Extracorporeal blood treatment machine, computer-implemented control method therefor, and computer program

The dialysis machine adjusts the oxygen content in the fresh dialysis fluid using a continuously adjustable throttle device, addressing hypoxemia and equipment costs by optimizing oxygen levels in the blood, enhancing treatment efficiency and safety.

DE102024102454A1Pending Publication Date: 2025-07-31B BRAUN AVITUM
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Patent Information

Application Number
DE102024102454
Authority / Receiving Office
DE · DE
Patent Type
Applications
Current Assignee / Owner
Filing Date
2024-01-29
Publication Date
2025-07-31

AI Technical Summary

Technical Problem

Existing extracorporeal blood treatment machines, such as dialysis machines, cause hypoxemia due to complete degassing of ultrapure water, leading to an increased precipitation of oxygen in the blood, which results in venous blood hypoxemia, and require costly and space-consuming equipment for gas component management.

Method used

A dialysis machine with a continuously adjustable throttle device to control the degassing pressure of ultrapure water, allowing targeted adjustment of the oxygen content in the fresh dialysis fluid, thereby influencing the oxygen content in the blood through a semipermeable membrane.

Benefits of technology

This approach enables a safer and more efficient extracorporeal blood treatment by maintaining optimal oxygen levels in the blood, reducing hypoxemia, and eliminating the need for costly and space-consuming gas management equipment.

✦ Generated by Eureka AI based on patent content.

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Abstract

The disclosure relates to an extracorporeal blood treatment machine (1) for extracorporeal blood treatment, comprising a dialyzer (2), an extracorporeal blood circuit (3), a sensor unit (44) adapted to determine a blood component (SpO2B) in the blood, a degassing unit (5) with a throttle device (78) adapted to throttle gas-containing ultrapure water to a degassing pressure (pE), a pressure detection unit (81) adapted to detect the degassing pressure (pE), a mixing unit (6) adapted to mix the at least partially degassed ultrapure water with at least one concentrate to form a fresh dialysis fluid, and a control unit (54) signal-connected to the sensor unit (44), the pressure detection unit (81), and the throttle device (78), wherein the throttle device (78) is designed with a continuously adjustable throttle cross-section.which is continuously adjustable depending on a control signal (S) of the control unit (54). In addition, the disclosure relates to a control method and a computer program according to the independent claims.
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Description

Technical area

[0001] The present disclosure relates to an extracorporeal blood treatment machine, in particular a dialysis machine, for extracorporeal blood treatment such as hemodialysis, hemofiltration, hemodiafiltration, and / or ultrafiltration. The blood treatment machine comprises a dialyzer with a semipermeable membrane for mass transfer between a patient's blood and a dialysis fluid, an extracorporeal blood circuit that runs through the dialyzer via a blood inlet and a blood outlet of the dialyzer, a sensor unit for detecting a blood component in the blood that correlates with an oxygen content in the blood, a degassing unit with a throttle device, via which ultrapure water provided in a gaseous state can be throttled to a degassing pressure in order to provide the at least partially degassed ultrapure water at an outlet of the degassing unit, and a pressure detection unit.via which the degassing pressure is detected, a mixing unit in which the at least partially degassed ultrapure water is mixed with at least one concentrate to form a fresh dialysis fluid and is provided to a dialysis fluid circuit of the blood treatment machine, and a control unit that is signal-connected to the sensor unit, the pressure detection unit, and the throttle device. In addition, the present disclosure relates to a computer-implemented control method for an extracorporeal blood treatment machine and a computer program according to the preambles of the independent claims. Technical background

[0002] In extracorporeal blood treatment, for example blood purification in the form of hemodialysis, hemofiltration or hemodiafiltration, blood is taken from a dialysis patient via an arterial vascular access and fed to a dialyzer for blood treatment via an extracorporeal blood circuit. Fresh dialysis fluid, prepared as needed, is also fed to the dialyzer via a dialysis fluid circuit. To produce the fresh dialysis fluid, ultrapure water is provided by a water treatment plant, in particular a reverse osmosis system, degassed and then mixed with at least one concentrate in a mixing unit. Conventional blood treatment / dialysis machines currently degas completely, in particular to ensure precise ultrafiltration. Degassing occurs when the ultrapure water flows through a fixed throttle, thereby experiencing a pressure loss.The pressure is released and then passed through a degassing chamber with a large surface area. The surface allows for efficient separation of the gas components of the ultrapure water released due to the pressure loss. The degassed ultrapure water then enters the aforementioned mixing unit for the production of the dialysis fluid.

[0003] In the dialyzer, the blood from the extracorporeal blood circuit and the dialysis fluid from the dialysis fluid circuit are brought into contact via the semipermeable membrane, allowing a substance exchange between the blood and the dialysis fluid. This allows harmful substances to be removed from the blood during dialysis treatment of patients with renal insufficiency, as well as excess water that accumulates in the body due to underlying kidney failure. The purified blood is then returned to the patient via a venous access.

[0004] It should be noted that the exchange of substances between the blood in the extracorporeal circulation and the dialysis fluid can occur in both directions. The resulting direction of substance transport depends on the concentration of the respective component in the blood / dialysis fluid. The oxygen content of the dialysis fluid is important for hemodialysis, as oxygen is highly permeable and, depending on the gradient, substance transport can be expected with a sufficient partial pressure difference between the blood in the extracorporeal circulation and the fresh dialysis fluid.

[0005] Since the partial pressure of oxygen in the fresh dialysis fluid approaches zero due to the complete degassing of the state-of-the-art blood treatment machine, and the fresh dialysis fluid is brought into contact with the oxygenated blood of the extracorporeal blood circuit at the dialyzer's semipermeable membrane, increased excretion of oxygen dissolved in the blood of the extracorporeal blood circuit and, consequently, hypoxemia of the venous blood in the extracorporeal blood circuit can be expected according to the current state of the art. This adverse effect can be avoided or at least reduced if it is possible to influence the partial pressure in the blood of the extracorporeal blood circuit.

