Method for Controlling a Blood Treatment Device While Considering Patient Feedback in the Treatment of Blood and Blood Treatment Device

Abstract

A control and/or regulation device, which is connected via signal link to a first input device, which in particular is operable by a doctor, and to a second input device, which in particular is operable by a patient, wherein the control or regulation device is programmed to control and/or regulate in signal link with a blood treatment

Claims

1-21. (canceled)

22. A control and/or regulation device, which is connected via signal link to a first input device, which is operable by a clinician, and to a second input device, which is operable by a patient, wherein the control and/or regulation device is programmed to control and/or regulate a blood treatment device that is connected to a blood filter by executing a method comprising: controlling and/or regulating the blood treatment device for a blood treatment of a patient with a first setting set using the first input device for at least one treatment parameter; checking whether an input has occurred using the second input device; evaluating the input entered using the second input device and/or specifying a second setting for the at least one treatment parameter based on the input entered using the second input device; and controlling or regulating the blood treatment device for the blood treatment of the patient with the second setting and/or controlling or regulating the blood treatment device while adjusting or changing the first setting according to the input or the second setting.

23. The control and/or regulation device according to claim 22, wherein the control and/or regulation device is programmed to allow the input using the second input device, the specifying of the target setting, and/or the adjusting or changing of the original setting of the at least one treatment parameter only within a previously specified frame or area or within previously specified limits.

24. The control and/or regulation device according to claim 22, wherein the treatment parameter is chosen from the group consisting of: flow of dialysis liquid; blood flow through the blood filter; inflow of an infusion solution; concentration of osmotically active substances in the dialysis liquid; concentration of bicarbonate, sodium, potassium, magnesium and/or calcium in the dialysis liquid; filtration rate; ultrafiltration rate; time period of the blood treatment; and temperature of the dialysis liquid.

25. The control and/or regulation device according to claim 22, wherein the second input device enables qualitative input to the control and/or regulation device, and wherein the control and/or regulation device is programmed to transform the qualitative input entered using the second input device according to predetermined routines or rules into the second setting.

26. The control and/or regulation device according to claim 22, wherein the control and/or regulation device is programmed such that when the second input device is used to enter a first input option or a second input option, the control and/or regulation device adjusts or changes the first setting of the treatment parameter.

27. The control and/or regulation device according to claim 22, wherein the control and/or regulation device is programmed such that the adjusting or changing of the first setting results in a predetermined change of the treatment parameter by a fixed value or number.

28. The control and/or regulation device according to claim 22, wherein the control and/or regulation device is programmed such that the adjusting or changing of the first setting comprises a variable and/or continuous adjustment.

29. The control and/or regulation device according to claim 22, wherein the control and/or regulation device is programmed to cause the adjusting or changing of the first setting of the treatment parameter and/or the specifying of the second setting depending on a time passed since a beginning of the blood treatment.

30. The control and/or regulation device according to claim 22, wherein the control and/or regulation device is programmed to control or regulate the adjusting or changing of the first setting of the treatment parameter by automatically adjusting or changing the first setting to a third setting, wherein the first setting occurred at a first time point or in a first time period during the blood treatment, the input was entered using the second input device at a second time point or in a second time period during the blood treatment, and the second time point or time period is after the first time point or time period, respectively.

31. The control and/or regulation device according to claim 30, wherein the third setting is determined such that a target of the blood treatment, aimed at by the first setting, is achieved.

32. The control and/or regulation device according to claim 31, wherein the target is a hydration state and/or a detoxification state of the patient.

33. The control and/or regulation device according to claim 30, wherein the third setting is determined such that an effect of a deviation from the first setting is compensated at least in part, is cancelled or is counteracted.

34. The control and/or regulation device according to claim 22, wherein the control and/or regulation device is programmed to return automatically at least in part from the second setting to the first setting after the controlling or regulating of the blood treatment device has taken place with the second setting.

35. The control and/or regulation device according to claim 22, wherein the control and/or regulation device is programmed to delay an end time point predetermined or calculated by the control or regulation device depending on the second setting or to extend a treatment duration predetermined or calculated by the control or regulation device depending on the second setting after the initiation of the controlling or regulating of the blood treatment device with the second setting.

36. The control and/or regulation device according to claim 22, wherein the control and/or regulation device is programmed such that the input made using the second input device and/or the specifying of the second setting only occurs if the input is made during a predetermined time period of the blood treatment.

37. The control and/or regulation device according to claim 22, wherein the control and/or regulation device is programmed such that the input made using the second input device can be made using speech and/or gestures.

