SYSTEMS AND METHODS FOR CONTROLLING PERITONEAL DIALYSIS

Abstract

The present disclosure relates generally to a system and a method (300) for controlling peritoneal dialysis, in particular tidal peritoneal dialysis (100) for a patient (110).The procedure (300) comprises: measuring (310) the solute content in the tidal dialysate (120) discharged from the patient (110) while the patient is undergoing tidal peritoneal dialysis (100); determining (320) a current solute clearance from the tidal peritoneal dialysis (100) based on the measured solute concentrations; comparing (330) the current solute clearance with a target solute clearance for the patient (110); generating (340), based on the comparison, control instructions for a set of parameters of the tidal peritoneal dialysis (100); and controlling (350) the parameters based on the control instructions while the patient (110) is undergoing tidal peritoneal dialysis (100) in order to adjust the current solute clearance towards the target solute clearance.

Description

Technical field

[0001] The present disclosure relates generally to systems and methods for controlling peritoneal dialysis, in particular tidal peritoneal dialysis. State of the art

[0002] Worldwide, millions of people suffer from kidney problems such as chronic kidney disease (CKD) and end-stage renal disease (ESRD) and may require dialysis, such as peritoneal dialysis, to stay alive. In peritoneal dialysis, the peritoneum in the patient's abdominal cavity acts as a natural filter membrane.

[0003] Several mathematical models describe the flow of solutes and water across the peritoneal membrane during peritoneal dialysis therapy. Examples include the three-pore model, the Pyle-Popovich model, the Vonesh model, and the Garred model. These models have been used to assist clinicians in prescribing conventional peritoneal dialysis therapies, such as automated peritoneal dialysis (APD), continuous ambulatory peritoneal dialysis (CAPD), and tidal peritoneal dialysis (TPD). Using samples of dialysate drained from the patient, these models can be used to determine the patient's peritoneal membrane mass transfer coefficient (MTAC), which is a measure of the patient's solute clearance.MTAC can be used by physicians to prescribe appropriate peritoneal dialysis therapy for the patient in order to improve the clearance of solutes.

[0004] In some TPD modes, a small tidal volume is frequently moved in and out of the patient, and this small tidal volume is purified, regenerated, and returned to the patient. Fig. Figure 1 shows an example of this TPD therapy 100 for a patient 110. The used or waste dialysate 120 is discharged from the patient and directed to a filter device 130, which includes a sorption material. The filter device 130 serves to purify the used dialysate 120 and convert it into regenerated dialysate 140. The regenerated dialysate 140 is then returned to the patient 110. Current models for prescribing peritoneal dialysis therapies are designed for therapies in which the solutes are removed exclusively through the peritoneal membrane 150. In the Fig. In the TPD therapy 100 shown, the removal of solutes (such as urea and creatinine) from the patient 110 occurs both through the peritoneal membrane 150 and through the filter device 130. Therefore, current models would not be suitable to determine the MTAC and the clearance of solutes from the TPD therapy 100, and the TPD therapy 100 cannot be reliably controlled to improve the clearance of solutes for the patient 110.

[0005] Accordingly, in order to address or mitigate at least one of the aforementioned problems and / or disadvantages, there is a need for improved procedures for controlling tidal peritoneal dialysis for a patient. Summary

[0006] According to a first aspect of the present disclosure, there is a system and a method for controlling tidal peritoneal dialysis for a patient. The method comprises: Measurement of the concentration of dissolved substances in the tidal dialysate delivered by the patient while undergoing tidal peritoneal dialysis; Determination based on the measured concentrations of solutes, a current clearance of solutes from tidal peritoneal dialysis; Comparison of the current clearance of the solute with a target clearance of the solute for the patient; Generating, based on comparison, control instructions for a set of parameters of tidal peritoneal dialysis; and Control of parameters based on control instructions while the patient undergoes tidal peritoneal dialysis in order to adjust the current clearance of solutes to the target clearance of solutes.

[0007] According to a second aspect of the present disclosure, there is a system and a procedure for controlling tidal peritoneal dialysis for a patient. The procedure includes: Received, from a local device communicating with a tidal peritoneal dialysis apparatus, of tidal measurement data which include the concentrations of solutes measured in the tidal dialysate delivered from the patient while the patient is undergoing tidal peritoneal dialysis; Determination based on the measured concentrations of solutes, a current clearance of solutes from tidal peritoneal dialysis; Comparison of the current clearance of the solute with a target clearance of the solute for the patient; Generating, based on comparison, control instructions for a set of parameters of tidal peritoneal dialysis; and Sending control instructions to the local device to control the parameters while the patient undergoes tidal peritoneal dialysis, thereby adjusting the current clearance of solutes towards the target clearance of the solute.

[0008] According to a third aspect of the present disclosure, there is a system and a method for controlling tidal peritoneal dialysis for a patient. The method comprises: Measuring the concentrations of dissolved substances in a series of previously taken dialysate samples from the patient; Determine, based on the measured concentrations of solutes, a total clearance of solutes from tidal peritoneal dialysis; Comparison of the total clearance of the solute with the target clearance of the solute for the patient; Generating, based on the comparison, control instructions for a set of parameters of a subsequent tidal peritoneal dialysis for the patient; and Sending, to a device communicating with an apparatus for performing tidal peritoneal dialysis, the control commands to control the parameters for the subsequent tidal peritoneal dialysis in order to adjust the total clearance of dissolved substances from the subsequent tidal peritoneal dialysis towards the target clearance of dissolved substances.

