Medical devices

Key reasons for the lack of utilization of magnetic resonance in neonate imaging are that the equipment is often bulky, difficult to site and therefore usually placed in separate and often distant areas of hospitals. There is a huge need for a dedicated, bespoke magnetic resonance imager that addresses these issues.

GE Healthcare have been awarded a Strategic Translation Award to co-fund the development of magnetic resonance imaging equipment capable of being located within neonatal units. First, engineers at GE Healthcare will build three small, high-field (3T) magnetic resonance prototype systems capable of being installed in a neonatal unit. Secondly, these prototype magnetic resonance systems will be placed in a minimum of two neonatal units to understand workflow elements and the requirements for a fully functioning finished product. As such, the hope is that the project output will be able to provide high quality information in 3 years that has a high chance of changing neonatal management.

One of the fastest growing bariatric procedures is laparoscopic gastric banding. Currently, post-surgery, the band requires a number of adjustments which are carried out in a trial and error fashion. Crospon Limited, established by John and Caroline O'Dea in 2006, has developed a product, EndoFLIP, for diagnosis of gastro-esophageal reflux. The funding granted will be used to re-design this product to allow it to provide a unique quantitative way of adjusting gastric bands, and to clinically demonstrate the improved clinical efficacy that can be achieved adjusting gastric bands by removing the guess-work associated with the current methodology. The new product ("BaroFlip") will also provide a new and unique capability to surgeons to measure the small stomach pouches created in another bariatric surgery procedure, known as gastric bypass.

Surgical interventional techniques have undergone significant changes since the introduction of keyhole surgery and the recent development of robotic assisted Minimal Invasive Surgery (MIS). In robotic surgery dexterity is enhanced by microprocessor-controlled mechanical wrists, which allow motion scaling for reducing gross hand movements and improved performance of micro-scale tasks. Existing surgical robots, however, are generally unsuitable for following curved operation pathways where obstacle avoidance is critical. Imperial College has been awarded a Strategic Translation Award to develop an Imaging-Sensing Navigated And Kinematically Enhanced (i-Snake) surgical robot for MIS. It is equipped with multiple sensing-enabled flexible joints that permit full forward control and tactile feedback of the operator for following curved anatomical pathways that are essential for performing complex procedures such as multi-vessel coronary bypass surgery. The proposed i-Snake robot uses a biologically inspired mechanical design with fully flexible locomotion control such that the device can reach inaccessible anatomical regions with enhanced precision, dexterity and safety. The robot is further equipped with a multi-purpose imaging probe at the tip to allow for both visible light navigation and tissue characterization. The robot will enable the performance of a range of procedures that are not possible with the current technology and ensure the greater success of future clinical robotic systems used for key-hole surgery.

There is no treatment: patients are 'managed' with puréed food, thickened liquids and in many cases are fed through a tube. Addressing this problem has been the main research focus for over 15 years of Professor Shaheen Hamdy at the University of Manchester. Daniel Green of Phagenesis Ltd, is turning the results of his work into a practical treatment for dysphagia. The company's first product has already proven effective in treating patients in the few weeks after a stroke while the patient is still in hospital. Now, via a Wellcome Trust Translation Award, it is developing and testing a version of the device that is suitable for use with patients in the community who are living with dysphagia. The treatment principle is to apply an electrical pulse to the pharynx (the back of the throat) for ten minutes a day for three days. A benefit of this medical device is that it avoids many of the safety issues associated with surgery or long term implants.

Additionally, access to the damaged joint and its proper visualisation are often difficult tasks for the surgeon, resulting in a high prevalence of implant misalignment that is exacerbated by uneven arthritic bone loss. The overall result can be premature TSR failure due to instability, loosening and accelerated wear. Professor Andrew Amis and colleagues at Imperial College London are researching an innovative artificial shoulder joint which will be less destructive and yet more secure when implanted. It will use novel bearing materials to reduce wear rates. The component which fixes to the upper bone of the arm will feature a compact ceramic shell to allow its placement with minimal soft tissue damage. The project team is also developing a surgical guidance system to ensure accurate insertion and alignment of the prosthesis and a less-invasive surgical procedure that will negate the need for shoulder dislocation and thus enhance rehabilitation. The project will culminate in a pilot clinical study in patients.

