Nephron+ - ICT-enabled Wearable Artificial Kidney and Personal Renal Care System

Acronym of the case:

Nephron+

Web address of the case:

http://www.nephronplus.eu

Country of the case:

EU Institutions

Posting Date:

15 December 2011

Last Edited Date:

02 January 2012

Author:

Costas Kotsokalis (Exodus S.A.)

chronic renal failure | ICT-enabled | artificial kidney

Type of initiative

Project or service

Case Abstract

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.

Description of the case

Domain

eHealth

Topic

Sector

Healthcare

Date

April 2010 to March 2014

Date operational

April 2010

Target Users

Add Patients | Health professionals

Scope

Pan-European

Status

Operation

Language(s)

English

Policy Context and Legal Framework

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

Project Size and Implementation

Type of initiative

IT infrastructures and products

Overall Implementation approach

Partnerships between administration and/or private sector and/or non-profit sector

Technology choice

Proprietary technology

Funding source

Public funding EU

Project size

Implementation: €5,000,000-10,000,000

Implementation and Management Approach

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.

Impact, innovation and results

Impact

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 â‚¬15.000-20.000/patient/year. With 340.000 patients in Europe this implies an annual saving of â‚¬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 â‚¬15 billion/year worldwide and â‚¬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.

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