[0009] Systems and methods for controlling tidal peritoneal dialysis according to the present disclosure are hereby disclosed. Various features, aspects, and advantages of the present disclosure will become more apparent from the following detailed description of embodiments of the present disclosure with reference to non-limiting examples and the accompanying drawings. Brief description of the drawings Fig. Figure 1 is a representation of tidal peritoneal dialysis. The Fig. Figures 2A to 2C are representations of measurements from tidal peritoneal dialysis. The Fig. 3A and Fig. Figure 3B shows a human body undergoing tidal peritoneal dialysis. The Fig. 4A and Fig. Figure 4B shows illustrative results from animal experiments on tidal peritoneal dialysis. The Fig. 5A and Fig. Figure 5B are representations for controlling tidal peritoneal dialysis according to embodiments of the present disclosure. The Fig. Figures 6A to 6C are flowchart representations of methods for controlling tidal peritoneal dialysis according to embodiments of the present disclosure. Detailed description

[0010] For the sake of brevity and clarity, the descriptions of the embodiments of this disclosure relate to systems and methods for controlling tidal peritoneal dialysis according to the drawings. Although aspects of this disclosure are described in connection with the embodiments provided herein, it is understood that they are not intended to limit this disclosure to these embodiments. On the contrary, this disclosure is intended to cover alternatives, modifications, and equivalents to the embodiments described herein, which are included within the scope of this disclosure as defined by the appended claims. Furthermore, specific details are set forth in the following detailed description to enable a comprehensive understanding of this disclosure. For a person skilled in the art in this field, i.e.,However, it is apparent to a knowledgeable person that the present disclosure can be implemented without specific details and / or with multiple details resulting from combinations of aspects of certain embodiments. In several cases, known systems, processes, procedures, and components have not been described in detail in order to avoid unnecessarily obscuring aspects of the embodiments of the present disclosure.

[0011] In embodiments of the present disclosure, the representation of a particular element or the inclusion or use of a particular element number in a particular figure or a reference thereto in corresponding descriptive material may include the same, an equivalent or analogous element or element number identified in another figure or related descriptive material.

[0012] References to “one embodiment / example”, “another embodiment / example”, “some embodiments / examples”, “some further embodiments / examples”, etc., indicate that the embodiments / examples so described may have a particular feature, structure, property, element, or limitation, but not every embodiment / example necessarily has that particular feature, structure, property, element, or limitation. Furthermore, the repeated use of the phrase “in one embodiment / example” or “in another embodiment / example” does not necessarily refer to the same embodiment / example.

[0013] The terms "comprehensive," "including," "with," and similar terms do not preclude the presence of features / elements / steps other than those listed in an embodiment. The mention of certain features / elements / steps in different embodiments does not mean that a combination of these features / elements / steps cannot be used in an embodiment.

[0014] As used here, the terms "a" and "an" are defined as "one" or "more than one." The use of " / " in a figure or associated text means "and / or" unless otherwise specified. The term "set" is defined as a non-empty, finite organization of elements that mathematically has a cardinality of at least one (e.g., a set defined herein may correspond to a unit, a singlet, a set with one element, or a set with several elements), according to known mathematical definitions.

[0015] An exemplary tidal peritoneal dialysis (TPD) therapy 100 is described in representative or exemplary embodiments of the present disclosure with reference to Fig. As described in Figure 1, in TPD therapy 100, a small amount of waste dialysate 120 is drained from patient 110 and purified by a filter device 130 containing a sorption material. The regenerated dialysate 140 from the purified waste dialysate 120 is then returned to patient 110. The amount of waste dialysate 120 that is purified, regenerated, and returned to patient 110 is called the tidal volume. As mentioned earlier, current models for prescribing peritoneal dialysis therapies are insufficient to determine the clearance of solutes from TPD therapy 100.

[0016] One factor contributing to this deficiency is that the toxins are absorbed by the sorption material and cannot be removed in the same way as in regular APD / CAPD / TPD therapy. In typical APD / CAPD / TPD therapy, the waste dialysate 120 is drained from the patient 110 and collected in a drainage bag. A sample taken from this bag is measured for its toxin concentration, and this concentration is multiplied by the total drained volume of waste dialysate 120 to determine the total toxin clearance from the patient 110. However, TPD therapy 100 uses a small tidal volume of the tidal dialysate 120, and this tidal volume is continuously purified by the sorption material in the filter device 130. The sorption material absorbs the toxins that pass through it, and once absorbed, they can no longer be directly measured.A sample taken from the drainage bag after completion of TPD therapy 100, as would be the case with typical APD / CAPD / TPD therapy, would not provide accurate measurements of toxin clearance.

