E!9525 A novel and versatile ultrasound diaphragm monitor to diagnose and treat respiratory disorders

The DiaMon (Diaphragm Monitoring) innovation project aims to develop a new ultrasound based medical device for monitoring and treatment of several respiratory related disorders and conditions, e.g. Chronic Obstruction Pulmonary Disease (COPD), weaning patients from a mechanical ventilator and in diagnosing sleep apnea. The proposed device accesses and analyses the movement of diaphragm related to lung capacity and breathing behaviour. This project will provide us an ample opportunity to enter into the global respiratory device market, where the growth is derived by healthcare cost cutting effort, longevity of patient population and an increase in chronic pulmonary disease rates. Respiratory diseases are a major cause of morbidity and mortality and is responsible for a very large proportion of the overall health and socioeconomic burden of illness. The symptom common among all respiratory diseases and which cause a patient to seek medical attention is difficulty in breathing, therefore an early measurement of breathing parameters such as breath rate, amplitude and consistency are vital for early diagnosis, monitoring and treatment of breath related diseases. There is growing desire to treat patient at home, requiring the industry to research and develop new technologies suitable for homecare environment and at the same time help to reduce both the cost of development for the manufacturer and maintenance costs for the customer. The leading technologies in the market are pulse oximetry, capnographs and spirometers, which are either complex to deploy in home environment or if deployed do not provide optimal diagnostic and treatment parameters. As a patented ultrasound-based medical device, DiaMon may have several uses in treatment, monitoring or diagnosis where diaphragm movements and respiration plays a role.

The goal of the DiaMon (Diaphragm Monitoring) innovation project is to develop a novel continuous diaphragm monitoring ultrasound medical device that can be used in monitoring and treatment of several respiratory related disorders and conditions, e.g. Chronic Obstruction Pulmonary Disease (COPD), weaning patients from a mechanical ventilator. The proposed ultrasound medical device accesses and analyses the movement of diaphragm and conditions related to lung capacity and breathing behaviour. The DiaMon medical device builds on key insights from an existing product (SimpliDETECT) from NeoRad. The results expected at the end of the Eurostars project are (i) Development of a flexible ultrasonic sensor array and probe which can be attached on the human torso, (ii) Development of a double faced adhesive tape which is biocompatible, sonolucent, durable and allow the ultrasonic probe to be attached to a human torso for several hours, (iii) Algorithms for data processing (iv) A compact control unit (v) Clinical studies on product efficacy as support device in weaning and diagnosis of breath/lung related diseases (vi) Health economic analysis based on outcomes in the clinical studies. Additional deliverables expected are patents or utility models for IPR protection of [a] DiaMon medical device prototype, [b] Signal processing algorithm and [c] adhesive component for fixing the ultrasound probes to a patient torso. When relevant, white papers and academic conference papers for disseminating project results, customer presentations, etc. will be considered (cf. WP8). The resulting system will be used to perform clinical tests in hospital settings to document the usefulness of the device. The achievement of above results will provide us an ample opportunity to enter into the global respiratory device market, where the growth is derived by healthcare cost cutting effort, longevity of patient population and an increase in chronic pulmonary disease rates