EXTRACORPOREAL BLOOD TREATMENT DEVICE

Abstract

The present invention pertains to an extracorporeal blood treatment device (1), preferably a hemodialysis device, hemofiltration device, or hemodiafiltration device, comprising a fluidic system (2) having a connection point (20) for adding substances, a detection arrangement (4) for detecting a flow of a substance at the connection point (20), wherein the detection arrangement is configured to generate a flow signal, when a flow of a substance is detected at the connection point (20), and a control unit (5), which is communicatively connected to the detection arrangement (4). The control unit (5) is furthermore configured to output a signal (50) in reaction to a received flow signal. The present invention furthermore pertains to a corresponding method for monitoring at least one connection point.

Claims

1. Extracorporeal blood treatment device (1), preferably a hemodialysis device, hemofiltration device, or hemodiafiltration device, comprising: a fluidic system (2) having a connection point (20) for adding substances; a detection arrangement (4) for detecting a flow of a substance at the connection point (20), wherein the detection arrangement is configured to generate a flow signal, when a flow of a substance is detected at the connection point (20); a control unit (5), which is communicatively connected to the detection arrangement (4) and is configured to output a signal (50) in reaction to a received flow signal.

2. Extracorporeal blood treatment device (1) according to claim 1, characterized in that the fluidic system comprises at least two connection points (20A, 20B) for adding substances, wherein the control unit (5) is configured to associate a flow signal to one of the connection points (20A, 20B) and to output the signal (50) according to the associated connecting point (20A, 20B).

3. Extracorporeal blood treatment device (1) according to claim 1, characterized in that the detection arrangement (4) comprises a respective pressure sensor (40A) and/or a flow sensor (40B) for each connection point (20A, 20B) and wherein the detection of the flow of a substance comprises the detection of a pressure and/or a flow.

4. Extracorporeal blood treatment device (1) according to claim 1, characterized in that a display (6) is provided and wherein the signal (50) that is outputted by the control unit (5) comprises the outputting of an indication (60) on the display (6).

5. Extracorporeal blood treatment device (1) according to claim 1, characterized in that at least one of the connection points (20A, 20B) comprises a closing element (3), preferably a clamp, wherein each of the closing elements (3) is communicatively connected to the control unit (5) and wherein the control unit (5) is configured to output a user prompt (62) in reaction to the presence of the signal (50) and wherein the control unit (5) is configured to actuate or at least partially open the closing element (3) based on a user input (64) and/or to output a further signal (52) based on the user input (64).

6. Extracorporeal blood treatment device (1) according to claim 5, characterized in that the control unit (5) is configured to actuate or at least partially open the closing element (3), when a flow signal is present and after a comparison with a predetermined flow status for the connection point (20A, 20B).

7. Extracorporeal blood treatment device (1) according to claim 5, characterized in that the control unit (5) is configured to set a flow rate, when a flow signal for the connection point (20 A, 20 B) is present, based on a comparison of the present flow rate with a predetermined flow rate for the connection point (20A, 20B) and/or based on a user input (64).

8. Extracorporeal blood treatment device (1) according to claim 1, characterized in that the control unit (5) is configured to output an alarm signal (54), preferably an optical and/or acoustic alarm signal, when a flow signal is present, preferably based on a comparison of a user input with a predetermined flow status for the connection point (20).

9. Extracorporeal blood treatment device (1) according to claim 1, characterized in that the detection of a flow of a substance comprises the detection of a coupling element (7) at the connection point (20), wherein the detection preferably comprises the readout of an indicator (70) attached to the coupling element (7) and/or a mechanical, and electromechanical, or electromagnetic switching.

10. Extracorporeal blood treatment device (1) according to claim 1, characterized in that the fluidic system (2) comprises a disposable (8) and wherein the connection point (20 A, 20 B) is arranged at the disposable (8), wherein the disposable (8) preferably comprises a container, a reservoir, a tube, a filter, a dialysis filter, and adsorption unit, a cassette, and/or a catheter.

