SISTEMA DE DIÁLISE BASEADO EM GRAVIDADE, DISPOSITIVO E MÉTODO PARA OTIMIZAÇÃO DA PRESCRIÇÃO DE TERAPIA

Abstract

Apparatus and methods are provided for performing continuous ambulatory peritoneal dialysis (CARD) on a patient using a device (10) with a user interface (28) and programmable circuitry on which prescription data is entered. Information according to the prescription is provided to the patient on the user interface (28), and treatment data relating to administered CARD are gathered and communicated to a healthcare provider. Multiple parameters of the treatment data are aggregated for multiple patients, along with outcomes data and expected likely outcomes of CARD treatment are modelled as a function of said multiple parameters of treatment data, to provide to assist in prescription optimisation and patient centric treatment.

Description

/ 39 Gravity-Based Dialysis System, Device and Method for Optimizing Therapy Prescription Field of invention

[001] This invention relates to continuous ambulatory peritoneal dialysis (CAPD). Fundamentals of the technique

[002] Patients suffering from End-Stage Renal Disease (ESRD) can be treated for their kidney failure with different modalities, including various forms of dialysis or through kidney transplantation. One of the dialysis modalities is Peritoneal Dialysis (PD), which is available through two modalities, one being Automated PD (APD) and the other Continuous Ambulatory Peritoneal Dialysis (CAPD).

[003] CAPD is typically performed manually by a patient four times a day. The dialysis fluid / solution (dialysate) is introduced into the patient's peritoneal cavity via an internal peritoneal catheter and infused by gravity flow with a bag containing the dialysis solution hanging above the patient's abdomen. The dialysis solution remains in the patient's peritoneal cavity for about four to six hours. The peritoneal membrane acts as a diffusion barrier for the exchange of excess water, metabolites, and other waste products to be eliminated from the body. At the end of this time, the fluid containing water and residual metabolites is drained from the patient's cavity under the influence of gravity. Once again, fresh dialysis fluid is infused into the cavity to continue the process.

[004] The patient performs the drainage and filling cycle mentioned above by executing a predetermined sequence of steps to first drain the spent fluid and then replenish the peritoneal cavity with fresh fluid. Performing each exchange requires a predetermined sequence of opening and closing steps, several pre-connected tubes in a closed system of bags and tubes that has been defined as a closed Peritoneal Dialysis Flush-Before-Fill system. These are now commonly referred to as the double bag procedure or variations thereof. Petition 870250100991, dated 04 / 11 / 2025, page 8 / 51 / 39

[005] The patient is typically treated by a specially trained renal physician, usually qualified as a nephrologist, with the support of a PD nurse who has specific training in the care of patients with PD. Together, they make up the healthcare team (HCP) along with another medical professional.

[006] Commercially available CAPD systems require many tightening and loosening steps for a single change. For example, a typical system may require the following manual steps: 1. Patients need to comply with the protocol in their PD unit training manual, for which they underwent approximately two weeks of training and a competency assessment upon completion, before they can perform PD at home on their own. 2. Patients need to be trained on the various PD solution products they will need throughout their treatment, which requires them to follow a prescription generated by their HCP overseeing their treatment. 3. Patients need to adjust their daily routine to accommodate the need to perform an average of four PD changes per day; 4. Patients need to remember which specific PD solution they need at each PD switch interval; 5. There are different manufacturers of PD dialysate solutions, and they use different technologies, and some patients may be required to use different technologies during the course of the same day; 6. The last PD exchange of the day is invariably of longer duration until they perform their next PD exchange the following day, and this specific PD exchange invariably uses a special solution concentration and physical contents that are different from the other PD dialysate solutions they would use the rest of the time; 7. Patients need to remember at the time of each diaper change to perform a series of preparatory steps to ensure they have the correct product, the correct materials, and other items so that they can perform a safe change. Petition 870250100991, dated 04 / 11 / 2025, page 9 / 51 / 39 8. The main risk against which a patient needs to protect themselves is an episode of peritonitis, which is an infection of the peritoneal membrane. The main cause of peritonitis is attributed to S. aureus through contamination by touch or inadequate hygiene practices. 9. Patients are also expected to meticulously record all events of their PD exchange, such as the solution they used, the volumes that were drained and filled, respectively, and other costly details. These records are captured in a standard logbook and handwritten. 10. Patients have a range of PD dialysate solution products they can use, and while they are expected to make each switch according to their attending physician's prescription, they are also able to substitute products that may give them a different dialysis outcome; 11. Once the patient has completed the various preparatory steps and ensured that he / she is adequately disinfected, he / she would connect to the abdominal catheter connector; 12. The patient opens a specified clamp to drain the housing solution from their abdomen into an empty bag lying on the floor; 13. The patient needs to monitor the drainage bag to ensure it is actually filling with effluent dialysate and cannot estimate if the flow rate is slow, which would indicate a potential mechanical defect in their catheter and therefore needs to ensure that the catheter has not become blocked or that the flow is not impeded by the patient's physical position. Mechanical catheter failure is considered, along with peritonitis, one of the main causes of technique failure for PD; 14. The patient closes the specified drainage clamp after the drainage cycle; 15. The patient places and closes a specified clamp on the tubing that connects to the sterile solution bag containing fresh dialysate; 16. The patient breaks a frangible seal or other device that seals the bag of fresh solution inside the tubing system; 17. The patient opens the upper clamp on the solution tube and the lower clamp on the drainage tube to initiate a flushing cycle; Petition 870250100991, dated 04 / 11 / 2025, page 10 / 51 / 39 18. The patient estimates that approximately 150 ml of fluid has left the solution bag, then closes the clamp on the solution tube once more, and also the clamp on the drainage tube, to complete the flushing cycle; 19. A major risk to patient safety during this pre-filling flushing procedure is that the catheter connector may not have been closed, and fluid with potential contaminants in the tubing may be infused into the patient's abdomen, thus representing another major source of peritonitis contamination; 20. The patient opens the clamp on the solution tube to begin infusing dialysate solution into the abdomen, which is referred to as the filling; 21. The height of the PD dialysate solution is variable, which can affect the solution flow rate; 22. The flow rate of PD dialysate solution is purely governed by gravity and the patient's intra-abdominal pressure resistance, and this can cause considerable pain during infusion or other discomfort, as the solution may be too cold or flowing too quickly; 23. The patient needs to monitor their filling bag to ensure it is emptying fresh dialysate and cannot estimate if the flow rate is slow, which would indicate a potential mechanical defect in the catheter, and therefore the patient needs to ensure that the catheter has not become blocked or that the flow is not impeded by the patient's physical position, as also referred to in point 10; 24. The patient needs to estimate how much fluid has flowed into the abdomen under gravity and then stop filling by closing the clamp on the solution tube; 25. This procedure is limited by the volume of solution in the bag during production and cannot be precisely measured or controlled, making this modality unsafe for patients with smaller anatomical size and therefore smaller Body Surface Area (BSA) or for children. 26. There is a standard manufacturing procedure for PD dialysate bags to have volumes + 10% of the volume shown on the solution bag, allowing a range of 1,800ml to 2,200ml of dialysate solution to be infused per patient; however, the estimation of fluid volume is addressed in point 30. Petition 870250100991, dated 04 / 11 / 2025, page 11 / 51 / 39 27. The patient closes the cuff at the solution line to complete the filling when the solution bag is empty; 28. The patient needs to close the catheter connector and disconnect from the CAPD bags; 29. The patient should check the drainage bag containing the waste and determine if there are any signs of foreign bodies associated with complications and possible early indication of infection; 30. The patient needs to record all the volumes that he / she estimates were drained and infused during this specific exchange; 31. The patient needs to calculate the Ultrafiltration (UF) of the specific exchange, which is calculated as: Drainage volume - Previous filling volume and determine if the UF is sufficient, according to previous UF measurements already achieved in previous exchanges, as well as according to a UF target that was provided to the patient by the responsible HCP; 32. The patient needs to notify the PD unit nurse if the drainage bag has any of the contaminants referred to in point 13; 33. The patient needs to bring a logbook with the recorded data to their next appointment at the PD unit; 34. The products that were used to achieve the UF results referred to in point 31 may well not be the products that were used for the specific PD exchange, as explained in point 5; 35. The attending physician, or other qualified healthcare professional, is required to provide a prescription for patients with CAPD in accordance with standard care guidelines established by international bodies and based on an assessment of the patient's clinical characteristics. Currently, there are no CAPD prescribing tools available to them to support decision-making regarding the most appropriate prescription for the patient. 36. The attending physician, or other qualified healthcare professional, is only able to provide a prescription for patients with CAPD that is currently limited to Petition 870250100991, dated 04 / 11 / 2025, page 12 / 51 / 39 some variables, such as the type of solution in a commercially available volume and the frequency per day, with the possibility of prescribing solutions that may or may not have better treatment results. 37. The dialysate filling volume that is prescribed is calculated based on the premise that a patient's weight and height, and therefore their body mass index, are the criteria by which the filling volume for the prescription is decided. 38. The attending healthcare professionals (HCPs) are unaware of the patient's treatment progress, except for routine clinical appointments that the patient may attend or informal phone conversations with the HCP team, and are unable to be informed about possible side effects. 39. Measuring the cumulative daily treatment outcome is not something healthcare professionals can accurately measure, and they are also unable to receive the information with any frequency. 40. There are no early notification indices available for healthcare professionals to allow them to monitor their patients while they perform CAPD in their homes. 41. The decline in UF, or even other clinical parameters such as temperature, over several days has been shown to be an indicator of peritonitis; however, for an attending physician, it is not possible to measure these changes in their patients with CAPD. 42. Healthcare staff in hospitals who do not directly care for patients with ESRD may have no indication of how to perform a dialysis change if the patient is hospitalized under their care. 43. The PD unit responsible for the patient's care may not have a 24-hour on-call team and therefore may not be able to respond to any emergencies the patient may experience.