Dr Clare Selden and her team at UCL have developed a prototype 'bio-artificial liver' (BAL) to address this unmet need. Its key element comprises functioning liver cells in an external bioreactor. Plasma from a patient with liver failure will be passed through the bioreactor, contacting the alginate encapsulated liver cells, so that the cells replace those functions that the sick liver cannot perform. The machine will buy time for a patient's liver to improve or, if damage to the liver is irreversible, may buy time until liver transplantation can be arranged. The technology combines alginate encapsulation of a human liver cell line and subsequent culture of the encapsulated cells in a fluidised bed bioreactor -  providing a convenient, manipulatable biomass in a form which maximises mass transfer between cells and perfusing plasma. The team have Translation Award funding to complete the design, specification, performance characterisation and manufacture of this fully biocompatible BAL.

The objective of the project led by Dr Gaetano Burriesci at UCL is the manufacture and pre-clinical assessment of a novel prosthetic aortic valve suitable for TAVI. An original design and the use of a novel synthetic functional nanocomposite polymer should result in a device which has the advantages over existing valve replacement of being fully retrievable/repositionable, has enhanced anchoring and sealing, maximises expanded/collapsed diameters ratio and has an extended durability

Medical agents are usually delivered systematically, but this may predispose the patient to severe infection and autoimmune reactions. Surgery using existing anal fistula plugs is successful in the treatment of simple fistulas but is associated with a high failure rate in more complex fistulas and in patients with Crohn?s disease. Dr Richard Day from University College London has received a translation award to develop a potential solution to this problem. He and his team have developed microspheres that, when packed into a fistula, provide a ?scaffold? that cells can grow between and into. As the microspheres dissolve, they are replaced by new tissue to heal the fistula. With this award, Dr Day and his team aim to demonstrate that the microspheres are safe when implanted into perianal fistulas in humans.

In children these can only be approximately measured in the clinic setting and similarly some adults have difficulties with the usual testing machine. Professor Robert Minns and colleagues at the University of Edinburgh have developed a new system to detect visual field defects by monitoring a child?s eye movements when he or she is sat in front of a TV screen. This translation award aims to further develop and validate the system to enable more detailed testing (threshold testing) which could be of benefit for adults, especially those with glaucoma. The system is patient friendly (child or adult), not at all threatening and does not involve any head or other restraints. All that is required is just a few minutes in front of a TV screen and this gives the doctor detailed information about the patient?s visual field.

The recording of urinary habits using a voiding diary and measurement of urinary flow rate are key steps in clinical assessment of men with LUTS, and the results guide treatment. At present, voiding diaries are manually completed by the patient and the urine flow test is performed in a clinic giving only a single, potentially inaccurate reading. Dr Michael Drinnan and colleagues at the Freeman Hospital in Newcastle have designed and built a simple electronic flow meter-diary, specifically intended for home use. It can measure urine flow and record the volume, time and duration of each void for up to two weeks. The team have received Translation Award funding to improve the design, durability and functionality of the device for prototype production, and then formally investigate its usefulness in the assessment pathway for men with LUTS.

Many common clinical investigations such as the taking of tissue samples from suspect organs such as the prostate, or breast are performed using ultrasound or X-rays to help the clinician find his/her target. Magnetic Resonance Imaging (MRI) is the best way of detecting subtle tissue differences that has yet been developed and it is logical to believe that it would provide clinicians with more accurate and useful information than any other approach. MRI systems are, however, very restricted in available space, with the patient occupying much of what might be useful and access to any particular target organ or region is very restricted. Using a robotic system is one practical way of improving access, as long as the robot is, completely safe and compatible with any MRI machine, small enough to allow it to be sited alongside the patient, and is flexible enough to allow it to be used in a variety of applications. Dr Mihailo Ristic and colleagues at Imperial College have been awarded translational funding to develop a novel form of remotely operated endoscope, with a variety of associated tools, to achieve this aim.