11. Method for monitoring a connection point (20A, 20B) of an extracorporeal blood treatment device (1), preferably a hemodialysis device, a hemofiltration device, or a hemodiafiltration device, wherein the extracorporeal blood treatment device (1) comprises at least one connection point (20A, 20B) for adding substances, comprising the steps of: detecting the presence of a flow of a substance at the connection point (20A, 20B); and outputting a signal (50), when a flow of a substance is present.

12. Method according to claim 11, characterized in that at least two connection points (20 A, 20 B) are provided and wherein the presence of a flow of a substance is associated to one of the connection points, wherein the outputted signal (50) corresponds to the associated connection point (20 A, 20 B).

13. Method according to claim 11, characterized in that the signal (50) is outputted based on a comparison of the detected flow of a substance with a predetermined flow status for the respective connection point (20A, 20B).

14. Method according to claim 11, characterized in that the signal comprises the presentation of an indication with a user prompt on a display and wherein a closing element provided at the connection point is actuated or at least partially opened based on a user input and/or wherein a further signal is outputted based on a user input.

15. Method according to claim 11, characterized in that the detection of a flow of a substance comprises the detection of a coupling element at the connection point (20 A, 20 B), wherein the detection preferably comprises the readout of an indicator attached to the coupling element and/or a mechanical, an electromechanical, or electromagnetic switching.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0063] The present disclosure will be more readily appreciated by reference to the following detailed description when being considered in connection with the accompanying drawings in which:

[0064] FIG. 1 shows an extracorporeal blood treatment device with a connection point;

[0065] FIG. 2 shows an extracorporeal blood treatment device with multiple connection points

[0066] FIG. 3 shows an extracorporeal blood treatment device according to FIG. 2 with a display;

[0067] FIG. 4 shows an extracorporeal blood treatment device according to FIG. 3 with closing elements and a further user feedback;

[0068] FIG. 5 shows an extracorporeal blood treatment device according to FIG. 1 with a coupled or connected coupling element; and

[0069] FIG. 6 shows a hemodialysis device with a blood side and a dialysate side and with coupled disposables.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

[0070] In the following, preferred embodiments will be explained with reference to the accompanying Figures. In the Figures, like elements are denoted by identical reference numerals and repeated description thereof may be omitted in order to avoid redundancies.

[0071] In FIG. 1 an extracorporeal blood treatment device 1 is schematically shown, which comprises a fluidic system 2. The fluidic system 2 is coupled to an outlet and an inlet of the extracorporeal blood treatment device 1 by means of a fluid coupling and hence forms a circuit, as schematically depicted with the arrow. The fluidic system 2 may also form the entire circuit in the extracorporeal blood treatment device and may e.g. be formed in the form of a tube set that is inserted in the extracorporeal blood treatment device 1.

[0072] A connection point 20 is arranged at the fluidic system 2, which permits the adding of substances into the fluidic system 2. For example, medicaments or generally liquids with a therapeutic effect for a patient (not shown) connected to the extracorporeal blood treatment device 1 may hence be added, either directly or indirectly. Here, the connection point 20 is formed as a reservoir having a Luer lock connection, such that e.g. a syringe with a corresponding coupling may be coupled to the connection point 20 in a simple manner. The reservoir forms a cavity and may either already include a liquid or be partly filled with air to hence prevent a premature introduction of the added liquids or to build up a counter pressure, which may be displaced after a corresponding addition. Instead of a reservoir with a particular or specific connection, however, generally every connection point 20 may be chosen, for example, also a simple tube and/or a self-sealing membrane.

[0073] The connection point 20 is connected to a detection arrangement 4, such that a flow of a substance may be detected at the connection point 20 via the detection arrangement 4. Accordingly, it may e.g. be detected whether the connection point is actively used or operated or is in a free or decoupled state. This information is forwarded to a control unit 5 via a flow signal, wherein the control unit 5 is configured to output a corresponding signal 50 in reaction to the reception of a flow signal, as depicted with the dashed arrows.

[0074] According to this embodiment the signal is an optical signal in the form of a lamp or light, e.g. an LED, which is arranged at the connection point 20. Thereby, the user may be directly provided with a feedback regarding the performed action or after the processing of the detected flow of a substance, such that a performed addition of a substance or a coupling at the connection point 20 is again checked by the user or to ensure that the coupling is detected by the control unit 5. Accordingly, a simple monitoring of the performed actions or operations during and/or prior to the treatment of the patient is provided.