[0006] Methods for influencing a gas component in an extracorporeal blood circuit are fundamentally known from the prior art. For example, membrane oxygenation combines continuous renal replacement therapy (CRRT) with venovenous, extracorporeal removal of carbon dioxide (CO2) (ECCO2R). In this case, a peristaltic pump pumps blood from an arterial tubing section of the extracorporeal blood circuit at a flow rate of approximately 10 ml / min to 500 ml / min into a CO2 absorber (ECCO2R filter). The CO2 absorber has an oxygen pressure connection fed by an external oxygen tank. The resulting oxygen purge gas stream removes the CO2 from the blood in the arterial tubing section.

[0007] The disadvantage of this solution is that the necessary CO2 absorber, the oxygen tank and the piping system for the supply and removal of the rinsing oxygen represent a comparatively high equipment complexity, which is reflected in costs and a high space requirement. Summary of the present disclosure

[0008] The object of the present disclosure is, in contrast, to avoid or at least mitigate the disadvantages of the prior art and, in particular, to provide an extracorporeal blood treatment machine, as well as a computer-implemented control method and computer program, which provides an even more efficient and safer therapy of an extracorporeal blood treatment.

[0009] The object of the present disclosure is achieved with regard to an extracorporeal blood treatment machine by the features of claim 1, with regard to a computer-implemented control method by the features of claim 10, and with regard to a computer program by the features of claim 15.

[0010] A basic concept of the present disclosure provides that a blood treatment machine is adapted to influence the oxygen content in the blood during blood treatment by influencing the oxygen content in the fresh dialysis fluid. For this purpose, the degassing pressure of gas-containing ultrapure water, which is provided for the preparation of the fresh dialysis fluid, is specifically adjusted or set by means of a continuously adjustable throttle device.

[0011] In other words, an extracorporeal blood treatment machine, in particular a dialysis machine, is provided for extracorporeal blood treatment of a patient's blood, comprising: a dialyzer; an extracorporeal blood circuit, which runs through the dialyzer via a blood inlet and a blood outlet of the dialyzer, with a sensor unit adapted to determine a blood component in the blood, in particular an oxyhemoglobin content of the blood, which correlates with an oxygen content in the blood, in particular an oxygen partial pressure in the blood, wherein the sensor unit is preferably arranged upstream of the blood inlet; a degassing unit with a throttle device adapted to throttle gas-containing ultrapure water to a degassing pressure in order to provide at least partially degassed ultrapure water at an outlet of the degassing unit, with a pressure detection unit adapted to detect the degassing pressure, wherein the pressure detection unit is arranged in particular downstream of the throttle device, a mixing unit adapted to mix the at least partially degassed ultrapure water with at least one concentrate to form a fresh dialysis fluid, preferably a dialysis fluid circuit adapted to provide the fresh dialysis fluid at a dialysis fluid inlet, to convey it through the dialyzer and to discharge used dialysis fluid at a dialysis fluid outlet, and a control unit which is signal-connected to the sensor unit, the pressure detection unit and the throttle device. According to the disclosure, the throttle device is designed with a continuously adjustable throttle cross-section, which is continuously adjustable depending on a control signal of the control unit, preferably proportional to the control signal.

[0012] Unlike what is known from the prior art, the throttle cross-section of the throttle device is thus continuously adjustable according to the disclosure. In other words, the throttle cross-section can be adjusted / set to a fully open position and a fully closed position, and to corresponding intermediate positions in the control signal. Since the degassing pressure depends on a pressure loss across the throttle device, and the pressure loss in turn – for a given volume flow of the ultrapure water entering the throttle device – is essentially determined by the throttle cross-section, the degassing pressure can be continuously adjusted and influenced between limits according to the disclosure.Since the solubility of gases in a liquid—and thus also of oxygen—is directly dependent on the liquid pressure according to Henry's law (in this case, this pressure is the degassing pressure of the ultrapure water downstream of the throttle device), the oxygen content of the ultrapure water downstream of the throttle device can be adjusted / set by means of the continuously adjustable throttle cross-section according to the disclosure. Since this at least partially degassed ultrapure water is mixed with a concentrate in the mixing unit to form fresh dialysis fluid, the oxygen content of the fresh dialysis fluid can be adjusted / set according to the disclosure.Since the fresh dialysis fluid in the dialyzer is in material exchange with the blood via the dialyzer's semipermeable membrane, and oxygen is permeable to the membrane, this opens up the possibility of influencing the oxygen content in the blood by adjusting / setting the oxygen content of the fresh dialysis fluid. This provides an even more efficient and safer extracorporeal blood treatment therapy using the blood treatment machine designed according to the disclosure.

[0013] A lower limit of the degassing pressure can be achieved with a minimally controlled throttle cross-section, which enables maximum, particularly complete, degassing of the gas-containing ultrapure water. In contrast, an upper limit of the degassing pressure can be achieved with a maximum controlled throttle cross-section, so that no degassing of the gas-containing ultrapure water occurs or only minimal degassing occurs, particularly due to an already occurring flow pressure loss.

[0014] Preferably, the throttle device is designed as an electromagnetically actuated proportional valve or has such a valve and is signal-connected to the control unit.

[0015] In a preferred development, the control unit is adapted to determine the control signal in such a way that, as a result of the adjustment of the throttle cross-section, the oxygen content in the blood is optionally increased, kept constant and / or decreased, so that the oxygen content in the blood is specifically influenced.

[0016] In a further preferred development, the control unit is adapted to determine the control signal such that an oxygen content in the at least partially degassed ultrapure water or the fresh dialysis fluid, in particular an oxygen partial pressure in the at least partially degassed ultrapure water or the fresh dialysis fluid, is adjusted, in particular increased, kept constant and / or decreased, depending on the oxygen content in the blood.

