WO2002022190A1 - Device for making secure peridural perfusions - Google Patents

Device for making secure peridural perfusions Download PDF

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Publication number
WO2002022190A1
WO2002022190A1 PCT/FR2001/002623 FR0102623W WO0222190A1 WO 2002022190 A1 WO2002022190 A1 WO 2002022190A1 FR 0102623 W FR0102623 W FR 0102623W WO 0222190 A1 WO0222190 A1 WO 0222190A1
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WO
WIPO (PCT)
Prior art keywords
catheter
suction
aspiration
sensor
tests
Prior art date
Application number
PCT/FR2001/002623
Other languages
French (fr)
Inventor
Jean Claude Ducloy
Original Assignee
Jean Claude Ducloy
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 Jean Claude Ducloy filed Critical Jean Claude Ducloy
Priority to EP01963103A priority Critical patent/EP1317298A1/en
Priority to AU2001284144A priority patent/AU2001284144A1/en
Publication of WO2002022190A1 publication Critical patent/WO2002022190A1/en

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Classifications

    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
    • A61M5/1456—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons with a replaceable reservoir comprising a piston rod to be moved into the reservoir, e.g. the piston rod is part of the removable reservoir
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16831—Monitoring, detecting, signalling or eliminating infusion flow anomalies
    • A61M5/16854—Monitoring, detecting, signalling or eliminating infusion flow anomalies by monitoring line pressure
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/15—Detection of leaks
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/18—General characteristics of the apparatus with alarm
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/70—General characteristics of the apparatus with testing or calibration facilities
    • A61M2205/702—General characteristics of the apparatus with testing or calibration facilities automatically during use

