Disconnection Method

Description

[0001] The present invention relates to a method for disconnecting fluid-carrying conduit sections of a medical device according to the preamble of claim 1 and to a medical device designed for carrying out a method according to the invention according to the preamble of claim 7.

[0002] When disconnecting fluid-carrying sections of medical devices, such as a machine-side fluidic system from a disposable fluidic system of extracorporeal blood treatment machines or dialysis machines, high hygiene standards must be maintained to ensure patient safety. A conventional extracorporeal blood treatment machine is described, for example, in JP5356853B2.

[0003] In practice, for example, after extracorporeal blood treatment, when disconnecting a tubing set from a blood treatment machine, fluid contained in the tubing set can enter the device's fluid circuit or hydraulics and contaminate it, necessitating elaborate disinfection procedures for the blood treatment machine.

[0004] Before the start of treatment, after completion of a priming process (filling and flushing a fluid system with physiological fluid), the fluid in the medical device's fluid system may contain air, for example in the form of air bubbles, or contaminants. When the fluid system is disconnected to connect a portion to a patient, as little air as possible should remain in the patient-connected portion. If air or contaminants remain in the patient-connected portion, they can enter the patient's bloodstream.

[0005] Furthermore, it is particularly desirable in the medical field to avoid leaks for hygienic reasons whenever fluid-carrying lines are disconnected.

[0006] The present invention is therefore based on the objective of mitigating or even completely eliminating the problems of the prior art. In particular, the present invention aims to provide a method for more hygienic disconnection of fluid connections and a corresponding medical device.

[0007] This problem is solved by the subject matter of the independent claims. Advantageous embodiments of the invention are the subject matter of the dependent claims.

[0008] A method according to the invention for disconnecting two fluid-carrying pipe sections of a medical device, which are detachably connected to each other, comprises the following steps: Enclosing a fluid volume in the two pipe sections, creating a vacuum in the two pipe sections, and releasing the connection between the pipe sections, wherein creating a vacuum in the two pipe sections causes an elastic deformation in and / or on the first pipe section, which has at least a partial elastic property, from an initial position to a stress position, wherein a fluid volume enclosed by the first pipe section in the stress position is smaller than a fluid volume enclosed in the initial position, and wherein the fluid volume enclosed by the first pipe section in the stress position increases when the connection between the pipe sections is released.

[0009] The term "fluid" encompasses liquids, gases, and mixtures of liquids and gases in dissolved form (no interface) or undissolved form (with interface). The theory presented here can be used, for example, in the disconnection of two pipe sections that are completely filled with liquid, completely filled with gas, or filled with both liquid and gas, and in particular with a liquid-filled system connected to a gas reservoir, or with a gas-filled system that is moist, for example, still containing droplets.

[0010] The process may include a step in which the pipe sections are filled with liquid.

[0011] The term "fluid volume" refers to an enclosed quantity. Applying a vacuum removes a portion of this enclosed quantity from the enclosed volume (in the sense of a geometric volume), thus reducing the fluid volume. This reaction can manifest as a reduction in the geometric volume, such as a decrease in the diameter of a hose. This is particularly relevant for liquids that are approximately incompressible or expandable. If the enclosed volume is partially filled with gas, this gas can expand, especially in the case of a rigid geometric volume, when some of the liquid / gaseous material is removed. Combinations of a reduction in geometric volume and the expansion of a gas with a decrease in fluid volume are also possible.

[0012] "Elastic" or "more elastic" means that when the connection is disconnected without the intervention of external forces, the fluid volume within the pipe section increases. For example, the pipe section may contract in response to the reduced pressure (resulting in a smaller geometric volume) and, upon disconnection, relax due to the intrinsic restoring force of the pipe section, increasing in volume and causing fluid to flow in. The pipe section may or may not return to its original volume. In the case of a gas, "elastic" can mean that when the reduced pressure is removed, more gas or liquid flows in, so that the pressure in the gas phase equalizes with the ambient pressure (approximately according to the ideal gas law). The gas with the lower pressure is also encompassed by the term "tension position," and the expansion or...Compression is encompassed by the term "deformation". "More elastic" means that the increase in volume in the considered pipe section is greater than in a comparable pipe section.

[0013] In other words, the relaxation of a deformed elastic pipe section or the negative pressure existing in a pipe section can be used to selectively divert fluid, especially gas or liquid, away from a connection area of ​​two pipe sections when a connection is broken.

[0014] For example, creating a vacuum causes the first section of the pipe to deform, with the inner walls of the pipe bulging inwards into the lumen, thus narrowing the flow cross-section. Due to the restoring force of the elastically deformed pipe section, the inner walls of the pipe move back towards their original position, and the volume enclosed by the first pipe section, for example the flow cross-section, expands again, drawing fluid into the previously narrowed area.

[0015] By adjusting or selecting the material and / or geometry, for example length, hose diameter, wall thickness, pipe diameter geometry, bending, in or of at least a sub-area of ​​the first pipe section and / or the second pipe section, and / or by providing gas, for example in the form of a gas reservoir, in the first and / or second pipe section, the elastic property of the first pipe section and / or the second pipe section of the two pipe sections can be predetermined, and thus fluid can be directed from the connection area towards one or both pipe sections when the pipe sections are separated from each other, in particular towards the first pipe section if it has the elastic property.The restoring force can also arise, for example, from a hose that is compressed returning to its round shape, or a more curved tubular section of pipe being bent further by the application of negative pressure and then straightening up again, or a stretched hose returning to a shortened length.

[0016] The first and second pipe sections each have an internal volume to hold the fluid. Neither pipe section is a lid or cover. The first and second pipe sections are designed to convey fluid through them during use.

[0017] The first pipe section can exhibit elasticity in at least a portion, such that when a vacuum is applied, at least that portion contracts. When the connection to the second pipe section is opened, the elasticity and the associated restoring force cause the pipe section to expand, displacing fluid from the disconnection point towards the relaxing section of the first pipe section.

[0018] Within the scope of the present invention, a partial area of ​​the first and / or the second conduit section or even the entire first and / or second conduit section can have an elastic property.