[0017] In a further preferred development, the control unit is adapted to determine the control signal so that a predetermined difference between an oxygen content in the at least partially degassed ultrapure water or the fresh dialysis fluid, in particular an oxygen partial pressure in the at least partially degassed ultrapure water or the fresh dialysis fluid, and the oxygen content in the blood is set, in particular kept constant.

[0018] To determine the control signal, according to a preferred embodiment, a first correlation of the oxygen content in the blood with the blood component is stored in a memory of the blood treatment machine, preferably in a memory of the control unit. Furthermore, the control unit is adapted to retrieve the first correlation and, from this, determine the oxygen content in the blood as a function of the blood component detected by the sensor unit.

[0019] In order to determine the control signal, the control unit is further adapted, according to a preferred development, to determine a target oxygen content in the at least partially degassed ultrapure water or the fresh dialysis fluid from the determined oxygen content in the blood and the predetermined difference, in particular as the sum of the oxygen content in the blood and the predetermined difference.

[0020] According to a preferred development, a second correlation of the oxygen content in the at least partially degassed ultrapure water or the fresh dialysis fluid with the degassing pressure is stored in the memory, and the control unit is adapted to call up the second correlation and to determine therefrom a target degassing pressure as a function of the determined target oxygen content in the at least partially degassed ultrapure water or the fresh dialysis fluid.

[0021] According to a preferred development, a third correlation of the degassing pressure with the control signal is stored in the memory, and the control unit is adapted to call up the third correlation and to determine therefrom the control signal as a function of the determined target degassing pressure and to control the throttle device with the control signal.

[0022] According to a further preferred development, the control unit is adapted to determine a deviation from the predetermined difference permanently, selectively, and / or periodically and to adapt the control signal depending on the deviation.

[0023] According to a possible further development, the extracorporeal blood treatment machine is adapted to carry out an automatic adjustment of the oxygen partial pressures in the blood and in the fresh dialysis fluid in chronic dialysis treatment.

[0024] According to a further possible development, the extracorporeal blood treatment machine is adapted to perform an adjustment of the oxyhemoglobin level in the blood in chronic dialysis treatment.

[0025] According to a further possible further development, the extracorporeal blood treatment machine is adapted to support oxygen supply in acute and chronic dialysis treatment.

[0026] With regard to a computer-implemented control method for an extracorporeal blood treatment machine, in particular a blood treatment machine according to the present disclosure, the object is achieved in that the control method comprises steps: Determining a blood component in the blood, in particular an oxyhemoglobin content in the blood, which correlates with an oxygen content in the blood, in particular an oxygen partial pressure in the blood, via a sensor unit in an extracorporeal blood circuit of the blood treatment machine and providing the determined blood component to a control unit, in particular a control unit of the extracorporeal blood treatment machine; Throttling gas-containing ultrapure water to a degassing pressure in order to provide at least partially degassed ultrapure water, via a throttling device, in particular a throttling device of a degassing unit of the extracorporeal blood treatment machine; Detecting the degassing pressure via a pressure detection unit, in particular the degassing unit, and providing the degassing pressure to the control unit; Mixing the at least partially degassed ultrapure water with at least one concentrate to form a fresh dialysis fluid, via a mixing unit, in particular a mixing unit of the extracorporeal blood treatment machine, According to the disclosure, the method comprises steps: Determining a control signal for controlling the throttle device, which is designed with a throttle cross-section that is adjustable as a function of the control signal, preferably proportional to the control signal, via the control unit; Controlling the throttle device with the control signal via the control unit; and Adjusting the throttle cross-section according to the control signal.

[0027] According to a preferred development, the control signal is determined via the control unit in such a way that as a result of the adjustment of the throttle cross-section, the oxygen content in the blood is optionally increased, kept constant and / or decreased.

[0028] The advantages resulting from the disclosed determination of the control signal, the control of the throttle device with the control signal, and the continuous adjustment of the throttle cross-section of the throttle device according to the control signal have already been disclosed above for the blood treatment machine, to which reference is made here. They will therefore not be mentioned again to avoid overloading this document. The computer-implemented control method according to the disclosed method thus provides an even more efficient and safer therapy for extracorporeal blood treatment.

[0029] According to a preferred development, the control signal is determined via the control unit in such a way that an oxygen content in the at least partially degassed ultrapure water or the fresh dialysis fluid, in particular an oxygen partial pressure in the at least partially degassed ultrapure water or the fresh dialysis fluid, is optionally raised, kept constant and / or lowered depending on the oxygen content in the blood.

[0030] According to a preferred development, the control signal is determined via the control unit in such a way that a predetermined difference between an oxygen content in the at least partially degassed ultrapure water or the fresh dialysis fluid, in particular an oxygen partial pressure in the at least partially degassed ultrapure water or the fresh dialysis fluid, and the oxygen content in the blood is set, in particular kept constant.

[0031] According to a particularly preferred development of the computer-implemented control method, a first correlation of the oxygen content in the blood with the blood component, a second correlation of the oxygen content in the at least partially degassed ultrapure water or the fresh dialysis fluid with the degassing pressure, a third correlation of the degassing pressure with the control signal, and the predetermined difference are stored in a memory of the blood treatment machine, preferably in a memory of the control unit. According to the disclosure, the step of determining the control signal can then be performed with the following steps: Calling up the first correlation and determining the oxygen content in the blood as a function of the blood component detected by the sensor unit, via the control unit; Determining a target oxygen content in the at least partially degassed ultrapure water or the fresh dialysis fluid from the determined oxygen content in the blood and the predetermined difference, in particular as their sum, via the control unit; Calling up the second correlation and determining a target degassing pressure as a function of the determined target oxygen content in the at least partially degassed ultrapure water or the fresh dialysis fluid, via the control unit; and Calling up the third correlation and determining the control signal as a function of the determined target degassing pressure via the control unit.