[007] Oreopolous first described the Continuous Ambulatory Peritoneal Dialysis procedure in the early 1980s. Since then, there has been limited innovation for CAPD patients worldwide. There has been the development of the dual-chamber bag approach with the so-called Y-connection to the patient and the built-in Flush-before-fill procedure to minimize the number of activities required for Petition 870250100991, dated 04 / 11 / 2025, page 13 / 51 / 39, to perform dialysis, which resulted in an improvement in the rates of peritonitis experienced by patients. Peritonitis is one of the main causes of technique failure. The Tenckhoff catheter used remained virtually unchanged throughout the CAPD treatment period, and catheter failure is classified as a Mechanical Complication, which is invariably another important cause of technique failure, as referred to in points 10 and 23 in the above list of steps followed by patients.

[008] Innovations to reduce contamination by touch, which are also causes of peritonitis, have seen several innovations, such as the use of luer-taper type connection systems or other connection systems that attempt to reduce errors during critical moments in the performance of dialysis exchanges. There has been the introduction of different dialysate solutions to try to reduce the exposure of glucose degradation products to the peritoneal membrane, and developments in the types of solutions continue. Finally, the other main area of ​​innovation has been an attempt to alleviate the patient's need to manually secure the tubing during critical phases of the dialysis procedure with the introduction of so-called dialing technologies to assist the patient. None of these innovations has been a distinct reason to improve CAPD outcomes on its own.

[009] It should also be noted that much innovation and investment has been made in a modality similar to CAPD, but different, which is automated peritoneal dialysis (APD). This procedure uses similar dialysate solutions, the same Tenckoff catheter to access the peritoneal cavity, and similar or identical tapered luer-taper technologies to Tenckoff catheters, but is otherwise a distinctly different form of peritoneal dialysis.

[010] Therefore, CAPD performance is still predominantly a manual process, conducted by the patient manually and according to a training program provided at the beginning of treatment and dependent on the patient to record the limited amount of information about the treatment in a written notebook. This information is, to a large extent, an estimate and an indication of how often the patient performs their treatment and their compliance with the procedure.

[011] Fabian Eibensteiner et al, “Monitoring Daily Ultrafiltration in Automated Peritoneal Dialysis” (CJASN 17: 1-4, 2022) further articulated the critical issue as: “The effectiveness Petition 870250100991, dated 04 / 11 / 2025, page 14 / 51 / 39. Peritoneal dialysis (PD) is often time-limited, accompanying chronic damage to the peritoneal membrane. High-quality goal-directed dialysis is characterized by adequate peritoneal ultrafiltration (UF) and low solute clearance, maintaining fluid and salt homeostasis. Occasional measurements of clinical parameters of peritoneal membrane dysfunction in individual PD patients are highly variable. Inspired by time-series analyses, such as Holter electrocardiography, we studied automated PD cycler (APD) readings on daily PD fluid inflows and outflows to investigate the value of continuous UF monitoring under clinically relevant conditions. Daily peritoneal UF monitoring using continuous PD data differs from traditional clinical data in quantity, noise, and missing normative values.Such analysis must consider unique patient trajectories, intra-individual variability, data noise, and temporal autocorrelation. Our study demonstrated that continuously collected data allow for the analysis of unexpected, otherwise undetected events related to PD and its effects on UF. Daily changes in UF are correlated with the evolution of peritoneal membrane function during long-term PD, in relation to clinical risk factors and outcomes. Increased use of APD cyclers with remote patient monitoring will generate large datasets for real-time treatment analysis through cloud-based services, enabling timely treatment modifications to improve patient outcomes.Therefore, continuous UF measurement with automated analysis can monitor peritoneal membrane function and alert clinical teams upon detection of relevant changes, without the need for serial screening membrane tests.

[012] As there are no CAPD devices available on the market today that compare to the APD devices available, it can be argued that there is a desperate need for such a device for several reasons. CAPD is still considered an effective form of renal replacement therapy (RRT) for patients suffering from advanced renal disease (ASRD). CAPD can be considered a better treatment modality than APD, with numerous advantages, but most notably the preservation of residual renal function (RRF). Petition 870250100991, dated 04 / 11 / 2025, p. 15 / 51 / 39 A brief summary of the benefits of CAPD compared to APD could be: concerns about increased cost, a faster decline in residual renal function, inadequate sodium removal, and disturbed sleep are the drawbacks of APD. Aside from the superiority of APD over CAPD in rapid transporters, any other medical advantages of APD remain controversial. However, it must be acknowledged that the main challenge for DPAC is the survival of the technique for several reasons. Some of these relate to the inability to manage the patient, as would be expected given the lack of precise anthropometric measurements.

[013] The proportion of patients undergoing continuous ambulatory peritoneal dialysis (CAPD) is increasing worldwide, partly because CAPD provides good clinical outcomes for a patient and allows the patient to lead an economically active life. The two main goals of dialysis, solute clearance and ultrafiltration (UF), depend on a number of variables and also on patient adherence to their prescription at a given time. However, these can also be influenced by a number of specific variables, such as the type of PD solution, the duration of therapy, and the filling volume. However, there may also be additional factors, such as the etiology of the patient's renal failure, the presence of additional comorbid diseases with which the patient may be afflicted, the patient's clinical presentation, and additional medication that the patient may already be prescribed to manage existing diseases.Prescribing CAPD therapy involves selecting one of each of these parameters, as well as the patient's need to self-monitor for important signs of well-being and potential side effects of the treatment. There are many combinations and possibilities to choose from, and the patient is trained during their enrollment and competency assessment to perform CAPD, to remember each step of the procedure they need to perform manually. It should also be remembered that, due to the nature of their illness, some patients may suffer cognitive decline and therefore find the task of safely performing their treatment a challenge. Petition 870250100991, dated 04 / 11 / 2025, page 16 / 51 / 39

[014] The treatment of CAPD typically relies on the patient to safely perform their treatment and then capture all their treatment data manually or, as in the recent past, capture it manually in digital format. The patient is also expected to manually estimate the volumes they drained, the amount of solution they flushed out before the filling procedure, and the volume they filled into the abdomen. It is not possible to measure important data such as the flow rate of the solution or the actual time the various sections of the treatment take. The patient is also expected to remember their prescription and use a specific product for which they were prescribed and also trained to use in specific circumstances. However, patients can be expected to change the solutions they use, but they have based their calculations on the assumption of volumes and their manually recorded UF for a specific treatment.

[015] A patient must also perform four CAPD dialysis exchanges per day, and the healthcare professional is unaware of how many dialysis treatments the patient has actually performed. It is also typical for most patients that, after a few months of treatment, they begin to neglect capturing all the data they should record for each treatment. The patient lacks the tools to easily communicate their treatment outcomes to their healthcare professionals. Consequently, some patients do not meet their goals and develop adverse conditions such as fluid overload and, in some cases, hypertension. Furthermore, as mentioned above, when there are indications that patients are beginning to experience side effects from their dialysis treatment, they may be inclined to wait a day before notifying their healthcare professional, and this can result in potentially harmful medical conditions.

[016] A patient with CAPD may also be denied the ability to have an automated peritoneal dialysis (APD) machine, since these require electricity, and the patient may not have a reliable electricity supply. Alternatively, they may not be able to afford the much more expensive APD dialysis option. These methods place the burden of therapy solely on the patient. The healthcare professional must devise ways to try to stay abreast of the patient's treatment outcomes to help the patient. Otherwise, they only have the ability Petition 870250100991, dated 04 / 11 / 2025, page 17 / 51 / 39 to evaluate a patient once a month in a clinical consultation, which can sometimes be even longer than four-week intervals.

