Licensed worldwide, except Japan, to

New APD Cycler System with optimized Prescription is Debiotech’s novel and innovative Approach to offer more Quality for Patients and Nephrologists in Peritoneal Dialysis

Medical Background

In several medical publications it is forecasted, when current trends in End Stage Renal Disease (ESRD) prevalence continue, that the ESRD population will exceed 2 million patients by the year 2010. These patients require a Renal Replacement Therapy, such as Hemodialysis or Peritoneal Dialysis, or a Kidney Transplantation. Hemodialysis and Peritoneal Dialysis have a big impact on the quality of life of these patients due to periodical treatment sessions. Peritoneal Dialysis in comparison to Hemodialysis is a preferred form of Renal Replacement Therapy, while treatments can be performed at patients´ homes during daytime or night time.

Peritoneal Dialysis

Principle of Peritoneal Dialysis

In Peritoneal Dialysis, a catheter is used to fill the abdomen with dialysis fluid. The walls of the abdominal cavity are lined with the peritoneum, which allows waste products (toxins) and extra fluid (ultra-filtrate) to pass from the blood into the dialysis fluid. Dialysis fluid contains osmotic agents, such as glucose, to drive the transport for this extra fluid and the toxins into the abdominal cavity, which are finally, after a specific waiting time (dwell time), drained from the body as “used” dialysis fluid via the catheter. Filling and draining of dialysis fluid, also named cycles and/or exchanges to and from the patient, can be performed purely manually by gravity or fully automated with a medical device, named APD (Automated Peritoneal Dialysis) Cycler.

Peritoneal Dialysis Prescriptions are made by nephrologists based on patient physiological data and the individual patient membrane (peritoneum) characteristics. A prescription contains a defined number of exchanges, the fill volume for each cycle, the dwell time and the pharmaceutical formulation of the dialysis fluid. To verify the adequate amount or dose of dialysis, several tests are required at the beginning and during Peritoneal Dialysis. From an analysis of the “used” dialysis fluid and from patient’s urine and blood samples, the urea clearance value, called Kt/V, and a creatinine clearance rate, normalized to the body surface area, allow the health care professionals to evaluate the achieved quality of Dialysis. By changing the prescription, necessary adaptations can be made to adjust and/or to increase the removal of toxins and extra fluid.

Renal Exprés - APD Cycler

For this described field of application, the innovative APD Cycler System in combination with optimized Prescriptions from Debiotech is a novel approach in Peritoneal Dialysis Treatments.

Development Portfolio and System Approach

Debiotech’s development portfolio includes the new APD Cycler, which is currently the smallest and most light-weight Cycler under development, named Renal Exprés, and an innovative mathematical Software Program for PC’s, named Renal Manager. Both development products should be seen as an integrated medical device system to offer improved efficiency for therapy and improved quality of life for the patients. This new system covers the user needs for all participants in the day-to-day Peritoneal Dialysis practise. In focussing on patient requirements, patient home environment, health care professional requirements, and quality of Peritoneal Dialysis therapy, both system components are working together in meeting the patient requirements such as instrument size and weight, “ease of use”, and reliability. The health care professional requirements are addressed by improvements for Dialysis Adequacy, Dialysis Compliance and Renal Patient Management.

The following diagram illustrates this integrated medical device system, where the Renal Exprés Cycler is used at the patient’s home and the Renal Manager Software is used at the hospital by the health care professionals. Based on physiological Patient Data, patient Peritoneal Membrane Transport Characteristics (Patient Test Data), previous Treatment Results, and a Prescription from the nephrologists, Renal Manager Software calculates and returns as a first step a predicted treatment outcome. This predicted treatment outcome can be rated by the health care professionals and modified by prescription parameters, where the treatment outcome can be improved step-by-step with the “Simulation Tool”. As a second step, an improved treatment outcome can be computed by using the “Optimization Tool”, which returns a modified, Optimized Prescription, calculated on available input data and set-ups, defined by the software user. Based on the nephrologists’ final decision, this prescription(s) can be transferred to the Renal Exprés Cycler, where the cycler performs the Treatment at the patient’s home. Finally the Treatment Results are transferred back to Renal Manager Software to close the loop for this integrated medical device system.

System Approach for integrated Medical Device System

Renal Exprès APD Cycler – Description

Data Transfer
As illustrated above, the data transfer between Renal Manager Software and Renal Exprés APD Cycler ensures the interaction between both systems. For the data transfer, various technical solutions are selectable, including Patient Data Cards and modem based data transfer. After receipt of those data, Renal Exprés displays one or more different prescription regimes and allows the patient to identify them, including the choice of treatment regimes for different days of the week for the patient’s comfort.

