Medical treatment device

Abstract

The invention relates to a medical treatment machine having connection points for one-way lines that can be connected to a patient's extracorporeal circulation. In order to improve hygiene, these connection points are dried in an optimized manner before the one-way line is connected.

Description

[0001] 230075W001

[0002] Fresenius Medical Care Deutschland GmbH

[0003] D-61352 Bad Homburg

[0004] Medical treatment device

[0005] Technical field

[0006] The invention relates to a medical treatment device for performing extracorporeal blood treatment and improving hygiene for interfaces between the treatment machine and the extracorporeal blood circulation.

[0007] background

[0008] Medical devices typically have one or more couplings. Fluid lines are connected to these couplings to transfer fluids from or into the device. A fluid line that is a one-way connection is called a disposable line.

[0009] Especially with coupling devices that establish a direct connection to the patient's extracorporeal circulation, hygiene requirements are very high, so the risk of germ transmission must be minimized or at least reduced. A major risk is germ transmission via residual fluids in the coupling device. To counter this risk, it is known to empty the coupling device before connecting it to the disposable tubing. However, the inventors recognized that with standard procedures, small fluid residues can remain due to the fluid adhering to surfaces. These can detach and / or accumulate in the coupling device throughout the day of treatment, for example, due to vibrations of the device or temperature changes within the device. This results in potentially unhygienic conditions in the coupling device, as germs can be introduced during connection or...When disconnecting the disposable tubing, germs from non-disinfected areas of tubing sections in fluidic contact with the coupling device, or from less hygienic areas of the coupling device itself, can be transferred into the disposable tubing and thus enter the patient. For example, the fluid could be a priming fluid used to fill the extracorporeal blood tube before connecting the patient, and / or a substitution solution used to dilute the patient's blood during treatment.

[0010] One object of the present invention is to provide a further medical treatment device (hereinafter referred to as the treatment device) comprising at least one such coupling device and a method for preparing a medical treatment device. Summary of the invention

[0011] The problem according to the invention can be solved by a medical treatment device with the features of claim 1 and a method with the features of claim 10. Particular embodiments are the subject of the dependent claims.

[0012] The medical treatment device according to the invention has at least one fluid line and at least one coupling device for establishing a fluid connection between the fluid line of the treatment device and a disposable fluid line.

[0013] The fluid line can be located inside the treatment device, in particular within a housing of the treatment device. The disposable fluid line may not be part of the treatment device itself, but may be connectable to or attached to the treatment device for the purpose of treatment. For this purpose, the disposable can be attached to the outside of the treatment device. The fluid line of the disposable can be, for example, a hose assembly, a cassette, or a part thereof, a substitute line, or the like.

[0014] The coupling device can, purely optionally, be located at the end of an internal fluid line, particularly for conveying a priming fluid, a substitute fluid, and / or a reinfusion fluid. The coupling device can include an opening in the treatment device, especially in the housing, to which the disposable can be attached. Fluid from inside the treatment device can be transferred into the disposable via this opening.

[0015] The treatment device further comprises a sealing means, in particular a flushing plug, for closing off the interior of the coupling device from the exterior of the treatment device. In other words, the opening into which a connector part of the disposable can be inserted, or through which the disposable can be connected to the fluid line of the treatment device, can be closed by means of the sealing means when no disposable is connected. The treatment device further comprises an air supply line, which opens at one end into the coupling device and at the other end is connected to the atmosphere.

[0016] Furthermore, the treatment device has at least one source of negative pressure.

[0017] The treatment device has a drain that includes a section through which dialysate flows during treatment, and which opens at one end into the coupling point and at the other end is, or can be, in fluid contact with the vacuum source. At least one shut-off device is arranged and operable on the air supply line and / or the drain and is designed to move between a closed position, in which fluid passage is prohibited, and an open position, in which fluid passage is permitted.

[0018] The treatment device further comprises a control and / or regulating device that is programmed or configured to operate the vacuum source when the coupling device is empty and while at least one shut-off device is initially closed. This can be the shut-off device in the supply air line or the shut-off device in the discharge line. This creates a vacuum in the fluid line between the shut-off device and the vacuum source. Preferably, only one of the shut-off devices is closed.

