Dialysis device with a connection unit

Abstract

The invention relates to a medical device having a housing (17) and a connection unit (2) for creating a fluid connection between the hydraulic system of the medical device and a connector (31) connected to a consumable that, during use, directs a fluid. This connection is used to convey a dialysis fluid into an extracorporeal blood circuit. The connection unit and the connector are designed in such a way that particularly hygienic conditions prevail during the connection and disconnection of the consumable.

Description

[Technical field]

[0001] The present invention relates to a machine for extracorporeal blood therapy having a connection unit which can be used to supply dialysate to an extracorporeal blood circuit. [Background technology]

[0002] In extracorporeal blood treatment, for example in chronic hemodialysis, it is considered advantageous to add treatment fluid, in particular dialysate, to the blood to be treated during the treatment. For this purpose, one or more connection units are made available on the treatment device, to which lines are attached in order to direct the fluids from the dialysate-carrying hydraulic system of the dialysis machine and deliver them to the extracorporeal blood circuit. Lines that can be discarded after use are called consumables. In most systems, the connection of the blood hose system to this connection unit is established by the operator. The connection unit is located at the front of the appliance together with the blood hose system. This connection unit of the treatment machine establishes a direct connection inside the machine to the consumables, in particular also to the patient's blood circulation, without filters being placed between the blood circulation and the machine hydraulic system. This connection unit must meet stringent hygiene requirements in order to minimize the risk of microorganisms getting into this interface from the outside. Summary of the Invention [Problem to be solved by the invention]

[0003] It is an object of the present invention to make available a medical device having a suitable connection unit and a suitable disposable connector, and a system consisting of a medical device and a connector. [Means for solving the problem]

[0004] According to the teachings of the present invention, this object is achieved by a medical device according to claim 1, a consumable according to claim 11 and a system according to claim 13. Particular embodiments are the subject matter of the dependent claims.

[0005] The invention relates to a medical device having a housing and a connection unit protruding through the wall of the housing to generate a fluid connection between at least a first fluid line allocated to the interior of the medical device and a second fluid line, for example a connector connected to a consumable fluid line that conducts the fluid during use. The second fluid line is not considered as part of the medical device, but is instead allocated to the exterior of the medical device. The fluid is to be understood in particular as a liquid, for example a dialysis treatment fluid. The consumable fluid line can be, for example, a hose set or part thereof, or an alternative line, etc.

[0006] The housing has a wall that surrounds the interior of the treatment machine.

[0007] The connection unit has an outer tube and an inner tube arranged in the lumen of the outer tube. A lumen in the sense of the present invention is the inner cavity of a hollow body, here the inner cavity of the outer tube of the connection unit. The inner tube can be arranged concentrically in the lumen of the outer tube. The inner tube can have an inner lumen that is conically tapered in the direction from the exterior to the interior of the medical device.

[0008] The outer tube has a first outer tube opening at an end facing the exterior of the medical device and at least a second and a third outer tube opening at an end facing the interior of the medical device.

[0009] The inner tube has a first inner tube opening at an end facing the exterior of the medical device and at least a second inner tube opening at an end facing the interior of the medical device.

[0010] The outer tube permanently protrudes from the housing of the medical device such that the first outer tube opening lies in a front plane of the housing.

[0011] Permanent here means that the outer tube, especially during connection and disconnection procedures, can be displaced relative to the wall along its longitudinal axis by 0.1-1.5 mm, for example to compensate for dimensional tolerances of consumables, but the outer tube opening directed towards the outside of the machine is never located in the plane of the housing or behind its wall.

[0012] Embodiments according to the invention may comprise one or more of the features described below in any combination which is technically possible.

[0013] Whenever spatial references such as "top," "bottom," "upper," or "lower" are mentioned in this specification, those skilled in the art will, in case of doubt, understand these as spatial indications relative to the orientation in the accompanying drawings and / or relative to the placement of a port according to the present invention in its intended use.

