Control Device or Closed-Loop Control Device, User Interface and Blood Treatment Apparatus for Determining New Adjustable Values

Abstract

The present disclosure relates to a control device or closed-loop control device programmed to control or regulate a blood treatment apparatus during an administered treatment of a patient's blood using an extracorporeal blood tubing set and the blood treatment apparatus based on set adjustable values of treatment parameters set by using the blood treatment apparatus or using another device optionally connected to the extracorporeal blood tubing set, wherein the control device or closed-loop control device is further programmed, after reading, to compare at least one measurement value collected during the administered treatment, as the actual value of a blood parameter with a stored target value of the blood parameter. Based on this comparison and observation of a set adjustable value of one of the treatment parameters, either a correction value or correction factor to change the set adjustable value or a new adjustable value is determined in each case.

Claims

1-16. (canceled)

17. A control device or closed-loop control device programmed to control or to regulate a blood treatment apparatus during an administered treatment of a patient's blood using an extracorporeal blood tubing set and the blood treatment apparatus based on set adjustable values of treatment parameters that are set at the blood treatment apparatus or at an optional device connected to the extracorporeal blood tubing set, wherein the control device or closed-loop control device is further programmed for: reading at least one measurement value of a blood parameter collected during the administered treatment as the actual value of the blood parameter; comparing the actual value with a stored target value of the blood parameter; determining a set adjustable value of a treatment parameter; and either: determining a correction value or correction factor to change the set adjustable value of the treatment parameter in order to change the actual value of the blood parameter towards its stored target value based on actual values and target values and an automatic provision of a new adjustable value in the control device or closed-loop control device to control or regulate the blood treatment apparatus based on the new adjustable value upon request, or determining a new adjustable value in order to change the actual value of the blood parameter towards its target value based on the actual values and target values and the automatic provision of the new adjustable value in the control device or closed-loop control device to control or regulate the blood treatment apparatus based on the new adjustable value upon request.

18. The control device or closed-loop control device according to claim 17, wherein determining the correction value or correction factor or the new adjustable value refers to saved values or a calculation.

19. The control device or closed-loop control device according to claim 17, wherein, in determining the correction value or correction factor or the new adjustable value, information is included regarding how much time has elapsed since a last change of the set adjustable value.

20. The control device or closed-loop control device according to claim 17, wherein the measurement value is a concentration value of calcium in the patient's blood within the extracorporeal blood circuit.

21. The control device or closed-loop control device according to claim 20, wherein the calcium comprises ionized calcium.

22. The control device or closed-loop control device according to claim 17, wherein the treatment parameter corresponds to a concentration of citrate added to blood present in the extracorporeal blood tubing set or corresponds to a dosage or a concentration of a citrate-containing solution.

23. The control device or closed-loop control device according to claim 17, wherein the control device or closed-loop control device is programmed to control or regulate the blood treatment apparatus based on the correction value or correction factor or the new adjustable value after its confirmation by a user.

24. The control device or closed-loop control device according to claim 23, wherein the control device or closed-loop control device is programmed to control or regulate the blood treatment apparatus based on a changed new adjustable value of the treatment parameter based on the correction value or correction factor after confirmation of the new adjustable value by the user.

25. A user interface connected in signal communication to a control device or closed-loop control device programmed to control or to regulate a blood treatment apparatus during an administered treatment of a patient's blood using an extracorporeal blood tubing set and the blood treatment apparatus based on set adjustable values of treatment parameters that are set at the blood treatment apparatus or at an optional device connected to the extracorporeal blood tubing set, wherein the control device or closed-loop control device is further programmed for: reading at least one measurement value of a blood parameter collected during the administered treatment as the actual value of the blood parameter; comparing the actual value with a stored target value of the blood parameter; determining a set adjustable value of a treatment parameter; and either: determining a correction value or correction factor to change the set adjustable value of the treatment parameter in order to change the actual value of the blood parameter towards its stored target value based on actual values and target values and an automatic provision of a new adjustable value in the control device or closed-loop control device to control or regulate the blood treatment apparatus based on the new adjustable value upon request, or determining a new adjustable value in order to change the actual value of the blood parameter towards its target value based on the actual values and target values and the automatic provision of the new adjustable value in the control device or closed-loop control device to control or regulate the blood treatment apparatus based on the new adjustable value upon request.

