EP4294477A1 - Dispositif et procédé de déconnexion - Google Patents

Dispositif et procédé de déconnexion

Info

Publication number
EP4294477A1
EP4294477A1 EP22707065.3A EP22707065A EP4294477A1 EP 4294477 A1 EP4294477 A1 EP 4294477A1 EP 22707065 A EP22707065 A EP 22707065A EP 4294477 A1 EP4294477 A1 EP 4294477A1
Authority
EP
European Patent Office
Prior art keywords
line
medical device
line section
pump
negative pressure
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
EP22707065.3A
Other languages
German (de)
English (en)
Inventor
Stefan Müller
Martin Thys
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Fresenius Medical Care Deutschland GmbH
Original Assignee
Fresenius Medical Care 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 Medical Care Deutschland GmbH filed Critical Fresenius Medical Care Deutschland GmbH
Publication of EP4294477A1 publication Critical patent/EP4294477A1/fr
Pending legal-status Critical Current

Links

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
    • A61M1/14—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
    • A61M1/1621—Constructional aspects thereof
    • 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
    • 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
    • A61M1/14—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
    • A61M1/1621—Constructional aspects thereof
    • A61M1/1635—Constructional aspects thereof with volume chamber balancing devices between used and fresh dialysis fluid
    • 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
    • A61M1/3643—Priming, rinsing before or after use
    • 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
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A61M2205/502—User interfaces, e.g. screens or keyboards