Definitions

  • the present invention relates to the securing of continuous epidural infusions carried out by an electric syringe pump or by a patient-controlled analgesia device (PCEA), by means of a device intended to detect disconnection of the catheter, migration vascular of it or its intra-thecal migration.
  • This device includes the performance of automatic suction tests and the possible analysis by a sensor placed on the perfusion line of the qualities of the fluid infused, or aspirated during the automatic suction tests.
  • the administration of local anesthetics, morphine drugs and adjuvants by means of a catheter placed beforehand in the epidural space is a very effective method of preventive and curative treatment of pain, in particular during the postoperative phase.
  • disconnection of the catheter. It most often occurs at the connection between the catheter and the bacterial filter, on the "patient" side of it (or distal side). The longer the catheter disconnection time, the greater the risk of microbial contamination, which can induce iatrogenic meningitis, is greater. The diagnosis of disconnection must therefore be made early. It can be done either on the visual observation of disconnection, or on the loss of resistance during a suction test preceding any manual injection into the catheter, or finally and later, on the observation of the decrease in efficiency epidural analgesia;
  • intravenous malposition of the distal end of the catheter in an epidural vein is most often done during its placement, a reflux of blood is then visualized in the Tuohy® needle or in the catheter. This reflux may be spontaneous or require a manual aspiration test with the syringe.
  • anesthesia or analgesia would expose to the risks of ineffectiveness of the technique, of neurological accidents due to the convulsive power of anesthetics effects on the central nervous system, cardiovascular accidents due to the cardiovascular depressant effects of local anesthetics.
  • the vascular break-in is delayed compared to the placement of the catheter, this is called migration of the latter.
  • the catheter may be at full channel in or near an injured epidural vein.
  • intra-thecal migration from the distal end of the catheter is a rare possibility. As with intravenous migration, this catheter positioning anomaly occurs most often when it is placed; reflux of cerebrospinal fluid is then visualized in the Tuohy® needle or in the catheter. This reflux may be spontaneous or require a manual aspiration test with the syringe.
  • anesthesia or analgesia would expose to the risks of complete spinal anesthesia including in particular: significant vasoplegia by extended sympatholysis, bulbar paralysis with cardiopulmonary arrest.
  • the intrathecal intrusion is delayed compared to the placement of the catheter, we speak then of migration of this one.
  • the catheter may be at full channel in the injured intra-thecal space or close to it.
  • catheter positioning anomalies can be encountered in 10% of cases. It is regrettable, however, to note that among the services, even intensive care, where this very effective technique is used, manual suction tests are almost never carried out since the injections are no longer carried out manually but by means of electrical devices. infusion: electric syringe pump or patient-controlled analgesia device. This therefore exposes these services to the above-described accidents.
  • the device according to the invention improves the safety of these medical techniques by the automatic performance by the perfusion apparatus of automatic aspiration tests.
  • the periodicity of these suction tests is a parameter programmable by the user who can choose: - a manual mode;
  • an occasional mode i.e. the triggering of an automatic aspiration test before the infusion of each bolus carried out by an analgesia device controlled by the patient or before each bolus requested manually by the caregiver on a electric syringe;
  • a sensor can be placed on the perfusion line (extension-filter-connection-catheter) to allow an analysis of the chemical or physical characteristics of the fluids circulating there.
  • the invention relates, according to a first aspect, to a device for improving the safety of epidural infusions carried out by devices of the electric syringe pump type or devices of the patient controlled analgesia type (PCEA), device comprising means for carrying out at least one automatic aspiration test for a predetermined duration on the perfusion system, in particular the plunger of a syringe, and means for detecting the loss of resistance to this aspiration controlling means for alarm and means for stopping the perfusion system upon detection of a loss of this resistance to aspiration, in particular due to disconnection of the catheter and / or vascular and / or intra-thecal intrusion.
  • PCEA patient controlled analgesia type
  • the device is such that:
  • the means for detecting the loss of resistance to aspiration include means for direct and / or indirect measurement of the perfusion pressure
  • the means for detecting the loss of suction resistance comprise means for measuring the torque and / or the driving force of the motor of the perfusion system;
  • the means for detecting the loss of resistance to suction include means for detecting movement behind the piston or its carriage following the suction test; - It includes means for performing automatic suction tests, periodically, at regular intervals programmable by the user;
  • It includes means for carrying out automatic aspiration tests carried out systematically before each bolus carried out by an electric syringe pump or an analgesia device controlled by the patient;
  • - it also includes an external sensor located on the epidural catheter, analyzing the physical characteristics of the fluid perfused or aspirated during automatic aspiration tests, any variation in the quality of the fluid causing an alarm and stopping the infusion; - it also includes a sensor analyzing the physical characteristics of the fluid perfused or aspirated during automatic suction tests, this single-use sensor being arranged in series between the filter and the catheter connection during the placement of the epidural catheter ;
  • a sensor analyzing the physical characteristics of the fluid perfused or aspirated during automatic suction tests, this sensor forming an integral part of the microbial filter and becoming a “filter-sensor” assembly put in place when the catheter is placed ;
  • the sensor is an internal sensor directly analyzing the electrical and / or physical, biochemical and / or chemical characteristics of the fluid perfused or aspirated during automatic aspiration tests;
  • the invention relates, according to a second aspect, to a method for improving the safety of epidural infusions carried out by devices of the electric syringe pump type or of analgesia type controlled by the patient, characterized in that at least one automatic aspiration test for a predetermined period on the perfusion system, in particular the plunger of a syringe and in that the resistance to aspiration is detected and that, upon detection of a loss of resistance to this aspiration, in particular due to a disconnection of the catheter and / or a vascular and / or intra-thecal breach, alarm means and means for stopping the infusion are controlled.
  • the method is such that:
  • - automatic suction tests are carried out periodically, at regular intervals programmable by the user; - an aspiration test is systematically carried out before each bolus carried out by an electric syringe pump or an analgesia device controlled by the patient.
  • the automatic aspiration test consists of pulling, in the opposite direction to the usual infusion, by the push-button of the infusion device 1 on the plunger of the syringe 2 and maintaining this pull for a few seconds .
  • This suction is accompanied by a depression in the perfusion tank 3 which thus prevents the piston from going back.
  • This tensile strength results in a negative pressure 4 which can be recorded by the device.
  • Any vascular or intra-thecal breach of the catheter 5 or any loss of tightness on the infusion line including the syringe 2, the extender 6, the filter 7, the catheter connector 8 and the catheter 5 will be accompanied by disappearance. or a decrease in negative pressure 4 and resistance to depression. This results in an alarm 9 and the stop of the per usion.
  • the detection of loss of suction resistance can be done:
  • a sensor 10 is placed on the epidural catheter 5 and analyzes the quality of the fluid perfused or aspirated during the automatic suction tests. He will be able to detect the presence of blood during vascular breaches, the presence of cerebrospinal fluid during intra-thecal breaches, the presence of air during disconnection of the catheter. Any variation in the quality of the fluid triggers an alarm 9 and stops the infusion.
  • the senor 10 is placed above the filter 7, on the perfusion extender 6 and can detect the passage of air during leaks by disconnecting the extender / syringe or extender / filter.
  • the senor is an external sensor through which passes the perfusion line without contact between the liquid and the sensor.
  • the analysis is done through the walls of the infusion line.
  • the properties studied are the physical or optical properties of the fluid.
  • the sensor 11 is a single-use sensor fixed, during the fitting of the epidural catheter, by two Luer-Lock® latches between the bacterial filter 7 and the connection of the catheter 8.
  • the senor forms an integral part of the microbial filter and becomes a sensor-filter assembly 12 for single use which is installed during the placement of the epidural catheter between the extender 6 and the catheter connector. 8.
  • the sensor is either:

Abstract

The invention concerns a device for enhancing the security of peridural perfusions performed by appliances such as electrical syringe pumps or analgesia appliances controlled by the patient (PCEA). The invention is characterised in that it comprises means for performing at least an automatic suction test for a predetermined duration on the perfusion system, in particular the plunger of the syringe (2), and means for detecting loss of resistance to said suction controlling alarm means (9) and means for stopping the perfusion system when said loss of suction resistance is detected resulting in particular from a disconnection of the catheter and/or and vascular and/or intrathecal collapse.