[017] The provision of renal replacement therapy, and specifically home peritoneal dialysis, is a challenging and complex treatment for healthcare professionals to manage. Innovative medical device systems are enabling improved management of PD patients. However, new medical device regulations are also requiring a greater degree of oversight, particularly regarding the clinical evaluation of the performance of these medical device systems. Routinely generated data underpin the ability to demonstrate performance, specifically with medical device software, where real-world experience needs to be actively managed. The importance of maintaining compliance with ethical standards, however, is paramount, and working mechanisms must be articulated before engagement.

[018] Guyton's model of how the kidney functions is central to long-term blood pressure control and is described as the pressure-natriuresis relationship. The relationship between renal perfusion pressure, sodium excretion, and blood pressure is an important mechanism for regulating circulatory volume. The kidneys regulate circulatory volume by controlling sodium and water balance, thus maintaining extracellular fluid volume (ECFV) homeostasis. End-Stage Renal Disease (ESRD) and Renal Replacement Therapy are therefore a challenging disease to manage.

[019] Ultrafiltration (UF) has been shown to be the only parameter directly correlated with mortality in patients with CAPD and ultimately led to the concept of High-Quality Goal-Directed Peritoneal Dialysis Prescription.

[020] Continuous Ambulatory Peritoneal Dialysis (CAPD) compared to other dialysis modalities has been shown to have beneficial effects on residual renal function.

[021] It is well documented that CAPD has two main burdens: the treatment burden experienced by healthcare professionals and the therapy burden experienced by patients. However, the survival of the treatment technique Petition 870250100991, dated 04 / 11 / 2025, page 18 / 51 / 39, is also known to have several quantifiable preventive and measurable qualitative risk factors that can affect the survival of the technique. Clinically, most notably infections, leaks, and catheter problems are important modifiable causes of technique failure. Direct procedural errors can have an immediate impact, for example, potential exposure to contamination that requires an immediate response, initiating treatment and monitoring of the patient. Early identification and notification of contaminated DP drain effluent can prevent hospitalization and even improve the survival rate of the technique. Non-compliance with a treatment prescription is not significant, but trend analysts identify patient overload. - Minor procedural errors that do not directly impact the change in PD, over time, indicate that the patient is beginning to show symptoms of burnout.

[022] Remote monitoring of PD patient care is highlighting the reorganization of PD medical teams, allowing for more proactive patient management and thus reducing the treatment burden.

[023] The treatment of patients with ESRD is complex, as each patient has different disease states (causes), etiology, and demographics. The effect of medication prescribed to treat the direct cause of their renal failure or additional medications prescribed on the outcome of the patient's dialysis results cannot be measured by the attending physician. More specifically, day-to-day observation and the establishment of trends over time are crucial to understanding the treatment response of a specific patient. Currently, there are fixed predictive models largely based on retrospective analysis and limited to only a few parameters that can be considered. How an individual patient responds is also not understood, as attending physicians can only review the patient's actual clinical status infrequently.

[024] The combination, therefore, of the patient's condition, their response to the specific CAPD prescription, their compliance with the CAPD prescription, as well as the impact Petition 870250100991, dated 04 / 11 / 2025, page 19 / 51 / 39, regarding the additional treatment provided to the patient for various other diseases, can only be reviewed infrequently. The specific response to certain PD solutions, the volumes used, and the impact that the combination of the chemical and physical properties of PD solutions has on the results cannot be measured. The dynamic response of the patient's body to the filling and draining of PD solutions is also not measurable, and although these kinetic forces are known to be present and their impact can be felt, it is not currently possible to measure them. Attending physicians must rely on static measurements to understand dynamic forces in order to try to provide the best care to their patients. The filling volume for a prescription has an existing formula; however, the forces affecting intraperitoneal pressure (IPP) are not known. - It is known that infusion affects changes in IPP and IPP during PD switching, but currently it is monitored only by static measurements, which can obscure the true (and more importantly, elevated) IPP levels that pose a danger to the patient. It is known that PPI measurements exceeding certain levels can directly cause hernia and can also affect cardiac function, but elevated PPI may go unnoticed or not attract the attention of healthcare professionals if it is measured only statically and infrequently.

[025] Medical device regulations (MDRs), for example in the EU, require manufacturers to create a clinical evaluation plan that demonstrates that the medical device's claims are substantiated and reviewed over time. The medical team not only needs to manage their individual patients, but also manage the PD program according to international standards. Data analysis is central to both requirements. - Essential patient rights and informed consent must be navigated alongside the need to use data, with due care for security and anonymity, in order to maintain efficient treatment and remain within legislative requirements. However, a clinical evaluation plan (CEP) and frequent subsequent reports are also necessary to ensure that the medical device... Petition 870250100991, dated 04 / 11 / 2025, p. 20 / 51 / 39, is functioning as claimed and also in compliance with the regulations of the competent local authority. Legacy medical devices already placed on the EU market do not require clinical investigation, but nevertheless need to comply with the new MDR-CEP requirements, and similar requirements exist in other jurisdictions. One of the recommendations is CEP supervision, and it is carried out on behalf of the manufacturer by a duly qualified specialist (medical consultant) supported by additional specialists in the field. Local institutions have also adopted procedures to evaluate a new medical device before accepting it as a standard medical device to be used in their procurement procedures. The evaluation requires controlled use by patients within a limited timeframe and following established and adopted internal protocols. As an example, 45 patients might be enrolled with performance and usability variables monitored and analyzed over a defined period. Subsequently, the review would recommend the use of the medical device or refuse its continuation.

[026] In this descriptive report, reference is made only to some errors, but the present invention relates to two main categories of errors: clinical errors and technical errors. Clinical errors can be divided into: critical, potentially fatal errors; and non-critical errors. Technical errors can be similarly divided into critical and non-critical errors. It is essential that critical errors be identified and addressed as quickly as possible.

[027] The present invention attempts to remedy or improve the aforementioned deficiencies of the prior art. Summary of the invention

[028] According to a first aspect of the present invention, an apparatus is provided for performing continuous ambulatory peritoneal dialysis (CAPD) for a patient, said apparatus comprising: Programmable circuits into which a healthcare professional can input prescription data; Petition 870250100991, dated 04 / 11 / 2025, page 21 / 51 / 39 a user interface that is configured for the patient to enter data and provide information to the patient, said information including at least sequential instructions for the patient to carry out CAPD treatment according to the prescription data; Instruments for collecting treatment data, including at least one of: dates and times when CAPD treatments are pre-formed; durations of flushing, filling and / or drainage; amounts of dialysate solution used during flushing, filling and / or drainage; and intraperitoneal hydrostatic pressure (IPP); A communication module configured to communicate treatment data to the healthcare provider.

[029] Instruments for collecting treatment data may include at least one balance configured to weigh a container of dialysate solution, said balance may include an analog load cell and circuits configured to convert an analog signal emitted from the load cell into a digital signal.

[030] The weighing scale circuits can be configured to convert variations in the weight of the dialysate solution container into the amount of dialysate solution used during washing, filling and / or draining, using the specific gravity of the dialysate solution, and can be configured to convert variations in the weight of the dialysate solution container over time to determine a dialysate solution flow rate. The programmable circuits can also be configured to convert the dialysate solution flow rate into IPP.

[031] The communication module can be remote from the instruments to collect treatment data and the device can include circuits configured to time / date the treatment data.

[032] The user interface can be configured to obtain feedback that CAPD treatment is being administered correctly. Petition 870250100991, dated 04 / 11 / 2025, page 22 / 51 / 39

[033] The user interface can be configured to record patient errors, to provide an indication of the patient's ability to cope with the burden of treatment, and to alert healthcare professionals if a serious error has been made.

[034] Instruments for collecting treatment data may include at least one flow management constrictor that is configured to measure the type of dialysate solution and the concentration of said dialysate solution, said flow management constrictor containing photometric instruments and circuits configured to convert chemical and physical properties of the dialysate solution into digital information. The flow management constrictor circuits may be configured to measure variations in the nature of a plastic-type tube in which the dialysate solution flows, to verify the material properties in the tube. The programmable circuits of the flow management constrictor may be configured to verify whether the nature of a solution being infused is in accordance with the feedback provided to the patient on the user interface.

[035] According to another aspect of the invention, a system is provided for performing comprehensive continuous ambulatory peritoneal dialysis (CAPD) management for a patient, said system comprising apparatus as described in this document above, wherein the healthcare provider is remote from the apparatus to perform CAPD and the communication module is configured to communicate treatment data to the healthcare provider remotely.