26. The user interface according to claim 25, comprising at least one first input interface for input by a user of the measurement value as an actual value taken during the blood treatment.

27. The user interface according to claim 26, further comprising at least one first output interface to give a correction value or correction factor and/or the new adjustable value for attention of the user.

28. The user interface according to claim 27, further comprising at least one second input interface for confirmation by the user of the correction value or correction factor and/or the new adjustable value.

29. A blood treatment apparatus comprising a control device or closed-loop control device programmed to control or to regulate a blood treatment apparatus during an administered treatment of a patient's blood using an extracorporeal blood tubing set and the blood treatment apparatus based on set adjustable values of treatment parameters that are set at the blood treatment apparatus or at an optional device connected to the extracorporeal blood tubing set, wherein the control device or closed-loop control device is further programmed for: reading at least one measurement value of a blood parameter collected during the administered treatment as the actual value of the blood parameter; comparing the actual value with a stored target value of the blood parameter; determining a set adjustable value of a treatment parameter; and either: determining a correction value or correction factor to change the set adjustable value of the treatment parameter in order to change the actual value of the blood parameter towards its stored target value based on actual values and target values and an automatic provision of a new adjustable value in the control device or closed-loop control device to control or regulate the blood treatment apparatus based on the new adjustable value upon request, or determining a new adjustable value in order to change the actual value of the blood parameter towards its target value based on the actual values and target values and the automatic provision of the new adjustable value in the control device or closed-loop control device to control or regulate the blood treatment apparatus based on the new adjustable value upon request.

30. The blood treatment apparatus according to claim 29, wherein the blood treatment apparatus comprises a dialysis apparatus, a hemodialysis apparatus, a hemofiltration apparatus, or a hemodiafiltration apparatus.

31. The blood treatment apparatus according to claim 29, wherein the blood treatment apparatus is an apparatus for chronic renal replacement therapy or for continuous renal replacement therapy (CRRT).

32. The blood treatment apparatus according to claim 29, further comprising a user interface connected in signal communication to the control device or closed-loop control device.

33. A digital storage medium configured to interact with a programmable computer system to provide a control device or closed-loop control device programmed to control or to regulate a blood treatment apparatus during an administered treatment of a patient's blood using an extracorporeal blood tubing set and the blood treatment apparatus based on set adjustable values of treatment parameters that are set at the blood treatment apparatus or at an optional device connected to the extracorporeal blood tubing set, wherein the control device or closed-loop control device is further programmed for: reading at least one measurement value of a blood parameter collected during the administered treatment as the actual value of the blood parameter; comparing the actual value with a stored target value of the blood parameter; determining a set adjustable value of a treatment parameter; and either: determining a correction value or correction factor to change the set adjustable value of the treatment parameter in order to change the actual value of the blood parameter towards its stored target value based on actual values and target values and an automatic provision of a new adjustable value in the control device or closed-loop control device to control or regulate the blood treatment apparatus based on the new adjustable value upon request, or determining a new adjustable value in order to change the actual value of the blood parameter towards its target value based on the actual values and target values and the automatic provision of the new adjustable value in the control device or closed-loop control device to control or regulate the blood treatment apparatus based on the new adjustable value upon request.

34. A computer program product for interacting with a programmable computer system to provide a control device or closed-loop control device programmed to control or to regulate a blood treatment apparatus during an administered treatment of a patient's blood using an extracorporeal blood tubing set and the blood treatment apparatus based on set adjustable values of treatment parameters that are set at the blood treatment apparatus or at an optional device connected to the extracorporeal blood tubing set, wherein the control device or closed-loop control device is further programmed for: reading at least one measurement value of a blood parameter collected during the administered treatment as the actual value of the blood parameter; comparing the actual value with a stored target value of the blood parameter; determining a set adjustable value of a treatment parameter; and either: determining a correction value or correction factor to change the set adjustable value of the treatment parameter in order to change the actual value of the blood parameter towards its stored target value based on actual values and target values and an automatic provision of a new adjustable value in the control device or closed-loop control device to control or regulate the blood treatment apparatus based on the new adjustable value upon request, or determining a new adjustable value in order to change the actual value of the blood parameter towards its target value based on the actual values and target values and the automatic provision of the new adjustable value in the control device or closed-loop control device to control or regulate the blood treatment apparatus based on the new adjustable value upon request.