Description

DISPOSITIF DE SECURISATION DES PERFUSIONS PERIDURALES SECURITY DEVICE FOR PERIDURAL PERFUSIONS
La présente invention concerne la sécurisation des perfusions continues par voie péridurale effectuées par un pousse-seringue électrique ou par un appareil d'analgésie contrôlée par le patient (PCEA), au moyen d'un dispositif visant à détecter le débranchement du cathéter, la migration vasculaire de celui-ci ou sa migration intra-thécale. Ce dispositif inclus la réalisation de tests d'aspiration automatiques et l'éventuelle analyse par un capteur disposé sur la ligne de perfusion des qualités du fluide perfusé, ou aspiré pendant les tests d'aspiration automatiques. L'administration d'anesthésiques locaux, de morphiniques et d'adjuvants au moyen d'un cathéter disposé préalablement dans l'espace péridural est une méthode très efficace de traitement préventif et curatif de la douleur, en particulier durant la phase postopératoire. Pourtant, la diffusion de cette méthode d'analgésie est limitée par ses risques et la nécessité de surveillance qui en résulte. Pour cette raison, certains auteurs ne préconisent pas cette méthode, pourtant très efficace, en dehors de services de soins intensifs. Trois des principaux risques de la méthode sont ici exposés : ils sont la cible de l'invention ici proposée :The present invention relates to the securing of continuous epidural infusions carried out by an electric syringe pump or by a patient-controlled analgesia device (PCEA), by means of a device intended to detect disconnection of the catheter, migration vascular of it or its intra-thecal migration. This device includes the performance of automatic suction tests and the possible analysis by a sensor placed on the perfusion line of the qualities of the fluid infused, or aspirated during the automatic suction tests. The administration of local anesthetics, morphine drugs and adjuvants by means of a catheter placed beforehand in the epidural space is a very effective method of preventive and curative treatment of pain, in particular during the postoperative phase. However, the spread of this analgesia method is limited by its risks and the resulting need for surveillance. For this reason, some authors do not recommend this method, however very effective, outside intensive care services. Three of the main risks of the method are exposed here: they are the target of the invention proposed here:
- débranchement du cathéter. Il se produit le plus souvent au niveau du raccord entre le cathéter et le filtre bactérien, du coté « patient » de celui-ci (ou coté distal). Plus le temps de débranchement du cathéter est long, plus le risque de contamination microbienne, pouvant induire une méningite iatrogène, est important. Le diagnostic du débranchement doit donc être précoce. Il peut se faire soit sur la constatation visuelle du débranchement, soit sur la perte de résistance lors d'un test d'aspiration précédant toute injection manuelle dans le cathéter, soit enfin et plus tardivement, sur la constatation de la diminution de l'efficacité de l'analgésie péridurale ;- disconnection of the catheter. It most often occurs at the connection between the catheter and the bacterial filter, on the "patient" side of it (or distal side). The longer the catheter disconnection time, the greater the risk of microbial contamination, which can induce iatrogenic meningitis, is greater. The diagnosis of disconnection must therefore be made early. It can be done either on the visual observation of disconnection, or on the loss of resistance during a suction test preceding any manual injection into the catheter, or finally and later, on the observation of the decrease in efficiency epidural analgesia;
- migration intraveineuse : la malposition intraveineuse de l'extrémité distale du cathéter dans une veine péridurale se fait le plus souvent lors de sa mise en place, un reflux de sang est alors visualisé dans l'aiguille de Tuohy® ou dans le cathéter. Ce reflux peut être spontané ou nécessiter un test d'aspiration manuel à la seringue. Certains auteurs préconisent de réaliser systématiquement une dose-test vasculaire, c'est à dire l'injection d'une dilution adrénalinée dans le cathéter. Si celle-ci est suivie de variations de fréquence cardiaque ou de pression artérielle, la dose-test est considérée comme positive et impose le repositionnement du cathéter. La poursuite de l'anesthésie ou de l'analgésie exposerait aux risques d'inefficacité de la technique, d'accidents neurologiques dus au pouvoir convulsivant des anesthésiques locaux sur le système nerveux central, d'accidents cardiovasculaires dus aux effets dépresseurs cardiovasculaires des anesthésiques locaux. Dans certains cas, l'effraction vasculaire est retardée par rapport à la mise en place du cathéter, on parle alors de migration de celui-ci. Le cathéter pouvant se trouver à plein canal dans une veine péridurale lésée ou à proximité de celle-ci. Ces effractions secondaires justifient que lors de toute injection manuelle ultérieure, un test d'aspiration soit réalisé recherchant une perte de résistance et/ou la visualisation d'un « retour sanguin » dans le cathéter ;- intravenous migration: intravenous malposition of the distal end of the catheter in an epidural vein is most often done during its placement, a reflux of blood is then visualized in the Tuohy® needle or in the catheter. This reflux may be spontaneous or require a manual aspiration test with the syringe. Some authors recommend systematically carrying out a vascular test dose, that is to say the injection of an adrenaline dilution into the catheter. If this is followed by variations in heart rate or blood pressure, the test dose is considered positive and requires repositioning of the catheter. The continuation of anesthesia or analgesia would expose to the risks of ineffectiveness of the technique, of neurological accidents due to the convulsive power of anesthetics effects on the central nervous system, cardiovascular accidents due to the cardiovascular depressant effects of local anesthetics. In some cases, the vascular break-in is delayed compared to the placement of the catheter, this is called migration of the latter. The catheter may be at full channel in or near an injured epidural vein. These secondary intrusions justify that during any subsequent manual injection, an aspiration test is carried out looking for a loss of resistance and / or the visualization of a "blood return" in the catheter;