[036] The communication module can be configured to allow the healthcare provider to remotely enter prescription data into the programmable circuits, can be configured to communicate treatment data to the healthcare provider in real time, and / or can be configured to allow the healthcare provider to remotely enter prescription data into the programmable circuits in real time.

[037] According to a further aspect of the present invention, a method for managing continuous ambulatory peritoneal dialysis (CAPD) of a person in need thereof is provided, said method comprising: Petition 870250100991, dated 04 / 11 / 2025, page 23 / 51 / 39 insert prescription data into programmable circuits; to understand the potential outcome of using the reported prescription of programmable circuits using aggregated data from individual CAPD treatment history or information collected and interpreted to affect such expectation; to generate interactive information and sequential instructions in programmable circuits, with said interactive information and sequential instructions being for carrying out CAPD treatment in accordance with prescription data; To display interactive information and sequential instructions in a user interface; Collect treatment data including at least one of the following: dates and times when CAPD treatments are pre-formed; durations of flushing, filling and / or drainage; quantities of a dialysate solution used during flushing, filling and / or drainage; potential hazardous events that may have occurred during treatment; and intraperitoneal hydrostatic pressure (IPP); and communicate the treatment data to a healthcare provider via a communication module.

[038] The method may include aggregating treatment data for the benefit of the healthcare provider and communicating such aggregated data in ways that are effective and efficient for the healthcare provider, and may include disseminating information collected from the treatment data and related information to appropriate role-players thus configured to receive and respond to such data.

[039] The treatment data collection step may include weighing at least one container of dialysate solution on a scale. The weighing scale may include an analog load cell and the method may include converting an analog signal emitted from the load cell into a digital signal.

[040] The method may include converting variations in the weight of the dialysate solution container into quantities of dialysate solution, using the specific gravity of Petition 870250100991, dated 04 / 11 / 2025, page 24 / 51 / 39 dialysate solution, and may include converting variations in the weight of the dialysate solution container over time into a dialysate solution flow rate. The method may also include converting the dialysate solution flow rate into IPP.

[041] The communication module can be remote from locations where CAPD treatments are performed and treatment data is collected, and the method can include time / date stamping of treatment data.

[042] The method may include obtaining feedback from the person needing CAPD treatment through the user interface that CAPD treatments are being administered correctly.

[043] The method may include recording errors made by the person needing CAPD treatment and generating an assessment of the ability of the person needing CAPD treatment to cope with a treatment load or whether, in fact, they need urgent medical attention.

[044] The method may include measuring a type and concentration of dialysate solution by converting chemical and physical properties of the dialysate solution into digital information using photometric instruments and circuits in at least one flow management constrictor. The method may include measuring variations in the nature of a plastic-type tube in which the dialysate solution flows, to verify the material properties in the tube and / or the method may include verifying that the nature of a solution is in accordance with the feedback provided by the person in need of CAPD treatment on the user interface.

[045] The method may include measuring and calculating dialysate flow rates, as well as the positive and counter-action forces that may affect flow rates. The results of the measurement and calculation may lead to the determination of safe dynamic pressure levels within which treatment is considered effective. Such measurements may also provide information for future prescription decisions in order to ensure patient safety and comfort.

[046] The method may also include: Petition 870250100991, dated 04 / 11 / 2025, page 25 / 51 / 39 to aggregate the treatment data collected for several of the aforementioned individuals in need of CAPD, said treatment data including multiple parameters; to gather and aggregate outcome data for the aforementioned individuals; and to model the likely expected outcomes of CAPD treatment as a function of the aforementioned multiple treatment data parameters, reviewing the aforementioned treatment data and outcome data.

[047] The method may include determining the Peritoneal Balance Test (PET) status for each of the people who need CAPD and evaluating the effectiveness of PET in relation to the expected CAPD outcomes.

[048] The method may include aggregating blood pressure data from the aforementioned multiple people in need of CAPD and modeling the expected blood pressure as a function of the aforementioned multiple parameters and / or determining an optimized prescription for a person in need of CAPD.

[049] The method may include determining the dynamic specific intraperitoneal pressure (IPP) of a person in need of CAPD, which may be used as a single measurement for the prevention of a side effect or used to assess the effectiveness of a CAPD treatment outcome.

[050] The method may include evaluating a combination of measurements that, in isolation, may not provide an interpretation of the meaning, however, when considered together, they may provide invaluable information that directly affects the response to the information.

[051] The method may also include: Collection and availability of relevant data needed to create prescriptions and allocate specific devices to specific patients; providing ancillary data to facilitate supplementary information and further describes the condition or activities of patients; and Petition 870250100991, dated 04 / 11 / 2025, page 26 / 51 / 39 to advance healthcare for the whole person with an emphasis on data aggregation for multifactorial analysis. Brief description of the drawings

[052] Other For a better understanding of the present invention, and to show how it can be carried out, the invention will now be described by way of non-limiting example, with reference to the accompanying drawings in which: Figure 1 shows a three-dimensional view of an embodiment of a CAPD device according to the present invention; Figure 2 shows a diagrammatic representation of the CAPD device from Figure 1, in use; Figure 3 shows a screenshot of a panel displayed by the medical device software (MDSW) in a user interface of the CAPD device from Figure 1; Figure 4 shows an example of a medical panel; and Figure 5 shows a schematic representation of one embodiment of a system according to the present invention. Detailed description of the drawings

[053] The present invention utilizes a system for performing CAPD on a patient and a preferred embodiment of the system includes a CAPD device as shown in Figures 1 and 2 and generally identified by reference number 10. The system is shown in Figure 5 and is generally identified by reference number 40.

[054] In the embodiment illustrated, the CAPD 10 device includes a mobile base 12 and a vertical post 14 to support parts of the device at preferred elevations, but in other embodiments, the device may include a different support structure.

[055] The CAPD 10 device includes an upper weight scale 16 which is supported on top of the post 14 at a height of 174 cm and a lower weight scale 18 supported on the post 14 at a height of 37 cm. Heights at which the weight scales 16,18 are Petition 870250100991, dated 04 / 11 / 2025, p. 27 / 51 / 39 supported, as well as the heights of other parts of the CAPD device 10 that will be described below, are measured from a floor on which the CAPD device is supported and are merely non-limiting examples of suitable heights - which may be varied in other embodiments of the invention. However, it is important for the aspects of the invention that will be described below that the heights of the weight scales 16,18 be known.

[056] In some embodiments of the invention, the CAPD 10 device may include only a single weight scale, preferably the upper weight scale 16, but two weight scales are preferred.

[057] Each of the weight scales 16,18 includes a cantilever arm with a fastening formation, such as a hook, which is configured to support a bag filled with dialysate solution. In use, a bag 20 for delivering fresh dialysate solution will be supported by the upper weight scale 16 and will be referred to in this document as the upper bag 20 for brevity. Similarly, a bag 22 for receiving fluid drained from a patient's peritoneal cavity (i.e., effluent or spent dialysate) will be supported by the lower weight scale 18 and will be referred to in this document as the lower bag 22.

[058] Each of the weight scales 16,18 is configured to weigh the bag 20,22 it supports, preferably with high precision, for example, using load cell technology. The upper weight scale 16 monitors the weight of the upper bag 20 to monitor the infusion of dialysate into a patient's peritoneal cavity, and the lower weight scale 18 monitors the weight of the lower bag 22 to monitor the spent dialysate drained from the peritoneal cavity under gravity. Both weight scales 16,18 monitor these weights over time and record data.

[059] The CAPD 10 device includes an upper clamp 24 at a height of 77 cm and a lower clamp 26 at a height of 45 cm, each of which clamps is supported by post 14. Each of the clamps 24, 26 is configured to secure a flexible tube and to serve as a flow management constrictor. In some embodiments of the invention, the CAPD 10 device may include only a single clamp. Petition 870250100991, dated 04 / 11 / 2025, page 28 / 51 / 39 brace, preferably the upper brace 24, but two braces are preferred.

[060] Each of the clamps 24,26 includes a constriction mechanism that is able to recognize the physical properties of the incoming tubing in the clamp's jaws and is configured to clamp the tubing to control the fluid flow rate in the clamp. Each constriction mechanism is automated and can restrict the tubing to stop or prevent fluid flow in the tubing, or to restrict and control the fluid flow rate in the tubing.

[061] In a preferred embodiment, each clamp 24,26 is also equipped with an optical sensor that is configured to monitor the fluid flowing in a tube held by the clamp. Optical monitoring can be used to monitor fluid color, fluid inclusions, fluid opacity, or the like. In particular, each clamp 24,26 preferably includes photometric instruments and circuits configured to convert chemical and physical properties of the dialysate solution into digital information.