[0075] In the embodiment according to FIG. 2 multiple connection points 20A, 20B are provided in the fluidic system 2 of the extracorporeal blood treatment device 1. At every connection point 20A, 20B a respective detection unit of the detection arrangement 4 is provided, which are here formed as a pressure sensor 40A or flow sensor 40B. Accordingly, a flow of a substance at the connection point 20A is determined via a measurement of the pressure, wherein the detection of the pressure occurs over a predetermined amount of time and wherein the values are accordingly averaged or wherein the variation of the values is evaluated. Accordingly, also a flow of a substance at the connection point 20B is determined, wherein here it is not the pressure, but a measured flow.

[0076] The flow signals are received by the control unit 5 and are associated with a particular or specific connection point 20A, 20B, such that the control unit 5 may differentiate between the flow status of the connection point 20A and the flow status of the connection point 20B. Furthermore, predetermined values of the flow states for the respective connection points 20A, 20B are stored in the control unit 5, such that the control unit 5 may accordingly compare the flow status received via the detection signal with a nominal value or a predetermined range.

[0077] When the detected flow of a substance is within a predetermined range or corresponds to a nominal value, a corresponding signal 50 may be output as a reaction, thereby providing the user with an implicit confirmation of the correct coupling at the respective connection point 20A, 20B. However, if the flow status deviates from the predetermined flow status, a signal may accordingly be output, which indicates the incorrect or erroneous coupling to the user an may include an information regarding the correct or intended coupling.

[0078] The embodiment according to FIG. 3 essentially corresponds to the extracorporeal blood treatment device of FIG. 2. In addition, the extracorporeal blood treatment device 1 comprises a display 6, which is communicatively connected or coupled to the control unit. By means of the display 6, the outputting of a signal in the form of a detailed indication 60 is possible, which includes additional information regarding the flow of a substance of the respective connection points 20A, 20B. For example, the indication 60 may represent a graphical depiction of the actual or current flow of a substance at a respective connection point 20A, 20B, for example, as an overview of the respective connection points 20A, 20B, wherein the corresponding position in the system or in the extracorporeal blood treatment device 1 is schematically depicted and is provided with a respective flow of a substance. Thereby, the indication 60 may also point to a desired or required change of a coupling, for example by means of a corresponding marking or highlighting of the respective connection points 20A, 20B.

[0079] Furthermore, the display 6 may optionally present the result of a comparison of the detected flow of a substance with a predetermined flow of a substance for the respective connection point 20A, 20B in the graphically depicted indication 60, wherein matching or erroneous values may comprise different color codes. Also, the values of the determined and/or predetermined flow states may be presented or depicted in the indication 60, such that it is indicated to the user to which extent the detected flow of a substance matches the predetermined flow of a substance.

[0080] In FIG. 4 the extracorporeal blood treatment device according to FIG. 3 is furthermore provided with closing elements 3 of a further user feedback. Each of the connection points 20A, 20B comprises a closing element 3, which provides a fluid coupling of the respective connection point 20A, 20B with a central tube of the fluidic system 2. The closing elements 3 according to the present embodiment are each formed as a clamp and avoid in the closed state that a substance added at the respective connection point 20A, 20B may flow into the fluidic system 2. The closing elements 3 are initially closed and may be actuated by the control unit 5.

[0081] When a connection point 20A, 20B is actuated or used to add a substance the flow of a substance is changed at the respective connection point 20A, 20B, which is detected or sensed by the detection arrangement 4. Since the control unit 5 associates the changed flow of a substance to a particular connection point 20A, 20B the indication on the display 6 includes a corresponding user prompt 62 or user request, which prompts the user to confirm that the used connection point 20A, 20B is indeed to be used and may also indicate a predetermined flow state, e.g. a substance that is intended for the respective connection point 20A, 20B.