35. The computer program product according to claim 34, wherein the computer program product comprises a signal wave or comprises a program code stored on a machine-readable carrier.

36. A computer program with a program code for providing a control device or closed-loop control device programmed to control or to regulate a blood treatment apparatus during an administered treatment of a patient's blood using an extracorporeal blood tubing set and the blood treatment apparatus based on set adjustable values of treatment parameters that are set at the blood treatment apparatus or at an optional device connected to the extracorporeal blood tubing set, wherein the control device or closed-loop control device is further programmed for: reading at least one measurement value of a blood parameter collected during the administered treatment as the actual value of the blood parameter; comparing the actual value with a stored target value of the blood parameter; determining a set adjustable value of a treatment parameter; and either: determining a correction value or correction factor to change the set adjustable value of the treatment parameter in order to change the actual value of the blood parameter towards its stored target value based on actual values and target values and an automatic provision of a new adjustable value in the control device or closed-loop control device to control or regulate the blood treatment apparatus based on the new adjustable value upon request, or determining a new adjustable value in order to change the actual value of the blood parameter towards its target value based on the actual values and target values and the automatic provision of the new adjustable value in the control device or closed-loop control device to control or regulate the blood treatment apparatus based on the new adjustable value upon request.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0056] The present disclosure is exemplarily explained with regard to the accompanying drawings in which same reference numerals refer to the same or similar elements. The following applies in the partly highly simplified figures: In the figures of the drawing the following applies:

[0057] FIG. 1 shows in a highly simplified representation a process flow chart of a blood treatment apparatus according to the present disclosure; and

[0058] FIG. 2 shows in a schematic representation the course of a method using an embodiment of a control device or closed-loop control device according to the present disclosure.

DETAILED DESCRIPTION

[0059] FIG. 1 shows in a highly simplified representation a process flow chart of a blood treatment apparatus 100 according to the present disclosure, optionally connected to an extracorporeal blood circuit 300.

[0060] The extracorporeal blood circuit 300 includes a first line 301, here in the form of an arterial line section.

[0061] The first line 301 is in fluid connection with a blood treatment device, here exemplarily, a blood filter or dialyzer 303. The blood filter 303 includes a dialysis liquid chamber 303a and a blood chamber 303b, which are separated from each other by a mostly semi-permeable membrane 303c.

[0062] The extracorporeal blood circuit 300 further includes at least one second line 305, here in the form of a venous line section. Both the first line 301 as well as the second line 305, can serve to be connected to the vascular system of the patient, not shown.

[0063] The first line 301 is optionally connected to a (first) tube clamp 302 for blocking or closing the line 301. The second line 305 is optionally connected to a (second) tube clamp 306 for blocking or closing the line 305.

[0064] The blood treatment apparatus 100 represented in FIG. 1 schematically and only by some of its devices, includes a blood pump 101. During the patient's treatment the blood pump 101 conveys blood through sections of the extracorporeal blood circuit 300 and in the direction of the blood filter or dialyzer 303 as shown by the small arrows, which generally indicate in each of the figures the direction of flow.

[0065] Using a pump for dialysis liquid 121, that may be embodied as a roller pump or as any otherwise occluding pump, fresh dialysis liquid is pumped from a source 200 along the dialysis liquid inlet line 104 into the dialysis liquid chamber 303a. The dialysis liquid leaves the dialysis liquid chamber 303a as dialysate, possibly enriched with filtrate, in the direction of the effluent bag 400 and will be referred to herein as effluent.

