Researchers Evaluate Feasibility of Closing Multiple Atrial Septal Defects Guided by 3D Printed Model

We’ve often seen physicians use 3D printed heart models to help during surgeries, but a group of researchers from China published a paper on using them to help with an alternative to surgery for repairing secundum atrial septal defect (ASD), a rare congenital defect characterized by a hole in the wall between the atria. Their goal was to evaluate how feasible it was to use a single device to close several ASDs guided by the 3D printed heart model and transthoracic echocardiography (TTE).

Due to interference between devices and threat of repeat intervention, it’s difficult to use multiple devices simultaneously, or in staged device closure, in percutaneous transcatheter closure of an ASD. But using an over-sized device, can tear the atrial septum. So the best plan is to use single device closure for patients with multiple ASDs, as it preserves the anatomical structure.

“However, this strategy is technically challenging because of inability to determine the target defect for catheter passage and occluder selection, warranting careful interventional planning with comprehensive anatomical information for successful device closure,” the team wrote.

That’s where the 3D printed heart model comes in. The researchers used the single-device strategy, assisted by 3D printing, to perform multiple ASDs closure, and compared their results of “3D printing-based and transthoracic echocardiography (TTE)-guided percutaneous transcatheter closure with those of traditional fluoroscopy-guided closure.”

Simple working flowchart in patients with multiple ASDs, from image acquisition to 3D printed solid and hollow model.

62 patients diagnosed by TTE with two or more ASDs with a 5mm or more diameter, were enrolled in their non-randomized study for analysis. 30 had cardiac computed tomography angiography (CTA) ahead of surgery in order to get data to create their 3D printed heart models. The CTA images were reconstructed and saved in DICOM format, before being imported to Materialise Mimics software. Cardiac masks were generated for 3D models, and 3-matic software was used to hollow them. The STL files were 3D printed, in hollow fashion, at 1:1 scale on a ProJet MJP 2500 Plus 3D printer out of silicone.

3D printed model of a patient with multiple ASDs. (a) and (b) show the model from left and right atrial sides, respectively. The arrows depict the position of the ASDs. (c) and (d) illustrate the status after occluder deployment in the model.

The surgeons performed in vitro simulated occlusion with the 3D printed models as a pre-op evaluation. Then, while the other 32 patients underwent ASD closure with fluoroscopic guidance, this group had TTE-guided closure procedures.

“The apical four-chamber view and parasternal short-axis view were used for guidance, and the multipurpose catheter was passed through the targeted defect, which was determined using the 3D printing model and intraoperative TTE,” the researchers explained.

“Then, a single septal occluder was inserted for ASD closure under TTE guidance. An ASD occluder or PFO occluder was selected based on the in vitro simulated occlusion in a 3D printing model.”

After implantation, the device position was evaluated through subcostal, apical four-chamber, and parasternal short-axis views, and they also performed Color Doppler assessment to detect any issues, like coronary sinus return or residual shunting. Once they determined that the occluder had been implanted correctly, “it was released by rotating the cable counterclockwise under TTE guidance,” and a reassessment was then performed in echo views, below.

Percutaneous closure of multiple ASDs under TTE guidance. (a) Multiple ASDs image displayed in subcostal view. (b) The left disc was released (parasternal short-axis view). (c) The ASDs were closed (four-chamber view).

“In the conventional group, multiple ASDs occlusion was performed under fluoroscopic guidance using the single occlusion device,” they wrote. “Based on TTE measurements, the single device was selected, equal to or up to 4 mm larger than the main defect [10]. According to experience [102021], the device was usually implanted into the largest defect. The occluder was replaced if echography found more than two residual shunts, the residual shunt was >5 mm in diameter, or the device compressed the mitral valve.”

Immediately post-op, and 6 months after the device closure, all 62 patients were evaluated via TTE and electrocardiogram, with the researchers noting the presence of any arrhythmia, residual shunt, or valve dysfunction. A Brand-Altman analysis was used to evaluate the agreement “between device size of 3D printed model and traditional estimation,” and the data was analyzed with SPSS software.

Bland–Altman plot analysis. Bland–Altman plot of empirical estimation versus 3D printed model estimation of occluder size.

