̽��ֱ�� of Cambridge - medical device

Inflatable, shape-changing spinal implants could help treat severe pain

sc604 — Fri, 25 Jun 2021 17:14:34 +0000

A team of engineers and clinicians has developed an ultra-thin, inflatable device that can be used to treat the most severe forms of pain without the need for invasive surgery.

3D ‘organ on a chip’ could accelerate search for new disease treatments

sc604 — Fri, 26 Oct 2018 18:00:00 +0000

̽��ֱ��device, which incorporates cells inside a 3D transistor made from a soft sponge-like material inspired by native tissue structure, gives scientists the ability to study cells and tissues in new ways. By enabling cells to grow in three dimensions, the device more accurately mimics the way that cells grow in the body.

̽��ֱ��researchers, led by the ̽��ֱ�� of Cambridge, say their device could be modified to generate multiple types of organs - a liver on a chip or a heart on a chip, for example – ultimately leading to a body on a chip which would simulate how various treatments affect the body as whole. Their results are reported in the journal Science Advances.

Traditionally, biological studies were (and still are) done in petri dishes, where specific types of cells are grown on a flat surface. While many of the medical advances made since the 1950s, including the polio vaccine, have originated in petri dishes, these two-dimensional environments do not accurately represent the native three-dimensional environments of human cells, and can, in fact, lead to misleading information and failures of drugs in clinical trials.

“Two-dimensional cell models have served the scientific community well, but we now need to move to three-dimensional cell models in order to develop the next generation of therapies,” said Dr Róisín Owens from Cambridge’s Department of Chemical Engineering and Biotechnology, and the study’s senior author.

“Three-dimensional cell cultures can help us identify new treatments and know which ones to avoid if we can accurately monitor them,” said Dr Charalampos Pitsalidis, a postdoctoral researcher in the Department of Chemical Engineering & Biotechnology, and the study’s first author.

Now, 3D cell and tissue cultures are an emerging field of biomedical research, enabling scientists to study the physiology of human organs and tissues in ways that have not been possible before. However, while these 3D cultures can be generated, technology that accurately assesses their functionality in real time has not been well-developed.

“ ̽��ֱ��majority of the cells in our body communicate with each other by electrical signals, so in order to monitor cell cultures in the lab, we need to attach electrodes to them,” said Dr Owens. “However, electrodes are pretty clunky and difficult to attach to cell cultures, so we decided to turn the whole thing on its head and put the cells inside the electrode.”

̽��ֱ��device which Dr Owens and her colleagues developed is based on a ‘scaffold’ of a conducting polymer sponge, configured into an electrochemical transistor. ̽��ֱ��cells are grown within the scaffold and the entire device is then placed inside a plastic tube through which the necessary nutrients for the cells can flow. ̽��ֱ��use of the soft, sponge electrode instead of a traditional rigid metal electrode provides a more natural environment for cells and is key to the success of organ on chip technology in predicting the response of an organ to different stimuli.

Other organ on a chip devices need to be completely taken apart in order to monitor the function of the cells, but since the Cambridge-led design allows for real-time continuous monitoring, it is possible to carry out longer-term experiments on the effects of various diseases and potential treatments.

“With this system, we can monitor the growth of the tissue, and its health in response to external drugs or toxins,” said Pitsalidis. “Apart from toxicology testing, we can also induce a particular disease in the tissue, and study the key mechanisms involved in that disease or discover the right treatments.”

̽��ֱ��researchers plan to use their device to develop a ‘gut on a chip’ and attach it to a ‘brain on a chip’ in order to study the relationship between the gut microbiome and brain function as part of the IMBIBE project, funded by the European Research Council.

̽��ֱ��researchers have filed a patent for the device in France.

Reference:
C. Pitsalidis et al. ‘Transistor in a tube: a route to three-dimensional bioelectronics.’ Science Advances (2018). DOI: 10.1126/sciadv.aat4253

Researcher profile: Dr Charalampos Pitsalidis

Dr Charalampos Pitsalidis is a postdoctoral researcher in the Department of Chemical Engineering & Biotechnology, where he develops prototypes of miniaturised platforms that can be integrated with advanced cell cultures for drug screening. A physicist with materials science background, he collaborates with biologists and chemists, in the UK and around the world, in order to develop and test drug screening platforms to help reduce the number of animals used in research.