[062] The CAPD 10 system also includes a user experience device or user interface which, in the example illustrated, takes the form of a tablet-type computer 28 that is supported by post 14. The tablet 28 is for patient interaction during the CAPD procedure and displays output that guides the patient during the procedure, but the tablet 28 also performs tests and monitors equipment conditions to ensure procedure compliance. The tablet 28 and its associated processing circuits also capture data, including the times at which the CAPD is performed, the duration of different process steps such as flushing, filling and draining.

[063] Tablet 28 provides the processing capacity for CAPD device 10 and several proprietary medical device software (MDSW) on the tablet receives input from weight scales 16,18 and cuffs 24,26 and controls the cuffs. In the illustrated embodiment of the invention, there are several MDSW programs in the form of application software or applications that operate on the tablet. The MDSW applications running on tablet 28 include firmware 44, an application 44 for CAPD management, which generates only CAPD data, and an application 46 for coordinating prescription. Petition 870250100991, dated 04 / 11 / 2025, page 29 / 51 / 39 of the patient and capture non-CAPD data, such as blood pressure, body weight, and temperature. In other embodiments of the invention, there may be more than one processing-capable device, which may be part of the user interface; there may be fewer or more applications, which may perform the same functions as the applications running on tablet 28 in the illustrated example. However, the presently preferred embodiment of the invention uses firmware and two applications on a single tablet 28, which provides all the processing capacity of device 10.

[064] System 40 can also monitor other parameters, such as dialysate pressures and flow rates, anthropometric data such as weight, blood pressure, etc. The system preferably includes sensors 48 that can communicate with the tablet 28, such as a thermometer, scale and blood pressure monitor that can communicate wirelessly with the tablet, for example, via Bluetooth. Patients operate the thermometer, scale and blood pressure monitor manually, but the data measured by the devices are automatically transmitted to the tablet 28, where they are captured and processed.

[065] The data captured in the CAPD 10 system are preferably stored and communicated or made available to the patient directly or to a healthcare professional. The data may be processed or partially processed on the tablet 28 and may be stored on the tablet, from where they can be accessed on demand, or the data may be transmitted wirelessly, for example, via the Internet, may be stored in cloud-based storage, may be transmitted and stored on a remote server or similar.

[066] With reference to Figure 2, when a patient 30 uses the CAPD device 10 to perform CAPD, the patient attaches the upper bag 20 to the upper weight scale 16 and the lower bag 22 to the lower weight scale 18 and attaches the tubing from the bags to the patient catheter 32 in the conventional manner. The upper tube 34 leading from the upper bag 20 is inserted between the jaws of the upper clamp 24 and the lower tube 36 leading to the lower bag 22 is inserted between the jaws of the lower clamp 26.

[067] The patent is requested during the preparation and conduct of the CAPD exchange and afterwards, with instructions issued by the CAPD management application 44 and displayed Petition 870250100991, dated 04 / 11 / 2025, page 30 / 51 / 39 on tablet screen 28. Some of these instructions require confirmation by the patient that the procedural steps have been completed, and some instructions require the patient to enter information or make menu selections. The patient is thus involved during the CAPD exchange and is guided through the process, while data relating to the CAPD exchange is continuously captured. An example of a panel displayed to a patient on tablet 28 is shown in Figure 3.

[068] The MDSW 46 coordinator application includes coordinator logic capable of handling the complexity of CAPD therapy prescriptions by which to request and monitor a minimum of a cuff and / or scale, providing comprehensive applicable information for each legally allocated therapy prescription by a duly authorized healthcare professional for a specific patient. In the illustrated embodiment, the coordinator logic is part of the MDSW 46 coordination application and runs on the tablet 28 processor, but in other embodiments of the invention, the coordinator logic may instead or in addition run on a different electronic device, processor, system, or network that can communicate with the tablet. For example, the coordinator logic may run on a cloud-based logic coordinator.

[069] The MDSW 46 coordinator application receives prescription data from a device 50 used by an authorized healthcare professional (or user). The prescription data is communicated to the CAPD management application 44 and is used to generate patient instructions / warnings, which are displayed on the tablet screen 28. The data collected by the CAPD management application 44 on the tablet 28 during CAPD is communicated to the MDSW 46 coordinator application, where it is processed and stored and from where it is made available to the user. The MDSW 46 coordinator application operates to accept or deny particular therapy allocated to the patient.

[070] Another important component of the CAPD system is that the logical coordinator access structure allows a healthcare professional to choose from a variety of therapy prescriptions to be executed on the CAPD device. An additional component is that it is possible for the healthcare professional to receive a wide range of applicable information on how the patient performed the various prescribed therapeutic treatments, including not only the results of the treatment, but also the results of the treatment. Petition 870250100991, dated 04 / 11 / 2025, page 31 / 51 / 39 CAPD procedure. An example of feedback for a healthcare professional in the form of a medical panel is shown in Figure 4. Another component is that the patient has the power to know their relevant treatment information and has the ability to receive historical results regarding the outcomes measured during treatment. An additional component, based on the logical coordinator's programming, is to suggest one of the therapy prescriptions to be executed on the CAPD device and courses of action that may be suggested.

[071] A feature of the present invention is that a patient needs to adjust their daily routine to perform their dialysis; however, each patient is unique and therefore must be able to organize their necessary dialysis sessions to accommodate their needs. The patient and healthcare professional can therefore jointly arrange the most appropriate times when the patient should attempt to perform their treatment. Standard time arrangements should also be within a time window and not a strict time event. The ability of a patient to know their daily routine, but also to be discreetly measured when actual dialysis treatments are performed, helps the medical team assess how the patient is coping and address possible causes of the therapy load the patient may be experiencing.Understanding the pressures the patient may be facing also allows the medical team to perhaps adjust the prescription or establish support structures to help the patient cope.

[072] Another feature of the invention is the ability to understand the actual volumes that are infused into the patient's peritoneal cavity and how much is drained out of the cavity. This precise information is not known to date for patients with CAPD. The time it actually takes for fresh dialysate to infuse into the peritoneal cavity and the time it actually takes to drain out of the peritoneal cavity is not known for every patient today. There is an assumption that the time is an approximation. Therefore, the actual dynamics of how the peritoneal cavity of a CAPD patient reacts to treatment are also unknown. Pain during fresh dialysate infusion, or pain during effluent dialysate drainage, is apparently experienced by several patients, and there is no way to limit the flow of dialysate to a CAPD patient in their peritoneal cavity. Prior to the present invention, a Petition 870250100991, dated 04 / 11 / 2025, page 32 / 51 / 39: A patient who has a smaller body surface area, which is directly proportional to the volume that their peritoneal cavity can comfortably tolerate, had to guess the volume they should infuse, as there is usually only one 2-liter bag of dialysate solution available. The patient in question may also be inclined to fill less than prescribed, and there is no real way to know this.

[073] Another feature of the present invention allows for improved prescribing and enhanced prescription personalization for a specific patient. An important baseline calculation for a patient is the peritoneal equilibration test or (PET). PET determines, among other characteristics, the characterization of the patient's transporter type in their peritoneal membrane. The data collected for UF according to the present invention are much more accurate than the data samples used in prior art tests for CAPD patients. This directly assists in developing a more accurate patient-specific UF characteristic curve. The generated data can then be used in conjunction with laboratory analysis to determine more accurate results. The knowledge generated will help healthcare professionals better tailor the treatment to their individual patient.

[074] Another feature of the present invention is the ability to monitor the prescriptions that patients routinely perform along with the patient's performance during their dialysis. The device 10 records a variety of performance characteristics while the patient interacts with the tablet 28. When a patient, for example, attempts to perform a task that is not appropriate, the MDSW running on the tablet 28 will recognize these tendencies through a performance log. The MDSW running on the tablet 28 has incorporated safety precautions, and one of these patient safety features is to perform a pressure test immediately before the Flush-Before-Fill sequence. If the patient has not closed the catheter connection, this will be detected and is an indication that the patient has infused potentially contaminated solution into their abdomen.Tablet 28 will urgently communicate this event to healthcare professionals so they can initiate preventative treatment as quickly as possible. Additional safety precautions include that, even if Tablet 28 is not connected to the internet, the patient will be prompted to contact them immediately. Petition 870250100991, dated 04 / 11 / 2025, page 33 / 51 / 39 with your doctor and confirm that you assume responsibility. The prescription will also be adjusted to include temperature monitoring by the patient in order to assess the possibility of infection. In the event that the patient, similarly in another function, such as during filling, neglects to open the catheter connection, this will be recorded by the user interface. As there is no immediate risk to the patient's health, the patient will be politely asked to close the catheter and this event will be recorded. If such an event occurs several times, healthcare professionals may initiate a root cause analysis to help the patient safely undergo dialysis treatment, addressing the needs that are derived from the root cause analysis.Device 10, its integrated add-ons, and other forms of data collection, such as questionnaires and its interactive software, can track various clinical outcome measures, such as UF removed, body weight, blood pressure, or also procedural events, which can then cumulatively allow for a better understanding of how the patient is doing.

