Gravity-based dialysis systems, equipment, and methods for optimizing treatment prescriptions.

Abstract

An apparatus and method for performing continuous ambulatory peritoneal dialysis (CARD) on a patient is provided using a device 10 having a user interface 28 into which prescription data is entered and a programmable circuit. Prescription information is provided to the patient via the user interface 28, treatment data related to managed CARD is collected and communicated to the healthcare provider. For multiple patients, multiple parameters of treatment data are aggregated along with outcome data, and similarly expected outcomes of CARD treatment are modeled as a function of the aforementioned multiple parameters of treatment data to assist in prescription optimization and patient-centered treatment.

Description

Technical Field

[0001] The present invention relates to continuous ambulatory peritoneal dialysis (CAPD).

Background Art

[0002] Patients suffering from end-stage renal disease (ESRD) may receive treatment for their renal insufficiency using various modalities including various forms of dialysis or as a kidney transplant. One of the dialysis modalities is peritoneal dialysis (PD) which is available in two modalities, namely automated PD (APD) on the one hand and continuous ambulatory peritoneal dialysis (CAPD) on the other hand.

[0003] CAPD is generally performed manually by the patient four times a day. The dialysis fluid / dialysis solution (dialysate) is introduced into the patient's abdominal cavity by an indwelling peritoneal catheter, and the bag containing the dialysis solution is infused by gravity flow with the bag suspended above the patient's abdomen. The dialysis solution remains in the patient's abdominal cavity for about 4 - 6 hours. The peritoneum acts as a diffusion barrier for the exchange of excess water, metabolites, and other waste products excreted from the body. At the end of this time, the fluid containing water and waste metabolites is drained from the patient's abdominal cavity under the action of gravity. Fresh dialysis fluid is infused into the abdominal cavity again to continue the process.

[0004] The patient performs the above-described drainage and filling cycles by performing a predetermined sequence of steps of draining the previously used fluid and then refilling the abdominal cavity with new fluid. Performing each exchange requires a predetermined sequence of steps of opening and closing several pre-connected tubes in a closed system of bags and tubes defined as a fill-before-flush peritoneal dialysis closed system. Here, these are usually referred to as the "twin bag" procedure or a variant of such a procedure.

[0005] Patients are generally treated by specially trained nephrologists, who are typically qualified as nephrologists, with the support of PD nurses who are also specially trained in caring for PD patients. Nephrologists and nurses, along with other healthcare professionals, form a healthcare practitioner (HCP) team.

[0006] Known commercially available CAPD systems require numerous clamping and unclamping steps for a single replacement. For example, a typical system may require the following manual steps: 1. Patients must adhere to the patient's PD unit training manual protocol. Therefore, patients will receive approximately two weeks of training, undergo a competency assessment upon completion, and then be able to perform PD independently at home. 2. Patients need to be trained with the various PD solution products required during their treatment, and must follow prescriptions created by the patient's HCP who oversees the patient's treatment. 3. Patients need to adjust their daily routines to account for the need to change their PD an average of four times a day. 4. Patients need to remember which specific PD solution they need between each PD change. 5. There are various manufacturers of PD dialysis solutions, and these manufacturers use various technologies. Depending on the patient, it may be necessary to use various technologies on the same day. 6. The last PD exchange of the day should always have a longer duration until the patient undergoes the next PD exchange the following day, and this particular PD exchange should always use a special solution concentration and different material contents than other PD dialysate solutions, and use the remaining time. 7. Patients should remember to take a series of preparation steps to ensure they have the appropriate product, the appropriate material, and other items to ensure they perform the PD change safely. 8. The main risk that patients need to be aware of is the development of peritonitis, an infection of the peritoneum. The main causes of peritonitis are thought to be contact contamination with S. aureus or inadequate hygiene practices. 9. Patients are also required to meticulously record all events of their PD exchange, including the solutions used, the amount drained and refilled, and any other cumbersome details. These records are stored in the specifications and are handwritten. 10. Patients are required to have a range of PD dialysis solution products available to them and to perform each exchange according to their physician's prescription, while they may also use alternative products that may give the patient different dialysis outcomes. 11. Once the patient has completed the various preparation steps and is properly disinfected, he / she will be connected to the abdominal catheter connector. 12. The patient opens a specific clamp to drain any stagnant fluid from their abdomen into an empty bag placed on the floor. 13. The patient must monitor the drainage bag to ensure that it is actually filled with waste dialysis fluid, as it is not possible to estimate whether the flow rate is slow, and such slowness may indicate a possible mechanical defect in the patient's catheter. Therefore, the patient must ensure that the catheter is not blocked or that the flow is not obstructed by the patient's physical posture, and mechanical failure of the catheter, which is one of the main causes of technical failure in PD, should be considered along with peritonitis. 14. The patient closes a specific drainage clamp after each drainage cycle. 15. The patient places a specific clamp on the tubing to which the sterile solution bag containing fresh dialysate is connected and closes it. 16. The patient breaks the fragile seal or such mechanism that seals the new solution bag in the tubing system. 17. The patient opens the upper clamp on the solution tube and the lower clamp on the discharge tube to begin the flush cycle. 18. The patient estimates that approximately 150 ml of fluid has come out of the solution bag, at which point they re-clamp the solution tube and also close the discharge tube clamp at the end of the flush / cycle. 19. The primary risk to patient safety during this pre-filling flushing procedure is that the catheter connector may not be closed, and fluid containing potentially contaminating bacteria in the tubing may be injected into the patient's abdomen, thus becoming another primary cause of peritonitis. 20. The patient opens the clamp on the solution tube and begins the infusion of the dialysis fluid into the abdomen, a process called filling. 21. The height of the PD dialysate solution is variable, and this can significantly affect the flow rate of the solution. 22. The flow rate of the PD dialysis fluid solution is simply determined by gravity and resistance from the patient's intra-abdominal pressure, which can cause considerable pain during infusion or other discomforts such as the solution being too cold or flowing too quickly. 23. The patient must monitor their filling bag to ensure that there is no more fresh dialysis fluid in it, and cannot estimate whether the flow rate is slow, as such a slow rate may indicate a mechanical defect in the catheter. Therefore, as mentioned in 10, the patient must ensure that the catheter is not blocked or that the flow is not obstructed by the patient's physical posture. 24. The patient needs to estimate how much fluid has flowed into the abdomen under gravity, and then stop the filling by closing the clamp on the solution tube. 25. This procedure is limited to the volume of solution in the bag during manufacturing, which cannot be accurately measured or controlled, making this modality unsafe for patients or children with smaller anatomical sizes, and therefore smaller body surface areas (BSA). 26. There is a standard manufacturing procedure for PD dialysate bags, which have a volume of ±10% of the volume indicated on the solution bag, and it is possible for a dialysate solution ranging from 1,800 ml to 2,200 ml to be injected by the patient, although the estimation of fluid volume is included in 30. 27. The patient closes the clamp on the solution line at the end of filling when the solution bag is empty. 28. The patient needs to close the catheter connector and disconnect himself / herself from the CAPD bag. 29. The patient must manage the drainage bag containing waste products and determine whether there are any signs of foreign body or early signs of infection that may be associated with complications. 30. The patient must record that all the estimated amount of fluid he / she has drained and injected during a particular exchange. 31. The patient, namely, Emissions - Previous fill volume The ultrafiltration (UF) of a specific exchange is calculated and it is necessary to determine whether the UF is sufficient according to the preceding UF measurement already achieved in the previous exchange and according to the UF target provided to the patient by the HCP in charge. 32. The patient must inform the PD unit nurse if the discharge bag contains any of the contaminating bacteria mentioned in 13. 33. The patient needs to have a record made with the data recorded with him / her regarding his / her next appointment at the PD unit. The products used to achieve the UF results mentioned in 34.31 may not be the same products used for the specific PD replacement described in section 5. 35. The attending physician, or other qualified healthcare professional, is required to provide prescriptions for CAPD patients in accordance with the treatment guidelines established by international organizations and with regard to the assessment of the patient's clinical characteristics. Currently, there are no CAPD prescribing tools available to patients to enable decision support related to the most appropriate prescription for the patient. 36. The attending physician, or any other qualified healthcare professional, may only provide prescriptions for CAPD patients, currently limited to several variables, including the type of solution available commercially, the quantity, and the frequency per day to which the solution may or may not have a better therapeutic outcome. 37. The prescribed volume of dialysis fluid is calculated on the premise that the patient's weight and height, and therefore the patient's body mass index, are the criteria for determining the volume to be prescribed. 38. The healthcare provider (HCP) is unaware of the patient's treatment progress and cannot be informed of potential side effects, except during the patient's regular outpatient appointments or informal phone conversations with HCP staff. 39. Accumulated daily treatment outcomes cannot be accurately measured by healthcare professionals, and healthcare professionals cannot receive the information at any frequency. 40. There are no early notification indicators available to healthcare professionals to enable them to monitor their patients while they are undergoing CAPD at home. 41. A decrease in UF over several days, or actually a decrease in other clinical parameters such as temperature, has been shown to be an indicator of peritonitis, but attending physicians are unable to measure these changes in their own CAPD patients. 42. Hospital-based HCP staff who do not directly care for ESRD patients may not provide any instructions on how to perform PD changes if the patient is hospitalized under their care. 43. The PD unit entrusted with the patient's care does not have 24-hour on-call staff and therefore may not be able to respond to any emergencies the patient may experience.