They found that 26 patients in the 3D printing/TTE group, and 27 patients in the conventional group, achieved successful transcatheter closure with a single device. The prevalence of residual shunts was lower in the first group immediately and 6 months post-op, and there were no complications in either group during the procedure or the two follow-ups.

“Gender, age [18.8 ± 15.9 (3–51) years in the 3D printing and TTE group; 14.0 ± 11.6 (3–50) years in the conventional group], mean maximum distance between defects, prevalence of 3 atrial defects and large defect distance (defined as distance ≥7 mm), and occluder size used were similarly distributed between groups,” the team wrote. “However, the 3D printing and TTE group had lower frequency of occluder replacement (3.8% vs 59.3%, ), prevalence of mild residual shunts (defined as <5 mm) immediately (19.2% vs 44.4%, ) and at 6 months (7.7% vs 29.6%, ) after the procedure, and cost (32960.8 ± 2018.7 CNY vs 41019.9 ± 13758.2 CNY, ).”

They did note that the occluder on the 3D printed model was “consistently larger than in the empirical estimation but similar to final clinical selection,” which indicates a higher level of accuracy. Even in patients with a large defect distance, the results of the study suggest that “interventional therapy with a single occluder for multiple ASDs is feasible,” especially as technical difficulties and complex anatomy make successful single device closure tricky to achieve. It’s important to remember that the accuracy of the 3D printed anatomic model is paramount in attaining single device closure in patients with multiple ASDs.

“Occluders’ sizes preestimated by the 3D printed model were similar to the size actually used for patients and larger than the size from conventional empirical estimation. These results indicate that preevaluation using the 3D printed model can avoid unnecessary interventions, the possibility of enlarging ASD by changing occluders and the financial waste of replacing occluders,” they explained.

The researchers ultimately determined that it’s feasible to use a 3D printed model to help achieve successful device closure for patients with multiple ASDs with a defect distance of ≥7 mm. The model can also help screen patients who may not be well-suited for the closure route, and should instead seek direct surgical repair.

“The combination of the 3D printing technology and ultrasound-guided interventional procedure provides a new approach for individualized therapeutic strategy of structural heart disease and in particular a reliable therapeutic method for multiple ASDs, especially for challenging cases with large defect distance,” they concluded.

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3D Printing News Briefs: April 4, 2020

It’s the first 3D Printing News Briefs of the month! To start with, SelfCAD released a new update, and ACEO is hosting a webinar series about 3D printing with silicones, while Objectify Technologies and TAGMA India are hosting a webinar series about AM adoption. Finally, SHINING 3D and Scan the World are using 3D scanners to bring art and culture to people during a time when most can’t leave their homes.

SelfCAD 2.9.2 Release

SelfCAD has released its latest software update, SelfCAD 2.9.2, which improves upon existing features and adds new ones to make 3D modeling and printing more efficient. First, there’s a new Environment Map feature in the Settings dropdown menu that lets you add lighting and scenery to your model, and even an environment map. In advanced settings, the new Macro Preview feature lets you see the results of the macros you’ve added without having to finalize your choices.

You can set a Minimum Step Size for Drawing, Transformation, and Deformation tools, and apply several operations, such as Chamfer, Fillet, Round Object, and Simplify, to Profiles. In addition, SelfCAD has fixed some bugs, and added more settings and options to the Round Object tool. If you have any questions or bugs to report, you can join the SelfCAD Facebook group or email support@selfcad.com.

ACEO Presenting 3D Silicone Printing Webinar Series

Due to newly implemented health and safety measures during the COVID-19 pandemic, ACEO continues to be operational, but is unable to receive customers right now. So, in an effort to stay connected during these strange times, the company’s team of application specialists, design engineers, and material experts are presenting a series of webinars – in English – all about silicone 3D printing.

The first one, “ACEO Basics,” will be held Tuesday, April 7, from 9-9:30 CET, and Wednesday, April 8, from 4-4:30 CET. You can sign up for the webinars here; the event password is jVMGwgX$242. Future topics for the series, with dates not yet announced, are “Real Silicones,” “Design Freedom,” and “ACEO Use Cases.” Please email service@aceo3d.com with your name, company/organization, and country if you’d like to sign up. A modern browser (i.e. not Internet Explorer) is recommended to watch the webinars.