38. A method of controlling a blood treatment device, the method comprising: providing a control and/or regulation device, which is connected via signal link to a first input device, which is operable by a clinician, and to a second input device, which is operable by a patient, wherein the control and/or regulation device is programmed to control and/or regulate a blood treatment device that is connected to a blood filter; controlling and/or regulating the blood treatment device for blood treatment of a patient with a first setting set using the first input device for at least one treatment parameter; checking whether an input has occurred using the second input device; evaluating the input entered using the second input device and/or specifying a second setting for the at least one treatment parameter based on the input entered using the second input device; and controlling or regulating the blood treatment device for the blood treatment of the patient with the second setting and/or controlling or regulating the blood treatment device while adjusting or changing the first setting according to the input or the second setting.

39. The method according to claim 38, wherein the treatment parameter is chosen from the group consisting of: flow of dialysis liquid; blood flow through the blood filter; inflow of an infusion solution; concentration of osmotically active substances in the dialysis liquid; concentration of bicarbonate, sodium, potassium, magnesium and/or calcium in the dialysis liquid; filtration rate; ultrafiltration rate; time period of the blood treatment; and temperature of the dialysis liquid.

40. A system comprising: a blood treatment device that comprises an extracorporeal blood circuit and a blood filter, or that is connected to an extracorporeal blood circuit and a blood filter, the blood treatment device further comprising or being connected to via signal link at least one control and/or regulation device that is programmed to control and/or regulate the blood treatment device by executing a method comprising: controlling and/or regulating the blood treatment device for a blood treatment of a patient with a first setting set using a first input device for at least one treatment parameter; checking whether an input has occurred using the second input device; evaluating the input entered using the second input device and/or specifying a second setting for the at least one treatment parameter based on the input entered using the second input device; and controlling or regulating the blood treatment device for the blood treatment of the patient with the second setting and/or controlling or regulating the blood treatment device while adjusting or changing the first setting according to the input or the second setting.

41. The system according to claim 40, comprising a first input device, which is operable by a clinician for adjusting or changing settings of at least one treatment parameter, the first input device being connected via signal link to the at least one control and/or regulation device; and a second input device, which is operable by a patient for adjusting or changing of settings of at least one treatment parameter, the second input device being connected via signal link to the at least one control and/or regulation device.

42. The system according to claim 40, wherein the blood treatment device is a hemodialysis device, a hemofiltration device, or a hemodiafiltration device.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0076] In the following, embodiments are described purely exemplarily using the enclosed figures. In these figures, the same reference numbers refer to the same components.

[0077] FIG. 1 is a simplified representation of a blood treatment device with an extracorporeal blood circuit in a first embodiment.

[0078] FIG. 2 is a simplified representation of an exemplary treatment course, being carried out with the blood treatment device in a first embodiment.

[0079] FIG. 3 is a simplified representation of an exemplary treatment course, being carried out with the blood treatment device in a second embodiment.

[0080] FIG. 4 is a simplified representation of an exemplary treatment course, being carried out with the blood treatment device in a third embodiment.

DETAILED DESCRIPTION

[0081] FIG. 1 shows in a simplified representation a blood treatment device 1000 with a source, which is not shown, for dialysis liquid and an extracorporeal blood circuit 2000.

[0082] The extracorporeal blood circuit 2000 possesses a blood treatment device 3000, here exemplarily a blood filter or dialyser, or is connected to such. An arterial line section 1 of the extracorporeal blood circuit 2000 carries blood from the vascular system of the patient P towards the blood filter 3000. A venous line section 3 of the extracorporeal blood circuit 2000 carries blood from blood filter 3000 towards the vascular system of the patient P.

[0083] The blood treatment device 1000 possesses a control and/or regulation device 4000 (in short: control device 4000) for controlling and/or regulating of the blood treatment being carried out using the blood treatment device 1000 or is connected to it by signal link.

[0084] The control device 4000 is connected by signal link with a first input device 4100 and with a second input device 4200. A display device 4300, on which settings regarding treatment parameters, the course of the blood treatment or entries made using the first and/or the second input device 4100, 4200 can be displayed, can be provided.

[0085] FIG. 2 shows in a simplified representation an exemplary treatment course being carried out using the blood treatment device 1000 in a first embodiment in a diagram, in which the solid line shows an actual ultrafiltration rate (UF_rate) of a dialysis treatment being carried out using a blood treatment device 1000 over a treatment time (t_dialyse).

[0086] The ultrafiltration treatment begins at a time t0 at the ultrafiltration rate UF_A (or UF original) entered by the doctor at the first input device 4100 as an original setting. At a time t1, the patient P, who desires a more gentle treatment than the one being carried out, submits a qualitative input (“gentle”, see the symbol “-”) using the second input device 4200, which leads to, after evaluation of the input and specification of the target setting, the ultrafiltration being carried out from that moment, deviating from the original setting, which is shown as a dashed line thereafter, at an ultrafiltration rate UF_Z (or UF target) as a target setting.