[0017] Another factor contributing to this deficiency is that the regular regeneration of the regenerated dialysate 140 from the sorption material does not allow the toxin concentration to reach the same level as in the patient's blood. More precisely, because the filter device 130 continuously cleans, regenerates, and returns the regenerated dialysate 140 to the patient 110, the constant removal of toxins from the dialysate in the patient 110 results in the waste dialysate 120 having a lower toxin concentration compared to the blood than in a typical APD / CAPD. The toxin concentration of the waste dialysate 140 increases until it reaches an equilibrium in which the rate of toxin absorption / removal by the sorption material equals the rate of toxin transport from the blood to the dialysate across the peritoneal membrane 150. As described in Fig. As shown in 2A, this equilibrium state then remains relatively constant for the entire remaining duration of the TPD therapy 100.

[0018] Another factor is that TPD therapy 100 comprises two phases – the sorption phase and the non-sorbing phase – as in Fig. Figure 2B illustrates this. During the sorption phase, the waste dialysate 120 is continuously purified, regenerated, and returned to patient 110 as regenerated dialysate 140. This continuous removal of toxins from the tidal dialysate 120 prevents it from becoming equal with the blood. The non-sorbing phase begins at the end of the sorption phase. During the non-sorbing phase, the waste dialysate 120 is no longer purified or regenerated, and the dialysate remains in the patient's peritoneum. Due to the toxin concentration gradient between the dialysate and the blood, toxins continue to be removed from the blood during the non-sorbing phase, so that the toxin concentration in the dialysate in the peritoneum reaches a similar level to that in the blood. After completion of the non-sorbing phase, the waste dialysate 120 is completely drained from patient 110.However, the toxin concentration in the drained waste dialysate 120 differs from the toxin concentration in the tidal volume of the waste dialysate 120. Existing models based on samples of the derived waste dialysate 120 cannot accurately measure the toxin clearance from the TPD therapy 100.

[0019] Another factor is that the regenerated dialysate 140 returning to the patient 110 is not homogeneously mixed with the dialysate within the peritoneal cavity due to other organs 160 within the peritoneal cavity and the position of the peritoneal dialysis catheter 170. As in Fig. As shown in Figure 3A, the catheter 170 is permanently installed in the abdominal cavity and connected to an external port through which fresh dialysate can be supplied. The tip of the catheter 170 is typically positioned at the base of the peritoneal cavity to facilitate complete drainage of the spent dialysate 120 from the peritoneal cavity. The peritoneal cavity is an abdominal cavity containing several internal organs 160, such as the stomach, spleen, liver, intestines, etc. Due to the various organs 160 within the peritoneal cavity and the relatively small tidal volume of the waste dialysate 120 compared to the dialysate volume in the peritoneal cavity, the regenerated dialysate 140 returning to the peritoneal cavity would not mix homogeneously with the dialysate volume in the entire peritoneal cavity.The portion of the dialysate volume closest to the catheter tip has a lower toxin concentration (since the regenerated dialysate is most concentrated there), while the portion of the dialysate volume furthest from the catheter tip has a higher toxin concentration. This concentration gradient allows the toxins to move along the arrows, as shown in [reference]. Fig. 3B, and then removed via the catheter tip as waste dialysate 120. However, due to this concentration gradient, the toxin concentration of the tidal dialysate 140 in the area around the catheter tip is lower than the average toxin concentration of the total dialysate volume. The average toxin concentration, measured from samples of the drained dialysate volume, cannot accurately measure the toxin clearance achieved by TPD therapy.

[0020] Another factor is that during the drainage of the waste dialysate 120 at the end of TPD therapy 100, toxins continue to pass into the waste dialysate 120 even though the volume of the drained waste dialysate 120 decreases. This drainage phase typically lasts about 15 to 20 minutes. During this time, additional toxin clearance occurs, similar to the non-adsorbing phase. As in Fig. As shown in 2C, the additional clearance from the outflow phase can lead to a difference in the measured toxin concentration of the derived dialysate 120 and consequently to an inaccurate measurement of the toxin clearance from the TPD therapy 100.

[0021] To measure toxin clearance, various parameters can be used based on samples of the final volume of dialysate waste drained at the end of therapy, including standard Kt / V urea clearance, creatinine clearance, and beta-2-microglobulin clearance. Standard Kt / V urea clearance can be calculated by X urea The clearance for creatinine can be determined using equation 1. Creatinine clearance can be calculated by dividing X by X. crea determined using equation 2 and later based on the body surface area (BSA = 1.73 m²). 2 ) can be normalized. Beta-2 microglobulin clearance can be determined by calculating X b2mThe clearance is determined using Equation 3 and later normalized using the BSA. Clearance calculations are typically performed using dialysate samples from a single therapy, and the clearance values ​​are then multiplied by the number of therapies per week to determine the weekly toxin clearance. Xurea=FDureaBurea×VFDVTBW XcreaFDcreaBcrea×VFD Xb2mFDb2mBb2m×VFD FD urea = Urea concentration (mmol / L) in the final volume FD crea = Creatinine concentration (mmol / L) in final volume FD b2m = Beta-2 microglobulin concentration (mmol / L) in final volume B urea = Urea concentration (mmol / L) in the blood B crea = Creatinine concentration (mmol / L) in the blood B b2m = Beta-2 microglobulin concentration (mmol / L) in blood V FD = Final volume (L) V TBW= Volume of total body water (L) The parameters B urea , B crea , B b2m , and V TBW are predetermined.