[0032] With regard to a computer program, the object of the present disclosure is achieved in that this computer program comprises instructions which, when executed by a computer, cause the computer to carry out the method steps of the control method according to the present disclosure. Short description of the characters

[0033] The disclosure is explained in more detail below using preferred embodiments with the aid of figures. They show: Fig. 1 is a schematic view of an extracorporeal blood treatment machine according to a preferred embodiment; Fig. 2 a first correlation of an oxygen content pO 2B in the blood of an extracorporeal blood circuit with a blood component SpO detected by a sensor unit in the blood of the extracorporeal blood circuit 2B , according to the extracorporeal blood treatment machine according to Fig. 1; Fig. 3 a temporal progression of the oxygen content pO 2B in the blood of the extracorporeal blood circuit in the case of a constant oxygen content pO 2D in a fresh dialysis fluid, according to the extracorporeal blood treatment machine according to Fig. 1; Fig. 4 a second correlation of a degassing pressure p E of ultrapure water with the oxygen content pO 2D in the ultrapure water or fresh dialysis fluid, according to the extracorporeal blood treatment machine according to Fig. 1; Fig. 5 a third correlation of a control signal S for a throttle device with the degassing pressure p E of ultrapure water, according to the extracorporeal blood treatment machine according to Fig. 1, and Fig. 6 is a flowchart of a computer-implemented control method according to a preferred embodiment.

[0034] The figures are schematic in nature and are intended only to assist in understanding the disclosure. Like elements are designated by like reference numerals.

[0035] Features of different embodiments can be interchanged. Detailed description of preferred embodiments

[0036] Fig. 1 shows a schematic view of an extracorporeal blood treatment machine 1 in the form of a dialysis machine for extracorporeal blood treatment of blood of a patient P according to a preferred embodiment of the present disclosure.

[0037] In the following, a disclosed adjustment or setting of a degassing pressure p E of ultrapure water, whereby an oxygen content pO 2D in a fresh dialysis fluid of the blood treatment machine 1 is variable and as a result, based on a mass exchange at a semipermeable membrane of a dialyzer 2 of the blood treatment machine 1, an oxygen content pO 2B in the blood of an extracorporeal blood circuit 3 of the blood treatment machine 1 can be influenced.

[0038] The extracorporeal blood treatment machine 1 (hereinafter referred to as the blood treatment machine) has, as its central component, a dialyzer 2 with, on the one hand, a dialysis fluid inlet 2.1 and a dialysate outlet 2.2 on the dialysis fluid side, and, on the other hand, a blood inlet 2.3 and a blood outlet 2.4 on the blood side of an extracorporeal blood circuit 3. Within the dialyzer 2, it is divided into a dialysis fluid side and a blood side by means of hollow fibers of a semipermeable membrane 2.5.

[0039] The dialysis fluid inlet 2.1 is fluidically connectable, in particular connected, to a mixing unit 6 via a dialysis fluid inlet 4. This mixing unit continuously produces fresh dialysis fluid from at least partially degassed ultrapure water, as well as a basic concentrate and an acidic concentrate. The added amounts are controlled by measuring devices. Accordingly, the mixing unit 6 has a first and second source 8, 10 for basic and acidic concentrate, a first and second conveying device 12, 14, and, downstream of the conveying devices 12, 14, a first and second measuring device 16, 18.

[0040] According to Fig. 1, the mixing unit 6 has an inlet 20, at which the at least partially degassed ultrapure water of a degassing unit 5, explained in detail below, is present. Downstream of the second measuring device 18, the mixing unit 6 has a third conveying device 22, via which the mixed, fresh dialysis fluid is conveyed to a balancing device 24. On the output side, the balancing device 24 is fluidly connectable to the dialysis fluid inlet 2.1 of the dialyzer 2 via the dialysis fluid inlet 4, wherein a valve 26 for shutting off the dialysis fluid inlet 2.1 is arranged in the dialysis fluid inlet 4.

[0041] The dialysate outlet 2.2 is fluidically connectable, in particular connected, to a disposal outlet 30 for used dialysis fluid / dialysate via a dialysate outlet 28. Arranged fluidically in series in the dialysate outlet 28 between the dialysate outlet 2.2 and the disposal outlet 30 are: an actuatable valve 34 for shutting off the dialysate outlet 2.2, a detection unit 32a for detecting a component in the dialysate, and a fourth conveying device 36, via which the dialysate is conveyed to the balancing device 24 and to the disposal outlet 30 for dialysate. The balancing device 24 ensures that a desired volume of excess water can be removed from the patient's blood during ultrafiltration. Upstream of the fourth conveying device 36, a pressure detection unit 35 for detecting a dialysate outlet pressure is provided in the dialysate outlet 28.

[0042] Additionally, a bypass flow path 38 is provided, via which the dialysis fluid inlet 4 can be fluidically connected to the dialysate outlet 28. An actuatable valve 40 is arranged in the bypass flow path 38, via which the bypass flow path 38 can be blocked.

[0043] With the aid of the aforementioned fluidic switching means / valves 26, 34, and 40, the dialysis fluid circuit can be switched via the control unit 54 into a main circuit, in which fresh dialysis fluid is provided via the dialysis fluid inlet 4 at the dialysis fluid inlet 2.1 and is conveyed through the dialyzer 2 to the dialysate outlet 2.2. Furthermore, the dialysis fluid circuit can be switched into a bypass circuit by means of the fluidic switching means / valves 26, 34, and 40, in which the dialysis fluid inlet 4 is fluidically separated from the dialysis fluid inlet 2.1 and the dialysate outlet 24 is fluidically separated from the dialysate outlet 2.2, while the dialysis fluid inlet 4 is fluidically connected to the dialysate outlet 24 via the bypass flow path 38.