Objectify Technologies and TAGMA India Holding Webinars

As many people around the world are staying indoors and away from other people during the pandemic, it’s easy to get bored. But, you can spend your time in a productive way, which is why Objectify Technologies and TAGMA India are holding their own 3D printing webinar series together. The series, themed “3D Printing: Prototype to Production,” was created to promote adoption of and spread awareness about additive manufacturing. Webinars will begin on April 6th and go through April 14th, with topics such as Additive Manufacturing/3D Printing 101, Learnings and Misconceptions, and Current Challenges and Demand of the Industry.

“To help engineers around the world learn something new in this lockdown time, we have come up with a series of webinars on Additive Manufacturing (AM). The idea behind this webinar is to spread awareness regarding the AM technology and help companies in their journey towards industry 4.0,” said Ankit Sahu, Founder & Director, Objectify Technologies Pvt Ltd. “The objective is to encourage individuals ranging from students, researchers, and industrialist, on 3D Printing and the value it possesses for Industry 4.0.

“I thank Mr. DK Sharma, President TAGMA India and the entire team of TAGMA for their support. During this challenging time, it’s the collective effort that will help us all grow. Let us all do our bit to help the industry in skill development.”

3D Scanning to Build a Museum Without Walls

Continuing on in our list of things to do while stuck inside during the coronavirus crisis, SHINING 3D has been working with MyMiniFactoryto to digitize important artifacts for its Scan the World community-built initiative, which archives 3D printable sculptures and other culturally significant objects. Together, they are basically building a 3D museum without walls that anyone can access at any time and from anywhere. Many museums open their data with an open license  in 2D, but don’t have the necessary resources to do so in 3D. Scan the World founder and manager Jon Beck is offering museums a free end-to-end service of scanning the sculptures, with the EinScan Pro 2X Plus, before processing the data into 3D models and uploading them to the museum’s Scan the World profile.

“The quality is very nice for the price that you pay. Scanning is still quite a high-level-entry technology, but what SHINING 3D has been able to do is to create an accessible affordable product, which still produces very good results for a wide range of industries, for me working with sculptures I haven’t found any issues so far working with marble and plaster sculptures and even bronze sculptures. EinScan has been able to solve all of these problems for me,” Beck said.

“There is so much story behind every single artwork whether it’s an original or it’s a copy which is quite beautiful and so, working with each member of staff in the museum who want to tell a different story about their collection is great.”

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3D Printing News Briefs: March 10, 2020

The big story in today’s 3D Printing News Briefs is the postponing of the Materialise World Summit. Then we’ll finish with a little business news, as 3D PRINT UK is moving to expanded premises. Finally, starting this week, you can get QUANT-U’s 3D printed silicone midsoles at ECCO’s flagship Zürich store for a limited time.

Materialise World Summit Postponed

Every two years, Materialise holds its Materialise World Summit (MWS) in Brussels, Belgium, gathering together the industry’s thought leaders and decision makers so they can share ideas about the additive manufacturing industry. This event typically takes place in the spring, which was the original plan for this year’s MWS…but not anymore. MWS 2020, originally scheduled for May 14-15, has been postponed, due to, as the company’s Kristof Sehmke tells us, “the coronavirus and its impact on international traffic.”

MWS 2020 will now take place November 5-6, which makes it a busy month considering that will just one week before formnext in Germany. This isn’t the only major industry event that’s had to change its plans due to the COVID-19 outbreak – JEC World, originally scheduled for last  week, has been pushed back to May, and after several big companies originally planning to attend the upcoming SXSW dropped out, including Apple, Facebook, Amazon Studios, TikTok, Intel, and Warner Music, the Texas-based conference was called off. With California Governor Gavin Newsome declaring a state of emergency in California over the coronavirus, should we all cancel our plans for RAPID + TCT next month? Time will only tell.