[0082] The user then inputs a user input 64, which may comprise only a confirmation or also a concrete or actual input of the used substance or even a desired flow rate for the administration of the substance. The user input 64 may, as depicted, be performed directly at the control unit 5. Accordingly, the user input 64 is stored in the control unit 5 and the corresponding closing element 3 is accordingly actuated, such that e.g. a clamp is opened and/or a flow rate is automatically set.

[0083] However, should the user input 64 not match a predetermined flow status or value or deviate from a predetermined range, the control unit 5 may then output a further signal 52, e.g. an acoustic alarm or the lighting of a lamp, to draw the attention of the user to the deviation and to signalize that the respective closing element 3 has not (yet) been actuated.

[0084] The user hence receives an extended feedback or feedback, which avoids that substances are inadvertently administered or infused via the wrong or incorrect connection point 20A, 20B. Thereby, the safety of the patient is significantly increased.

[0085] In the extracorporeal blood treatment device 1 according to FIG. 5 the embodiment according to FIG. 1 is provided with a coupled coupling element 7. The detection arrangement 4 is thereby configured to read out an indicator 70 attached to the coupling element 7, wherein the indicator is formed in the form of an RFID. Accordingly, the detection arrangement 4 may be configured to automatically read out or receive the relevant information relating to the coupling element 7 and the corresponding substance and forward this information as a corresponding flow signal to the control unit 5.

[0086] The control unit 5 is communicatively connected to the extracorporeal blood treatment device 1, such that the control unit 5 may determine the predetermined flow of a status based on at least one detected parameter in the extracorporeal blood treatment device 1 and compare said flow status with a detected flow of a substance. If the detected flow of a substance does not match the predetermined flow status, the control unit 5 may output a corresponding alarm signal 54, such that the user is directly pointed to the coupling of an incorrect coupling element 7 and may accordingly examine or check the connection point 20 in order to remedy the failure or to couple a container with the predetermined or intended substance.

[0087] The embodiment according to FIG. 6 essentially corresponds to the extracorporeal blood treatment device 1 according to FIG. 4, wherein the extracorporeal blood treatment device 2 is formed as a hemodialysis device having a blood side 10A and a dialysate side 10B and wherein the components are at least partially formed as coupled disposables 8.

[0088] Accordingly, on both sides 10A, 10B of the hemodialysis device the respective fluidic systems 2, the closing elements 3, and the connection points 20A, 20B are formed as disposables 8. The venous access and the arterial access on the blood side 10A are not shown.

[0089] At respective connection points 20A, 20B of the disposables 8 the sensors 40A, 40B are accordingly coupled, such that the control unit 5 may receive and process or evaluate flow signals regarding the detected flow of a substance. Furthermore, the control unit 5 is communicatively connected with the respective closing elements 3, such that the control unit 5, as in FIG. 4, may actuate the respective closing elements 3 based on a user input 64. The inputting of the user input 64 is performed according this embodiment on the display 6, which allows or enables the inputting of the user input 64, for example, when this is accordingly formed as a touchpad or comprises a keyboard. The interface between the display 6 and the control unit 5 allows in this case a communication in both directions, such that the user input 64 is also forwarded to the control unit 5.

[0090] Thereby, the control unit 5 may monitor the connection points 20A, 20B of the respective side 10A, 10B and hence may differentiate between the sides 10A, 10B, such that the particular association of the connection points 20A, 20B and the required user input 64 provide an increased safety of the patient and at the same time a correct functioning according the therapeutic prescriptions may be maintained.

[0091] Where applicable, all individual features depicted in the embodiments may be combined and/or replaced without leaving the scope of the invention.

LIST OF REFERENCE NUMERALS

[0092] 1 Extracorporeal blood treatment device [0093] 10A Blood side [0094] 10B Dialysate side [0095] 2 Fluidic system [0096] 20 Connection point [0097] 20A Connection point [0098] 20B Connection point [0099] 3 Closing element [0100] 4 Detection arrangement [0101] 40A Pressure sensor [0102] 40B Flow sensor [0103] 5 Control unit [0104] 50 Signal [0105] 52 Signal [0106] 54 Alarm signal [0107] 6 Display [0108] 60 Indication [0109] 62 User prompt [0110] 64 User input [0111] 7 Coupling element [0112] 70 Indicator [0113] 8 Disposable