[0022] As explained above, the toxin concentrations in the final volume of the drained waste dialysate 120 cannot accurately determine the toxin clearance from the TPD therapy 100. Embodiments of the present disclosure measure the toxin concentrations in the volumes of the tidal dialysate 120 during the TPD therapy 100. Various animal experiments (on pigs) were conducted with the TPD therapy 100, in particular with the filter device 130 and the sorption material for regenerating the dialysate. As described in the Fig. 4A and Fig. As shown in Figure 4B, the data from these studies show that the toxin concentrations (urea and creatinine) in the final volume at the end of TPD therapy 100 are consistently higher than in the tidal volumes taken at different cycles during TPD therapy 100.

[0023] Due to the varying toxin concentrations, equations 1-3 cannot be used to measure toxin concentrations in the tidal volume for the aforementioned final volume. During therapy, tidal volume samples should be taken to better visualize the toxins absorbed by the sorption material. Additional parameters are used to measure toxin clearance based on tidal dialysate 120 tidal volume samples during therapy. The standard Kt / V urea clearance can be calculated by determining Y urea can be determined using equation 4. Creatinine clearance can be calculated by dividing Y by Y. creadetermined using equation 5 and later normalized by BSA. The beta-2 microglobulin clearance can be calculated by Y b2m determined using Equation 6 and later normalized by the BSA. Yurea=TDureaBurea×VTDVTBW×N YcreaTDcreaBcrea×VTD×N Yb2mTDb2mBb2m×VTD×N TD urea = Urea concentration (mmol / L) in tidal volume TD crea = Creatinine concentration (mmol / L) in tidal volume TD b2m = Beta-2 microglobulin concentration (mmol / l) in tidal volume V TD = Tidal volume (L) N = Efficiency factor of the device (%) The parameters V TD and N are given.

[0024] The value for TD urea , TD crea , or TD b2mThis can be a single efflux time point representing the average toxin clearance through the sorbent material, or an average of multiple time points or continuous measurements to determine the toxin clearance through the sorbent material more accurately. When using multiple time points or continuous measurements, the parameters Y urea , Y crea , Y b2m can be divided into several segments with different concentrations and tidal volumes. For example, in continuous measurements, the V TO for each cycle 250 ml, and there can be 56 discrete outflow concentrations to calculate the total clearance from the tidal volumes.

[0025] Furthermore, the efficiency factor N for the device is taken into account to account for potential efficiency losses due to dead volume and / or the clearance efficiency of the sorbent. This is particularly important for small tidal volumes, as any dead volume has a greater impact on efficiency compared to standard peritoneal dialysis. For example, a dead volume of 25 ml with a tidal volume of 250 ml results in a 10% reduction in efficiency, while a dead volume of 25 ml with a final volume of 2500 ml results in a 1% reduction in efficiency.

[0026] Parameters Y, derived from samples taken during TPD therapy 100, can be combined with parameters X, derived from samples taken at the end of TPD therapy 100, to more accurately determine the total toxin clearance. The clearance values ​​are then multiplied by the number of therapies per week to determine the weekly toxin clearance. Based on the clearance values ​​and the target clearance for patient 110, appropriate peritoneal dialysis therapy can be prescribed to improve toxin clearance.

[0027] Various embodiments of the present disclosure describe devices and methods for controlling tidal peritoneal dialysis for a patient 110, in particular for improving the clearance of solutes or toxins. The tidal peritoneal dialysis can be TPD therapy 100, in which the sorption material is used for purification and regeneration of the dialysate for the patient 110. More precisely, the TPD therapy 100 can be performed using a TPD device 200, which includes the filter device 130 with the sorption material. As in Fig. As shown in Figure 5A, a patient tube 210 is connected between the device 200 and the catheter 170 in the patient 110 to perform the TPD. The waste dialysate 120 flows from the patient 110 through the patient tube 210 to the device 200 for purification (outflow phase), and the regenerated dialysate 140 flows from the device 200 through the patient tube 210 to the patient 110 (inflow phase). Furthermore, a device 220 is connected to or integrated into the device 200 to control the TPD and improve the clearance of dissolved substances.

[0028] In some embodiments, such as in Fig. As shown in Figure 6A, there is a method 300 for controlling the TPD for patient 110, wherein the method 300 can be performed by the device 220. The method 300 comprises a step 310 for measuring the concentrations of solutes in the tidal dialysate discharged from patient 110, i.e., the waste dialysate 120, during the outflow phase while patient 110 is undergoing TPD. For example, the device 220 comprises suitable probes / sensors for measuring the concentrations of toxins or solutes, such as urea and creatinine, in the tidal dialysate.

[0029] In some embodiments, such as in Fig. As shown in Figure 5A, the device 220 comprises a sampling component connected to a sampling port 230 in the patient tubing 210. The sampling component is configured to take a series of samples from the tidal dialysate flowing along the patient tubing 210. In one embodiment, the device 220 measures the concentrations of solutes in the samples while the samples continue to flow along the patient tubing 210. Since the samples come into contact with the sampling component and are returned to the patient 110, the sampling component should be sterile and biocompatible to prevent contamination. In another embodiment, the samples are sacrificial, and the device 220 measures the concentrations of solutes in the sacrificial samples. The sacrificial samples are not returned to the patient 110, and it would not be necessary for the sampling component to be sterile.