Definitions

  • the present invention relates to a method for releasing (disconnecting) two fluid-carrying line sections of a medical device and a medical device which is designed to carry out a method according to the invention.
  • liquid contained in the tubing set can get into the device-side fluid circuit or the hydraulic system of the device and contaminate them, which necessitates complex disinfection processes for the blood treatment machine.
  • the fluid in the fluidic system of a medical device may contain air, for example in the form of air bubbles, or contain contamination. If the fluidic system is disconnected to share a portion of the fluidic system with a patient connect, as little air as possible should remain in the part of the fluidic system to be connected to the patient. If air or contamination remains in the part of the fluidic system to be connected to the patient, this or these can get into the bloodstream of the patient.
  • the present invention is therefore based on the object of alleviating the problems of the prior art or even eliminating them entirely.
  • the object of the present invention is to provide a method for more hygienic disconnection of fluid connections and a corresponding medical device.
  • a further object of the present invention is to reduce the entry of air into at least one line section during the disconnection.
  • a first aspect of the invention relates to a medical device, set up to accommodate a detachable fluid-carrying first line section, with a second line section set up for connection to the first line section, with a displaceable element being arranged in the second line section, by means of which the second line section can be moved into a first subsection and a second subsection is separated, at least a first and a second shut-off element for enclosing a fluid volume in the first line section and the second line section, a pump for generating a negative pressure in a first of the two subsections of the second line section, causing an elastic deformation in and /or takes place on the second of the two sub-sections with movement of the slidable element, and a controller for driving the pump, wherein the controller is programmed to operate the pump to generate the vacuum in a disconnection mode.
  • the displaceable element is displaced toward a connection point of the first and second line section when a negative pressure is generated between the connection point and the displaceable element in the second line section.
  • the displaceable element divides the line section, for example the second line section, into two subsections.
  • the reversible movement of the displaceable element reduces the volume of the first subsection between the displaceable element and the connection point of the first and second line sections.
  • the displaceable element is preferably hydraulically permeable and fluidically impermeable and preferably transmits the negative pressure generated by the pump from one of the two subsections to the other of the two subsections.
  • the two subsections are preferably always fluidly separated from one another by the displaceable element.
  • the fluidic separation by the displaceable element makes it possible, by means of the displaceable element, to separate a circuit of the medical device with fresh, uncontaminated liquid, for example fresh water or fresh dialysis solution, from a circuit of the medical device with used, potentially contaminated liquid, for example used water or used dialysis solution , is always separate.
  • the first can Subsection include an area of the cycle are placed on the lower hygiene requirements than on the second subsection.
  • the displaceable element is at least partially formed by a balancing system of the medical device and/or preferably a membrane, in particular a fluidically impermeable, elastically deformable membrane, for example of the balancing system or a separately provided one, the second Line section separating membrane, includes or consists of this.
  • the displaceable element can have or consist of a movable ball and/or a piston.
  • pistons are used in combination with flow sensors.
  • the use of pistons has the disadvantage that the inner wall of a hollow cylinder in which the piston moves is exposed alternately to the process water side and the fresh water side of a medical device as the piston moves.
  • a membrane which always completely separates the process water side and the fresh water side from one another in terms of fluids, this entails a higher risk of contamination.
  • the edge of the membrane is always connected to the same area of the wall of the subsection.
  • the controller can be programmed to close at least one of the shut-off elements to close off the fluid volume on one side before the negative pressure is generated and/or to close one of the shut-off elements to enclose the fluid volume after the negative pressure has been generated.
  • at least one of the shut-off elements can also be closed manually.
  • the second line section is part of a permanently installed device-side fluidic system of the medical device.
  • the first and/or the second line section can also have one or more branches. To generate the negative pressure or to maintain it, each branch of these branched line sections can be shut off by shut-off elements provided on the line sections.
  • the controller can be programmed to close all necessary shut-off elements that are required to obtain a negative pressure in a line system that includes at least the first and second line sections, or in other words, a pressure equalization between the To prevent negative pressure area and another area of the circuit. It is known to those skilled in the art to shut off portions of a piping system to maintain a negative pressure there.
  • the medical device according to the invention can also have a fluid source, in particular a fluid source for a physiological liquid, fluidly connected to the second subsection, optionally a sterile filter fluidly arranged between and connected to the fluid source and the second subsection, and a connector on the medical device side at one end of the second Subsection for connection to one end of the first line section.
  • a fluid source in particular a fluid source for a physiological liquid
  • a sterile filter fluidly arranged between and connected to the fluid source and the second subsection
  • a connector on the medical device side at one end of the second Subsection for connection to one end of the first line section.
  • a medical device according to the invention can preferably also have an outflow line, with the first subsection being fluidically connected to the outflow line or being part of it.
  • a medical device according to the invention can be equipped with at least one direct connection line between the first subsection and the second subsection and a valve for opening and closing the connection line, and the controller can be programmed to shut off the at least one connection line in the disconnection mode.
  • a medical device according to the invention can have one or more connecting lines or short-circuit lines between a circuit of the medical device with fresh uncontaminated liquid, for example fresh water or fresh dialysis solution, and a circuit of the medical device with used, potentially contaminated liquid, for example used water or used dialysis solution , exhibit.
  • the controller can be programmed during the disconnection process of the first and second line sections to shut off all existing connecting lines or short-circuit lines.
  • the pump used within the scope of the invention is a peristaltic pump and at least one actuator of the peristaltic pump is part of the first or second shut-off element or is the first or second shut-off element.
  • the pump used within the scope of the invention is a membrane pump, which is optionally arranged on the first subsection, in particular on a branch line.
  • the first sub-section may have a branch and the diaphragm pump may be arranged on a line section which is connected to a branch of the sub-section which is not the branch in which the displaceable element is arranged.
  • the pump is an ultrafiltration pump or a flow pump, blood pump or substituate pump or balancing chamber pump of an extracorporeal blood treatment device, in particular a dialysis machine.
