NEPHRON+ will provide a major leap forward in Renal Care. It aims at a next generation, integrated solution for personalized treatment and management of patients with chronic renal failure. It presents an ideal solution for continuous dialysis outside the hospital offering better blood clearance, while patients can stay mobile and active in social and economic life. It relies on an ICT-enabled wearable artificial kidney for on-body blood purification.
In order to achieve this major goal the project has identified the following objectives:
NEPHRON+ will optimise the renal treatment based on a closed-loop and context aware operations.
NEPHRON+ will develop major technological innovations in four key areas:
- In-vivo real-time sensing of more than 8 blood parameters
- Accurate wearable, wirelessly enabled hydration sensor
- Embedded software and remotely operating applications for multi-sensor data fusion and
- Embedded, energy optimised control of device ICT and non-ICT integrated components
The new components will be packaged, assembled and integrated into a complete solution, with adapted State-of-the-Art components which are:
- Latest and upcoming wireless connectivity
- Advanced nanofiltration technology
- Commercial wireless telemonitoring devices for periodic weight and blood pressure measurement
- NEPHRON+ solution oriented Electronic Health Record and Clinical application and workflows.
Policy Context
The project is funded by the European Commission's FP7-ICT-2009-4, ICT-2009.5.1: Personal Health Systems
The project partners are:
- EXODUS S.A. (Coordinator), Greece
- Centre Suisse d'Electronique et de Microtechnique S.A., Switzerland
- Nederlandse organisatie voor toegepast natuurwetenschappelijk onderzoek TNO, Netherlands
- Nierstichting Nederland, Netherlands
- IMST GmbH, Germany
- Nanodialysis BV, Netherlands
- Commissariat a l'Energie Atomique, France
- Universitaet fuer Weiterbildung Krems, KREMS, Austria
- Universitair Medisch Centrum Utrecht, Netherlands
- OFFIS E.V., Germany
Description of the way to implement the initiative
The work plan of NEPHRON+ has the following major phases:
Phase 1: System Design - An elaborated and complete system design will be developed based on user scenarios and on in-depth detailing of all medical and user requirements. It requires input from all expected users (incl. patients, clinicians) and from experts, resulting in a detailed requirements report and complete system design (WP2, WP3)
Phase 2: System engineering - Parallel development activities of all hardware and software parts will be performed within a system engineering approach. (WP 4, 5, 6 and 7)
Phase 3: System integration and prototyping (WP8).
Phase 4: Validation phase covering in-vitro and in-vivo tests (WP9)
With this approach and in order to accomplish its goals, the project is further decomposed into ten (10) manageable Work Packages (WPs).
In order to accomplish its goals, the project is decomposed into ten (10) manageable Work Packages (WPs).
WP1 | Project Management and Quality Assurance |
WP2 | Medical and User Requirements |
WP3 | Complete system design |
WP4 | Development of sensors |
WP5 | Development of Wireless Connectivity |
WP6 | Development of Embedded Software |
WP7 | Development of Renal Care Applications |
WP8 | Integration and Prototyping |
WP9 | Verification and Validation |
WP10 | Exploitation & Dissemination |
Technology solution
The overall NEPHRON+ solution will incorporate:
A. Wearable Artificial Kidney Device (WAKD) for real-time treatment and accurate monitoring and purification of blood, enabled by a smart configuration of available and newly developed ICT components.
B. Wearable on-body sensors to measure essential physiological body parameters to be combined with the blood sensor data
C. Patient's Personal Renal Care Application for his/her personal handheld device (e.g. PDA or Smartphone). It provides appropriate interfaces for (i) Patients interaction for information, management and maintenance of the device and the treatment execution, including alarms, malfunctions, emergency situations (ii) Remote reconfiguration of the treatment by clinicians.
D. Remote Back-End Renal Care Applications for the clinic, collecting and analysing data from registered patients, supporting clinical workflows.
E. NEPHRON+ integrated system and components will be verified and validated in a series of test sessions, ranging from in-vitro to in-vivo on animals and a small group of (approx. 8) patients in between their regular dialysis treatment. The whole process will follow a very detailed and concentrated methodology, ensuring no-risk for patient health.
F. NEPHRON+ imposes and will document a medical paradigm shift which involves the necessary restructuring and modification of existing medical workflows.
Technology choice: Proprietary technologyMain results, benefits and impacts
EPHRON+ Expected Impact | How |
Reduced hospitalisation and improved disease management and treatment at the point of need, through more precise assessment of health status. | The wearable artificial kidney monitors continuously more than 10 chemical and physiological parameters, and adjusts itself to the personal needs. |
Economic benefits for health systems without compromising quality of care. | Cost savings in medical care are expected to €15.000-20.000/patient/year. With 340.000 patients in Europe this implies an annual saving of €5-7 billion. Demand on medical care (doctors, nurses) will drop dramatically with a factor 3. |
Facilitating the development of prospective aspects of ICT-enabled prevention of diseases | The new ICT-platform monitors patients (renal and others) continuously on 10 chemical and physiological parameters, is a strong new tool for the medical society |
Leadership Europe's eHealth | NEPHRON+ would be worldwide the first ICT-platform for remote multiparametric monitoring of patients with chronic renal disease |
Market opportunity | The market potential of the NEPHRON+ system amounts to €15 billion/year worldwide and €5 billion/year for Europe |
Saving lives and Improving life condition | Life expectancy or renal patients is expected to increase with 10 years (age 45-64) to 16 years (age 20-44). The wearable kidney brings renal patients back into a normal social and working life, becoming productive again in the economic world. |
Track record of sharing
NEPHRON+ advances State-Of-The-Art as far as it concerns:
A. Socio-Medical aspects and technology of the treatment of the end-stage renal disease (ESRD) patients
B. Technological components and multiple disciplines necessary to compose the integrated solution.
A. Socio-Medical aspects - Advances by NEPHRON+
- Next generation, continuous, multi-parametric, self monitoring and self alarming, continuous monitoring and treatment outside the hospital, at the point of need.
- NEPHRON+ Clinical Practice: renal patients treat themselves with a small, wearable kidney device, eliminating the need for personnel and costly infrastructure.
- Continuous treatment (24h/d, 7d/week) rather than intermittent treatment (3h/d, 3d/week).
- Filtration and adsorption are used to replace kidney function instead of dialysis. Conventional treatment requires many liters of dialysis fluid per session, which implies that the patient cannot be mobile during treatment. Our novel approach thus liberates the patient.
- Miniaturization of all components so that the device is readily wearable
B. Technological components
- Electrochemical sensors with bio-selective nanostructured coatings to detect potassium (K+), urea, phosphate, overall salt and pH.
- Sensors will be integrated on a collective electrochemical sensing platform controlled by an electronic board.
- Ultra low power Wireless Body Sensor Network (WBSN) using an Ultra Low Power (ULP) wireless technology with special protocol stack on upper layers for a secure and transparent data communication.
- Information Fusion addressing energy efficiency.
- Progressively degrading Storage model.
- The NEPHRON+ WAKD Real-Time Operating System
- Next generation renal applications
- New and improved Renal Care Practice
Lessons learnt
This field will be completed by the submitter when the lessons learnt have been identified and understood.
Scope: Pan-European