A team across two continents to open up keyhole surgery
Dr Pete Culmer, Associate Professor in the School of Mechanical Engineering, explains how international teamwork makes for better design.
Fifteen million keyhole surgeries are performed each year around the world. Nearly one-third of these operations takes place in the USA alone, despite the country accounting for only around four per cent of the world’s population.
This statistic highlights a stark health inequality: the benefits of keyhole surgery — a smaller cut with less pain, less risk of infection and a quicker recovery — are enjoyed almost exclusively by people in advanced economies.
Laparoscopy — the official name for keyhole surgery — actually takes longer, costs more and is more technically demanding than open surgery. This can make it prohibitive for health systems with fewer resources. One of the main limiting factors is, surprisingly, carbon dioxide. This gas is pumped into a patient’s abdomen, to create the physical space for the surgeon to do their work. In lower income countries the gas is either simply not available or its supply is unreliable, which could put a patient at risk mid-operation.
Operating without gas
Surgeons working in remote, rural parts of India have been pioneering an alternative way of mechanically lifting a patient’s abdomen to carry out laparoscopy without the need for gas. The aim is to enable the use of keyhole surgery for ‘simple’ operations such as gall bladder or appendix removal, hysterectomies or to take biopsies for diagnosis. Although surgically simple these procedures are still potentially life-saving.
Dr Jesudian Gnanaraj, a pioneering urologist at Karunya University in Coimbatore, has been leading this drive. He partnered with the University of Leeds NIHR Global Health Research Group to help train rural surgeons in the technique. But the equipment they were using was cumbersome, difficult to maintain and hard to sterilise. So we put together a team of surgeons, engineers and designers from the UK and India to see if together, we could take a fresh look and design a new system that was easier to use.
The reality of designing something jointly with the people who will actually use it is a long way from the ‘tick-box’ exercise that, sadly, co-design can sometimes become. Too often, engineers consult with users at the start to see what’s needed and then test it out with them at the end, once the design has been finalised.
Experience and innovation
Right from the start of this project, we adopted an iterative design loop, and we consulted regularly with our surgical team before agreeing on a final design. As well as having the experience of Dr Gnanaraj, our team included two innovative assistant professors of surgery from Maulana Azad Medical College in New Delhi, Lovenish Bains and Anurag Mishra, who are working to demonstrate the huge potential of gasless surgery.
Spending time with them and seeing how they worked, we got a good understanding of what the device needed to do, rather than just how it had worked in the past. By ensuring regular communication — messaging on our WhatsApp group — we built a strong relationship where we knew we’d get honest feedback. At times this could be brutal — our first prototype didn’t quite go to plan and we were told about its faults in no uncertain terms!
We also tested our prototypes more widely, running a hands-on session at the Association of Rural Surgeons of India annual conference. This felt quite high risk — if things went wrong, we risked undermining confidence in the system. But luckily it went well and the feedback we received led to more improvements to the design.
True team working
Central to it our success was the strength of the team, comprising:
- the surgeons in India and in Leeds, including Noel Aruparayil, who brings experience of surgical training and practice in India
- engineers passionate about global health
- product design company Pd-m, who embraced the humanitarian nature of the project and gave their time generously
- manufacturing partners XLO, who have helped transform the system into a commercial product
It felt like we’d created a community, all working together and keen for success. And we hope that has led to a design that perfectly fits the bill.
The mechanism we’ve devised, which we call RAIS (retractor for insufflation-less surgery), is lighter than the original equipment, has its own box for easy transportation, can fit into an autoclave for full sterilisation, can be assembled and manipulated by the surgeon alone, without the need for other clinical staff, and is — we’re told — easy to use.
Due to Covid19, our final evaluation of RAIS was a virtual one. But rather than play safe and showcase the finished prototype only to surgeons in Leeds, we made sure our Indian partners could dial in to see the equipment in action and give valuable feedback. We had both an external camera filming the set-up of the system and a feed from the camera inserted inside the abdomen, so the surgeons in India could see exactly what space was created to operate in.
Last, but definitely not least, we’ve been working with XLO, an Indian orthopaedics company, to transform our early prototype into a product which can be manufactured with approval for use in India. Thanks to our work with the Association of Rural Surgeons in India and the Global Health Research Group, we hope we’ve got a willing group of clinicians ready to pilot the device for us.
Innovation doesn’t always mean designing something that’s never been thought of before. Sometimes, as our project shows, it can mean looking at something that doesn’t work well and going back to first principles, to design something that will do the job much better. And to get that right, you need to design it with whoever will ultimately use it.
The RAIS project team
Association of Rural Surgeons of India and International Federation of Rural Surgeons, Biru, India
- Gnanaraj Jesudian
Maulana Azad Medical College, New Delhi, India
- Anurag Mishra, Department of Surgery
- Lovenish Bains, Department of Surgery
Ortho Life Systems, New Delhi, India
- Sundeep Singh Sawhney
- Tamandeep Singh Kochhar
Pd-m International Ltd, Thirsk, UK
- Philippa Bridges
- Richard Hall
University of Leeds, UK
- Noel Aruparayil, Leeds Institute of Medical Research at St. James’s Hospital
- Cheryl Harris, Leeds Institute of Medical Research at St. James’s Hospital
- Peter Culmer, School of Mechanical Engineering
- Millie Marriott Webb, School of Mechanical Engineering
