BLOOD TREATMENT DEVICE WITH AUTOMATIC AIR REMOVAL

Abstract

A blood treatment device includes an extracorporeal blood circuit, a dialyzer and a dialysis fluid circuit. The extracorporeal blood circuit has an arterial portion, a venous portion, an air detector configured to monitor whether air is present in the venous portion, at least one blood pump configured to pump blood through the extracorporeal blood circuit, a venous hose clamp configured to selectively clamp or release the venous portion, a user interface, and a control unit. When the control unit receives information from the air detector that there is air in the venous portion, the control unit is configured to stop the blood pump, close the venous hose clamp, raise an alarm, and display on the user interface instructions for removing air in the venous portion and displaying status reports about the removal of air, and carry out automatic removal of air from the venous portion on a user-initiated basis.

Claims

1. A blood treatment device for use in blood treatment therapies, comprising: an extracorporeal blood circuit, a dialyzer and a dialysis fluid circuit, wherein the extracorporeal blood circuit and the dialysis fluid circuit are separated from each other via a membrane provided in the dialyzer, via which blood can be filtered, and the extracorporeal blood circuit has an arterial portion upstream of the dialyzer and a venous portion downstream of the dialyzer; an air detector arranged in the venous portion and configured to continuously monitor whether air is present in the venous portion; a plurality of pumps, including at least one blood pump which is a pump in the arterial portion and is configured to pump blood through the extracorporeal blood circuit; a venous hose clamp, which is a hose clamp in the venous portion and is configured to selectively clamp or release the venous portion; a user interface comprising a display with a touch screen; and a control unit, which is configured, when it receives information from the air detector that there is air in the venous portion, to stop the blood pump, to close the venous hose clamp, to raise an alarm, and to display on the display a venous air removal window displaying instructions to a user for removing air in the venous portion and displaying status reports about the removal of air, the control unit further configured to carry out an automatic removal of air from the venous portion on a user-initiated basis.

2. The blood treatment device according to claim 1, wherein a manually actuatable clamp is provided in the venous portion in addition to the venous hose clamp, by which a user can selectively clamp or release the venous portion.

3. The blood treatment device according to claim 2, wherein the manually actuatable clamp is arranged at the dialyzer outlet in the venous portion and thus upstream of the venous hose clamp.

4. The blood treatment device according to claim 2, wherein the control unit is configured, when there is air in the venous portion, to display in the venous air removal window an instruction for the user to close the manually actuatable clamp in the venous portion.

5. The blood treatment device according to claim 4, wherein the control unit is configured, when there is air in the venous portion, to display in the venous air removal window an air-removal button which is actuatable by the user by pressing the touch screen.

6. The blood treatment device according to claim 5, wherein the control unit is configured, when it detects that the air-removal button has been pressed by the user, to check whether the manually actuatable clamp is closed by monitoring a pressure change in the extracorporeal circuit, and to generate an alarm to close the manually actuatable clamp if the manually actuatable clamp is not closed.

7. The blood treatment device according to claim 5, wherein the control unit is configured, when it detects that the air-removal button has been pressed by the user, to generate a negative pressure, which is less than a predefined value, in a venous air trap arranged in the venous portion by operating a gauge/level control pump and then to open the venous hose clamp to automatically suck out air from the venous portion.

8. The blood treatment device according to claim 7, wherein the predefined value is −50 mmHg.

9. The blood treatment device according to claim 7, wherein the control unit is configured, when it detects that air has been sucked out of the venous portion, to close the venous hose clamp again and to indicate in the venous air removal window that the removal of air is complete.

10. The blood treatment device according to claim 9, wherein the control unit is configured, when it detects that the removal of air is complete, to display in the venous air removal window a prompt to the user to open the manually actuatable clamp again.

11. The blood treatment device according to claim 10, wherein the control unit is configured to resume a blood treatment therapy when the user has confirmed on the touch screen that he has opened the manually actuatable clamp, and the control unit receives the information from the air detector that there is no more air in the venous portion.

12. The blood treatment device according to claim 11, wherein the control unit is configured: to check whether the manually actuatable clamp is actually open after a resumption of the therapy by monitoring a change in pressure in the extracorporeal circuit; and if the manually actuatable clamp is still closed, to generate an alarm to open the manually actuatable clamp.

Description

BRIEF DESCRIPTION OF THE DRAWING FIGURES

[0031] The disclosure is further explained in conjunction with the drawing figures, of which:

[0032] FIG. 1 is a schematic view of a blood treatment device according to the present disclosure; and

[0033] FIG. 2 is a venous air removal window according to the present disclosure.

