WO2006054957A1 - Novel extracorporeal hemodialysis circuit - Google Patents

Novel extracorporeal hemodialysis circuit Download PDF

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Publication number
WO2006054957A1
WO2006054957A1 PCT/TN2005/000006 TN2005000006W WO2006054957A1 WO 2006054957 A1 WO2006054957 A1 WO 2006054957A1 TN 2005000006 W TN2005000006 W TN 2005000006W WO 2006054957 A1 WO2006054957 A1 WO 2006054957A1
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Prior art keywords
novel
circuit
bubble trap
blood
arterial
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PCT/TN2005/000006
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French (fr)
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WO2006054957B1 (en
Inventor
Naoufel Bou Akez
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Naoufel Bou Akez
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Publication of WO2006054957A1 publication Critical patent/WO2006054957A1/en
Publication of WO2006054957B1 publication Critical patent/WO2006054957B1/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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3627—Degassing devices; Buffer reservoirs; Drip chambers; Blood filters
    • 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3601—Extra-corporeal circuits in which the blood fluid passes more than once through the treatment unit
    • A61M1/3603—Extra-corporeal circuits in which the blood fluid passes more than once through the treatment unit in the same direction

Definitions

  • Hemodialysis consists in purifying the blood of the patients (renal insufficiency) of the toxic waste by a filter (the dialyzer).
  • Dialysis without heparin; the reutilization of the dialyser; perdialytic transfusions; dialysis in uni puncture; the heparin dosage error; the poor degassing quality of the dialyser; the alarms with stopping of the blood pump, are the main causes causing the formation of these clots.
  • the present invention consists in the use of a new extracorporeal circuit making it possible to remedy these drawbacks thanks to the possibility of realizing new functions impossible to achieve by the conventional circuit; these functions have favorable repercussions on the different evaluation criteria of the hemodialysis session and which are the epurative quality, the thrombotic risk and the asepsis.
  • the main new features are:
  • the new extracorporeal circulation invented consists of an arterial line (Fig. 2-b), a venous line (Fig. 2r ⁇ ), a dialyzer (Fig. 2-e), a re-circulation line (Fig. 2-c). ), there are two models:
  • the venous line (Fig. 5) is characterized by a venous bubble trap (Fig. 5-a) with an additional blood outlet (recirculation line) at its upper end (Fig. 5-b). equipped with an infusion line (Fig. 5-c).
  • This re ⁇ circulation line can be located at its lower part (Fig. 6-a) or both.
  • the venous injection site is located downstream of the venous bubble trap (fig.5-d).
  • the recirculation line (Fig. 2-c) is a tubule which connects the venous bubble trap (Fig. 2-a) to the arterial line (fig 2-b), it may be equipped with a body of This pump is used with double-pump generators (Fig. 7-a), thus allowing the possibility of recirculating the blood with a flow rate set by the second pump (P 2) (Fig. 7).
  • the clot sensor is a removable part consisting of a filter (Fig. 8-a) with or without air intake (Fig 8-b) whose role is to capture the blood clots formed in the circuit, it can be mounted at the exit of the venous bubble trap or that of the arterial bubble trap:
  • the clot sensor can be mounted between the arterial bubble trap and the arterial line on its portion connecting the arterial bubble trap to the pump body (Fig. 10-a).
  • the clot sensor can be mounted between the arterial bubble trap and the arterial line on either side of the blood pump (Fig. 11 - at).
  • An arterial bubble trap that has two blood outlets, an exit to the dialyzer and an exit to the re-circulation line; unlike the conventional arterial bubble trap which has only one exit to the dialyzer.
  • a venous bubble trap that has two blood outlets, an exit to the patient and an exit to the re-circulation line; unlike the conventional venous bubble trap that has only one exit to the patient.
  • a new invented component that involves the creation of a line connecting the venous bubble trap to the arterial line and which will allow the blood to circulate again; it is the recirculation line that does not exist in the conventional circuit.
  • a new invented device that will be used to capture and extract blood clots formed in the circuit is the clot sensor that can be removed to be placed on the recirculation line and that does not exist in the circuit conventional.
  • the industrial application consists in the manufacture of the new molds for these new components (the arterial bubble trap, the venous bubble trap, the clot sensor) followed by the injection with the plastic-based raw material (medical PVC) After having manufactured these components, they are assembled to obtain the new circuit (FIG. 2).

