Arrangement for generating treatment fluid for renal replacement therapy

Abstract

A system comprises a fluid generating apparatus (FGA), a user interface (UI) and a control unit. The FGA is operable to mix one or more concentrates with water to generate a treatment fluid for use in renal replacement therapy. The control unit is connected to the UI and arranged to configure the FGA by a computer-implemented method. In the method, the control unit receives (201) from the UI a candidate set value for a selected component of the treatment fluid, calculates (202) a calculated component of the treatment fluid for the candidate set value, and displays (204) on the UI consequent concentration values for one or more components of the calculated component other than the selected component. By the system, the caregiver is made aware of the respective changes in the components of the treatment fluid other than the selected component. Thus, the system facilitates the use of online fluid generation while maintaining patient safety.

Description

Technical Field

[0001] This disclosure relates to the field of renal replacement therapy, and more particularly to the online generation of processing fluids for such therapy. Background Technology

[0002] Renal replacement therapy (RRT) is a treatment that replaces the kidneys' normal blood filtration function. RRT is used when the kidneys are not functioning properly (this is called kidney failure and includes acute kidney injury and chronic kidney disease). RRT involves removing solutes from the blood of patients with kidney failure, for example, through hemodialysis (HD) or peritoneal dialysis (PD). Typically, RRT is performed using a machine.

[0003] In RRT, a treatment fluid containing one or more specific components is used to treat a patient. Over time, RRT consumes a significant amount of treatment fluid.

[0004] In some RRT (Recovery-Based Treatment) models, readily available treatment fluids are delivered to the point of care in prefilled bags. For example, routine PD (Potential Disease) is performed using prefilled bags. In HD (Hot-Disease Management), different types of machines are used to treat patients with acute kidney injury (AKI) and patients with chronic kidney disease (CKD). Machines for treating patients with AKI are generally configured to use prefilled bags of readily available treatment fluids, while machines for treating patients with CKD generally have an integrated capability to generate treatment fluids on demand by mixing one or more concentrates with water (so-called online fluid generation). Recently, PD machines with integrated online fluid generation capabilities have been proposed.

[0005] For example, considering the environmental issues associated with the transport of pre-filled bags and the problems related to the handling of heavy pre-filled bags, it is anticipated that online fluid generation will at least partially replace pre-filled bags in all types of RRT in the future. Another advantage of online fluid generation is that it allows caregivers to adjust the composition of the treatment fluid to improve patient care without altering the pre-filled bags.

[0006] One limitation of online fluid generation is that, due to logistical reasons, the concentrate may contain multiple substances. Therefore, depending on the type of concentrate(s) used, an intentional change in the concentration of one substance in the treatment fluid can lead to changes in the concentration of one or more other substances. The caregiver who triggers the desired concentration change of one substance in the treatment fluid may overlook or even be unaware of the inherent concentration change of another substance.

[0007] This issue applies to all types of resuscitation therapy (RRT) that utilize online fluid generation, both now and in the future. As mentioned above, future high-intensity resuscitation (HD) machines used to treat acute kidney injury (AKI) may rely on online fluid generation rather than off-the-shelf fluids, or they may rely on online fluid generation in addition to off-the-shelf fluids. These HD machines are primarily used in intensive care units (ICUs), where caregivers must handle many different types of life-saving equipment and are not RRT specialists. Therefore, ICU staff may find it particularly difficult to fully utilize the capabilities provided by online fluid generation. Summary of the Invention

[0008] The aim is to at least partially overcome one or more limitations of the existing technology.

[0009] Another objective is to promote the use of online fluid generation in RRT.

[0010] Another objective is to improve patient safety in RRT by using a treatment fluid generated by mixing one or more concentrates with water.

[0011] One or more of these objectives, as well as other objectives that may be apparent from the following description, are achieved, at least in part, by the system, computer-implemented method, and computer-readable medium according to the independent claims, and by embodiments thereof as defined in the dependent claims.

[0012] The first aspect is a system comprising: a fluid generating device operable to mix one or more concentrates with water to generate a treatment fluid for renal replacement therapy; a user interface; and a control unit connected to the user interface and arranged to configure the fluid generating device. The control unit is configured to: receive candidate setpoints for selected components of the treatment fluid from the user interface; calculate calculated components of the treatment fluid against the candidate setpoints; and display on the user interface the corresponding concentration values ​​of one or more components in the calculated components, excluding the selected components.

[0013] The first aspect of the system allows users (e.g., caregivers) to change settings for the fluid generating device that affect selected components in the resulting processed fluid, while ensuring that the user is also aware of consequential changes in other components of the processed fluid, such as because the concentrate contains more than one component. Therefore, the first aspect facilitates the online use of the fluid generating device without compromising patient safety.

[0014] Therefore, the system of the first aspect is configured to display the characteristics of the treatment fluid if a treatment fluid is to be generated based on candidate setpoints. The cognitive content of the characteristics presented to the operator (i.e., one or more concentration values) relates to the underlying internal state of the system and enables the user to operate the system correctly. This underlying internal state can change dynamically based on candidate setpoints input by the user and is automatically detected as the system calculates the computational components generated from the candidate setpoints. The display of the concentration values(one or more) prompts the user to interact with the system, particularly to determine whether the characteristics of the treatment fluid are considered suitable for the patient and the RRT to be performed, and provides a confirmation signal if the characteristics are deemed suitable. Those skilled in the art also recognize that the manner in which the characteristics are presented (i.e., upon input of candidate setpoints) helps the user perform technical tasks by means of a guided human-computer interaction process.