- migration intra-thécale : la migration intra-thécale de l'extrémité distale du cathéter est une éventualité rare. Comme pour la migration intraveineuse, cette anomalie de positionnement du cathéter se fait le plus souvent lors de la mise en place de celui-ci ; un reflux de liquide céphalo-rachidien est alors visualisé dans l'aiguille de Tuohy® ou dans le cathéter. Ce reflux peut être spontané ou nécessiter un test d'aspiration manuel à la seringue. Certains auteurs préconisent de réaliser systématiquement après la pose du cathéter une dose-test rachidienne c'est à dire l'injection d'une solution concentrée d'anesthésique local dans le cathéter sous un faible volume (par exemple 1,5ml de lidocaïne à 5%). Si celle-ci est suivie d'une anesthésie médullaire de type rachi-anesthésie, la dose test est considérée comme positive et impose le retrait du cathéter. La poursuite de l'anesthésie ou de l'analgésie exposerait aux risques de rachianesthésie complète comportant notamment : vasoplégie importante par sympatholyse étendue, paralysie bulbaire avec arrêt cardio-respiratoire. Dans certains cas l'effraction intra-thécale est retardée par rapport à la pose du cathéter, on parle alors de migration de celui-ci. Le cathéter pouvant se trouver à plein canal dans l'espace intra-thécal lésé soit à proximité de celui-ci. Ces effractions secondaires justifient que lors de toute injection manuelle ultérieure, un test d'aspiration soit réalisé recherchant une perte de résistance avec retour dans le cathéter d'un liquide clair et riche en glucose.- intra-thecal migration: intra-thecal migration from the distal end of the catheter is a rare possibility. As with intravenous migration, this catheter positioning anomaly occurs most often when it is placed; reflux of cerebrospinal fluid is then visualized in the Tuohy® needle or in the catheter. This reflux may be spontaneous or require a manual aspiration test with the syringe. Some authors recommend systematically performing a spinal test dose after placement of the catheter, i.e. injecting a concentrated solution of local anesthetic into the catheter in a small volume (for example 1.5 ml of 5-lidocaine %). If this is followed by spinal-anesthesia-type spinal anesthesia, the test dose is considered to be positive and requires withdrawal of the catheter. The continuation of anesthesia or analgesia would expose to the risks of complete spinal anesthesia including in particular: significant vasoplegia by extended sympatholysis, bulbar paralysis with cardiopulmonary arrest. In some cases the intrathecal intrusion is delayed compared to the placement of the catheter, we speak then of migration of this one. The catheter may be at full channel in the injured intra-thecal space or close to it. These secondary intrusions justify that during any subsequent manual injection, an aspiration test is carried out looking for a loss of resistance with return in the catheter of a clear liquid and rich in glucose.
Selon certains auteurs, les anomalies de positionnement du cathéter peuvent se rencontrer dans 10% des cas. Il est regrettable de constater pourtant que parmi les services, même de soins intensifs, où cette très efficace technique est utilisée, les tests manuels d'aspirations ne sont quasiment jamais réalisés puisque les injections ne sont plus réalisées manuellement mais au moyens de dispositifs électriques de perfusion : pousse-seringue électrique ou appareil d'analgésie contrôlée par le patient. Ceci expose donc ces services aux accidents sus-décrits. Le dispositif selon l'invention améliore la sécurité de ces techniques médicales par la réalisation automatique par l'appareil de perfusion de tests d'aspiration automatiques. La périodicité de ces tests d'aspiration est un paramètre programmable par l'utilisateur qui pourra choisir : - un mode manuel ;According to some authors, catheter positioning anomalies can be encountered in 10% of cases. It is regrettable, however, to note that among the services, even intensive care, where this very effective technique is used, manual suction tests are almost never carried out since the injections are no longer carried out manually but by means of electrical devices. infusion: electric syringe pump or patient-controlled analgesia device. This therefore exposes these services to the above-described accidents. The device according to the invention improves the safety of these medical techniques by the automatic performance by the perfusion apparatus of automatic aspiration tests. The periodicity of these suction tests is a parameter programmable by the user who can choose: - a manual mode;
- un mode périodique (horaire par exemple) pour les pousse-seringue électrique et les appareils d'analgésie contrôlée par le patient ;- a periodic mode (hourly for example) for electric syringe pumps and analgesia devices controlled by the patient;
- un mode occasionnel, c'est à dire le déclenchement d'un test d'aspiration automatique avant la perfusion de chaque bolus effectué par un appareil d'analgésie contrôlée par le patient ou avant chaque bolus demandé manuellement par le soignant sur un pousse-seringue électrique ;- an occasional mode, i.e. the triggering of an automatic aspiration test before the infusion of each bolus carried out by an analgesia device controlled by the patient or before each bolus requested manually by the caregiver on a electric syringe;
- ou bien sûr, un mode combinant deux ou trois des chois précédents.- or of course, a mode combining two or three of the previous choices.
Selon des modes particuliers de réalisation, un capteur peut être placé sur la ligne de perfusion (prolongateur-filtre-raccord-cathéter) pour permettre une analyse des caractéristiques chimiques ou physiques des fluides y circulant.According to particular embodiments, a sensor can be placed on the perfusion line (extension-filter-connection-catheter) to allow an analysis of the chemical or physical characteristics of the fluids circulating there.
