Endoscope-I

Patients referred to Ear, Nose and Throat (ENT) clinics are set to receive faster cancer diagnosis and treatment thanks to a part manufactured by Protolabs.

A nasendoscopy is a diagnostic procedure that involves the examination of the nasal tube, throat, and larynx. A specialised telescopic instrument called an endoscope is guided through the nasal channel and down the back of the throat, collecting detailed photos of the structures.

The part, designed by Endoscope-I and 3D printed by Protolabs, is used to secure an Apple iPhone to a flexible endoscope. This, in conjunction with Endoscope-i’s proprietary software, allows high-resolution endoscopic images to be captured, stored and transferred on the iPhone. This technique allows fast, remote diagnosis of cancers of the throat.

The brainchild of Ajith George, now an ENT head and neck cancer consultant at Royal Stoke University Hospital, Endoscope-i was established in 2012. CEO Chris Coulson, an ENT Otology consultant at Queen Elizabeth Hospital in Birmingham, heads the company whilst the team’s engineering expertise is brought by co-founders Simon Pargeter, an electrical and software engineer and Mark Prince, a mechanical design engineer.

Endoscope-i’s innovative approach to ENT assessment was trialed in the Hoarse Voice Clinic at University Hospital North Midlands (NHNM), Stoke during the height of the Covid pandemic.

Traditionally, patients who are being investigated for throat cancer are seen by a Consultant within a hospital setting. To make a diagnosis, consultants perform a nasoendoscopy using an endoscope and an endoscopy stack, which is a large computer with video imaging software. An endoscopy stack can cost up to £50,000, and whilst they provide very high-resolution images, the accompanying high cost means hospitals generally don’t have access to many of these machines.

The beauty of Endoscope-i’s unique system is that, at a fraction of the price, it can effectively turn an iPhone into an endoscopy stack. The company have been pioneering and refining this technology for almost a decade, but it was the advances in smartphones’ imaging capability and the unique challenges presented by lockdown that prompted NHS interest in trialing the use of Endoscope-i’s devices in UHNM’s Hoarse Voice Clinic.

During the trial, patients who had been referred by their GP and were deemed to be at high risk of having throat cancer, based on their history, were sent through the traditional route of attending the consultant’s Hoarse Voice Clinic at the hospital. Meanwhile, referred patients who were classed as being at low risk were invited to attend their local clinic for an assessment using Endoscope-i’s technology. A specially trained nurse, rather than a consultant performed this nasendoscopy.

Following the procedure, Endoscope-i’s device enabled the nurse to store and quickly send the images to a consultant, who would often be working remotely due to Covid restrictions. In turn, Endoscope-i’s software allowed the consultant to look through the images and swiftly identify key frames.

With Endoscope-i’s system, the consultant was able to efficiently review a patient, assess the severity of the pathology and make a diagnosis in just a few seconds before sending a referral back, usually within 2 days. The whole system dramatically improved use of the consultant’s time, which is the most expensive part of the process.

During the pilot, the Endoscope-i clinic was found to be so effective at assessing the low-risk patients, it was tasked with assessing the high-risk patients too, to help relieve pressure on the Consultants’ standard clinic.

Such was the success of Endoscope-i’s device, UHNM’s Hoarse Voice Clinic in Stoke was able to increase the number of patients they were assessing. This was particularly remarkable considering that during Covid most hospitals’ services were down to approximately 10% capacity. Stoke was able to increase capacity.

The Hoarse Voice clinic piloted at Stoke is now being rolled out to other hospitals in the UK. “The trial had remarkable results,” explains Endoscope-i’s design engineer Mark Prince. “One patient in the Hoarse Voice Clinic was deemed to have a low probability of cancer on their risk index. However, our endoscope was used and the resulting images showed that they did have throat cancer. Luckily as a result of our system, this patient was diagnosed faster and was able to seek treatment more quickly than they may otherwise have done. “

“And it’s down to a little piece of plastic manufactured by Protolabs,” says Mark. “Naturally there’s a lot that goes on around that little piece of plastic, but it is key to our system. The results are fantastic for patients and for hospitals.”

As the world’s fastest digital manufacturer, and with their leading online quoting and automated feedback system, Protolabs offer the best possible service to innovators like Mark.

In addition to design development for Endoscope-i, Mark is senior lecturer at Aston University where his specialism is automation and additive manufacturing – so Mark knows almost everything there is to know about 3D printing!

Mark is a long-standing customer of Protolabs, with the first collaboration taking place in 2014. So why did this additive manufacturing expert choose to work with Protolabs in the first place?