[0007] Oreopolous first described the continuous ambulatory peritoneal dialysis technique in the early 1980s. Since then, innovations for CAPD patients worldwide have been limited. To minimize the number of activities required to perform dialysis, there has been the development of the dual-chamber bag technique with so-called Y-set connection and implantable pre-filling flush procedure for the patient, which has resulted in an improvement in the rate of peritonitis suffered by patients. Peritonitis is one of the leading causes of technique failure. The Tenckoff catheter used has remained largely unchanged throughout the course of CAPD treatment, and catheter failure is classified as a mechanical complication, and this is always another major cause of technique failure, as mentioned in steps 10 and 23 of the list above of steps the patient follows.

[0008] Innovations aimed at reducing contact contamination, which is also a cause of peritonitis, have undergone various advancements, such as the use of Luer-taper connection systems or other such connection systems that attempt to reduce errors during critical phases in the performance of dialysis exchanges. Various dialysate solutions have been introduced to attempt to reduce exposure of the peritoneum to glucose breakdown products, and the development of solution types continues. Finally, another major area of ​​innovation has been attempts to ease the burden on patients who need to manually clamp tubing during critical phases of dialysis procedures, using so-called dialer techniques to assist patients. None of these innovations have provided a clear basis for improving CAPD outcomes on their own.

[0009] It must also be noted that much innovation and investment has been made in the automated peritoneal dialysis (APD) modality, which is similar to but different from CAPD.

[0010] This procedure is a completely different form of peritoneal dialysis, although it uses a similar dialysate solution, the same Tenckoff catheter to access the abdominal cavity, and a similar Luer taper or similar connection technique for the Tenckoff catheter.

[0011] Therefore, the execution of CAPD remains a manual process, primarily performed manually by the patient, and carried out according to a patient-dependent training program provided at the start of treatment, which involves recording a limited amount of information about the treatment in a written notebook. This information primarily serves as an assessment and indication of how often the patient is performing their treatment and how well they are following the procedure.

[0012] Fabian Eibensteiner et al., "Monitoring Daily Ultrafiltration in Automated Peritoneal Dialysis" (CJASN 17:1-4, 2022) states the following important issues even more clearly: "The effectiveness of peritoneal dialysis (PD) is often limited over time by chronic damage to the peritoneum. High-quality, goal-directed dialysis is characterized by appropriate peritoneal ultrafiltration (UF) and low solute clearance while maintaining fluid and salt homeostasis. Irregular measurement of clinical parameters of peritoneal dysfunction in individual PD patients is very uneven. Influenced by time series analysis such as Holter electrocardiogram examination, we studied the automated PD (APD) cycler readings regarding daily inflow and outflow of PD fluid retention to examine the value of continuous UF monitoring in clinically relevant situations. Daily peritoneal UF monitoring with continuous APD data has different amounts, noise, and missing norm values compared to conventional clinical data. Such analysis must consider unique patient trajectories, inter-individual variability, data noise, and time autocorrelation. The study demonstrated that continuously collected data enables the analysis of PD-related events and their impact on UF that were not expected or otherwise undetected. Daily UF changes are correlated with the changing peritoneal function that gradually changes during long-term PD in relation to clinical risk factors and outcomes. The increasing use of APD cyclers with remote patient monitoring generates large datasets for real-time treatment analysis by cloud-based services, enabling timely treatment changes and improving patient outcomes. Therefore, continuous UF measurement by automated analysis could monitor peritoneal function and alert the clinical team when related changes are detected without the need for continuous "screening" membrane tests."

[0013] Since there are no market-available CAPD devices comparable to currently available APD devices, it will be understood that there is an urgent need for such devices for various reasons.

[0014] CAPD remains considered an effective form of renal replacement therapy (RRT) for patients with advanced-stage renal disease (ASRD). CAPD can be considered a better treatment modality than APD due to its numerous advantages, particularly the preservation of residual renal function (RRF). A concise summary of the benefits of CAPD comparable to APD can be said to be that the setbacks of APD are concerns regarding increased cost, very rapid decline in residual renal function, insufficient sodium removal, and sleep disturbances. In addition to the superiority of APD over CAPD in fast transporters, any other medical advantages of APD remain debatable. However, it must be acknowledged that the main challenge of CAPD is the technique retention rate for several reasons. Some of these relate to the inability to manage patients, which would be expected given the lack of accurate anthropometric measurements.

[0015] The proportion of patients undergoing continuous ambulatory peritoneal dialysis ("CAPD") is increasing globally, in part due to CAPD providing good clinical outcomes for patients and enabling them 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 the patient's compliance to perform their own prescription at a given time. However, these can also be affected by a number of specific variables such as PD solution type, therapy duration, and fill volume. However, these can also be further factors such as the cause of the patient's renal failure, the presence of additional co-morbidities the patient may be suffering from, the patient's clinical profile, and additional medications the patient may already be prescribed to manage existing diseases. Prescribing CAPD therapy consists of selecting each one of these parameters, and the patient needs to monitor themselves for important signs of health and the possibility of side effects of the treatment. There are many combinations and possibilities to be selected, and the patient is trained during their enrollment and assessment of their ability to perform CAPD to remember each step of the procedure they need to perform manually. Depending on the nature of the patient's disease, some patients may be at risk of cognitive decline, and therefore, it must not be forgotten that the task of safely performing their own treatment can be a challenge.

[0016] CAPD treatment typically relies on the patient safely performing their treatment and then manually capturing all their treatment data, or, more recently, manually capturing that data in digital format. Patients are also required to manually assess the volume drained, the volume of solution flushed during the pre-filling flush procedure, and the volume filled into their abdomen. Important data such as the flow rate of the solution or the actual time taken for different sections of treatment cannot be measured. Patients are also required to remember their prescriptions and use the specific products prescribed, and receive training for their use in specific environments. However, patients may be required to change the solution they use based on their own calculations regarding volume estimates and manually recorded UF for specific treatments.

[0017] Patients are also required to undergo four CAPD dialysis changes per day, and healthcare professionals do not know how many dialysis treatments the patient actually received. Furthermore, it is typical for most patients to begin neglecting to keep track of all the data they should have recorded for each treatment after several months of treatment. Patients have no easy way to inform their healthcare professionals of their treatment outcomes. Consequently, some patients fail to reach their goals and develop adverse conditions such as fluid overload and, in some cases, hypertension. In addition, as mentioned above, if a patient shows signs of beginning to experience side effects from their dialysis treatment, they may tend to "wait a day" before informing their healthcare provider, which can result in the potential for adverse medical conditions.

[0018] CAPD patients may also be denied access to automated peritoneal dialysis (APD) machines because these machines require electricity, and patients may not have a reliable power supply. Alternatively, patients may not be able to afford the cost of the more expensive APD dialysis option. These methods place a burden of treatment on the individual patient. Healthcare professionals need to devise ways to continuously monitor patients' treatment outcomes in order to support them. Otherwise, healthcare professionals will be left with only being able to assess patients at outpatient appointments, which may be monthly, or even at intervals of more than four weeks.

