Monitoring system for at least one peritoneal dialysis device.

Abstract

The invention relates to a monitoring system (1) for at least one peritoneal dialysis device (pd1), wherein the monitoring system (1) obtains data from a peritoneal dialysis device (pd1) via a first data transmission network (net1), wherein the data is selected from a data group that includes equipment data, error codes, operational data, environmental data, consumables data, network data, treatment history data, wherein the data obtained in relation to a respective peritoneal dialysis device (pd1) is stored, and at least some of the stored data relating to the equipment is evaluated, and based on the evaluation, an action is selected and executed to notify a patient (p), notify a medical professional (fp), notify maintenance personnel (sp),notify a quality officer (qb) via a second data transmission network (net2).

Description

"MONITORING SYSTEM FOR AT LEAST ONE PERITONEAL DIALYSIS DEVICE" Background

[0001] The invention relates to a monitoring system for at least one peritoneal dialysis device. Many people suffer from kidney failure, either chronic or acute. In fact, there is, in principle, the possibility of a kidney transplant; however, the availability of suitable organs is limited, and not all patients are eligible for a transplant. Therefore, in the past, methods of filtering the blood, called dialysis, were developed. Dialysis as a procedure is characterized by the fact that, through a membrane, an exchange of substances is carried out. In this case, the fluid to be filtered is on one side of the membrane, and a suitable dialysis solution is on the other side.

[0002] Several procedures have been established in the past. Hemodialysis, for example, involves the extraction of urea, uric acid, and other substances from the blood under the influence of osmotic pressure through a semipermeable membrane. Other procedures include hemoperfusion, hemodiafiltration, and hemofiltration.

[0003] In addition, in the past, the peritoneal dialysis method was developed. Peritoneal dialysis (PD) is also known as peritoneal dialysis. The term also includes different methods, such as, for example, manual CAPD (continuously ambulatory peritoneal dialysis) procedures or the Petition 870190107056, dated 10 / 22 / 2019, page 18 / 40 2 / 17 processes of the CCPD performed with equipment (continuous cyclic PD), IPD (intermittent PD), NIPD (intermittent nocturnal PD), etc., collectively referred to as peritoneal dialysis.

[0004] These procedures are based on the fact that the peritoneum is a membrane that lines the abdominal cavity and is well supplied with blood.

[0005] Due to its special structure, the peritoneum can also be used as a filtering membrane. Generally, patients receive a tube (catheter) in the abdominal cavity. A dialysis solution is fed into the abdomen through this catheter and left in place for a certain period of time. Now, small molecular substances can pass from the blood through the capillaries of the peritoneum into the dialysis solution, since there is a concentration gradient. The dialysis solution must be drained after a certain time and replaced with a new one.

[0006] Compared to an artificial membrane, in blood dialysis, the peritoneum is also quite permeable to proteins, resulting in a significant loss of proteins.

[0007] Peritoneal dialysis, however, proves advantageous in many respects. Compared to other dialysis procedures, peritoneal dialysis allows for longer maintenance of any remaining renal function. Furthermore, fewer complications are reported with peritoneal dialysis, as the circulation is less burdened. This is a major advantage, especially for patients with heart problems. Essentially, peritoneal dialysis can also be used by patients in Petition 870190107056, dated 10 / 22 / 2019, page 19 / 40 3 / 17 at home, while hemodialysis is only available in specially equipped medical centers / offices / clinics.

[0008] Despite these advantages, the prevalence of peritoneal dialysis is low. This is due, among other reasons, to the fact that it is not possible to reliably guarantee the correct operation of the corresponding devices. This is because the peritoneal dialysis device is also subject to wear and tear, which depends, among other things, on its use. Objective

[0009] Therefore, the objective of the invention is to provide a monitoring system for peritoneal dialysis devices, which will offer a high level of safety for patients. Brief description of the invention

[0010] This objective is solved by a monitoring system for at least one peritoneal dialysis device, wherein the monitoring system of a peritoneal dialysis device to be monitored obtains data through a first data transmission network, wherein the data is selected from a group that presents device data, error codes, operational data, environmental data, consumables data, network data, treatment history data, wherein the data obtained in relation to a respective peritoneal dialysis device is stored, and at least some of the stored data related to the devices are evaluated, and based on the evaluation, a notification action is selected and executed. Petition 870190107056, dated 10 / 22 / 2019, page 20 / 40 4 / 17 a patient, notify a medical professional, notify the maintenance team, notify a quality officer via a second data transmission network.