[0066] The source 200 may for example be a bag or a container. The source 200 may further be a fluid line, for example, a hydraulic outlet or hydraulic port of the blood treatment apparatus 100, from which the online and/or continuously generated or mixed liquid is provided.

[0067] A further source 201 with substituate may optionally be provided. It may correspond to the source 200 or be a separate source.

[0068] A schematically shown control device or closed-loop control device 150 can be configured to control or regulate the blood treatment session.

[0069] Where the effluent bag 400 connects to the blood treatment apparatus 100 is indicated in the bottom right of FIG. 1.

[0070] In addition to the aforementioned blood pump 101, the arrangement shown in FIG. 1 further includes, purely optionally, a number of other optional pumps, namely the pump 111 for substituate, the pump 121 for dialysis liquid and the pump 131 for the effluent.

[0071] The pump 121 is provided to supply dialysis liquid to the blood filter 303, from a source 200, for example a bag, through an optional available bag heater H2 having a heat pack, using the dialysis liquid inlet line 104.

[0072] The thus supplied dialysis liquid exits from the blood filter 303 via a dialysate outlet line 102, aided by the pump 131, and may be discarded.

[0073] An optional arterial sensor PS1 is provided upstream of the blood pump 101. It measures the pressure in the arterial line during a patient's treatment.

[0074] A further optional pressure sensor PS2 is provided downstream of the blood pump 101, but upstream of the blood filter 303 and if provided, upstream of an addition point °25 for Heparin. It measures the pressure upstream of the blood filter 303 (“pre-hemofilter”).

[0075] To measure the filtrate pressure of the blood filter 303 a further pressure sensor may be provided as PS4 downstream of the blood filter 303, however, preferably upstream of the pump 131 in the dialysate outlet line 102.

[0076] Blood, which leaves the blood filter 303, passes through an optional venous blood chamber 29, which may include a ventilation device 31 and/or a further pressure sensor PS3.

[0077] The control device or closed-loop control device 150 shown in FIG. 1 may be in wired or wireless signal connection to any of the components referred to herein—such as to the blood pump 101—in order to control or regulate the blood treatment apparatus 100.

[0078] The optional pump 111 is provided to supply substituate from the optional source 201, for example a bag, via an optional available bag heater H1 having a heat pack, to the second line 305.

[0079] In several embodiments a citrate solution is dispensed from an optionally provided source for citrate solution, here exemplarily embodied as a citrate bag 9, into the first line 301, optionally by a citrate pump 15. For example, 4%-iges Na.sub.3Citrat is added from the citrate solution source.

[0080] An optional feed device, embodied herein as a calcium pump 12, is provided to supply a calcium solution from an optional source for calcium solution, embodied, for example, in FIG. 1 as a calcium bag 13, into the line 305. For example, a CaCl.sub.2-solution is supplied from the source of calcium solution. This may have a calcium concentration of 91 mmol/l, 100 mmol/l or another and/or comparable calcium concentration.

[0081] FIG. 2 schematically shows, the sequence of a method initiated by a control device or closed-loop control device 150 according to the present disclosure of a blood treatment apparatus 100 in an exemplary embodiment. This example relates to anticoagulation using citrate and calcium, without limiting the disclosure thereto.

[0082] Hereby M1 corresponds to a measurement value, for example a blood parameter which was not determined by the blood treatment apparatus 100 nor by the control device or closed-loop control device 150, but is the actual value of the blood parameter, which was determined, e.g., in the laboratory based on a blood sample. M1 may be, for example, a measured calcium concentration Ca++_Ist. The measurement value M1 is known to a user U.

[0083] The user U may enter the measurement value M1 for example, via a first input interface of a user interface 3 and allow it to be read by the control device or closed-loop control device 150, wherein the user interface 3 may be part of the control device or closed-loop control device 150, the blood treatment apparatus 100 or another apparatus. Alternatively the control device or closed-loop control device 150 automatically reads the measurement value M1.

[0084] This reading step is indicated by S1 in FIG. 1.

[0085] The user U may have the current adjustable value, for example, Ci Konz_prev checked upon request.