“Animal studies remain the major means of drug screening in the later stages of drug development however they are increasingly questioned due to ethics, cost and relevance concerns. ̽��ֱ��reduction of animals in research is what motivates my work.

“I hope that one day I will have managed to make a small contribution in accelerating the drug discovery pipeline and towards the replacement reduction and refinement of animal research,” he said. “I believe that in 2018, we have everything in our hands, huge technological advancements, and all we need is to develop better and more predictive tools for assessing various therapies. It is not impossible; it just requires a systematic and highly collaborative approach across multiple disciplines.”

He calls Cambridge a truly inspiring place to work. “ ̽��ֱ��state-of-the-art facilities and world-class infrastructure with cutting-edge equipment allow us to conduct high-quality research,” he said. “On top of that, the highly collaborative environment among the various groups and the various departments support multidisciplinary research endeavours and well-balanced research. ̽��ֱ��strong university and entrepreneurial ecosystem in both high tech and biological science makes Cambridge an ideal place for innovative research in my field.”

Researchers have developed a three-dimensional ‘organ on a chip’ which enables real-time continuous monitoring of cells, and could be used to develop new treatments for disease while reducing the number of animals used in research.

Two-dimensional cell models have served the scientific community well, but we now need to move to three-dimensional cell models in order to develop the next generation of therapies

Róisín Owens

̽��ֱ�� of Cambridge

Tubistor device

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Low-cost AI heart monitor developed by Cambridge start-up

sc604 — Tue, 11 Sep 2018 14:00:23 +0000

̽��ֱ��company, Cambridge Heartwear, hopes to use its wireless monitor to improve the detection of irregular and dangerous heart rhythms and reduce the impact of stroke and stroke-related mortality and morbidity, which affects 120,000 people in the UK each year.

Professor Roberto Cipolla from Cambridge’s Department of Engineering met cardiologist and clinical academic Dr Rameen Shakur in 2015, a year after Roberto’s father had died of a stroke. Their ongoing research collaboration has now led to the formation of Cambridge Heartwear, a company based on the Cambridge Science Park.

̽��ֱ��company’s device, called Heartsense, includes a multiple lead ECG, oxygen sensing, temperature and tracking device which can be comfortably worn by patients for early screening. Sensors are enclosed in a robust waterproof casing, and the data produced is far more sensitive than that from current single lead wearable devices, as the development team have used their knowledge of clinical anatomy and electrophysiology to place leads for maximal signal output.

This data is wirelessly streamed in real time to the cloud where adaptive AI algorithms are able to identify clinically relevant irregular and dangerous rhythms just as a physician would. ̽��ֱ��device incorporates multiple independent sensors, in order to produce more specific and sensitive data than current heart monitors can provide.

̽��ֱ��research challenge was to produce algorithms that can learn from a limited amount of supervision from the cardiologist. “Our aim was not to replace the cardiologist, but to give them diagnostic support in real time,” said Cipolla.

To encourage the adoption by clinicians the team ensured that the output of the AI algorithms also included the information commonly used by a cardiologist. “This was not necessary for the final diagnosis but made the system a little more understandable and explainable than typical Deep Learning systems, which are still thought of as black boxes,” said Cipolla.

NHS figures suggest atrial fibrillation (AF), the most common heart rhythm disturbance encountered by doctors, affects in excess of one million people across the UK. According to national and international data, more than 80% of people who either die or are left with severe neurological deficits following a stroke had an irregular heartbeat as the underlying cause. However, irregular heartbeat is often diagnosed only after a person has had a stroke.

There are more than 100,000 strokes in the UK every year, and it is the fourth biggest killer in the in the UK, with more than 23,000 deaths last year. ̽��ֱ��NHS spends £2.5 billion annually on neurological treatment and rehabilitation for stroke patients.

“It makes sense to pick up AF before someone has a stroke and put preventative treatment in place,” said Shakur, who was formerly a Wellcome Trust Clinical Fellow at Cambridge and is now based at MIT. “Unfortunately, the technology and clinical care systems we currently have in place aren’t really doing this.”

Heart rhythms are currently measured by an electrocardiogram (ECG). To use an ECG as someone is going about their daily business, rather than in a GP surgery, a device called a Holter monitor is used. This requires fixing 12 leads to the patient’s chest and carrying the cumbersome device around for 24 hours.