  • the ultrafiltration pump can be the membrane pump and the displaceable element can be a membrane of a balancing chamber.
  • a medical device according to the invention can have a user interface for input of an instruction by a user, the controller being programmed to activate the disconnection mode or to start the pump in response to an input of the instruction at the user interface.
  • a special mode can be activated in the program code of the controller.
  • a special sequence of a program code can run, with which the medical device carries out the disconnection method.
  • the disconnection mode can also be integrated into another mode.
  • a priming mode can be stored in the program code and the disconnection mode can represent a step, for example the last step, of the priming mode.
  • the controller can activate the pump in order to generate the negative pressure and/or activate the shut-off element or elements to shut off the corresponding line.
  • the user interface can have a display, a screen, a touch screen, a keyboard, an operating button, a microphone for recording a voice signal, a camera for recognizing a gesture by the user.
  • the controller can be programmed to activate a plurality of modes and to automatically transition from one of the modes to the disconnect mode.
  • the controller in a so-called reinfusion mode, can be connected to a sensor of the medical device, for example an optical sensor, which detects that there is no blood left in the tubing set.
  • the controller can process this signal in its program code in such a way that another mode can be started.
  • This mode can be the Act disconnection mode.
  • an additional mode can be provided in the program code of the controller, which includes emptying the tubing set and/or a dialyzer and/or a machine-side fluid system after the reinfusion mode has been completed, and the controller can be programmed after a predetermined time interval or after a predetermined fluid volume has been transported or after air or an interface between blood and a reinfusion liquid with optical properties other than blood has been detected in the area to be emptied by means of a sensor or after a predetermined pressure has been detected, to switch to the disconnection mode.
  • a mode can be provided in the program code of the controller, which - before the start of the treatment - fills the tubing set or the cassette with priming liquid and/or rinses the tubing set or the cassette with liquid, and the control can be programmed to switch to disconnection mode after completing priming mode.
  • the controller may be programmed to operate a pump during the priming mode to move fluid from a fluid source toward the tubing set or cassette.
  • the controller can be programmed to determine the end of the priming, for example by a specified time having elapsed, a specified volume of liquid being pushed into the tubing set or the cassette, an air detector or liquid sensor indicating that there is no more air or mostly only liquid .
  • the controller can also be programmed in such a way that the disconnection mode is initially switched to automatically, but the pump is only started after a corresponding input via the user interface.
  • the controller may be further programmed to allow user interface input to start the pump, specifically only when the disconnect mode is activated.
  • the program code of the controller can provide that there are modes or phases that are not the Disconnection modes are in which the pump does not start despite appropriate input via the user interface.
  • a medical device can also have an output unit which shows a user, for example, whether the first and second line sections can or should be disconnected. For example, a user may be prompted to disconnect the first and second conduit sections when sufficient vacuum has been created in the subsection or the displaceable element is in the displaced position. Alternatively or additionally, a user may be discouraged from disconnecting the first and second conduit sections unless sufficient negative pressure has been created in the subsection or the displaceable element is not in the displaced position.
  • the display can be done, for example, by a message on a screen.
  • the controller may comprise a computer system and may be implemented in the form of digital circuitry, computer hardware, firmware, software, or any combination thereof.
  • the invention can also be implemented in the form of a computer program product, eg a computer program on a physical information carrier (eg machine-readable storage medium).
  • the controller can be a general purpose processor, a digital signal processor (DSP) for continuous manipulation of digital signals, a microprocessor, an application specific integrated circuit (ASIC), an integrated circuit (FPGA) made up of logic elements, or other integrated circuits (IC) or hardware components have to carry out the individual process steps.
  • a data processing program (software) can be installed on the hardware components to carry out the procedural steps to run. A plurality or combination of the various components is also possible to control their operation.
  • the controller can also have a memory in which the program code is stored, for example a read-only memory (ROM) or random access memory (RAM) or both, magnetic, magneto-optical, optical or solid state (SSD) storage media -volatile memory elements such as semiconductor memory elements (e.g. EPROM, EEPROM), flash memory devices, magnetic or magneto-optical storage media, CD-ROM, DVD-ROM or Blue-Ray disks.
  • ROM read-only memory
  • RAM random access memory
  • SSD solid state
  • semiconductor memory elements e.g. EPROM, EEPROM
  • flash memory devices magnetic or magneto-optical storage media
  • CD-ROM, DVD-ROM or Blue-Ray disks e.g.
  • the storage can also be provided when required (on demand) or be accessible via the Internet (e.g. cloud computing).
  • Suitable data carriers for storing program instructions and data include all types of non-volatile memory elements such as semiconductor memory elements (e.g. EPROM, EEPROM), flash memory devices, magnetic or magneto-
  • one line section of the two line sections is preferably part of a disposable, in particular a tubing set or cassette system used in blood treatment, or optionally both line sections are part of one or more disposables, in particular a tubing set used in blood treatment or cassette system.
  • both line sections are part of one or more disposables, in particular a tubing set used in blood treatment or cassette system.
  • only the first line section is part or itself a disposable.
  • a further aspect of the invention relates to a disposable, in particular a tube or a tube set, which can be used within the scope of a medical device according to the invention.
  • This disposable can be provided in combination with the features of the medical device explained above or as an independent unit.
  • the disposable can be used in conjunction with the medical device with the movable element that is displaced on disconnection and provided with a medical device without a displaceable element that is displaced on disconnection.
  • the disposable is described below using the medical device according to the invention with the displaceable element that is displaced upon disconnection, but the description applies to the same extent to the medical device without a displaceable element that is displaced upon disconnection.
  • the disposable which can be used in the medical device, for example, can have a tube or consist of a tube or be a section of a tube.
  • the disposable can exhibit a change in volume of 1 to 5000 cubic millimeters, in particular from 1 to 1000 cubic millimeters, in particular 1 to 500 cubic millimeters, in particular from 200 to 500 cubic millimeters, in particular from 350 to 475 cubic millimeters, when a vacuum of less than -200 mbar is applied.
  • the volume change can occur in a section of tubing where the vacuum is applied.
  • the values given can relate to that area of the disposable which, when the disposable is used as intended, is arranged between a connection point to the medical device and a hose clamp which closes off the hose.
  • This disposable can form the first line section or the first line section can be part of this disposable or the disposable can be part of this first line section.