[0030] Furthermore, the concentrations of dissolved substances are measured using samples of the tidal dialysate discharged from patient 110 during the outflow phase. In the preceding inflow phase, regenerated dialysate 140 flows from the device 200 through the patient tubing 210 to patient 110. At the end of the inflow phase, a dead volume of dialysate remains in the patient tubing 210, which can be approximately 25 ml. As explained above, a dead volume of 25 ml with a tidal volume of 250 ml represents a 10% reduction in efficiency. No samples should be taken from the patient tubing 210 at the beginning of the outflow phase, as there is still dead volume from the regenerated dialysate 140 in the tubing. After the outflow phase begins, the tidal dialysate flow from patient 110 starts to push the dead volume back towards the device 200.During this outflow phase, samples can be taken from the patient tube 210 so that the measured concentrations of the dissolved substance can more accurately indicate the toxin clearance of the patient 110.

[0031] Preferably, the sampling component is configured to take samples from the tidal dialysate flowing along the patient tubing 210 after a predefined time following the start of the tidal dialysate outflow from patient 110, i.e., after the tidal dialysate begins to flow out of patient 110. For example, if it takes 1 minute for the outflowing tidal dialysate to push the dead volume back to the device 200, the sampling component can take samples 2 minutes after the start of the outflow phase. Optionally, the device 220 can also take into account the device efficiency factor to account for potential efficiency losses due to the dead volume.

[0032] In some embodiments, such as in Fig. As shown in Figure 5B, the device 220 is integrated into the apparatus 200, and the sampling component is configured to take a series of samples from the tidal dialysate flowing within the apparatus 200. In one embodiment, the device 220 measures the concentrations of solutes in the samples, and the samples continue to flow within the apparatus 200. Since the samples come into contact with the sampling component and are returned to patient 110, the sampling component should be sterile and biocompatible to prevent contamination. In another embodiment, the samples are sacrificial samples, and the device 220 measures the concentrations of solutes in the sacrificial samples. The sacrificial samples are not returned to patient 110, and it would not be necessary for the sampling component to be sterile.

[0033] Furthermore, the concentrations of dissolved substances are measured using samples of the tidal dialysate discharged from patient 110 during the outflow phase to account for the dead volume described above. Preferably, the sampling component is configured to take samples from the tidal dialysate after a predefined time interval following the start of tidal dialysate outflow from patient 110. Optionally, the device 220 can also incorporate the device efficiency factor to account for potential efficiency losses due to the dead volume.

[0034] Procedure 300 further includes a step 320 in which a current solute clearance from the TPD is determined based on the measured solute concentrations. More precisely, the device 220 is configured to determine the current solute clearance using equations 4-6, since the solute concentrations were measured from samples of the tidal dialysate. Procedure 300 further includes a step 330 in which the current solute clearance is compared with a target solute clearance for patient 110. The target solute clearance is predetermined by physicians for patient 110 based on the individual biological, health, and medical conditions of patient 110.

[0035] Method 300 further comprises a step 340 in which control commands for a set of TPD parameters are generated based on a comparison. Method 300 further comprises a step 350 for controlling the parameters based on the control commands while the patient 110 undergoes TPD in order to adjust the current solute clearance towards the target solute clearance. For example, the device 220 is connected to the device 200, for example via wired or wireless connections, to control various components of the device 200 and the TPD parameters. Preferably, Method 300 is performed iteratively, with the solute concentrations of the tidal dialysate being measured and the TPD parameters being checked regularly so that the patient 110 can achieve the target solute clearance.TPD parameters can include glucose dosage, flow rate, and tidal volume. For example, glucose dosage, flow rate, and tidal volume can be increased or decreased as needed based on the difference between the current and target solute clearance.

[0036] At the end of TPD therapy 100, the final volume of waste dialysate 120 is drained and collected in a drainage bag. The device 220 can be used to measure the dissolved substance concentration in the waste dialysate 120 during the final drainage phase. Alternatively, the device 220 can be connected to the drainage bag to measure the dissolved substance concentration in the waste dialysate 120 collected in the drainage bag. Accordingly, in some embodiments, the method 300 can include measuring the dissolved substance concentrations in the dialysate drained from the patient 110 after completion of TPD.

[0037] Method 300 can further include determining the total solute clearance from the TPD based on the measured solute concentrations in the tidal dialysate and the drained dialysate. More specifically, the device 220 is configured to determine the total solute clearance using equations 1 to 6, since the solute concentrations were measured from samples of the tidal dialysate and the drained dialysate. Method 300 can further include comparing the total solute clearance with the target solute clearance. Method 300 can further include generating control instructions for the parameters of a subsequent TPD for patient 110 based on the comparison and controlling the parameters of the subsequent TPD based on these control instructions.More precisely, when patient 110 undergoes the next TPD therapy 100, the device 220 controls the TPD parameters based on the difference between the total clearance of the solute and the target clearance of the solute, so that patient 110 can achieve the target clearance of the solute.

