WO2023166055A1 - Dispositif de régulation de débit pour un système de perfusion et système de perfusion - Google Patents

Dispositif de régulation de débit pour un système de perfusion et système de perfusion Download PDF

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Publication number
WO2023166055A1
WO2023166055A1 PCT/EP2023/055179 EP2023055179W WO2023166055A1 WO 2023166055 A1 WO2023166055 A1 WO 2023166055A1 EP 2023055179 W EP2023055179 W EP 2023055179W WO 2023166055 A1 WO2023166055 A1 WO 2023166055A1
Authority
WO
WIPO (PCT)
Prior art keywords
fluid
fluid line
control device
flow control
infusion system
Prior art date
Application number
PCT/EP2023/055179
Other languages
English (en)
Inventor
Harry Pütter
Original Assignee
Fresenius Kabi Deutschland Gmbh
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Fresenius Kabi Deutschland Gmbh filed Critical Fresenius Kabi Deutschland Gmbh
Publication of WO2023166055A1 publication Critical patent/WO2023166055A1/fr

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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
    • A61M5/168—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
    • A61M5/16804—Flow controllers
    • A61M5/16827—Flow controllers controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths
    • 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
    • A61M5/1407—Infusion of two or more substances
    • A61M5/1408—Infusion of two or more substances in parallel, e.g. manifolds, sequencing valves
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22—Valves or arrangement of valves
    • A61M39/223—Multiway valves
    • A61M2039/224—Multiway valves of the slide-valve type

