les figures, les orifices par lesquels arrive le contenu intestinal débouchent dans un canal dans lequel coulisse l'axe. Le canal présente un diamètre supérieur à celui de l'axe, qui est guidé par un certain nombre de joints toriques dans son mouvement de translation. L'axe comporte une rainure circulaire qui, avant le déclenchement, est placée entre deux joints de telle façon que l'intrusion du liquide intestinal dans la chambre de stockage soit impossible. Au moment du déclenchement, l'axe se déplace longitudinalement et arrive à un moment donné à une position telle que la rainure de l'axe soit au même niveau que le dernier joint, mettant ainsi le réservoir de stockage en relation avec l'extérieur. Le liquide intestinal est alors aspiré par la dépression de la chambre de stockage, ici dénommé réservoir. Consécutivement, l'axe poursuit ensuite sa course et la rainure passe au-delà du dernier joint, 1'étanchéité de la chambre est ainsi à nouveau assurée.According to a possible embodiment of the capsule and of the sampling module according to the invention, not shown in the figures, the orifices through which the intestinal contents arrive open into a channel in which the axis slides. The channel has a diameter greater than that of the axis, which is guided by a number of O-rings in its translational movement. The axis has a circular groove which, before triggering, is placed between two seals so that the intrusion of intestinal fluid into the storage chamber is impossible. At the moment of triggering, the axis moves longitudinally and arrives at a given moment in a position such that the groove of the axis is at the same level as the last joint, thus putting the storage tank in contact with the outside. The intestinal fluid is then sucked by the depression of the storage chamber, here called reservoir. Subsequently, the axis then continues its course and the groove passes beyond the last joint, the sealing of the chamber is thus again ensured.
L'invention est décrite dans ce qui précède à titre d'exemple. Il est entendu que l'homme du métier est à même de réaliser différentes variantes du dispositif pour la délivrance de substances et le prélèvement intracorporel selon l'invention, en particulier concernant le nombre ou la forme des réservoirs, les substances éjectées et les éléments intracorporel prélevés l'ajout de certaines fonctionnalités . The invention is described in the foregoing by way of example. It is understood that the person skilled in the art is able to produce different variants of the device for delivering substances and intracorporeal sampling according to the invention, in particular concerning the number or the shape of the reservoirs, the substances ejected and the intracorporeal elements. charged the addition of certain features.