DETAILED DESCRIPTION

[0034] 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.

[0035] FIG. 1 shows a schematic view of an extracorporeal blood treatment device (dialysis device) 2. The blood treatment device 2 is basically configured to be used in both continuous and intermittent blood treatment therapies, in particular renal replacement therapies. The blood treatment device 2 is 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 device 2 of 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.).

[0036] The blood treatment device 2 basically has an extracorporeal circuit 4, a dialyzer (hemofilter) 6 and a dialysis fluid circuit 8. The extracorporeal circuit 4 and the dialysis fluid circuit 8 are separated by a membrane 10 provided in the dialyzer 6, through which blood can be filtered using a dialysis fluid solution or without using a dialysis fluid solution.

[0037] The extracorporeal circuit 4 comprises an arterial portion 12 and a venous portion 14. In principle, it is provided that the arterial portion 12, 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 portion 14, in particular one end thereof, is to be connected or attached to a vein of a patient, in particular an intensive care patient.

[0038] The arterial portion 12 has, starting from an arterial end 16 in a blood flow direction towards the dialyzer 6, an arterial pressure sensor 18, an (arterial) blood pump 20, and a dialyzer inlet pressure sensor 22. Starting from the dialyzer 6 (a dialyzer outlet 23) in a blood flow direction towards a venous end 24, the venous portion 14 has a manually actuatable clamp 25, a venous expansion chamber or air trap 26, a safety air detector/air detector 28 and a venous hose clamp 30. By means of the manually actuatable clamp 25, a user can selectively clamp off the venous portion 14 or release it. A venous pressure can be measured on/behind the venous expansion chamber 26 using a venous pressure sensor 32. A level/gauge control pump 33, which is provided behind the venous pressure sensor 32, can press air into the venous expansion chamber or air trap 26 or 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 trap 26 and thus in the venous portion 14.

[0039] As shown in FIG. 1, the venous expansion chamber 26 is connected to a substitution solution bag/container 34. A substitution solution pump 36 is provided and configured to pump a substitution solution from the substitution solution bag 34 into the extracorporeal blood circuit 4, in particular into the venous portion 14 thereof (into the venous expansion chamber 26).

[0040] The dialysis fluid circuit 8 has at least one outlet 38 for effluent/used dialysis fluid (dialysate)/another fluid. In principle, the effluent/dialysate/the other liquid can flow through the outlet 38 from the dialyzer 6 to a collecting bag/container 40 for effluent/dialysate/etc. In the outlet 38, an effluent pressure sensor 42, a blood leak detector 44 and an effluent pump 46 are arranged or provided in a direction of flow from the dialyzer 6 to the collecting bag 40.

[0041] As can be further seen in FIG. 1, a further bag/container 48 is provided in addition to the substitution solution bag 34 and the collecting bag 40. Depending on the desired blood treatment therapy to be performed, the bag 48 may contain, for example, a substitution solution/fluid or a dialysis fluid.

[0042] When, for example, a hemodialysis/hemodiafiltration treatment etc. is to be carried out with the extracorporeal blood treatment device 2, i.e. a blood treatment therapy in which dialysis fluid flows through the dialyzer 6 and thus a substance transport from the extracorporeal circuit 4 to the dialysis fluid circuit 8 takes place both by diffusion and convection, then the bag 48 contains dialysis fluid. When a first valve 50 is now opened and both a second valve 52 and a third valve 54 are closed, then the dialysis fluid can be pumped to the dialyzer 6 via a pump 56. When, for example, hemofiltration etc. is to be performed with the extracorporeal blood treatment device 2, i.e. a blood treatment therapy in which no dialysis fluid flows through the dialyzer 6 and thus substance transport from the extracorporeal circuit 4 to the dialysis fluid circuit 8 takes place only via convection/filtration, the bag 48 can contain a substitution solution. When the first valve 50 and the second valve 52 are closed and the third valve 54 is opened, the substitution solution can be pumped from the bag 48 into the arterial portion 12 of the extracorporeal circuit 4 (pre-dilution). When the first valve 50 and the third valve 54 are closed and the second valve 52 is opened, the substitution solution can be pumped from the bag 48 into the venous portion 14 of the extracorporeal circuit 4 (post-dilution). When the first valve 50 is closed and the second valve 52 and the third valve 54 are opened, the substitution solution can be pumped from the bag 48 into both the arterial portion 12 and the venous portion 14 of 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 bag 34 via the substitution solution pump 36 into the venous portion 14 of the extracorporeal circuit 4 (post-dilution) and simultaneously pumping the substitution solution from the bag 48 via the pump (substitution solution pump) 56 into the arterial portion 12 of the extracorporeal circuit 4 (pre-dilution).

