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____________________________________________________Press Release | Presseinformation | Communiqué de presse | Comunicado de prensa | Comunicato stampa | Пресс-релиз | Imprensa | Persbericht | Notatka prasowa

█ Powder-bed-based laser melting with metals (LaserCUSING ® )

Additive manufacturing for cardiology

Redesigning medical instruments using 3D metal printing

3D metal printing helps surgeons to perform heart operation

New medical instruments for cardiology

Less risk in heart operations

PR 05-2017 Words: 1,628 | Characters : 8,304

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Lichtenfels (Germany), May 12, 2017: Additive manufacturing methods of 3D printing are increasingly opening up new paths in medical technology. Alex Berry, founder of Sutrue (UK), and Richard Trimlett, consultant at the Royal Brompton Hospital, are focusing strategically on AM for applications in cardiology. Is it possible to improve the “golden hands” of an experienced heart surgeon? Yes, it is. Using the example of a machine for performing sutures during operations and a cardiac stabilizer for endoscopic heart operations, Sutrue shows how operations on the heart can be performed more safely. Heart operations are soon to become faster and safer. And there is even more good news: patients are recovering faster.

Sutures following operations are still stitched up today in almost the same way as they

were in the days of the ancient Egyptians. Alex Berry discovered that around 240,000

medical professionals a year globally suffer needlestick injuries as a direct consequence

of this stitching. Even experienced operators are confronted with the drawbacks and

inaccuracies of previous suturing methods. To change this trend, Sutrue developed an

instrument which automatically passes any curved needle with a suture through the

tissue of a patient. The requirements placed on the automated suturing device were that

the stitches are made quickly, are positioned precisely, are reproducible and are made

with the necessary force. The better and more quickly the suturing can be performed,

the shorter the operation is for the patient as well. And a clean stitch also leads to better

recovery.

The perfect mechanics of an automated instrument: Suture quickly, reproducibly and cleanly in a heart operation


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http://www.sutrue.com/


The extremely slender suturing device is inserted via a conventional endoscope the size

of a drinking straw during the heart operation and moved into position. Its head can

rotate and be pivoted in order to find any desired batch of tissue. The needle rotates

softly and with pinpoint precision during suturing. This is possible thanks to a complex

miniature gear mechanism that drives the needle. The entire gear mechanism is an AM

assembly. 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. A few

small stitches in arteries or in delicate structures are now possible. Each stitch can be

performed with reproducible accuracy using the suturing device. Complicated operations

in particular can be performed faster and more safely. Thanks to the suture device, up to

three rotations of a needle per second are now possible, instead of one stich per 25

seconds while doing by hand. This reduces the risk associated with the operation for

both, patients and surgeons.

Idea of stabilizing the heart muscle during the operationIn Great Britain alone, around half a million people live with a heart defect. Treatment

with drugs only delivers very minor improvements to patients and often an operation on

the heart is the only way to save a person’s life. In Great Britain, cardiovascular disease

is the second most common cause of death, accounting for 27% of deaths, after cancer,

which accounts for 29% of all deaths. During open-heart surgery, the surgeon needs the

heart muscle to be stabilized for an intervention to be made. Richard Trimlett outlines

the task: “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


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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?’” For Richard Trimlett it was clear that the heart stabilizer should be

small, be capable of being dismantled, and be designed with exposed channels pre-

assembly. The role of the stabilizer is to keep the heart muscle still at the precise point

where the surgeon wants to make an intervention. Alex Berry took on the task and

presented a biocompatible prototype of the heart stabilizer: one part made of plastic

(SLS) and one part made of metal (LaserCUSING). The component consists of a rod on

which the U-shaped heart stabilizer is inserted, like a stamp. The surgeon presses the

stabilizer onto the operating site that he wants to keep still to make an intervention.

Short development time and care for the patientThe heart stabilizer was successfully developed in just three months. Previously, it was

not uncommon for such a new development to take up to ten years. The component

itself is printed by ES Technology on an Mlab cusing from Concept Laser in the space of

three to four hours. It consists of a metallic basic body and several plastic suction points

that aspirate by means of a vacuum. Both parts are joined together using a sandwich

technique. “The solution is estimated to have cost only around £15,000 to develop.