Claims

REVENDICATIONS
1. Dispositif pour la délivrance de substances et le prélèvement intracorporel par ingestion, en particulier à destination de l'intestin d'un patient ou d'un animal, d'une capsule (1) formé par un corps comportant une source d'énergie, un émetteur-récepteur, des moyens de mesure physique de l'environnement ainsi que de la position (7) dudit corps, un module pour la délivrance (4) de substances et/ou un module pour le prélèvement (5, 17), le tout étant commandé par des moyens de commande caractérisé en ce que les moyens pour la délivrance de substances et de prélèvement consistent en une pluralité de réservoirs (11) rigides étanches, comprenant chacun un moyen d'éjection ou d'injection et un moyen d'obturation (14) étanche apte, après la libération ou l'aspiration d'une substance, à venir refermer automatiquement le réservoir (11).1. Device for delivering substances and intracorporeal sampling by ingestion, in particular intended for the intestine of a patient or an animal, of a capsule (1) formed by a body comprising an energy source , a transceiver, means for physical measurement of the environment as well as of the position (7) of said body, a module for the delivery (4) of substances and / or a module for the sampling (5, 17), the whole being controlled by control means characterized in that the means for the delivery of substances and of sampling consist of a plurality of rigid sealed reservoirs (11), each comprising an ejection or injection means and a means of sealing (14) able, after the release or aspiration of a substance, to automatically close the reservoir (11).
2. Dispositif pour la délivrance de substances et le prélèvement intracorporel selon la revendication 1, caractérisé en ce qu'il comprend en outre des moyens de visualisation aptes à visualiser et/ou à stocker des images ou des données par voie optique.2. Device for the delivery of substances and the intracorporeal sample according to claim 1, characterized in that it further comprises display means suitable for viewing and / or storing images or data optically.
3. Dispositif pour la délivrance de substances et le prélèvement intracorporel selon la revendication 1, caractérisé en ce que le moyen d'obturation (14) consiste en un bouchon, de forme et de diamètre adapté à l'ouverture d'un réservoir (11), maintenu fermé par un élastique.3. Device for delivering substances and intracorporeal sampling according to claim 1, characterized in that the sealing means (14) consists of a plug, of shape and diameter adapted to the opening of a reservoir (11 ), kept closed by an elastic band.
4. Dispositif pour la délivrance de substances et le prélèvement intracorporel selon la revendication 1, caractérisé en ce que le moyen d'éjection consiste en un piston (13, 19), ou une membrane élastique, actionné par un mécanisme mécanique et/ou électrique, par exemple un dispositif à came (20) actionné par un module moto- réducteur.4. Device for delivering substances and intracorporeal sampling according to claim 1, characterized in that the ejection means consists of a piston (13, 19), or an elastic membrane, actuated by a mechanical and / or electrical mechanism , for example a cam device (20) actuated by a geared motor module.
5. Dispositif pour la délivrance de substances et le prélèvement intracorporel selon la revendication 1, caractérisé en ce que le moyen d'obturation (14) récupère, lors de son retour pour la fermeture du réservoir (11), une partie du contenu intestinal grâce par exemple à sa forme particulière.5. Device for the delivery of substances and the intracorporeal sample according to claim 1, characterized in that the sealing means (14) recovers, when it returns for the closure of the reservoir (11), part of the intestinal contents thanks for example to its particular shape.
6. Dispositif pour la délivrance de substances et le prélèvement intracorporel selon l'une des revendications précédentes, caractérisé en ce que les réservoirs (11) sont aptes à être placés en dépression par rapport à la pression extérieure à la capsule (1).6. Device for the delivery of substances and the intracorporeal sample according to one of the preceding claims, characterized in that the reservoirs (11) are capable of being placed in depression relative to the pressure external to the capsule (1).
7. Dispositif pour la délivrance de substances et le prélèvement intracorporel selon l'une des revendications précédentes, caractérisé en ce que le corps de la capsule (1) comporte au moins un orifice obturable de façon étanche débouchant dans l'un au moins des réservoirs (11) de sorte que le contenu intestinal est aspiré dans lesdits réservoirs (11).7. Device for the delivery of substances and the intracorporeal sample according to one of the preceding claims, characterized in that the body of the capsule (1) comprises at least one orifice which can be closed in leaktight manner opening into at least one of the reservoirs (11) so that the intestinal contents are sucked into said reservoirs (11).
8. Dispositif pour la délivrance de substances et le prélèvement intracorporel selon l'une des revendications précédentes, caractérisé en ce qu'il comprend un moyen de commande extérieur, par exemple un ordinateur classique, ainsi qu'un moyen de communication avec ladite capsule (1), situés à distance.8. Device for the delivery of substances and the intracorporeal sample according to one of the preceding claims, characterized in that it comprises an external control means, for example a conventional computer, as well as a means of communication with said capsule ( 1), located at a distance.
9. Dispositif pour la délivrance de substances et le prélèvement intracorporel selon la revendication 8, caractérisé en ce que le moyen de commande extérieur comprend en outre des moyens de stockage pour stocker l'ensemble des informations collectées par les moyens de mesure et/ou les moyens de visualisation.9. Device for the delivery of substances and the intracorporeal sample according to claim 8, characterized in that the external control means further comprises storage means for storing all the information collected by the measurement means and / or the display means.
10. Dispositif pour la délivrance de substances et le prélèvement intracorporel selon la revendication 1, caractérisé en ce que le moyen de mesure de la position consiste en une roue dentée (8) comportant au moins un aimant réparti, ou situé, sur les dents.10. Device for delivering substances and intracorporeal sampling according to claim 1, characterized in that the position measuring means consists of a toothed wheel (8) comprising at least one magnet distributed, or located, on the teeth.
11. Dispositif pour la délivrance de substances et le prélèvement intracorporel selon les revendications 1 et 10, caractérisé en ce qu'il comprend au moins un relais Reed, le ou les aimants de la roue dentée (8) provoquant sa fermeture ; chaque impulsion, correspondant à une fermeture, équivalent à une distance prédéterminée par la construction de ladite roue.11. Device for the delivery of substances and the intracorporeal sample according to claims 1 and 10, characterized in that it comprises at least one Reed relay, the magnet or magnets of the toothed wheel (8) causing its closure; each pulse, corresponding to a closure, equivalent to a distance predetermined by the construction of said wheel.
12. Dispositif pour la délivrance de substances et le prélèvement intracorporel selon la revendication 1, caractérisé en ce qu'au moins un des réservoirs (11) contient des substances sous forme de poudres ou de granulés.12. Device for the delivery of substances and the intracorporeal sample according to claim 1, characterized in that at least one of the reservoirs (11) contains substances in the form of powders or granules.
13. Dispositif pour la délivrance de substances et le prélèvement intracorporel selon la revendication 12, caractérisé en ce que les substances sont des médicaments.13. Device for the delivery of substances and the intracorporeal sample according to claim 12, characterized in that the substances are medicaments.
14. Dispositif pour la délivrance de substances et le prélèvement intracorporel selon la revendication 1, caractérisé en ce que le moyen d'obturation consiste en une membrane, prédécoupée ou non, apte à se déchirer sous pression. 14. Device for the delivery of substances and the intracorporeal sample according to claim 1, characterized in that the sealing means consists of a membrane, pre-cut or not, able to tear under pressure.
PCT/FR2003/000437 2002-02-11 2003-02-11 Device that is used for delivering and/or intracorporeal sampling of substances WO2003068061A1 (en)

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FR2835730A1 (en) 2003-08-15
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