[0086] Optional plausibility checks via the control device or closed-loop control device 150, are possible at any point when entering data and/or values or when calculating other values, for example, and may also be encompassed in the present disclosure.

[0087] In a step S2 the read-in actual value Ca++_Ist is compared with target values Ca++_Soll of the blood parameter Ca-Konz, e.g., stored in the machine.

[0088] If a difference is detected between actual value and target value, either a correction value or correction factor Ci-Konz_korr or a proposal for a new adjustable value Ci-Konz_new will be calculated now in a step 3 based on a set adjustable value Ci-Konz_prev and on the values determined in step S2. Using these newly calculated values, it is possible in each case to work towards a change in the future actual values of the blood parameter Ca-Konz in the direction of its target value Ca++_Soll, e.g., using the citrate pump 15. When determining a correction value or Ci-Konz_korr this is achieved by changing the set adjustable value Ci-Konz_prev, when determining a new adjustable value Ci-Konz_new, this is achieved by replacing the previously set adjustable value Ci-Konz_prev with the new adjustable value for the further course of the treatment, as further explained in the following with regard to step S4.

[0089] In the optional step S4, the output of the value calculated in S3, therefore that of either the correction value or Ci-Konz_korr or of the new adjustable value Ci-Konz_new, is initiated via an output interface I2 for acknowledgment and/or confirmation by the user U.

[0090] Purely as an example, in this embodiment a confirmation is requested from the user U via a second input interface I3. The step S5 represents an evaluation and possibly a further processing of this second input, which may be for example “yes” or “no”, “ok” or “C”.

[0091] In step S6, the new adjustable value (Ci-Konz_new) is, upon request, automatically provided in the control device or closed-loop control device 150 for controlling and regulating the blood treatment apparatus 100, based on the new adjustable value Ci-Konz_new for further treatment, such as until a new change, indicated using the wide arrows in the direction of the blood treatment apparatus 100 (the request may be the accepting of the new adjustable value Ci-Konz_new by the user U).

[0092] In the present embodiment the control device or closed-loop control device 150 according to the present disclosure is exemplarily represented as a section of the blood treatment apparatus 100. Embodiments of the present disclosure also include other like arrangements, for example, separately at, on and/or next to the blood treatment apparatus 100.

[0093] The aforementioned exemplary embodiment relates to the measurement of calcium as a blood parameter and the dosage of citrate as an adjustable value. However, the present disclosure is by no means limited to this.

LIST OF REFERENCE NUMERALS

[0094] 3 user interface [0095] 9 source for citrate solution, here, e.g., a citrate bag [0096] 12 calcium pump [0097] 13 source for calcium solution, calcium bag [0098] 150 citrate pump [0099] 25 addition point for Heparin (optional) [0100] 29 venous blood chamber (optional) [0101] 31 ventilation/venting, de-aeration or de-airing device [0102] 100 blood treatment apparatus [0103] 101 blood pump [0104] 102 dialysate outlet line, effluent inlet line [0105] 104 dialysis liquid inlet line [0106] 111 pump for substituate [0107] 121 pump for dialysis liquid [0108] 131 pump for dialysate or effluent in effluent inlet line [0109] 150 control device or closed-loop control device [0110] 200 dialysis liquid source [0111] 201 substituate source, optional [0112] 300 extracorporeal blood circuit [0113] 301 first line (arterial line section) [0114] 302 (first) tube clamp [0115] 303 blood filter or dialyzer [0116] 303a dialysis liquid chamber [0117] 303b blood chamber [0118] 303c semi-permeable membrane [0119] 305 second line (venous line section) [0120] 306 (second) tube clamp [0121] M1 measurement value of a blood parameter [0122] I1 first input interface [0123] I2 output interface [0124] I3 second input interface [0125] S1 reading of input [0126] S2 comparing of input with other values [0127] S3 calculation of a proposal or recommendation [0128] S4 giving/displaying of a proposal or recommendation [0129] S5 processing of the confirmation [0130] S6 accepting/carrying out of the proposal/recommendation [0131] U user; clinic personnel