Comparable conventional developments used to cost upwards of a million pounds,”

says Berry to illustrate the relative sums involved. But from Richard Trimlett’s point of

view, it is primarily the patient who benefits from the new instruments using in heart

operations. Here he cites an average rehabilitation time for the patient of around six

months following a conventional surgical intervention. “Initial experience indicates,”

according to Richard Trimlett, “that patients undergo a demonstrably gentler procedure

and can recover after just three to four weeks.”


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https://www.concept-laser.de/en/home.html

https://www.concept-laser.de/en/technology.html


Cooperation between surgeons and SutrueThe Sutrue Team have been involved in the development of medical operating

equipment for more than 10 years. A precise analysis of the operating method is

absolutely essential to allow suitable medical instruments to be developed. To achieve

this, surgeons work together closely with expert medical consultants, such as Richard

Trimlett. Trimlett, who is a cardiologist, attempts to translate the specifications and

wishes into a specific set of requirements. With Alex Berry from Sutrue, he has access

to a manufacturing expert who transfers the requirements into CAD designs and

geometries. Sutrue has been working with AM methods for around (ten) 7 years. “AM

makes it possible to produce geometries that cannot be achieved using traditional

manufacturing methods. In addition, the parts have greater performance capacity or

functional precision, or else they are extremely delicate or small. This is often precisely

what the surgeon was previously lacking,” explained Alex Berry.

Sutrue relies on machine technology from Concept LaserES Technology, Concept Laser’s UK distributor, manufactures the parts for the

automated suturing device on an Mlab cusing machine using the LaserCUSING

process, also known as 3D metal printing. The Mlab cusing is particularly suitable for

manufacturing delicate parts where a high level of surface quality is demanded. The

special thing about the compact machine is its very user-friendly, pull-out drawer system

that is very safe at the same time. This includes both the build chamber with dose

chamber and the storage container. It allows a rapid change of material without the risk

of any contamination of powder materials. The patented drawer system is available with

three different sizes of build envelope (50 x 50 x 80 mm3, 70 x 70 x 80 mm3, 90 x 90 x


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https://www.concept-laser.de/en/technology.html

https://www.concept-laser.de/en/products/machines.html




80 mm3). Also available now is its “big brother,” the Mlab cusing 200R, which allows

even greater productivity thanks to a doubling of the laser power from 100 watts to 200

watts. In addition, a larger build envelope has been created and this increases the build

volume by as much as 54% (max. 100 x 100 x 100 mm3).

In this case, the machine technology from Concept Laser makes it possible to produce

the teeth of the gear mechanism, which are just 0.4 mm long. Up to 600 parts can be

printed on one single build plate. After the tooth system has been removed from the

powder bed, it does not require any finishing thanks to the very high accuracy of the

metal-powder-based process. Stainless steel 316L is used. Alex Berry explains: “In

addition to the restrictions on geometry, conventionally milled or cast parts have a few

other drawbacks. It takes a great deal of time to get to the finished prototype. In

addition, the costs are very high. 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.”

OutlookRichard Trimlett and Alex Berry already see an even greater challenge on the horizon.

The buzzword is artificial hearts, that is to say mechanical pumps that perform the

function of the heart. The previous models have weaknesses. AM could lead to new

thinking in this area. The pump could be designed to be smaller. The really intriguing

thing, according to Richard Trimlett, is the possibility of integrating electromagnetic

functions for moving the pump. These are just a few of the basic considerations for


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https://www.concept-laser.de/en/products/machines.html


redesigning mechanical heart pumps. AM seems to be inspiring the experts in the field

of cardiology.

Summary

How has the Mlab cusing helped to create a medical instrument:

- Design freedom is key for redesign of traditional instruments

- Delicate and complex parts through high accuracy

- High density (over 99,5%) and high surface quality

(e.g. suturing device, optimized parts needed no post-processing)

- Drastically reduced development times and costs

- No tooling costs and reduced waste

- Ready for production: many parts in parallel in consistent quality

(e.g. 600 parts in one build plate/ 10 parts for each suturing device)

- Materials are established and certified for use in medicine.

Benefits for patients and medical professionals:

- Turning a conventional surgical intervention to a minimally invasive surgery

- (e.g. cardiac stabilizer, leads to a better patient recovery)

- Safe and fast suturing method through guided and reproducible stitches

- (e.g. suturing device, up to 3 rotations of a needle per second, instead of 1 per 25

seconds by hand)

- Gentler procedure for patient and less risk for medical professionals


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- Optimized medical instruments for a better outcome

- Reduced operative time leads to less stress for the patient and reduced costs.