[0019] Renal replacement therapy, and especially home-based peritoneal dialysis, is a challenging and complex treatment managed by healthcare professionals. Innovative medical device systems have made it possible to improve the management of PD patients. However, new medical device regulations also demand a higher level of oversight, particularly regarding the clinical evaluation of the performance of these medical device systems. The data generated on a daily basis needs to be actively managed based on real-world experience, especially through the demonstration of performance by medical device software. However, the importance of maintaining compliance with ethical standards is paramount, and the operating mechanisms should be organized before management.

[0020] The Guyton model of kidney function is central to long-term blood pressure control and is explained as the "pressure-natriuretic relationship." The relationship between renal perfusion pressure, sodium excretion, and blood pressure is a crucial mechanism for regulating circulating volume. The kidneys regulate circulating volume by controlling the balance of sodium and water, and thus maintain extracellular fluid volume (ECFV) homeostasis. As a result, end-stage renal disease (ESRD) and renal replacement therapy are difficult diseases to manage.

[0021] Ultrafiltration (UF) has been shown to be one parameter directly related to mortality in CAPD patients, ultimately leading to the concept of "prescribing high-quality, goal-oriented peritoneal dialysis."

[0022] As a benchmark for comparison with other dialysis modalities, continuous ambulatory peritoneal dialysis (CAPD) has been shown to have beneficial effects on residual renal function.

[0023] CAPD is well documented to have two main burdens: the treatment burden on the treatment provider and the treatment burden on the patient. However, treatment technique retention rates have also been shown to have several measurable and quantifiable qualitative preventive risk factors that can influence technique retention rates. Clinically most significant infections, leaks, and catheter problems are major modifiable causes of technique failure. Direct procedural errors, such as potential exposure to contamination that requires immediate response by commencing treatment and monitoring the patient, can have immediate consequences. Early identification and notification of contaminated PD emissions can prevent hospitalizations and even improve treatment continuation rates. Non-compliance with a single treatment prescription may not be significant, but trend analysts can identify patient burden. Minor procedural errors that occur over time and do not directly affect PD exchange can indicate that the patient is beginning to show signs of fatigue. Remote patient care monitoring for Parkinson's disease (PD) patients highlights the restructuring of PD healthcare teams, reducing the burden of treatment by enabling greater preventative management of patients.

[0024] Treating ESRD patients is complex because each patient has a different disease state (cause), etiology, and demographics. The effectiveness of medications prescribed to a patient to treat the direct cause of the patient's renal failure, or additional medications prescribed in relation to the patient's dialysis outcome, cannot be measured by the attending physician. More specifically, establishing temporal trends to understand the treatment response of a particular patient is a daily challenge. Currently, there are fixed predictive models based primarily on retrospective analysis, and these fixed models are limited to only a few parameters that can be considered. How individual patients respond is also not understood because attending physicians can only occasionally examine the patient's actual clinical condition.

[0025] Therefore, the combination of the patient's condition, their response to a specific CAPD prescription, their compliance with the CAPD prescription, and the impact of further treatments provided to the patient for various other conditions can only be considered occasionally. The impact of a specific response to a particular PD solution, the amount used, and the combination of the chemical and physical properties of the PD solution on the outcome cannot be measured. The dynamic response of the patient's body to the filling and draining of the PD solution also cannot be measured; although these motor forces are known to exist and their effects can be perceived, they cannot currently be measured. Attending physicians must rely on static measurements to understand dynamic forces in order to attempt and provide the best possible care for their patients. While there are existing prescriptions for the amount to be filled, the force that affects intraperitoneal pressure (IPP) is unknown. While it is known that infusion affects IPP and IPP changes during PD exchange, it is currently only monitored by static measurements, which may obscure the critical (more importantly, high) IPP levels that pose a risk to patients. While it is known that IPP levels exceeding a certain level may be a direct cause of hernia formation and may also affect cardiac function, if these are measured only occasionally and statically, high IPP levels may go undetected or fail to attract the attention of a cardiac cardiologist.

[0026] For example, the Medical Device Regulations (MDR) in the European Union require manufacturers to create clinical evaluation plans that clearly indicate that claims for medical devices are justified and reviewed over time. Medical teams not only need to manage their own individual patients, but also need to manage their PD programs according to international standards. Data analysis is central to both requirements. To effectively maintain treatment and comply with legal requirements, patients' fundamental rights and informed consent must be navigated with due consideration to security and anonymity, given the necessity of using data. However, clinical evaluation plans (CEPs) and subsequent frequent reporting are also required to ensure that medical devices are evaluated as required and in compliance with local competent authority regulations. Legacy medical devices already on the European Union market do not require clinical evaluations, but nevertheless must comply with the new MDR-CEP requirements, similar requirements exist in other jurisdictions. One recommendation is the supervision of CEPs, which should be carried out on behalf of manufacturers by appropriately qualified experts (medical advisors) supported by further experts in the field. Regional facilities also have procedures in place to evaluate new medical devices as standard medical devices to be used within their procurement regulations before accepting them. The evaluation requires controlled patient use within a limited timeframe, in accordance with established and adopted internal protocols. For example, 45 patients may be enrolled, and efficacy and usefulness variables are monitored and analyzed over a period of time. The subsequent review will determine whether the use of the medical device is recommended or whether its continued use is rejected.

[0027] Although only a few types of negligence are mentioned in this specification, the present invention considers two main categories of negligence: clinical negligence and technical negligence. Clinical negligence can be divided into serious, potentially life-threatening negligence and non-serious negligence. Technical negligence can similarly be divided into serious negligence and non-serious negligence. It is essential that serious negligence be identified and addressed as soon as possible. [Prior art documents] [Non-patent literature]

[0028] [Non-Patent Document 1] Fabian Eibensteiner et al., “Monitoring Daily Ultrafiltration in Automated Peritoneal Dialysis” (CJASN 17:1-4, 2022) [Overview of the project] [Problems that the invention aims to solve]

[0029] This invention aims to alleviate or improve upon the aforementioned shortcomings of the prior art. [Means for solving the problem]

[0030] According to a first aspect of the present invention, an apparatus for performing continuous ambulatory peritoneal dialysis (CAPD) for a patient, A programmable circuit that allows healthcare providers to input prescription data, A user interface configured to allow a patient to input data and to provide information to the patient, wherein the information includes at least sequential instructions to the patient for performing CAPD treatment according to prescription data. An instrument for collecting treatment data, including at least one of the following: the date and time when CAPD treatment is performed, the duration of flushing, filling and / or draining, the amount of dialysate solution used during flushing, filling and / or draining, and intraperitoneal static pressure (IPP), A communication module configured to communicate treatment data to healthcare providers, An apparatus is provided that includes the following.

[0031] An instrument for collecting treatment data may include at least one weighing scale configured to weigh a dialysis fluid solution container, the weighing scale may include an analog load cell and a circuit configured to convert the analog signal emitted from the load cell into a digital signal.

[0032] The weighing circuit can be configured to use the specific gravity of the dialysate solution to convert the change in weight of the dialysate solution container into the amount of dialysate solution used during flushing, filling, and / or draining, and can be configured to use the specific gravity of the dialysate solution to convert the change in weight of the dialysate solution container over time to determine the flow rate of the dialysate solution. The programmable circuit can further be configured to convert the flow rate of the dialysate solution into IPP (Integrated Pulse).

[0033] The communication module may be located remotely from the instrument for collecting treatment data, and the device may include a circuit configured to time / date stamp the treatment data.

[0034] The user interface can be configured to provide feedback indicating that CAPD treatment is being properly managed.

[0035] The user interface may be configured to log errors made by the patient, provide an indicator of the patient's ability to manage the burden of treatment, and warn healthcare professionals if serious errors occur.

[0036] The instrumentation for collecting treatment data may include at least one flow control constrictor configured to measure the type of dialysate solution and the concentration of the dialysate solution, the flow control constrictor including a photometric instrument and circuitry configured to convert the chemical and physical properties of the dialysate solution into digital information. The circuitry of the flow control constrictor may be configured to measure changes in the properties of a plastic-type tube through which the dialysate solution flows to verify the properties of the material in the tube. The programmable circuitry of the flow control constrictor may be configured to verify that the properties of the solution being injected match feedback provided by the patient through the user interface.