[0015] In some embodiments, the control unit is further configured to configure the fluid generation device to generate a processing fluid based on the calculated components when a confirmation signal is received from the user interface.

[0016] In some embodiments, while the fluid generating apparatus is operated to generate a processed fluid having a current component different from the calculated component, the control unit is operable to receive candidate setpoints, calculate the calculated component, and display the corresponding concentration value, wherein the control unit is configured to keep the fluid generating apparatus in operation to generate a processed fluid according to the current component without a confirmation signal.

[0017] In some embodiments, one or more concentrates include a combination of acid concentrate and bicarbonate concentrate.

[0018] In some embodiments, the selected component includes one of sodium, bicarbonate, or potassium.

[0019] In some embodiments, one or more components other than the selected components include one or more electrolytes.

[0020] In some embodiments, one or more electrolytes are one or more of magnesium, potassium, calcium, sodium, chloride, phosphate, bicarbonate, lactate, acetate, and citrate.

[0021] In some embodiments, one or more components other than the selected components include a penetrant.

[0022] In some embodiments, one or more components other than the selected components include glucose.

[0023] In some embodiments, the control unit is further configured to: obtain nominal component data of one or more concentrates, wherein the control unit is configured to calculate a computed component based on the nominal component data, such that a candidate set value is achieved in the computed component.

[0024] In some embodiments, the control unit is further configured to: evaluate the concentration of the components in the calculated components relative to the corresponding concentration range, and display a warning message on the user interface if at least one of the components has a concentration that deviates from the corresponding concentration range.

[0025] In some embodiments, the control unit is configured to display a warning message to indicate at least one of the components on a user interface.

[0026] In some embodiments, the concentration of a component includes a nominal concentration, and the control unit is configured to calculate the nominal concentration based on the nominal components of the respective concentrates in one or more concentrates.

[0027] In some embodiments, the concentration of a component includes calculating at least one of the maximum or minimum concentration of the corresponding component in the component, the control unit is configured to calculate at least one of the maximum or minimum concentration based on an allowable deviation from the nominal concentration in the processed fluid, and the control unit is also configured to display a warning message if at least one of the maximum or minimum concentration deviates from the concentration range.

[0028] In some embodiments, the system further includes a processing device for renal replacement therapy, and the control unit is further configured to operate a fluid generating device to generate dialysis fluid according to a calculated composition, and to operate the processing device to perform renal replacement therapy by using the processing fluid generated by the fluid generating device.

[0029] In some embodiments, the processing device is configured to perform extracorporeal blood processing.

[0030] In some embodiments, the processing device is configured to perform acute kidney injury (AKI) treatment.

[0031] In some embodiments, the processing apparatus is configured to perform peritoneal dialysis.

[0032] In some embodiments, the control unit is configured to automatically configure the fluid generation device to generate a processing fluid based on the calculated components when a candidate setpoint is received from the user interface.

[0033] The second aspect is a computer-implemented method for configuring a fluid generation device operable to mix one or more concentrates with water to generate a process fluid. The method includes: receiving candidate setpoints for selected components of the process fluid from a user interface; calculating calculated components of the process fluid against the candidate setpoints; and displaying on the user interface the corresponding concentration values ​​of one or more components in the calculated components, excluding the selected components.

[0034] The embodiments of the first aspect can also be applied to the embodiments of the second aspect. For example, in some embodiments, the method further includes: configuring the fluid generation device to generate a processing fluid based on calculated components upon receiving a confirmation signal from the user interface. In alternative embodiments, the method further includes: configuring the fluid generation device to generate a processing fluid based on calculated components upon receiving a candidate setpoint.

[0035] The third aspect is a computer-readable medium including computer instructions that, when executed by a processor, cause the processor to perform the methods of the second aspect and any embodiments thereof.

[0036] The second and third aspects share the same technological advantages as the first aspect.

[0037] Other objects, aspects, advantages, features, and embodiments may become apparent from the following detailed description, from the appended claims, and from the accompanying drawings. Attached Figure Description

[0038] Figure 1 This is a block diagram of an example system that includes a fluid generation device and a control unit.

[0039] Figures 2A-2C It can be made by Figure 1 A flowchart of an example method or program executed by the control unit in the process.

[0040] Figures 3A-3C Through Figure 2A A schematic example of the message displayed to the user using the method in the example.

[0041] Figure 4 This is a block diagram of an example fluid loop used to mix concentrate with water into a process fluid.

[0042] Figure 5 This is a schematic diagram of an example extracorporeal blood circuit used for RRT. Detailed Implementation

[0043] Embodiments will now be described more fully below with reference to the accompanying drawings, which illustrate some, but not all, of the embodiments. In fact, the subject matter of this disclosure may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure may satisfy applicable legal requirements. The same reference numerals throughout refer to the same elements.

[0044] Furthermore, it should be understood that, where possible, any advantages, features, functions, apparatus and / or operational aspects of any embodiment described and / or contemplated herein may be included in any other embodiment described and / or contemplated herein, and / or vice versa. Additionally, where possible, unless expressly stated otherwise, any term expressed in the singular form herein is intended to also include the plural form and / or vice versa. As used herein, “at least one” shall mean “one or more”, and these expressions are intended to be interchangeable. Thus, the terms “a” and / or “an” shall mean “at least one” or “one or more”, even though the expressions “one or more” or “at least one” are used herein. As used herein, unless the context requires otherwise due to explicit language or necessary meaning, the word “comprising” or variations such as “including” or “containing” are used in an inclusive sense, i.e., specifying the presence of the stated feature but not excluding the presence or addition of other features in various embodiments.

