A UK company has developed a novel biosensor for measuring blood propofol concentration in real-time incorporated into an analyte recovery platform that does not require blood withdrawal.
Under technical cooperation agreements, partner organisations will contribute to and influence the further development of the technology to facilitate successful integration into established or newly developed devices.
The company is led by a senior hospital doctor and a leading clinical researcher with an international reputation. Both have a track record of successfully commercialising patient safety products. The company was established specifically to address a clinical need in hospital based anaesthetic and sedation practice. The need is currently unmet by any other product(s).
Approximately 4 million patients in the UK and 400 million globally receive a general anaesthetic each year. In 90% of cases this is achieved with the administration of anaesthetic gases. These are greenhouse gases and highly damaging to the environment as well as having unwanted side effects for patients. Their use persists, however, partly because the concentration being delivered to each patient can be measured.
For more than 20 years an alternative has existed; total intravenous anaesthesia (TIVA) using a drug called propofol. TIVA has many advantages for patients including a far lower risk of nausea, smoother recovery, and greater chance of long-term survival for patients with cancer. In addition, it is tens of thousands of times less damaging to the environment than anaesthetic gases.
One of the main reasons given by anaesthetists for not using it more often is the lack of technology to measure in real-time the concentration of propofol in the patient's blood stream, an equivalent facility to that which is available for gaseous anaesthesia. Enquiry of Patient and Public Involvement groups shows surprise that such monitoring is not already in use.
In addition, propofol is widely used in intensive care units where it is administered by intravenous infusion to sedate patients undergoing invasive therapies such as assisted ventilation.
The company has been partly funded by the UK government (using its Innovate UK platform) to develop a novel real-time blood propofol sensor for incorporation into a system that does not require blood withdrawal. The output from the monitoring system can be transmitted to a variety of different displays ranging from a stand-alone propofol monitor to incorporation into existing equipment such as processed EEG depth of anaesthesia monitors. Here it will offer an invaluable additional data source with which to assess the adequacy of anaesthesia. Additionally, the data can be utilised to provide TIVA pumps delivering propofol to patients with real-time information about what concentration is actually being achieved and thus offer a personalised, dynamic feedback loop.
Working with international biosensor experts at a UK university, the company has developed and patented a novel biosensor based on cyclic voltammetry in which the activity of an immobilised enzyme draws electrons from an electrode resulting in a measured current proportional to the propofol concentration. Studies of sensor response to repeated use over three days (far longer than any surgical procedure) show good stability (see Fig.1)
The biosensor has been developed to Technology Readiness Level (TRL) 4; ‘functioning lab prototype'
Collaborating partners are now sought for the further development and utilisation of the novel real-time blood propofol concentration monitor.
In addition, collaborating partners are sought for the integration of the sensor in to existing near point of care monitoring equipment utilised in intensive care units such as blood gas analysers or other equipment used to analyse blood samples at the bed side.
The conclusion of these partnering opportunities will be a product or products developed to TRL 8 or beyond where partners possess full commercialisation capability.
- Type of partner sought: The company envisages two product streams from its technology:
1) a continuous monitoring system for perioperative use, and
2) a sensor for use in blood gas analysers to indicate drug levels during sedation in intensive care.
For the former, preferable partners would be a data handling / software / AI specialist with hardware and software capability to acquire substantial data input, process and manage such data, providing a cogent user interface, and ultimately generate algorithms to facilitate feedback drug administration in the future. The wireless data transmission system must be secure, interfaceable with healthcare systems, and comply with regulatory standards.
For the latter, preferable partners would be a blood gas analyser company or such that currently provides intensive care based biochemical diagnostics, with an interest in expanding their sensor portfolio to include the sedative agent propofol allowing clinicians to dose patients for appropriate sedation.
- Specific area of activity of the partner: The data handling / software / AI specialist partners can be from industry, academia or research organisations.
Working in collaboration, the desired partners will collectively develop a system that can acquire electrochemical signals from multiple sensors, develop a redundancy capability to enhance robustness, wireless transmit data using a secure interface, develop appropriate hardware, firmware and software to provide meaningful data to clinicians working within a operating theatre.
Ideally such a system would also capture brain activity, modified EEG processing to be incorporated to provide indices of awareness. A user-friendly interface will allow data inspection in a real-time continuous and recordable format. Using big datasets, the desired partner will collectively develop algorithms to facilitate drug concentration prediction, and ultimately feedback drug administration in the future. The partner will be cognisant of the Medical Device Regulations and to be compliant or aim to be compliant before project completion.
The blood gas analyser / ICU ward based biochemical diagnostics partners should be from industry and already have product on the market or about to launch such products. They should have Quality Management Systems and products compliant with ISO 13485 under the Medical Devices Directive (MDD) or more preferably under the new Medical Devices Regulations or FDA equivalence.
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