[075] Another feature of the invention is that the dialysate flow rates from the upper bag 20 to the abdomen and from the abdomen to the lower bag 22 are accurately and continuously determined by changes in bag weight, detected on weight scales 16,18. The patient's IPP is calculated in the MDSW coordinator application 46 from each of these flow rates, in an algorithm that uses the Bernoulli interrelation between the flow rates, the known elevations of the bags 20,22, gravity, and the known density of the dialysates. The system 40 is therefore capable of continuously monitoring IPP and can communicate IPP to the HCP 50. IPP is known to vary during PD, therefore, measuring IPP only occasionally does not provide the HCP with sufficiently accurate information to detect potential risks of elevated IPP, such as heart failure or hernia.

[076] Another feature of the invention controls how information from different prescriptions works in relation to the results achieved and other parameters and how these can be adjusted. Trends are very important for the healthcare professional to assess how patient outcomes are being achieved over time and therefore averages such as a weekly moving average for UF or any other useful trend analyses can be performed. The information available to the Petition 870250100991, dated 04 / 11 / 2025, page 34 / 51 / 39. Healthcare professionals can also customize their dashboards to allow them to adjust them to accommodate their needs. Similarly, a patient is, due to the present invention, also able to work with the healthcare professional to understand what important information they should monitor to enable them to become empowered. Relieving the patient's manual demands:

[077] The present invention alleviates the manual demands on the patent, reducing the typical 39 steps required in CAPD to 27. Differentiating the actual PD exchange into two phases is also extremely important. The preparation phase is the one that has a series of infection control points of increasing importance. However, the actual PD exchange phase is the one in which patient interaction is limited to only a few interactions, thus reducing the complexity and the challenge of not making a mistake and thus decreasing the therapy burden for the patient.

[078] Weighing scales 24,26 for bags 20,22 of infused and drained dialysate can use analog load cells, but the analog signals can be converted into digital signals - or digital pressure sensors can be used. As there is also the possibility that the specific gravity of the various solutions being measured may vary, the ability to provide modified volume calculations is also provided by the system.

[079] The system according to the present invention not only minimizes the manual steps required, but also allows the retrieval of unrecorded information, such as when a patient may have performed a manual exchange without using the system or device 10 of the present invention.

[080] The information captured effortlessly in the present invention can become important for patient management. Gravity-based infusion system:

[081] A critical technical achievement of the present invention is that the power plate system in device 10 (in tablet 28) uses time / date heartbeats and this is Petition 870250100991, dated 04 / 11 / 2025, page 35 / 51 / 39 adjusted to synchronize with the larger CAPD system 50 when the patient starts PD treatment on their user interface (tablet 28) and more specifically the signal from the CAPD management application 44 ensuring viable and reliable data for each CAPD dialysis session performed by the patient. - The user interface (tablet 28) and device 10 are also uniquely paired, and a process to confirm the actual identity of the user interface (tablet 28) and dialysis device 10 in an environment such as a medical ward, where there may be more than one patient using a dialysis device, prevents communication with the wrong device. - Similarly, in a familiar home environment where the cause of ESRD is familial and there are two or more patients undergoing dialysis, unique pairing can prevent cross-contamination of data from device 10 to the user interface (tablet 28). While the system utilizes gravity and the patient's intraperitoneal pressure (IPP) as the pressure forces to drive dialysate infusion and drainage, the interaction of these forces allows for individualized calculations that are dynamic in nature and enable individual knowledge of each patient.

[082] There are a number of safety features incorporated into the gravity-assisted dialysis device procedure: Infection control points directly ensure that the patient has completed the essential activities defined by international treatment guidelines or by a protocol from a specific medical team responsible for the patient's treatment. There are critical safety points that are not only important for patient safety, but also for patient well-being. - Critical safety points - if the device loses control of the CAPD procedure, an emergency feature is triggered, prompting the patient to physically stop or turn off the device to prevent harm. Patient flow control devices, i.e., the cuffs 24,26 are also designed so that when there is a loss of power to the motor of one or both of the Petition 870250100991, dated 04 / 11 / 2025, page 36 / 51 / 39 clamps, by their design nature, will close automatically. Furthermore, to reduce undue stress on the mechanical designs of the clamps, when they are fully open or fully closed, they do not require excessive mechanical force to remain in those positions. There are also several verification steps to ensure that the electronic circuit is actually recording as shown in the user interface reading in the form of a dialysis treatment application (patient experience module) to be validated by the patient or by electronic feedback mechanisms. In the event that a specific device component needs to be reset, the patient can initiate this step and the device's power control console would activate such a procedure. - Pressure tests and leak tests are performed at critical stages of treatment to ensure that the patient is closing their catheter and not exposing themselves to dangerous situations, or that the device is operating within the required specifications. Performance records exist to identify when patients make small mistakes that individually are not significant, but building them up over time allows the medical team to identify a patient who is beginning to struggle to cope with their therapy load. There are also indicators of specific physical measurements of the patient that are taken, and although the individual measurement may be within the tolerance of the attending physician, there may be a progressive increase or decrease in these measurements that allows the interpretation that the patient is beginning to develop an unfavorable health condition. [ 083] There are actual physical steps that must be taken, which are now simplified using the user interface (tablet 28): This means that the patient is not left alone to undergo treatment, but has easy access to resources for guidance. The accumulated stress that occurs for the patient when they need to perform numerous sequential activities, some of which can lead to unfavorable health conditions, is a cause of patient "burnout," and changing the Petition 870250100991, dated 04 / 11 / 2025, page 37 / 51 / 39 emphasis on what the patient needs to accomplish, drastically reduces stress and accumulated stress. If a patient is unsure, he / she can consult the training and support materials. - They can contact a dedicated support line, similar to the type of technology-enabled service available 24 / 7. - In countries where resources are insufficient to provide 24 / 7 support, for example, in Spain, the medical team can only work half a day and no other specially trained nurse is available to support a patient. The technology-enabled call center is trained and equipped to provide support, as they would have the treatment protocol and any notification escalation protocol in place. During the critical stages of treatment that a patient needs to be physically restrained today, this is no longer necessary. Furthermore, they don't need to know precisely how much fluid is being drained, or if the filling solution has stopped, as they are now assisted by the procedure being performed on them in these critical treatment steps. They have no way of knowing the fluid flow rate of the drainage fluid or the filling fluid, and the patient also doesn't need to monitor whether their drainage flow rate is adequate. They need to open and close the cuffs during the actual treatment, and the device's performance now takes that burden off their shoulders and manages those steps. - Especially unique to each patient is if the volume required to fill in each dialysis treatment is less than the volume in the commercially available solution bag. This is because the patient may have a smaller body surface area, and the patient is not under stress to avoid overfilling, as the prescribed volume is strictly infused by the device. Petition 870250100991, dated 04 / 11 / 2025, pages 38 / 51 / 39 - Children are currently considered unsuitable for performing CAPD based on the high risk of volume overload, which can be dangerous, but with the present invention, children can now safely undergo CAPD. - If a patient is hospitalized and the medical team is unfamiliar with the necessary CAPD treatment, the medical team can now safely perform dialysis because it is possible to have a caregiver function activated that guides the medical team to perform the steps sequentially. - Device 10 checks with the patient at the end of each change of the lower drain or bag 22 and allows for instant communication of any potential side effects. This allows the medical team to intervene earlier than is experienced in the state of the art to initiate treatment for side effects - most notably peritonitis. If repeated complications of the slow drainage catheter are identified, the incidence of total mechanical catheter failure can be avoided. - Identifying insufficient flow soon after a patient has started treatment identifies possible complications caused by the surgical procedure to insert the catheter.

[084] The cumulative results of these innovations of the present invention are to reduce the stress that patients may experience and reduce their treatment burden.

[085] The present invention includes a dedicated observer system to enable efficient recording and management by medical professionals of patients using a remote patient care module, the treatment coordination application to coordinate all their medical treatments, and then the dialysis experience module (user / patient interface) to manage their specific dialysis treatment. The dialysis device communicates with the dialysis experience module. Other medical devices that may be needed for a patient's treatment are coordinated with the treatment coordination application.