[0014] The connector may be a disposable connector, but the connector may also be reusable several times.

[0015] In one embodiment, the outer tube can protrude through the wall of the housing.

[0016] The distance along the longitudinal axis of the connection unit between the first outer tube opening and the wall of the housing may measure at least 10 mm.

[0017] In relation to the outer tube opening, the inner tube opening can be set back in the direction of the inside of the machine. Along the longitudinal axis of the connection unit, the distance between the inner and outer tube openings can be measured, i.e., at least 5 mm, preferably 6 mm. That is, if the outer tube opening has a diameter of 11 mm, it is possible to prevent accidental contact with non-sterile surfaces during the connection and disconnection procedures.

[0018] The outer tube can be spaced from the wall so as to receive the wall of the connector in the resulting gap, preferably sealingly received through placement of a sealing element in the wall or the outer tube.

[0019] The connection unit can be arranged on the treatment machine such that its longitudinal axis is arranged substantially vertically, which means for example 80-100° to the wall of the housing. The connection unit, in particular the outer tube of the connection unit, can be fastened in an axially elastic manner to the housing or to the wall by means of fastening means. The fastening means can have a spring force of 20-40 N. The fastening means can be a helical spring. This elastic fastening means can ensure that even in the case of certain dimensional tolerances of the consumable or the connection unit, it is possible to generate a reliable and tight connection between the two components and to prevent leakages that represent a risk to hygiene.

[0020] For a secure connection of the consumables, threading means can also be provided on the walls, which threading means are provided on the consumables with each other.

[0021] The connection unit may comprise a leak sensor, in particular a conductivity sensor, in the lumen between the outer tube and the inner tube.

[0022] The leak sensor preferably protrudes into the second lumen, i.e. it terminates freely out of the side wall. The leak sensor is preferably or has a pin or ring.

[0023] In some embodiments, the leak sensor carries or includes an insulating layer or electrical insulator, which can prevent inaccurate measurements caused by residual moisture, especially if this protrudes from the wall to which the leak sensor is connected.

[0024] The leak sensor can detect and signal any loss of leak tightness between the inner tube of the connection unit and the connector of the consumable. Contamination of the connection unit potentially occurring as a result of loss of leak tightness can then be remedied by initiating sanitization of the machine hydraulic system.

[0025] When the connection unit is not connected to a consumable, it can be closed by a closure element at its end of the outer tube directed towards the outside of the machine.

[0026] The closure element may comprise a cylindrical element, preferably of stainless steel, which in the closed state projects into the outer tube of the connection unit.

[0027] The elastic sealing element can be fitted onto the inner surface of the end of the outer tube facing the outside of the medical device, preferably by being pressed securely into the outer tube, and this elastic sealing element forms a radially fitting seal with the cylindrical element of the closure element.

[0028] The closure element may be provided in a receiving portion of a pivot lever which is translationally displaceable along a pivot axis preferably arranged perpendicular to the wall for opening and closing the connection unit, the medical device having a damping device for slowing down this translational movement.

[0029] On the side facing the housing front, the pivot lever may have a peripheral molded seal that prevents liquids or particles from penetrating into the receiving portion of the pivot lever.

[0030] Before and / or during dialysis treatments, the hydraulic system of the treatment machine is disinfected and / or cleaned. Before the closure element is opened for connection to the consumables, the cleaning solution is pumped out of the connection unit and replaced by air. To avoid microbial transfer, it is required to remove the liquid as completely as possible. For this reason, the lumen between the outer tube and the inner tube can be narrowed in a tapered manner, preferably in a conically tapered manner, towards the inside of the machine. Improved removal of the liquid is achieved, i.e. when emptying the port.

[0031] The fastening of the connection sites can be performed in such a way that the longitudinal axis of the connection sites is inclined by 5° or more with respect to the mounting surface of the medical device in such a way that at least one of the outer tube openings facing the inside of the machine is located lower than the outer tube openings facing the outside of the machine. Also in this way, the complete drainage of the cleaning solution is improved.

