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May 15, 2017 | By Tess

Sutrue, a UK-based medical technology company, has been using metal 3D printing technology to develop tools aimed at radically improving surgical procedures. The company used German company Concept Laser’s MLab Cusing additive manufacturing system to create a suturing tool and a cardiac stabilizer.

Sutrue founder Alex Berry has been working closely with Richard Trimlett, a consultant at the Royal Brompton Hospital, to explore the benefits of using additive manufacturing for cardiology-related applications. Using 3D design and printing technologies, the medical tech company believes it can greatly improve certain cardiology procedures, making them safer for both medical professionals and patients.

According to Berry, over 200,000 medical professionals a year suffer needlestick injuries while giving sutures. Now, with the help of 3D printing, the company has devised an “instrument which automatically passes any curved needle with a suture through the tissue of a patient.” The thin device, which can be inserted using a conventional endoscope, can be controlled by a miniature 3D printed gear mechanism which drives the suturing needle.

The innovative suturing tool reportedly speeds up the suturing process significantly (it is capable of doing 3 rotations per second rather than the manual average one stitch per 25 seconds), and makes it easier to reproduce stitching motions, making it safer for both the patient and the surgeon. “What this innovation actually means for the operator is that the suture is pulled through quickly and cleanly and the stitch is automatically set in place,” reads a statement by the company.

3D printing also helped Sutrue in the development of a heart stabilizer device, which is crucial during open-heart surgery. Trimlett describes the process, saying: “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.”

To find a solution for this procedure, Trimlett asked Berry if it would be feasible to develop a small heart stabilizing device which could be taken apart, customized to different hearts, and then disposed of. Faced with the challenge, Berry developed a biocompatible prototype of a heart stabilizer made up of one SLS plastic 3D printed part, and one metal 3D printed part. When inserted, the device—which consists of a rod and a U-shaped stabilizer—can be pressed onto the operating site, holding it still when the surgeon is prepared to make an intervention.

Impressively, Sutrue was able to develop the heart stabilizer in just three short months, largely thanks to Concept Laser’s Mlab Cusing technology, which was able to turn out prints of the device in just three or four hours. The 3D printing itself was done by ES Technology, and the device reportedly cost around £15,000 to develop—not bad when compared to conventional developments that often cost more than a million.

According to Trimlett, patients who undergo surgery with the new heart stabilizer and suturing device could have a chance to recover from the procedure in just three to four weeks, a much shorter time frame than the six months it can take to recover from traditional surgical operations.

Concept Laser’s metal 3D printing technology, a LASERCusing process, offered many benefits to Sutrue, including design freedom, high accuracy, high density and surface finish quality, and faster turnover and production. The metal 3D printer was especially notable for being able to accurately 3D print the tiny teeth (which were just 0.4mm long) on the suturing device’s gear mechanism.

Berry commented: “In 3D printing, the parts are produced very quickly and at a fraction of the previous costs of prototyping. But the potential for bionic designs, reproducibility, miniaturization and not least the reduction in the number of parts and outlay on assembly is also vast. If one looks at the full spectrum of optimizing manufacturing and product design coupled with an increase in functionality, 3D printing is capable of revolutionizing medical instruments.”

(Images: Concept Laser)

Concept Laser interview with Alex Berry, Director of Sutrue (UK)

Editor: Can one talk about additive manufacturing having made a breakthrough in medical technology?

Alex Berry: Yes and no would be the balanced answer. I would say Yes in relation to dental laboratories or implant manufacturers. Here specific materials are used for specific patients and metal-based solutions are probably very widespread nowadays. In the case of medical instruments, we are some way off exploiting all of the possibilities on offer. The importance of AM is still underestimated today. Sutrue is one of the pioneers that have sought to use 3D parts to offer better and more efficient solutions than were previously possible.

Editor: So is there still a need for more information? What reasons would you cite?