[0019] The fluid can be moved more strongly into the first pipe section (relatively elastic material or geometry in the first pipe section and relatively stiff material or geometry in the second pipe section) or into the second pipe section (relatively elastic material or geometry in the second pipe section and relatively stiff material or geometry in the first pipe section).

[0020] The first pipe section may have at least a portion that is more elastic relative to the second pipe section. This can cause the volume reduction when a vacuum is applied to the first pipe section to be greater than that in the second pipe section. Upon disconnection, the first pipe section experiences a greater volume increase, and more fluid can be displaced towards the first pipe section than towards the second.

[0021] The first pipe section and the second pipe section can each have at least one sub-section which is made of a more elastic material relative to the rest of the first pipe section and the second pipe section, wherein the sub-section of the first pipe section is made of a more elastic material relative to the sub-section of the second pipe section, such that when the connection of the pipe sections is released, fluid from a connection area of ​​the pipe sections is drawn into the first pipe section to a greater extent than into the second pipe section.

[0022] In other words, the first pipe section and, optionally, the second pipe section can have a sub-section that is more elastic relative to the second pipe section or to the remainder of the second pipe section. However, the entire first pipe section can also be more elastic than the entire second pipe section.

[0023] The above description shows that a longer hose section can have a higher elasticity than a shorter hose section (assuming the same geometry and material).

[0024] The first section of the cable can be longer than the second section.

[0025] The first and / or second pipe section may be partially filled with a gas, for example, air, while the remainder of the first and second pipe sections may be filled with a liquid. The gas-filled section must not be directly connected to a junction between the first and / or second pipe sections and / or must not be transferred from the first and / or second pipe sections during the creation of the vacuum.

[0026] For example, a pump can pump liquid out of the first and / or second pipe section. This decrease in fluid volume results in a larger volume being available to the gas, which is stored in a gas reservoir and in fluidic connection with the first and / or second pipe section, causing it to expand and the pressure in the gas to drop.

[0027] If the connection between the first pipe section and the second pipe section is then disconnected, the gas contracts again (pressure equalization) and at the same time liquid from the other pipe section and / or gas from the environment can be drawn in towards the gas via the disconnection point.

[0028] The disconnection method can include the step of closing a shut-off element arranged along the second pipe section, at one end of which another shut-off element is already arranged. This allows the length of the second pipe section to be shortened. In particular, it may be possible for the fluid to be preferentially drawn into the first pipe section (for example, into a hose set or another disposable, or for example, into the internal fluidic system of a medical device) due to differing elastic properties. A medical device according to the invention can be equipped with such a valve.

[0029] Such targeted fluid displacement can be used to reduce the risk of unwanted material in the fluid passing from the first tubing section to the second, or from the environment into the second. This can reduce the contamination risk of a reusable fluidic system or the amount of air entering a tubing set connected to a patient.

[0030] The section exhibiting elastic properties can be, for example, a loop or a section of the pump line of a pump, particularly a peristaltic pump. During the pumping process, the loop or pump line of a peristaltic pump is compressed by one or more actuators, such as rollers or fingers, and relaxes when the actuator(s) are removed. Especially in pumps with rollers as actuators, the loop may also be subjected to tensile forces, which can lead to a reduction in volume. The loop or pump line of such a pump, or the section upon which the actuators of such a pump act, typically consists of a softer or more elastic material than other sections of the first and / or second pump line.By using the pipe loop or pipe pump section as an area of ​​higher elasticity, a more elastic pipe section specifically designed for the purpose of the disconnection method disclosed herein can be dispensed with. This can make it possible to offer a more cost-effective, material-saving solution. Additionally, the actuator of the peristaltic pump can also be used as a shut-off element. This can further reduce costs and material, as no separate component is required to contain the fluid volume.

[0031] Alternatively or additionally, both the first and second pipe sections can have a section with elastic properties. The remainder of each pipe section can then be made of a relatively rigid material.

[0032] In this embodiment, the relaxation of the elastic material sections during disconnection of the pipe segments facilitates the separation of the fluid column. Fluid is moved from the connection area into the first and second pipe segments, thereby preventing leaks and improving hygiene.

[0033] In this case too, the elastic part of one pipe section can be more elastic than the elastic part of the other pipe section, so that the fluid is preferentially moved in the direction of the more elastic part.

[0034] The method according to the invention can be carried out when no patient is yet connected to a device executing the method.

[0035] A method according to the invention can thus serve to prepare a medical device before treatment, for example when priming the hose sets used or when connecting or coupling the required lines, as well as to prepare a medical device after treatment, for example when disconnecting or uncoupling the required lines, discarding used disposables.

[0036] The method according to the invention therefore does not act on the body of a patient, but takes place on the part of the device and the disposables or other fluidically coupled components connected to it.

[0037] Another aspect of the present invention relates to a medical device with at least two detachable fluid-carrying pipe sections, with at least a first and a second shut-off element for enclosing a fluid volume in the two pipe sections, a pump for generating a vacuum in the two pipe sections, and a control unit for controlling the pump, wherein a first pipe section of the two fluid-carrying pipe sections has at least partially an elastic property and the control unit is programmed to operate the pump in a disconnection mode to generate the vacuum, so that by generating a vacuum in the two pipe sections an elastic deformation occurs in and / or on the first pipe section from an initial position to a tensioned position.

[0038] The medical device may be designed to perform a disconnection procedure, or may be designed so that a disconnection procedure can be performed on this medical device, wherein the disconnection procedure comprises the disconnection of at least two fluid-carrying conduit sections which are detachably connected to one another. A first conduit section of the two conduit sections exhibits at least partial elastic properties.

[0039] The medical device comprises at least a first and a second shut-off element for enclosing a fluid volume in the two pipe sections, a pump for generating a vacuum in the two pipe sections, thereby enabling elastic deformation of the first pipe section from an initial position to a tensioned position, and a controller for controlling the pump, wherein the controller is programmed to operate the pump in a disconnection mode to generate the vacuum.