[0037] According to another aspect of the present invention, a system is provided for comprehensive management of continuous ambulatory peritoneal dialysis (CAPD) for a patient, the system comprising the apparatus described herein above, wherein the healthcare provider is remote from the apparatus for performing CAPD, and a communication module is configured to remotely communicate treatment data to the healthcare provider.

[0038] The communication module can be configured to enable healthcare providers to remotely input prescription data via a programmable circuit, to communicate treatment data to healthcare providers in real time, and / or to enable healthcare providers to remotely input prescription data via a programmable circuit in real time.

[0039] A further aspect of the present invention relates to a method for managing continuous ambulatory peritoneal dialysis (CAPD) in an individual requiring CAPD, Inputting prescription data using a programmable circuit, Understanding the potential consequences of using communicated prescriptions in programmable circuits by using aggregated data of an individual's CAPD treatment history, or aggregated data of information collected and interpreted as influencing such predictions, The invention involves generating interactive information and sequential instructions in a programmable circuit, wherein the interactive information and sequential instructions are for the execution of CAPD treatment according to prescription data. To display interactive information and sequential commands in the user interface, Collect treatment data including at least one of the following: the date and time when CAPD treatment is performed, the duration of flushing, filling and / or draining, the amount of dialysate solution used during flushing, filling and / or draining, the likelihood of any hazardous events occurring during treatment, and intraperitoneal static pressure (IPP). The communication module transmits treatment data to healthcare providers, A method is provided that includes this.

[0040] The method may include aggregating treatment data for healthcare providers and communicating such aggregated data in a manner that is effective and efficient for healthcare providers, and may include disseminating the collected information and related information of the treatment data to appropriate role players configured to receive and respond to such data.

[0041] The step of collecting treatment data may include weighing at least one dialysis fluid solution container using a weighing scale. The weighing scale may include an analog load cell, and the method may include converting the analog signal emitted from the load cell into a digital signal.

[0042] The method may include converting the change in weight of the dialysate solution container into the volume of the dialysate solution using the specific gravity of the dialysate solution, and may also include converting the change in weight of the dialysate solution container over time into the flow rate of the dialysate solution. The method may further include converting the flow rate of the dialysate solution into IPP.

[0043] The communication module is located remotely from the location where CAPD treatment is performed and treatment data is collected, and the method may include time / date stamping the treatment data.

[0044] The method may include obtaining feedback from individuals requiring CAPD treatment via a user interface to confirm that their CAPD treatment is being properly managed.

[0045] The method may include logging errors made by individuals requiring CAPD treatment and generating an assessment of the ability of individuals requiring CAPD treatment or emergency medical assistance to successfully manage the treatment burden.

[0046] The method may include measuring the type and concentration of a dialysate solution by converting its chemical and physical properties into digital information using a photometric instrument and circuit in at least one flow control constrictor. The method may also include measuring changes in the properties of a plastic-type tube through which the dialysate solution flows to verify the properties of the material within the tube, and / or the method may include verifying that the properties of the solution are consistent with feedback provided by the individual requiring CAPD treatment via a user interface.

[0047] The method may include measuring and calculating the flow rate of the dialysate and the positive and reactive forces that may affect the flow rate. The results of these measurements and calculations can provide a dynamic measurement determination of a safe pressure level at which treatment is considered efficient. Such measurements can also provide guidance for future prescription decisions to ensure patient safety and comfort.

[0048] The method is, The process involves aggregating treatment data collected for multiple individuals requiring CAPD, wherein the treatment data includes multiple parameters. To collect and aggregate the outcome data of the aforementioned individuals, By examining the aforementioned treatment data and outcome data, we can model the similarly expected outcomes of CAPD treatment as a function of multiple parameters of the treatment data, It can further include

[0049] The method may include determining the peritoneal equilibrium test (PET) status for each individual requiring CAPD, and evaluating the effectiveness of PET for the expected outcome of CAPD.

[0050] The method includes aggregating blood pressure data from several individuals who require CAPD, modeling the expected blood pressure as a function of the several parameters, and / or determining an optimized prescription for the individuals who require CAPD.

[0051] The method may include determining the dynamic, specific intraperitoneal pressure (IPP) of an individual requiring CAPD, which may be used as a single measure to prevent side effects or to evaluate the effectiveness of CAPD treatment outcomes.

[0052] The method may include evaluating combinations of measurements that, while not providing meaningful interpretation on their own, can offer highly useful information when considered together, directly influencing responses to that information.

[0053] The method is, The collection and availability of relevant data necessary to create prescriptions and assign specific devices to specific patients, To encourage supplementary information and to further describe the patient's condition and activities, and To promote holistic medicine that focuses on aggregating data for multifactor analysis, It can further include

[0054] Next, in order to better understand the present invention and to show how it can be carried out, the present invention will be described as a non-limiting example with reference to the accompanying drawings. [Brief explanation of the drawing]

[0055] [Figure 1] This figure shows a three-dimensional view of one embodiment of the CAPD device according to the present invention. [Figure 2] This figure shows a schematic representation of the CAPD device shown in Figure 1 during use. [Figure 3] This figure shows a screenshot of the dashboard displayed on the user interface of the CAPD device shown in Figure 1, provided by the medical device software (MDSW). [Figure 4] This diagram shows an example of a physician's dashboard. [Figure 5] This figure shows a schematic depiction of one embodiment of the system according to the present invention. [Modes for carrying out the invention]

[0056] The present invention uses a system for performing CAPD on a patient, and a preferred embodiment of the system includes a CAPD device, broadly identified by reference numeral 10, as shown in Figures 1 and 2. The system is shown in Figure 5 and broadly identified by reference numeral 40.

[0057] In the shown embodiment, the CAPD device 10 includes a movable base 12 and an upright support 14 for supporting several components of the device at a suitable height; however, in other embodiments, the device may include a different support structure.

[0058] The CAPD device 10 includes an upper weighing scale 16 supported at a height of 174 cm on top of a support column 14, and a lower weighing scale 18 supported at a height of 37 cm on the support column 14. The heights at which the weighing scales 16 and 18 are supported are measured from the floor on which the CAPD device is supported, as are the heights of other components of the CAPD device 10 as described below, and are merely non-limiting examples of appropriate heights, which can vary in other embodiments of the present invention. However, it is important that the heights of the weighing scales 16 and 18 are known with respect to the embodiments of the present invention described below.

[0059] In some embodiments of the present invention, the CAPD device 10 may include only one weighing scale, preferably only an upper weighing scale 16, but two weighing scales are preferred.

[0060] Each of the weighing scales 16 and 18 includes a cantilever arm having a mounting structure such as a hook configured to support a bag filled with dialysate. When in use, a bag 20 for supplying fresh dialysate is supported by the upper weighing scale 16 and, for brevity, is referred to herein as the “upper bag 20”. Similarly, a bag 22 for receiving fluid drained from the patient’s abdominal cavity (i.e., waste or used dialysate) is supported by the lower weighing scale 18 and is referred to herein as the “lower bag 22”.

[0061] Each of the weighers 16 and 18 is configured to weigh the bags 20 and 22 supported by the weighers, preferably with high accuracy, for example, by using load cell technology. The upper weigher 16 monitors the weight of the upper bag 20 to monitor the infusion of dialysate into the patient's abdominal cavity, and the lower weigher 18 monitors the weight of the lower bag 22 to monitor the used dialysate being drained from the abdominal cavity under gravity. Both weighers 16 and 18 monitor these weights over time and record the data.

[0062] The CAPD device 10 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 is supported by a column 14. Each of the clamps 24 and 26 is configured to clamp a flexible tube and act as a flow control constrictor. In some embodiments of the present invention, the CAPD device 10 may include only one clamp, preferably only the upper clamp 24, but two clamps are preferred.