[0038] Several steps of the process 300, including comparing the clearance of dissolved substances and generating the control commands, are performed by the device 220, which is connected to or integrated into the apparatus 200. For example, the device 200 is configured to perform various functions of the device 220 to improve the clearance of dissolved substances.

[0039] In many embodiments, there is a system for controlling the TPD, and this system includes the device 220. Furthermore, the system may include a remote server or a remote computer connected to the device 220 via a communication network. The device 220 can be referred to as a local device that communicates with the apparatus 200 to perform the TPD.

[0040] In some embodiments, such as in Fig. As shown in Figure 6B, there is a procedure 400 for controlling the TPD for patient 110, whereby the procedure 400 can be executed from the remote server.

[0041] The remote server can be based on a centralized model, a decentralized model, or a hybrid model. As used here, a server is a physical or cloud-based data processing system on which a server program runs. The server can be implemented in hardware, software, or a combination of both. Some non-restrictive examples of a server include computers, laptops, minicomputers, mainframes, any non-volatile and tangible machine capable of executing machine-readable code, cloud-based servers, distributed server networks, and a network of computers.

[0042] A communication network is a medium or environment through which content, notifications, and / or messages are communicated between different components. Appropriate security protocols, such as encryption protocols, can be implemented within the communication network to ensure secure communication between these components. Some non-restrictive examples of communication networks include a virtual private network (VPN), a wireless fidelity network (Wi-Fi), a light fidelity network (Li-Fi), a local area network (LAN), a wide area network (WAN), a metropolitan area network (MAN), a satellite network, the internet, a fiber optic network, a coaxial cable network, an infrared (IR) network, a radio frequency (RF) network, and any combination thereof.Various components in the communication network can connect to it using different wired and wireless communication protocols, such as the Transmission Control Protocol / Internet Protocol (TCP / IP), the User Datagram Protocol (UDP), 2nd to 5th generation (2G to 5G) communication protocols, Long Term Evolution (LTE) communication protocols, and any combination thereof. Each component of the communication network includes a data communication or transceiver module to communicate and send / receive data over the communication network.Some non-restrictive examples of a transmit / receive module include an antenna module, a radio frequency transmit / receive module, a wireless transmit / receive module, a Bluetooth transmit / receive module, an Ethernet port, a Universal Serial Bus (USB) port, or any other module / component / device configured to send and receive data.

[0043] Method 400 comprises a step 410 in which the device 220 receives tidal measurement data, which includes the dissolved substance concentrations measured in the tidal dialysate delivered from patient 110 while the patient is undergoing TPD. More precisely, the dissolved substance concentrations are measured by the device 220, which is connected to the device 200, as described above with reference to the Fig. 5A and Fig. 5B described, and the measurement data is sent from device 220 to the remote server.

[0044] Procedure 400 further includes a step 420 in which the current solute clearance from the TPD is determined based on the measured solute concentrations. Procedure 400 further includes a step 430 in which the current solute clearance is compared with the target solute clearance for patient 110. Procedure 400 further includes a step 440 in which control instructions for a set of TPD parameters are generated based on this comparison. It should be noted that steps 420, 430, and 440 are similar or analogous to steps 320, 330, and 340 and are not described further for brevity.

[0045] Method 400 further comprises a step 450 in which control commands for controlling the parameters are sent to the device 220 while the patient 110 is undergoing TPD in order to adjust the current solute clearance towards the target solute clearance. Upon receiving the control commands, the device 220 controls various components of the device 200 and the TPD parameters. Preferably, Method 400 is performed iteratively by the device 220 and the remote server, with the solute concentrations of the tidal dialysate being measured regularly and the TPD parameters being controlled regularly so that the patient 110 can achieve the target solute clearance.

[0046] It should be noted that several aspects of procedure 300 apply equally to procedure 400 and are not described further here for the sake of brevity. For example, the device 220 can measure the dissolved substance concentrations in the dialysate drained from patient 110 after completion of the TPD and send the drained measurement data, which includes the dissolved substance concentrations measured in the drained dialysate, to the remote server. The remote server can then determine the total solute clearance based on the measured solute concentrations in the tidal dialysate and the drained dialysate, compare the total solute clearance with the target solute clearance, and, based on this comparison, generate control instructions for the parameters of a subsequent TPD for patient 110.

[0047] In some embodiments, such as in Fig.As shown in Figure 6C, there is a procedure 500 for controlling the TPD for patient 110. First, a series of samples of the dialysate derived from patient 110 are taken. More precisely, the samples are taken from the tidal dialysate during the TPD and from the outflow dialysate at the end of the TPD. For example, the samples can be taken from the sampling port 230 in the patient tubing 210. For example, the device 220 can be configured so that the sampling component automatically takes the samples at predetermined cycles of the TPD. Alternatively, the sampling can be triggered manually by patient 110. The samples are then delivered to a laboratory where the procedure 500 is carried out, for example, using a suitable remote computer in the laboratory.

