Medical Background
End Stage Renal Disease (ESRD) prevalence continues to grow, while the existing worldwide ESRD population already exceeds 2 million Patients. These Patients require a Renal Replacement Therapy, such as Hemodialysis or Peritoneal Dialysis, in the most favorable case until Kidney Transplantation. Hemodialysis and Peritoneal Dialysis have a big impact on the Quality of Life of these Patients due to frequent treatment sessions. In comparison to Hemodialysis, Peritoneal Dialysis is a preferred form of Renal Replacement Therapy, since treatments can be performed at Patients´ homes during daytime or nighttime with less impact on Patients' Quality of Life in-between sessions.
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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 set by nephrologists based on Patient physiological data and 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 based on the peritoneal membrane characteristics. By changing the prescription, necessary adaptations can be made to adjust and/or to increase the removal of toxins and extra fluid.
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Specifically for this field of application, the innovative DialEase™ APD Cycler System in combination with its novel DialEase™ Expert Prescription System from Debiotech is offering an entirely new approach to Home Peritoneal Dialysis Treatments.
Development Portfolio and System Approach
Debiotech’s portfolio includes the new DialEase™ APD Cycler, which is currently the smallest and most light-weight Cycler under development, and an innovative mathematical Software Program DialEase™ Expert. Both 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 better meets the needs of all stakeholders in day-to-day Peritoneal Dialysis practice. In focusing on Patient requirements, the Patient home environment, health care professional requirements, and the quality of Peritoneal Dialysis therapy, both system components are working together to ensure Patient Safety and Comfort, while improving Doctor’s and Nurse’s work. In addition, the DialEase™ Telecare Visio-conferencing system enables direct communication between Patient and Nurse at any moment in time through internet, WiFi, or a conventional telephone line.
The DialEase™ system used at Patient home, together with the DialEase™ Expert Software used at the hospital by the health care professionals, is the basis for a complete Home Dialysis Therapy and Control.
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The DialEase™ APD Cycler is today’s smallest and most discreet bedside dialysis equipment for home care use. It is virtually noiseless for Patient Comfort over night and can be carried in a small bag with a total weight of less than 5kg.
The DialEase™ APD Cycler is also equipped with the Automatic Alarm Resolution feature, which prevents inadvertent nuisance over night and helps completion of the Therapy in most circumstances.
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DialEase™ Data Transfer
Data transfer between DialEase™ Expert Software and DialEase™ APD Cycler is enabled by a DialEase™ USB Key. After insertion of the Key into the DialEase™ APD cycler, one or more different prescription regimes are made available to the Patient, including the choice of treatment regimes for different days and automatic adaptive treatments in case of dry weight and/or compliance changes.
Weight and Blood Pressure are automatically transferred into the DialEase™ APD Cycler via wireless communication, when requested.
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DialEase™ - User Interface
The DialEase™ User Interface consists of a graphical display with a touch screen function and includes visio guidance, large soft buttons in selectable colors, and numerical values. Only two additional hardware buttons are needed to operate the cycler, thus minimizing the number of programming steps. Patient is guided at all times through visio and audio guidance in the language of his choice. Dialysis fluid bag connections and Patient line connection are illustrated step by step, and explained on the display for easy operation.
As a result, the DialEase™ user interface is made extremely intuitive and helps resolving any issue at all times in a very simple and efficient way.
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DialEase™ - Disposable Cartridge
DialEase™ operates fluid pumping and flow path distribution through a unique and patented Disposable Cartridge. This cartridge is inserted into a cartridge holder, which opens and closes automatically. Automated self-test and priming procedures are performed to ensure simple, aseptic and efficient connection to the Patient.
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Fluid Warming System
A novel integrated fluid heating device allows the “inline” warming of the peritoneal dialysis fluid during each “Fill” phase. Incoming dialysis fluid with temperatures as low as 10°C can be warmed up to body temperature at any selectable “Fill” flow rate. Pre-warming procedures are not required, making DialEase™ immediately ready for use.
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DialEase™ Expert Software
The DialEase™ Expert Software brings new tools in the hands of the nephrologist, such as the Target Prescription and the Adaptive Prescription:
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With the Target Prescription tool, DialEase™ Expert visualizes a Patient related diagram reflecting related weekly treatment objectives and results (UF and clearance). Just select available fluid volume and night treatment duration for the required UF and clearance and the other treatment parameters will be automatically computed;
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With the Adaptive Prescription tool, DialEase™ Expert accounts for most conditions under which a Patient prescription should be adjusted at home, based on changes in Patient dry weight and/or treatment compliance. Just program up to 5 treatment alternatives into DialEase™ Expert and automatic prescription adjustments will be proposed to the Patient at home as appropriate, while automatic email will keep the nurse informed. As such, DialEase™ Expert simplifies Patient training and assists the patient in making appropriate treatment corrections, without the need for nurse intervention;
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With its established Breakpoint algorithm, DialEase™ Expert enables the optimum drainage at all times while improving dwell time efficiency;
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With its Patient USB Key, DialEase™ Expert enables an easy and safe exchange of Patient prescription and treatment history between Doctor and Patient;
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DialEase™ Expert - Membrane Characterization
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Starting point of Peritoneal Dialysis is the determination of each Patient’s peritoneal membrane characteristics based on its transport properties. The DialEase™ Expert Software Program supports any established standard test methods to calculate and/or validate each Patient’s membrane characteristics. It can further establish membrane characteristics from any available exchange profile, as long as dialysis fluid measurements and blood samples are available. A graphical user interface with several data entry protocols provides the health care professional fast and easy access to all useful information.
DialEase™ Expert further enables simulation of each treatment, based on such calculated Patient membrane characteristics, and further indicates the level of confidence of such simulation.
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