The method uses a revolutionary mathematical technique to analyse the signals arising from accelerometers. The healthcare benefits arising from the work should include improved detection of changes in condition of people with movement issues (for example: stroke and other neurological patients) leading to better decision making with regards to direction of treatment changes.

A closed loop system provides the potential to improve HbA1c levels while avoiding hypoglycaemia.  Professor Christofer Toumazou and Dr Pantelis Georgiou at the Institute of Biomedical Engineering together with Professor Desmond Johnston and Dr Nick Oliver at the St Mary's Hospital of Imperial College London have received a Translation Award to develop a bio-inspired artificial pancreas that will be used for closed loop control of type 1 diabetes.  They aim to develop and clinically trial a microchip that will be used in conjunction with clinically approved glucose sensors and pumps to control blood glucose.  The overall system will replicate the concentrations between 4 and 8mM and will therefore be the world’s first bio-inspired artificial pancreas.

A film of Dr Nick Oliver and Dr Pantelis Georgiou talking about the device is available to watch on the YouTube channel of Imperial College London.

The burden of infectious and parasitic diseases in the tropical regions is truly alarming and continues to kill millions of people in developing countries every year. Many of these tropical diseases are preventable and may be routinely diagnosed by the simple microscopic examination of patient fluid samples.Nevertheless the lack of low cost and effective microscopes is a major logistical bottleneck in the identification and treatment of these life-threatening diseases, especially amongst field-based health workers in remote regions.Cambridge Optronics has been awarded translational funding to design and test a simple, pragmatic alternative to expensive laboratory instruments. The company has now developed an effective, low-cost, highly portable microscope prototype with the potential to be distributed to the developing world within as little as a year.

Open heart aortic valve replacement (AVR) is the gold standard surgical treatment of advanced aortic valve disease. However, it requires sternotomy (splitting the breastbone) to expose the heart. Sternotomy inflicts significant patient trauma and discomfort, requires extensive recuperation and may result in life-threatening complications. CardioPrecision's approach will cause patients less pain, reduce infection and lead to earlier mobilisation and recovery from surgery. Furthermore, CardioPrecision's technology will not only benefit patients but also provide substantial economic savings to health service providers through reductions in operating time, blood loss, infection rates, intensive care utilisation and hospital stay.

The majority of complications occur during the opening of the anterior lens through a central circular opening (capsulorrhexis). This procedure is challenging for even an experienced ophthalmologist as it involves the crude application of a needle or forceps to tear a circle in the capsule, which can result in irregular, inaccurate openings and errant tears to run outwards from the opening. John Stokes, Nottingham University Hospital has been awarded translational funding to develop and test a single use, ophthalmic cutting device which will create a precise and predictable capsulorrhexis, thereby reducing the risk associated with the procedure. The device does not aim to de-skill the procedure; rather it will make this complicated and important part of the surgery easier with the potential to increase the success rate and in turn will reduce the incidence of secondary complications.

Support has been given to Dr Michael Garvey and Dr Rachel Williams at the University of Liverpool, in collaboration with Professor David Wong at St Paul's Eye Unit, The Royal Liverpool University Hospital.  Silicone oils are the commonest fluid used for this therapy, but as silicone oil has a density lower than water it floats on any remaining aqueous fluid in the eye and does not provide an effective contact for repair of the lower part the retina. Heavy silicone oils, which are based on a mixture of liquids, are available but there are concerns over their tendency to break up within the eye. The nanoparticles discovered by the team in Liverpool have a higher density than the liquid thus permitting a stepwise increase in overall density of the mixture providing the ability to tailor the density over a wide range to optimise the fluid's effect in different clinical situations.

Professors Christofer Toumazou and Chris McLeod together with colleagues at the Institute of Biomedical Engineering, Imperial College London have been awarded a three-year Translation Award to develop a wireless Surface Acoustic Wave (SAW) based pressure transducer that can be permanently implanted in the heart to allow continuous blood pressure monitoring. SAW technology is already ubiquitously used in televisions and mobile phones, and has been adapted to be pressure sensitive for tyre pressure monitoring systems in the automotive industry. Professor Sir Magdi Yacoub will lead work exploring surgical and minimally invasive procedures for implantation of the device, in order to inform best practice.