  • the change in volume can take place over a length of the tube as described below.
  • the hose can be a line which, when used during an extracorporeal treatment, is connected to a dialyzer at one end and to a patient's vascular system at a second end.
  • the hose can have a venous drip chamber or be in fluid communication with one.
  • the negative pressure at which this change in volume takes place can be a predetermined negative pressure that is defined in the program code of the controller of the medical device is stored and the controller can be programmed to generate this predetermined vacuum in the first line section.
  • the negative pressure can have a value of or less than -500mbar, -200mbar, -175mbar or -120mbar. Negative pressure may refer to a pressure compared to atmospheric pressure. If the sign related to
  • an adapter can be arranged between the first line section and the second line section and the controller can be programmed to generate a predetermined negative pressure in the first line section in the disconnection mode, the change in volume of the first line section when the Negative pressure is smaller than an inner volume of the adapter, wherein the inner volume of the adapter is preferably constant.
  • the internal volume of the adapter can remain largely constant. If an “internal volume” or “volume” of the adapter is mentioned in the remainder of the description, this preferably means that volume which is in fluid communication with the line sections connected or to be connected to the adapter.
  • the disposable in particular the tube, can be connected to the medical device by means of an adapter and designed in such a way that a change in volume of the part of the tube belonging to the first line section to which negative pressure has been applied is less than one when the tube is disconnected from another line section Volume of the adapter is, wherein the volume of the adapter is preferably constant during the disconnection or changes only very slightly.
  • the adapter can be made of a material that has a lower compliance than the hose.
  • the adapter can have a compliance per unit of length that is at least a factor of 10, in particular at least a factor of 20, lower than the compliance of the hose.
  • the adapter can be made of a rigid material, for example hard plastic, so that the volume of the adapter does not change or does not change noticeably as a result of the negative pressure.
  • the adapter can be straight or angled between two openings, preferably at right angles, ie two openings of the adapter can be oriented at right angles to one another. Between the two openings, the adapter can have an internal volume of 10 ml to 10000 ml, in particular 200 ml to 1000 ml, in particular 300 to 600 cubic millimetres, in particular 400 to 600 cubic millimetres, in particular 450 to 600 cubic millimetres.
  • the dimension of the adapter between the two openings can be between 4 cm and 8 cm, preferably between 5 and 7 cm.
  • the ratio of the length of the inner volume of the adapter to the inner diameter of the inner volume of the adapter can be between 3 to 500, in particular between 5 to 30 lie.
  • the inner volume can run straight or have a bend, in particular a right-angled bend.
  • One of the openings can be designed as a Luer connection and be suitable for establishing a Luer connection with a hose.
  • the Luer connection of the opening can account for a total volume of up to 100 cubic millimeters of the internal volume of the adapter.
  • the internal volume of the adapter can total 570 cubic millimeters and the internal volume minus the internal luer volume can be approximately 467 cubic millimeters.
  • the disposable, in particular the tube is a venous tube, preferably made from a polymer material, of an extracorporeal blood treatment device, in particular a dialysis machine.
  • the hose can have or consist of PVC as the polymer material.
  • the material of the hose can contain a plasticizer.
  • the change in volume of the disposable is preferably at a Disconnection of the tubing smaller than a volume of the adapter, the volume of the adapter preferably being constant.
  • the change in volume of the disposable under the above conditions is 0.5 ml or 1 ml greater than a volume of the adapter.
  • the said change in volume of the hose is preferably present at a temperature between 0°C and 50°C, in particular between 30°C and 42°C, in particular between 35°C and 42°C, in particular at 39°C.
  • the first line section of the hose or the disposable to which a vacuum is applied can have a length of 1000 mm to 2000 mm, in particular between 1500 mm and 1900 mm, in particular between 1500 mm and 1700 mm.
  • the first line section of the hose or the disposable to which a vacuum is applied can have an inner diameter of 3 mm to 10 mm, in particular 3 mm to 5 mm, in particular 3.5 mm to 4.5 mm, in particular 4 0mm to 4.5mm.
  • the specified length can be a length which, when used as intended, lies between one end of the hose or disposable and a clamp that can be controlled by the machine, measured along the hose or disposable.
  • the compliance of the first line section or of the disposable can have different values, for example depending on the design of the overall system made up of the volume of the adapter and the negative pressure applied.
  • the compliance of the first line section of the hose to which negative pressure is applied can be between 0.1 ml/mbar and 40 ml/mbar.
  • Suitable tubing sets used for dialysis, in which the method of disconnection described here is used typically have a compliance of 0.4 mL/mbar to 5 mL/mbar.
  • the first line section of the hose, to which negative pressure is applied can in particular have a compliance of 1 ml/mbar to 3.5 ml/mbar, in particular of 1 mL/mbar to 3 mL/mbar.
  • Compliance can also be referred to as yielding.
  • the change in volume of the hose during the disconnection should be smaller than the volume of the adapter and is achieved by the fact that air that is pulled toward the tubing during disconnection should not be pulled further than into the adapter.
  • the change in volume represents a lower limit for the internal volume of the adapter.
  • the inner volume of the adapter can also be larger than the change in volume. In this case, the system has an additional safety margin.
  • the compliance as an expression of a change in volume with a change in pressure—can be temperature-dependent due to the material properties of polymers and knows how to take this into account. It is also known to those skilled in the art that the absolute volume change is dependent on the length and diameter of the pressurized (positive or negative pressure) tubing section.
  • the disposable can have a hose clamp that can be actuated manually as a shut-off element.
  • the hose clamp which can be actuated manually, can be displaceable along the disposable or its hose.
  • An advantage and at the same time a disadvantage of such a manually operable, displaceable hose clamp is that the change in volume when the negative pressure is applied can be influenced by the displacement.
  • such a manual interaction is subject to errors, in that the user can forget to close the hose clamp that can be actuated manually or does not do so at the right place. Therefore, the area of the disposable covered by the vacuum is preferably closed off by a hose clamp that can be controlled on the machine side, and the parameter values specified above can relate to this area of the disposable.
  • the parameter values mentioned are not arbitrarily selected parameter values, but rather take into account the actual circumstances of a dialysis treatment, for example.
  • the length specifications mentioned, for example, can be traced back to the distance normally required between the dialysis machine as a medical device and a patient.
  • the hose diameters also correspond to the commonly used diameters.
  • the pressure values correspond to pressure values at which, for example, there is no complete collapse of the hose and/or at which there are no leaks along the hose lines, for example at one or more
  • the controller is also designed to release a disconnection of the first and second line sections only if it is ensured that there is a sufficient vacuum in the at least one subsection of the line section with the displaceable element, with the release being either takes place on the basis of a detection of the negative pressure by means of a pressure sensor or based on an estimate of a period of time in which after the operation of the pump in