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Cardiology (AREA)
  • Urology & Nephrology (AREA)
  • Emergency Medicine (AREA)
  • External Artificial Organs (AREA)

Abstract

The invention concerns the design of a novel arteriovenous extracorporeal circuit used in hemodialysis in patients suffering from renal failure; said novel circuit enables novel functions to be performed by the physician which have beneficial effects on the quality of hemodialysis and on the patient's safety. Among these novel manipulations, the following can be mentioned: extraction of blood clots formed in the circuit; high-flow rate rinsing of the circuit and of the dialyser. The invention concerns this novel circuit and its components (a novel arterial bubble trap, a novel venous bubble trap, a recycling line, a blood clot sensor) and to protect all the types of their constituent assemblies as well as the various models of the novel extracorporeal hemodialysis circuit.

Description

NOUVEAU CIRCUIT EXTRA-CORPOREL DΗEMODIALYSE NEW EXTRA-BODY CIRCUIT OF DEMODIALYSIS
L'hémodialyse consiste à épurer le sang des malades (insuffisants rénaux) des déchets toxiques par un filtre (Ie dialyseur).Hemodialysis consists in purifying the blood of the patients (renal insufficiency) of the toxic waste by a filter (the dialyzer).
Pour assurer l'épuration extracorporelle du sang, nous utilisons une tubulure assurant la sortie du sang de l'organisme vers le dialyseur : c'est la ligne artérielle (fig. la) ; une fois le sang filtré par le dialyseur (fig. Ib), il sera véhiculé par une autre tubulure pour reprendre la circulation corporelle : c'est la ligne veineuse (fig. Ic), la circulation du sang étant assurée par une pompe à sang (fig. Id).To ensure the extracorporeal purification of the blood, we use a tubing ensuring the exit of the blood from the body towards the dialyzer: it is the arterial line (fig la); once the blood has been filtered by the dialyzer (Fig Ib), it will be conveyed by another tube to take up the body circulation: it is the venous line (Fig. Ic), the circulation of the blood being ensured by a blood pump (Fig. Id)
Chez les malades hémodialysés, au cours de l'utilisation du circuit extracorporel conventionnel, le contacte du sang avec les tubulures provoque une adhésion des plaquettes et des fibrines sur la paroi interne du circuit, cette adhésion évolue vers la formation des caillots sanguins dans la circulation extracorporelle et a des conséquences défavorables sur le risque thrombotique ainsi que sur la qualité épurative du dialyseur.In hemodialysis patients, during the use of the conventional extracorporeal circuit, the contact of the blood with the tubules causes an adhesion of platelets and fibrins on the inner wall of the circuit, this adhesion evolves towards the formation of blood clots in the circulation. extracorporeal and has adverse consequences on the thrombotic risk as well as the purifying quality of the dialyzer.
La dialyse sans héparine ; la reutisation du dialyseur ; les transfusions perdialytique ; la dialyse en uni poncture ; l'erreur de dosage d'héparine ; la mauvaise qualité de dégazage du dialyseur ; les alarmes avec arrêt de la pompe à sang, sont les principales causes provoquant la formation de ces caillots.Dialysis without heparin; the reutilization of the dialyser; perdialytic transfusions; dialysis in uni puncture; the heparin dosage error; the poor degassing quality of the dialyser; the alarms with stopping of the blood pump, are the main causes causing the formation of these clots.
La présente invention consiste à l'utilisation d'un nouveau circuit extracorporel permettant de remédier à ces inconvénients grâce à la possibilité de réaliser des nouvelles fonctions impossible à réaliser par le circuit conventionnel ; ces fonctions ont des répercussions favorables sur les différents critères d'évaluation de la séance d'hémodialyse et qui sont la qualité épurative, le risque thrombotique et l'asepsie. Les principales nouvelles fonctions sont :The present invention consists in the use of a new extracorporeal circuit making it possible to remedy these drawbacks thanks to the possibility of realizing new functions impossible to achieve by the conventional circuit; these functions have favorable repercussions on the different evaluation criteria of the hemodialysis session and which are the epurative quality, the thrombotic risk and the asepsis. The main new features are:
- Le rinçage du circuit et du dialyseur à haut débit (600 ce par minute)- flushing circuit and dialyzer at high flow rate (600 cc per minute)
- Passage instantané en recirculation à circuit fermé sans aucune déconnection- Instantaneous recirculation closed circuit without any disconnection
- L'extraction des caillots sanguins présents dans le piège à bulle artériel- The extraction of blood clots present in the arterial bubble trap
- L'extraction des caillots sanguins présents dans le piège à bulle veineux- The extraction of blood clots present in the venous bubble trap
- Restitution du sang vers le malade par une voie de secours- Restitution of blood to the patient by an emergency route