[0032] The medical device may further comprise a sensor for detecting a state of connection of the connecting unit to the connector of the consumable.

[0033] The medical device may be a device for extracorporeal blood treatment.

[0034] The invention also includes a consumable comprising a fluid line and a connector having a connector lumen for fluidly connecting the fluid line to an inner tube of a connection unit of a medical device according to one of claims 1 to 10.

[0035] The connector has a touch protection sleeve with a free connection opening and a wall. The connector lumen surrounded by the wall leads into an opening set back relative to the free connection opening of the touch protection sleeve. With this embodiment it is possible to reduce the risk of transfer of microorganisms that could potentially enter the line system of the treatment machine during connection or disconnection of the consumable by collision with a non-sterile surface or touching a touchable surface. The wall of the touch protection sleeve has sealing means directed radially outwards, which can prevent or reduce the ingress of liquids positioned on the exterior of the housing into the interior of the housing.

[0036] Furthermore, the walls can have means for creating a screw-type closure, e.g. a cam, so that accidental loosening of the consumables does not occur during treatment. Locking on the housing surface eliminates the need for locking means in the connection unit, allowing for better and / or easier cleaning.

[0037] For a more convenient connection of the connector, the connector can have a cylindrical part for connection to the connection site and a square grip part.

[0038] The present invention includes a system consisting of a medical device according to one of claims 1 to 10 and a consumable according to any of claims 11 and 12.

[0039] The system can be designed such that the outer tube of the connection unit is inserted into the lumen of the touch protection sleeve and the connector lumen of the consumable is inserted into the lumen of the inner tube of the connection unit. A leak-tight fluid line is created by conically tapering the cross section of the inner tube.

[0040] Furthermore, the connection between the connection unit and the connector can be secured by threaded means on the outer surface and on the housing or wall of the medical device.

[0041] The plugging force of between 20 and 40 N on the consumable is set by the elastic fastening of the connection unit, as a result of which easy disconnection by the operator is ensured. [Brief description of the drawings]

[0042] [Figure 1] 1 is a schematic diagram of a medical device. [Diagram 2] FIG. 2 is a schematic diagram of the machine end of the connection unit with cross-sectional planes A and B. [Diagram 3] FIG. 2 is a schematic diagram of a longitudinal section through plane A of a connection unit with a closure element. [Figure 4] 2 is a schematic diagram of a longitudinal section through plane B of a connection unit according to the invention with a plug-in connector. [Diagram 5] 1 is a schematic diagram of a leak sensor according to the present invention; [Figure 6] FIG. 2 is a schematic diagram of a pivot lever with a damper. [Figure 7] FIG. 1 is a longitudinal section through a connector. [Figure 8] FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0043] FIG. 1 shows in a highly simplified schematic diagram an extracorporeal blood medical device 1 as an example of a medical device.

[0044] The extracorporeal blood medical device 1 is a hemo(dia)filtration device, which is connected to a hemofilter 10. The hemofilter 10 is separated by a semipermeable membrane 49 into a blood chamber 51 and a dialysate chamber 50 through which dialysate flows. The blood chamber 51 is part of the extracorporeal blood circuit, while the dialysate chamber 50 is connected to the dialysate system of the blood medical device.

[0045] The extracorporeal blood circuit includes an arterial blood line 11 leading to a blood chamber 51 and a venous blood line 12 flowing out of the blood chamber 51 of the blood filter.

[0046] Fresh dialysate is provided to a dialysate source 13. From the dialysate source 13, a dialysate supply line 3 leads to a first sterile filter 5, the permeate of which is sent directly to a dialysate waste line 4. The permeate of the sterile filter 5 is sent to a second sterile filter 6. The permeate of this second sterile filter is sent through the dialysate supply line 3 to a fresh dialysate coupling 8 and from there to the dialysate chamber 50 of the hemofilter 10.