It can take as long as four to six weeks from the time when a patient is referred by their GP to when the data from the Holter monitor is analysed and an irregular heartbeat is detected or not. Additionally, a Holter monitor costs as much as £2000.

“If you’re wearing an ECG over a long period of time, you’re collecting a huge amount of data,” said Shakur. “Finding an irregularity among all the normal rhythms can be like looking for a needle in a haystack. I wanted to automate this process, helping the patient to get a diagnosis and start on treatment.”

To solve this problem, Shakur began collaborating with Cipolla, a world leader in computer vision and real-world applications, and students from the Department of Engineering. ̽��ֱ��collaboration led to the founding of Cambridge Heartwear in 2017 and the development of the unique device and some powerful algorithms that can automatically interpret ECG data, which have an accuracy level in excess of 95%.

In 2017, the company secured funding to build and test 100 prototypes of the new heart monitor and to extend its AI capability. ̽��ֱ��Royal College of Art was also helped in the ergonomic design of the device. Heartsense will cost substantially less than a Holter monitor.

Clinical trials in Lancashire, UK have begun with patients enrolled from the primary care setting.

Inset image: (L-R) Roberto Cipolla, Rameen Shakur, James Charles

A Cambridge start-up has developed a low-cost next-generation wearable heart and cardiovascular function monitor which uses AI to diagnose heart rhythm and respiratory problems in real time.

Our aim was not to replace the cardiologist, but to give them diagnostic support in real time.

Roberto Cipolla

Cambridge Heartwear

Heartsense monitor

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Commercialising medical device innovation

amb206 — Fri, 13 Jul 2012 11:30:52 +0000

Biotechnology and healthcare developments require huge financial and resource investment, in-depth research and clinical trials. Consequently, these developments involve a complex multidisciplinary structure, which is inherently full of risks and uncertainty. Jon Johnson, a researcher in the Institute for Manufacturing, is looking at the process by which medical devices are taken from early concept through to commercialisation, including technology confidence, early testing, investment implications, and regulatory compliance.

̽��ֱ��feasibility stage of medical device design is critical, and there is currently little guidance for practitioners to navigate this inherently complex set of activities. In a similar fashion to high-tech industries, the medical sector has huge incentives to increase development efficiency, reduce time to market and increase profits. ̽��ֱ��medical industry has unique requirements, including extensive science and technology management, considerable testing, clinical trials and regulatory control. When addressing scientific and technical innovation within this industry, it is critical to have a clear understanding of the clinical need, market potential and technical risks.

A major challenge lies in the process of determining technical feasibility without demonstrating preliminary function and early test data. These requirements mean that the development of medical devices is often extremely expensive, with project schedules taking between four and ten years. There is genuine pressure on industry to reduce these costs and improve time to market by reducing the inherent risks at the feasibility stage of development. Therefore it is necessary to gain confidence within the technology as soon as possible and preferably before investing excessively.

Johnson is particularly interested in the early stages of medical device development – the early feasibility studies which determine whether a technology is viable years down the line – and how designers, engineers and scientists work closely with medical practitioners, healthcare providers and patients. He believes that this stage offers the biggest potential to test concept viability, establish whether the technology will function sufficiently, meet critical user needs, identify genuine health benefits and determine regulatory viability.

“According to the FDA (Food and Drug Administration), a vast majority of investigational products never make it through clinical approval and market adoption. This failure represents a huge loss of time and investment,” said Johnson.

What is needed is better evaluation at the early stages of development. In order to understand how a product makes the journey from first concept to commercial adoption, Johnson has been working with eight leading medical organisations to track this complex process. ̽��ֱ��output from this study includes an original approach by which companies can better analyse, manage and measure the success of early technology innovation within the healthcare sector. Such studies would also improve regulatory viability, provide significant cost savings and maximise benefits to the healthcare industry.

Jon Johnson is a PhD candidate in the Institute for Manufacturing, Department of Engineering at the ̽��ֱ�� of Cambridge. He is supervised by Dr James Moultrie.

New medical devices take a long time to reach the market – and many never make it. Jon Johnson, a researcher at Cambridge’s Institute for Manufacturing, is looking at ways of making the process of commercialisation more efficient.

According to the FDA, a vast majority of investigational products never make it through clinical approval and market adoption.

Jon Johnson

Institute for Manufacturing

Medical technology in action

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