A ces fins, l'invention se rapporte, selon un premier aspect, à un dispositif pour améliorer la sécurité des perfusions péridurales effectuées par des appareils de type pousse-seringue électrique ou des appareils de type analgésie contrôlée par le patient (PCEA), ce dispositif comprenant des moyens pour réaliser au moins un test d'aspiration automatique pendant une durée prédéterminée sur le système de perfusion, notamment le piston d'une seringue, et des moyens de détection de la perte de résistance à cette aspiration commandant des moyens d'alarme et des moyens d'arrêt du système de perfusion lors de la détection d'une perte de cette résistance à l'aspiration notamment due à un débranchement du cathéter et/ou d'une effraction vasculaire et/ou intra-thécale.For these purposes, the invention relates, according to a first aspect, to a device for improving the safety of epidural infusions carried out by devices of the electric syringe pump type or devices of the patient controlled analgesia type (PCEA), device comprising means for carrying out at least one automatic aspiration test for a predetermined duration on the perfusion system, in particular the plunger of a syringe, and means for detecting the loss of resistance to this aspiration controlling means for alarm and means for stopping the perfusion system upon detection of a loss of this resistance to aspiration, in particular due to disconnection of the catheter and / or vascular and / or intra-thecal intrusion.
Selon diverses réalisations, le dispositif est tel que :According to various embodiments, the device is such that:
- les moyens de détection de la perte de résistance à l'aspiration comprennent des moyens de mesure directe et/ou indirecte de la pression de perfusion ;the means for detecting the loss of resistance to aspiration include means for direct and / or indirect measurement of the perfusion pressure;
- les moyens de détection de la perte de résistance à l'aspiration comprennent des moyens de mesure du couple et/ou de la force motrice du moteur du système de perfusion ;the means for detecting the loss of suction resistance comprise means for measuring the torque and / or the driving force of the motor of the perfusion system;
- les moyens de détection de la perte de résistance à l'aspiration comprennent des moyens de détection du mouvement en arrière du piston ou de son chariot consécutif au test d'aspiration ; - il comprend des moyens pour réaliser des tests d'aspiration automatiques, de manière périodique, à intervalles réguliers programmables par l'utilisateur ;the means for detecting the loss of resistance to suction include means for detecting movement behind the piston or its carriage following the suction test; - It includes means for performing automatic suction tests, periodically, at regular intervals programmable by the user;
- il comprend des moyens pour réaliser des tests d'aspiration automatiques réalisés systématiquement avant chaque bolus effectué par un pousse-seringue électrique ou un appareil d'analgésie contrôlée par le patient ;- It includes means for carrying out automatic aspiration tests carried out systematically before each bolus carried out by an electric syringe pump or an analgesia device controlled by the patient;
- il comprend en outre un capteur externe situé sur le cathéter péridural, analysant les caractéristiques physiques du fluide perfusé ou aspiré lors des tests d'aspiration automatiques, toute variation de la qualité du fluide entraînant une alarme et l'arrêt de la perfusion ; - il comprend en outre un capteur analysant les caractéristiques physiques du fluide perfusé ou aspiré lors des tests d'aspiration automatiques, ce capteur à usage unique étant disposé en série entre le filtre et le raccord du cathéter lors de la mise en place du cathéter péridural ;- it also includes an external sensor located on the epidural catheter, analyzing the physical characteristics of the fluid perfused or aspirated during automatic aspiration tests, any variation in the quality of the fluid causing an alarm and stopping the infusion; - it also includes a sensor analyzing the physical characteristics of the fluid perfused or aspirated during automatic suction tests, this single-use sensor being arranged in series between the filter and the catheter connection during the placement of the epidural catheter ;
- il comprend en outre un capteur analysant les caractéristiques physiques du fluide perfusé ou aspiré lors des tests d'aspiration automatiques, ce capteur faisant partie intégrante du filtre microbien et devenant un ensemble « filtre-capteur » mis en place lors de la pose du cathéter ;- it further includes a sensor analyzing the physical characteristics of the fluid perfused or aspirated during automatic suction tests, this sensor forming an integral part of the microbial filter and becoming a “filter-sensor” assembly put in place when the catheter is placed ;
- le capteur est un capteur interne analysant directement les caractéristiques électriques et/ou physiques, biochimiques et/ou chimiques du fluide perfusé ou aspiré lors des tests d'aspiration automatiques ;- the sensor is an internal sensor directly analyzing the electrical and / or physical, biochemical and / or chemical characteristics of the fluid perfused or aspirated during automatic aspiration tests;
- il comprend un capteur externe analysant les caractéristiques physiques du fluide perfusé ou aspiré lors des tests d'aspiration automatique situé entre la seringue et le filtre.- it includes an external sensor analyzing the physical characteristics of the fluid perfused or aspirated during the automatic suction tests located between the syringe and the filter.
L'invention se rapporte, selon un deuxième aspect, à un procédé pour améliorer la sécurité des perfusions péridurales effectuées par des appareils de type pousse-seringue électrique ou de type analgésie contrôlée par le patient, caractérisé en ce qu'on réalise au moins un test d'aspiration automatique pendant une durée prédéterminée sur le système de perfusion notamment le piston d'une seringue et en ce que l'on détecte la résistance à l'aspiration et que, lors de la détection d'une perte de la résistance à cette aspiration notamment due à un débranchement du cathéter et/ou d'un effraction vasculaire et/ou intra-thécale, l'on commande des moyens d'alarme et des moyens d'arrêt de la perfusion.The invention relates, according to a second aspect, to a method for improving the safety of epidural infusions carried out by devices of the electric syringe pump type or of analgesia type controlled by the patient, characterized in that at least one automatic aspiration test for a predetermined period on the perfusion system, in particular the plunger of a syringe and in that the resistance to aspiration is detected and that, upon detection of a loss of resistance to this aspiration, in particular due to a disconnection of the catheter and / or a vascular and / or intra-thecal breach, alarm means and means for stopping the infusion are controlled.
Selon diverses réalisations, le procédé est tel que :According to various embodiments, the method is such that:
- on réalise les tests d'aspiration automatique de manière périodique, à intervalles réguliers programmables par l'utilisateur ; - un test d'aspiration est réalisé systématiquement avant chaque bolus effectué par un pousse-seringue électrique ou un appareil d'analgésie contrôlée par le patient.- automatic suction tests are carried out periodically, at regular intervals programmable by the user; - an aspiration test is systematically carried out before each bolus carried out by an electric syringe pump or an analgesia device controlled by the patient.
Les dessins annexés illustrent l'invention. En figure 1, le test d'aspiration automatique consiste en une traction, dans le sens inverse de la perfusion habituelle, par le poussoir de l'appareil de perfusion 1 sur le piston de la seringue 2 et un maintien de cette traction pendant quelques secondes. Cette aspiration s'accompagne d'une dépression dans le réservoir de perfusion 3 qui empêche ainsi le retour en arrière du piston. Cette résistance à la traction se traduit par une pression négative 4 enregistrable par l'appareil. Toute effraction vasculaire ou intra-thécale du cathéter 5 ou toute perte d'étanchéité sur la ligne de perfusion comprenant la seringue 2, le prolongateur 6, le filtre 7, le raccord de cathéter 8 et le cathéter 5 s'accompagnera d'une disparition ou d'une diminution de la pression négative 4 et de la résistance à la dépression. Ceci entraîne une alarme 9 et l'arrêt de la per usion. Selon les modes particuliers de fabrication, la détection de perte de résistance à l'aspiration peut se faire :The accompanying drawings illustrate the invention. In FIG. 1, the automatic aspiration test consists of pulling, in the opposite direction to the usual infusion, by the push-button of the infusion device 1 on the plunger of the syringe 2 and maintaining this pull for a few seconds . This suction is accompanied by a depression in the perfusion tank 3 which thus prevents the piston from going back. This tensile strength results in a negative pressure 4 which can be recorded by the device. Any vascular or intra-thecal breach of the catheter 5 or any loss of tightness on the infusion line including the syringe 2, the extender 6, the filter 7, the catheter connector 8 and the catheter 5 will be accompanied by disappearance. or a decrease in negative pressure 4 and resistance to depression. This results in an alarm 9 and the stop of the per usion. Depending on the particular manufacturing methods, the detection of loss of suction resistance can be done:
- par mesure directe de la pression de perfusion ;- by direct measurement of the perfusion pressure;
- par mesure indirecte de la pression de perfusion ;- by indirect measurement of the perfusion pressure;
- par mesure du couple moteur nécessaire pour réaliser l'aspiration ; - par détection d'un retour en arrière du piston ou du chariot consécutif au test d'aspiration.- by measuring the motor torque necessary to perform the suction; - by detection of a backward movement of the piston or the carriage following the suction test.
Dans la forme de réalisation selon la figure 2, un capteur 10 est disposé sur le cathéter péridural 5 et analyse la qualité du fluide perfusé ou aspiré lors des tests d'aspiration automatiques. Il sera en mesure de dépister la présence de sang lors d'effractions vasculaires, la présence de liquide céphélo-rachidien lors des effractions intra-thécales, la présence d'air lors des débranchements du cathéter. Toute variation de la qualité du fluide déclenche une alarme 9 et l'arrêt de la perfusion.In the embodiment according to FIG. 2, a sensor 10 is placed on the epidural catheter 5 and analyzes the quality of the fluid perfused or aspirated during the automatic suction tests. He will be able to detect the presence of blood during vascular breaches, the presence of cerebrospinal fluid during intra-thecal breaches, the presence of air during disconnection of the catheter. Any variation in the quality of the fluid triggers an alarm 9 and stops the infusion.
Dans la forme de réalisation selon la figure 3, le capteur 10 est placé au dessus du filtre 7, sur le prolongateur de perfusion 6 et peut détecter le passage d'air lors des fuites par débranchements prolongateur/seringue ou prolongateur/filtre.In the embodiment according to FIG. 3, the sensor 10 is placed above the filter 7, on the perfusion extender 6 and can detect the passage of air during leaks by disconnecting the extender / syringe or extender / filter.
Dans les formes de réalisation selon les figures 2 et 3, le capteur est un capteur externe dans lequel passe la ligne de perfusion sans contact entre le liquide et le capteur. L'analyse se fait au travers des parois de la ligne de perfusion. Les propriétés étudiées sont les propriétés physiques ou optiques du fluide. Dans la forme de réalisation selon la figure 4, le capteur 1 1 est un capteur à usage unique fixé, lors de la pose du cathéter péridural, par deux verrous Luer-Lock® entre le filtre bactérien 7 et le raccord du cathéter 8.In the embodiments according to Figures 2 and 3, the sensor is an external sensor through which passes the perfusion line without contact between the liquid and the sensor. The analysis is done through the walls of the infusion line. The properties studied are the physical or optical properties of the fluid. In the embodiment according to FIG. 4, the sensor 11 is a single-use sensor fixed, during the fitting of the epidural catheter, by two Luer-Lock® latches between the bacterial filter 7 and the connection of the catheter 8.
Dans la forme de réalisation selon la figure 5, le capteur fait partie intégrante du filtre microbien et devient un ensemble capteur-filtre 12 à usage unique que l'on installe lors de la pose du cathéter péridural entre le prolongateur 6 et le raccord du cathéter 8.In the embodiment according to FIG. 5, the sensor forms an integral part of the microbial filter and becomes a sensor-filter assembly 12 for single use which is installed during the placement of the epidural catheter between the extender 6 and the catheter connector. 8.
Dans la forme de réalisation selon les figures 4 et 5, le capteur est soit :In the embodiment according to FIGS. 4 and 5, the sensor is either:
- un capteur externe : l'analyse se fait au travers du plastique rigide de la chambre de mesure ;- an external sensor: the analysis is done through the rigid plastic of the measurement chamber;
- un capteur interne au contact du fluide, mesurant directement les propriétés physiques, chimiques ou biochimiques de celui-ci. - an internal sensor in contact with the fluid, directly measuring the physical, chemical or biochemical properties of the latter.