There is a clinical need for a smaller diameter CABG (<5mm) that mimics the properties of native human artery, and this is being developed by Professor Alexander Seifalian and colleagues at University College London.  The conduits are to be made from a novel patented polymer based on polyhexal oligomeric silsequioxanes and poly(carbonate urea) urethane.  The translational funding will be used to validate the small diameter cardiac bypass graft in an animal model, experiments that are required in accordance with the regulatory authority requirements for an implantable device.

However, it is limited in its sensitivity for spotting the early signs of breast cancer and in differentiating between normal and cancerous tissue. An alternative X-ray imaging technique, phase contrast imaging (XPCi), has been developed and shown to have much greater sensitivity for seeing the early stages of disease. Professor Robert Speller and Dr Alessandro Olivio at UCL have been awarded translational funding to develop a laboratory prototype that will allow XPCi images of excised breast tissue to be taken using conventional equipment.

The crash team uses a large array of medicines and medical devices such as a defibrillator, which are stored on a 'crash trolley'. Professor Charles Vincent, working in collaboration with the Helen Hamlyn Centre (HHC), has been given Translation Award support to trial the award-winning Resus:station, a novel crash trolley designed by the HCC to store equipment in a visible, logical manner, based on the airway, breathing and circulation (ABC) principles.

Dr Liam Marnane, Dr Geraldine Boylan and Dr Gordon Lightbody from University College Cork, together with their clinical collaborator, Dr Janet Rennie of University College London hospitals, have received a Translation Award to develop a signal processing system, based on EEG and ECG, which will help medical staff identify all seizures in newborn babies without the need for complicated equipment or an expert to interpret the results. Failure to detect seizures and the resulting lack of treatment can result in brain damage and, in severe cases, death. They will assess how well the system works in clinical practice, and adjust the design to make it baby-friendly, easy to use and acceptable to parents.

Ultrasound reveals what's inside the body because the various tissue types reflect ultrasound waves differently. However, some cancers reflect ultrasound waves just like their surroundings, and are therefore invisible in an ultrasound scan. To circumvent this problem, an ultrasound scanner can be modified to display a stiffness image, showing which regions are stiff and which are soft. Because tumours are generally stiffer than their surroundings, they are easily spotted in these 'elastograms'. Elastography could therefore play a key role in the diagnosis and treatment of cancer. Dr Andrew Gee and colleagues from the University of Cambridge has recently developed innovative techniques for generating two- and three-dimensional elastograms without any hardware modifications to the scanner: the processing is all done in software. Dr Gee has been awarded translational funding to take this technology out of the laboratory and into the hospital, so that it can be tailored to specific clinical needs.

The need for brain imaging is increasing with growing concern over neurodegenerative diseases, such as Alzheimer's; hence there are larger numbers of patients to be routinely scanned than ever before. Current scanners are not available in every hospital due to their high cost. Where they are available they are large, noisy, fixed installations that are not portable. Professor Hugh McCann and Dr Chris Pomfrett from the University of Manchester have been awarded translational funding to develop a newly discovered technique called 'functional electrical impedance tomography of evoked responses' (fEITER), which is directly sensitive to the brains electrical operation. This tool will enable screening of large populations, and prompt action to be taken in emergencies. The scans could be performed wherever the patient is, even at home.

CardioDigital Limited, a spin-out company from Napier University, Edinburgh, was established by Professor Paul Addison and Drs Jamie Watson and Brendan McGuckin to harness the increased signal analysis capacity of an established engineering-based method to give real-time patient status information.

Laryngoscopes are used to guide a tracheal tube into the larynx to maintain a patient's airway during anaesthesia. A difficult intubation can lead to severe trauma and in some cases, death. Aircraft Medical Limited, established by Matt McGrath, was granted Translation Award funding to develop an innovative laryngoscope that offers a near-guaranteed view of the larynx through the integration of a miniature video camera into the device and a display screen on the handle.

See our video: Developing the video laryngoscope