[0047] After passing through the hemofilter, the hemofilter waste is pumped through dialysate waste coupling 9 into dialysate waste line 4 of the hydraulic system to dialysate drain 14.

[0048] The permeate of the sterile filter 6 is conveyed to the connection unit 2, from where it can be conveyed directly to the extracorporeal blood circuit through a consumable line (not shown) having a connector.

[0049] Unless connected to a consumable, the connection unit 2 is closed by a pivot lever 28 having a closing means 17 (not shown here). The blood medical device comprises a sensor 15. The latter is able to detect and report to the control unit the exact connection or pivot lever position in the closed state of the connection unit or in the open state of the connection unit.

[0050] FIG. 2 shows a schematic view of the machine end of the connection part 2, 2′ with the outer tube 18 and the second and third outer tube openings, the inner tube 19 and the second inner tube opening 24, and shows in the cross-sectional planes A and B the fastening means 52 for fixing the connection unit 2, 2′ to the machine housing.

[0051] FIG. 3 shows a longitudinal section A of an embodiment of the connection unit 2, 2', closed with a cylindrical, stainless steel closure means 27 fastened to the lever handle of a pivot lever 28. The closure means is screwed into the lever handle and can be easily replaced for maintenance. The pivot lever 28 has a circumferential molded seal 29 on the side directed towards the outer housing front 17a. The closure means 27 projects into the interior of the outer tube 18 of the connection unit. On the inner surface of that end of the outer tube 18 directed towards the outside of the medical device, an elastic sealing element 29 is securely pressed in and a cylindrical element of the closure element forms a radially fitting seal. The connection unit 2, 2' is formed by the outer tube 18 and the inner tube 19, which is arranged concentrically in the lumen of the outer tube 18. The outer tube 18 and the inner tube 19 project through the wall of the housing 17 of the treatment machine, in which a screwing means 26 for fastening consumables (not shown here) is provided on the outer appliance front 17a. The outer tube 18 protrudes through the wall from inside to outside the housing 17 of the treatment machine, such that the first outer tube opening 20 is located on the plane of the outer housing front surface 17a and not outside the treatment machine. The second and third outer tube openings 21, 22 are located inside the treatment machine. Similarly, the first inner tube opening 23 is located outside the treatment machine and the second inner tube opening 24 is located inside the treatment machine. The first inner tube opening 23 is set back by 6 mm in the machine interior direction relative to the first outer tube opening 20, so as to avoid contact during the plugging process when the latter has an opening diameter of 1 mm. In the arrangement shown here, the connection unit 2, 2' is positioned in a so-called short-circuit position, in which the connection unit 2, 2' can be cleaned and disinfected. For this purpose, a cleaning or disinfecting liquid is then conveyed through the second inner tube opening to the inner tube and from there to the outer tube. It can be discarded through the third outer tube opening to the dialysate waste. Before connecting the connection unit 2, 2' to the consumable, the connection unit 2, 2' is intended to drain the liquid.The drainage is achieved by pumping the liquid from the lower third outer tube opening 22. At the same time, sterile air is delivered through the second outer tube opening 21 into the lumen 30 to compensate for the resulting pressure deficit. During this drainage, the correct speed is important. The flow rate must be less than 50 ml / min to avoid the water column being pulled away in the port. To further optimize this process, the second outer tube opening 21 is spatially positioned above the third outer tube opening 22. The lumen 30 between the outer tube 18 and the inner tube 19 is tapered towards the inside of the treatment machine to reduce the annular gap in the rear area with a slight inclination of the entire component. This shape not only allows an optimized drainage, but also allows the cavity of the connector to be completely filled.

[0052] FIG. 4 shows a longitudinal section B of an embodiment of a connection unit 2 , 2 ′ connected to a plug-in connector 31 .

[0053] The entire connection unit 2, 2' is fastened in an axially elastic manner in the housing by means of a helical spring 37. This serves to compensate for the tolerances of the conical connection of the connector 31 in the inner tube 19 of the connection unit 2, 2', thus ensuring that slight dimensional differences of consumables or machine components do not lead to any loss of leak tightness of the interface when connected.