[0045] Furthermore, it should be understood that although the terms first, second, etc., may be used herein to describe various elements, these elements should not be limited by these terms. These terms are used only to distinguish one element from another. For example, without departing from the scope of this disclosure, a first element may be referred to as a second element, and similarly, a second element may be referred to as a first element. As used herein, the terms “plural,” “multiple,” and “a plurality of” are intended to imply the provision of two or more elements. The term “and / or” includes any and all combinations of one or more of the associated listed elements.

[0046] For the sake of brevity and / or clarity, well-known functions or structures may not be described in detail. Unless otherwise defined, all terms used herein (including technical and scientific terms) have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure pertains.

[0047] As used herein, a “concentrate” is a substance containing one or more compounds at a concentration higher than that of the substance when it is ultimately used. A concentrate may be in liquid or powder form. If it is a liquid, the concentrate can be diluted in a solvent, or if it is a powder, the concentrate can be dissolved in a solvent. In the context of this specification, the solvent is water. Before or after dilution / dissolution in a solvent, the concentrate may be mixed with one or more other concentrates, which may also be in liquid or powder form.

[0048] As used herein, RRT refers to any machine-based treatment that replaces the normal blood filtration function of the kidneys. RRT includes treatments involving the extracorporeal processing of blood, including but not limited to hemodialysis (HD), hemodiafiltration (HDF), and hemofiltration (HF). RRT also includes peritoneal dialysis (PD) in any mode. Extracorporeal blood processing is generally classified as “acute blood processing” for patients with AKI and “chronic blood processing” for patients with CKD, depending on the cause of kidney failure. Generally, acute blood processing differs from chronic blood processing in that it uses extended treatment times and lower flow rates of blood and processing fluids. Chronic blood processing is typically performed intermittently, such as for 3-5 hours, for example, 2-3 times per week, while acute blood processing can be performed continuously (24-hour treatment) or semi-continuously (e.g., for 6-12 hours or longer per day). Non-limiting examples of acute treatment include CRRT (Continuous Renal Replacement Therapy), CVVH (continuous veno-venous hemofiltration), CVVHD (continuous veno-venous hemodialysis), CVVHDF (continuous veno-venous hemodiafiltration), SLEF (slow extended hemofiltration), SLED (sustained low-efficiency dialysis), and PIRRT (Prolonged Intermittent Renal Replacement Therapy).

[0049] As used herein, “processing fluid” refers to any fluid solution that can be administered to a patient as part of RRT treatment. Processing fluids can be dialysis fluids, administered to patients in extracorporeal blood processing or peritoneal dialysis to cleanse the patient’s blood. Processing fluids can also be so-called replacement fluids or substitution fluids, administered directly into the patient’s blood in HDF or HF.

[0050] As used herein, the term "component" in a treatment fluid refers to any compound in the treatment fluid that is relevant to the patient's health or RRT. Components may be electrolytes or non-electrolytes.

[0051] As used in this article, “electrolyte” refers to ions in a fluid being processed, where ions are particles, atoms, or molecules that have a net charge.

[0052] Figure 1 An example system 1, which will be used to describe some embodiments, is shown. System 1 includes a fluid generation device (FGA) 10, which is operable to mix two different concentrates with water to produce a process fluid. Water is schematically indicated by reference numeral 11, and the concentrates are schematically indicated by reference numerals 12 and 13. The resulting process fluid TF is output by the FGA 10 on a fluid line 30 for use by an RRT device 20, which may or may not be part of system 1, as shown by dashed lines. The RRT device 20 is configured to perform conventional RRT processing using the process fluid TF. System 1 also includes a control unit or controller 40, which is configured to provide one or more control signals Ci to the FGA 10. By means of the control signals Ci(one or more), the control unit 40 causes the FGA 10 to generate the process fluid TF having the desired composition. In one conceivable embodiment, the FGA 10 has a local controller (not shown) that controls the operation of the FGA 10. In such an implementation, one or more control signals Ci may include configuration data that allows the local controller to operate the FGA 10 to produce a process fluid TF with the desired composition. In another conceivable implementation, the control unit 40 directly controls the operation of the FGA 10 by providing multiple control signals Ci to various operable elements in the FGA 10, such as pumps, valves, etc. Although... Figure 1 Not shown, but control unit 40 can be configured, for example, to receive one or more output signals from one or more sensors of FGA 10. Reference will be made below. Figure 4 An example describing FGA 10.

[0053] If system 1 includes an RRT device 20, control unit 40 can also be configured to provide one or more control signals Cj to the RRT device 20. Through the control signals Cj(1) and Cj(1), control unit 40 causes the RRT device 20 to perform RRT processing by using a processing fluid. The RRT device 20 can be operated to consume the processing fluid at a rate matching the output rate of the processing fluid from FGA 10, or to buffer the processing fluid. Control unit 40 can provide configuration data to a local processor (not shown) in the RRT device 20 via the control signals Cj(1) and Cj(1), or directly control various operable elements in the RRT device 20, such as pumps, valves, etc. Although Figure 1 Not shown, but control unit 40 can be configured, for example, to receive one or more output signals from one or more sensors of RRT device 20. Reference will be made below. Figure 5 An example describing the RRT device 20.