  • Disconnection mode is to assume a sufficient negative pressure.
  • connection point of the first and second line sections can be locked if they are not released by the controller. If a user does not disconnect quickly enough after the negative pressure has built up, the negative pressure can decrease again to an insufficient level, for example due to small leaks.
  • the disconnection can be unlocked when the negative pressure reaches a first threshold and the connection between the line sections can be locked again when the negative pressure falls below a second threshold.
  • the negative pressure can be detected using a pressure sensor.
  • the controller can initiate the disconnection after the suppression reaches a first threshold for a defined in the program code unlock stored time. Thereby it can be achieved that the possibility that the negative pressure is reduced is reduced.
  • the output unit of the medical device can be used to output information to a user as to whether or not a disconnection is enabled.
  • Another aspect of the invention relates to a method for disconnecting two fluid-carrying line sections of a medical device, in particular a medical device according to the invention, set up for receiving a detachable fluid-carrying first line section and with a second line section set up for connection to the first line section, which are detachably connected to one another, wherein a displaceable element is arranged in the second line section, by means of which the line section is separated into a first subsection and a second subsection, with the steps:
  • the controller is programmed to operate the pump to generate the vacuum in a disconnect mode.
  • a method according to the invention can be understood as a method for controlling a medical device when two line sections are disconnected.
  • the medical device can have at least one direct connection line between the first subsection and the second subsection and a valve for opening and closing the connection line, wherein in a method according to the invention during the release of the connection Line sections the at least one connecting line, preferably all existing such connecting lines of the medical device, is / are blocked.
  • the displaceable element is at least partially formed and/or encompassed by a balancing system of the medical device and/or preferably consists of a membrane preferably of the balancing system or has it.
  • the displaceable element can have or consist of at least one movable ball and/or a piston.
  • the first line section is preferably part of a disposable that can be detached from the medical device and the second line section is part of a device-side fluidic system, in particular of the medical device.
  • a disconnection of the first and second line sections is only enabled if it is ensured that there is sufficient negative pressure in the at least one subsection of the line section with the displaceable element, the release preferably being based on a detection of the negative pressure by means of a pressure sensor and / or on an estimate of a period of time in which after the operation of the pump in disconnection mode or a appropriate user input to select the disconnection mode is to assume sufficient underpressure.
  • the step of enclosing a fluid volume in the two line sections can include manual closing of a shut-off element and/or automatic closing of a shut-off element.
  • a hose clamp can be closed manually or automatically.
  • FIG. 1 shows two line sections which are used as part of the method for disconnecting two fluid-carrying line sections
  • FIG. 2 shows two line sections which are used as part of the method for disconnecting two fluid-carrying line sections, and the medical device;
  • FIG 3 shows an embodiment with a pump arranged outside the first line section
  • Figures 5a and 5b show embodiments of the user interface
  • FIG. 6 shows a disposable according to the invention in the form of a venous tube which is connected to a medical device by means of an adapter;
  • FIG. 7 shows a hose according to the invention according to a first embodiment
  • FIG. 8 shows a hose according to the invention according to a second embodiment
  • FIG. 9 shows a flow chart of a method according to the invention.
  • An embodiment of the medical device 1, shown schematically in FIG. 9 An embodiment of the medical device 1, shown schematically in FIG.
  • Connector elements 4, 5 of the two line sections can be fluidically connected.
  • the medical device 1 has a pump 6 .
  • the first and second line sections each have a shut-off element 7, 8 at one end.
  • the second line section 2 has a displaceable element 38 which divides the second line section 2 into two subregions 2a and 2b.
  • the displaceable element 38 is arranged between the pump 6 and the shut-off element 7 .
  • a negative pressure can be generated in the first line section 2, in particular in its subsection 2a.
  • the negative pressure moves the displaceable element 38 from a first position or home position 38a to a second position 38b, wherein a volume of fluid encompassed by the first subsection 2a with the displaceable element in the second position is smaller than a volume of fluid encompassed by the displaceable element in the home position .
  • the shut-off elements 7, 8 can be closed, thereby enclosing a fluid volume in the two line sections 2, 3.
  • the shut-off elements 7, 8 can be closed one after the other or simultaneously, in particular a first shut-off element can be closed first, then the negative pressure can be generated and then the second shut-off element can be closed.
  • the sub-section 2a itself may also have elastic deformability.
  • applying the negative pressure causes a deformation of the second line section 2, which also includes a deformation of the second subsection 2b, although the second subsection 2b is not fluidly connected to the first subsection 2a.
  • the medical device 1 can have a controller 9 .
  • the controller 9 can be programmed to operate the pump 6 to generate the negative pressure in a disconnection mode.
  • the controller 9 can also be programmed to activate at least one or both shut-off elements 7, 8.
  • the controller can be connected via signal lines 10, 11, 12 of the medical device 1 to the respective components to be controlled, for example pump 6, shut-off elements 7, 8.
  • the controller 9 can be programmed to start and/or stop the pump 6 .
  • the controller can be programmed to start the pump 6 when the first valve 7 or valve 8 is closed and to close the other valve 7, 8, so that an enclosed volume in which there is a vacuum or the second subsection 2b has deformed.
  • the medical device 1 can have a user interface 13 .
  • the user interface 13 can be set up for an instruction to be entered by a user and the controller 9 can be programmed to activate the disconnection mode in response to the instruction being entered on the user interface 13.
  • the line sections 2, 3 are not both necessarily part of the medical device 1, but one or both of the line sections 2, 3 can only be connected to the pump 6 and the shut-off elements 7, 8 when the medical device 1 is used.
  • the medical device 1 can have the first line section 3 and/or the second line section 2 .
  • the first line section 3 and/or the second line section 2 can be part of a device-side fluidic system of the medical device 1 .
  • the first line section 3 and/or the second line section 2 can be part of a disposable.
  • the pump 6 can be arranged along the first line section 3 and/or the second line section 2 or at a point of a fluidic system outside the two line sections 2, 3 which is in fluid communication with the two line sections 2, 3.
  • the pump 6 can be arranged on the side of the shut-off elements 7.8 lying beyond the connectors 4.5. It must only be possible with the pump 6 to remove liquid from a sub-section of the second line section 2 with the displaceable element 38 .
  • the pump 6 is not arranged directly in the branch of the second pipe section 2 having the displaceable element 38, but is arranged on a branch pipe 2c which is open to the atmosphere.
  • a further shut-off element (not shown) can be provided to close off the branch line 2c, or the pump 6 itself can serve as a shut-off element.
