Design Network North Members- PDM design New surgical concept for abdominal keyhole surgery
There are clear benefits for the patient in laparoscopic or keyhole surgery. Being minimally invasive, laparoscopic or keyhole surgery is associated with much quicker recovery, less tissue trauma and lower infection rates.
But laparoscopic surgery is technically challenging for the surgeon because they have to operate on the patient through small ports. The issue of tissue retraction is one of a number of barriers limiting the adoption of this approach.
Dr Pete Culmer, Associate Professor in Mechanical Engineering at the University of Leeds, and his industry partner Richard Hall, Founder and Managing Director of design consultancy pd-m International, set about developing a concept for use in abdominal procedures to address this clinical challenge and provide improved retraction.
“The idea for our project arose through the NIHR Colorectal Therapies Healthcare Technology Co-operative (HTC), which has access to a surgical technologies research group,” said Dr Pete Culmer. “We also work closely with surgeons at Leeds Teaching Hospitals NHS Trust, and one of the gaps they identified in clinical practice is being able to retract or hold tissue in laparoscopic surgery so that it is out of the way during a procedure or operation.”
Need for a device to hold tissue in place
The concept was to provide a device for the surgeon that could be inserted inside the abdominal cavity so that tissue could be hooked or clipped back onto a scaffold system. As a consequence, the lead surgeon would be directly in control of tissue retraction, whereas normally they would have an assistant to do the job for them, which introduces challenges of communication between the two.
“We got to the point of producing an early-stage concept, which looked like an inverted umbrella,” said Dr Culmer. “When we knew it could potentially work and be effective, we realised we needed to translate the prototype into a commercial product in order for it to benefit patients and their surgeons.”
That is where Dr Culmer and colleagues started to work with Richard and the team at pd-m, a small to medium-sized design consultancy specialising in medical devices. “We were introduced to the project in its early stages, when University of Leeds had a small amount of funding to take it through,” said Mr Hall. “We provided design consultancy, and then we took the instrument to an in vivo in porcine trial, which demonstrated that in theory the medical device had opportunities.
The initial metal device was sterilisable and reusable. One of the challenges to this approach was that it was expensive to manufacture because it was of very complex design. Cleaning and sterilisation were a challenge and the question arose whether, between one procedure and the next, the product would be in a good shape to be reused.
“That is when we decided that, although we had good results in the in vivo in porcine trial, the device needed to go through a step change in order to be commercialised,” said Mr Hall. “Then we applied for funding to develop our product from a good concept into something that would be manufacturable, consistent, cost-effective and functional.”
He added: “Translating it from purely being a good idea into something that would be commercially viable and would fit into its niche in the marketplace.”
Moving towards a marketable device
Using the £445,000 of funding, the device went through several cadaver trials, design development, Finite Element Analysis, prototyping, meetings and finally some laparoscopic tests. “Having gone through the design iterations, we’ve got to a stage of a product that is single use, can be manufactured very cost effectively, hits the target in terms of health economics, and at the same time is functional and clinician centred,” said Mr Hall.
The team is using 3-D prints to carry out validation and is producing injection-moulded products that can be used in a wider context. “We are now asking surgeons to carry out isolated testing and more cadaver tests,” said Mr Hall. “The purpose is to demonstrate that the product can be realistically produced and used. That would put us in a much stronger position with a licensee.
Dr Culmer’s decision to bring on board medical device design by pd-m, as well as a wider team to look at different attributes of the project, was critical to its success. The group involved had experts in health economics, intellectual property, engineering, design and surgery, who worked in collaboration to take the device from a sterilisable, expensive product to something that is fit for market.
Pd-m is a valued members of Design Network North. Design Network North is part of RTC’s new programme called ‘Designing Better Business’ – launched in 2016 - which will provide support for north east businesses looking to continue to innovate and design better world leading products.
RTC was founded in 1989 with the sole purpose of helping businesses innovate and create new higher value products. Today, the business operates out of offices in Sunderland, Gateshead, Leeds and Daresbury and specialises in helping companies develop new products, embed new skills through training and access funding for innovation.
‘Designing Better Business’ is part funded by European Regional Development Fund, as part of the European Structural and Investment Funds Growth Programme 2014-2020.