[0054] After the connector 31 is connected to the connection unit 2, 2', the touch protection sleeve remains completely outside the outer tube 18 of the connection unit with the sealing element 25. This has the advantage that particles or microorganisms in areas inaccessible to disinfection are not entrained from the consumable into the interior of the port. The inner tube 33 of the consumable is sealingly inserted into the inner tube 19 of the connection unit 2, 2'. The connection of the connector is fixed through a bayonet fastener formed between the threading means 26 in the housing 17 and the cam of the touch protection sleeve. The connector is screwed onto the connection unit. An ergonomically advantageous rotational movement of only about 30° is sufficient. The plugging force of the cone is determined solely by the spring force of the axial spring arrangement 37, which is between 20 and 40 N. It prevents connections that are considered too tight and which could be problematic when disassembling the consumable.

[0055] Arranged on the outer surface of the touch protection screen 36 is a sealing means 33 arranged as a peripheral lamella wall and injection molded at a slight angle onto the touch protection tube. It is conceivable that during treatment, i.e. with the consumable adapter assembled, liquid will run down the front of the housing. The lamella also prevents contamination and adhesion caused by liquid penetrating into the threads 26 of the connection unit.

[0056] 5 shows a schematic diagram of the leak sensor. To detect loss of leak tightness at the cone connection between the connection unit 2, 2' and the connector 31 (not shown), a conductivity sensor 38 is placed in the lumen 30 between the inner tube 19 and the outer tube 18 of the connection unit 2, 2'. For this purpose, an electrical insulator 39 is placed between the inner tube 19 and the outer tube 18.

[0057] 6 shows a schematic diagram of the pivot lever 28. The pivot lever consists of a lever handle located outside the machine housing and a lever stem.

[0058] To open the connection unit 2, 2', the pivot lever 28 is pulled farther to an axial stop at the lever handle. A grooved guide (not shown) at the lever axle mechanically allows a rotational movement at the stop. The lever handle can only be pivoted to the side at this position. This position is dimensioned such that the lever handle can be pivoted far enough away over the first outer tube opening 20. The axial movement is mechanically prevented in the pivoting area. This prevention is only overridden at the stop. When the lever handle reaches the stop position, the axial movement is released again and the lever handle is pulled against the outer housing front face 17a through the spring 41. Closing of the connection unit 2, 2' is performed in the same way. The axial movement is slowed down by the damping mechanism 40. This serves to ensure that any liquid residues or particles located on the closure means are not loosened and cause contamination of the inside of the connection unit 2, 2'.

[0059] FIG. 7 shows a longitudinal section through the connector 31. The connector has a conical inner tube 33 through which the sterile infusion fluid is guided through a fluid line into the extracorporeal hose system. This inner tube is surrounded by a concentrically arranged touch protection sleeve 36. The sterile inner tube 33 is set back by 8 mm relative to the touch protection sleeve 36 so that it is protected from accidental contact and collision with the machine surface. Two chamfered cams 35 are injection molded on the outer surface of the touch protection sleeve. They serve as threading means for connecting to the threading means 26 (not shown) of the machine. A lamella wall 34, injection molded at a slight angle on the touch protection sleeve and arranged around it, serves to seal the connector 31 against the machine front surface.

[0060] FIG. 8 shows a top view of connector 31 in which cam 35 is also shown.