Alex Berry: A medical instrument is the “tool of the trade” for a doctor or surgeon. But doctors and surgeons are not designers or manufacturing experts. They are highly specialist skilled artisans with a strong background in theory and practical experience of working in hospitals and operating rooms. It is quite common to find surgeons who perform 200 or 300 operations a year in a specific region of the body. These highly specialist people have very precise ideas about how a specific instrument could be improved. Ultimately, what is helpful for the doctor is to have dialog or guidance from an outside party to find out exactly how a tool can be designed more effectively. These bridge-builders are people like Richard Trimlett. Richard talks to the surgeons and attends operations to understand what an instrument should look like and how it can do a certain job better. We then come together with these ideas and develop prototypes. This is followed by trials and further modifications to the design until the final solution is produced. This is an interactive process that takes a certain amount of time. However, with AM nowadays this can again also be done very quickly. What used to take years can now be accomplished in three, six or nine months. However, for the automated suturing device we still had a development period of six years. But it was only toward the end that we were able to make enormous progress with 3D printing. I am convinced that when it comes to medical instruments we will be able to achieve a great deal more with AM. The freedom of geometry, miniaturization, short development times and other benefits of AM can be exploited even more widely. The process almost calls for a redesign of previous solutions.

Editor: How did you get your references?

Alex Berry: In every business there are customers that maintain a close dialog in which each party is good at listening to the other. We were then able to try out our promises with a few pilot customers. The sector is small after all and everyone knows everyone else. You quickly get into conversations – and also quickly get to follow-up projects. Richard Trimlett is of course a very important driving force for Sutrue. His expertise and contacts in cardiology are significant sources for our developments. This allows us to focus our products very closely on the particular application and develop them further during everyday use in the operating room. Fundamentally I must say: Our products tell a story. The story is test, test, test. You could also call this an evolutionary design and redesign process. It is only when many surgeons state every day in the operating room: Yes, this is clearly better than our old instruments that you can be satisfied.

Editor: How significant are SLS or SLM for your product solutions?

Alex Berry: Sutrue has long been engaged in the full range of rapid prototyping and prototyping methods. These also include SLS, which is laser sintering with plastics, or SLM, which is selective laser melting of metals. This is slightly easier with metals because the original materials are certified for use in or on the body. In the last 10 or 15 years, AM has made huge progress here. It can now be said that laser melting has established itself as an interesting option. We can assemble very many parts in parallel on a build plate. These parts have exceptional geometries or ergonomic or bionic principles. Not least we can very quickly trial a prototype without using any tools in order to improve the application. Metal AM has massively changed the way we look at our products and we can develop solutions in terms of design and function that were unthinkable just a few years ago.

Editor: How did you end up choosing Concept Laser as the plant and machine manufacturer?

Alex Berry: AM has always fascinated me. This is simply because you can produce prototypes very quickly. Development used to take six months and the component cost £1,500. But the end product was not even convincing. This was initially also the case with the automated suturing device. In 2015 I came across ES Technology. The company is based in Kingston Bagpuize, Oxfordshire. ES Technology has an Mlab cusing machine from Concept Laser and a great deal of experience in the 3D printing of metals. The results on the Mlab cusing were fantastic. The system performed much better than other 3D metal printer, we tried at the same time. We began to fabricate our prototypes with the STL data. AM provides us with a huge opportunity to keep on improving prototypes. We were able to optimize the design again and again and continuously improve the focus on the application. It was, as I would call it, a “design journey” before we actually had a properly functioning automated suturing device on the table. The secret is a miniature gear mechanism which allows the needle to rotate very smoothly and whose head can be rotated and tilted so that the surgeon can use the instrument optimally in an endoscopy. Even an experienced surgeon with “golden” hands will appreciate this assistance.

Editor: How do you want to market your products?

Alex Berry: Sutrue is a “think & engineering tank.” We do not especially want to market our solutions ourselves. Customers can acquire a license and we then provide them with the 3D printing data. With the appropriate industrial 3D machine technology, our product can be printed out anywhere in the world.

Editor: What are your plans for the future?

Alex Berry: I may be an idealist because with AM solutions we can help to develop and advance surgery. I think this is hugely exciting. We are thinking ahead in very different directions. It is now possible to have additive solutions but also hybrid solutions in which traditional machining processes are combined with laser melting. At the same time, we can now set about modifying the geometries to suit the process so that parts or assemblies can be manufactured more quickly or easily or also embrace new performance criteria or functional integrations. When it comes to functional integrations, temperature control, cooling or even sensor technology can be incorporated. In terms of miniaturization, AM also provides a great deal of potential for the future. The short development times and optimization options for prototypes are also very interesting. We should also not forget that, as well as technical advancement, AM solutions also offer huge advantages in terms of costs. Added value and economic efficiency can be significantly enhanced as a result. These are all very interesting topics. In principle, any conventional component can be reconceived with AM: redesign will probably be our consistent theme in the future.

 

 

Posted in 3D Printing Application

 

 

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