Ces fonctions sont devenues possibles grâce aux nouveaux pièges à bulles artériel et veineux qui disposent d'une deuxième sortie de sang pour faire recirculer le sang ou le sérum en passant par un dispositif qui capte les caillots.These functions have become possible thanks to the new arterial and venous bubble traps that have a second blood outlet to recirculate blood or serum through a device that captures clots.
La nouvelle circulation extracorporelle inventée est constituée par une ligne artérielle (fig. 2-b), une ligne veineuse (fig. 2rά), un dialyseur (fig. 2-e), une ligne de re-circulation (fig. 2-c) , on distingue deux modèles :The new extracorporeal circulation invented consists of an arterial line (Fig. 2-b), a venous line (Fig. 2rά), a dialyzer (Fig. 2-e), a re-circulation line (Fig. 2-c). ), there are two models:
- Le premier modèle dont le piège à bulle artériel est situé en aval du corps de pompe (fig. 3) et la ligne artérielle se caractérise par la présence d'une bifurcation qui la relie au piège a bulle veineux (fig. 3-a) ; le piège à bulle artériel se caractérise par une deuxième sortie du sang située à sa partie supérieure (fïgn3-b) et qui va servir à l'extraction des caillots et leurs migration vers le capteur des caillots.- The first model in which the arterial bubble trap is located downstream of the pump body (Figure 3) and the arterial line is characterized by the presence of a bifurcation which connects it to the venous bubble trap (Fig. 3-a); the arterial bubble trap is characterized by a second blood outlet located at its upper part (fgn3-b) and which will be used for the extraction of clots and their migration to the clot sensor.
- Le deuxième modèle dont le piège à bulle artériel est situé en avant de la pompe à sang (fig4) et la ligne artérielle se caractérise par la présence de deux bifurcations, la première avant le piège a bulle artériel (fig. 4-a), la deuxième juste avant le corps de pompe (%4-b).- The second model in which the arterial bubble trap is located in front of the blood pump (fig4) and the arterial line is characterized by the presence of two bifurcations, the first one before the arterial bubble trap (Fig. 4-a) the second just before the pump body (% 4-b).
La ligne veineuse (fig. 5) se caractérise par un piège à bulle veineux (fig. 5-a) disposant d'une sortie de sang supplémentaire (ligne de re-circulation) située à sa partie supérieure (fig. 5-b) munie d'une ligne de perfusion (fig. 5-c). Cette ligne de re¬ circulation peut se situer à sa partie inférieure (fig. 6-a) ou les deux à la fois. Le site d'injection veineux se situ en aval du piège à bulle veineux (fig.5-d).The venous line (Fig. 5) is characterized by a venous bubble trap (Fig. 5-a) with an additional blood outlet (recirculation line) at its upper end (Fig. 5-b). equipped with an infusion line (Fig. 5-c). This re¬ circulation line can be located at its lower part (Fig. 6-a) or both. The venous injection site is located downstream of the venous bubble trap (fig.5-d).
La ligne de re-circulation (fig. 2-c) est une tubulure qui relie le piège à bulle veineux (fig. 2-a) à la-ligne artérielle (fig2-b), elle peut être-munie_d'un_ corps de pompe qu'on utilise avec des générateurs à double pompes (fig. 7-a) permettant ainsi la possibilité de faire re-circuler le sang avec un débit fixé par la deuxième pompe (P 2) (fig. 7).The recirculation line (Fig. 2-c) is a tubule which connects the venous bubble trap (Fig. 2-a) to the arterial line (fig 2-b), it may be equipped with a body of This pump is used with double-pump generators (Fig. 7-a), thus allowing the possibility of recirculating the blood with a flow rate set by the second pump (P 2) (Fig. 7).
Le capteur de caillot est une pièce démontable constituée d'un filtre (fig. 8-a) avec ou sans prise d'air (fig. 8-b) dont le rôle est de capter les caillots sanguins formés dans le circuit, on peut être monté à la sortie du piège à bulle veineux ou celle du piège à bulle artériel :The clot sensor is a removable part consisting of a filter (Fig. 8-a) with or without air intake (Fig 8-b) whose role is to capture the blood clots formed in the circuit, it can be mounted at the exit of the venous bubble trap or that of the arterial bubble trap:
- Sur la ligne de re-circulation entre le piège à bulle veineux et la ligne artérielle (fig. 9-a)- On the recirculation line between the venous bubble trap and the arterial line (Fig. 9-a)
- Sur la ligne artérielle (deux modèles):- On the arterial line (two models):
Dans le premier modèle le piège à bulle artériel est situé avant la pompe à sang, le capteur de caillot peut être monté entre le piège à bulle artériel et la ligne artérielle sur sa portion reliant le piège à bulle artériel au corps de pompe (fig. 10-a). Dans le deuxième modèle le piège à bulle artériel est situé après la pompe à sang, le capteur de caillot peut être monté entre le piège à bulle artériel et la ligne artérielle de part et d'autre de la pompe à sang (fig. 11 -a).In the first model the arterial bubble trap is located before the blood pump, the clot sensor can be mounted between the arterial bubble trap and the arterial line on its portion connecting the arterial bubble trap to the pump body (Fig. 10-a). In the second model the arterial bubble trap is located after the blood pump, the clot sensor can be mounted between the arterial bubble trap and the arterial line on either side of the blood pump (Fig. 11 - at).