“Originally, I chose Protolabs because as well as working for Endoscope-i, I’m a university academic, teaching mechanical engineering and design,” explains Mark. “One of the places we always point the students to is Protolabs to get quotes on the parts they are designing in order to be injection moulded, because Protolabs have very quick and very responsive costing and quoting software. It’s brilliant because it lets the students see how they need to change their designs in order to make their parts manufacturable.”

“So, I was aware of Protolabs because of that, so when the initial Endoscope-i manufacturing project came up back in 2014, I decided to give Protolabs a go and I found them to be very, quick, very responsive and very supportive. It’s been great ever since. Their level of service has always been superb.”

Mark regularly works with Protolabs to ensure Endoscope-I’s product portfolio keeps apace with Apple’s regular product launches.

As Mark explains, “Every two years, Apple brings out new devices. So their product range is getting broader. We supply directly to our customers who are surgeons, consultants and veterinarians in both the public and private sectors and we never know what devices they’re going to be using. That means we have to offer adapters that will fit any iPhone. So every two years I’m designing four new devices that align with Apple’s new releases.”

On the most recent collaboration with Protolabs, Mark created four new parts - adaptors for the iPhone 13, iPhone 13 Pro, iPhone 13 Pro Max and iPhone 13 Mini. They all have very similar geometry, measuring approximately between 10-15cm in length, depending on the iPhone it’s designed for. These parts look similar to a smartphone protective cover and secure the iPhone to the rigid or flexible endoscopes used in various medical procedures; gastroscopes and laparascopes for checking the intestines, bowels or internal organs, nasendoscopes for checking the throat, base of the tongue and larynx, and rigid otoscopes for inspecting the middle ear and tympanic membrane.

“For this iPhone 13 generation, I didn’t have them injection moulded as we have done with parts in the past,” says Mark. “That’s because the production requirements of injection moulding tend to push me down a particular direction for the morphology or shape of the design, but 3D printing gives me greater flexibility. I can do much more complex forms and I don’t need to worry about undercuts and things like that. And so the majority of our full-body chassis adapters - the ones that look like a phone case - are 3D printed.”

Protolabs’ 3D printing, or additive manufacturing, ensures accuracy and repeatability so that designers get highly precise parts. The technology is suitable for functional prototypes, complex designs, and production components in extremely short timescales. Additive parts are built by stereolithography, selective laser sintering, Multi Jet Fusion, PolyJet and direct metal laser sintering processes, and in a range a plastics and metals.

The Endoscope-I project was fairly straightforward. The material, Bayblend T65 XF (Black), was supplied by Protolabs, and has been used in previous devices. Protolabs originally gave advice when choosing this material, as Mark explains, “Going back to when I first worked with Protolabs on these smartphone adaptors, I was trying to find the appropriate material. I wanted it to be robust and do the job well but be safe around people. Protolabs offered excellent advice and we chose T65 XF, which is a polycarbonate ABS; the same material used in car interiors. It has good temperature resistance, and Protolabs were able to advise on shrinkage.”

“Protolabs are excellent for advice on materials. There was an instance where we were looking to see if we could use a Nylon 11 for one of our parts, and we weren’t sure if it would work, so Protolabs did a test for us. They printed it in Nylon 11 and 12, in black and white, so we could try them out in different colours as well as different materials, to make sure it was going to do what we needed it to do. Protolabs did this at their own expense, which allowed us to nail the specifics down without spending more money on prototypes. It was brilliant.”

“We enjoy working with Protolabs because their service is always excellent. On past projects, they have given us advice on the advisories that we need to put on the manufacturing notes, which we still use today to make sure that the parts come out just as we need them to do. What’s particularly useful, is that when you ask Protolabs whether something will work, they can explain why they think it won’t. They’ve given us support on which processes we might want to look at; for a while we were having problems with deformation and some of the threads not working properly on the parts, so they advised us on a different process, and once we adopted that process, it worked fine every time.”

In addition to their roll out of the Hoarse Voice Clinic to other NHS hospitals, Endoscope-i are working on a number of projects in the public and private sectors, including a collaboration with the Ministry of Defence to use Endoscope-i’s groundbreaking devices to screen rapidly screen the ear-health of troops in the field, identifying strategies for treating percussive ear damage following IED explosions.

It’s a busy time for this innovative company who are going from strength to strength - and Mark is already planning the next project with Protolabs.

“So far we’ve used Protolabs for injection moulding and additive manufacturing. Our next project, coming up shortly, is going to be CNC machining. So I’m interested to see how that goes, but I’m confident that we’ll get the right result working with Protolabs.”