[0054] Control device 40 includes processor 41 and computer memory 42. Control programs may be stored in memory 42 and executed by processor 41 to perform any methods, programs, or functions as described herein. Control programs may be supplied to control device 40 on a computer-readable medium, which may be a tangible (non-transitory) product (e.g., magnetic media, optical disc, read-only memory, flash memory, etc.) or a propagating signal. In the illustrated example, control device 40 includes a signal interface 43A for providing one or more control signals Ci to FGA 10. Control device 40 also includes an input / output (I / O) interface 43B for connecting to user interface (UI) 50. The term "user interface" is intended to include any and all devices capable of performing guided human-computer interaction (including the display of information and the reception of input). Therefore, UI 50 may include a combination of display devices and data input hardware. Data input hardware may include one or more of a keyboard, keypad, computer mouse, control buttons, touch panel, microphone and voice control functions, camera and gesture control functions, etc. In one embodiment, UI 50 is or includes a touch-sensitive display, also known as a touchscreen. I / O interface 43B may be operable to output signals controlling the display functions of UI 50 and input response signals indicative of user input via UI 50. UI 50 may or may not be integrated with control unit 40. (As in...) Figure 1 As further indicated, the control device may include an additional signal interface 43C for providing one or more control signals Cj to the RRT device 20. Each of interfaces 43A, 43B, and 43C may be configured to transmit wired or wireless data according to any standardized or proprietary protocol. It can be noted that interfaces 43A, 43B, and 43C (if present) may be implemented by a single interface device.

[0055] like Figure 1 The system 1 depicted, including the RRT device 20, can be integrated into a dialysis machine. Alternatively, system 1 without the RRT device 20 can be integrated into a fluid preparation device. In another alternative, the RRT device 20 and control unit 40 are integrated into the dialysis machine, while the FGA 10 is physically separated from the dialysis machine. In yet another alternative, the control unit 40 (e.g., a conventional computer) can be physically separated from both the FGA 10 and the RRT device 20.

[0056] Figure 2A It can be made by Figure 1A flowchart of an example method 200 executed by the control unit 40. Dashed lines indicate optional steps. Method 200 is designed to assist users (e.g., caregivers) who wish to generate a treatment fluid with a specific concentration of selected components. As understood from the discussion in the Background section, by Figure 1 At least one of the concentrates 12 and 13 used in the FGA 10 can be a multi-component concentrate that contributes multiple components to the treatment fluid. If the selected component originates from such a multi-component concentrate, it is not possible to adjust the concentration of the selected component independently of the additional components in the multi-component concentrate. It is also conceivable that the selected component originates from two or more concentrates and / or another component of the treatment fluid originates from two or more concentrates. This interdependence between components can make it difficult, even for experienced caregivers, to determine how the modified concentration of the selected component will affect the concentration of other components in the treatment fluid. This difficulty is further exacerbated if the clinic has a practice of using different combinations of concentrates in its FGA from time to time, or if different FGAs within the clinic use different combinations of concentrates.

[0057] In step 201, the control unit 40 receives candidate setpoints for the selected components in the treatment fluid to be generated from the UI 50. The candidate setpoints may be the desired concentrations of the selected components. Step 201 may be the result of a caregiver selecting a component and inputting the candidate setpoints via the UI 50.

[0058] Figure 3A An example of screen image 300A is shown, which can be displayed on UI 50 after the user has commanded control unit 40 to enable modifications to the processing fluid. In the example shown, screen image 300A prompts the user to select between two components in the processing fluid, specifically sodium (Na). + ) or bicarbonate (HCO3) - Caregivers may need to adjust these specific components during HD treatment. The sodium concentration in the dialysis fluid used for HD treatment can be adjusted based on the patient's predialysis serum sodium concentration, for example, to improve treatment tolerability and prevent unnecessary sodium overload. To correct metabolic acidosis, patients undergoing HD treatment require bicarbonate supplementation from the dialysis fluid via diffusion. The concentration of bicarbonate in the dialysis fluid is typically individualized for the patient to ensure that serum bicarbonate concentrations are within physiologically acceptable limits. However, it should be understood that, depending on the mode and treatment fluid, the user may be allowed to adjust additional components and / or other components in the treatment fluid. It is also conceivable that the user may be allowed to select more than one component.

[0059] UI 50 can be manipulated to present the user's selected component and activated continuation button (CONT) in screen image 300A. Figure 3BScreen image 300B prompts the user to enter a set value for the concentration of the selected component in a dedicated field. Although not shown, screen image 300B may display the current value of the selected component if step 201 is performed during ongoing fluid generation. Step 201 is completed by control unit 40 when the user has entered a candidate set value and activated the continue button (CONT.).

[0060] In step 202, the control unit 40 calculates a provisional component of the processing fluid against the candidate setpoint. The provisional component is also referred to herein as the “calculated component.” The provisional component is calculated to at least approximately match the candidate setpoint. In other words, the provisional component includes selected components whose concentrations match the candidate setpoint. The provisional component also includes concentration values ​​of one or more other components in the processing fluid. As used herein, “other components” refers to components in the processing fluid to be generated other than the selected components.

[0061] In step 204, the control unit 40 displays the corresponding concentration values ​​of one or more other components on the UI 50 based on the provisional component calculated in step 202. Thus, the caregiver will be aware of the effect of the modified concentration of the selected component on one or more other components in the treated fluid. The control unit 40 may also display the concentration value of the selected component. Figure 3C An example is shown in the figure. Figure 3C A screen image 300C that can be displayed on UI 50 in step 204 is shown. In the example shown, screen image 300C lists the selected components ( Figure 3A Sodium or bicarbonate in the solution) and several other components (including chlorides (Cl) - ), potassium (K) + ), calcium (Ca 2+ ), magnesium (Mg) 2+ The concentration values ​​of (acetate and glucose) are displayed (indicated by XX). If method 200 is performed during an ongoing RRT, screen image 300C can also display the current concentration values ​​of the corresponding components (indicated by YY) to further assist caregivers in deciding whether to accept provisional components.