[0019] This fluid line includes at least part of the drainage system. This fluid line may also include part of the supply air line.

[0020] The control and / or regulating device is further configured or programmed to subsequently cause the opening of at least one shut-off device, so that during pressure equalization a gas flow is created from the opening of the supply air line to the atmosphere through the coupling device in the direction of the negative pressure source.

[0021] This gas flow, generated by pressure equalization, not only leads to the evaporation of the liquid film but, due to its high kinetic energy, also carries away the residual liquid on the walls of the coupling device towards the vacuum source. In all the preceding and following descriptions, the use of the expressions "may be" or "may have" is to be understood synonymously with "is preferably" or "preferably has," etc., and is intended to explain embodiments of the invention. The discharge line can be connected via branches to one or more further lines. Additional valves can be provided on these further lines so that the vacuum can be selectively built up. In particular, the discharge line can be fluidically connected to a drain line through which the dialysate is discharged from a dialyzer during treatment.

[0022] The vacuum source can be, for example, a peristaltic pump, a gear pump, or a diaphragm pump. Pumps can be used to pump the dialysate during preparation of the treatment machine or during treatment. Pumping can include pumping away from the dialyzer.

[0023] The vacuum source can be an ultrafiltration pump, which removes water from the patient's blood during treatment. Specifically, the vacuum source can be a flow pump used to move the dialysate away from the dialyzer.

[0024] The source of negative pressure can be located in the drainage system of the treatment device.

[0025] The vacuum source can have a flow rate of 50-1000ml / min, preferably a flow rate of 100-300ml / min.

[0026] The vacuum source can provide a vacuum between 200mbar and 800mbar in the fluid lines between the vacuum source and the shut-off device.

[0027] The vacuum source can be operated for a period of 5-60 seconds.

[0028] The larger the volume in which the negative pressure is applied, the greater the amount of kinetic energy available when the pressure is equalized by opening the shut-off devices, and thus the greater the desired effect. To obtain optimal gas flow, the volume in which the negative pressure is applied should be between 3 and 1000 cm³. 3 , especially 80 to 200 cm 3 be.

[0029] This can be ensured by the distance between the vacuum source and the shut-off device. For example, with a diameter of 4-15 mm for the fluid lines in the treatment device, the distance between the shut-off device and the vacuum source can be 40-600 cm.

[0030] To achieve maximum effect, a fluid connection can be established by opening one or more of the necessary shut-off devices across which a pressure gradient exists after the application of the vacuum. This can be achieved, in particular, by establishing the fluid connection, for example, by opening the corresponding valve(s) in the supply air line and / or the exhaust line and creating a connection to the atmosphere. Additionally, a connection to the vacuum source can also be established. In this case, it may be advantageous if the vacuum source is still running while the shut-off device is opened.

[0031] A fluid sensor, preferably a conductivity sensor, can be arranged in the coupling device to detect that the coupling device is empty, i.e., not filled with fluid, before the shut-off device is closed. This sensor can protrude into a lumen of the coupling device in the form of a pin or a pin. The term "empty" here does not mean completely free of fluid, since, as explained above, residual fluid may be present, particularly in the form of drops or a surface film.

[0032] Appropriate power sources, lines, evaluation devices, and alarm devices can be provided and appropriately programmed where required. Corresponding test routines, such as how signals are evaluated and which messages are output depending on the result, can be programmed, for example, in the control device. The shut-off device can be a valve, such as a solenoid valve, a pinch valve, etc.

[0033] A sterile filter or particle filter may be installed in the air supply line of the medical treatment device.

[0034] A pressure sensor can be installed in the section of the fluid lines where the vacuum is generated. The pressure sensor can be designed to measure the vacuum, and the control system can be configured to open the shut-off device when the measured vacuum falls below a predetermined limit.

[0035] The coupling device may, usually in an end section thereof, have a first fluid guide, which is or comprises a first lumen through which fluid can flow longitudinally, with a first end-side opening or opening plane. The fluid guide is designed to receive and / or guide a medical fluid and to establish the fluid connection with the connector. The first fluid guide may be connected via a line to a fluid source, in particular for priming fluid and / or substitute fluid and / or reinfusion fluid, and a valve may be arranged on the line. This valve may be closed during the build-up of negative pressure.

