Patent ID: 12201763

DETAILED DESCRIPTION

The figures are merely schematic in nature and serve exclusively for understanding the present disclosure. The same elements are marked with the same reference signs.

FIG.1shows a schematic view of an extracorporeal blood treatment device (dialysis device)2. The blood treatment device2is basically configured to be used in both continuous and intermittent blood treatment therapies, in particular renal replacement therapies. The blood treatment device2is configured in particular as an acute dialysis machine or an acute dialysis device and is thus essentially prepared for use in intensive care units with predominantly unstable patients. With the blood treatment device2of the present disclosure, principally a variety of different blood treatment therapies can be performed (e.g. slow continuous ultrafiltration (SCUF), continuous veno-venous hemofiltration (CVVH), continuous veno-venous hemodialysis (CVVHD), continuous veno-venous hemodiafiltration (CVVHDF), therapeutic plasma exchange (TPE), etc.) as well as dilution modes (e.g., pre-dilution, post-dilution, pre-dilution and post-dilution) and anticoagulation types (e.g., none, heparin, citrate, etc.).

The blood treatment device2basically has an extracorporeal circuit4, a dialyzer (hemofilter)6and a dialysis fluid circuit8. The extracorporeal circuit4and the dialysis fluid circuit8are separated by a membrane10provided in the dialyzer6, through which blood can be filtered using a dialysis fluid solution or without using a dialysis fluid solution.

The extracorporeal circuit4comprises an arterial portion12and a venous portion14. In principle, it is provided that the arterial portion12, in particular one end thereof, is to be connected or attached to an artery of a patient, in particular an intensive care patient. It is also provided that the venous portion14, in particular one end thereof, is to be connected or attached to a vein of a patient, in particular an intensive care patient.

The arterial portion12has, starting from an arterial end16in a blood flow direction towards the dialyzer6, an arterial pressure sensor18, an (arterial) blood pump20, and a dialyzer inlet pressure sensor22. Starting from the dialyzer6(a dialyzer outlet23) in a blood flow direction towards a venous end24, the venous portion14has a manually actuatable clamp25, a venous expansion chamber or air trap26, a safety air detector/air detector28and a venous hose clamp30. By means of the manually actuatable clamp25, a user can selectively clamp off the venous portion14or release it. A venous pressure can be measured on/behind the venous expansion chamber26using a venous pressure sensor32. A level/gauge control pump33, which is provided behind the venous pressure sensor32, can press air into the venous expansion chamber or air trap26or extract air from it and is therefore basically configured and provided to create a negative pressure or an overpressure in the venous expansion chamber or air trap26and thus in the venous portion14.

As shown inFIG.1, the venous expansion chamber26is connected to a substitution solution bag/container34. A substitution solution pump36is provided and configured to pump a substitution solution from the substitution solution bag34into the extracorporeal blood circuit4, in particular into the venous portion14thereof (into the venous expansion chamber26).

The dialysis fluid circuit8has at least one outlet38for effluent/used dialysis fluid (dialysate)/another fluid. In principle, the effluent/dialysate/the other liquid can flow through the outlet38from the dialyzer6to a collecting bag/container40for effluent/dialysate/etc. In the outlet38, an effluent pressure sensor42, a blood leak detector44and an effluent pump46are arranged or provided in a direction of flow from the dialyzer6to the collecting bag40.

As can be further seen inFIG.1, a further bag/container48is provided in addition to the substitution solution bag34and the collecting bag40. Depending on the desired blood treatment therapy to be performed, the bag48may contain, for example, a substitution solution/fluid or a dialysis fluid.

When, for example, a hemodialysis/hemodiafiltration treatment etc. is to be carried out with the extracorporeal blood treatment device2, i.e. a blood treatment therapy in which dialysis fluid flows through the dialyzer6and thus a substance transport from the extracorporeal circuit4to the dialysis fluid circuit8takes place both by diffusion and convection, then the bag48contains dialysis fluid. When a first valve50is now opened and both a second valve52and a third valve54are closed, then the dialysis fluid can be pumped to the dialyzer6via a pump56. When, for example, hemofiltration etc. is to be performed with the extracorporeal blood treatment device2, i.e. a blood treatment therapy in which no dialysis fluid flows through the dialyzer6and thus substance transport from the extracorporeal circuit4to the dialysis fluid circuit8takes place only via convection/filtration, the bag48can contain a substitution solution. When the first valve50and the second valve52are closed and the third valve54is opened, the substitution solution can be pumped from the bag48into the arterial portion12of the extracorporeal circuit4(pre-dilution). When the first valve50and the third valve54are closed and the second valve52is opened, the substitution solution can be pumped from the bag48into the venous portion14of the extracorporeal circuit4(post-dilution). When the first valve50is closed and the second valve52and the third valve54are opened, the substitution solution can be pumped from the bag48into both the arterial portion12and the venous portion14of the extracorporeal circuit (pre-dilution and post-dilution). According to the present disclosure, pre-dilution and post-dilution can also be achieved by pumping the substitution solution from the substitution solution bag34via the substitution solution pump36into the venous portion14of the extracorporeal circuit4(post-dilution) and simultaneously pumping the substitution solution from the bag48via the pump (substitution solution pump)56into the arterial portion12of the extracorporeal circuit4(pre-dilution).