[0087] As a predetermined ultrafiltration performance or ultrafiltration amount is to be achieved, despite the change made or initiated by the patient at time t1 in the exemplary embodiment shown herein, the dialysis session of the patient extends beyond a time t2, previously considered to be the end of treatment, to a time t3, at which the predetermined ultrafiltration performance is achieved despite the input made by the patient.

[0088] FIG. 3 shows in a simplified representation an exemplary treatment course being carried out using the blood treatment device in a second embodiment.

[0089] In a dialysis treatment, in principle, four processes running in parallel can be identified:

a) extraction of water
b) extraction of toxic substances
c1) correction of electrolytes (adjusting of sodium, potassium, magnesium and calcium)
c2) correction of the pH by adding of bicarbonate

[0090] The extraction processes a) and b) lead to imbalances in the body, which the patient can possibly feel and which, as a result, can lead to the known symptoms of feeling unwell.

[0091] However, imbalances during dialysis do not occur uniformly. Rather, a dialysis treatment can roughly be divided into essential phases 1 and 2: in phase 1, a strain is put on the patient by the extraction of osmotically active substances (“disequilibrium syndrome”). In phase 2, a strain is put on the patient by the extraction of water (with a possible severe hypotension).

[0092] In phase 1, the concentration gradient between blood and dialysis liquid in the blood filter 3000 is characteristic for the elimination speed of the osmotic substances. This is the highest at the start of the dialysis, at t0, and declines over time in a natural exponential function. As a result of the rapid extraction of water in phase 1, a concentration difference arises for osmotically active substances between the blood circulation and the surrounding tissue cells. This leads to, for example, the flow of water from the plasma into the cells of the brain and thus to an increase of pressure there, which can lead to headache. Similar mechanisms lead to cardiac arrhythmias due to the rapid decrease of potassium levels. In this phase, the patient can find relief, if he slows down the removal of osmotically active substances. To this end, he can make an input, described as “gentle”, using the second input device 4200, which takes the form of a regulator, slider, toggle switch or switch, for example. As a result, the blood treatment device 1000 reduces the diffusion of substances from the blood. To this end, one of the following measures—or any combination thereof—can be initiated: [0093] reduction or stopping of the dialysis liquid flow [0094] reduction of the blood flow through the blood filter [0095] reduction of the flow rate of infusions applied [0096] increase of the original concentration of the osmotically active substances in the dialysis liquid [0097] reduction of the bicarbonate and/or of the sodium concentration in the dialysis liquid

[0098] FIG. 3 shows the result of a patient input in a representation of the deviation (A) over the duration of the dialysis (t_dialyse).

[0099] In the example of FIG. 3, the patient desired a “more gentle” treatment at time t1 and made a corresponding input. This input is “translated” via the control device 4000 into a target setting, with which the treatment is carried out from time t1 onwards.

[0100] The input can occur qualitatively either as a pulse or as a pulse with a quantitative intensity information. The input is translated simultaneously as pulse Δ1 for one or several of the parameters described previously. If the input represents a pulse then the value Δ1 is a fixed value, otherwise a specified translation (deposited in the software) was specified between the input of the patient P and the absolute value Δ1.

[0101] The fact that the strain by the osmotic changes on the body decreases degressively from the dialysis start at t0, leads to the following thoughts:

a) The fixed value for Δ1 as well as the translation of a variable input can be made to be dependent on time point t1, hence on the treatment time completed thus far. In certain embodiments, Δ1 can be decreased or amplified depending on the time, which has been completed since treatment start t0, by accessing the routines, algorithms or the like stored in the control device 4000. This way, it can be achieved that the felt impact of the intervention of the patient during the time period of phase 1 mostly corresponds to the desired benefit.
b) In the embodiment discussed here, the correcting intervention is retracted automatically until the end of phase 1 (t2, phase 1 lasts from t0 to t2; phase 2 starts from t2) by the control device 4000. Ideally, this occurs progressively, to counteract the degressive development of the concentration differences between blood and dialysis liquid. As a consequence, a linear concentration course of the osmotically active substances in the blood results, as shown in FIG. 3.

[0102] The intervention on the flow rates of the pumps used leads to a decrease of the cleaning performance (regarding the blood) in the current treatment session. The decrease in performance corresponds in FIG. 3 exemplarily to the triangular area designated F1.

[0103] As at the time t2, the concentration of toxic substances and electrolytes in the blood deviates from the desired value (shown in the time axis of FIG. 3) further than would be the case if the patient had not intervened, a certain catch-up-effect concerning the remaining time until the end of the dialysis at time t3 results automatically. However, this effect is not sufficient to achieve the same cleaning performance at the end of dialysis as would have been achieved without the interference occurred at t1. For this reason, optionally, a counter-correction of the parameters by Δ2 could occur in phase 2, to compensate this difference entirely or partially. The result of the counter-correction is to be understood in FIG. 3 as the triangular area designated F2.