Definitions

  • the invention relates to a flow control device for an infusion system and to an infusion system.
  • a first fluid e.g., a saline solution
  • a second fluid e.g., containing a drug, e.g., a cytostatic drug for cancer therapy
  • an operator at first manually sets up a fluid flow of the second fluid and, commonly, adjusts a flow rate.
  • the operator sets up a fluid flow of the first fluid and may adjust a flow rate.
  • a flow control device for an infusion system comprises a base for supporting a first fluid line and a second fluid line.
  • the flow control device further comprises a closure device.
  • the closure device comprises an actuator and at least one closure element movable with respect to the base by means of the actuator to selectively act on the first or second fluid line, when the first and second fluid lines are supported by the base, for closing or opening the respective fluid line for a fluid flow.
  • the flow control device may comprise a timer. After administering one of the two fluids for a predetermined or adjustable period of time, the flow control device may switch to the other fluid.
  • the flow control device comprises an air sensor for detecting air in the first fluid line and/or in the second fluid line, and to generate a signal upon the detection of air in the first and/or second fluid line. This allows two detect when the corresponding first or second fluid line runs empty, e.g., after the fluid with the drug has been completely administered.
  • the flow control device may further comprise a controller.
  • the controller may be adapted to operate the closure device.
  • the controller is adapted to control the closure device based on the signal of the air sensor. This allows to automatically switch the fluid supply if the fluid administered first runs empty. Thus, a continuous operation of the infusion system without the need of an intervention by an operator is possible.
  • the at least one closure element is adapted to clamp the first or second fluid line (when the first and second fluid lines are supported by the base, e.g., mounted on the base).
  • the closure element may thus exert a clamping force selectively on the first or on the second fluid line. This clamping force effects the closure of the respective fluid line.
  • the at least one closure element may have a (first) contact surface to contact the first fluid line (when the first fluid line is supported by the base), and/or a (second) contact surface to contact the second fluid line, (when the second fluid line is supported by the base). This allows to close the fluid lines in a simple manner. Further, the closure device may simply be movably mounted between the first and second fluid lines (and their respective supports).
  • the base may comprise a (first) receptacle adapted to receive the first fluid line and/or a (second) receptacle adapted to receive the second fluid line. This allows to securely retain the fluid lines on the base.
  • the closure element may be adapted to selectively clamp the first or second fluid line against a wall of the respective receptacle.
  • the at least one closure element is selectively movable into the first receptacle or the second receptacle.
  • the closure element may be displaceable on the base between the first and second receptacles.
  • the closure element may be displaceable on the base along a straight line. This allows a secure closure of the respective fluid line.
  • first receptacle and the second receptacle are oriented in parallel to one another. This allows a simple construction of the closure device and a simple insertion of the fluid lines by an operator.
  • an infusion system comprising the flow control device according to any embodiment described herein.
  • the infusion system further comprises the first fluid line and/or the second fluid line.
  • first fluid line and/or the second fluid line comprise(s), or consist(s) of, elastic tubes, e.g., made of silicone.
  • the closure device may simply, yet securely, clamp the respective line.
  • the first fluid line and the second fluid line are in fluid connection with one another by means of a connector.
  • the connector may be a Y-shaped connector.
  • the connector may define a Y-shaped fluid path.
  • the connector may merge the first and second fluid lines into a common fluid line. This allows to administer both fluids, e.g., though the same cannula.
  • the first fluid line may be connected or connectable with a first bag containing a first fluid and the second fluid line may be connected or connectable with a second bag containing a second fluid.
  • the base of the flow control device is arranged between the respective bag and the connector. This allows a simple and reliable setup.
  • the infusion system may further comprise a pump device for conveying fluid, e.g., along a common fluid line.
  • the common fluid line is in fluid connection with the first and second fluid lines via the connector.
  • a pump device e.g., a volumetric pump
  • the pump device may be operatively connected to the flow control device, e.g., via a cable.
  • the pump device provides electrical power to the flow control device.
  • the pump device receives data from the flow control device, e.g., data indicative for the position of the closure element and/or data indicative for air sensor readings. Further, the pump device may control the flow control device.
  • Fig. 1 shows a flow control device for an infusion system with a base, a closure device, an air sensor, a controller and a battery;
  • Fig. 2 shows an infusion system with the flow control device according to Fig. 1 in a first condition
  • Fig. 3 shows the infusion system of Fig. 2 in a second condition
  • Fig. 4 shows the infusion system of Fig. 2 in a third condition
  • Fig. 5 shows the infusion system of Fig. 2 in a fourth condition.
  • Fig. 1 shows a flow control device 1 for an infusion system 2 shown in Figs. 2-5.
  • the flow control device 1 comprises a base 10 and a closure device 11.
  • the base 10 is adapted for supporting a first (or primary) fluid line 20A and a second (or secondary) fluid line 20B of the infusion system 2.
  • the base 10 forms a first receptacle 100A to receive (and retain) the first fluid line 20A and a second receptacle 100B to receive (and retain) the second fluid line 20B.