- End of the press release –

Questions to Alex Berry, Director of Sutrue (UK)

Although fascinating stories from the world of 3D printing are not uncommon, Sutrue’s

story still amazed us. Alex Berry from Sutrue had lots to recount when we met him at a

conference in Bamberg (Germany). He told us about two developments of products for

use in cardiology and in the interview he also explained what motivates him and Sutrue:

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.


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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.


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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


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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?


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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.

Editor: Thank you for the interview.


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About Sutrue

Sutrue is a CAD and design development center that specializes in the development of

medical instruments for use in cardiology. The company was officially founded in 2012

by Alex Berry, Sutrue boasts a board of specialists. Richard Trimlett from the Royal

Brompton Hospital in London acts as the expert medical consultant to Sutrue. He

presents the requirements from surgeons and thus provides the impetus for product

development. Trimlett then assesses the practical experiences gained from hospital

operations.

Print approved – copy requested

Captions ████████████████████████████████████████

Caption 1: Alex Berry, founder of Sutrue (UK): “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.”


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Caption 2: Alex Berry, founder of Sutrue (UK): “In principle, any conventional component

can be reconceived with AM: redesign will probably be our consistent theme in the

future.”

Caption 3: Richard Trimlett: “Initial experience indicates that patients undergo a

demonstrably gentler procedure and can recover after just three to four weeks.”

Captions 4 a + b: Automated suturing device from Sutrue. The head can be rotated and

pivoted to place sutures in any position you want.

Caption 5: How the automated suturing device from Sutrue works: A rotating needle on

the head of the automated device lays reproducible stitches for the suture

Caption 6: From prototype to handy tool: The six-year “design journey” of the automated

suturing device from Sutrue

Caption 7: View of the opened gear mechanism for driving the rotating needle of the

automated suturing device - the gear teeth are just 0.4 mm long

Caption 8: Additively manufactured parts of the automated suturing device on the build

plate of an Mlab cusing from Concept Laser

Caption 9 a + b: This is a pressure stabiliser as opposed to a vacuum one, which can be

disadvantageous for certain patients


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Caption 10: Mlab cusing machine from Concept Laser at ES Technology Ltd in Kingston

Bagpuize, Oxfordshire (UK)

All pictures courtesy of Sutrue (UK) (unless indicated otherwise)Picture 3: Courtesy of Richard TrimlettPicture 10: Courtesy of ES Technology Ltd.

Contacts ███████████████████████████████████████

Concept Laser GmbHAn der Zeil 8

D-96215 Lichtenfels

Germany

T: +49 (0) 9571 / 1679-0

Internet: www.concept-laser.de

Press contact:Daniel Hund

T: +49 (0) 9571 / 1679-251

E-mail: [email protected]

SutrueAlex Berry, Director


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mailto:[email protected]

http://www.concept-laser.de/


United Kingdom

T: +44 (0) 7716 359016

E-mail [email protected]

Internet: www.sutrue.com

ES Technology Ltd,Units H1 – H3 Kingston Business Park

Kingston Bagpuize, Oxfordshire, OX13 5FB

United Kingdom

T: +44 (0) 1865 821 818

E-mail: [email protected]

LaserCUSING® background information ██████████████████

Key word: LaserCUSING®

The patented LaserCUSING® process from Concept Laser is used to create high-

precision mechanically and thermally resilient metallic components. The term

"LaserCUSING®," coined from the C in Concept Laser and the word FUSING, describes

the technology: The fusing process generates components layer-by-layer using 3D-CAD

data.


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In this process, fine metal powder is fused locally by a high-energy fiber laser. The

material solidifies after cooling. The contour of the component is created by redirecting

the laser beam using a mirror redirection unit (scanner). The component is built up layer

by layer (with a layer thickness of 15 – 500 μm) by lowering the bottom of the build

chamber, applying more powder and then fusing again.

Source: Concept Laser GmbH

What makes systems from Concept Laser unique is stochastic navigation of the slice

segments (also referred to as "islands") which are processed successively. This

patented process ensures a significant reduction in stress when manufacturing very

large components.