[0011] Other advantageous embodiments are the subject of the dependent claims, the Figures and the full description. Brief description of the figures

[0012] The invention is further explained in detail below based on the Figures. These show:

[0013] Figure 1 is a schematic top view of a monitoring system and peritoneal dialysis device according to embodiments of the invention,

[0014] Figure 2 is a schematic top view of components of a peritoneal dialysis device, according to embodiments of the invention, and

[0015] Figure 3 is a schematic top view of components of a monitoring system, according to embodiments of the invention. Detailed description

[0016] The invention is represented below based on the Figures. In this case, it should be noted that different aspects are described that can be used individually or in combination, respectively. That is, each aspect can be used with different embodiments of the invention, unless explicitly stated as a pure alternative.

[0017] Furthermore, for the sake of simplicity, only one entity is taken as a reference hereafter. Except where not explicitly stated, the invention may also, however, present respectively Petition 870190107056, dated 10 / 22 / 2019, p. 21 / 40 5 / 17 several of the entities mentioned. In this sense, the use of the terms "a," "an," and "of one" only as an indication should be understood to mean that, in a simple modality, at least one identity is used.

[0018] A monitoring system according to invention 1 is represented, in its context, in Figure 1. The monitoring system 1 is suitable for monitoring at least one PD1 peritoneal dialysis device, but generally a variety of PD1 - PDn peritoneal dialysis devices.

[0019] An exemplary peritoneal dialysis device PD1 is shown in Figure 2. The peritoneal dialysis device PD1 has, for example, one or more sensors S, one or more actuators A, at least one CPU for processing sensor data and / or for controlling the actuators A, as well as at least one communication unit IO, which is configured for transmission on the respective first data transmission network NET1.

[0020] Monitoring system 1 obtains data from at least one PD1 peritoneal dialysis device to be monitored or from a selection or from all PD1 peritoneal dialysis devices - PDn, through a first data transmission network NET1.

[0021] The NET1 data transmission network can be any wired or wireless data transmission network connection. Furthermore, the choice of transmission protocol depends on the respective implementation. Additionally, the term "data transmission network" should not be considered limiting; different networks can be envisioned. Petition 870190107056, dated 10 / 22 / 2019, page 22 / 40 6 / 17 data transmission for different data or also redundant data transmission networks. In addition, the mechanism for making data available may include active sending by a user input on the PD1 peritoneal dialysis device, and / or periodic or event-related data sending through the PD1 peritoneal dialysis device and / or data retrieval through the monitoring system 1 (periodic, non-periodic, on demand).

[0022] The data, which are made available by the PD1 peritoneal dialysis device or retrieved by it, are retrieved by the monitoring system 1, and are selected from a group that includes device data, error codes, operational data, environmental data, consumables data, network data, and treatment history data.

[0023] An exemplary monitoring system 1 is represented in Figure 3. The monitoring system 1 has, for example, at least one CPU for data processing and / or a database DB or other local or remote data storage, as well as at least one first logical communication unit 101, which is configured for transmission to the respective first data transmission network NET1, and a second logical communication unit I02, which is configured for transmission on the respective second data transmission network NET2.

[0024] It should be noted that the first data transmission network NET1 and the second data transmission network NET2 are represented separately as logical networks of Petition 870190107056, dated 10 / 22 / 2019, page 23 / 40 7 / 17 data transmission. However, it is not a mandatory requirement that the data transmission networks be different. On the contrary, the first data transmission network NET1 and the second data transmission network NET2 can be a component of a data network.

[0025] In monitoring system 1, the data obtained by the peritoneal dialysis device PD1 relating to a respective peritoneal dialysis device PD1 are stored, for example, in a local or remote database DB or a local or remote data memory.

[0026] In monitoring system 1, at least some of the stored data relating to the device can be evaluated, and based on the evaluation, an action is selected and executed to notify a patient P, notify a medical professional FP, notify maintenance personnel (SP), notify a quality employee QB through a second data transmission network NET2.

[0027] For example, this could be implemented in such a way that the PD1 peritoneal dialysis machine makes available, via email / SMS or similar services, the data related to the machine and maintenance, in monitoring system 1. Monitoring system 1 extracts numerical values ​​from the transmitted data. In monitoring system 1, an evaluation takes place considering cases of error, wear, as well as a classification of the results considering the difficulties of the error and the level of wear.