3D PRINT UK Moves to Bigger Facility

Moving on to some better news, 3DPRINTUK has just finished the move to its new purpose-designed facility in North London’s Leyton Industrial Village. The service provider of polymer SLS 3D printing solutions for manufacturing applications was seeing increased demand for low volume production, and determined that a move was needed to accommodate the company’s current, and future, plans for expansion. 3DPRINTUK’s new home is larger, with nearly 10,000 square feet of space, and was custom-designed to hold the company’s EOS polymer SLS 3D printers, as well as offer a space for post-processing operations and a break down room that’s sealed to avoid powder contamination.

“At 3DPRINTUK we are able to work with our customers — and potential new customers — to illustrate when and why the SLS process will work for them. But we are not afraid to tell them when it won’t, either. This is really important to us, and something the industry at large is not very good at confronting,” stated Nick Allen, 3DPRINTUK’s Founder and Managing Director. “I think this approach has contributed to our growth, which has been organic year on year, and the new premises are testament to that. We are still settling in, but the printers have been working non-stop since we got here and we are looking to further expand our capacity in the near future.”

QUANT-U’s In-store Experience at ECCO

In 2018, the Innovation Lab at Danish heritage footwear brand and manufacturer ECCO introduced an experimental footwear customization project called QUANT-U, which uses real-time analysis, data-driven design, and in-store 3D printing to create custom, personalized midsoles out of a heat cured two-component silicone in just two hours. The QUANT-U experience is now coming to ECCO’s flagship Zürich store as an exclusive pop-up event from now until April 15, with a “unique limited collection” available to both men and women, along with the full customization service.

The process is simple – 3D scanners determine your orthotic fit in 30 seconds, so your midsoles have the correct shoe size and arch height. Then, during a walking analysis, wearable sensors will create an accurate representation of how you move around. The anatomical scan and the sensor data will help QUANT-U build a unique digital footprint just for you, which leads to customized, 3D printed midsoles within two hours. You can use the cloud-based service to print your own midsoles from any location and have them shipped to you, but at the upcoming ECCO pop-up event, you can just pick them up in the store. Book your fitting now!

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3D Printed Wireless Earbuds Help Enhance Hearing and Reduce Stigma Around Traditional Hearing Aids

Manchester Metropolitan University graduate Elen Parry, a current Industrial Digitalisation masters student at the university and an International Autodesk Student Ambassador for the UK, is focused on using “Human-Centred Design methods” to reduce exclusion against people. Her current project is a 3D printed wireless earbud concept, aimed at helping people with hearing disabilities fight the stigma around traditional hearing aids, while enhancing their hearing at the same time.

Parry’s HeX earbuds, which were chosen by the Design Council’s CEO Sarah Weir as the top pick for this year’s ‘New Designers’ event, are audio headphones that can also be used as an advanced hearing device. The concept calls for the use of an advanced chip, which would receive and process sound signals and be able to differentiate and control what you actually want to hear and normal background noise. Users could decrease or increase the volume of their environment, which could help extend their ability to hear while at the same time protecting them against hearing loss.

Thanks to technology like 3D printing and connected manufacturing systems, it’s now possible to produce devices like hearing aids and earbuds, and combined products like HeX, on a large scale.

“My mission is to encourage social inclusion through my designs, to create improved situations for everyone. The driving principle behind creating HeX earbuds was to create a hearing device that is for everyone – whether you live with hearing loss or perfect hearing,” said Parry.

“People with disabilities often feel excluded and conspicuous because of their medical devices, so I want to transform hearing aids into a desirable wearable tech product that gives people enhanced hearing, style and confidence – something that anyone might want to wear.

“3D printing enables us to manufacture them quickly and relatively simply, so HeX earbuds could be easily produced for a mass audience.”

The HeX earbuds would be made out of silicone, with single to three flange protection and medical-grade titanium casing, and able to be personalized and 3D printed to exactly fit any ear size or shape. The product’s hexagonal shape offers a more natural, multi-directional hearing experience, which would make it possible for users to hear and process a multitude of different sounds. The idea is for the hearing aid earbuds to also provide the latest connective technologies, so that no matter a person’s hearing ability or lack thereof, HeX is still a sought after product in the mass market.