Renal Exprés - User Interface

User Interface
The Renal Exprés User Interface consists of a graphical display with a touch screen function, capable of displaying graphics, large soft buttons in selectable colours, and numerical values. Only two additional hardware buttons are integrated and required to operate the cycler, thus minimizing the number of programming steps. Simple, but efficient technical solutions are implemented to make this user interface attractive also for non-computer literate users. The user interface is supported by an integrated audible Voice Guidance with selectable languages.

Renal Exprés - Disposable Cartridge

Disposable Cartridge
Renal Exprés operates the fluid pumping, fluid warming, and flow path distribution with a Disposable Cartridge. This cartridge is inserted into a loader, which opens and closes automatically, supported by graphics on the display with simple explanations for all steps of operation. Automated self-test procedures are performed to verify functional, safety, and reliability test results, before and during the cartridge priming process. Dialysis fluid bags connections and patient line connection are step by step illustrated and explained on the display for easy operation.

Fluid Warming System
A novel integrated fluid heating device allows the “online” warming of the peritoneal dialysis fluid during each “Fill” phase. Incoming dialysis fluid with temperatures as low as 10°C can be warmed up at any selectable “Fill” flow rate. Pre-warming procedures are not required.

Renal Exprés - Disposable Cartridge

Air and Drain Management
An air management system prevents air infusion into the patient’s peritoneal cavity by an air detection system and an air rejection or air removal feature. Intelligent “Drain” management algorithms in conjunction with fluid pressure controls allow safe and time efficient cycle management.

Renal Manager Software - Description

The current Renal Manager Software consists of several functional elements. Starting from an integrated data base, holding all patient data, a first element allows the nephrologists to individually characterize the natural dialysis membrane function for each of his patients (Peritoneal Membrane Transport Characteristics).

In a second step, a prescribed treatment regime or prescription can be used to simulate “online” an expected treatment outcome. Various prescription parameters can be modified and applied to predict improved treatment results.

Finally, based on a mathematical iteration program, optimized treatment or prescription parameters can be computed and the computed treatment results can afterwards be compared to the actually obtained treatment results.

Renal Manager - Membrane Transport
Characteristics Diagram

Peritoneal Membrane Transport Characteristics
Starting point of Peritoneal Dialysis is the determination of transport characteristics of each patient’s peritoneal membrane. The Renal Manager Software Program supports several established standard test methods to calculate and/or validate each patient’s membrane characteristics. The required individual data collection for these tests from “used” dialysis fluid and urine and blood samples, in conjunction with pre-defined test regimes, is part of the Renal Manager Software. A graphical user interface with several data entry protocols provides the health care professional fast and easy with the calculated transport characteristics result diagram as shown.

Renal Manager - Prescription Entry Protocol

Prescription Entry Protocol
A numerical data entry protocol for prescriptions allows the definition of all treatment regimes applicable to PD patients, including CAPD, CCPD, Tidal etc. A graphical image from the prescribed treatment is presented to allow easy verification of all treatment parameters by the health care professionals.

Renal Manager – Comparison Diagram
of simulated Treatment Results

Simulation Tool
Starting with the peritoneal membrane transport characteristics and other physiological patient data, one or more prescriptions can be made by the health care professionals. Based on iterative numerical techniques, the mathematical model in the Computer Simulation Tool will compute and predict the kinetics of each individual fluid exchange as defined in the prescription. Furthermore, a prescription modification tool allows the “online” result simulation and graphical images are displayed to compare the results of the treatment outcome between the initial, unchanged prescription regime and “manually” modified prescription regime.

Renal Manager – Comparison Diagram
of simulated and optimized
Treatment Results

Optimization Tool
Finally, Renal Manager Software allows with the Optimization Tool an optimized computation for each individual prescription parameter, based on available data and controlled activated data setups, chosen by the software user. The aim of this optimization is to increase the efficiency of the medical therapy by direct use of mathematical optimization, applying specific patient dedicated treatment regimens based on the patient’s own specific characteristics. As a result, Renal Manager Software calculates and returns a suggested prescription, which may be different from the initial prescription, with novel fluid exchange recommendations, including dynamic exchange profiles with variable dwell times, “Fill” fluid volumes, and number of cycles.

Glucose Modelling
A glucose optimization tool will allow to propose specific glucose concentrations for each cycle to prescribe a suitable balance between water removal and glucose absorption. A practical solution will be to mix the proposed glucose concentrations from available Peritoneal Dialysis fluid bags.