Claims

REVENDICATIONS
1. Dispositif pour améliorer la sécurité des perfusions péridurales effectuées par des appareils de type pousse-seringue électrique ou des appareils de type analgésie contrôlée par le patient (PCEA) caractérisé en ce qu'il comprend des moyens pour réaliser au moins un test d'aspiration automatique pendant une durée prédéterminée sur le système de perfusion, notamment le piston d'une seringue (2), et des moyens de détection de la perte de résistance à cette aspiration commandant des moyens d'alarme (9) et des moyens d'arrêt du système de perfusion lors de la détection d'une perte de cette résistance à l'aspiration notamment due à un débranchement du cathéter et/ou d'une effraction vasculaire et/ou intra-thécale.1. Device for improving the safety of epidural infusions carried out by devices of the electric syringe pump type or devices of the patient controlled analgesia type (PCEA) characterized in that it comprises means for carrying out at least one test of automatic aspiration for a predetermined period of time on the perfusion system, in particular the plunger of a syringe (2), and means for detecting the loss of resistance to this aspiration controlling alarm means (9) and means for stopping the perfusion system upon detection of a loss of this resistance to aspiration, in particular due to disconnection of the catheter and / or vascular and / or intra-thecal intrusion.
2. Dispositif selon la revendication 1, caractérisé en ce que les moyens de détection de la perte de résistance à l'aspiration comprennent des moyens de mesure directe et/ou indirecte de la pression de perfusion.2. Device according to claim 1, characterized in that the means for detecting the loss of suction resistance comprise means for direct and / or indirect measurement of the perfusion pressure.
3. Dispositif selon la revendication 1, caractérisé en ce que les moyens de détection de la perte de résistance à l'aspitation comprennent des moyens de mesure du couple et/ou de la force motrice du moteur du système de perfusion.3. Device according to claim 1, characterized in that the means for detecting the loss of resistance to the suction comprise means for measuring the torque and / or the driving force of the motor of the perfusion system.
4. Dispositif selon la revendication 1, caractérisé en ce que les moyens de détection de la perte de résistance à l'aspiration comprennent des moyens de détection du mouvement en arrière du piston ou de son chariot consécutif au test d'aspiration.4. Device according to claim 1, characterized in that the means for detecting the loss of suction resistance comprise means for detecting movement behind the piston or its carriage following the suction test.
5. Dispositif selon l'une quelconque des revendications 1 à 4, caractérisé en ce qu'il comprend des moyens pour réaliser des tests d'aspiration automatiques, de manière périodique, à intervalles réguliers programmables par l'utilisateur.5. Device according to any one of claims 1 to 4, characterized in that it comprises means for carrying out automatic suction tests, periodically, at regular intervals programmable by the user.
6. Dispositif selon l'une quelconque des revendications 1 à 5, caractérisé en ce qu'il comprend des moyens pour réaliser des tests d'aspiration automatiques réalisés systématiquement avant chaque bolus effectué par un pousse-seringue électrique ou un appareil d'analgésie contrôlée par le patient.6. Device according to any one of claims 1 to 5, characterized in that it comprises means for carrying out automatic aspiration tests carried out systematically before each bolus carried out by an electric syringe pump or a controlled analgesia device by the patient.
7. Dispositif selon l'une quelconque des revendications 1 à 6, caractérisé en ce qu'il comprend en outre, un capteur externe (10) situé sur le cathéter péridural (5), analysant les caractéristiques physiques du fluide perfusé ou aspiré lors des tests d'aspiration automatiques, toute variation de la qualité du fluide entraînant une alarme (9) et l'arrêt de la perfusion.7. Device according to any one of claims 1 to 6, characterized in that it further comprises, an external sensor (10) located on the epidural catheter (5), analyzing the physical characteristics of the fluid perfused or aspirated during automatic aspiration tests, any variation in the quality of the fluid causing an alarm (9) and stopping the infusion.
8. Dispositif selon l'une quelconque des revendications 1 à 6, caractérisé en ce qu'il comprend en outre un capteur (1 1) analysant les caractéristiques physiques du fluide perfusé ou aspiré lors des tests d'aspiration automatiques, ce capteur à usage unique étant disposé en série entre le filtre (7) et le raccord de cathéter (8) lors de la mise en place du cathéter péridural.8. Device according to any one of claims 1 to 6, characterized in that it further comprises a sensor (1 1) analyzing the physical characteristics of the fluid perfused or aspirated during automatic suction tests, this sensor single use being arranged in series between the filter (7) and the catheter connector (8) during the placement of the epidural catheter.