[0043] As shown in FIG. 1, a fluid warmer 58 and a pressure sensor 60 are provided between the pump 56 and the valve assembly consisting of the first valve 50, the second valve 52, and the third valve 54.

[0044] The three bags, i.e. the substitution solution bag 34, the collecting bag 40 and the bag 48, each have load cells attached to them, namely a first load cell 62, a second load cell 64 and a third load cell 66. The first load cell 62 is basically configured to measure or monitor the weight of the substitution solution bag 34. The second load cell 64 is basically configured to measure or monitor the weight of the collecting bag 40. The third load cell 66 is basically configured to measure or monitor the weight of the bag 48.

[0045] The extracorporeal blood treatment device 2 furthermore has a control unit (CPU) 68, which receives information from the sensors provided in the blood treatment device 2 and which controls the actuators provided in the blood treatment device 2. According to the disclosure, this provides software-supported therapy in particular. The control unit 68 receives in particular information from the arterial pressure sensor 18, the dialyzer inlet pressure sensor 22, the safety air detector 28, the venous pressure sensor 32, the effluent pressure sensor 42, the blood leak detector 44, the pressure sensor 60, the first load cell 62, the second load cell 64, the third load cell 66, etc. The control unit 68 controls in particular the blood pump 20, the venous hose clamp 30, the level/gauge control pump 33, the substitution solution pump 36, the effluent pump 46, the first valve 50, the second valve 52, the third valve 54, the pump 56, the fluid warmer 58, etc. Furthermore, the control unit 68 exchanges information with a user interface 70 designed as a display with touch screen. For example, the control unit 68 may be configured to display information on the user interface 70. Furthermore, input by a user/operator on the user interface 70 can be transferred to the control unit 68.

[0046] The control unit 68 of the present disclosure basically receives information from the safety air detector 28, which is located in the venous portion 14 of an extracorporeal (blood) circuit 4. When air is detected by the safety air detector 28, the control unit 68 stops the (arterial) blood pump 20 (preferably all pumps, i.e. not only the arterial blood pump 20 but also the substitution solution pump 36, the effluent pump 46, and the pump 56), closes the venous hose clamp 30, generates an alarm and displays a venous air removal window 74 on a display 72 of the user interface 70.

[0047] FIG. 2 shows the venous air removal window 74. The window informs the user that air has been registered/detected in the venous portion 14 of the extracorporeal circuit 4. In a first step, the user is asked to close a manually actuatable (blue) clamp 25 on the venous portion 14, which is located near/at the dialyzer outlet 23 of the dialyzer 6 of the extracorporeal blood treatment device 2.

[0048] In a second step, the user is prompted on the venous air removal window 74 to press an air-removal button 76. When the air-removal button 76 is pressed by the user, the control unit 68 checks whether the manually actuatable clamp 25 is actually closed, by monitoring a pressure change in the extracorporeal circuit 4, in particular in its venous portion 14, by means of the venous pressure sensor 32. If the control unit 68 determines that the manually actuatable clamp 25 is not closed, the control unit 68 generates an alarm (acoustic and/or optical), which informs the user that he has to close the manually actuatable clamp 25.

[0049] When the control unit 68 determines that the manually actuatable clamp 25 is closed, the control unit 68 of the blood treatment device 2 reduces the pressure in the venous portion 14, in particular in the venous expansion chamber/air trap 26, to a low/negative pressure which is less than a predefined value (preferably −50 mmHg) by controlling the gauge/level control pump 33.

[0050] Then the control unit 68 of the blood treatment device 2 opens the venous hose clamp 30, whereby the air is automatically sucked out.

[0051] When the control unit 68 detects that the air has been sucked out of the venous portion 14, the control unit 68 closes the venous hose clamp 30 again. The user can then examine the venous portion 14. If necessary, he can press the air-removal button 76 again. When the air has been removed, the venous air removal window 74 indicates 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) clamp 25 on the venous portion 14 and press an ok button 78 to resume the blood treatment therapy. The blood treatment device 2 will resume therapy when no more air is detected in the venous portion 14 by the safety air detector 28.

[0052] After resuming the blood treatment therapy, the control unit 68 checks whether the manually actuatable clamp 25 is actually open. For this purpose, the control unit 68 monitors a pressure change in the venous portion 14 of the extracorporeal circuit 4, which is detected by the venous pressure sensor 32. If the manually actuatable clamp 25 is still closed, the control unit 68 generates an alarm (acoustic and/or optical), which indicates to the user that he should open the manually actuatable clamp 25.