  • the fist and second receptacles 100A, 100B are elongate and extend in parallel to one another. The enumeration with first/second is made for illustrative reasons.
  • the first fluid line 20A contains a first fluid 3A
  • the second fluid line 20B contains a second fluid 3B.
  • the first fluid line 20A and the second fluid line 20B are tubes.
  • the first fluid line 20A and the second fluid line 20B are made of an elastic material. In this example silicone.
  • each of the first and second fluid lines 20A, 20B is an elastic silicone tube.
  • the closure device 11 is configured to selectively close the first fluid line 20A or the second fluid line 20B.
  • the closure device 11 comprises an actuator 111 and at least one closure element 110, here exactly one closure element 110.
  • the closure element 110 is movable with respect to the base 10 by means of the actuator 111.
  • the closure element 110 is configured to selectively act on the first or second fluid line 20A, 20B, when the first and second fluid lines 20A, 20B are supported by the base 10, particularly, mounted in the first and second receptacles 100A, 100B.
  • the actuator 111 is configured to move the closure element 110 with respect to the base 10 so as to selectively act on the first or second fluid line 20A, 20B of the infusion system 2.
  • the closure element 110 has a first contact surface 112A and a second contact surface 112B.
  • the first and second contact surfaces 112A, 112B are on opposing sides of the closure element 110.
  • the first contact surface 112A is arranged inside the first receptacle 100A (and the second contact surface 112B is not inside the second receptacle 100B).
  • the first contact surface 112A of the closure element 110 contacts the first fluid line 20A and presses against the first fluid line 20A (and the second contact surface 112B does not press against the second fluid line 20B).
  • the closure element 110 when the closure element 110 is positioned so as to act on the second fluid line 20B, the second contact surface 112B is arranged inside the second receptacle 100B (and the first contact surface 112A is not inside the first receptacle 100A).
  • the second contact surface 112B of the closure element 110 contacts the second fluid line 20B and presses against the second fluid line 20B (and the first contact surface 112A does not press against the first fluid line 20A). That is, the closure element 110 either acts on the first fluid line 20A or on the second fluid line 20B.
  • the first and second fluid lines 20A, 20B are made of a flexible material.
  • the closure element 110 when the closure element 110 is pressed against one of the first and second fluid lines 20A, 20B, the closure element clamps the respective fluid line 20A, 20B against a wall of the corresponding receptacle 100A, 100B. Thereby, the respective fluid line 20A, 20B is clamped and closed.
  • the fluid line 20A, 20B is closed, no fluid may flow though the fluid line 20A, 20B.
  • FIG. 1 shows, as an example, the situation where the first and second fluid lines 20A, 20B are inserted into the first and second receptacles 100A, 100B, and the closure element 110 clamps the first fluid line 20A.
  • the first fluid line 20A is closed for a flow of the first fluid 3A and the second fluid line is opened for a flow of the second fluid 3B.
  • the closure element 110 may be displaced relative to the receptacles 100A, 100B to instead closure the second fluid line 20B and open the first fluid line 20A.
  • the actuator 111 may be or comprise an electric motor, an electromagnet, or the like.
  • the actuator 111 is adapted to displace the closure element 110 in two opposing directions.
  • the flow control device 1 further comprises an air sensor 12.
  • the air sensor 12 is adapted to detect air inside a fluid line 20A, 20B.
  • the air detector 12 provides signals that are indicative of the presence of air inside the respective fluid line 20A, 20B.
  • the air detector 12 is arranged at the second receptacle 100B to detect air in the second fluid line 20B.
  • the flow control device 1 further comprises a controller 13.
  • the controller 13 is operatively connected to the actuator 111 of the closure device 11.
  • the controller 13 controls the actuator 111 of the closure device 11.
  • the controller 13 is operatively connected to the air sensor 12.
  • the controller 13 receives the signals provided by the air sensor 12.
  • the controller 13 is adapted to control the actuator 111 based on the signals of the air sensor 12.
  • the controller 13 may be configured to control the actuator 111 so as to close the first fluid line 20A (and open the second fluid line 20B) when no air is detected in the second fluid line 20B.
  • the controller 13 is further configured to control the actuator 111 so as to open the first fluid line 20A (and close the second fluid line 20B) when air is detected in the second fluid line 20B.
  • the controller 13 and the actuator 111 are provided with power by a battery 14 of the flow control device 1.
  • the battery 14 is a rechargeable battery.
  • the flow control device 1 can be used standalone and does not need to be connected to an external power supply.
  • the battery 14 of the flow control device 1 may be charged by a pump device 25 of the infusion system 2, e.g., via a cable 26.
  • the base 10 may be a part of a housing.
  • the housing may be openable and closable.
  • the fluid lines 20A, 20B commonly are disposable items. They are used only once. The flow control device 1, however, is reusable. To start an infusion operation, a new set of fluid lines 20A, 20B may be inserted into the receptacles 100A, 100B of the flow control device 1 base 10. After the infusion operation, the fluid lines 20A, 20B may be removed from the flow control device 1 again and disposed, while the flow control device 1 may be used with another set of fluid lines 20A, 20B and so forth. Since the closure device 11 of the flow control device 1 clamps the fluid lines 20A, 20B to close them, no part of the flow control device 1 comes into contact with the first or second fluid 3A, 3B.
  • Fig. 2 shows the infusion system 2 comprising the flow control device 1 , the first fluid line 20A and the second fluid line 20B. Further, the infusion system 2 comprises a first bag 22A and a second bag 22B. The fist bag 22A contains the first fluid 3A, the second bag 22B contains the second fluid 3B. In the example of Fig. 2, the bags 22A, 22B are mounted on a pole 21.