  • the second subsection 2b can be part of a fresh water line system, or in the sense of this invention equivalent to a dialysis system of the medical device 1, and the first subsection 2a can be part of a waste water line system, or in the sense of this Invention equivalent to a dialysate flow.
  • the second subsection 2b can have a greater compliance than first subsection 2a and first line section 3 together.
  • a further shut-off element 40 can be provided on the first subsection 2a. This is open during disconnection.
  • displaceable element 38 fluidically separates the waste water line system and the fresh water line system from one another, contamination of the fresh water line system by used water carried in the first and second line sections 2, 3 is prevented.
  • FIG. 4 shows an embodiment of the medical device 1 in the form of a dialysis machine.
  • some components are optional, in particular some components can be designed as disposables and do not have to be a permanent part of the medical device 1 .
  • the disconnection point can be a connection point in the outlet of the extracorporeal blood line system, for example the connection point of the first line section 3 to the second line section 2, or connector elements 4, 5 arranged at their respective ends explicitly described components and configurations are present.
  • the medical device 1 has the following components or the dialysis machine can have the following components as a medical device 1: Fluid source or liquid source 14, balancing system 15 with pump, first sterile filter (optional) 16, second sterile filter (optional) 17, dialyzer (optional) 18, venting chamber ( optional) 19, ultrafiltration pump (optional) 6A, priming or substituate port, e.g. in the form of the connector element 5', priming or substituate pump (optional) 6B, outflow port e.g.
  • venous clamp 21 - can be used as a shut-off element 8 -, arterial clamp (optional) 22, a pre-dialysator shut-off element 23, a post-dialysator shut-off element 24, a first Drain line shut-off element 7 (optional), a first priming line shut-off element 25.
  • the components can be connected to liquid-carrying lines as follows:
  • the liquid usually a physiological liquid or dialysate, is fed from the liquid source 14 in a dialysate line 26 through the balancing system 15, which has the displaceable element 38, for example in the form of a balancing chamber membrane M , and optionally pumped through the first sterile filter 16 to the dialyzer 18 and then from the dialyzer 18 in a drain line 2, optionally through a venting chamber 19, again through the balancing system 15 into a drain 27 (not part of the medical device 1) discarded.
  • a physiological liquid or dialysate is fed from the liquid source 14 in a dialysate line 26 through the balancing system 15, which has the displaceable element 38, for example in the form of a balancing chamber membrane M , and optionally pumped through the first sterile filter 16 to the dialyzer 18 and then from the dialyzer 18 in a drain line 2, optionally through a venting chamber 19, again through the balancing system 15 into
  • the dialysate line 26 can have a branch line in the form of an inlet line 3 ' , for example optionally via a second sterile filter 17, which can lead via a priming or substituate port, ie the connector element 5 ' to a so-called priming or substituate line 2 ' .
  • This priming or substituate line 2 ' can be connected to an arterial blood line 28.
  • Liquid, eg blood during the treatment or priming or rinsing liquid in the priming phase, in the blood line(s) 28, 2 ' can be pumped by means of a blood pump 20.
  • the balancing system 15 ensures that only a predetermined amount of liquid is withdrawn from the patient or that no liquid is withdrawn.
  • balancing systems for example by flow measurement the amount of liquid being pumped to the patient and the amount being pumped away from the patient can be determined and the delta - as prescribed - can be adjusted so that a desired ultrafiltration rate, in in other words net balance rate, is realized.
  • FIG. 1 Another balancing system is shown in FIG.
  • a volumetric balancing system 15 for example, the same volume is pumped in the direction of the patient as is pumped away from the patient.
  • An ultrafiltration pump 6A connected in parallel pumps additional liquid away from the patient and thus generates the net balance or ultrafiltration rate.
  • a membrane M which is arranged in a volume-rigid balancing chamber, can be used as the displaceable element 38 for the balancing system.
  • the membrane M separates a fresh water line system of the medical device from a service water line system.
  • one or more direct connecting lines 47a, 47a ' can be present, which a
  • the following components or lines can be designed as disposables: the dialyzer 18, the arterial blood line 28, the venous blood line 3, the priming or substituate line 2'.
  • These lines together can form a tube set or a cassette system.
  • a cassette system means that at least two of these lines are permanently connected to one another and/or the lines are at least partially formed by dimensionally stable channels.
  • the medical device 1 can be set up, for example, to fill the tubing set or the cassette system with physiological fluid before the treatment.
  • the controller 9 can be programmed, for example in a filling mode, which can also be called priming mode, by means of the pumps of the balancing system 15 from the liquid source 14 via the priming or substituate port or the connector element 4' into the tubing set or the cassette system to transfer.
  • a filling mode which can also be called priming mode
  • the tubing set or the cassette system can be rinsed, liquid being flushed through the tubing set or the cassette system and through the outflow port or the connector element 5 into the outflow line 2 is flushed.
  • a method according to the invention can be applied, for example, to detaching the venous line 3 , which is connected to one another via two connector elements 4 and 5 , from the outflow line 2 .
  • the venous line 3 corresponds to the detachable fluid-carrying first line section 3 from Figures 1 to 3.
  • the discharge line 2 corresponds to the machine-side fluid-carrying second line section 2 from Figures 1 to 3 in this embodiment
  • the pump 6 generally provided with the reference numeral 6 in Figures 1-3 is implemented in this example in the form of the ultrafiltration pump 6A and the membrane M of the balancing system 15 acts as a displaceable element 38.
  • the invention can also be applied to detaching the priming line 2 ' from the feed line 3 ' , which are connected to one another via two optional connector elements 4 ' and 5 ' .
  • the substituate pump 6B is used here.
  • the venous line 3 is connected to the patient.
  • the venous line 3 is connected to the patient.
  • the patient for example in the embodiment of FIG.
  • the controller 9 causes a fluid volume to be enclosed in the lines 2 and 3 by means of shut-off elements being closed.
  • the controller can For example, control the ultrafiltration pump 6A and pump out with this liquid, so that a negative pressure is created. Because of the negative pressure, the displaceable element, in this case for example the membrane M of the balancing system 15, moves from the starting position to the second position. Consequently, a negative pressure is generated in the outflow line 2 by the pump 6A and as a result of this, a negative pressure is generated in the dialysate line 26 by this displacement of the membrane M.
  • the second line section e.g. the outflow line 2
  • the line system into which the negative pressure is transmitted via the membrane can have a greater compliance than the area of the line area exposed to the negative pressure upstream the membrane.
  • the controller can control at least one, optionally several, shut-off elements in order to keep the system in this voltage position.
  • the system can relax again from the tensioned position into a relaxed position while the membrane M of the balancing system 15 is displaced. Fluid is thus sucked away from the connection point of the connector elements 4 and 5 into the drain line 2 .
  • FIGs 5a and 5b show the user interface 13 schematically.
  • the user interface 13 can have a screen 29 and at least one button 39.