[0063] Each of the clamps 24 and 26 includes a clamping mechanism capable of recognizing the physical properties of the tubing accepted into the jaws of the clamp, and configured to clamp the tube and control the flow rate of fluid in the clamp. Each clamping mechanism is automated and can clamp the tube to stop or block the flow of fluid in the tube or to limit and control the flow rate of fluid in the tube.

[0064] In preferred embodiments, each clamp 24, 26 also includes an optical sensor configured to monitor the fluid flowing through the tube held by the clamp. Optical monitoring may be used to monitor the color of the fluid, inclusions in the fluid, the opacity of the fluid, etc. In particular, each clamp 24, 26 preferably includes a photometric instrument and circuit configured to convert the chemical and physical properties of the dialysate into digital information.

[0065] The CAPD system 10 also includes a user experience device or user interface, which in the example shown takes the form of a tablet computer 28 supported by a column 14. The tablet 28 is for interacting with the patient during CAPD treatment and displays output to guide the patient through the treatment, but the tablet 28 also checks the equipment and monitors the equipment status to ensure treatment compliance. The tablet 28 and its associated processing circuitry also capture data when CAPD is performed, including the duration of various steps in the process, such as flushing, filling, and emptying.

[0066] The tablet 28 provides processing power for the CAPD device 10, and on the tablet, various copyrighted medical device software (MDSW) receives input from the weighers 16, 18 and clamps 24, 26 and controls the clamps. In the shown embodiments of the present invention, there are multiple MDSW programs in the form of application software, or "apps," that run on the tablet. The MDSW apps running on the tablet 28 include firmware 44, an app 44 for CAPD management that only generates CAPD data, and apps 46 for adjusting patient prescriptions and capturing non-CAPD data such as blood pressure, weight, and body temperature. In other embodiments of the present invention, there may be two or more devices having processing power that can form part of the user interface, and there may be fewer or more apps that can perform the same functions as the apps running on the tablet 28 in the shown embodiment. However, the currently preferred embodiment of the present invention uses firmware and two apps on a single tablet 28 that provides all the processing power of the device 10.

[0067] System 40 also monitors other parameters such as the pressure and flow rate of the dialysis fluid, as well as anthropometric data such as weight and blood pressure. The system preferably includes sensors 48 that can communicate with the tablet 28, such as a thermometer, weighing scale, and blood pressure monitor, which can communicate wirelessly with the tablet, for example, via Bluetooth. The patient manually operates the thermometer, weighing scale, and blood pressure monitor, but the data measured by the devices is automatically transmitted to the tablet 28, where it is captured and processed.

[0068] The data captured in the CAPD system 10 is preferably stored and communicated or made available directly to the patient or to healthcare professionals. The data can be processed or partially processed in the tablet 28, stored in the tablet, and accessed on demand from the tablet, or the data can be transmitted wirelessly, for example, over the internet, stored in cloud-based storage, and transmitted and stored on a remote server.

[0069] Referring to Figure 2, when patient 30 performs CAPD using the CAPD device 10, the patient attaches the upper bag 20 to the upper weighing scale 16 and the lower bag 22 to the lower weighing scale 18, and attaches the tubing from these bags to the patient's 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.

[0070] The patient is prompted by instructions displayed on the screen of the tablet 28, issued by the CAPD management app 44, during and after the CAPD exchange. Some of these instructions require the patient to confirm that the treatment step is complete, and some prompts require the patient to enter information or make menu selections. Thus, the patient engages in the CAPD exchange and is guided through the process while data related to the CAPD exchange is continuously captured. An example of the dashboard displayed to the patient on the tablet 28 is shown in Figure 3.

[0071] The Coordinating MDSW app46 includes coordinator logic capable of handling the complexity of CAPD treatment prescriptions, thereby providing comprehensive relevant information for each treatment prescription lawfully assigned by a properly authorized healthcare professional to a particular patient in order to indicate and monitor minimum clamp and / or weighing requirements. In the shown embodiment, the coordinator logic forms part of the Coordinating MDSW app46 and operates on the processor of the tablet 28, but in other embodiments of the invention, the coordinator logic may instead or in addition run on different electronic devices, processors, systems, or networks that can communicate with the tablet. For example, the coordinator logic may run on a cloud-based logic coordinator.

[0072] The Coordinating MDSW app 46 receives prescription data from a device 50 used by an authorized healthcare professional (or user). The prescription data is communicated to the CAPD Management app 44 and used to generate instructions / prompts for the patient that are displayed on the screen of the tablet 28. Data collected by the CAPD Management app 44 on the tablet 28 during CAPD is communicated to the Coordinating MDSW app 46, processed and stored in the Coordinating MDSW app 46, and made available to the user from the Coordinating MDSW app 46. The Coordinating MDSW app 46 operates to accept or reject specific treatments assigned to the patient.

[0073] Another important element of the CAPD system is that the coordinator logic access structure allows healthcare professionals to select from a number of treatment prescriptions to be performed in the CAPD device 10. A further element is that healthcare professionals can receive a wide range of relevant information, including not only how the patient performed the various prescribed treatments but also the results of the CAPD treatment. One example of feedback to healthcare professionals in the form of a physician dashboard is shown in Figure 4. Another element is that patients are empowered to know their relevant treatment information and can be provided with historical results regarding the outcomes measured while undergoing treatment. A further element, based on the programming of the logic coordinator, is to suggest treatment prescriptions to be performed in the CAPD device 10 and one of a set of actions that may be suggested to be taken.

[0074] A key feature of this invention is that while patients need to adjust their daily routines to perform their dialysis, each patient is different, and therefore, the dialysis sessions required by the patient should be able to be arranged to suit the patient's needs. Thus, the patient and healthcare provider can work together to plan the most appropriate time for the patient to try and perform their treatment. Default time arrangements should also be within a time window, not a strict time event. Knowing that the patient's routine, and that this can be carefully measured when the actual dialysis treatment is performed, helps the healthcare team assess how well the patient is coping and address potential causes of any treatment burden the patient may be experiencing. Understanding the pressure the patient may be experiencing also allows the healthcare team to potentially adjust prescriptions or establish support structures to help the patient cope better.

[0075] A further feature of the present invention is the ability to understand the actual amount injected into the patient's abdominal cavity and the extent to which it is drained. This precise information has not been known to CAPD patients until now. The actual time it takes for fresh dialysate to be injected into the abdominal cavity and the actual time it takes for it to be drained are currently unknown to each patient. There is an assumption that the times are approximate. Consequently, the actual dynamic force of how the abdominal cavity of CAPD patients responds to treatment is also unknown. Clearly, several patients experience pain during the injection of fresh dialysate or the drainage of used dialysate, and there is no way for CAPD patients to limit the flow of dialysate into their abdominal cavity. Prior to the present invention, only 2-liter dialysate bags were generally available, so patients with a smaller body surface area, which is directly proportional to the volume their abdominal cavity can comfortably tolerate, had to estimate how much to inject. In such cases, these patients may tend to fill less than prescribed, and there is no practical way to know this.

[0076] Another feature of the present invention is that it enables improved prescriptions and enhanced customization of prescriptions for specific patients. A key reference point for patients is the peritoneal equilibrium test, i.e., "PET." PET, among other features, seeks to assess the type of peritoneal permeability state of the patient's peritoneum. The data collected for UF according to the present invention are far more accurate than the data samples used in prior art examinations of CAPD patients. This directly helps in generating more accurate UF patient-specific evaluation curves. The generated data can then be used in conjunction with laboratory analysis to obtain more accurate results. The generated recognition helps healthcare professionals better tailor treatment for their individual patients.