[086] This is a unique CAPD care environment that is adapted to the patient’s lifestyle, helping him or her to cope with the problem. Petition 870250100991, dated 04 / 11 / 2025, page 39 / 51 / 39 They can remain economically active, which is very important because their medical condition can represent a substantial financial burden for them and their families. The invention allows the medical team to have the vital information they need to better manage the patient. The invention addresses the challenges of patients' built environments, such as living in developing countries where they lack reliable and efficient electricity, by having sufficient energy stored in the device in case of a power outage. The invention caters to patients who do not have constant live internet access or expensive data access, allowing data packets to be sent when convenient. The invention does not use excessively expensive electronic solutions, but can operate using the most affordable communication devices available on the market, such as conventional tablets 28. The invention caters to the lifestyles of patients, whether they live in rural communities or are urban but spend their free time in rural areas, allowing their device to operate on a commercially available 12-volt portable battery.

[087] Choice and flexibility of prescription: The invention allows patients to adjust their solutions as instructed by medical professionals and as required by their condition, or based on the results of their previous dialysis treatment. The invention also allows patients to undergo treatments that they are aware are normally performed later or earlier in the day, as they may have an exceptional event planned for that specific day. The invention does not allow the patient to adjust the filling volumes, but it accurately measures the amount that has been determined as ideal for their dialysis treatment by medical professionals. Petition 870250100991, dated 04 / 11 / 2025, pages 40 / 51 / 39 The invention has the capability to ensure that the long-term solution is the one they need and have available to optimize their treatment outcomes. The invention provides medical professionals with insight into how a patient is using the desired prescription in practice. The attempt to manage patients using a 'remote control' approach has always faced the challenge that the 'remote control' didn't reach the patient when and where it was needed. This essentially resulted in treatment being carried out in the dark.

[088] Analytical tools: The invention allows for customizable dashboards in the treatment coordination application to enable the medical team to manage their patient group and each patient as needed. The invention allows a patient to access their own patient information portal within the dialysis experience module, enabling them to be part of the treatment solution if they so desire. The invention allows for the treatment of a patient as a whole; this is done by enabling the import of other disease information that is then compiled into their data if deemed relevant. Regulatory authorities are requiring medical device companies to provide real-world data on the performance of specific medical devices to achieve patient safety and patient outcomes. Designing anonymous event logs for devices will be one way to meet this important new regulatory requirement, which is potentially having a major impact on the cost of supporting devices in the market. The invention protects the patient's data privacy rights. The invention utilizes a series of algorithms that were developed to meet the specific needs of patients with APD (Auditory Processing Disorder). Petition 870250100991, dated 04 / 11 / 2025, page 41 / 51 / 39 The invention allows standardized formulas used under the influence of different global, regional, or national centers of expertise to be modified as needed.

[089] The system according to the invention measures several factors, for example: - UF due to PD exchange, which by itself is not a definable specific treatment outcome, but calculated over 24 hours and over comparative time segments, can be significant. Optimizing UF outputs through prescription adjustment is known to have a long-term impact on the survival of the technique. The invention provides a solution that assists medical staff in managing their patients, attempting to identify and measure many of the variables, as well as providing defined notifications of parameters outside of limits.

[090] Privacy and Information Management The patient's Personal Information is created and made available only to the medical professionals directly responsible for the patient's care, and resides in the remote patient care module under their control. - All treatment-related data communicated from the user interface (tablet 28) and generated by the medical device system, and subsequently returned, are anonymized and encrypted in accordance with international standards. No personal information is transmitted to medical devices, except for a double-authenticated username, which is chosen at the patient's discretion. Limited personal information (e.g., name, phone number, address, and details of next of kin) is also made available to Technology Enable Care (TEC) emergency response organizations, which may be contracted to provide after-hours support to patients. Specific details of the emergency they are responding to are also provided (e.g., blood pressure exceeding levels set by the supervising physician) in order to ensure that the protocol for Petition 870250100991, dated 04 / 11 / 2025, pp. 42 / 51 / 39, to allow appropriate emergency response, such as hospitalization, to be implemented. Technical support, also provided through the contracted TEC supplier, will have limited information available to ensure support for the use of the device or to replace a defective device. Optimizing Patient Outcomes:

[091] The present invention allows the complex management of patients with ESRD to be used to improve patient outcomes by assessing the interactive nature of all key data parameters. The primary cause of ESRD can currently be one of 285 different causes that need to be verified by diagnostic criteria. The added complexity of the possibility that there may be secondary causes of ESRD is also well established. Treatment of the disease can also vary according to several well-defined criteria that are currently assessed with the expertise of the healthcare professional. Such examples are the kinetic model within the abdomen and the characteristics of the peritoneal membrane, such as the results of the PET (Peritoneal Equilibrium Test) and the categorization of patients in relation to their assigned 'Transport Status'. The amount of existing renal function and the generation of daily urine volume may be another.

[092] The coordinating logic of the present invention includes a prescription algorithm that is capable of using extensive cohort data of patients using the invention, to analyze and evaluate expected treatment outcomes in relation to actual measured outcomes. These modeled outcomes can be used to provide decision support to healthcare professionals and constantly review the actual outcome based on all parameters being measured. This is done by evaluating the generated and aggregated data according to various expected outcomes and outcomes generated in hegemonic communities. Online PET assessment:

[093] Today, PET scan results and classification of the patient's peritoneal transport status are considered important components of patient-specific prescriptions. The present invention allows accurate data to be used in PET testing and also aggregates the necessary important patient data. The results of Petition 870250100991, dated 04 / 11 / 2025, page 43 / 51 / 39. Pathology of certain effluents can also be added to provide PET status. The coordinating logic of the present invention includes an algorithm to evaluate the effectiveness of the PET model in relation to expected and actual results. Optimizing Hypertension Treatment:

[094] Healthy kidneys provide long-term maintenance of blood pressure control, and renal replacement therapy also strives to achieve this goal. The complexity of managing hypertension in patients with ESRD is expansive and is generally managed pharmacologically and also using PD prescriptions to ensure efficient ultrafiltration. The coordinating logic of the present invention includes logic that uses data obtained from CAPD to provide decision support in the management of patient hypertension by comparing outcomes and prescription data. This hypertension management model can be implemented in the overall management of patients. Patient Prescription Optimizer Model:

[095] PD outcomes have improved over time, but with great variability, driven by individual and system-level inequalities and central effects. This variation is exacerbated by the lack of standardized outcome definitions. Potential strategies for outcome improvement include enhanced standardization, monitoring and reporting of PD outcomes, and the implementation of continuous quality improvement programs and PD-specific interventions, such as incremental PD, the use of biocompatible PD solutions, and remote PD monitoring.

[096] The present invention addresses the challenges of providing results with data aggregation to ensure that the relevant results report is provided, but also supports decision-making. As an example, the coordinating logic of the present invention includes logic that performs PD fluid exchange rate optimization and that allows the measurement of fluid flow rates experienced by the patient to be aggregated and allow adjustment. As an example, the flow rate can create painful abdominal episodes, which can now be relieved by adjusting the flow rate. Petition 870250100991, dated 04 / 11 / 2025, page 44 / 51 / 39

[097] The present invention meets or improves an unmet need to enable the management of complex CAPD variables to enable decision-making and leverage the global patient population and achieve patient-centered outcomes that are constantly updated and evolving. Online Health Economic Modeling:

[098] Economic health data for the benefit of multiple perspectives are generally very difficult to generate and invariably can cause controversy. However, data aggregation in the present invention allows economic health data to be provided from the perspective of the health economics stakeholders that is needed. As an example, Quality Adjusted Life Year (QALY) type assessments can be easily performed on the aggregated data in the present invention, and analysis of the results provides efficient feedback for health economics reporting tools. Experimental Study

[099] Context: PD is one of the main renal replacement modalities for patients with ESRD. Heart failure is a common adverse event among PD patients, especially for those who operate CAPD at home due to lack of professional monitoring and management of inflow-outflow volume during treatment.

[100] Objective: This study aimed to develop new mobile health (mHealth) tools to improve the quality of home treatment for CAPD and to build a heart failure prediction model based on daily treatment monitoring data from the systems.

[101] Methods: mHealth tools with a four-layer system were designed and developed using Spring Boot, MyBatis Plus, MySQL, and Redis as the back-end technology stack and Vue, Element UI, and WeChat Mini Program as the front-end technology stack. Patients were recruited to use the mHealth tool during daily PD treatment from January 1, 2017, to April 20, 2023. The logistic regression model based on monitoring data from Petition 870250100991, dated 04 / 11 / 2025, page 45 / 51 / 39 real-time treatment was used for heart failure prediction. Sensitivity, specificity, accuracy, and Youden index were calculated to evaluate the performance of the prediction model.