“It was my intention to design an accessible hearing aid that removes social barriers and can enhance human ability, making it desirable to a wider range of people,” Parry wrote on her site.

For instance, HeX users could connect with other devices in order to easily complete tasks like streaming music or answering the phone while out and about through the use of embedded Bluetooth, infrared, and motion technologies.

Additional technologies Parry hopes to incorporate into HeX include rechargeable graphene batteries, along with dual connectivity strips for fast charging.

A 3D printed prototype of Parry’s HeX earbud concept has already been produced at the university’s advanced 3D printing and digital manufacturing hub Print City, which is open to both industry and researchers.

“This is one of many examples of how additive manufacturing and out-of-the box thinking by Elen disrupts the current design of medical devices,” said Professor Craig Banks, the academic lead of Print City.

Few industries have been affected quite as much by 3D printing as the hearing aid manufacturing industry, which switched entirely to 3D printing several years ago after Phonak, owned by Sonova, began using the technology to produce its hearing aids. The global company was seeing such success with 3D printing that the rest of the industry noticed, and quickly followed suit. Not long after, other production methods in the hearing aid world were basically wiped out by 3D printing.

With innovative products like the HeX earbuds, and makers like Parry who are conscious of and fight back against the social issues of the day, we’re truly seeing what 3D printing is capable of helping us create. I bet we haven’t even cracked the surface yet.

[Source: Design Products & Applications / Images: Elen Parry]

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Sterne Bringing Silicone 3D Printing to COMPAMED Trade Fair

Sterne Elastomere, a company located in the south of France, specializes in manufacturing items out of silicone materials for industries such as food and drink, mass transit, medical, nuclear, and pharmaceuticals and cosmetics. Two years ago, Sterne made its move into the 3D printing world and debuted its SiO-Shaping 1601 silicone 3D printer at K 2016, a top plastics and rubber trade show, for the first time.

In order to provide its clients with 3D printed silicone prototypes that possessed properties similar to that of the final product, Sterne developed its technology so it could deposit filaments of 100% UV-cured silicone. It’s definitely not easy to 3D print with silicone, due to properties that make it unable to be heated and extruded in the same way that typical thermoplastic materials can be, but companies like Sterne, Wacker Chemie, and Fripp Design Research have been making great strides over the last few years.

Over the last two years, Sterne, which has over 20 years of experience in the silicone industry, has been working hard to refine its 3D printing silicone technology, so it can be a viable alternative option for customers looking to meet their technical needs. Now the company is bringing its SiO-shaping 3D silicone printing method to COMPAMED 2018, a trade fair for medical suppliers and manufacturers which begins in a little over a week in Düsseldorf, Germany.

According to a release by the company, “Sterne is able to manufacture little to medium series on projects dedicated to 3D printing. An approved solution for pieces with a need situated between molding and extrusion technics, on specific applications both medical and short term implantable. Now, it is only in one step that devices with complex and atypical forms can be produced. A research and development department composed of 3D specialists and engineers, go with clients on project development and monitoring, perpetuating new concepts and ideas. A quick manufacturing on competitive deadlines since no design or validation of tools is necessary.”

The company’s SiO 3D silicone printing has been further refined since it was first introduced. In 2016, it promised a minimum 3D print layer height of 0.25 mm, but can now achieve a minimum of 0.1 mm (100 microns). Its SiO-Shaping 1601 silicone 3D printer offers a maximum print volume of 205 x 200 x 100 mm, along with hardness from 30 to 60 Shores A.

Sterne’s silicone 3D printing can help all of its customers with their fast prototyping needs. But its specialty is manufacturing thin, accurate silicone products for the medical sector that meet the necessary aesthetic and technical needs.

“Whether High Consistency Silicone Rubber (HCR) or Liquid Silicone Rubber (LSR), Sterne masters a large range of manufacturing process such as extrusion, molding, making, over-molding inside ISO 6, ISO 7 and ISO 8 cleanrooms,” the company’s release states.

In addition, Sterne’s SiO silicone 3D printing also offers a full panel of colors, including phosphorescent, translucent, and opaque, which is available for colors like red, yellow, black, and green. However, these colors are only available for materials that meet the necessary quality requirements according to the FDA or USP class VI medical grade.