[0044] On the blood side, the extracorporeal blood circuit 3 is provided, which can withdraw blood from the patient P via an arterial tube section 42 and supply it to the dialyzer 2 via the blood inlet 2.3. In the arterial tube section 42, an arterial tube clamp 41, an arterial hematocrit sensor or HCT sensor 44 for detecting an oxyhemoglobin content SpO 2Bin the blood, a blood pump 46 and a blood inlet pressure sensor 48 are arranged. After the blood of patient P has been passed through the blood side of the dialyzer 2 in the extracorporeal blood circuit 3, it is withdrawn at its blood outlet 2.4 and fed to the shunt S via a venous tube section 50. A blood outlet pressure sensor 52 and a venous tube clamp 43 are arranged in the venous tube section 50. In the dialyzer 2, the blood is fed to the dialysis fluid in a countercurrent process and freed of urinary components and excess water, and then returned / returned to patient P in a cleaned state.

[0045] According to Fig. 1, the extracorporeal blood treatment machine 1 has a degassing unit 5 for providing at least partially degassed ultrapure water, the inlet 58 of which is connected to a supply connection of a reverse osmosis system (not shown) and at which gas-containing ultrapure water is available.

[0046] Its inlet 58 is connected via an ultrapure water inlet 60 to a degassing tank 62 of the degassing unit 5. An adjustable pressure reducing valve 64, in particular for adjusting an inlet pressure, and a shut-off valve 66, in particular for blocking / opening the ultrapure water inlet 60, are arranged in the ultrapure water inlet 60. The ultrapure water inlet 60 opens into a supply chamber 68 of the degassing tank 62. The supply chamber 68 has two float switches 70, 72, a lower one 70 and an upper one 72, which interact with a float 74 and are signal-connected to the control unit 54.

[0047] At the bottom of the flow chamber 68, a degassing channel 76 is located, which fluidically connects the flow chamber 68 to a degassing chamber 80 via a throttle device 78, which is designed as disclosed with a continuously adjustable throttle cross-section and is designed as an electromagnetically actuated proportional valve according to the exemplary embodiment. In the degassing channel 76, downstream of the throttle device 78, there is a pressure detection unit 81 for detecting the degassing pressure p E arranged. A fixed throttle 82 is provided in fluidically parallel connection to the adjustable throttle device 78, via which a parallel flow path can be formed when the adjustable throttle device 78 is closed.

[0048] The degassing channel 76 opens into the degassing chamber 80 at the bottom. A discharge section 84a of a connecting channel 84 emerges at an apex of the degassing chamber 80 and leads, via a feed pump 86, into a heating chamber 88 of the degassing tank 62. The connecting channel 84 then spirals through the heating chamber 88 and exits at an apex of the heating chamber 88 with a return section 84b. This finally opens into a settling chamber 90 of the degassing tank 62, which is located between the feed chamber 68 and the heating chamber 88. The return section 84b of the connecting channel 84 has a temperature sensor 92 and a shut-off valve 94.

[0049] At the bottom side, a supply channel 96 emerges from the settling chamber 90, which is connected via a check valve 98 to the already mentioned inlet 20 of the mixing unit 6.

[0050] Based on Fig. 3 illustrates the basic idea of the invention - namely to influence the oxygen content in the blood by adjusting the oxygen content in the fresh dialysis fluid. To create the graph according to Fig. 3, a first correlation is disclosed, which is derived from the graph of the Fig. 2, and a second correlation, which is represented by the graph according to Fig. 4 is used.

[0051] Fig. 2 shows the first correlation of the oxygen content pO 2B in the blood of the extracorporeal blood circuit 3 with the blood component detected by a sensor unit 44 in the blood of the extracorporeal blood circuit 3, that is to say with the oxyhaemoglobin component SpO 2B . Fig. 4 shows the second correlation of the degassing pressure p E of ultrapure water with the oxygen content pO 2Din the ultrapure water or the fresh dialysis fluid. Both correlations are stored in the memory 56 of the control unit 54 and can be retrieved by the control unit 54.

[0052] According to the Fig. In the first correlation shown in Figure 2, the oxygen partial pressure pO is on the X-axis. 2B in the blood (in mmHg) and on the Y-axis the oxyhemoglobin content SpO 2B in the blood (in %) is plotted. The first correlation is stored in the memory 56 and can be called up via the control unit 54. By calling up the first correlation, the control unit 54 is able to calculate the oxyhemoglobin content SpO 2B in the blood the oxygen partial pressure pO 2B in the blood. The first correlation is based on empirically determined data.

[0053] The first correlation of the oxyhemoglobin fraction SpO 2B in the blood with the oxygen partial pressure pO 2Bin the blood is preferably stored in the memory 56 in the following form: pO2B(SpO2B)=a*e(b*SpO2B)+c*e(b*SpO2B)

[0054] According to the Fig. In the second correlation shown in Figure 4, the degassing pressure p is on the X-axis E and on the Y-axis the oxygen partial pressure pO 2D in the at least partially degassed ultrapure water or the fresh dialysis fluid (both in mmHg). The second correlation according to Fig. 4 is stored in the memory 56 and can be called up by the control unit 54. By calling up the second correlation, the control unit 54 is able to determine from the degassing pressure p detected by the pressure detection unit 81 E the corresponding oxygen partial pressure pO 2D in the at least partially degassed ultrapure water or the fresh dialysis fluid, and vice versa, from a target oxygen partial pressure pO determined by it 2D,sollin the at least partially degassed ultrapure water or the fresh dialysis fluid a target degassing pressure p E,soll of the at least partially degassed ultrapure water.

