Utilising the Vibro-Impact Self-Propulsion Technique for Gastrointestinal Endoscopy

Gastrointestinal (GI) disease is the third most common cause of death, the leading cause of cancer death, and the most common cause of hospital admission. The burden of GI disease in the UK is heavy for patients, the National Health Service (NHS), and the economy. Endoscopy plays a vital role in the diagnosis of GI disorders, and the demand for GI endoscopy has doubled in the past 5 years, with on-going growth of 6.5% per annum predicted by the NHS (Scoping the Future, Cancer Research UK, 2015).

Since its introduction into clinical practice 15 years ago, capsule endoscopy has become established as the primary modality for examining the surface lining of the small intestine, an anatomical site previously considered to be inaccessible to clinicians. However, its reliance on peristalsis for passage through the intestine leads to significant limitations, in particular due to the unpredictable and variable locomotion velocity. Significant abnormalities may be missed, due to intermittent high transit speeds that lead to incomplete visualisation of the intestinal surface. Furthermore, each case produces up to 100,000 still images, from which video footage is generated, taking between 30 and 90 minutes for the clinician to examine in its entirety. The procedure is therefore considered both time-consuming and burdensome for clinicians.

There is, therefore, in GI endoscopic practice a desperate need for new modalities that are safe, painless, accurate, reliable and disposable, and which require minimal training for practitioners. This project attempts to find the way to adapt the vibro-impact self-propulsion technique into capsule endoscopy, and to explore the feasibility of innovation for the next generation of endoscopy: the self-propelled capsule endoscopy.

Dr Yang Liu is an early-career researcher with a research background in applied dynamics and control, who has focused on developing this self-propulsion technique for different engineering systems. The nature of his applied research urges him to transfer any research findings into practical applications, and capsule endoscopy is one of the core deliverable areas for which the technique can make a revolutionary breakthrough. This requires to equip Dr Liu with the necessary clinical experience and knowledge to transfer his engineering research technologies into the healthcare domain. Therefore, the aims of the proposed discipline hop are: (1) to widen his healthcare technologies' expertise and clinic experience, (2) to embed his research into healthcare technologies, (3) to initiate the development work of the self-propelled capsule endoscopy, and (4) to build a long-lasting working relationship with clinicians, initially in the local NHS hospital, and later worldwide.

The approach for Dr Liu to realize this ambitious goal is: 1) to undertake a 6 month discipline hop, learning, observing and being trained in the Endoscopy Department at the Royal Devon & Exeter NHS Foundation Trust; 2) to refine research questions and develop potential solutions; and 3) to fully understand the development cycle of implementing such technique in healthcare sector, including the key activities at the stages of Translational Development, Clinical Evaluation and Regulatory Approval, and Adoption and Diffusion.

Major changes in patient demography and lifestyle in developing countries and the UK are prompting a rise in the incidence of conditions associated with so-called western diets, such as oesophageal and gastrointestinal (GI) cancers, which are largely diagnosed through endoscopy. The proposed discipline hop will explore an approach to embed the vibro-impact self-propulsion technique into capsule endoscopy, which will provide controllable, reliable, and efficient diagnostic tools for future minimally invasive surgeries. The self-propelled capsule endoscope will be particularly suitable for long duration diagnosis overcoming GI peristalsis when disease is suspected in the small intestine, and can be used for searching inflammatory bowel disease, polyps, ulcers, and tumours under the control of clinician. The resulting outcome of this discipline hop will have a significant impact on the economy and the society, as both NHS hospitals and individual patients will be the ultimate beneficiaries of such advanced tools and techniques.

Impacts on economy and industry
Demands for endoscopy in the UK has doubled in the past 5 years and is predicted to grow by at least 40% in the next 5 years (Scoping the Future, Cancer Research UK, 2015). Rapidly growing economies in developing countries, such as China, India, and Brazil, are fueling rises in their populations, wealth and longevity of life. The rapid growth of these countries' economies is also prompting a rise in healthcare spending. Consequently, the number of endoscopic procedures has already begun to rapidly increase. According to the Visiongain report (2012) on endoscopic devices, the market has generated sales of $23.3bn in 2010, and it predicts that the global market will be worth $75.8bn by 2022. There is now a need to aid early/better diagnosis for devices that have enhanced image quality and access to regions of the body previously thought "inaccessible", such as small intestine. Controllable capsule endoscopes thus have a potential economic impact on growing worldwide healthcare expenditure in this area. A new modality such as this may also rapidly gain market share in the field and can also stimulate investment and economic growth from wider applications both within and beyond healthcare.

Impacts on healthcare professionals
By designing a device with high-precision control, we will have a controllable capsule that provides the means to examine areas of interest both carefully and reliably in real time, which will represent a major advance in the examination of the small intestine. Being capable of overcoming GI peristalsis, the controllable self-propelled capsule endoscope will improve the efficiency of endoscopic examinations, due to the potential major reduction in examination times compared to existing standard and capsule endoscopic modalities. Clinicians will no longer need to concentrate on the technical aspects of endoscope passage but will be able to control the speed of the examination. The expensive, extensive and rigorous periods of training in endoscope passage can be reduced from years to days. Furthermore, single-use, disposable, capsule-based devices can potentially lead to wholesale change in endoscopy unit design, obviating the needs for large examination suites, decontamination units and teams of staff to monitor and care for patients during examinations.

Impacts on patients
The introduction of the self-propelled technique into capsule-based diagnostic devices that can propel themselves in a controlled way, affords the possibility of providing a new modality to meet future demands for diagnostic imaging and drug delivery. This will provide direct improvements in patient care, thanks to the enhanced safety, comfort, accuracy and reliability of such devices. The need for patients to be sedated will be minimised, allowing them to undergo examinations with minimal disruption to their lives and own workplaces.