You can see the company’s silicone 3D printing prowess for yourself at COMPAMED from November 12-15 in the Düsseldorf exhibition center. To rediscover, or see for the first time, Sterne’s range of products for the medical sector, visit the company at Stand L02 in Hall 08b.

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WACKER to open million dollar ACEO silicone 3D printing lab in the U.S.

The Munich-based WACKER chemical group is set to open its first regional 3D printing lab outside Germany at the end of 2018. Located in Ann Arbor, Michigan, the new facility will provide ACEO silicone rubber 3D printing services to the growing North American market. “In general, North America is the largest and most dynamic market […]

ECCO Steps Forward with 3D Printed Custom Silicone Midsoles

German company ViscoTec, which manufactures systems required for conveying, dosing, applying, filling, and emptying medium to high-viscosity fluids for multiple industries, including automotive, medical, and aerospace, is well-known in the 3D printing world for its two-component print head for viscous materials like silicone. The Bavaria-based company, which began working with 3D printing four years ago, employs about 200 people worldwide, and is now putting its print head to the test through a collaboration with Danish heritage footwear brand and manufacturer ECCO.

ECCO, a family-owned business founded in 1963 with factories and subsidiaries in China, Indonesia, Portugal, Slovakia, Thailand, and Vietnam, has a vision of becoming the top premium brand for leather goods and shoes. The latest innovation to be introduced by the Innovation Lab of ECCO is called QUANT-U, an experimental footwear customization project.

QUANT-U relies on three core technologies: real-time analysis, data-driven design, and in-store 3D printing. The project combines these technologies to create custom, personalized midsoles, in just two hours, out of a heat cured two-component silicone.

Most everyone likes personalized products such as shoes, but due to the necessary cost, production time, and expertise involved in making custom footwear, they’re typically not available to everyone. But thanks to ECCO’s partnership with ViscoTec, this is going to change.

3D printing of silicone midsoles with ViscoTec printhead.

In order to specifically coordinate the material properties and the process, ECCO had to rethink its approach to customization, and now plans to utilize ViscoTec’s print head technology and two-component silicone to 3D print customer-specific midsoles for its customers, so each person can enjoy their own tailored fit and comfort.

According to the Innovation Lab ECCO website for QUANT-U, “A midsole is the functional heart of the shoe. It plays a key role in the performance and comfort of your footwear. Two years of research has proven that replacing the standard PU midsoles with 3D printed silicone can tune its inherent properties; viscoelasticity, durability and temperature stability.”

The QUANT-U process has three steps, starting with using scanners and wearable sensors to measure the customer’s feet and build a unique digital footprint. This biomechanical data is then evaluated and interpreted using a sophisticated algorithm, and a unique configuration is generated through structural simulations and machine learning.

This augmented pattern is optimized for each person’s respective feet and activity level by making adjustments to its densities, patterns, and structures, and the final 3D printed midsoles are personalized according to the customer’s own orthopedic parameters for a far more comfortable fit than you’d get with typical store-bought midsoles. Within just a few hours, you’re able to take home your custom 3D printed midsoles, along with your chosen pair of ECCO shoes.

Thermal cross-linking of the individual silicone layers.

By 3D printing the two-component silicone, ECCO is able to optimally counteract the high mechanical stresses we often deal with in everyday life; this is thanks to the midsole’s algorithmic designs combining with the silicone’s unique properties. By utilizing 3D printing, ECCO will be able to fabricate large quantities of personalized midsoles.

Using ViscoTec’s print heads gives ECCO several unique advantages, such as the usage of heat cured two-component silicone and precise 3D printing results, in addition to making sure that the silicone is uniformly mixed in the static mixing tube.

The footwear industry, which often utilizes 3D printing, has been growing fast over the last few years, with its global market expected to reach $371.8 billion by 2020. We often see 3D printed insoles and midsoles available for purchase now, and ECCO’s collaboration with ViscoTec and its unique 3D print head will certainly help keep it in the game.

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[Images provided by ViscoTec]