[0055] The second correlation of the oxygen partial pressure pO 2D in the at least partially degassed ultrapure water or the fresh dialysis fluid with the degassing pressure p E is preferably stored in the memory 56 in the following form: pO2D(pE)=a*pE+b

[0056] Fig. 3 shows the time courses of the oxygen partial pressures in the blood pO determined with the help of the two correlations via the control unit 54 2B and in the fresh dialysis fluid pO 2D for an exemplary blood treatment. At the beginning - and throughout the entire treatment - the oxygen partial pressure pO 2Din the fresh dialysis fluid is about 32 mmHg. In the blood, however, the oxygen partial pressure pO 2B at about 91 mmHg. This means that according to Fig. 3, a clear gradient of the oxygen content from the blood across the membrane 2.5 of the dialyzer 2 towards the dialysis fluid is present. The pore size of a dialysis membrane is approximately between 1.8 nm (low flux) and 3.3 nm (high flux). The atomic radius of oxygen, however, is approximately 0.06 nm. In principle, the oxygen dissolved in the dialysis fluid is thus transported across the membrane 2.5 of the dialyzer 2 according to Fig. 1 well permeable, so that according to the prevailing difference in the oxygen partial pressures pO 2B , pO 2D Oxygen transport is to be expected. In the present exemplary case according to Fig. 3 it can actually be observed that the oxygen partial pressure pO 2Bin the blood decreases over the treatment period t, from about 91 mmHg to about 86 mmHg.

[0057] Since, as already mentioned, the oxygen partial pressure pO 2D in the fresh dialysis fluid already at the beginning and throughout the entire duration t considerably below the oxygen partial pressure pO 2B in the blood, it can be seen that the Fig. 3 shown drop in oxygen partial pressure pO 2B in the blood is due to a transfer of oxygen from the blood into the dialysis fluid.

[0058] Conversely, it is possible to describe this transfer by the value of the oxygen partial pressure pO 2D in the fresh dialysis fluid, in particular to reduce, prevent or even reverse it, which is the basic idea of the present disclosure.

[0059] It can therefore be stated that extracorporeal blood treatment machines, by influencing the oxygen partial pressure pO 2D in the fresh dialysis fluid a new functionality can be added.

[0060] The following is a description of the disclosed degassing of the gas-containing ultrapure water via the degassing unit 62 based on the Fig. 1 to 5 and in particular based on the Fig. 6, which shows the control method according to the disclosure, computer-implemented in the control unit 54.

[0061] According to Fig. 1, gas-containing ultrapure water supplied by the reverse osmosis system (not shown) is present at the inlet 58 of the degassing unit 62. Under normal conditions, this water contains considerable amounts of dissolved gases. At an inlet temperature of, for example, 20°C, it contains up to 19 cm³ at normal pressure. 3 / l dissolved gas. The solubility of gas in ultrapure water is generally described by Henry's law. According to this law, the capacity of ultrapure water to dissolve gas increases with pressure and decreases with temperature. If a multicomponent gas, such as air, is dissolved in a liquid, the individual partial pressures of the components are important for the amount of gas dissolved in the liquid. Reference is made to the second correlation described above. Approximately one-third of the gas dissolved in the liquid is oxygen, which is easily accessible for measurement.

[0062] According to Fig. 1, the control unit 54 opens the shut-off valve 66 as long as the upper float switch 72 is not activated. Accordingly, gas-containing ultrapure water flows into the supply chamber 68 and further via the degassing channel 76 to the throttle valve 78. To simplify the description, it is assumed that there is a continuous flow of ultrapure water in the degassing channel 76.

[0063] The computer-implemented control method is started or initialized with a step S0. The start or initialization can, for example, be automated when the blood treatment machine 1 is started up or by manual input from an operator via a user interface of the blood treatment machine 1.

[0064] After commissioning, the following steps are continuously carried out: Determination S1 of the oxyhemoglobin content SpO 2Bin the arterial blood conducted in the extracorporeal blood circuit 3, via the sensor unit 44, and providing S2 of the determined oxyhaemoglobin content SpO 2B to the control unit 54, as well as the steps S4 detecting the degassing pressure p E , via the pressure detection unit 81 in the degassing channel 76 downstream of the throttle device 78 and providing S5 of the detected degassing pressure p E to the control unit 54.

[0065] By means of the throttling device 78, a throttling step S3 of the gas-containing ultrapure water to the degassing pressure p E , so that the ultrapure water is subjected to the degassing pressure p E is fully or partially degassed accordingly.

[0066] The degassed or partially degassed ultrapure water then flows through the degassing chamber 80, whose surface structure efficiently separates the released gas from the ultrapure water. The degassed or partially degassed ultrapure water exits the degassing chamber 80 and flows back into the settling chamber 90 via the connecting channel 84 and the heating chamber 88, where it can be heated. Here, it is drawn off at the bottom and flows via the check valve to the outlet of the degassing unit 5 and thus to the mixing unit 6.

[0067] In the mixing unit 6, the step S6 of mixing the degassed or partially degassed ultrapure water with at least one concentrate to form the fresh dialysis fluid then takes place. The fresh dialysis fluid subsequently enters the dialyzer 2 via the dialysis fluid inlet 4 and the dialysis fluid inlet 2.1.

[0068] With the control procedure according to Fig. 6, the control unit 54 carries out the steps of determining S7 a control signal S for controlling the throttle device 78 and controlling S8 the throttle device 78 with the control signal S, which results in the step of adjusting S9 the throttle cross section according to the control signal S.

[0069] The step S7 of determining the control signal S for controlling the throttle device 78 is carried out in accordance with the disclosure in sub-steps S7.1 to S7.4. The basis for the execution of these sub-steps is that the two previously described correlations according to Fig. 2 and Fig. 4, a third correlation of the degassing pressure p E with the control signal S according to Fig. 5, as well as a predetermined target oxygen partial pressure difference ΔpO 2,soll between the oxygen partial pressure pO 2D in the fresh dialysis fluid and the oxygen partial pressure pO 2B in the blood are deposited.

[0070] First, a step is carried out calling S7.1 of the first correlation and determining the oxygen partial pressure pO 2B in the blood depending on the oxyhaemoglobin content SpO determined by the sensor unit 44 2B in the blood, via the control unit 54 (cf. Fig. 2). Based on this, a step S7.2 is carried out to determine a target oxygen partial pressure pO 2D,soll in the fresh dialysis fluid as the sum of the determined oxygen partial pressure pO 2B in the blood and the predetermined target oxygen partial pressure difference ΔpO 2,soll , via the control unit 54. This is followed by a step S7.3 calling the second correlation and determining a target degassing pressure p E,soll depending on the determined target oxygen partial pressure pO 2D,soll in the fresh dialysis fluid, via the control unit 54 (see Fig. 4). This is followed by a step S7.4 calling the third correlation and determining the control signal S as a function of the determined target degassing pressure p E,soll , via the control unit 54 (see Fig. 5).