[0104] FIG. 4 shows in a simplified representation an exemplary treatment course being carried out by the blood treatment device in a third embodiment.

[0105] In phase 1, see the remarks concerning FIG. 3, or generally in the initial phase of the dialysis treatment, the elimination of water causes usually few problems for the patient's body. The excessive water (the overhydration) is in the tissue as well as in the cells and in the vasculature. Due to this, the blood vessels are slightly expanded. The removal of water from the vasculature initially leads to a tension release, which the patient feels to be rather positive.

[0106] As more plasma water is removed from the vasculature, however, the blood pressure falls further. While water flows into the vessel lumina from the tissue surrounding the vessels, the body still tries to maintain blood pressure by constricting peripheral vessels and increased pulse frequency. This leads to an increased strain on the patient, which can be felt. As the case may be, the body is not able to compensate the mechanisms previously mentioned and the patient can become dangerously hypotensive.

[0107] Patient P can now take countermeasures, for example by reducing the ultrafiltration rate (UF_rate), that is the removal rate of fluid (for example indirectly via the “gentle/efficient”-regulator as the second input device 4200). In this way, the blood volume (the degree to which the vessels are filled) is increased and the blood pressure stabilised.

[0108] FIG. 4 shows the blood treatment in the phase described as phase 2 above. As in phase 1, the intervention of patient P, caused by the input into the second input device 4200, which occurs in FIG. 4 at time t21, can occur qualitatively as a pulse or quantitatively as intensity information.

[0109] The intervention regarding the ultrafiltration rate UF_rate can be interpreted by the software of the control device 4000 according to preferably at least three options: a), b) or c):

a) constant: that is, the ultrafiltration rate (UF_rate) remains limited until the end of the dialysis. As a consequence, there is a deviation from the prescribed dry weight after dialysis independent of the time point (could be t21, for example, or t22, for example, see FIG. 4), at which the patient intervened. FIG. 4 shows this option with each two different courses, shown once with a dotted line and once with a dashed line.
b) reducing: that is, the ultrafiltration rate UF_rate is returned by the end of the dialysis, that is until time point t3 increased to the regular value.
c) compensating: that is, the ultrafiltration rate UF_rate is returned and the remaining time of the dialysis is divided such that at the moment, less fluid is extracted, afterwards, however, more fluid is extracted, to achieve the dry weight prescribed by the doctor.

[0110] The choice of the options a) to c) as well as the maximum admissible height of the weight deviation at the end of the dialysis, and thus the admissible correction of the ultrafiltration rate UF_rate at the time of the intervention by the patient, is individually set for each patient by the doctor and stored in the software.

[0111] Regarding FIGS. 3 and 4, only the results of “more gentle” are described, which reduces the strain on the patient. Particularly concerning the ultrafiltration rate (UF_rate), “more efficient” is conceivable as well. Here, the ultrafiltration rate would be increased by a value and the dry weight at the end of the dialysis would be lower than the prescribed dry weight. The same mechanisms are valid, as described, in analogy. In this variant, the patient P understands “efficient” to be “allowed to drink more”.

[0112] As a technical result of this setting, the ultrafiltration rate (UF_rate) is corrected upwards already in phase 1, for example, if the patient P triggers “more efficient” at this time.

[0113] The above explanations concern the conceptual division of the treatment duration in two phases. It is also conceivable, however, to introduce more phases. For example, there could be a phase 1′ between phase 1 and phase 2, in which the operation of the second input device 4200, for example by setting “more gentle” or “more efficient”, has no influence, a target setting is thus not created. Such further phases, their start and end and the like can be specified in the setup of the blood treatment device 1000 and/or in the control device 4000.

[0114] If patient P operates the second input device 4200, for example within a certain time frame, several times, the control can convert each operation into a weight difference at the end of the dialysis, which can be restricted by a prescribed limit.

LIST OF REFERENCE NUMBERS

[0115] 1 arterial line section [0116] 2 dialysate line [0117] 3 venous line section [0118] 4 dialysis liquid line [0119] 1000 blood treatment device [0120] 2000 extracorporeal blood circuit [0121] 3000 blood treatment device, blood filter or dialyzer [0122] 4000 control or regulation device [0123] 4100 first input device [0124] 4200 second input device [0125] 4300 display device [0126] P patient [0127] t_dialyse treatment duration of a dialysis treatment [0128] t0 start of treatment [0129] t1 time point during the treatment; interference by the patient [0130] t2 time point during the treatment [0131] t3 end of treatment [0132] UF_A ultrafiltration rate as initial setting [0133] UF_rate ultrafiltration rate [0134] UF_Z ultrafiltration rate as target setting