[0036] The coupling device may further comprise a second fluid guide, which is located further outwards (relative to the coupling device) than the first fluid guide. The second fluid guide includes at least a second lumen and a second end-end opening or opening plane. The first fluid guide is thus located further inwards within the coupling device than the second fluid guide. In any case, the first end-end opening is located further inwards within the coupling device than the second end-end opening.

[0037] Here, the first end opening of the first fluid guide is located, at least partially, within the second lumen of the second fluid guide. A fluid sensor can preferably be arranged in the second lumen of the coupling device and can project at least partially into the second lumen. This fluid sensor can be used to check whether the coupling device has been emptied, i.e., whether it no longer contains any fluid, such as cleaning solution. The fluid sensor can have two electrodes, so that it can detect if a fluid bridge exists between the two electrodes.

[0038] The medical treatment device according to the invention is designed in certain embodiments as an extracorporeal treatment device, in particular as an extracorporeal blood treatment device, for example as a dialysis device and / or hemodialysis device and / or hemofiltration device and / or hemodiafiltration device and / or ultrafiltration device.

[0039] Such a medical treatment facility may include a dialysis preparation unit comprising one or more concentrated sources containing a suitable concentrate solution and designed to prepare a mixed solution, a dialysis solution, or a priming or substitution solution.

[0040] Such a medical treatment device may optionally include lines for transporting dialysis solution from a dialysis preparation unit to a dialyzer and from the dialyzer to the drain, and a flow pump for circulating the fluid in these lines. Furthermore, it may include a device for monitoring the flow into and out of the dialyzer on the machine side.

[0041] The treatment device also includes means for the precise removal of a fluid volume specified by the user and / or by the control device from the balanced circuit, such as the ultrafiltration pump.

[0042] The control device can consist of one or more processors and one or more memories. The processor(s) can be a microcontroller, a microprocessor unit (MPU), a controller, an application-specific integrated circuit (ASIC), a central processing unit contained in one or more integrated circuits, etc. The memory can be any volatile or non-volatile data / instruction storage device. For example, the memory can be flash memory, random-access memory (RAM), read-only memory (ROM), electrically erasable programmable read-only memory (EEPROM), etc. The memory can be configured to store one or more instructions executable by the processor to cause the processor to perform operations disclosed herein. The instructions can be part of one or more software programs or applications.

[0043] The invention further relates to a method for preparing a medical treatment device, preferably according to one of claims 1 to 9, comprising the following steps: a) emptying a fluid-filled coupling device of the medical treatment device; b) closing a fluid line connected to the coupling device by means of a shut-off device between an opening to the atmosphere and a vacuum source; c) creating a vacuum in a section of the fluid line between the vacuum source and the shut-off device by operating the vacuum source; d) opening the shut-off device so that a gas flow from the opening to the atmosphere through the coupling device is created.

[0044] In the method according to the invention, process steps b)-d) can be repeated 2-5 times.

[0045] In the method according to the invention, the vacuum produced by operating the vacuum source can be between 200-800mbar, preferably 300-500mbar.

[0046] To create this vacuum, the vacuum source can be operated for 3-60 seconds.

[0047] To carry out step a) of the procedure, all shut-off devices between the opening of the drain to the atmosphere and the vacuum source can be opened, and a vacuum can be created in the drain of the medical treatment device by operating the vacuum source. The fluid can then be directed to a drain.

[0048] To verify that the coupling device is completely empty, a fluid sensor integrated into the coupling device can send a signal to a control unit. The fluid sensor can protrude into a cavity within the coupling device.

[0049] In another embodiment, the vacuum can be applied once, twice, or several times, followed by the opening of the shut-off device, or the control unit can be programmed accordingly. The number of times can be predetermined.

[0050] Inventive embodiments may have some, a few or all of the described features in any combination, provided that this is not technically impossible to the person skilled in the art.

[0051] Further details and advantages of the invention are described in more detail with reference to the exemplary embodiments shown in the drawings.