  • the screen 29 may be a touchscreen and the button 39 may be a softkey, a button operated on the touchscreen, as shown in Figure 5a.
  • the button 39 can also be embodied as a hard key, a button provided separately from the screen, as shown in FIG. 5b.
  • the controller 9 can be set up to send instructions to the user interface 13 via a data line or to receive such instructions from it.
  • the user interface 1 can be programmed, after pressing the button 39, to cause the controller to switch to the disconnection mode or to start the disconnection mode.
  • the controller 9 can be programmed, a Carry out a sequence of methods and send a message 40, for example for display, to the user interface 13 if one or more or all of the following situations occur or the control in the execution of a program reaches this point: the program flow allows activation of the Disconnection mode, the disconnection mode can be started, the connection can be released after the process steps to be carried out on the machine side have been carried out, a disinfection process must be carried out, for example because the controller has recognized that a treatment is to be prepared or carried out or a sensor, for example a Pin, which indicates the presence of a disposable, indicates to the controller that a disposable has been removed from the machine without the process steps to be carried out by the machine having taken place.
  • a sensor for example a Pin
  • FIG. 6 shows a disposable according to the invention in the form of a venous tube 3 which is connected to a machine-side connector 42 of the medical device 1 by means of an adapter 41 .
  • the venous line 3 comprises a hose, for example made of polyvinyl chloride (PVC) or another polymer, which has a connecting piece 3a, in this embodiment a Luer lock connector for example, at one end, by means of which the venous line is connected to the adapter 41 can.
  • PVC polyvinyl chloride
  • the venous line 3 has, for example, a compliance of less than 500 cubic millimeters, for example 450 cubic millimeters in this embodiment.
  • a compliance of 500 cubic millimeters or 450 cubic millimeters denotes the volume by which the inner volume of the venous line 3 changes when the connection between the adapter 41 and the machine is opened.
  • the volume of the adapter 41 is, for example, more than 450 cubic millimeters, in particular 487 cubic millimeters.
  • the change in volume of the hose, in particular the area affected by the negative pressure, after opening the connection of the venous line 3 from another line section at its end opposite the adapter 41 is therefore smaller than the volume of the adapter 41.
  • the change in volume of the venous line 3 is smaller than the volume of the adapter 41, in particular with an applied negative pressure of ⁇ 200 mbar, preferably ⁇ 175 mbar, particularly preferably ⁇ 120 mbar.
  • a negative pressure value means the pressure difference from the ambient pressure.
  • the indication "negative pressure of -120mbar” means that the pressure in the affected line section is 120mbar lower than the ambient pressure.
  • the measurement of the change in volume takes place or applies in this example at a temperature of 39 °C.
  • the area 41a of the volume of the adapter 41 into which air is allowed to enter can correspond to the volume from the machine-side end of the adapter to the point where the venous line or the connector attached thereto ends. This can be explained in more detail with reference to FIG be explained.
  • the venous line 3 can have a connector 3a at one end, which is connected to the connector 43 of the adapter.
  • the connector 43 can be a thread that is pre-stamped in the adapter or can have a thread onto which the connector 3a can be screwed. In this case, this connector 3a pushes itself into or over the connector 43. This creates a common volume which is formed by both the adapter 41 and the connector 43 as is also surrounded by the venous line 3 or the connector 3a.
  • this common volume does not belong to the area 41a into which the air is allowed to enter.
  • the length of the adapter shown from bottom to top in the drawing i.e. the area perpendicular to the lumen connected to the machine, may total 13mm to 14mm, but only 6mm to 7mm of that may extend to the area 41a, since the connector 3a of the venous line 3 overlaps the adapter over a length of 6mm to 7mm.
  • the adapter 41 can be designed as a one-piece hard plastic component with a length measured between two openings of the adapter of 4 cm to 8 cm or 5 cm to 7 cm in length.
  • the compliance of the adapter 41 can be negligibly small.
  • the venous line 3 can have an inner diameter of 4.3 mm and the length of the area exposed to the negative pressure can be 1900 mm starting from the Luer lock connector 3a to a second shut-off element (for example a hose clamp) in this embodiment.
  • the length of the area exposed to the negative pressure can also be 1700 mm, but at least 1000 mm, preferably at least 1500 mm.
  • the compliance of this hose section can be less than 3.5 ml/mbar, preferably less than 3 pl/mbar and preferably more than 0.5 ml/mbar.
  • the venous line 3 can also be implemented with the parameters as stated in the description preceding the description of the figures.
  • the venous line 3 has the Luer lock connector 3a at a first end, by means of which the venous line 3 can be connected to the adapter 41 .
  • the venous line 3 has a further connector 3b, by means of which the venous line 3 can be connected to a dialyzer, for example.
  • the venous line 3 includes an air separation chamber 44, for example in the form of a drip chamber, by means of which air can be removed from the venous line 3.
  • the Air separation chamber on an opening, this opening can be closed, for example, by a clamp, not shown, or a valve, not shown.
  • the venous line 3 can have a clot catcher 45, for example in the form of a plastic sieve, which is preferably integrated in the air separation chamber 44 and serves to catch blood clots.
  • a venous line according to this embodiment is preferably used with a manually operable hose clamp 46 as a shut-off element.
  • the venous line 3 has at least one marking 47 which shows the patient an area in which the hose clamp 46 is to be positioned in order to clamp the venous line 3 shut off in a desired position and thus with a desired length. It is also conceivable to provide several markings in order to specify several defined positions of the hose clamp 46 for the patient. With the different position of the hose clamp 46, a different compliance of the venous line 3 can be set, for example, when a negative pressure is applied and the hose clamp 46 closes the venous line 3.
  • step S1 the disconnection mode is selected, for example by a corresponding user input in the case of the embodiment shown in FIGS. User interface shown in Figures 5a and 5b.
  • step S2 the medical device is then controlled in such a way, for example by activating individual valves, that a fluid volume is enclosed in the first and second line sections, which are intended to be detached or disconnected from one another.
  • the second line section can have two subsections separated by a movable element.
  • step S3 a negative pressure is then generated in a first of the two sub-sections of the second line section, for example by activating a pump accordingly. This negative pressure is transferred to the second of the two sub-sections by the movement of the movable element.
  • a check can then be carried out in step S4 as to whether the negative pressure generated in step S3 corresponds to a target value or falls within a tolerance range surrounding it.
  • step S4 If the check in step S4 yields a positive result, the first line section and the second line section are separated from one another in step S5.
  • step S4 If the check in step S4 yields a negative result, a negative pressure is generated according to step S3.
  • Embodiments according to the invention can have one or more of the features mentioned above in any combination, provided that the specific embodiment is not recognizable as technically impossible for the person skilled in the art.
  • Second line section comprising e.g. the drain line of the dialysis machine from Fig. 4
  • First line section comprising e.g. the venous line of the dialysis machine from Fig. 4