As shown inFIG.1, a fluid warmer58and a pressure sensor60are provided between the pump56and the valve assembly consisting of the first valve50, the second valve52, and the third valve54.

The three bags, i.e. the substitution solution bag34, the collecting bag40and the bag48, each have load cells attached to them, namely a first load cell62, a second load cell64and a third load cell66. The first load cell62is basically configured to measure or monitor the weight of the substitution solution bag34. The second load cell64is basically configured to measure or monitor the weight of the collecting bag40. The third load cell66is basically configured to measure or monitor the weight of the bag48.

The extracorporeal blood treatment device2furthermore has a control unit (CPU)68, which receives information from the sensors provided in the blood treatment device2and which controls the actuators provided in the blood treatment device2. According to the disclosure, this provides software-supported therapy in particular. The control unit68receives in particular information from the arterial pressure sensor18, the dialyzer inlet pressure sensor22, the safety air detector28, the venous pressure sensor32, the effluent pressure sensor42, the blood leak detector44, the pressure sensor60, the first load cell62, the second load cell64, the third load cell66, etc. The control unit68controls in particular the blood pump20, the venous hose clamp30, the level/gauge control pump33, the substitution solution pump36, the effluent pump46, the first valve50, the second valve52, the third valve54, the pump56, the fluid warmer58, etc. Furthermore, the control unit68exchanges information with a user interface70designed as a display with touch screen. For example, the control unit68may be configured to display information on the user interface70. Furthermore, input by a user/operator on the user interface70can be transferred to the control unit68.

The control unit68of the present disclosure basically receives information from the safety air detector28, which is located in the venous portion14of an extracorporeal (blood) circuit4. When air is detected by the safety air detector28, the control unit68stops the (arterial) blood pump20(preferably all pumps, i.e. not only the arterial blood pump20but also the substitution solution pump36, the effluent pump46, and the pump56), closes the venous hose clamp30, generates an alarm and displays a venous air removal window74on a display72of the user interface70.

FIG.2shows the venous air removal window74. The window informs the user that air has been registered/detected in the venous portion14of the extracorporeal circuit4. In a first step, the user is asked to close a manually actuatable (blue) clamp25on the venous portion14, which is located near/at the dialyzer outlet23of the dialyzer6of the extracorporeal blood treatment device2.

In a second step, the user is prompted on the venous air removal window74to press an air-removal button76. When the air-removal button76is pressed by the user, the control unit68checks whether the manually actuatable clamp25is actually closed, by monitoring a pressure change in the extracorporeal circuit4, in particular in its venous portion14, by means of the venous pressure sensor32. If the control unit68determines that the manually actuatable clamp25is not closed, the control unit68generates an alarm (acoustic and/or optical), which informs the user that he has to close the manually actuatable clamp25.

When the control unit68determines that the manually actuatable clamp25is closed, the control unit68of the blood treatment device2reduces the pressure in the venous portion14, in particular in the venous expansion chamber/air trap26, to a low/negative pressure which is less than a predefined value (preferably −50 mmHg) by controlling the gauge/level control pump33.

Then the control unit68of the blood treatment device2opens the venous hose clamp30, whereby the air is automatically sucked out.

When the control unit68detects that the air has been sucked out of the venous portion14, the control unit68closes the venous hose clamp30again. The user can then examine the venous portion14. If necessary, he can press the air-removal button76again. When the air has been removed, the venous air removal window74indicates this to the user and gives him a status report on the removal of the air. In a third step, the user can open the manually operated (blue) clamp25on the venous portion14and press an ok button78to resume the blood treatment therapy. The blood treatment device2will resume therapy when no more air is detected in the venous portion14by the safety air detector28.

After resuming the blood treatment therapy, the control unit68checks whether the manually actuatable clamp25is actually open. For this purpose, the control unit68monitors a pressure change in the venous portion14of the extracorporeal circuit4, which is detected by the venous pressure sensor32. If the manually actuatable clamp25is still closed, the control unit68generates an alarm (acoustic and/or optical), which indicates to the user that he should open the manually actuatable clamp25.