[0077] A further feature of the present invention is that it allows patients to monitor their routine prescriptions along with their patient behavior during dialysis. The device 10 logs a range of performance evaluations while the patient interacts with the tablet 28. If, for example, the patient attempts to perform an inappropriate task, the MDSW operating on the tablet 28 considers these tendencies as performance logs. The MDSW operating on the tablet 28 has established safety precautions, one such patient safety feature being to perform a pressure test immediately before the pre-filling flush sequence. If the patient fails to close their catheter connection, this is detected and it is noted that potentially contaminated fluid has been injected into their abdomen. The tablet 28 urgently notifies healthcare workers of this event so that they can begin preventive measures as soon as possible. Further safety precautions include requiring the patient to immediately contact their healthcare worker and acknowledge responsibility in the event that the tablet 28 is not connected to the internet. Prescriptions are also adjusted to include temperature monitoring by the patient to assess the possibility of infection. In the event that the patient forgets to open their catheter connection during another function, such as during filling, this is recorded by the user interface. Since there is no immediate health risk to the patient, the patient is politely asked to close their catheter, and this event is recorded. If such events occur multiple times, healthcare professionals can initiate a root cause analysis and help the patient safely undergo dialysis treatment by addressing the requests derived from the root cause analysis. Device 10, its further integrated devices, and other such forms of data collection, such as questions and its interactive software, can track several clinical outcome measurements, such as removed UF, weight, blood pressure, or even treatment events, which can then cumulatively enable a better understanding of how the patient is performing.

[0078] A further feature of the present invention is that the flow rate of dialysate from the upper bag 20 to the abdomen and from the abdomen to the lower bag 22 is accurately and continuously determined by the change in bag weight detected by weighers 16 and 18. From each of these flow rates, the patient's IPP is calculated in the coordinating MDSW app 46 using an algorithm that employs the Bernoulli relationship between the flow rate, the known height of bags 20 and 22, gravity, and the known density of the dialysate. Thus, the system 40 can continuously monitor the IPP and communicate the IPP to the HCP 50. Since IPP is known to change during PD, sometimes simply measuring IPP does not provide the HCP with sufficiently accurate information to detect potential risks from high IPP, such as heart failure or hernia.

[0079] A further feature of the present invention is the control over the extent to which information on various prescriptions functions with respect to the outcomes and other parameters achieved, and to the extent to which these can be adjusted. Measuring the extent to which patient outcomes are achieved over time is of great importance to healthcare professionals, and therefore, averages such as a one-week moving average of UF or any such useful trend analysis can be performed. The information available to healthcare professionals can also be customized to allow healthcare professionals to adjust their dashboards to suit their needs. Similarly, the present invention also allows patients to work with healthcare professionals to understand what key information they should monitor in order to enable them to be empowered.

[0080] Reduce manual requests to patients: This invention reduces the manual demands on patients by reducing the typical 39 steps required in CAPD to 27. It is also critically important to distinguish the actual PD exchange into two stages. The preparation stage is a stage with a series of increasingly important infection control points. However, the actual PD exchange stage reduces complexity and error-free challenges by limiting interaction with the patient to minimal interaction, thereby reducing the treatment burden on the patient.

[0081] The weighing scales 24 and 26 for the bags 20 and 22 of dialysate being injected and discharged may use analog load cells, but the analog signals can be converted to digital signals, or digital pressure sensors may be used. Since the specific gravities of the various solutions being measured may vary, the system may also be provided with the ability to perform correction volume calculations.

[0082] The system according to the present invention not only minimizes the manual steps required, but also enables "catch-up" of unrecorded information, such as when a patient may have performed a manual replacement without using the system or device 10 of the present invention.

[0083] The easily captured information in this invention can be important for patient management.

[0084] Gravity-based injection system: A key technical achievement of the present invention is that the power board system in the device 10 (within the tablet 28) uses a heart rate time / date stamp, which is set to synchronize with signals from the larger CAPD system 50 and, more specifically, from the CAPD management application 44, which ensures viable and reliable data for each CAPD dialysis session performed by the patient, when the patient initiates PD treatment on their user interface (tablet 28). The user interface (tablet 28) and the device 10 are also uniquely paired, and a process to verify the actual identification of the user interface (tablet 28) and the dialysis device 10 in environments such as hospital wards where there may be two or more patients using dialysis equipment prevents communication with the wrong device. Similarly, in a 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 the device 10 to the user interface (tablet 28). While the system uses gravity and the patient's intraperitoneal pressure (IPP) as the pressure for injecting and draining the dialysate, the interaction of these forces allows for individually distinct calculations that are inherently dynamic and enable individual recognition of each patient.

[0085] The following numerous safety features are incorporated into gravity-assisted dialysis machine procedures: Infection control points directly ensure that patients have performed those essential activities as determined by international treatment guidelines or protocols from the specific medical team responsible for the patient's treatment. There are important safety points that are not only crucial for patient safety but also for patient health. A critical safety feature is triggered if the device loses control of the CAPD procedure, prompting the patient to physically stop or terminate the device to prevent harm. The patient flow control mechanism, namely clamps 24 and 26, is also designed to close automatically by design if there is a power loss to the motors of either or both clamps. Furthermore, to reduce excessive strain on the mechanical design of the clamps, when the clamps are fully open or fully closed, no excessive mechanical force is required to keep them in those positions. There are also various verification steps to ensure that the electronic circuitry is actually recorded as indicated by a reading in the user interface of a dialysis treatment application (patient experience module), which is approved either by the patient or by an electronic feedback mechanism. In events where certain components of the device need to be reset, the patient can initiate this step, and the device's power control console will start up in such a procedure. Pressure and leak tests are performed at critical stages of treatment to ensure that the patient closes their catheter and does not put themselves in a dangerous situation, or that the device operates within the required specifications. There are execution logs that allow healthcare teams to identify patients who make "minor errors"—individually insignificant but which escalate over time—and who begin to take steps to better manage their treatment burden. There are indicators of specific physical measurements of a patient, and while individual measurements may remain well within the physician's tolerance level, there may be a gradual increase or decrease in these measurements, which can be interpreted as the patient beginning to develop an unfavorable health condition.

[0086] The following are the actual physical steps that must be taken, which have now been simplified using the user interface (tablet 28): The significance of this is that while patients are not entrusted with managing their own treatment, they have access to simple resources for guidance. For patients, the accumulated stress that arises when they have to perform numerous sequential activities, some of which may lead to undesirable health conditions, is the cause of their "fatigue." By shifting the focus of what the patient needs to do, stress and accumulated stress can be dramatically reduced. If the patient is unsure, they can refer to training and support materials. Patients can contact a dedicated helpline, as is the case with 24 / 7 assisted, technically-supported care molds. In countries where resources are insufficient to provide 24 / 7 support, such as Spain, medical teams may only work half-days, and there may not be other specially trained nurses available to support patients. Therefore, technically responsive care call centers are trained and equipped to provide support, as they would have treatment protocols and escalation protocols for any notifications that exist. During this crucial step, the patient does not currently require any treatment that necessitates physical management of their own body. Furthermore, if these important treatment steps are performed according to the procedure for the patient, the patient will be helped, so the patient does not need to know exactly how much fluid is being drained or whether the filling solution has stopped. Patients do not need to know the fluid flow rate of the discharged or filled fluid, nor do they need to monitor whether their discharge flow rate is appropriate. Patients previously had to open and close clamps during their actual treatment, but now, thanks to the capabilities of the equipment, this burden is removed from the patient, and these steps are managed. Whether the amount required to be filled with each dialysis treatment is less than the amount in a commercially available solution bag is specific to each patient, as the patient may have a smaller body surface area, and the patient is not under stress to prevent overfilling himself / herself, as the prescribed amount is precisely injected by the device. Children are currently considered unsuitable for CAPD, which involves a significant risk of potentially dangerous overfilling; however, with the present invention, children can now safely undergo CAPD. If a patient is hospitalized and medical staff are unfamiliar with the required CAPD treatment, dialysis can now be performed safely by activating a caregiver function that guides the assigned medical staff step by step. The device 10 checks with the patient at the end of each drainage or replacement of the lower bag 22, enabling instantaneous communication regarding potential side effects. This allows medical staff to intervene sooner than with conventional techniques and begin treatment for side effects, most notably peritonitis. In cases of repeated slow drainage and identified catheter complications, overall mechanical failure of the catheter can be prevented. Identifying blood flow insufficiency immediately after the patient begins treatment helps identify potential complications caused by the surgical procedure for inserting the catheter.

[0087] The cumulative result of these innovations in the present invention is to reduce the stress that patients may experience and to reduce the burden of treatment on patients.