[0040] The medical device may have means for enclosing a fluid volume in the two conduit sections and means for generating a vacuum in the two conduit sections, causing elastic deformation of at least a sub-area of ​​the first conduit section from an initial position to a tensioned position, such that when the connection between the two conduit sections is released, at least the sub-area of ​​the first conduit section returns from the tensioned position to the initial position, thereby drawing fluid from a connection area of ​​the conduit sections into the first conduit section.

[0041] The control system can be programmed to close one of the shut-off elements before the vacuum is generated. This allows the fluid volume to be sealed off on one side. Alternatively or additionally, the control system can be programmed to close one of the shut-off elements after the vacuum is generated. This allows the fluid volume to be enclosed.

[0042] The controller can actuate at least one, several, or all active components from the group of means for generating the vacuum and the means for enclosing the system. For example, the controller can be programmed to start a pump and thus generate a vacuum, and / or to close a valve or clamp, thereby creating a closed system.

[0043] The first or second line section may be part of a device-side fluidic system of the medical device.

[0044] The medical device may further comprise a fluid source, in particular a physiological fluid source, fluidically connected to the second line section, optionally a sterile filter - fluidically arranged between and fluidically connected to the fluid source and the second line section -, and a medical device-side connector at one end of the second line section for connecting to one end of the first line section.

[0045] In this embodiment, the medical device can be equipped, for example, with a pump that supplies physiological fluid via the second tubing section to the first tubing section in a priming process and / or during treatment, passing through a sterile filter in which contaminants can be retained. The first tubing section can form part of a tubing system and can be connected to a tubing system filled with blood during treatment. After treatment, the first tubing section can be disconnected from the second tubing system using the method according to the invention or in the disconnection mode and, for example, discarded. The second tubing section can remain in the medical device and be reused in a subsequent treatment.

[0046] The medical device may have a drainage line, the first section of which may be fluidically connected to the drainage line or form part of it. Furthermore, the medical device may have a medical device-side connector at one end of the first section of the line for connecting to one end of the second section of the line.

[0047] In this embodiment, the second tubing section can be part of a blood-carrying line during blood treatment. During a priming procedure, the second tubing section can be detachably connected to the first tubing section via the medical device-side connector, and fluid containing the second tubing section can be transferred from the second tubing section to the first tubing section and then into the drainage line in a flushing step of the priming procedure. For treatment purposes, the second tubing section can be detached from the connector or the first tubing section and connected to the patient.

[0048] The pump or the means for generating the vacuum can be one or more pumps from the group consisting of a peristaltic pump, a diaphragm pump, a centrifugal pump, an impeller pump and a gear pump.

[0049] The pump or the means for generating the negative pressure can be one or more pumps from the group of ultrafiltration pumps, blood pumps, or substitution pumps.

[0050] The pump can be a peristaltic pump and at least one actuator of the peristaltic pump can be part of the first or second shut-off element.

[0051] The shut-off element(s) or the means of containment may each include one or more pumps, valves, check valves or clamps, or a combination thereof.

[0052] The shut-off elements can be manually operated components or controllable by the control system. Alternatively, one shut-off element can be manually operated and a second shut-off element can be controlled by the control system. Multiple shut-off elements can also be provided.

[0053] The first and / or second pipe section may be branched. A shut-off element may be provided at each end of the first and / or second pipe section, except at detachable connection ends of the first and second pipe sections.

[0054] In embodiments with controllable shut-off elements, the control system can be programmed to actuate these elements to contain the fluid volume. For example, the control system can be programmed to operate the pump in one direction. Furthermore, the control system can be programmed to first close all upstream shut-off elements, then operate the pump, and finally close all downstream shut-off elements. Alternatively, one, more, or all downstream controllable shut-off elements can be closed in the first step, provided there is an open connection for fluid discharge. This connection could be, for example, a check valve or a manually operated clamp.

[0055] The medical device may have a user interface for a user to enter an instruction, and the controller may be programmed to activate the disconnection mode in response to an instruction being entered at the user interface.

[0056] Activating the disconnection mode can trigger a special mode in the controller's program code. This activation can then execute a specific sequence of program code that the medical device uses to perform the disconnection procedure. The disconnection mode can also be integrated into another mode.

[0057] For example, a priming mode can be defined in the program code, and the disconnection mode can represent a step, such as the last step of the priming mode.

[0058] The user interface can include a display, a screen, a touchscreen, a keyboard, a control knob, a microphone for recording a voice signal, and a camera for recognizing a user gesture.

[0059] The controller can be programmed to activate multiple modes and to automatically switch from one of the modes to the disconnection mode.

[0060] For example, the controller can be connected to a sensor on the medical device, such as an optical sensor, in a so-called reinfusion mode. This sensor detects that there is no more blood in the tubing. The controller can then process this signal in its program code to initiate another mode, such as the disconnection mode.Alternatively or additionally, an additional mode can be provided in the control's program code, which, after completion of the reinfusion mode, empties the tubing set and / or a dialyzer and / or a machine-side fluid system, and the control can be programmed to switch to disconnect mode 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 fluid 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.

[0061] Alternatively or additionally, a mode ("priming mode") can be provided in the controller's program code that fills the tubing set or cassette with priming fluid and / or rinses the tubing set or cassette with fluid before the start of treatment. The controller can be programmed to switch to disconnection mode after the priming mode is complete. The controller can also be programmed to operate a pump during the priming mode to transfer fluid from a fluid source towards the tubing set or cassette. Furthermore, the controller can be programmed to detect the end of the priming process, for example, by a predetermined time elapsed, a predetermined volume of fluid being transferred into the tubing set or cassette, or an air detector or fluid sensor indicating that no air remains or that the system is predominantly filled with fluid.

[0062] The controller can also be programmed to automatically switch to disconnection mode first, but the pump is only started after input via the user interface.

[0063] The controller can also be programmed to allow input via the user interface to start the pump, specifically only when the disconnection mode is activated. In other words, the controller's program code can provide for modes or phases other than the disconnection mode in which the pump will not start despite corresponding input via the user interface.

[0064] By limiting the initiation of the disconnection procedure in this way, it may be possible to prevent such a disconnection procedure from being initiated, for example, during treatment.

[0065] As revealed above, the medical device can have neither the first nor the second line section, but can only be connected to them for the purpose of treatment.