[0048] Procedure 500 includes a step 510 for measuring the dissolved substance concentrations in the series of previously taken samples from patient 110. Procedure 500 further includes a step 520 in which the total solute clearance from the TPD is determined based on the measured dissolved substance concentrations. Procedure 500 further includes a step 530 in which the total solute clearance is compared with the target solute clearance for patient 110. Procedure 500 further includes a step 540 in which, based on the comparison, control instructions are generated for a set of parameters of a subsequent TPD for patient 110.

[0049] Method 500 further comprises a step 550 in which the control commands for controlling the parameters for the downstream TPD are sent to the device 220 in order to adjust the overall clearance of the solute from the downstream TPD towards the target clearance of the solute. It should be noted that various aspects of methods 300 and 400 apply equally to method 500 and are not described further here for the sake of brevity.

[0050] In procedure 300, the dissolved substance concentration measurement data is processed by device 220 to determine the current solute clearance and compare it to the target solute clearance for patient 110. Device 220 automatically controls the TPD parameters in real time to adjust the current solute clearance to the target solute clearance. In procedure 400, the dissolved substance concentration measurement data is processed by the remote server, which sends instructions to device 220 to control the TPD parameters. For example, the remote server can send instructions to automatically control the TPD parameters in real time. Alternatively, a physician can review the measurement data and manually trigger the sending of instructions to device 220.In procedure 500, the dissolved substance concentrations are measured in a laboratory, and the control instructions are generated there. These instructions can be automatically sent to device 220 to control the TPD parameters for the next TPD therapy 100. Alternatively, a physician can review the measurement data and manually trigger the sending of instructions to device 220. Furthermore, the control instructions can also be manually programmed into device 220.

[0051] Procedures 300, 400, and 500 can be used by various stakeholders, including physicians and product designers, to improve the dialysis device 200 and optimize its use for patients 110 undergoing peritoneal dialysis. For example, a TPD device 200 should be optimized for a specific patient 110 for the optimal combination of dialysate flow rate and tidal volume so that the patient 110 can achieve the target clearance of the solute.

[0052] The preceding detailed description describes embodiments of the present disclosure relating to systems and methods for controlling tidal peritoneal dialysis with reference to the figures provided. The description of the various embodiments in this disclosure is not intended to highlight or limit specific or particular representations of the present disclosure, but merely to illustrate non-limiting examples of the present disclosure. The present disclosure serves to solve at least one of the aforementioned problems and questions related to the prior art.Although only some embodiments of the present disclosure are disclosed here, it will be obvious to a person skilled in the art, in light of this disclosure, that a multitude of changes and / or modifications can be made to the disclosed embodiments without deviating from the scope of the present disclosure. Therefore, the scope of the disclosure and the scope of the following claims are not limited to the embodiments described herein.