[0062] In step 206, the control unit 40 receives an acknowledgment signal from the UI 50. Step 206 may involve the caregiver receiving the results of the provisional / calculated components displayed in step 204 via the UI 50. Return Figure 3C When the user activates the "Accept" (Yes) button in screen image 300C, a confirmation signal can be generated. The confirmation signal causes control unit 40 to configure FGA 10 to generate a processing fluid with provisional components. (See also: [link to relevant documentation]) Figure 1The control unit 40 can configure the FGA 10 by providing configuration data to the local controller in the FGA 10 or by directly controlling the operation of the FGA 10. If the user alternatively activates the reject button (No) in the screen image 300C, no confirmation signal is generated, and the FGA 10 is not configured according to the provisional components.

[0063] In some embodiments, while the FGA 10 is optionally operated to generate the processing fluid after step 206 according to a user request via the UI 50, the control unit 40 continuously displays the components of the processing fluid on the UI 50, such as... Figure 3C As shown. This will allow caregivers who may be responsible for treating many patients to be quickly informed of the current composition of the treatment fluid provided to a specific patient.

[0064] Caregivers (especially under stressful circumstances) may find it difficult to assess whether the provisional / calculated components shown in step 204 are acceptable and medically safe for the patient. Furthermore, it should be noted that the components calculated in step 202 are nominal components, calculated based on the nominal components of the concentrate(s) to be mixed with water. Due to manufacturing tolerances, the concentration of components in the concentrate will vary between batches. Permissible deviations from nominal values ​​are, for example, specified by pharmacopoeia or legal frameworks. Permissible deviations may be defined for the concentrate itself or for the resulting processed fluid. For example, deviations from the nominal concentration of a component in the processed fluid of ±10%, ±5%, or ±2.5% may be permissible. Permissible deviations may vary between components. Given that the nominal components of each batch of concentrate are known, but batch-to-batch deviations are not, the provisional components shown in step 204 may deviate from the actual components of the processed fluid to be generated by FGA 10. This can make it even more difficult for caregivers to assess whether the provisional components are acceptable and medically safe. These issues are addressed through… Figure 2A The optional steps 203 and 205 in the process can be used to resolve this.

[0065] In step 203, the control unit 40 evaluates the concentration value of the corresponding component calculated in step 202 relative to the corresponding concentration range. The concentration range is a “safe range” and is given by a lower and upper limit of concentration. Within the safe range, the patient’s medical risk is considered low. For example, the safe range may be defined by a regulatory agency or other organization or by an individual clinic. The safe range may be general for all patients or a group of patients, or it may be patient-specific. Whenever the concentration value of a provisional component deviates from the safe range, the control unit 40 can detect a potential medical risk.

[0066] In step 205, if a potential medical risk is detected in step 203, the control unit 40 displays a corresponding warning message on the UI 50. The warning message may also indicate specific components considered to constitute a potential medical risk. This can be done in many different ways. Figure 3C An example is shown where warning message 60 is displayed in component (here, K). + Next to it. The warning message may also include a violation of safety limits. Alternatively, display the safety limits for all components and highlight any violations.

[0067] In step 203, the control unit 40 may also consider the aforementioned deviations when evaluating the nominal concentration value. Therefore, in addition to the nominal concentration value, the control unit 40 can calculate the minimum and maximum concentration values ​​of the components in the processed fluid, given the permissible deviations for a given component. If the maximum or minimum concentration value falls outside the safe range, the control unit 40 can detect a potential medical risk even if the nominal concentration value falls within the safe range.

[0068] To provide a non-limiting example, consider a dialysis fluid for extracorporeal blood processing prepared by mixing an acid (A) concentrate and a bicarbonate (B) concentrate with water. Assume that when a dialysis fluid with a nominal sodium concentration of 140 mM is prepared, the dialysis fluid also has a nominal potassium concentration of 4 mM. If the applicable pharmacopoeia specifies an accuracy of ±10% for potassium concentration in the dialysis fluid, the actual potassium concentration in the dialysis fluid will be in the range of 3.6–4.4 mM. Assuming an upper limit of the safety range of 4.6 mM, no medical risk will be identified in step 203. If the caregiver instead wants to prepare a dialysis fluid with a nominal sodium concentration of 160 mM, the nominal potassium concentration will be 4.57 mM. However, the actual potassium concentration in the dialysis fluid will be in the range of 4.1–5.0 mM. Therefore, if step 203 only considers the nominal potassium concentration, no medical risk will be detected, although such a risk may actually exist.

[0069] If the lower limit of the safe concentration range of a component is violated, the caregiver can compensate for the deficiency by transfusing an additional amount of the component separately into the patient's bloodstream. It should be recognized that steps 203 and 205 will also serve to raise caregivers' awareness of the need for this compensation.

[0070] Method 200 is particularly applicable to extracorporeal blood processing, especially acute blood processing. Such processing is typically performed in critical care settings such as the ICU by staff who may be under significant stress and may not be specialists in extracorporeal blood processing. Such staff will greatly benefit from the support provided by Method 200. For patients with AKI, Figure 1The RRT device 20 in this example is typically configured for continuous renal replacement therapy (CRRT). CRRT treatment is performed by the machine 24 hours a day to slowly and continuously remove waste and fluids from the patient. CRRT is well known to those skilled in the art and will therefore not be described in further detail.