[0066] As revealed above, the medical device can have one of the two conduit sections and only be connected to the second of the two conduit sections for the purpose of treatment.

[0067] In a further embodiment, the medical device has both the first and the second conductor section. The first conductor section can have at least a partial elastic property, wherein the first conductor section is elastically deformable from an initial position to a stressed position due to the elastic property, and wherein the volume enclosed by the first conductor section in the stressed position is smaller than the volume enclosed in the initial position.

[0068] Optionally, one of the two tubing sections can be part of a disposable device, in particular a tubing set or cassette system used in blood treatment.

[0069] Optionally, both pipe sections can be part of one or more disposables, in particular a hose set or cassette system used in blood treatment, or a hydraulic system designed as a disposable (machine-side fluidic system that is not permeated by blood during treatment) to supply a dialyzer with dialyze fluid.

[0070] The first section of the line can have at least one sub-section which is more elastic relative to the second section of the line.

[0071] According to one embodiment, the first conduit section and the second conduit section have at least a partial area which is made of a more elastic material relative to the rest of the first conduit section and the second conduit section, wherein the partial area of ​​the first conduit section is made of a more elastic material relative to the partial area of ​​the second conduit section, such that when the connection of the conduit sections is released, fluid from a connection area of ​​the conduit sections is drawn to a greater extent into the first conduit section than into the second conduit section, or vice versa.

[0072] The control system can, for example, comprise a computer system and can be implemented in the form of digital circuits, computer hardware, firmware, software, or any combination thereof. The invention can also be implemented in the form of a computer program product, e.g., a computer program on a physical information carrier (e.g., a machine-readable storage medium). The control system can comprise a general-purpose processor, a digital signal processor (DSP) for the continuous processing of digital signals, a microprocessor, an application-specific integrated circuit (ASIC), a free-to-flow gate array (FPGA), or other integrated circuits (ICs) or hardware components to execute the individual process steps. A data processing program (software) can run on the hardware components to perform the process steps.It is also possible to control the operation of multiple or combined components.

[0073] The controller may also include memory in which the program code is stored, such as a read-only memory (ROM) or random access memory (RAM), or both; magnetic, magneto-optical, optical, or solid-state (SSD) storage media; non-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 Blu-ray discs. The memory may also be provided on demand or be accessible via the internet (e.g., cloud computing). Suitable storage media for 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-optical storage media, CD-ROM, DVD-ROM, or Blu-ray discs.The processor and memory elements can be supplemented by special logic modules, or even be part of them.

[0074] Further features and effects of the present invention will become apparent from the following description of selected embodiments of the invention with reference to the accompanying figures, in which identical or similar components are designated by the same reference numerals. The features described below may be implemented in embodiments described above. These embodiments described above are not all listed again below. The figures show: Fig. 1a two pipe sections which are used in the process for disconnecting two fluid-carrying pipe sections, and the medical device; Fig. 1b a first line section of the two fluid-carrying line sections in a stress position using the example of a mechanical deformation; Fig. 1c the first section of the line Fig. 1b in a starting position / relaxation position; Fig. 2 one embodiment with a pump as a shut-off element; Fig. 3 one embodiment with a check valve as a shut-off element; Fig. 4 an embodiment with a hydraulic system as part of the first pipe section; Fig. 5a one embodiment with an externally arranged pump; Fig. 5b an embodiment with a branched line section; Fig. 6a an embodiment with a T or Y piece for connecting two lines; Fig. 6b an embodiment in which the T or Y piece is arranged at one end of a line section; Fig. 7a an embodiment of a medical device; Fig. 7b an embodiment of the medical device in a different configuration; and Fig. 8a und 8b User interface designs.

[0075] An embodiment of the medical device 1, schematically depicted in Fig. 1a When applying the method according to the invention, the medical device 1 has two fluidically connected pipe sections 2, 3, which can be fluidically connected to each other via two optional connector elements 4, 5 of the two pipe sections. Furthermore, the medical device 1 has a pump 6. At one end each, the first and the second pipe section have a shut-off element 7, 8. The pipe section 2 has at least a partial elastic property, in particular an elastically deformable section. The elastic property or the deformable section can be embodied or arranged between the connection point to the second pipe section 3 or between the connector element 4 and the shut-off element 7. A vacuum can be generated in the first pipe section 2 or in the first pipe section 2 and the second pipe section 3 by means of the pump 6.Due to the negative pressure, a deformation from an initial position to a stress position can occur in and / or on the first line section 2, whereby a fluid volume encompassed by the first line section 2 in the stress position is smaller than a fluid volume encompassed in the initial position.

[0076] The shut-off elements 7, 8 can be closed, thereby enclosing a fluid volume in the two pipe sections 2, 3. The closing of the shut-off elements 7, 8 can be sequential or simultaneous; in particular, a first shut-off element can be closed first, then the negative pressure can be created, and subsequently the second shut-off element can be closed.

[0077] Subsequently, the connection between the line sections 2 and 3 can be released, whereby the fluid volume encompassed by the first line section 2 increases compared to the fluid volume in the tension position.

[0078] Based on the Fig. 1b und 1c The process is explained using the example of elastic mechanical deformation. As described, this is just one of several ways in which the elastic property can be achieved.

[0079] If the shut-off element 8 at the end of the second pipe section is closed and the pump 6 pumps fluid from the first pipe section 2 towards the second shut-off element 7 (open), a negative pressure is created at least in part of the first pipe section 2. This can cause the volume of the first pipe section 2 to deform, for example inwards (see the arrows in Fig. 1b ) contract, thus reducing the volume of the first pipe section 2. If, in this state, the first and second pipe sections 2, 3 are enclosed, for example by closing the shut-off element 7 at the end of the first pipe section 2, the system remains with the reduced volume.

[0080] In other words, the wall of pipe section 2 thus leaves the one in Fig. 1a The schematically depicted starting position, shown with dashed lines, assumes a tension position, which is defined by a solid line. Fig. 1b is reproduced.

