Changing Cardiac Healthcare with 3D Printing

- Alex Berry founder of Sutrue and Mr Richard Trimlett, Consultant Adult Cardiac Surgeon at the Royal Brompton Hospital opened TCT Show 2016 with an astonishing keynote.

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Amongst all the insight and innovation served up at the plethora of 3D printing conferences I have attended in the past four years, never have I seen a presentation that is a direct call to action for the designers and engineers of the audience to stand up and be counted… until the 28th September 2016. 

The opening keynote of TCT Show 2016 from Founder and Creator of Sutrue, Alex Berry and his on-stage companion Mr Richard Trimlett, a Consultant Adult Cardiac Surgeon at the Royal Brompton Hospital saw the latter end the talk by saying, “this is a cry for help from the medical community”.

This wasn’t some hat-in-hand, charity drive this was the talk of a man, who has seen how rapidly additive manufacturing (AM) technology can improve healthcare thanks, in no small, part to the developments of Alex Berry. 

The Jan/Feb 2015 issue of TCT Magazine featured an in-depth piece on Alex Berry’s medical device that had been prototyped using a Formlabs desktop machine. What had amazed Alex was that suturing (stitching) had pretty much remained the same since Ancient Egypt in a world where robotic surgery is a norm. Alex discovered that around 240,000 healthcare workers a year have needle-stick injuries as a direct result of suturing and set about changing this trend by developing a device that would automatically pass a swaged (rounded) needle through a patient’s skin.

Before Alex discovered 3D printing, his first milled prototype took six months to make, cost £1,500 and simply wasn’t fit for purpose. The Form 1 machine exponentially increased the speed in which Alex and his team could prototype and develop. Come TCT Show 2015 he was able to demonstrate a working device that could generate twice the force of doing it by hand and be produced in less than a week for just a few pounds. And 3D printing is no longer just used for prototyping, in fact, all of the components of the current Sutrue device are 3D printed bar one. 

Small Packages

After being one of the first surgeons to develop the device, Richard Trimlett then threw down a gauntlet to team Sutrue, “For robotics we cannot get the dexterity of the instruments without force feedback, to the point where we can suture in anything like the speed of an open procedure. My challenge to Alex was, now that we have the tools could we make this small enough to adapt to the robotic equipment so that we could do the stitching as neatly as the machine does?" 

When Richard says “small”, we’re not talking half the size, for keyhole robotic surgery the device would have to be small enough to pass through a tube only just wider than your average drinking straw. Once passed through the other end it would have to be able to rotate and be angled to stitch on a beating heart. Alex was unsure whether there existed a technology capable of printing gears small enough with the required surgical precision until he spoke to ES Technology on the 2015 TCT Show floor. 

ES Technology was demonstrating a raft of Concept Laser technology and believed that by using the Mlab machine they could print the gears that have teeth just 0.4 mm long. Concept’s LaserCusing process on its smallest machine enables the Sutrue team to put 600 components on a single build plate. After removal from the bed the gears require no post-processing such is the accuracy of the the metal powder-based process. 

"Part of the TCT story is about meeting people here and collaborating.” - Alex Berry

A year on from the conversation and the endoscopic version of the Sutrue device was being used during an actual keyhole surgery.

A stable condition

After seeing how quickly 3D printing has been able to iterate a product, Mr Richard Trimlett wondered if it could be used to create another device that would help him with robotic surgery.

“We're doing a beating heart operation so the heart is in use by the body but we need to hold the small area that we're working on still. With the chest open we can put a big suction device in but when we're doing keyhole surgery we need very small parts that we can pass in and out. What we don't want to do is disadvantage the patient by offering them an inferior stability of the heart so that the quality of the operation isn't as good when you do it as a keyhole. I said to Alex, 'could you make something that comes apart in pieces, pass through a very small incision that we can use to hold the heart stable? Could we make it to throw it away and even customise it to the different shapes and sizes?'" 

Alex took the task on, knowing that with additive technologies this was achievable. He knew that they could make a device using metal 3D printing technology for the top and use a bio-compatible plastic 3D print as the disposable part that would clamp onto the patient’s part. Although Alex designed most of the device he struggled to finalise the mechanism for fitting the two parts together securely. He called on the help of design innovation agency, Minima who were able to finish what Sutrue had started. 

Remarkably, in what we believe must be a first at any trade show, Alex enlisted the help of two exhibitors to print a cardiac stabiliser that will be used on a patient directly on the show floor. ES Technology used Concept’s metal 3D printing to print the top and Tri-Tech 3D printed the disposable part on a Stratasys’ Objet 30 Prime using the bio-compatible, medically approved MED610 material. 

From finalising the design to being used on a patient’s heart during surgery took just three months and that includes jumping through the certification hoops, “We haven't cut any corners with regulations we're going through all the proper channels,” said Mr Trimlett.

The Challenge

There are over half a million people living with heart failure in the UK alone and the best drug-based treatment in the world offers very little improvement to the condition. 

“Those people are on home oxygen, they have their bed downstairs, they can't drive a car, they can't work, they don't feel part of society,” said Richard in his closing plea. 

For years conventional engineering has looked at the workings of the heart and thought of it merely as a traditional mechanical pump. Countless solutions have been tested… 

“When they work they transform the lives of the people but the technology is not good enough,” said Richard. “Hydraulic engineers look at the heart and think 'it's a pump, it needs to pump five litres a minute, great I've got one on the shelf,’ but it doesn't work like that." added Alex Berry. 

The speed of innovation for both endoscopic devices demonstrated at TCT has brought hope to Richard - one of the most experienced heart surgeons in the world - that the future of medical care for cardiac problems could be about to change exponentially.

Richard and Alex believe that we need to think outside the box; one big pump hasn’t worked so could we theoretically print smaller points to be implemented at various intersections of the human body? 3D printing is revolutionising the way we design many of the things around us, could it be about to revolutionise the things inside us?

Watch the keynote, download the podcast and join in the discussion on social media.