[0071] Returning to step 201 of method 200, the selected component can be any component of the processed fluid to be generated. In the field of extracorporeal blood processing, non-limiting examples of the selected component include sodium, bicarbonate, and potassium. In the field of peritoneal dialysis, non-limiting examples of the selected component include sodium.

[0072] Furthermore, the other components for which the concentration value is calculated in step 202 can be any or all components present in the processed fluid to be generated (excluding selected components). Generally, the other components include one or more electrolytes. In some embodiments, the other components include small ions, such as monatomic ions. Such electrolytes may include one or more of magnesium, potassium, calcium, sodium, or chloride. In some embodiments, the other components include polyatomic ions, such as acetate, citrate, lactate, phosphate, or bicarbonate. In some embodiments, the other components include permeabilizers, such as glucose (also known as dextrose), L-carnitine, glycerol, icodextrin, fructose, sorbitol, mannitol, or xylitol.

[0073] Any commercially available concentrate or combination of two or more concentrates can be used in the FGA 10 to generate a treatment fluid. Several embodiments for generating dialysis fluid are described below. In some embodiments, dialysis fluid for chronic blood treatment is generated by mixing a single concentrate with water at a volume dilution ratio of 10-50. In a non-limiting example, the single concentrate includes lactate, sodium, potassium, calcium, magnesium, glucose, and chloride. For example, such concentrates are commercially available for the PureFlow SL system from NxStage. Alternatively, dialysis fluid can be generated by mixing two concentrates with water. For example, a bicarbonate (B) concentrate and an acid (A) concentrate can be mixed with water at a dilution ratio of 10-50. The bicarbonate concentrate is also referred to as an "alkali concentrate" and does not need to contain only bicarbonate. Concentrates A and B are commercially available and well known in the art. In a non-limiting example, concentrate B includes bicarbonate, and concentrate A includes sodium, potassium, calcium, magnesium, glucose, acetate, and chloride. In some A concentrates, acetate is replaced or supplemented by another acid (such as lactic acid, citric acid, or hydrochloric acid). In BiCart from Baxter... In the system, three different concentrates (i.e., bicarbonate concentrate) are mixed. Sodium chloride concentrate And concentrates containing acids and other electrolytes. The dialysis fluid is generated. In some embodiments, a dialysis fluid for CRRT treatment is generated by mixing at least one concentrate with water. In non-limiting examples, such a dialysis fluid includes bicarbonate, sodium, potassium, calcium, magnesium, phosphate, glucose, acetate, and chloride. In some embodiments, a dialysis fluid for PD is generated by mixing at least one concentrate with water. Example compositions of PD concentrates to be mixed with water, individually or in combination, are disclosed in US2018 / 0021501 and WO2017 / 193069, which are incorporated herein by reference.

[0074] Figure 2B It shows that in response to Figure 1 Method 200 is executed within the context of the overall operating procedure 210 of FGA 10. Method 210 can be executed by control unit 40. Operating procedure 210 involves step 211, in which FGA 10 is operated to generate a process fluid having the current composition. At any time during step 211, control unit 40 executes method 200 triggered by user interaction via UI 50. If in step 206 ( Figure 2A If no confirmation signal is received, FGA 10 remains in operation to generate the process fluid based on the current composition (step 213). If a confirmation signal is received, procedure 210 proceeds from step 212 to step 214, in which FGA 10 is operated to generate the process fluid with the provisional / calculated composition accepted by the user in step 206. Therefore, the current composition is changed to the provisional composition.

[0075] Figure 2C It shows that it can be Figure 2A This is an example procedure for a portion of step 202. In step 202A, control unit 40 obtains the concentrate ID of each concentrate in FGA 10 that can be used to generate the processing fluid. In one example, the user manually enters one or more concentrate IDs via UI 50. Alternatively or additionally, one or more concentrate IDs can be provided to control unit 40 from an automatic detection system (not shown) in FGA 10. The detection system can be operable to automatically detect the concentrate ID of a container with concentrates when the container with concentrates is installed in FGA 10, for example, by detecting text or machine-readable code on the container. In step 202B, control unit 40 obtains component data for each concentrate ID. The component data can specify the nominal components of the corresponding concentrate based on the included components and their nominal concentrations. For example, control unit 40 can obtain the components from internal memory (see [link to relevant documentation]). Figure 1Component data can be retrieved from either 42) or an external database accessible to control unit 40. In optional step 202C, control unit 40 obtains constraint data for the mixing of one or more concentrates with water. For example, the constraint data may define one or more mixing ratios that cannot be changed, such as one of a plurality of concentrates must be mixed with water in a predetermined ratio, or two concentrates must be mixed in a predetermined ratio. Alternatively or additionally, the constraint data may define an allowable range for one or more mixing ratios. Control unit 40 may retrieve component data from internal memory (see 42). Figure 1 (42) or retrieve constraint data from an external database. In step 202D, the control unit 40 operates a predetermined calculation function on the component data, constraint data (if available), and candidate setpoints to determine the provisional components of the process fluid. The provisional components may, but need not, include the concentration values ​​of all components in the process fluid to be generated. The calculation function is based on direct relationships, and a technician can easily derive a calculation function tailored to a specific process fluid generated from one or more specific concentrates. The calculation function can be implemented using one or more predetermined lookup tables and / or through runtime evaluation of mathematical algorithms. It can be noted that if constraint data is not available in step 202C, the constraint data can be embedded in the calculation function.