[0081] When the two conductor sections 2 and 3 are separated, the elastically deformable portion relaxes due to its elastic properties, and the first conductor section 2 returns from its stressed position to its original position. As in Fig. 1c As shown, the wall of conductor section 2 moves, for example, from the tensioned position (dashed line) back towards the initial position or into the initial position (solid line). Fluid can flow from the connection area or, in other words, from the disconnection area, for example, in the area of ​​connector element 4, where the Figuren 1a-1c The example shown is to be sucked to the right, into the second section of the line 2.

[0082] Before the first and second pipe sections are separated, liquid or a column of liquid may be present in the connection area. Without the suction effect caused by relaxation, the liquid column could simply break, and the liquid would, at least due to gravity, leak downwards and outwards from the connection area.

[0083] When the first and second pipe sections 2, 3 are separated in the case described here, the relaxation in the first pipe section 2 can cause air to be drawn from the outside to the inside in the disconnection area, and the fluid column can also at least partially follow this suction effect. As a result, more liquid can remain in the first pipe section 2 after separation, and a directed flow of the liquid into the first pipe section 2 can also be achieved.

[0084] This reduces the risk of contamination of the second pipe section 2 and / or a leak (ejection of fluid to the outside).

[0085] The medical device 1 can have a controller 9. The controller 9 can be programmed to operate the pump to generate the vacuum in a disconnection mode. Optionally, the controller 9 can also be programmed to control at least one or both shut-off elements 7, 8. For this purpose, the controller can be connected to the respective components to be controlled (e.g., pump 6, shut-off elements 7, 8) via signal lines 10, 11, 12 of the medical device 1. The controller 9 can, for example, be programmed to start and / or stop the pump 6.

[0086] For example, the control system can be programmed to start 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 is created in which a vacuum is present or the deformable part has deformed.

[0087] The medical device 1 can have a user interface 13. User interface 13 can be configured for input of an instruction by a user, and the controller 9 can be programmed to activate the disconnection mode in response to an input of the instruction at user interface 13.

[0088] The pipe sections 2, 3 are not both necessarily part of the medical device 1, but one or both of the pipe sections 2, 3 can only be connected to the pump 6 and the shut-off elements 7, 8 when the medical device 1 is in use.

[0089] The medical device 1 may have the first line section 2 and / or the second line section 3. The first line section 2 and / or the second line section 3 may be part of a device-side fluidic system of the medical device 1.

[0090] The first line section 2 and / or the second line section 3 can be part of a disposable.

[0091] The pump 6 can be arranged along the first pipe section 2 and / or the second pipe section 3, or at a point in a fluidic system outside the two pipe sections 2, 3 that are in fluidic communication with the two pipe sections 2, 3. For example, the pump 6 can be arranged on the side of the shut-off elements 7, 8 located beyond the connectors 3, 4. The pump 6 must only be capable of removing fluid from the elastically deformable section.

[0092] The medical device 1 can have an automatic disconnection device 14. This automatic disconnection device 14 can, for example, include a motor that moves the first and / or the second line section 2, 3, thereby disconnecting the connection between the first and the second line section 2, 3. The controller 9 can be programmed to control the automatic disconnection device 14. This can enable the hygienic disconnection procedure to be carried out fully automatically, i.e., without human intervention.

[0093] In Fig. 2 An embodiment is shown in which a pump 6 serves as a shut-off element 7 or as a means for enclosing a fluid volume. The illustration in Figur 2 This is not an enlargement, but is intended to facilitate the comparison of the components of the respective embodiments of the medical device 1, as for example in Fig. 1 schematically represented, to facilitate. The control unit 9, the user interface 13, the signal lines 10, 11, 12, the automatic disconnection device 14 may all or some of them also be present in this embodiment, and with regard to these, reference is made to the description of the Figuren 1a bis 1c Reference is made to the following: Designs of the control unit 9, the user interface 13, the signal lines 10, 11, 12, and the automatic disconnection device 14, which are described below, can also be implemented in the medical device 1, as described in connection with, where technically feasible. Figuren 1a bis 1c described, are present. The same applies to the Figuren 3 bis 8a .

[0094] The pump 6 can be a peristaltic pump and an actuator 15 can engage with the first hose section 2 in the area of ​​a pipe loop 16. This allows the closed fluid volume to be formed.

[0095] In this example, pump 6 is a roller pump (an embodiment of a peristaltic pump) and the cable loop 16 is inserted into pump 6.

[0096] Before disconnecting pipe sections 1 and 2, the rollers of pump 6 are moved into a predetermined disconnection position such that at least part of the pipe loop 16 lies within the second section (between the connection point and the fluidic shut-off point of pump 6) and remain in this closed configuration during disconnection. In this example, pump 6 serves as a shut-off element on the side of the first pipe section 2. On the side of the device, valve 8 serves as a shut-off element. Pump 6 also serves to generate the negative pressure in the interconnected pipe sections 1 and 2.

[0097] To generate a vacuum, the rollers of pump 6 perform at least one rotation through a predetermined angle. If the rollers are positioned such that the angle is insufficient at the start of the process, they can be rotated an additional full turn, or half a turn if there are two rollers. The rotation can continue until a predetermined vacuum is reached.

[0098] A pressure sensor 17 can be provided in the medical device 1, which measures the pressure in the enclosed volume and, if necessary, in conjunction with the user interface 13, displays the pressure or indicates when the vacuum is sufficient, and / or indicates to the controller 9 that the pump 6 should be turned further.

[0099] The controller can be programmed to control the pump accordingly.

[0100] When the first pipe section 1, 2 is detached from the second pipe section 1, 2, the second pipe section 2 or its subsection 16 moves back to the starting position and fluid is drawn into the second pipe section 2 or its subsection 16.

[0101] As in Fig. 3 As shown, a pump 6 can be used in combination with a shut-off device 8 in the form of a check valve. The fluidic closure of the first pipe section 2 is thus effected by the check valve, the flow direction of which is away from the connector or from the second pipe section 3.

[0102] The pump 6 conveys fluid, in particular liquid, through the check valve 8, thereby bringing the first pipe section 2, in particular its subsection 16, into a tensioned position. In this embodiment, the enclosed volume can already be present before the pump is started. When the pump is operated, fluid is removed from the area of ​​the first and / or second pipe section 2, 3.