[0028] For example, an error code is assigned to errors. Petition 870190107056, dated 10 / 22 / 2019, page 24 / 40 8 / 17

[0029] Depending on the error code, a corresponding user group is assigned. That is, for each error code there is a clear assignment to one or more user groups.

[0030] For example, in the case of an error requiring the use of a service technician, the detected error and the specification of the defective peritoneal dialysis machine PD1 are forwarded to the maintenance personnel SP.

[0031] An error case indicating a lack of operator training is directed, for example, to a QB quality employee. This could be, for example, a special application consultant or a healthcare specialist, such as a doctor or nurse.

[0032] For example, data from the respective peritoneal dialysis machine PD1 can be sent to a central address / postal code, which is assigned to monitoring system 1. Monitoring system 1 then separates the data obtained, for example, by sender (corresponding to the peritoneal dialysis machine). Thus, the data corresponding to monitoring system 1 are stored in relation to a specific device.

[0033] A WWW server, for example, can be included in monitoring system 1. On the one hand, it can process and represent (highlighted in colors and / or classified) the data in a way that is specific to the device and, on the other hand, also upon request, perform certain data analyses (related to the device).

[0034] In other words, in addition to active notification, the possibility is also made available that certain groups of users (related to the device) can Petition 870190107056, dated 10 / 22 / 2019, page 25 / 40 9 / 17 initiate data analysis and retrieve results. The results can be made available on the web server or, alternatively, sent via email / SMS to an address provided by the respective user to the respective recipient, for example, patient P, a doctor and / or caregivers FP, a maintenance professional SP, a quality officer QB, and others.

[0035] It should be noted that the analysis and notification functions can be designed in a configurable way.

[0036] For example, serious errors may trigger the immediate request for a maintenance professional SP. Other errors indicating signs of wear may be forwarded, along with corresponding data and / or assessments, to the maintenance professional SP. For example, it can be determined, based on the pressure flow of a membrane pump (recorded by a sensor S), whether overpressure or underpressure buildup occurs at corresponding intervals or speeds. Furthermore, it can be recognized, for example, from the pressure flow, whether the pressure is stable. From other and / or additional data, it can be recognized whether the valves close / open safely. Additionally, a startup test may show that certain elements of the peritoneal dialysis machine have reached their limits. Furthermore, monitoring of sensor zero points, linearity of length sensors, etc., can be recognized.Based on the number of degassing cycles, a conclusion can be drawn about the tightness of the hydraulic elements. Furthermore, the overall recorded flow can be monitored, for example. Petition 870190107056, dated 10 / 22 / 2019, page 26 / 40 10 / 17 If the recorded flow is comparatively high, then this signifies high internal friction, for example, loss of lubricant, corrosion, etc. Furthermore, the overall speed of individual components can be recorded. From this, conclusions about internal friction can also be drawn. Additionally, heating energy can also be detected. If this increases, it is an indication, for example, of a failure in the heating system. Other data, such as barcode fault recognition within a short period of time, also provide conclusions about an error in the optical properties of a subsystem of the peritoneal dialysis machine's barcode reader. Other parameters, such as the data memory used in the peritoneal dialysis machine or electrical batteries, can also provide status data.

[0037] In other words, through monitoring system 1 it is possible to determine, by means of data evaluation, the wear data. Particularly, in a PD1 peritoneal dialysis device to be monitored, which has a membrane pump, it is possible, for example, by evaluating similarities in pressure and / or flow profiles, i.e., loss data, to determine wear data.

[0038] In one embodiment, the wear of the pump unit is determined based on a pressure / flow profile of a diaphragm pump in the PD machine, the wear level is determined depending on the changes in the determined pressure / flow profile.

[0039] Although, in the description given so far, the peritoneal dialysis machine has come first Petition 870190107056, dated 10 / 22 / 2019, page 27 / 40 11 / 17 plan, the monitoring system 1 also allows the recognition of batch dispersion in disposable articles. Thus, for example, from the evaluation of air detections, it is possible to trace an indication of leaks in the different connectors in relation to patient P.

[0040] In a very simple way, it is also possible to provide other sensors in the peritoneal dialysis machine to recognize, for example, unfavorable environmental conditions. Thus, for example, the ambient temperature can be inferred to determine, for example, whether the heating power is actually sufficient. In addition, the air pressure can be determined to judge, for example, the performance capacity of a compressor. Air humidity can also be determined to recognize, in the short term, for example, damage to the electronic components, corrosion due to condensed air humidity. Furthermore, it is possible to monitor the electrical network that supplies power to the peritoneal dialysis machine.