[0076] Back Figure 1 In method 200, it is conceivable that in some embodiments, the confirmation step 206 may be omitted. This means that the operator is not required or asked to confirm the calculated components given in step 202. Instead, for example, immediately following step 201 where candidate setpoints have been entered, the control unit 40 automatically configures the FGA 10 to generate a treatment fluid with the calculated components. This type of operational control may be acceptable for at least some types of RRT (e.g., in chronic blood treatment). Step 204 informs the operator of the components of the resulting treatment fluid based on the displayed concentration(s) values(s).

[0077] include Figure 4To provide a non-limiting example of FGA 10. In the illustrated example, FGA 10 is configured to generate a process fluid TF by mixing water 11 with two liquid concentrates 12, 13. Water 11 is contained in container 14A, and concentrates 12, 13 are contained in corresponding containers 14B, 14C. Containers 14B, 14C can be replaced when empty, while water container 14A is repeatedly replenished from water source 16. FGA 10 also includes a mixing container 14D and a storage container 14E. Feed line 15A extends from water source 16 to mixing container 14D and is connected in fluid communication with containers 14A, 14B, 14C. Control valve 16A is arranged in feed line 15A to control the water flow from the source, and control valves 17A, 17B, 17C are arranged in the connecting lines between feed line 15A and containers 14A, 14B, 14C. A first fluid pump 18A is disposed in the feed line 15A downstream of the connecting line. A supply line 15B is arranged to extend between the mixing tank 14D and the storage tank 14E. A recirculation line 15C connects the supply line 15B to the top of the mixing tank 14D. A second fluid pump 18B and a control valve 17D are disposed upstream and downstream of the recirculation line 15C in the supply line 15B, respectively. An outlet line 15D extends from the storage tank 14E and can be connected to... Figure 1 The fluid line 30 is located in the outlet line 15D. The third fluid pump 18C is located in the outlet line 15D.

[0078] The operation can be performed by selectively opening valves 16A and 17A while simultaneously closing valves 17B and 17C and stopping pump 18A. Figure 4 FGA 10 intermittently replenishes water container 14A. Pump 18A is considered blocked. To generate the treatment fluid, valves 17A, 17B, and 17C are opened sequentially, and pump 18A is started to pump proportional amounts of water 11 and concentrates 12 and 13 into mixing container 14D. When valve 17D is closed, pump 18B starts to recirculate the fluid in mixing tank 14D, thereby improving the mixing of water and concentrates. After a period of time, valve 17D is opened, and the treatment fluid is pumped from mixing tank 14D into storage tank 14E. The treatment fluid is then pumped by pump 18C into outlet line 15D to provide the treatment fluid to the RRT unit ( Figure 1 (20 in the middle).

[0079] As is known in the art, the ratio of water and concentrate pumped into the mixing tank 14D can be controlled by using one or more flow meters and / or one or more conductivity sensors and / or by monitoring the weight of the mixing container 14D and / or containers 11, 12, 13.

[0080] In a variant, mixing tank 14D, pump 18B, and recirculation line 15C are omitted, and water 11 and concentrates 12 and 13 are pumped to storage tank 14E for mixing therein. In another variant, storage tank 14E and pump 18C are also omitted, and water 11 and concentrates 12 and 13 are simultaneously and proportionally distributed to feed line 15A for mixing therein, thereby providing the process fluid without intermediate storage.

[0081] include Figure 5 To provide compatibility with FGA 10 (e.g., as...) Figure 4 The above is a non-limiting example of the RRT device 20 used in combination. For example, the RRT device 20 can be used in CRRT. Figure 5 In this RRT device 20, the blood extraction device 20 is connected to the patient P at both the blood extraction end and the blood return end. The connection can be made using any conventional device, such as a needle or catheter. The RRT device 20 includes a disposable item 21 with blood tubing or tubes defining a blood extraction path 23 and a blood return path 24. A dialyzer 26 is connected between the extraction path 23 and the return path 24. A blood pump 22 is arranged to extract blood from the patient P and pump the blood back to the patient P via the blood compartment of the dialyzer 26. Dialyzer 26 is connected to receive dialysate in fluid path 29' and output effluent in fluid path 29"". In the illustrated example, RRT device 20 also includes a first source 27A of replacement fluid, which is connected to extraction path 23 via fluid line 27B between blood pump 22 and dialyzer 26. Fluid pump 27C is arranged to pump replacement fluid from source 27A into extraction path 23. RRT device 20 also includes a second source 28A of replacement fluid, which is connected to return path 24 via fluid line 28B. Fluid pump 28C is arranged to pump replacement fluid from source 28A into return path 24. In the CRRT example, RRT device 20 may also include means for infusing anticoagulants (e.g., citrate or heparin) or means for infusing calcium-containing solutions.

[0082] It should be understood, for example, Figure 4 The FGA 10 shown can be connected via a fluid line ( Figure 1 30) connection in the middle, to to Figure 5 The dialyzer 26 in the middle provides dialysate fluid. Alternatively or additionally, the replacement fluid can be generated by FGA 10.

[0083] As pointed out, Figure 5 This is merely an example; the RRT device 20 may include other conventional components such as clamps, pressure sensors, air detectors, etc. Furthermore, the pre-infusion and / or post-infusion of the replacement fluid may be omitted.

[0084] While the subject matter of this disclosure has been described in conjunction with embodiments that are now considered to be the most practical and preferred, it should be understood that the subject matter of this disclosure is not limited to the disclosed embodiments, but rather is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the appended claims.