[0103] Various pump types can be used in this embodiment, for example, since occlusive properties are not required for enclosing the fluid volume in this example; for example, a peristaltic pump 6 with retractable actuators, a gear pump, an impeller pump, a centrifugal pump, or a diaphragm pump can be used.

[0104] The check valve can also be used in connection with Fig. 2 The described embodiment is present. This can provide additional protection against liquid entering the area of ​​the connection between the two pipe sections, as both the blocking effect of the check valve and the shut-off effect of the actuator must be overcome. Such an additional measure can be particularly useful in peristaltic pumps, since, due to their design, the rollers are usually spring-mounted and can lift off under excessive force, thus losing their occlusive function.

[0105] The level of the generated vacuum can be adjusted by a predetermined number of pump rotations / finger presses (using a finger pump) or by setting a predefined vacuum level. This control and monitoring can be performed by control unit 9.

[0106] When the first and second pipe sections 1 and 2 are released, the second pipe section 2 or its subsection 16 moves back to the starting position and fluid is drawn into the second pipe section 2 or its subsection 16.

[0107] Medical device 1, shown schematically in Fig. 4 The medical device 1 may have a device-side hydraulic system 18, which may be in fluidic communication with the first line section 2 or may form part of the first line section 2. The device-side hydraulic system 18 may be fluidically shut off by means of one or more shut-off elements. The device-side hydraulic system 18 may include a gas reservoir 20. During operation of the medical device 1, the first and second line sections 2, 3 and the hydraulic system 18, with the exception of the gas reservoir 19, may be filled with fluid. A pump 6 may be provided to generate the negative pressure. The pump 6 may, for example, be a pump that pumps a fluid during blood treatment, such as dialysate during dialysis treatment. The pump 6 may be an ultrafiltration pump or a balancing pump.

[0108] In such an arrangement, fluid can be drawn towards the first line section 2 as part of the device-side hydraulics 18. This arrangement can be used when a fluid-filled tubing set, for example after priming, is to be at least partially separated from the first line section 1 via the second line section 3 and then connected to a patient. This may help to keep the second line section 3 in a more hygienic condition.

[0109] The medical device 1 can have a shut-off device 20. The shut-off device 20 can be opened, or the control unit 9 can be programmed to open it, before the negative pressure is generated. This allows the volume (due to the additional volume of the hydraulics 18) in which the negative pressure acts to be increased, or the fluid volume of the first line section 2 to be increased, and / or the gas reservoir to become part of the first line section 2. This can result in a more elastic property of the first line section 2 than when the shut-off device 20 is closed. This can increase the effect of relaxation from the stress position.

[0110] The hydraulic system on the device side 18 can have a section made of an elastic material. This section can be moved into a tensioned position by the generated negative pressure.

[0111] The Figuren 5a and 5bFurther embodiments of the medical device are shown. 1. This embodiment differs from the embodiments shown, as described above. Figs. 2 , 3 This is described by the fact that the pump 6 is arranged outside the first pipe section 2. The shut-off element 8 can be a check valve, but it can also be another shut-off element mentioned in this description.

[0112] Pump 6 can be a blood pump of a blood treatment machine. The blood pump can be configured to pump blood into blood line 21 during a blood treatment. The first line section 2 can be a fluid supply line. During a treatment, fluid can be transferred from the first line section 2 into blood line 21.

[0113] The vacuum generated by the externally arranged pump 6 can bring the line section 2, or at least a part of it, into a tension position, so that when the line sections 2 and 3 are released, fluid is drawn into the second line section 2.

[0114] Fig. 5b shows a variant of the embodiment Fig. 5a , in which a branch to the pump 6, for example a substitute pump for hemodiafiltration treatment, is additionally provided in the first pipe section 2. In this embodiment, the pump 6 also assumes the function of the shut-off element 7 for this branch of the first pipe section 2. The negative pressure in the first pipe section 2 can be generated by the pump 6.

[0115] Fig. 6a and 6b show embodiments of the medical device 1 as in connection with Fig. 4 described. In this embodiment, the second line section 3, as a disposable, comprises at least parts of an arterial 22 and a venous 23 line, which are connected to each other via a T-piece 24. As described in Fig. 6a As shown, the T-piece 24 can be directly connected to the first line section 2, for example via a drain port of a blood treatment machine. In the Fig. 6b In the illustrated embodiment, the T-piece 24 is not directly connected to the first line section 2, for example, a drain port of a blood treatment machine, but rather via a further line section 25. The T-piece 24 can also have the shape of a Y-piece. The drain port can also be a so-called flushing port, through which flushing fluid from the second line section 3 can be transferred to the first line section 2 when flushing the arterial line 22 and / or the venous line 23.

[0116] The configuration, as in connection with the Figuren 6a As described in section 6b, this can be used in particular when priming / filling the hose set / disposables before the start of a treatment. When disconnecting the first and second line sections 2, 3, fluid should preferably be drawn towards the first line section (to the device-side hydraulics 18).

[0117] In Fig. 7a and 7bThe figures schematically depict embodiments of the medical device 1 in the form of a dialysis machine. In the figures, some components are optional; in particular, some components may be disposable and need not be an integral part of the medical device 1. The dialysis machines differ only with regard to their disposable components or the configuration of the tubing. The medical device 1 may have two disconnect points (reference numerals 2, 3, 4, 5 on the one hand and reference numerals 2', 3', 4', 5' on the other) or only one of the two. The two embodiments are examples. The disconnect point may be a connection point in the fluid inflow to the extracorporeal blood supply system, for example, the connection point of the first tubing section 2 with the second tubing section 3, or connectors 4, 5 arranged at their respective ends.The disconnection point can be a connection point in the flow path of the extracorporeal blood supply system, for example, the connection point of the first supply line section 2' with the second supply line section 3', or connectors 4', 5' located at their respective ends. The embodiments and configurations described in this text can also be used instead of the components and configurations explicitly described here.