9. Dispositif selon l'une quelconque des revendications 1 à 6, caractérisé en ce qu'il comprend en outre, un capteur analysant les caractéristiques physiques du fluide perfusé ou aspiré lors des tests d'aspiration automatiques, ce capteur faisant partie intégrante du filtre microbien et devenant un ensemble « filtre-capteur » mis en place lors de la pose du cathéter.9. Device according to any one of claims 1 to 6, characterized in that it further comprises, a sensor analyzing the physical characteristics of the fluid perfused or aspirated during automatic suction tests, this sensor forming an integral part of the filter microbial and becoming a “filter-sensor” assembly put in place when the catheter is placed.
10. Dispositif selon la revendication 8 ou 9, caractérisé en ce que le capteur est un capteur interne analysant directement les caractéristiques électriques et/ou physiques, biochimiques et/ou chimiques du fluide perfusé ou aspiré lors des tests d'aspiration automatiques.10. Device according to claim 8 or 9, characterized in that the sensor is an internal sensor directly analyzing the electrical and / or physical, biochemical and / or chemical characteristics of the fluid perfused or aspirated during automatic aspiration tests.
1 1. Dispositif selon l'une quelconque des revendications 1 à 6, caractérisé en ce qu'il comprend un capteur externe analysant les caractéristiques physiques du fluide perfusé ou aspiré lors des tests d'aspiration automatique situé entre la seringue (2) et le filtre (7).1 1. Device according to any one of claims 1 to 6, characterized in that it comprises an external sensor analyzing the physical characteristics of the fluid perfused or aspirated during the automatic suction tests located between the syringe (2) and the filter (7).
12. Procédé pour améliorer la sécurité des perfusions péridurales effectuées par des appareils de type pousse-seringue électrique ou de type analgésie contrôlée par le patient, caractérisé en ce qu'on réalise au moins un test d'aspiration automatique pendant une durée prédéterminée sur le système de perfusion notamment le piston d'une seringue et en ce que l'on détecte la résistance à l'aspiration et que, lors de la détection d'une perte de la résistance à cette aspiration notamment due à un débranchement du cathéter et/ou d'un effraction vasculaire et/ou intra-thécale, l'on commande des moyens d'alarme (9) et des moyens d'arrêt de la perfusion. 12. A method for improving the safety of epidural infusions carried out by devices of the electric syringe pump type or of analgesia type controlled by the patient, characterized in that at least one automatic aspiration test is carried out for a predetermined period of time. perfusion system, in particular the plunger of a syringe and in that the resistance to aspiration is detected and that, upon detection of a loss of resistance to this aspiration in particular due to disconnection of the catheter and / or a vascular and / or intra-thecal invasion, alarm means (9) and means for stopping the infusion are controlled.
13. Procédé selon la revendication 12, caractérisé en ce qu'on réalise les tests d'aspiration automatique de manière périodique, à intervalles réguliers programmables par l'utilisateur.13. Method according to claim 12, characterized in that the automatic suction tests are carried out periodically, at regular intervals programmable by the user.
14. Procédé selon la revendication 12 ou 13, caractérisé en ce qu'un test d'aspiration est réalisé systématiquement avant chaque bolus effectué par un pousse- seringue électrique ou un appareil d'analgésie contrôlée par le patient. 14. The method of claim 12 or 13, characterized in that a suction test is systematically carried out before each bolus carried out by an electric syringe pump or an analgesia device controlled by the patient.
PCT/FR2001/002623 2000-09-15 2001-08-16 Device for making secure peridural perfusions WO2002022190A1 (en)

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EP01963103A EP1317298A1 (en) 2000-09-15 2001-08-16 Device for making secure peridural perfusions
AU2001284144A AU2001284144A1 (en) 2000-09-15 2001-08-16 Device for making secure peridural perfusions

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FR00/11814 2000-09-15
FR0011814A FR2814081B1 (en) 2000-09-15 2000-09-15 DEVICE FOR SECURING PERIDURAL PERFUSIONS BY PERFORMING AUTOMATIC SUCTION TESTS WITH LOSS OF RESISTANCE AND ANALYSIS OF PERFUSED OR ASPIRE FLUID

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FR2814081B1 (en) 2002-12-27
EP1317298A1 (en) 2003-06-11
FR2814081A1 (en) 2002-03-22

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