- Entre le piège à bulle veineux et l'aiguille veineuse (fig. 12) et nous permet de restituer le sang du malade malgré l'obstruction totale du piège à bulle veineux.- Between the venous bubble trap and the venous needle (Fig. 12) and allows us to restore the blood of the patient despite the complete obstruction of the venous bubble trap.
La nouveauté inventive se résume à 4 éléments :The inventive novelty comes down to 4 elements:
- Un piège à bulle artériel qui comporte deux sorties de sang , une sortie vers le dialyseur et une sortie vers la ligne de re-circulation ; contrairement au piège à bulle artériel conventionnel qui ne comporte q'une seule sortie vers le dialyseur.An arterial bubble trap that has two blood outlets, an exit to the dialyzer and an exit to the re-circulation line; unlike the conventional arterial bubble trap which has only one exit to the dialyzer.
- Un piège a bulle veineux qui comporte deux sorties de sang, une sortie vers le malade et une sortie vers la ligne de re-circulation ; contrairement au piège a bulle veineux conventionnel qui ne comporte qu'une seule sortie vers le malade.- A venous bubble trap that has two blood outlets, an exit to the patient and an exit to the re-circulation line; unlike the conventional venous bubble trap that has only one exit to the patient.
- Un nouveau composant inventé qui consiste à la création d'une ligne reliant le piège a bulle veineux à la ligne artérielle et qui va permettre le sang de re-circuler ; c'est la ligne de re-circulation qui n'existe pas dans le circuit conventionnel. - Un nouveau dispositif inventé qui va servir à capter et extraire les caillots sanguins formés dans le circuit , c'est le capteur des caillots qui peut être démontable pour être placé sur la ligne de re-circulation et qui n'existe pas dans le circuit conventionnel.- A new invented component that involves the creation of a line connecting the venous bubble trap to the arterial line and which will allow the blood to circulate again; it is the recirculation line that does not exist in the conventional circuit. - A new invented device that will be used to capture and extract blood clots formed in the circuit is the clot sensor that can be removed to be placed on the recirculation line and that does not exist in the circuit conventional.
L'application industrielle consiste à la fabrication des nouveaux moules pour ces nouveaux composants (le piège à bulle artériel ; le piège à bulle veineux ; le capteur des caillots) suivie par l'injection par la matière première à base de plastique (PVC médical).Apres avoir fabriquer ces composants, on réalise leur assemblage pour obtenir le nouveau circuit (fig 2)The industrial application consists in the manufacture of the new molds for these new components (the arterial bubble trap, the venous bubble trap, the clot sensor) followed by the injection with the plastic-based raw material (medical PVC) After having manufactured these components, they are assembled to obtain the new circuit (FIG. 2).
L'application pratique sur des malades a été réalisée avec succès et a confirmé les résultats des études expérimentales in vitro. Ces résultats sont obtenus grâce aux nouvelles manipulations devenues possibles avec le nouveau circuit et impossible à réaliser par le circuit conventionnel. ; parmi ces nouvelles manipulations nous citons particulièrement :The practical application on patients has been successfully carried out and confirmed the results of in vitro experimental studies. These results are obtained thanks to the new manipulations made possible with the new circuit and impossible to achieve by the conventional circuit. ; Among these new manipulations we cite particularly:
- L'extraction des caillots sanguins formés dans le circuit en faisant re-circuler le sang par la ligne de re-circulation et le capteur des caillots .Cette manipulation est très utile pour les malades qui présentent une contre indication à l'utilisation des anticoagulants.- The extraction of blood clots formed in the circuit by circulating the blood through the re-circulation line and the clot sensor. This manipulation is very useful for patients who have a contraindication to the use of anticoagulants .
- Le rinçage à haut débit du circuit en faisant re-circuler le sérum à travers la ligne de re-circulation et en traversant le capteur des caillots .Cette manipulation va assurer une meilleure qualité de nettoyage du circuit ainsi que du dialyseur donc améliorer du coefficient d'épuration des déchets toxiques dans le sang. - High-speed rinsing of the circuit by re-circulating the serum through the re-circulating line and through the clot sensor. This manipulation will ensure a better cleaning quality of the circuit as well as the dialyser thus improving the coefficient purification of toxic waste in the blood.