[0088] The present invention includes a dedicated “observer” system positioned in place to enable efficient registration and management of a patient by a healthcare professional using a remote patient care module, a treatment coordination application for coordinating all of the patient’s medical-based treatments, and a dialysis experience module (user / patient interface) for caring for the patient’s specific dialysis treatments. The dialysis machine communicates with the dialysis experience module. Other medical devices that may be required for patient treatment coordinate with the treatment coordination application. This is a unique CAPD care environment that helps patients cope by being tailored to their lifestyle. It is crucial that patients remain financially active, as their medical condition can impose a significant financial burden on them and their families. This invention enables medical teams to possess critically important information necessary for better managing patients. This invention addresses challenges in the patient's living environment, such as when patients live in developing countries where reliable and efficient electricity is unavailable, by ensuring that sufficient power is stored in the device even during power outages. This invention addresses the issue of patients who do not have effective (live) continuous internet access or costly data access by enabling them to receive data packets at their convenience. The present invention can operate using the most readily available and affordable communication devices on the market, such as a conventional tablet 28, rather than employing extremely expensive electronic solutions. This invention addresses the lifestyles of patients who live in rural communities or who are city-based but spend their free time in rural areas by enabling them to operate their devices using commercially available 12-volt "portable" batteries.

[0089] Prescription selection and flexibility The present invention allows patients to adjust their own solutions as they have been trained by medical professionals, and as required by the patient's condition or based on the results of the patient's previous dialysis treatment. The present invention also allows patients to receive treatment that takes into account what would normally happen later or earlier on a particular day, as they may have special events planned for that day. This invention does not allow the patient to adjust the filling volume, but instead accurately measures the amount determined by a medical professional as ideal for his / her dialysis treatment. The present invention has the ability to ensure that long-stay solutions are available to meet the needs of patients and to optimize their treatment outcomes. This invention provides healthcare professionals with insights into how patients practically use desired prescriptions. Attempts at "remote control" for patient management have always faced the challenge of not providing "remote control" when it was needed or required. As a result, treatment was essentially administered without the patient's knowledge.

[0090] Analysis tools: This invention enables a customizable dashboard for a treatment coordination application, allowing medical teams to manage their patient populations and individual patients as needed. This invention enables patients to access their own patient information portal within the dialysis experience module, thereby granting them the authority to become part of the treatment solution if they choose to do so. This invention enables the treatment of patients as a whole, by allowing the import of other disease information, which is linked to patient information when disease information is considered important. Regulatory requirements demand that medical device companies provide real-world data on how specific medical devices are performing to achieve patient safety and patient outcomes. Designing anonymized event logs for devices would be one way to meet this most important new regulatory requirement, which could have a major impact on the cost of supporting devices in the market. This invention protects the patient's right to privacy regarding data. This invention utilizes numerous algorithms developed to address the specific needs of CAPD patients. This invention enables standardized prescriptions, which are used under the influence of various global, regional, or international centers of specialized technology and are modified as needed.

[0091] The system according to the present invention measures various factors, such as the following: While not a specific, definitive treatment outcome in itself, the UF for each PD exchange, calculated over a 24-hour period and across relative time segments, can be considered statistically significant. Optimizing UF output through formulation adjustments has been shown to have a long-term impact on technique retention rates. The present invention provides a solution that helps medical teams manage their patients by attempting to identify and measure many variables, and also provides defined notifications for parameters that exceed limits.

[0092] Privacy and Information Management Patient personal information is created and made available only to healthcare professionals directly responsible for the patient's care, and resides in the remote patient care module under the control of these healthcare professionals. All treatment-related data, communicated from the user interface (tablet 28), generated by the medical device system, and subsequently returned, is anonymized and encrypted in accordance with international standards. Except for the user name, which is determined by two-factor authentication at the patient's discretion, no personal information is transmitted to medical devices. Limited personal information (e.g., name, telephone number, address, and nearest relative) will also be made available to technology-enable care (TEC) emergency response agencies that may be contracted to provide after-hours support to patients. Specific details of the corresponding emergency (e.g., blood pressure exceeding levels established by the attending physician) will also be provided to ensure that protocols are implemented to enable appropriate emergency responses, such as hospitalization. Technical support provided by contracted TEC providers will also have limited information available to ensure support for equipment use or replacement of defective equipment.

[0093] Patient outcome optimization This invention enables the complex management of patients with ESRD, used to improve patient outcomes by evaluating the interactive nature of all major parameters of the data. The primary cause of ESRD can be one of 285 different causes, all of which must be verified by diagnostic criteria. The further complexity of ESRD, which may have secondary causes, is also well established. Treatment of the disease can also vary according to various well-defined criteria, which are currently evaluated by the experience of the healthcare professional in charge. Examples of such examples include models of intra-abdominal movement and peritoneal characteristics, such as the results of PET (peritoneal equilibrium testing) and the patient's classification against a designated "transport status". The amount of existing renal function and the production of daily urine volume may be other factors.

[0094] The coordinator logic of the present invention includes a prescribing algorithm that can utilize extensive data from patient cohorts using the invention to analyze and evaluate predicted treatment outcomes against actual measured results. These modeled results can be used to provide decision support to healthcare professionals and to continuously review actual results based on all measured parameters. This is done by evaluating data generated and collected according to various predicted outcomes and results generated in leadership communities.

[0095] Online PET evaluation: Currently, PET results and classification of a patient's peritoneal permeability state are considered a crucial component of patient-specific prescriptions. This invention enables the accumulation of data used in PET studies and also allows for the aggregation of essential patient data. Pathological results of specific waste products can also be added to provide PET status. The coordinator logic of this invention includes algorithms for evaluating the effectiveness of the PET model against predicted and actual results.

[0096] Optimizing hypertension treatment: A healthy kidney maintains long-term blood pressure control, and renal replacement therapy also strives to achieve this goal. The complexity of managing hypertension in ESRD patients is wide-ranging and is generally managed pharmacologically, as well as by using PD prescriptions to ensure efficient ultrafiltration. The coordinator logic of this invention includes logic that uses data obtained from CAPD to provide decision support in the management of patient hypertension by comparing outcomes with prescription data. This model of hypertension management can be deployed in the general management of patients.

[0097] Patient Prescription Optimizer Model: While PD outcomes have improved over time, they remain highly volatile due to individual and systemic biases and central effects. This variability is exacerbated by the lack of standardized outcome definitions. Potential measures to improve outcomes include improved standardization, monitoring and reporting of PD outcomes, and the implementation of continuous quality improvement programs and PD-specific interventions such as additional PD, use of biocompatible PD solutions, and remote PD monitoring.

[0098] The present invention addresses the challenge of providing results by collecting data to ensure that relevant results are reported and subsequently supported in decision-making. For example, the coordinator logic of the present invention is a logic for optimizing the flow rate of PD exchange, and includes logic that enables the measurement of the fluid flow rate received by the patient, which can be collected and adjusted. For example, a flow rate may cause abdominal pain attacks, but these attacks can now be mitigated by adjusting the flow rate.

[0099] This invention addresses or improves upon unmet needs for enabling the management of complex variables in CAPD to facilitate decision-making, providing advantages to large patient populations, and achieving constantly updated and evolving patient-centered outcomes.

[0100] Online Health-Economic Modeling Health-economic data for multiple perspectives is generally very difficult to generate and can always be controversial. However, the data aggregation in this invention makes it possible to provide health-economic data from the perspective of the health-economic stakeholders who need it. For example, a Quality Adjusted Life Year (QALY) type assessment can be easily performed with the data aggregated in this invention, and outcome analysis provides efficient feedback for health-economic reporting tools.