Concept Laser at a glance ██████████████████████████

Concept Laser GmbH from Lichtenfels, Germany is today, unlike almost any other

company, one of the real pioneers and key drivers of powder-bed-based laser melting

with metals. The technology driver here is the patented LaserCUSING® process, also

referred to as 3D metal printing, which over the course of 15 years has evolved the


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additive manufacturing of 3D components from a rapid technology to the stage of

industrial series production.

When Frank Herzog founded Concept Laser GmbH back in 2000 in Lichtenfels, a metal

laser melting machine was an entirely unknown quantity in the market. How is a 3D

geometry created from metal powder using a laser? What does 3D printing or a digital

process chain mean for the manufacturing of the future?

The answer was industrial machine technology: Concept Laser unveiled the first

machine of this type in 2001 at Euromold in Frankfurt. With 65 patents granted today

and over 120 patent applications, Frank Herzog and his workforce of around 190

employees continue to champion and develop the LaserCUSING® process. The

company caters for the global market for laser melting machines across all different

sectors from sites in Germany, the USA and China and through a network of more than

35 distribution and service partners.

Concept Laser's high quality standards, expertise in processes, applications and

materials deliver reliable and cost-effective solutions which prove their effectiveness in

everyday production and are primarily aimed at reducing part costs. In addition to

commercial aspects, the process offers a large number of other benefits compared to

conventional methods of production: The components are lighter, the designer has new

freedoms, the topology and geometry are optimized, additional functions can be

integrated, and less raw material is required. What this means is components that were

previously manufactured using machining processes are now being redesigned to fully

exploit the new potential offered by additive manufacturing.

Concept Laser offers a range of small machines (50 x 50 x 80 mm3) right through to the

machine with the world’s largest build envelope (800 x 400 x 500 mm3). Machines from


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Concept Laser that are equipped with multilaser technology are among the fastest,

safest and highest-quality laser melting machines in the world. Around 650 installed

machines and prestigious references and projects of this Franconian “hidden champion”

around the globe send out a clear message and symbolize an outstanding technology

for the future sealed with the endorsement “Made in Germany”.

For example, today the aerospace industry, automotive industry, medical technology,

dental technology, toolmaking and other sectors focus strategically on 3D metal printing

as the economical and high-quality production strategy of the future that embraces the

notion of "Industry 4.0.”

Prizes & awards ██████████████████████████

2001 Presented with the EuroMold Silver AWARD for the M3 linear

LaserCUSING® machine

2008 Presented with the Bavarian Innovation Prize for the M2 cusing


2012 Presented with the EuroMold Bronze AWARD for the X line 1000R


2014 BAVARIA’S BEST 50 prize-winner

2014 Finalist in the “Large Companies” category for the German Industry

Innovation Prize in the shape of Frank Herzog, Managing Director of


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Concept Laser GmbH

Project: “The first 3D-printed titanium component on board the A350 XWB”

2015 The "European CEO of the Year Additive Manufacturing" award was

presented to Frank Herzog, Managing Director of Concept Laser GmbH

2015 Nominated for the German Future Prize – Prize awarded by the German

President for technology and innovation

Project: “3D printing in commercial aircraft engineering – a manufacturing

revolution is taking off” in the shape of Frank Herzog, Managing Director of

Concept Laser GmbH

2015 FOCUS Growth Champion

2016 Winner of the “International Additive Manufacturing Award” with the QM

Meltpool 3D quality monitoring tool, which was developed in-house

2016 The ”Technologie Award by the Ostbayerischen Technologie-Transfer-In-

stituts e.V.“ was presented to Frank Herzog, President & CEO of Concept

Laser GmbH, for his entrepreneurial technology and innovation services

2016 Winner “Materialica Design+Technology Award 2016“ for the ”NextGen

Spaceframe” project, together with its project partners

2016 The “Best Pioneer in the Manufacturing and 3D Printing Industry 2016”

award was presented to Frank Herzog, President & CEO of Concept Laser

GmbH, by the European Business Magazine


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2016 FOCUS Growth Champion

2016 Winner “Bavarian Innovation Award 2016“ with the QM Meltpool 3D quality

monitoring tool, which was developed in-house

2016 The “Best CEO of the Year Additive Manufacturing” award was presented

to Frank Herzog, President & CEO of Concept Laser GmbH, by the Euro-

pean CEO Magazine

2017 iF DESIGN AWARD 2017 for the user interface design of the software CL

WRX 3.0 from Concept Laser

The art of LaserCUSING® by Concept Laser


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