Claims

55
REVENDICATIONS
- Circuit extracorporel utilisé en hémodialyse constitué d'un nouveau piège à bulle artériel, un nouveau piège à bulle veineux, une ligne de recirculation (fig. 2)- Extracorporeal circuit used in hemodialysis consisting of a new arterial bubble trap, a new venous bubble trap, a recirculation line (Fig. 2)
- Piège à bulle artériel comporte une ou plusieurs sorties supplémentaires de re-circulation (fig. 3-b)- Arterial bubble trap has one or more additional re-circulation outlets (Fig. 3-b)
- Piège à buUe veineux comporte une ou plusieurs sorties supplémentaires de re-circulation (fig. 5-b) (fig. 6-a)- Venous circulation trap has one or more additional recirculation outlets (Fig. 5-b) (Fig. 6-a)
- Ligne de re-circulation avec ou sans corps de pompe (fig7a)- Recirculation line with or without pump body (fig7a)
- Capteur des caillots avec ou sans prise d'air (fig. 8)- Clot sensor with or without air intake (Fig. 8)
- Emplacement du capteur des caillots selon quatre possibilités (fig.9) (figlO) (fig. 11) (fig. 12) - Location of clot sensor according to four possibilities (fig.9) (figlO) (fig.11) (fig.12)
PCT/TN2005/000006 2004-11-22 2005-11-21 Novel extracorporeal hemodialysis circuit WO2006054957A1 (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012134409A1 (en) 2011-03-31 2012-10-04 Naoufel Bou Akez Improved cap for a bubble trap

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020017489A1 (en) * 1997-10-21 2002-02-14 Utterberg David S. Automatic priming of blood sets
WO2003082376A2 (en) * 2002-03-28 2003-10-09 Naoufel Bou Akez Generator involving the use of a single blood pump
EP1457218A1 (en) * 2001-12-18 2004-09-15 JMS Co., Ltd. Automatic apparatus for blood dialysis and priming method using the apparatus

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020017489A1 (en) * 1997-10-21 2002-02-14 Utterberg David S. Automatic priming of blood sets
EP1457218A1 (en) * 2001-12-18 2004-09-15 JMS Co., Ltd. Automatic apparatus for blood dialysis and priming method using the apparatus
WO2003082376A2 (en) * 2002-03-28 2003-10-09 Naoufel Bou Akez Generator involving the use of a single blood pump

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012134409A1 (en) 2011-03-31 2012-10-04 Naoufel Bou Akez Improved cap for a bubble trap
CN103648541A (en) * 2011-03-31 2014-03-19 N·布阿凯兹 Improved cap for a bubble trap

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