  • the first bag 22A is in fluid connection with the first fluid line 20A.
  • the first bag 22A is in fluid connection with the first fluid line 20A via a drip chamber 27.
  • the second bag 22B is in fluid connection with the second fluid line 20B.
  • the second bag 22B is in fluid connection with the second fluid line 20B via another drip chamber 27.
  • the respective fluid 3A, 3B flows through the flow control device 1 (when the respective fluid line 20A, 20B is open). Downstream the flow control device 1 the fluid lines 20A, 20B are connected with one another by means of a connector 24.
  • the connector 24 has a Y shape.
  • the connector 24 may be referred to as a Y-site.
  • the connector 24 connects the two fluid lines 20A, 20B with a common fluid line 20C. Via the connector 24, each of the first and second fluid lines 20A, 20B is connected with the common fluid line 20C.
  • the common fluid line 20C is inserted into a pump device 25.
  • the pump device 25 is a volumetric pump.
  • the pump device 25 is adapted to pump fluid in the common fluid line 20C downstream, i.e., in the direction from the bags 22A, 22B via the flow control device 1 and the connector 24 through the pump device 25 towards a patient for infusion.
  • the pump device 25 is also mounted on the pole 21.
  • the pump device 25 is or can be operatively coupled to the flow control device 1.
  • the pump device 25 is coupled to the flow control device 1 by a cable 26.
  • the flow control device 1 may be provided with electrical current by the pump device 25, namely, to charge the battery 14.
  • FIG. 2 An infusion operation using the infusion system 2 and particularly the flow control device 1 will be described with reference to Figs. 2-5.
  • the pole 21 has only been shown in Fig. 2 for the ease of illustration.
  • an infusion for cancer therapy is described, wherein the first fluid 3A (indicated by striped areas with stripes inclined to the right) is a saline solution and the second fluid 3B (indicated by striped areas with stripes inclined to the left) is a cytostatic drug.
  • an operator primes the fluid lines 20A, 20B, i.e., fills the fluid lines 20A- 20C with the fluids 3A, 3B to remove air from the fluid lines 20A-20C, e.g., by means of gravity.
  • the first fluid line 20A may be primed, the first bag 22A hung on the pole 21, and the common fluid line 20C may be installed in the pump device 25.
  • the second fluid line 20B may be primed, and (if not yet connected) it may be connected with the connector 24.
  • the connector 24 may have a port to connect the second fluid line 20B.
  • the second bag 22B is hung on the pole 21.
  • first and second fluid lines 20A, 20B are inserted in the flow control device 1 upstream the connector 24.
  • the flow control device 1 opens the second fluid line 20B and closes the first fluid line 20A.
  • the flow control device 1 comprises a start button that, when operated, effects the controller 13 to adjust the closure device 11 to open the second fluid line 20B and close the first fluid line 20A.
  • the flow control device 1 e.g., the controller 13
  • the flow control device 1 may be configured to automatically open the second fluid line 20B and close the first fluid line 20A when no air is detected by the air sensor 12, and/or receive a start signal from the pump device 25.
  • the pump device 25 is activated to convey fluid through the common fluid line 20C.
  • the common fluid line 20C has been primed with the first fluid 3A.
  • the pump device 25 conveys the second fluid from the second bag 22B towards the patient.
  • the common fluid line 20C is filled with the second fluid 3B while the second bag 22B contains second fluid 3B. This process continues until all of the second fluid 3B in the second bag 22B and the second fluid line 20B up to the air sensor 12 of the flow control device 1 has been conveyed. After that, air enters the section of the second fluid line 20B monitored by the sir sensor 12, and the air sensor 12 provides a signal to the controller 13 indicative of the presence of air. This situation is shown in Fig. 4.
  • the controller 13 then controls the actuator 111 to displace the closure element 110 to open the first fluid line 20A and close the second fluid line 20B. Therein, the first fluid line 20A is opened and the second fluid line 20B is closed at the same time.
  • the first fluid 3A is pumped by the pump device 25 from the first bag 22A towards the patient. This is shown in Fig. 5.
  • the pump device 25 is continuously operating before, while and after the flow control device 1 changes the supply of fluid, in this example from the second fluid 3B to the first fluid 3A. That is, after first activating the infusion system 2, no intervention of an operator is necessary, so the operation is significantly simplified. In addition, it is not necessary to hang the fist and second bags 22A, 22B at specific heights on the pole 21 with respect to one another, because the system does not depend on a static height difference of the bags 22A, 22B, in contrast to other systems. Further, the flow control device 1 and infusion system 2 prevent a concurrent flow of both fluids 3A, 3B at the same time, in contrast to other systems, which could lead to a dilution of the fluids 3A, 3B.
  • the flow control device 1 no residual volume of second fluid 3A upstream the flow control device 1 remains in the second bag 22B or second line 20B. Thereby, a loss of drugs can be prevented. Also, due to the automatic switching between the fluid lines 20A, 20B, no upstream occlusion takes place after infusion of the second fluid 3B, and the pump device 25 does not stop operation due to an air alarm by air entering the pump device 25.
  • the infusion system 2 further allows to use more than one second fluid bag 22B, one after the other. Further, it is possible to use more than one second fluid line 20B.
  • the second receptacle 100B may be formed to receive one, two or more second fluid lines 20B at the same time. Using the flow control device 1 a programming of the pump device 25 can be simplified, because a volume-to-be-infused value does not necessarily have to be entered.