[0101] Experimental research Background: Parkinson's disease (PD) is one of the primary renal replacement modalities for patients with ESRD. Among PD patients, particularly those undergoing CAPD at home, heart failure is a common adverse event due to the lack of specialized input-output monitoring and management during treatment. Objective: This study aimed to develop a novel mobile health (mHealth) tool to improve the quality of home-based CAPD treatment and to build a predictive model for heart failure based on the system's daily treatment monitoring data. Methods: We designed and developed a four-tier mHealth tool using Spring Boot, MyBatis Plus, MySQL®, and Redis as the backend technology stack, and Vue, Element UI, and WeChat Mini Program as the frontend technology stack. Patients were recruited to use the mHealth tool during their daily PD treatment from January 1, 2017 to April 20, 2023. A logistic regression model based on real-time treatment monitoring data was used to predict heart failure. The performance of the predictive model was evaluated by calculating sensitivity, specificity, accuracy, and the Youden index. Results: We developed a WeChat mini program for patients called Futou Bao and a patient data management platform for physicians. The Futou Bao software included an intelligent data upload function module and auxiliary function modules. The four function modules constituted the physician's data management platform, including patient management, data visualization and marking, data statistics, and system management. During the study period, records of a total of 6,635 peritoneal dialysis patients were uploaded to Futou Bao, of which 0.71% (47 patients) experienced heart failure. A predictive model including sex, age, and diastolic blood pressure was considered the optimal model, and using the validation dataset, the sensitivity, specificity, accuracy, and Youden index of the optimal model were 0.75, 0.91, 0.89, and 0.66, respectively, with an area under the curve (AUC) value of 0.879 (95%Cl: 0.772~0.986). Conclusion: This study provides a novel home-based peritoneal dialysis management paradigm that enables real-time monitoring and early warning of heart failure risk. This novel paradigm is highly valuable for improving the efficiency, safety, and personalization of peritoneal dialysis. The study demonstrates that the invention fulfills a previously unmet need for modeling techniques that utilize dynamic data instead of statistical data alone.

Claims

1. A device for performing continuous ambulatory peritoneal dialysis (CAPD) for patients, A programmable circuit that allows healthcare providers to input prescription data, A user interface configured to allow the patient to input data and to provide information to the patient, wherein the information includes at least sequential commands to the patient for performing CAPD treatment according to the prescription data. An instrument for collecting treatment data, including at least one of the following: the date and time when the CAPD treatment is performed, the duration of flushing, filling and / or draining, the amount of dialysate solution used during flushing, filling and / or draining, and intraperitoneal static pressure (IPP), A communication module configured to communicate the aforementioned treatment data to the healthcare provider, A device equipped with the following features.

2. The apparatus according to claim 1, wherein the instrument for collecting the aforementioned treatment data includes at least one weighing scale configured to weigh a dialysis fluid solution container.

3. The apparatus according to claim 2, wherein the weighing scale includes an analog load cell and a circuit configured to convert an analog signal emitted from the load cell into a digital signal.

4. The apparatus according to claim 2, wherein the programmable circuit is configured to use the specific gravity of the dialysate solution to convert the change in weight of the dialysate solution container into the amount of dialysate solution used during flushing, filling and / or discharge.

5. The apparatus according to claim 2, wherein the programmable circuit is configured to determine the flow rate of the dialysate solution by converting the amount of change in the weight of the dialysate solution container over time.

6. The apparatus according to claim 5, wherein the programmable circuit is configured to convert the flow rate of the dialysate solution into the IPP.

7. The apparatus according to claim 1, wherein the communication module is located remotely from the instrument for collecting the treatment data, and the apparatus includes a circuit configured to stamp the treatment data with a time / date.

8. The apparatus according to claim 1, wherein the user interface is configured to provide feedback that the CAPD treatment is being properly managed.

9. The apparatus according to claim 1, wherein the user interface is configured to log errors made by the patient and to provide an indicator of the patient's ability to successfully manage the burden of treatment.

10. The apparatus according to claim 1, wherein the instrument for collecting the treatment data includes at least one flow control constrictor configured to measure the type of the dialysate solution and the concentration of the dialysate solution, the flow control constrictor including a photometer and circuit configured to convert the chemical and physical properties of the dialysate solution into digital information.

11. The apparatus according to claim 10, wherein the circuit of the flow control constrictor is configured to measure changes in the properties of a plastic-type tube through which the dialysate solution flows and to confirm the properties of the material inside the tube.

12. The apparatus according to claim 10, wherein the circuit of the flow control constrictor is configured to ensure that the properties of the dialysate solution match the feedback provided by the patient through the user interface.

13. A system for comprehensive management of continuous ambulatory peritoneal dialysis (CAPD) for a patient, wherein the system includes the apparatus described in claim 1, the healthcare provider is remote from the apparatus for performing CAPD, and the communication module is configured to remotely communicate the treatment data to the healthcare provider.

14. The system according to claim 13, wherein the communication module is configured to enable the healthcare provider to remotely input prescription data into the programmable circuit.

15. The system according to claim 13, wherein the communication module is configured to communicate the treatment data to the healthcare provider in real time.

16. The system according to claim 14, wherein the communication module is configured to enable the healthcare provider to remotely input prescription data in real time using the programmable circuit.

17. A method for managing continuous ambulatory peritoneal dialysis (CAPD) in individuals requiring CAPD, Inputting prescription data using a programmable circuit, The programmable circuit generates interactive information and sequential instructions, wherein the interactive information and sequential instructions are for the execution of CAPD treatment according to the prescription data. The interactive information and the sequential commands are displayed in the user interface, To collect treatment data including at least one of the following: the date and time when the CAPD treatment is performed, the duration of flushing, filling and / or draining, the amount of dialysate solution used during flushing, filling and / or draining, and intraperitoneal static pressure (IPP), The communication module communicates the treatment data to the healthcare provider, Methods that include...

18. The method according to claim 17, wherein the step of collecting the treatment data includes weighing at least one dialysis fluid solution container with a weighing scale.

19. The method according to claim 18, wherein the weighing scale includes an analog load cell, and the method includes converting an analog signal emitted from the load cell into a digital signal.

20. The method according to claim 18, comprising using the specific gravity of the dialysate solution to convert the change in weight of the dialysate solution container into the volume of the dialysate solution.

21. The method according to claim 18, comprising converting the amount of change in the weight of the dialysate solution container over time into the flow rate of the dialysate solution.

22. The method according to claim 21, comprising converting the flow rate of the dialysate solution to the IPP.

23. The method according to claim 17, wherein the communication module is located remotely from the location where the CAPD treatment is performed and the treatment data is collected, and the method includes time / date stamping the treatment data.

24. The method according to claim 17, further comprising obtaining feedback from an individual undergoing CAPD treatment via the user interface that the CAPD treatment is being properly managed.

25. The method according to claim 17, comprising logging errors made by the individual requiring CAPD treatment, and generating an assessment of the individual's ability to successfully manage the treatment burden.

26. The method according to claim 17, comprising measuring the type and concentration of the dialysate solution by converting the chemical and physical properties of the dialysate solution into digital information using a photometric instrument and circuit in at least one flow control constrictor.

27. The method according to claim 26, further comprising measuring the change in properties of a plastic-type tube through which the dialysis fluid solution flows to confirm the properties of the material inside the tube.

28. The method according to claim 26, comprising confirming that the properties of the dialysate solution are consistent with feedback provided by the individual requiring CAPD treatment through the user interface.

29. The process involves aggregating the treatment data collected for multiple individuals who require CAPD, wherein the treatment data includes multiple parameters. To collect and aggregate the outcome data of the aforementioned individuals, By examining the aforementioned treatment data and outcome data, the similarly expected outcomes of CAPD treatment are modeled as a function of the aforementioned multiple parameters of the treatment data, The method according to claim 17, further comprising:

30. The method according to claim 29, comprising determining the PET status for each of the individuals who require CAPD, and evaluating the effectiveness of PET for the expected outcome of CAPD.

31. The method according to claim 29, comprising aggregating blood pressure data from a plurality of individuals who require the CAPD, and modeling the expected blood pressure as a function of the plurality of parameters.

32. The method according to claim 29, comprising seeking an optimized prescription for an individual requiring the aforementioned CAPD.

33. The method according to claim 29, comprising determining a dynamic specific intraperitoneal pressure (IPP) of an individual requiring CAPD, which may be used as a single measurement to prevent side effects or to evaluate the effectiveness of CAPD treatment outcomes.

34. The method according to claim 29, comprising evaluating a combination of measurements that, while not providing a meaningful interpretation on their own, can provide highly useful information when considered together and directly influence the response to such information.

35. The collection and availability of relevant data necessary to create prescriptions and assign specific devices to specific patients, To encourage supplementary information and to further describe the patient's condition and activities, and to provide additional data, To promote holistic medicine that focuses on aggregating data for multifactor analysis, The method according to claim 17, further comprising:

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