[0118] The following components are present or may be present on the dialysis machine as a medical device 1: fluid source 26, balancing system with pump 27, first sterile filter (optional) 28, second sterile filter (optional) 29, dialyzer (optional) 30, venting chamber (optional) 19, ultrafiltration pump (optional) 6', priming or substitution port 5, priming or substitution pump (optional) 6, outflow port 4', blood pump 31, control unit 9, user interface 13, signal lines (only a selection shown) 10, 11, 12, venous clamp 8', arterial clamp (optional) 32, a pre-dialyzer shut-off element (optional) 36, a post-dialyzer shut-off element (optional) 37, a first outflow shut-off element 7' (optional), a first priming shut-off element 8, a second priming shut-off element 7, a Drainage stopper element (optional) 20, and T or Y pieces (optional) 24.

[0119] The components can be connected to fluid-carrying lines as follows: The fluid, usually a physiological fluid or dialysate, is pumped from the fluid source 26 in a dialysate line 33 through the balancing system 27, optionally through the first sterile filter 28, to the dialyzer 30 and then discharged from the dialyzer 30 in a drain line 34, optionally through a venting chamber 19, back through the balancing system 27 into a drain 35 (not part of the medical device 1). The dialysate line 33 can have a branch line, in the form of a second line section 3, for example, optionally via a second sterile filter 29, which can lead via a priming or substitution port 5 to a so-called priming or substitution line, in the form of a second line section 2. This priming or substitution line 2 can be connected to an arterial blood line 22 or a venous blood line 23. Fluid, e.g.B. Blood during treatment or priming / rinsing fluid in the priming phase, in the blood lines 22, 23, can be pumped by means of a blood pump 31. The balancing system ensures that only a predetermined amount of fluid is removed from the patient. Various balancing systems are known; for example, the amount of fluid pumped to the patient and the amount pumped away from the patient can be determined by flow measurement, and the delta—as prescribed—can be adjusted so that a desired ultrafiltration rate, in other words, net balance rate, is achieved. Another balancing system is described in the . Fig. 7a and 7bAs shown, a volumetric balancing system 26, for example, pumps the same volume towards the patient as is pumped away from the patient. An ultrafiltration pump 6' connected in parallel additionally pumps fluid away from the patient, thus generating the net balance or ultrafiltration rate.

[0120] Additionally, the medical device 1 may have a number of shut-off elements. For example, the device 1 may have a venous shut-off element 8' (venous clamp), an arterial shut-off element 32 (arterial clamp), a pre-dialyzer shut-off element 36, a post-dialyzer shut-off element 37, a first drain line shut-off element 7', and a first and a second priming line shut-off element 7, 8.

[0121] The difference in the Figs. 7a and 7b The embodiments shown consist in that, in the Fig. 7a In the illustrated embodiment, the priming or substitution line 2 is connected to one end of the arterial blood line 22 – normally the end connected to the patient during treatment – ​​and only the venous blood line 23 is connected to the outflow port 4' at one end – normally the patient-side end. Fig. 7b In the illustrated embodiment, the priming or substitution line 2 is connected to a port arranged along the venous blood line 23, and the end of the arterial blood line 22 – normally the patient-side end – is also connected to the drain or rinse port 4'. In a further embodiment, the priming or substitution line is connected to a port arranged along the arterial blood line.

[0122] In particular, the following components or lines can be designed as disposable: the dialyzer 30, the arterial blood line 22, the venous blood line 23, and the priming or substitution line 2. These lines together can form a tubing set or a cassette system. A cassette system means that at least two of these lines are permanently connected and / or that the lines are formed at least partially by rigid channels rather than flexible tubing.

[0123] The medical device 1 can, for example, be configured to fill the tubing set or cassette system with physiological fluid before treatment. For this purpose, the controller 9 can be programmed, for example, in a filling mode, also called priming mode, to transfer fluid from the fluid source 26 via the priming or substitute port 4 into the tubing set or cassette system using the pumps of the balancing system 27. In a further process step, for example, a flushing mode, after filling, the tubing set or cassette system can be flushed, whereby fluid is flushed through the tubing set or cassette system and discharged through the outlet port 4' into the outlet line 34. For treatment, the venous line 23 must be connected to the patient. For this purpose, for example, in the embodiment of the Fig. 7a The end of the venous line, which is connected to the drain port 4' via the optional adapter 5', is disconnected from the drain port 4'. However, before this disconnection, which can be done manually or automatically, the controller 9 causes at least a first line section 2' connected to the drain port 4' and a portion of the venous line to be terminated as a second line section 3', at least on the side of the venous line 23. The controller can, for example, activate the ultrafiltration pump 6' and use it to pump out the fluid, creating a vacuum. Due to the elastic properties of the first line section 2', at least a portion of the first line section 2' deforms into a stressed position. The first line section 2' can also be more elastic than the second line section 3'.The controller can then actuate at least one, optionally several, shut-off elements 7' to hold the system in this tensioned position. Upon subsequent release, optionally manually or automatically, of the second line section 3' from the drain or rinse port 4', the first line section 2' can relax.

[0124] It should be noted at this point that the medical devices 1, as in connection with the Figuren 7a and 7b described, may also have one or more of the following components with the function described in this description: a gas reservoir 19, a valve 20 for increasing the elastic property of the first line section 2', a pressure sensor (not shown).

[0125] The medical device 1 can also be configured for a disconnection step after treatment. For this purpose, the controller 9 can close the shut-off element 8 and operate the pump 6. The pump 6 can be a peristaltic pump in the form of a substitution pump. Alternatively, the blood pump 31 can also be used to generate the negative pressure in the line section 2 or to pump fluid out of it. The shut-off element 7 can be a check valve and can also be part of an adapter or part of the arterial tube 22, so that active closing of this shut-off element is not necessarily required. In other configurations of the shut-off element 7, the controller can be programmed to close the shut-off element 7 after the pump 6 has been operated. Due to the elastic properties of the first line section 2, at least part of the first line section 2 deforms into a stressed position.The first conductor section 2 can also be more elastic than the second conductor section 3. Upon subsequent disconnection of the second conductor section 3 from the priming or substitute port 5, optionally manually or automatically, the first conductor section 2 can relax.