[0041] Other serious errors, in turn, indicate incorrect training in the handling of the peritoneal dialysis machine. Possible catheter problems can be determined by the number of executions of the Wake Up functionality and / or by determining the increase in a volume / time diagram. In addition, any reductions in the prescribed inflow volume, which are an indication of non-compliance, can be determined. Furthermore, the switching points between an inlet and outlet connection can be evaluated through a large number Petition 870190107056, dated 10 / 22 / 2019, page 28 / 40 12 / 17 entries. Again, this may be an indication of non-compliance. Furthermore, from general monitoring, it can be tracked whether treatment occurs. From the number of error message displays, it is possible to conclude that there is a failure in training for handling the peritoneal dialysis machine. Also, the time intervals between the availability of a treatment and the actual start of the treatment may be an indication of training failure, as a very long interval can cause bacterial contamination. In this case, a QB quality manager can be informed, and a new training session for patient P can be initiated.

[0042] The corresponding drive mechanisms can be configured in the monitoring system 1. For example, the drive parameters can be specified. In addition, it is possible to configure the people to be contacted or the contact flow. In this case, certain people and / or equipment can also be grouped, so that, for example, the same parameters are always associated with certain patients or certain equipment.

[0043] In a very simple way, however, the profile of the data to be transmitted by the monitoring system 1 on the corresponding peritoneal dialysis machine can also be configured.

[0044] Based on the equipment data, the server creates a specific device assessment, which extracts and displays the equipment's technical data and therapeutic data. operating hours Petition 870190107056, dated 10 / 22 / 2019, pp. 29 / 40 13 / 17 continuous data, equipment failures with error statistics, procedural parameters, such as pump parameters, initial test measurement results, sensor values, ... The history of the displayed screen, the total volume of input and output, the total downtime, the reduction in input, the reduction in downtime, the UF (state abbreviation).

[0045] Analysis rules are integrated into the server and allow it to examine equipment data for specific results or patterns. The following data can be used. Environmental conditions, repair status {wear data, operating hours, technical service, replaced components, equipment code, device failure}

[0046] Several conclusions regarding the device can be drawn from this analysis. • Repair recommendations and technical visits • Adjustment of device recording behavior • In-depth conclusions regarding batch dispersion of disposable items • Detection of component failure trends in devices. • Adjusting treatment or patient care Petition 870190107056, dated 10 / 22 / 2019, pages 30 / 40 14 / 17 • Device usage behavior

[0047] In the DB database or in memory, the data obtained is preferably stored linked to a time.

[0048] If frequent errors occur within a predetermined time interval, then additional data from the respective peritoneal dialysis machine can be requested via monitoring system 1, allowing for a more advanced analysis.

[0049] Based on the frequency within a given time (error rate) it is possible to estimate, for example, whether an error is serious or how urgently the device failure needs to be repaired.

[0050] If rare errors occur within a predetermined time interval, then, through monitoring system 1, less data can be requested from the respective peritoneal dialysis machine, allowing for a satisfactory analysis.

[0051] Monitoring system 1 filters, from specific single or multiple machine data and continuous run data, data obtained from the peritoneal dialysis machine and stores the same.

[0052] The specific machine data includes: a unique equipment number, a unique number for the peritoneal dialysis machine hardware, a unique identifier for the currently installed software version, the country to which the peritoneal dialysis machine was supplied, the language in which the peritoneal dialysis machine was supplied, as well as the production date and the date of the last service entry by a technician who performed repairs on the peritoneal dialysis machine.

[0053] Continuous data contains the operating hours of Petition 870190107056, dated 10 / 22 / 2019, pp. 31 / 40 15 / 17 peritoneal dialysis machine since delivery, operating hours of the peritoneal dialysis machine since the last technical service performed on it, as well as the number of valve, motor and heater switching procedures since the delivery of the peritoneal dialysis machine.

[0054] Additionally, the number of treatments can be determined from all the data available for the monitoring system 1.

[0055] Specific machine data is extracted to analyze, among other things, whether there are certain fault patterns connected to the software used or the hardware version of the peritoneal dialysis machine. Conversely, it is possible, for example, upon learning of production errors, to identify all peritoneal dialysis machines related to a specific software version or hardware version and send an automatic message to the technician to repair these peritoneal dialysis machines.

[0056] The number of operating hours in connection with the switching operations of electromechanical components and certain failure schemes are analyzed to monitor the wear of mechanical / electrical components and eventually inform the SP team about the imminent replacement of these parts. In addition, a reminder about the next maintenance schedule is sent to the maintenance team based on operating hours.

