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New device for continuous monitoring analysis, organisation and visualization of integrated cardiovascular and respiratory signals

Country of Origin: Spain
Reference Number: TOES20190716001
Publication Date: 24 July 2019

Summary

Spanish consortium of biomedical research centers is offering under license or joint venture agreements a device (external or integrated within a monitoring apparatus) that provides doctors with a disruptive way to integrate, analyse and visualize cardiovascular and respiratory signals. It provides new information such as pleural pressure (without further invasive device) or fluid response prediction for all patients. Main market is intensive care units, surgery and chronic diseases monitoring

Description

Severe and acute patients at Intensive Care Units (ICU) and surgery are the ones being continuously monitored. They have a high degree of complexity and monitoring analysis of several variables simultaneously is needed to have real time information about their situation. Organization and categorization of this information is essential for decision-making in order to avoid severe consequences (with 30% mortality indexes). Evaluation of patient’s situation and best treatment to use is done in short time and relies on the physician criteria, knowledge and experience. Current monitoring devices present separated information for each parameter monitored, doctors have lots of information but also lots of noise. Moreover, current algorithms used for the integration of signals measurements in clinical monitoring devices are affected by the regularity and intensity of breathing. Therefore the current approach has reliability and application limitations due to the fact that patients with hemodynamic instability or respiratory or cardiac arrhythmias cannot benefit from this analysis. Moreover, the only current way to estimate pleural pressure is with an oesophageal balloon, an invasive device very often not indicated for clinical situations where pleural pressure is a great help for treatment decision-making. 
The presented device improves both data and variables management and information data extracted from monitoring.
Main organs involved in respiration and circulation are anatomical and functionally related; every breath provokes changes in variables related with circulation. The new method offers new information extracted from the respiratory and circulatory systems’ interactions in its most extended way. Mechanical and functional relationships between respiratory and cardiovascular systems depend quantitatively and qualitatively of the intensity of breathing and the particular conditions of the respiratory and cardiovascular system in the specific evaluated condition according to patient characteristics. The method builds a highly descriptive waveform of variation of hemodynamic variables along breathing. The application of analytic techniques allows the tool to quantify and describe these interactions in a precise and clear way to decide best treatment, or predict response to a particular intervention for a patient in a particular situation, all this without limitations of patient condition. It can also be used for short punctual hemodynamic signals analysis outside ICU such as for diagnosis and treatment monitoring in many cardiovascular and respiratory chronic diseases.
The research group belongs to the biggest consortium of biomedical research in Spain and they work, within and out the consortium, with many of the best national and international experts in respiratory diseases. They are experts of clinical-physiology in signal analysis and monitoring field (the principal investigator has 2 PhDs in this field), as well as and Magnetic resonance imaging and positron-emission tomography imaging and data analysis specialists for pulmonary and cardiovascular function. The group combines expertise from ICU specialists and researchers with the one from physics and engineers.
The technology needs to obtain data from vital monitoring devices already used at ICU and surgery. It can be developed as an independent device connected to these ones or within a current available monitoring device. Thus, the group is looking for a monitoring company already in the sector. The envisaged collaboration could be a license agreement, where the company could further develop the technology or integrate it into its products, or to create a joint venture to develop and bring new products to the market.

Advantages and Innovations

The system increases the precision in the description and quantification of the interaction between respiratory and circulatory systems. It provides continuous monitoring of new parameters from signals already monitored by current devices used in ICU. This makes possible to know patient’s hemodynamic clinical state with high precision, and accurately choose best therapy to use for a particular patient in a specific situation.
The method provides a detailed waveform describing how a hemodynamic variable is affected along breathing for all patients, even for the ones with arrhythmic frequencies, under mechanical ventilation or by punctual monitoring, without the current monitoring limitations. It provides new and integrated information from all signals recorded, well-organised and with friendly visualisation for the doctor. This fact reduces time doctor analysis’ time for the patients’ whole clinical situation, improving right treatment and time decision-making without relying only in doctor´s expertise and reducing mortality, complications and costs derived.
It can predict for a particular patient his response to fluids administration, evaluation of pleural pressure, arterial tone etc. Currently, pleural pressure can only be quantified by the oesophageal balloon, an invasive method very often not recommended due to the state of patients.
The approach is a revolutionary concept in patient monitoring, since it evaluates cardiovascular and respiratory system not as separate concepts but as a unit and it will move the actual stage of functional monitoring to a new scenario of extended relevance in clinical practice and patient’s management in and out of ICU.

Stage Of Development

Field tested/evaluated

Stage Of Development Comment

Proof of concept of pleural pressure monitoring done in pigs under ventilation.
Pleural pressure & fluid response done for for ICU patients at different conditions (proved for usefulness, accuracy and strength).

Requested partner

The group is seeking a monitoring medical devices company. The group envisages a license agreement with the company. Its role will be to co-develop with the group a new product or to integrate the technology into the company’s existing products. The licensee will be also responsible for the production and commercialization. Other option is a joint venture agreement where the new entity will develop new products, as well as bring them to the market.

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