[0085] Furthermore, although the operations are depicted in a specific order in the accompanying drawings, this should not be construed as requiring the operations to be performed in the specific order shown or sequentially, or as requiring all the operations shown to achieve the desired result. In some cases, parallel processing may be advantageous.

Claims

1. A system comprising: A fluid generating device (10) is operable to mix one or more concentrates (12, 13) with water (11) to generate a treatment fluid (TF) for use in renal replacement therapy. User interface (50), and A control unit (40), connected to the user interface (50) and arranged to configure the fluid generating device (10), is configured to: Receive candidate set values ​​for the selected components of the processing fluid (TF) from the user interface (50). The calculated components of the processing fluid (TF) are calculated for the candidate setpoint, such that the calculated components include the selected components whose concentrations match the candidate setpoint, and The corresponding concentration values ​​of one or more components in the calculated composition other than the selected component are displayed on the user interface (50).

2. The system according to claim 1, wherein, The control unit (40) is also configured to, upon receiving a confirmation signal from the user interface (50), configure the fluid generation device (10) to generate the processing fluid (TF) according to the calculated components.

3. The system according to claim 2, wherein, While the fluid generating device (10) is operated to generate the processing fluid (TF) having a current component different from the calculated component, the control unit (40) is operable to receive the candidate setpoint, calculate the calculated component, and display the corresponding concentration value, wherein the control unit (40) is configured to keep the fluid generating device (10) in operation to generate the processing fluid (TF) according to the current component in the absence of the confirmation signal.

4. The system according to any one of claims 1-3, wherein, The one or more concentrates (12, 13) include a combination of acid concentrates and bicarbonate concentrates.

5. The system according to any one of claims 1-3, wherein, The selected component includes one of sodium, bicarbonate, or potassium.

6. The system according to any one of claims 1-3, wherein, The one or more components other than the selected components include one or more electrolytes.

7. The system according to claim 6, wherein, The one or more electrolytes are one or more of magnesium, potassium, calcium, sodium, chloride, phosphate, bicarbonate, lactate, acetate, and citrate.

8. The system according to any one of claims 1-3, wherein, The one or more components other than the selected components include a penetrant.

9. The system according to any one of claims 1-3, wherein, The one or more components other than the selected components include glucose.

10. The system according to any one of claims 1-3, wherein, The control unit (40) is further configured to: obtain nominal component data of the one or more concentrates (12, 13), wherein the control unit (40) is configured to calculate the calculated component based on the nominal component data, such that the candidate set value is achieved in the calculated component.

11. The system according to claim 1, wherein, The control unit (40) is also configured to: evaluate the concentration of the components in the calculated composition relative to a corresponding concentration range, and display a warning message (60) on the user interface (50) if at least one of the components has a concentration that deviates from the corresponding concentration range.

12. The system according to claim 11, wherein, The control unit (40) is configured to display the warning message (60) to indicate at least one of the components on the user interface (50).

13. The system according to claim 11 or 12, wherein, The concentration of the component includes a nominal concentration, wherein the control unit (40) is configured to calculate the nominal concentration based on the nominal components of the respective concentrates in the one or more concentrates (12, 13).

14. The system according to claim 11 or 12, wherein, The concentration of the component includes at least one of the maximum or minimum concentration of the corresponding component in the calculated components, wherein the control unit (40) is configured to calculate at least one of the maximum or minimum concentration based on an allowable deviation from the nominal concentration in the processed fluid, and wherein the control unit (40) is further configured to display the warning message (60) if at least one of the maximum or minimum concentration deviates from the concentration range.

15. The system according to any one of claims 1-3, further comprising a processing device (20) for renal replacement therapy, wherein, The control unit (40) is also configured to operate the fluid generating device (10) to generate the processing fluid (TF) according to the calculated components, and to operate the processing device (20) to perform the renal replacement therapy by using the processing fluid (TF) generated by the fluid generating device (10).

16. The system according to claim 15, wherein, The processing device (20) is configured to perform in vitro blood processing.

17. The system according to claim 15, wherein, The processing device (20) is configured to perform acute kidney injury (AKI) treatment.

18. The system according to claim 15, wherein, The processing device (20) is configured to perform peritoneal dialysis.

19. The system according to claim 1, wherein, The control unit (40) is configured to automatically configure the fluid generation device (10) to generate the processing fluid (TF) according to the calculated components when the candidate set value is received from the user interface (50).

20. A computer-implemented method for configuring a fluid generating apparatus, said fluid generating apparatus being operable to mix one or more concentrates with water to generate a process fluid, said computer-implemented method comprising: Receive candidate settings for the selected components of the processed fluid from the user interface (201); (202) Calculate the calculated components of the processing fluid for the candidate setpoint, such that the calculated components include the selected components whose concentration matches the candidate setpoint; The user interface displays (204) the corresponding concentration values ​​of one or more components in the calculated composition other than the selected component.

21. The computer-implemented method according to claim 20, further comprising: Upon receiving a confirmation signal from the user interface, the fluid generation device is configured (206) to generate the processing fluid according to the calculated components.

22. The computer-implemented method according to claim 20, further comprising: Upon receiving (201) the candidate set value, the fluid generation device is configured to generate the processing fluid according to the calculated components.

23. A computer-readable medium comprising computer instructions, which, when executed by a control unit (40) in a system according to any one of claims 1-19, cause the control unit (40) to perform the method according to any one of claims 20-22.

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