[0071] Thus, for step S7, the control signal S is determined in such a way that the gas-containing ultrapure water is heated to a degassing pressure p E which leads to a partial degassing, after which the fresh dialysis fluid mixed from the partially degassed ultrapure water reaches the target oxygen partial pressure pO 2D,soll has.

[0072] In addition, the control method comprises a permanent, selective, and / or periodically performed step S10 of determining a deviation of the actual oxygen partial pressure difference ΔpO 2,lst from the predetermined oxygen partial pressure difference ΔpO 2,soll and adapting the control signal S to the deviation. List of reference symbols 1 Extracorporeal blood treatment machine 2 Dialyzer 2.1 Dialysis fluid inlet 2.2 Dialysate outlet 2.3 Blood inlet 2.4 Blood output 2.5 semipermeable membrane 3 extracorporeal blood circulation 4 Dialysis fluid inlet 5 Degassing unit 6 Mixing unit 8 first source acid concentrate 10 second source alkaline concentrate 12 first conveyor device 14 second conveyor device 16 first measuring device 18 second measuring device 20 Ultrapure water inlet 22 third conveyor device 24 Balancing device 26 first valve 28 Dialysate drain 30 Disposal exit 32 registration unit 34 second valve 38 Bypass flow path 40 third valve 41 arterial tube clamp 42 arterial tube section 43 venous tube clamp 44 Blood component sensor 46 Blood pump 48 Blood inlet pressure sensor 50 venous tube section 52 Blood outlet pressure sensor 54 Control unit 56 storage 58 Degassing unit inlet 60 ultrapure water inlet 62 Degassing tank 64 Pressure reducing valve 66 Shut-off valve 68 Pre-flow chamber 70, 72 float switches 74 swimmers 76 Degassing channel 78 adjustable throttle device 80 Degassing chamber 81 Pressure detection unit 82 fixed throttle 84 connecting channel 86 feed pump 88 Heating chamber 90 Calming chamber 92 Temperature sensor 94 check valve 96 Delivery channel 98 check valve S0 Start control procedure S1 Step Determine blood component S2 Step Provide blood component S3 Step Throttling gas-containing ultrapure water S4 Step Determine Degassing Pressure S5 Step Provide degassing pressure S6 Step Mix fresh dialysis fluid S7 Step Determine Control Signal S7.1 Step Determine blood oxygen content S7.2 Step Determine target oxygen content of dialysis fluid S7.3 Step Determine target degassing pressure S7.4 Step Determine control signal from target degassing pressure S8 Step Control Throttle Device S9 Step Adjust throttle cross section S10 Step Adjust Target Partial Pressure Difference Oxygen Content P Patient S Shunt SpO 2B Blood component pO 2BBlood oxygen content pO 2D Oxygen content of ultrapure water / fresh dialysis fluid pO 2D,soll Target oxygen content of ultrapure water / fresh dialysis fluid ΔpO 2,soll predetermined difference p E Degassing pressure p E,soll Target degassing pressure S control signal