[0057] Long-term monitoring of continuous data allows, among other activities, the analysis and evaluation of the behavior, wear and tear, and robustness of Petition 870190107056, dated 10 / 22 / 2019, pp. 32 / 40 16 / 17 hydraulic and pneumatic systems of the peritoneal dialysis machine.

[0058] In this way, product improvements can be initiated in advance.

[0059] Data from the requesting country and the language of the peritoneal dialysis machine are extracted to draw conclusions about specific problems in each country, for example, extreme weather conditions (temperature, humidity) or special handling.

[0060] Insofar as a wireless or wired NET1 or NET2 data transmission network is referenced, it is evident to those skilled in the art that here it may mean, in particular, a local area network up to the global Internet network, and any suitable means are understood, such as, for example, wired, fiber or mobile communications (Bluetooth, ZigBee, WLAN, GSM, UMTS, LTE, LTE-A, and subsequent technologies).

[0061] Separation into two (virtual) networks is seen as advantageous, since, by means of this, direct access to the peritoneal dialysis machine can be avoided, as well as access to the peritoneal dialysis machine data, which is stored in the monitoring system 1. As a result, unauthorized access can be prevented.

[0062] Thus, it can be easily foreseen, in one embodiment of the invention, that a particular evaluation may be requested by a user P, SP, QM, FP.

[0063] As previously described, at least some of the saved data and assessments relating to the stored data can be retrieved using a web browser. Petition 870190107056, dated 10 / 22 / 2019, pp. 33 / 40 17 / 17

[0064] In particular, it is advantageous when using unencrypted means of communication, if the PD1 peritoneal dialysis device data is transmitted encrypted.

[0065] In one embodiment of the invention, notifications are sent via a messaging service. That is, the system can be installed on existing communication infrastructures.

[0066] Although the invention has been represented above in relation to the PD1 peritoneal dialysis device, the invention is not limited to it. On the contrary, the monitoring system 1 monitors a plurality of peritoneal dialysis devices (PD1, PD2, ... PDN) - as shown in Figure 1.

Claims

1. Monitoring system (1) for at least one peritoneal dialysis device (PD1), the monitoring system (1) receiving data from a peritoneal dialysis device (PD1) to be monitored through a first data transmission network (NET1), the data obtained being stored in relation to a respective peritoneal dialysis device (PD1), the stored data related to the devices being evaluated, and based on the evaluation a notification action being selected and executed through a second data transmission network (NET2), characterized by the data being selected from a group that presents device data, error codes, operational data, environmental data, consumables data, network data, treatment history data, the notification action comprising notifying a patient (P), notifying a medical professional (FP), notifying maintenance staff (SP), notifying a quality officer (QB),The peritoneal dialysis device (PD1) to be monitored has a membrane pump, and by evaluating changes in pressure or flow profiles, membrane pump wear data is determined.

2. Monitoring system (1), according to claim 1, characterized in that the first data transmission network (NET1) is a wireless or wired data transmission network.

3. Monitoring system (1), according to claim 1 or 2, characterized in that the second data transmission network (NET2) is a wireless or wired data transmission network. Petition 870260049440, dated 05 / 25 / 2026, page 11 / 16 2 / 3 4. Monitoring system (1), according to any of the preceding claims, characterized in that the evaluation can be requested by a user.

5. Monitoring system (1), according to any of the preceding claims, characterized in that at least one of the saved data and evaluations relating to the stored data can be retrieved by means of a web browser.

6. Monitoring system (1), according to any of the preceding claims, characterized in that the data from the peritoneal dialysis device (PD1) are transmitted encrypted.

7. Monitoring system (1), according to any of the preceding claims, characterized in that notifications are sent via a messaging service.

8. Monitoring system (1), according to any of the preceding claims, characterized in that wear data can be determined by evaluating changes in pressure profiles.

9. Monitoring system (1), according to any of the preceding claims, characterized by monitoring a plurality of peritoneal dialysis devices (PD1, PD2, ... PDN).

10. Monitoring system (1), according to any of the preceding claims, characterized in that the recording behavior of a peritoneal dialysis device (PD1) from a plurality of peritoneal dialysis devices (PD1, PD2, ... PDN) is adjusted as a response in a comparison to the current error rate Petition 870260049440, dated 05 / 25 / 2026, page 12 / 16 3 / 3 with a reference error rate.

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