[102] Results: A mini WeChat program called Futou Bao for patients and a patient data management platform for physicians were developed. The Futou Bao software included an intelligent data loading function module and an auxiliary function module. Four function modules comprised the physician data management platform, including patient management, data visualization and tagging, data statistics, and system management. During the study period, a total of 6635 peritoneal dialysis patient records were loaded by Futou Bao, with 0.71% of them (47 patients) presenting with heart failure.The prediction model that included sex, age, and diastolic blood pressure was considered the ideal model, with sensitivity, specificity, accuracy, and Youden index of 0.75, 0.91, 0.89, and 0.66, respectively, and an area under the curve (AUC) value of 0.879 (95% CI: 0.772-0.986) using the validation dataset.

[103] Conclusions: This study provided a new paradigm for home peritoneal dialysis management that achieved real-time monitoring and early warning of heart failure risk. This new paradigm was of great value in improving the efficiency, safety, and personalization of peritoneal dialysis. The study demonstrated that the present invention meets a substantial, previously unmet need for a modeling technique that uses dynamic data, rather than just static data. Petition 870250100991, dated 04 / 11 / 2025, pp. 46 / 51

Claims

1 / 7 CLAIMS 1. COMPOSITION APPARATUS for performing continuous ambulatory peritoneal dialysis (CAPD) for a patient, said apparatus characterized by comprising: programmable circuits into which a healthcare professional can enter prescription data; a user interface configured for the patient to enter data and provide information to the patient, said information including at least sequential instructions for the patient to perform the CAPD treatment according to the prescription data; instruments for collecting treatment data including at least one of the following: dates and times when CAPD treatments are performed; duration of flushing, filling and / or drainage; amounts of dialysate solution used during flushing, filling and / or drainage; and intraperitoneal hydrostatic pressure (IHP); a communication module configured to communicate treatment data to the healthcare professional.

2. APPARATUS, according to claim 1, characterized in that the instruments for collecting treatment data include at least one balance configured to weigh a container of dialysate solution.

3. APPARATUS, according to claim 2, characterized in that said scale includes an analog load cell and circuits configured to convert an analog signal emitted by the load cell into a digital signal.

4. APPARATUS, according to claim 2, characterized by the programmable circuit being configured to convert variations in the weight of said dialysate solution container into the amount of dialysate solution used during washing, filling and / or draining, using the specific gravity of the dialysate solution.

5. APPARATUS, according to claim 2, characterized by the programmable circuit being configured to convert variations in the weight of said dialysate solution container over time to determine a flow rate of the dialysate solution.

6. APPARATUS, according to claim 5, characterized by the programmable circuit being configurable to convert the flow rate of the dialysate solution into PHI.

7. APPARATUS, according to claim 1, characterized by the communication module being remote from the instruments for collecting treatment data, and by the apparatus including circuits configured to stamp the time / date of the treatment data.

8. DEVICE, according to claim 1, characterized by the user interface being configured to obtain feedback that the DPAC treatment is being administered correctly.

9. APPARATUS, according to claim 1, characterized in that the user interface is configured to record errors made by the patient, in order to provide an indication of the patient's ability to cope with the treatment load.

10. APPARATUS, according to claim 1, characterized in that the instruments for collecting treatment data include at least one flow management constrictor configured to measure the type of dialysate solution and the concentration of said dialysate solution, said flow management constrictor containing photometric instruments and circuits configured to convert chemical and physical properties of the dialysate solution into digital information. Petition 870250079894, dated 05 / 09 / 2025, page 11 / 109 3 / 7 11. APPARATUS, according to claim 10, characterized in that the flow management constrictor circuit is configured to measure variations in the nature of a plastic-type tube in which the dialysate solution flows, in order to verify the material properties in the tube.

12. APPARATUS, according to claim 10, characterized in that the flow management constrictor circuit is configured to verify whether the nature of the dialysate solution is in accordance with the feedback provided by the patient on the user interface.

13. A SYSTEM for performing comprehensive management of continuous ambulatory peritoneal dialysis (CAPD) for a patient, said system comprising the device according to claim 1, characterized by the healthcare professional being remote from the device to perform the CAPD and the communication module being configured to communicate treatment data to the healthcare professional remotely.

14. SYSTEM, according to claim 13, characterized in that the communication module is configured to allow the healthcare professional to remotely enter prescription data into the programmable circuit.

15. SYSTEM, according to claim 13, characterized by the communication module being configured to communicate treatment data to the healthcare professional in real time.

16. SYSTEM, according to claim 14, characterized by the communication module being configured to allow the healthcare professional to remotely enter prescription data into the programmable circuit in real time.

17. A method for managing continuous ambulatory peritoneal dialysis (CAPD) in a person who needs it, said method characterized by: entering prescription data into programmable circuits; Petition 870250079894, dated 05 / 09 / 2025, page 12 / 109 4 / 7 generating interactive information and sequential instructions in the programmable circuits, said interactive information and sequential instructions for carrying out CAPD treatment according to the prescription data; displaying the interactive information and sequential instructions in a user interface; collecting treatment data including at least one of the following: dates and times when CAPD treatments are performed; duration of flushing, filling and / or drainage; quantities of a dialysate solution used during flushing, filling and / or drainage; and intraperitoneal hydrostatic pressure (IHP); and communicating the treatment data to a healthcare professional through a communication module.

18. METHOD, according to claim 17, characterized in that the data collection step includes weighing at least one container of dialysate solution on a balance.

19. METHOD, according to claim 18, characterized in that the balance includes an analog load cell and the method includes converting an analog signal emitted by the load cell into a digital signal.

20. METHOD, according to claim 18, characterized by including the conversion of variations in the weight of the dialysate solution container into quantity of dialysate solution, using the specific gravity of the dialysate solution.

21. METHOD, according to claim 18, characterized by including the conversion of variations in the weight of the dialysate solution container over time into a dialysate solution flow rate. Petition 870250079894, dated 05 / 09 / 2025, p. 13 / 109 5 / 7 22. METHOD, according to claim 21, characterized by including the conversion of the dialysate solution flow rate into PHI.

23. METHOD, according to claim 17, characterized in that the communication module is remote from the locations where CAPD treatments are performed and treatment data are collected, said method including the date / time stamp of the treatment data.

24. METHOD, according to claim 17, characterized by including obtaining feedback from the person performing the DPAC treatment through the user interface, that the DPAC treatments are being administered correctly.

25. METHOD, according to claim 17, characterized by including the recording of errors made by the person needing CAPD treatment and the generation of an assessment of the ability of the person needing CAPD treatment to cope with a treatment load.

26. METHOD, according to claim 17, characterized by including the measurement of a type and concentration of dialysate solution by converting the chemical and physical properties of the dialysate solution into digital information using photometric instruments and circuits in at least one flow management constrictor.

27. METHOD, according to claim 26, characterized by including measuring variations in the nature of a plastic-type tube in which said dialysate solution flows, to verify the material properties in the tube.

28. METHOD, according to claim 26, characterized by including verification of whether the nature of a dialysate solution conforms to the feedback provided by the person needing CAPD treatment on the user interface.

29. METHOD, according to claim 17, characterized by further including: Petition 870250079894, dated 05 / 09 / 2025, page 14 / 109 6 / 7 aggregating treatment data collected for several people who need CAPD, said treatment data including multiple parameters; collecting and aggregating outcome data for these people; and modeling the likely expected outcomes of CAPD treatment as a function of said multiple parameters of the treatment data, by reviewing said treatment data and outcome data.

30. METHOD, according to claim 29, characterized by including the determination of the TEP status for each of the persons who need DPAC, and the evaluation of the effectiveness of the TEP in relation to the expected results of DPAC.

31. METHOD, according to claim 29, characterized by including the aggregation of blood pressure data from several people who need CAPD and modeling of the expected blood pressure as a function of said multiple parameters.

32. METHOD, according to claim 29, characterized by including the determination of an optimized prescription for a person who needs DPAC.

33. METHOD, according to claim 29, characterized by including the determination of the dynamic specific intraperitoneal pressure (PHI) of a person who needs CAPD, which can be used as a single measure for the prevention of a side effect or used to evaluate the effectiveness of a CAPD treatment outcome.

34. METHOD, according to claim 29, characterized by including the evaluation of a combination of measurements that, in isolation, may not provide interpretation of meaning, however, when considered together, may provide valuable information that directly affects the response to information. Petition 870250079894, dated 05 / 09 / 2025, page 15 / 109 7 / 7 35. METHOD, according to claim 17, characterized by further including: collection and provision of relevant data necessary to create prescriptions and allocate specific devices to specific patients; provision of adjunct data provided to facilitate supplementary information and better describe the condition or activities of patients; and advancement of the person's overall health with emphasis on data aggregation for multifactorial analysis. Petition 870250079894, dated 05 / 09 / 2025, p. 16 / 109

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