Claims

[1] Extracorporeal blood treatment machine (1), in particular dialysis machine, for extracorporeal blood treatment of blood of a patient (P), comprising: - a dialyzer (2), - an extracorporeal blood circuit (3) which runs through the dialyzer (2) via a blood inlet (2.3) and a blood outlet (2.4) of the dialyzer (2), with a sensor unit (44) which is adapted to measure a blood component (SpO 2B ) in the blood, in particular an oxyhaemoglobin content of the blood that corresponds to an oxygen content (pO 2B ) in the blood, in particular an oxygen partial pressure in the blood, wherein the sensor unit (44) is preferably arranged upstream of the blood inlet (2.3), - a degassing unit (5) with a throttle device (78) adapted to reduce gas-containing ultrapure water to a degassing pressure (p E) in order to provide at least partially degassed ultrapure water at an outlet (96) of the degassing unit (5), with a pressure detection unit (81) which is adapted to detect the degassing pressure (p E ), wherein the pressure detection unit (81) is arranged in particular downstream of the throttle device (78), - a mixing unit (6) adapted to mix the at least partially degassed ultrapure water with at least one concentrate to form a fresh dialysis fluid, and - a control unit (54) which is signal-connected to the sensor unit (44), the pressure detection unit (81) and the throttle device (78), characterized by that the throttle device (78) is designed with a continuously adjustable throttle cross-section which is continuously adjustable as a function of a control signal (S) of the control unit (54), preferably proportional to the control signal (S). [2] Extracorporeal blood treatment machine (1) according to claim 1, characterized by that the control unit (54) is adapted to determine the control signal (S) in order to determine the oxygen content (pO 2B ) in the blood to raise, maintain constant and / or lower. [3] Extracorporeal blood treatment machine (1) according to claim 1 or 2, characterized by that the control unit (54) is adapted to determine the control signal (S) in order to determine an oxygen content (pO 2D ) in the at least partially degassed ultrapure water or the fresh dialysis fluid, in particular an oxygen partial pressure in the at least partially degassed ultrapure water or the fresh dialysis fluid, depending on the oxygen content (pO 2B ) in the blood, in particular to raise, maintain constant and / or lower. [4] Extracorporeal blood treatment machine (1) according to one of the preceding claims, characterized bythat the control unit (54) is adapted to determine the control signal (S) in order to obtain a predetermined difference (ΔpO 2,soll ) between an oxygen content (pO 2D ) in the at least partially degassed ultrapure water or the fresh dialysis fluid, in particular an oxygen partial pressure in the at least partially degassed ultrapure water or the fresh dialysis fluid, and the oxygen content (pO 2B ) in the blood, especially to keep it constant. [5] Extracorporeal blood treatment machine (1) according to one of the preceding claims, characterized by that in a memory (56) of the blood treatment machine (1), preferably in a memory (56) of the control unit (54), a first correlation of the oxygen content (pO 2B ) in the blood with the blood component (SpO 2B ) is stored, and that the control unit (54) is adapted to call up the first correlation and to determine the oxygen content (pO 2B) in the blood depending on the blood component (SpO 2B ) to determine. [6] Extracorporeal blood treatment machine (1) according to claims 4 and 5, characterized by that the control unit (54) is adapted to provide a desired oxygen content (pO 2D,soll ) in the at least partially degassed ultrapure water or the fresh dialysis fluid from the determined oxygen content (pO 2B ) in the blood and the predetermined difference (ΔpO 2,soll ), in particular as their sum. [7] Extracorporeal blood treatment machine (1) according to claim 6, characterized by that in the memory (56) a second correlation of the oxygen content (pO 2D ) in the at least partially degassed ultrapure water or the fresh dialysis fluid with the degassing pressure (p E ) is stored, and that the control unit (54) is adapted to call up the second correlation and to determine a desired degassing pressure (pE,soll ) depending on the determined target oxygen content (pO 2D.soll ) in the at least partially degassed ultrapure water or the fresh dialysis fluid. [8] Extracorporeal blood treatment machine (1) according to claim 7, characterized by that in the accumulator (56) a third correlation of the degassing pressure (p E ) with the control signal (S), and that the control unit (54) is adapted to call up the third correlation and to adjust the control signal (S) as a function of the determined desired degassing pressure (p E,soll ) and to control the throttle device (78) with the control signal (S). [9] Extracorporeal blood treatment machine (1) at least according to claim 4, characterized by that the control unit (54) is adapted to detect a deviation from the predetermined difference (ΔpO 2,soll)permanently, selectively, and / or periodically and to adapt the control signal (S) depending on the deviation. [10] Computer-implemented control method for an extracorporeal blood treatment machine (1) with a dialyzer (2), in particular a blood treatment machine (1) according to one of the preceding claims, comprising steps: - Determination (S1) of a blood component (SpO 2B ) in the blood, in particular an oxyhemoglobin fraction, which is associated with an oxygen content (pO 2B ) in the blood, in particular an oxygen partial pressure in the blood, via a sensor unit (44) in an extracorporeal blood circuit (3) of the blood treatment machine (1), - Provision (S2) of the determined blood component (SpO 2B ) to a control unit (54); - Throttling (S3) of gas-containing ultrapure water to a degassing pressure (p E) to provide at least partially degassed ultrapure water, via a throttle device (78), - Detecting (S4) the degassing pressure (p E ), via a pressure detection unit (81), - Providing (S5) the degassing pressure (p E ) to the control unit (54); - Mixing (S6) the at least partially degassed ultrapure water with at least one concentrate to form a fresh dialysis fluid, via a mixing unit (6), characterized by Steps - determining (S7) a control signal (S) for controlling the throttle device (78), which is designed with a throttle cross-section that is adjustable as a function of the control signal (S), preferably proportional to the control signal (S), via the control unit (54); - controlling (S8) the throttle device (78) with the control signal (S), via the control unit (54); and - Adjustment (S9) of the throttle cross-section according to the control signal (S). [11] Computer-implemented control method according to claim 10, characterized by that the control signal (S) is determined via the control unit (54) in such a way that the oxygen content (pO 2B ) in which blood is optionally raised, kept constant and / or lowered. [12] Computer-implemented control method according to claim 10 or 11, characterized by that the control signal (S) is determined via the control unit (54) in such a way that an oxygen content (pO 2D ) in the at least partially degassed ultrapure water or the fresh dialysis fluid, in particular an oxygen partial pressure in the at least partially degassed ultrapure water or the fresh dialysis fluid, depending on the oxygen content (pO 2B ) in which blood is optionally raised, kept constant and / or lowered. [13] Computer-implemented control method according to one of claims 10 to 12, characterized bythat the control signal (S) is determined via the control unit (54) in such a way that a predetermined difference (ΔpO 2,soll ) between an oxygen content (pO 2D ) in the at least partially degassed ultrapure water or the fresh dialysis fluid, in particular an oxygen partial pressure in the at least partially degassed ultrapure water or the fresh dialysis fluid, and the oxygen content (pO 2B ) in the blood is adjusted, in particular kept constant. [14] Computer-implemented control method according to claim 13, wherein in a memory (56) of the blood treatment machine (1), preferably in a memory (56) of the control unit (54), a first correlation of the oxygen content (pO 2B ) in the blood with the blood component (SpO 2B ), a second correlation of the oxygen content (pO 2D ) in the at least partially degassed ultrapure water or the fresh dialysis fluid with the degassing pressure (p E), a third correlation of the degassing pressure (p E ) with the control signal (S), as well as the predetermined difference (ΔpO 2,soll ) are stored, characterized by Steps to determine (S7) the control signal (S): - Calling (S7.1) the first correlation and determining the oxygen content (pO 2B ) in the blood depending on the blood component (SpO 2B ), via the control unit (54); - Determination (S7.2) of a target oxygen content (pO 2D,soll ) in the at least partially degassed ultrapure water or the fresh dialysis fluid from the determined oxygen content (pO 2B ) in the blood and the predetermined difference (ΔpO 2,soll ), in particular as their sum, via the control unit (54); - Calling (S7.3) the second correlation and determining a target degassing pressure (p E,soll ) depending on the determined target oxygen content (pO 2D,soll) in the at least partially degassed ultrapure water or the fresh dialysis fluid, via the control unit (54); and - Calling (S7.4) the third correlation and determining the control signal (S) as a function of the determined target degassing pressure (p E,soll ), via the control unit (54). [15] Computer program comprising instructions which, when executed by a computer, cause the computer to carry out the method steps of the control method according to one of claims 10 to 14.

Citation Information

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