[0052] Brief description of the drawings

[0053] Figure 1 shows a schematic representation of a section of a medical treatment device according to the invention.

[0054] Figure 2 shows a simplified schematic representation of a procedure that can be initiated or performed using the medical treatment device.

[0055] Detailed description of an exemplary implementation

[0056] Figure 1 shows a part of a medical treatment device according to the invention. The components relevant to the invention are shown. Other components necessary for the function of the treatment device are known to those skilled in the art. Before the start of treatment, all fluid lines of the treatment device are usually cleaned or disinfected. The fluid lines 2, 8, 18, 19, 27, 28, 33, the coupling device 3, and the filters 12 and 13 are filled with rinsing fluid supplied from the dialysis preparation unit 23. The connection points 29 and 30 are directly connected to each other at this point. The rinsing is carried out by operating the flow pump 9'. This pump conveys rinsing solution from the dialysis preparation unit through the balance chamber 26 and the fluid lines 2, 8, 18, 19, 27, 28, 33 into the drain 24. The filters 12 and 13 serve to clean the fluids conveyed through fluid lines 2 and 27, respectively.Fluid lines 18 and 19 can be used as a bypass if at any time the fluid is to be pumped not into the coupling device, but directly into the drain 24.

[0057] Before connecting the disposable connector 15, the coupling device 3 is emptied.

[0058] The coupling device 3 has a first fluid guide 21, which is or comprises a first lumen through which fluid can flow in the longitudinal direction and has a first end-side opening or opening plane. The fluid guide 21 is designed to receive and / or guide a medical fluid and to establish the fluid connection with the connector 15. During the cleaning process, the fluid guide 21 carries cleaning or rinsing solution.

[0059] The coupling device 3 has a second fluid guide 22, which is located further outwards (relative to the coupling device) than the first fluid guide. The second fluid guide 22 comprises at least a second lumen and a second end-end opening or opening plane. The first fluid guide 21 is thus located further inwards in the coupling device 3 than the second fluid guide 22. In any case, the first end-end opening is located further inwards in the coupling device 3 than the second end-end opening.

[0060] Here, the first end-side opening of the first fluid guide 21 is arranged, at least sectionally, in the second lumen of the second fluid guide 22.

[0061] The second fluid channel 22 is closed at the second end opening by the sealing element 4 as long as no disposable line is connected. For this purpose, the flushing cap with a largely flat end face is inserted into the second fluid channel 22 in the manner of a plug. The end face may have a raised rim.

[0062] To empty the coupling device 3, the control unit 20 opens the shut-off devices 6 and 7 and starts the flow pump 9'. Alternatively, the vacuum can be created by the ultrafiltration pump 9. Shut-off devices 10 and 11 remain closed. This removes the fluid from the second fluid guide and drain 8, with the drain opening into the interior from below, thus enabling the interior to be emptied, at least by gravity.

[0063] The fluid sensor 14 protrudes into the second lumen 22 of the coupling device. This fluid sensor 14 checks and reports to the control unit whether the coupling device has been emptied, i.e., whether it no longer contains any fluid, such as cleaning solution.

[0064] Subsequently, valve 6 is closed while the vacuum source 9 continues to pump. This evacuates the supply air line 16 between valve 6, the second lumen 22 of the coupling device 3 and the outlet 8.

[0065] Alternatively, valve 7 is closed while the vacuum source 9 continues to pump. This evacuates the section of the line 8 between valve 7 and vacuum source 9. To maximize the evacuated volume and thus the generated kinetic energy, valve 7 is located near the coupling device 3, e.g., after a fluid line length of 20 cm.

[0066] When valve 6, or alternatively valve 7, is subsequently opened, a very high airflow is suddenly forced through the previously evacuated area by atmospheric pressure for a fraction of a second. This high-energy airflow carries away any residual liquid adhering to the inner surface of the second lumen 22 of the coupling device 3 towards the vacuum source 9, thus sufficiently emptying the coupling device 3 of liquid.

[0067] A valve can be arranged upstream of the vacuum source (not shown in the figure) and be controllable by the control device, wherein the valve is closed after the vacuum has been generated and before the shut-off device is opened, and / or wherein the shut-off device is opened while the vacuum pump is running.