Claims

[1] Method for controlling tidal peritoneal dialysis for a patient, the method comprising: Measurement of the concentration of dissolved substances in the tidal dialysate delivered by the patient during tidal peritoneal dialysis. Determination based on the measured concentrations of solutes, a current clearance of solutes from tidal peritoneal dialysis; Comparison of the current clearance of the solute with a target clearance of the solute for the patient; Generating, based on comparison, control instructions for a set of parameters of tidal peritoneal dialysis; and Control of parameters based on control instructions while the patient undergoes tidal peritoneal dialysis in order to adjust the current clearance of solutes to the target clearance of solutes. [2] The method of claim 1, further comprising: Taking a series of sacrificial samples from the tidal dialysate; and measuring the dissolved substance concentrations in the sacrificial samples. [3] Method according to claim 1 or 2, further comprising measuring the dissolved substance concentrations in the tidal dialysate after a predefined period of time, after the tidal dialysate has drained from the patient. [4] Method according to any one of claims 1 to 3, further comprising measuring the dissolved substance concentrations in the tidal dialysate drained from the patient after completion of tidal peritoneal dialysis. [5] The method of claim 4, further comprising determining the total clearance of the solute from tidal peritoneal dialysis based on the measured solute concentrations in the tidal dialysate and in the dialysate outflow. [6] The method of claim 5, comprising: Comparison of the total clearance of the solute with the target clearance of solutes of the solute; Generating control instructions for the parameters of subsequent tidal peritoneal dialysis for the patient based on the comparison; and Control of parameters based on the control instructions for the subsequent tidal peritoneal dialysis. [7] System for controlling tidal peritoneal dialysis for one patient, the system comprising: a device that communicates with a device for performing tidal peritoneal dialysis, wherein the device is configured to: Measurement of the concentration of dissolved substances in the tidal dialysate delivered by the patient while undergoing tidal peritoneal dialysis; Determination based on the measured concentrations of solutes, a current clearance of solutes from tidal peritoneal dialysis; Comparison of the current clearance of the solute with a target clearance of the solute for the patient; Generating, based on comparison, control instructions for a set of parameters of tidal peritoneal dialysis; and Control of parameters based on control instructions while the patient undergoes tidal peritoneal dialysis in order to adjust the current clearance of solutes to the target clearance of solutes. [8] System according to claim 7, wherein the device is further configured to: Taking a series of sacrificial samples from the tidal dialysate; and measuring the dissolved substance concentrations in the sacrificial samples. [9] System according to claim 7 or 8, wherein the device is configured to measure the dissolved substance concentration in the tidal dialysate after a predefined period of time after the start of the delivery of the tidal dialysate from the patient. [10] System according to any one of claims 7 to 9, wherein the device is further configured to measure the dissolved substance concentration in the dialysate flowing out of the patient after completion of tidal peritoneal dialysis. [11] System according to claim 10, wherein the device is further configured to determine a total clearance of the solute from tidal peritoneal dialysis based on the measured solute concentrations in the tidal dialysate and in the effluent. [12] System according to claim 11, wherein the device is further configured to: to compare the total clearance of the solute with the target clearance of solutes of the solute; To generate control instructions for the parameters of subsequent tidal peritoneal dialysis for the patient based on the comparison; and To control parameters based on the control instructions for the subsequent tidal peritoneal dialysis. [13] Method for controlling tidal peritoneal dialysis for a patient, the method comprising: Received, from a local device communicating with a tidal peritoneal dialysis apparatus, of tidal measurement data which include the concentrations of solutes measured in the tidal dialysate delivered from the patient while the patient is undergoing tidal peritoneal dialysis; Determination based on the measured concentrations of solutes, a current clearance of solutes from tidal peritoneal dialysis; Comparison of the current clearance of the solute with a target clearance of the solute for the patient; Generating, based on comparison, control instructions for a set of parameters of tidal peritoneal dialysis; and Sending control instructions to the local device to control the parameters while the patient undergoes tidal peritoneal dialysis, thereby adjusting the current clearance of solutes towards the target clearance of the solute. [14] The method of claim 13, further comprising: Receiving dehydrated measurement data, which includes the dissolved substance concentrations measured in the patient's drained tidal dialysate after completion of tidal peritoneal dialysis; and Determination of the total clearance of the solute from tidal peritoneal dialysis based on the measured concentrations of solutes in the tidal dialysate and in the drained dialysate. [15] The method of claim 14, further comprising: Comparison of the total clearance of the solute with the target clearance of solutes of the solute; Generating control instructions for the parameters of subsequent tidal peritoneal dialysis for the patient based on the comparison; and Sending control commands to the device to control the parameters of the subsequent tidal peritoneal dialysis. [16] System for controlling tidal peritoneal dialysis for one patient, the system comprising: a local device that communicates with a device for performing tidal peritoneal dialysis, a remote server communicating with the local device, wherein the remote server is configured to: To receive tidal measurement data from the local device, which includes the dissolved substance concentrations measured in the tidal dialysate delivered from the patient during tidal peritoneal dialysis; to determine a current clearance of solutes from tidal peritoneal dialysis based on the measured concentrations of solutes; to compare the current clearance of the solute with a target clearance of the solute for the patient; based on the comparison of generating control instructions for a set of parameters of tidal peritoneal dialysis; and to send the control instructions to control the parameters to the local device while the patient is undergoing tidal peritoneal dialysis in order to adjust the current clearance of solutes towards the target clearance of the solute. [17] System according to claim 16, wherein the remote server is further configured to: to receive dehydrated measurement data from the local device, which includes the dissolved substance concentrations measured in the patient's dehydrated tidal dialysate after completion of tidal peritoneal dialysis; and to determine the total clearance of the solute from tidal peritoneal dialysis based on the measured concentrations of solutes in the tidal dialysate and in the drained dialysate. [18] System according to claim 17, wherein the remote server is further configured such that it: compares the total clearance of the solute with the target clearance of solutes of the solute; Control instructions for the parameters of subsequent tidal peritoneal dialysis for the patient are generated based on the comparison; and Sends control commands to the local device to control the parameters of the subsequent tidal peritoneal dialysis. [19] Method for controlling tidal peritoneal dialysis for a patient, the method comprising: Measuring the concentrations of dissolved substances in a series of previously taken dialysate samples from the patient; Determine, based on the measured concentrations of solutes, a total clearance of solutes from tidal peritoneal dialysis; Comparison of the total clearance of the solute with the target clearance of the solute for the patient; Generating, based on the comparison, control instructions for a set of parameters of a subsequent tidal peritoneal dialysis for the patient; and Sending, to a device communicating with an apparatus for performing tidal peritoneal dialysis, the control commands to control the parameters for the subsequent tidal peritoneal dialysis in order to adjust the total clearance of dissolved substances from the subsequent tidal peritoneal dialysis towards the target clearance of dissolved substances. [20] System for controlling tidal peritoneal dialysis for one patient, the system comprising: a local device that communicates with a device for performing tidal peritoneal dialysis, a remote computer that communicates with the local device, the remote computer being configured to: Measuring the concentrations of dissolved substances in a series of previously taken dialysate samples from the patient; Determine, based on the measured concentrations of solutes, a total clearance of solutes from tidal peritoneal dialysis; Comparison of the total clearance of the solute with the target clearance of the solute for the patient; Generating, based on the comparison, control instructions for a set of parameters of a subsequent tidal peritoneal dialysis for the patient; and Sending control commands to the local device to control the parameters for the subsequent tidal peritoneal dialysis, thereby adjusting the overall clearance of the solute from the subsequent tidal peritoneal dialysis towards the target clearance of the solute.

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