Medtech company Sutrue has created an automated suturing device that enables surgeons to easily perform stitches more accurately and safely in challenging sites.
Sutrue joined our Future 20 programme last year and is set to bring much needed innovation to the traditional suturing process which has not seen much progression in thousands of years. We spoke to Sutrue’s Director, Nia Dokova about what they have achieved so far:
What was the inspiration behind Sutrue?
Our founder Alex was watching a documentary about robotic surgery a few years back. He couldn’t believe that technology has advanced so much that a robot can be controlled to do surgery, and yet suturing has not really changed since ancient Egypt.
Minimally invasive surgery such as keyhole surgery or robotic surgery has huge benefits for patients and it’s growing at an incredible pace. Instruments adapted for this minimally invasive approach are available for most surgical tasks, but not for suturing. When Alex identified the unmet need here, he decided to create an automatic suturing device himself.
You have created two different stitching devices. Could you talk us though the difference between them?
The ‘head’ of the devices, which incorporates the suture (needle and thread) is the same mechanism across all devices – and it can take any size or type of standard needle. The difference is in the surgeon interface. For our endoscopic device, that’s a handle which contains electronics and controls. Our robotic device, on the other hand, connects to a medical robot which is controlled by a surgeon.
The mechanism in the ‘head’ can drive a standard needle both forwards and backwards, which is different from anything else that we’ve seen.
“Comfortable to handle and intuitive” Surgeon trial user
The method of suturing has not changed for thousands of years. Why do you think that is?
It is really difficult. There have been 10,000 different attempts to secure a patent for a suturing device, but none have succeeded using a standard needle. Getting a needle to rotate in circles is a difficult thing to do without modifying the needle itself, and by changing the shape of the needle, it creates more trauma when passing through tissue. This is very significant in minimally invasive surgery, where the nature of the internal tissue means any damage can have significant consequences for the patient.
“Better accuracy and better clinical quality improve patient outcomes, which is ultimately what we want to achieve.”
What are some of the benefits of using an automated suturing device as opposed to traditional techniques?
One of the main benefits is improving access. With our device we can access hard to reach and narrow places that are currently considered extremely challenging. Our device also saves time as opposed to traditional suturing. One minute of operating theatre time costs between £20 and £30, so speed is really of the essence. The patient would typically be under anaesthetic, and the longer they are under, the more risk for the patient.
The suture itself is also performed with increased accuracy because the needle is moving in a perfect 360-degree rotation every time which traditional techniques using needle drivers can never achieve. Our device can offer consistent, uniform sutures even in hard to reach, tight and restrictive sites. Better accuracy and better clinical quality improve patient outcomes, which is ultimately what we want to achieve.
The other benefit is safety. Needlestick injuries cost more than £4bn globally each year – where anyone could potentially be exposed to HIV, Hepatitis and other blood-borne viruses. Our device encloses the needle in the cartridge which prevents any chance of exposure.
Has Sutrue been part of any trials and what has the feedback been like?
Both devices have been tested in pre-clinical trials and we have had some very positive feedback from surgeons. They said it’s intuitive to use, the safety element was very well received, and they especially like that it delivers a consistent, even, circular stitch.
Are there any challenges that come with being in the Medtech sector?
Absolutely. One of the biggest challenges is regulation, which is very expensive and time-consuming. On average, from the beginning of testing to the moment you can apply for a CE mark is between two and a half and three years. And that’s after you’ve finished the design and achieved an advanced prototype. In Medtech you can’t launch anything before it’s regulated, so it can be a real challenge to get large volumes of feedback.
You used 3D printing for your prototyping. How significant has it been to have access to that technology?
Prototyping on the same timescale, or with the same amount of funding, would not have been possible for us without 3D printing. Traditional manufacturing would have cost between 40 and 60 times as much and take eight times as long.
Has being part of the F20 programme helped you with any challenges?
We’ve found Future 20 so useful. The programme manager Emma has been really thorough with her questions and getting a full picture of how she can help, and through the mentoring, we’ve had some really useful introductions which has helped to drive us forward.
To find out more about Sutrue, visit their website: www.sutrue.com