[0068] Figure 2 shows a flowchart of an embodiment of the method according to the invention.

[0069] Before the start of the dialysis treatment, in step 101 the coupling device 3 is emptied by opening the valves 6 and 7 and simultaneously operating the pump 9'.

[0070] In step 101a, the fluid sensor checks whether the coupling device 3 is empty.

[0071] In step 102, the connection to the atmosphere is interrupted by actuating the shut-off device 6.

[0072] In step 103, a vacuum is created in the fluid line 8, the coupling device and a section of the air supply line 6 by actuating the pump 9.

[0073] Subsequently, in step 104, the connection to the atmosphere is reopened by opening the shut-off device 6 in the supply air line 2, so that a gas flow from the opening to the atmosphere is created through the coupling device 3 due to pressure equalization.

[0074] Alternatively, in the second step 102, the connection to the atmosphere can be interrupted by actuating the shut-off device 7 in the downpipe 8.

[0075] Then, in the third step 103, a suppression is created in a part of the derivative 8.

[0076] Steps 102 to 104 can be repeated 2 to 5 times.

Claims

Patent claims 1. Medical treatment device comprising a fluid line, at least one coupling device with an interior and a closable opening for establishing a fluid connection between the fluid line of the treatment device and a disposable fluid line, a sealing means, in particular a flushing plug, for closing the closable opening, an air supply line which opens at one end into the interior and at another end is in contact with the atmosphere, at least one negative pressure source, a drain which opens at one end into the interior and at another end is in or can be brought into fluid contact with the negative pressure source, at least one shut-off device arranged on the air supply line and / or the drain, a control device configured for opening and closing the shut-off device and for operating the negative pressure source,wherein the control device is programmed to operate the vacuum source with the clutch assembly empty, while the at least one shut-off device is closed in order to create a vacuum in a region of the fluid lines between the shut-off device and the vacuum source, and subsequently to open the at least one shut-off device so that during pressure equalization a gas flow is created through the air supply line and through the interior.

2. Medical treatment device according to claim 1, wherein the vacuum source is a peristaltic pump, a diaphragm pump or a gear pump.

3. Medical treatment device according to claim 1 or 2, wherein the vacuum source has a delivery rate of 50-1000 ml / min, preferably a delivery rate of 100-300 ml / min.

4. Medical treatment device according to one of claims 1 to 3, wherein the vacuum source provides a vacuum between 200 mbar and 800 mbar.

5. Medical treatment device according to one of claims 1 to 4, wherein the vacuum source is operated for a period of 5-60 seconds.

6. Medical treatment device according to one of claims 1 to 5, wherein the treatment device has a fluid sensor arranged in the coupling device.

7. Medical treatment device according to one of claims 1 to 6, wherein the shut-off device is a valve, e.g. a solenoid valve or pinch valve.

8. Medical treatment device according to one of claims 1 to 7, wherein the shut-off device is arranged on the supply air line.

9. Medical treatment device according to one of claims 1 to 7, wherein the shut-off device is arranged at the drain.

10. A method for removing residual fluid quantities in preparation for a medical treatment device, preferably according to any one of claims 1 to 9, comprising the following steps: a) emptying a fluid-filled coupling device of the medical treatment device; b) closing a fluid line by means of a shut-off device between an opening to the atmosphere and a vacuum source; c) creating a vacuum in the fluid line between the vacuum source and the shut-off device by actuating the vacuum source. d) Opening the shut-off device so that a gas flow from the opening to the atmosphere is created through the coupling device.

11. Method according to claim 10, wherein, for emptying the coupling device, fluid is pumped out from a fluid line leading away from the interior of the coupling device by means of the vacuum source.

12. Method according to claim 10 or 11, wherein the method steps b) - d) are repeated 2 to 5 times.

13. Method according to one of claims 10 to 12, wherein the negative pressure is between 200-800 mbar, preferably 300-500 mbar.

14. Method according to one of claims 10 to 13, wherein in step c) the vacuum source is actuated for 5-60 s.

15. Method according to any one of claims 10 to 14, wherein the emptying of the coupling device is detected by means of a fluid sensor.

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