Abstract

Un dispositif de régulation de débit (1) d'un système de perfusion (2) comprend une base (10) permettant de supporter une première conduite de fluide (20A) et une seconde conduite de fluide (20B) et un dispositif de fermeture (11) comprenant un dispositif d'actionnement (111) et au moins un élément de fermeture (110) mobile par rapport à la base (10) au moyen du dispositif d'actionnement (111) pour agir sélectivement sur la première ou la seconde conduite de fluide (20A, 20B), lorsque les première et seconde conduites de fluide (20A, 20B) sont supportées par la base (10), permettant de fermer ou d'ouvrir la conduite de fluide (20A, 20B) respective pour un écoulement de fluide.
PCT/EP2023/055179 2022-03-03 2023-03-01 Dispositif de régulation de débit pour un système de perfusion et système de perfusion WO2023166055A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP22159960 2022-03-03
EP22159960.8 2022-03-03

Publications (1)

Publication Number Publication Date
WO2023166055A1 true WO2023166055A1 (fr) 2023-09-07

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4966579A (en) * 1988-05-21 1990-10-30 Fresenius Ag Apparatus for dosed continuous simultaneous infusion of a plurality of infusion solutions or medicaments
US20030212381A1 (en) * 2002-05-09 2003-11-13 Whitehead Clarence Mark Enteral tube feeding device with in-operation cleaning capability
US20120283630A1 (en) * 2011-05-06 2012-11-08 Chaoyoung Lee Flow Control Line Management Apparatus
US20130331789A1 (en) * 2012-06-12 2013-12-12 Carefusion 303, Inc. Managing a fluid flow
WO2014121676A1 (fr) * 2013-02-08 2014-08-14 Gong He Infuseur manuel à plusieurs flacons
EP3165241A2 (fr) * 2015-11-04 2017-05-10 DePuy Mitek, LLC Système de gestion de fluide anti-colmatage

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4966579A (en) * 1988-05-21 1990-10-30 Fresenius Ag Apparatus for dosed continuous simultaneous infusion of a plurality of infusion solutions or medicaments
US20030212381A1 (en) * 2002-05-09 2003-11-13 Whitehead Clarence Mark Enteral tube feeding device with in-operation cleaning capability
US20120283630A1 (en) * 2011-05-06 2012-11-08 Chaoyoung Lee Flow Control Line Management Apparatus
US20130331789A1 (en) * 2012-06-12 2013-12-12 Carefusion 303, Inc. Managing a fluid flow
WO2014121676A1 (fr) * 2013-02-08 2014-08-14 Gong He Infuseur manuel à plusieurs flacons
EP3165241A2 (fr) * 2015-11-04 2017-05-10 DePuy Mitek, LLC Système de gestion de fluide anti-colmatage

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