Abstract

L'invention concerne un appareil médical conçu pour recevoir une première section de conduite (3) d'acheminement de fluide amovible. L'appareil médical comporte une deuxième section de conduite (2) qui est conçue pour être raccordée à la première section de conduite (3), un élément mobile (38) étant disposé dans la deuxième section de conduite (2) et servant à diviser la deuxième section de conduite (2) en une première sous-section (2a) et en une deuxième sous-section (2b). L'appareil médical comprend également au moins un premier et un deuxième élément d'arrêt (7, 8) pour enfermer un volume de fluide dans la première section de conduite (3) et la deuxième section de conduite (2) ; et une pompe (6) servant à créer une dépression dans une première des deux sous-sections (2a, 2b) de la deuxième section de conduite (2), ce qui permet d'obtenir une déformation élastique dans et/ou sur la deuxième des deux sous-sections (2a, 2b) par déplacement de l'élément mobile (38) ; ainsi qu'une commande pour commander la pompe (6), la commande étant programmée, dans un mode de déconnexion, pour faire fonctionner la pompe (6) afin que la dépression soit créée.
EP22707065.3A 2021-02-18 2022-02-16 Dispositif et procédé de déconnexion Pending EP4294477A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102021103885.5A DE102021103885A1 (de) 2021-02-18 2021-02-18 Vorrichtung und Verfahren zur Diskonnektion
PCT/EP2022/053718 WO2022175289A1 (fr) 2021-02-18 2022-02-16 Dispositif et procédé de déconnexion

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EP4294477A1 true EP4294477A1 (fr) 2023-12-27

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EP22707065.3A Pending EP4294477A1 (fr) 2021-02-18 2022-02-16 Dispositif et procédé de déconnexion

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EP (1) EP4294477A1 (fr)
JP (1) JP2024508276A (fr)
CN (1) CN116867527A (fr)
CA (1) CA3208509A1 (fr)
DE (1) DE102021103885A1 (fr)
WO (1) WO2022175289A1 (fr)

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Publication number Priority date Publication date Assignee Title
DE102007024463A1 (de) 2007-05-25 2008-11-27 Fresenius Medical Care Deutschland Gmbh Verfahren und Vorrichtung zur Überprüfung der korrekten Ankopplung einer Zugabevorrichtung an ein Therapiegerät
JP5356853B2 (ja) * 2009-02-12 2013-12-04 日機装株式会社 血液浄化装置
DE102009024575A1 (de) 2009-04-23 2010-12-23 Fresenius Medical Care Deutschland Gmbh Verbindungseinrichtung und Verfahren zum Konnektieren wenigstens zweier fluidführender medizinitechnischer Systeme, sowie medizintechnische Vorrichtung
JP5858868B2 (ja) * 2012-05-30 2016-02-10 澁谷工業株式会社 血液透析装置の操作方法および血液透析装置
DE102013106830A1 (de) * 2013-06-28 2015-01-15 Gbn Systems Gmbh Anschlussstück zum abgeschlossenen, tropffreien und sicheren Transfer von Fluiden
DE102020114988A1 (de) * 2020-06-05 2021-12-09 Fresenius Medical Care Deutschland Gmbh Verfahren zur Diskonnektion

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DE102021103885A1 (de) 2022-08-18
CA3208509A1 (fr) 2022-08-25
JP2024508276A (ja) 2024-02-26
CN116867527A (zh) 2023-10-10

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