[0061] List of References 1 Medical Unit 2, 2' Connection unit 3 Dialysis fluid inlet 4 Dialysis fluid waste port 5 Sterile Filter 1 6 Sterile Filter 2 7 Air Source 8 Fresh Dialysis Fluid Coupling 9 Waste dialysate coupling 10 Hemofilter 11 Blood inlet line 12 Blood Disposal Line 13 Dialysis fluid source 14 Dialysate drain pipe 15 Position Sensor 16 Control Unit 17 Housing 17a Outer housing front 18 Outer tube of connection unit 19 Inner tube of connection unit 20 first outer tube opening 21 Second outer tube opening 22 Third outer tube opening 23 First inner tube opening 24 Second inner tube opening 25 Sealing element 26 Screw-in means 27 Closing means 28 Pivot lever 29 Pivot lever seal 30 Lumen between the inner and outer tubes 31 Connector 32 Consumable Fluid Lines 33 Connector lumen of consumable inner tube 34 Consumables Sealing Method 35 Cam 36 Consumable touch protection sleeve / outer tube 37 Fastening means / spiral spring 38 Leak Sensor 39 Electrical insulators 40 Attenuation 41 Elastic fastening of pivot lever 49 Translucent membrane 50 Blood Chamber 51 Dialysis fluid chamber 52 Fastening means

Claims

1. 1. A medical device having a housing and a connection unit protruding through a wall of said housing for creating a fluid connection between at least a first fluid line allocated inside the medical device and a connector connected to a second fluid line, the connection unit includes an outer tube and an inner tube disposed in a lumen of the outer tube; the outer tube having a first outer tube opening at an end facing the exterior of the medical device and at least second and third outer tube openings at an end facing the interior of the medical device; the inner tube has a first inner tube opening at an end facing the exterior of the medical device and at least a second inner tube opening at an end facing the interior of the medical device; the outer tube permanently protrudes from the housing; A medical device characterized by:

2. 10. The medical device of claim 1, wherein the distance between the wall of the housing and the first outer tube opening of the connection unit measures at least 10 mm.

3. The medical device of claim 1 , wherein the lumen between the outer tube and the inner tube is conically tapered toward the interior of the medical device.

4. 2. The medical device according to claim 1, wherein the connection unit, in particular the outer tube, is fastened in an axially elastic manner to the housing of the machine by fastening means.

5. The medical device of claim 4 , wherein the fastening means is a helical spring.

6. 2. The medical device of claim 1, wherein an elastic sealing element is mounted on the inner surface of the outer tube at the end of the outer tube facing the exterior of the medical device, and is preferably tightly pressed into the outer tube.

7. 2. The medical device according to claim 1, wherein a leakage sensor, in particular a conductivity sensor, is arranged in the connection unit and in the lumen between the outer tube and the inner tube.

8. The medical device of claim 1 , wherein the medical device comprises a closure element for closing the end of the outer tube that faces the exterior of the machine.

9. 9. The medical device of claim 8, wherein the closure element is a cylindrical element, preferably made of stainless steel, that projects into the outer tube of the connection unit in the closed state and forms a radially fitting seal therewith.

10. the closure element is provided on a receiving part of a pivot lever which is translationally displaceable along a pivot axis and which is preferably arranged perpendicular to the housing surface in order to open or close the connection unit; the medical device having a damping device for slowing the translational movement.

10. The medical device of claim 8 or claim 9.

11. 10. A consumable comprising: a fluid line; and a connector having a connector lumen for fluidly connecting the fluid line to the inner tube of the connection unit of claim 1 and to a medical device, The connector has a touch protection sleeve having a free connection opening and a wall, the connector lumen being surrounded by the wall and leading into an opening recessed relative to the free connection opening of the touch protection sleeve; the outer surface of the touch protection sleeve has sealing means directed radially outward; A consumable item characterized by:

12. 12. The consumable of claim 11, wherein the touch-protective sleeve has means, such as a cam, on the outer surface for creating a threaded closure.

13. A system comprising the medical device of claim 1 and the consumable of claim 11.

14. 14. The system of claim 13, wherein the outer tube of the connection unit is inserted into the lumen of the touch protection sleeve and the connector lumen of the consumable is inserted into the lumen of the inner tube of the connection unit.

15. 15. The system of claim 13 or claim 14, wherein the consumable and attachment site are securely connected by threaded means on the outer surface of the touch protection sleeve and on the housing of the medical device.

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