[0126] The Figuren 8a und 8b Figure 1 schematically shows the user interface 13. The user interface 13 can have a screen 38 and at least one button 39. The screen 38 can be a touchscreen and the button 39 can be a softkey, a button to be pressed on the touchscreen, as shown in Figure 1. Fig. 7a The button 39 can also be implemented as a hard key, a button separate from the screen, as shown in Fig. 7bThe controller 9 can be configured to send instructions to or receive instructions from the user interface 13 via a data line. For example, the user interface 1 can be programmed to cause the controller to switch to or start disconnect mode after button 39 is pressed. The controller 9 can be programmed to execute a sequence of procedures and send a message 40, for example, for display, to the user interface 13 when one, more, or all of the following situations occur:The control system reaches this point in the execution of a program: the program flow allows activation of the disconnection mode, the disconnection mode can be started, the connection can be broken after the machine-side process steps have been completed, a disinfection procedure must be carried out, for example because the control system has recognized that a treatment is to be prepared or carried out, or a sensor, for example a pin that indicates the presence of a disposable, indicates to the control system that a disposable has been removed from the machine without the machine-side process steps having been completed.

[0127] When an embodiment is mentioned herein, it is to be understood as a purely exemplary embodiment according to the invention.

[0128] Inventive embodiments may have one or more of the above-mentioned features in any combination, provided that the specific embodiment is not recognizable as technically impossible to the person skilled in the art.

Claims

1. A method for disconnecting two fluid-conducting line sections of a medical device, in particular of a medical device according to one of claims 7 to 17, which are releasably connected to one another, comprising the steps of: enclosing a fluid volume in the two line sections, generating a negative pressure in the two line sections, and releasing the connection of the line sections, characterized in that by generating a negative pressure in the two line sections, an elastic deformation in and / or on the first line section, which has at least partially an elastic property, takes place from an initial position into a tension position, wherein a fluid volume encompassed by the first line section in the tension position is smaller than a fluid volume encompassed in the initial position, and upon releasing the connection of the line sections, the fluid volume encompassed by the first line section of the tension position increases.

2. The method according to claim 1, wherein the first line section has at least one partial region which is more elastic relative to the second line section.

3. The method according to claim 1 or 2, wherein the first line section and the second line section have at least one partial region which is more elastic relative to the rest of the first line section and the second line section.

4. The method according to one of the preceding claims, wherein the elastic property is provided by an elastic material and / or a geometry with elastic restoring force and / or enclosed gas.

5. The method according to one of the preceding claims, wherein the first line section is part of a device-side fluidic system, in particular of the medical device, and the second line section is part of a disposable, or the second line section is part of a device-side fluidic system, in particular of the medical device, and the first line section is part of a disposable.

6. The method according to one of the preceding claims, wherein a physiological fluid and no blood is located substantially in the first and second line section.

7. A medical device (1), comprising at least two fluid-conducting line sections (2,3) releasable from one another, comprising at least one first and one second shut-off element (7,8) for enclosing a fluid volume in the two line sections (2,3), a pump (6) for generating a negative pressure in the two line sections (2,3), and a control unit (9) for actuating the pump (6), characterized in that a first line section of the two fluid-conducting line sections (2,3) has at least partially an elastic property; and the control unit (9) is programmed to operate the pump (6) in a disconnection mode for generating the negative pressure, so that by generating a negative pressure in the two line sections (2,3), an elastic deformation in and / or on the first line section takes place from an initial position into a tension position.

8. The medical device (1) according to claim 7, wherein the control unit is programmed, before generation of the negative pressure, to close one of the shut-off elements (7,8) for one-sidedly closing off the fluid volume and / or, after generation of the negative pressure, to close one of the shut-off elements (7,8) for enclosing the fluid volume.

9. The medical device (1) according to claim 7 or 8, wherein the first or second line section (2,3) is part of a device-side fluidic system of the medical device (1).

10. The medical device (1) according to claim 9, comprising a fluid source (26), in particular a fluid source for a physiological liquid, fluidically connected to the second line section (3), optionally a sterile filter (28) fluidically arranged between and connected to the fluid source (26) and the second line section (3), and a medical-device-side connector (5) at one end of the second line section (3) for connecting to one end of the first line section (2).

11. The medical device (1) according to claim 9, comprising a discharge line (34), wherein the first line section (2) is fluidically connected to the discharge line or is a part thereof, a medical-device-side connector (4) at one end of the first line section (2) for connecting to one end of the second line section (3).

12. The medical device (1) according to one of claims 7 to 11, wherein the pump (6) is a peristaltic pump and at least one actuator of the peristaltic pump is part of the first or second shut-off element (7, 8) or is the first or second shut-off element (7,8).

13. The medical device (1) according to one of claims 7 to 12, wherein the pump (6) is an ultrafiltration pump and / or a blood pump and / or a substitute fluid pump of an extracorporeal blood treatment apparatus, in particular a dialysis apparatus.

14. The medical device (1) according to one of claims 7 to 13, comprising a user interface (13) for inputting an instruction by a user, wherein the control unit (9) is programmed to activate the disconnection mode or to start the pump (6) in response to an input of the instruction at the user interface (13), and / or wherein the control unit (9) is programmed to activate a plurality of modes and to automatically perform a change from one of the modes into the disconnection mode.

15. The medical device (1) according to one of claims 9 to 14, with the respective other line section of the two line sections (2,3), wherein the first line section (2) has at least partially an elastic property, wherein a fluid volume encompassed by the first line section (2) in the tension position is smaller than a fluid volume encompassed in the initial position, and wherein optionally the respective other line section of the two line sections (2,3) is part of a disposable, in particular of a tube set or cassette system used in the context of a blood treatment, or optionally both line sections (2,3) are part of one or more disposables, in particular of a tube set or cassette system used in the context of a blood treatment.

16. The medical device (1) according to claim 15, wherein the first line section (2) has at least one partial region which is more elastic relative to the second line section (3).

17. The medical device (1) according to claim 15 or 16, wherein the first line section (2) and the second line section (3) have at least one partial region which is more elastic relative to the rest of the first line section (2) and the second line section (3).