medical device Archives - Perfect 3D Printing Filament

LuminoGO: Comfortable and Sustainable 3D Printed Face Mask

LUMINO was founded by Bernhard Neuwirth, Michael Marcovici and Nadine Damblon to provide a new type of face mask that would be comfortable and reusable. The LuminoGo mask allows the wearer’s face to be fully visible and sterilizes breathing air with UVC light or with an integrated filter. Using Shapeways’ services to 3D print nearly all of the parts for the mask, the LUMINO team was able to prototype quickly and affordably with different material and color options.

We interviewed Bernhard Neuwirth, CTO of LUMINO, to understand how they utilized Shapeways’ 3D printing technology and services to develop their innovative face mask.

Can you take us through the start of LUMINO?

When the pandemic
started in China, my business partner Michael Marcovici and I, were in the
business of freeze dryer production. Our business slowed down immediately, as
we could not get many needed parts anymore. While we have been in lockdown in
Austria we started to look into the mask market and the various designs.

*LuminoGO – UV-C based ventilated sterilizing mask. Image source: LUMINO*

How has the pandemic influenced your business decisions?

The pandemic certainly was the reason for us to look into mask design and technology. But LUMINO was certainly not created just for the pandemic, we believe the design solves many problems of current masks on the market. The currently used masks in urgent care are one-way disposable. We want a product that is nice to wear and sustainable.

Who are LUMINO’s customers?

The LUMINO mask is
a very versatile product and has up to 16 different configurations, its use
ranges from hospitals to sales personnel, from bartenders to public services
and many more. LUMINO can be configured to sterilize in one or both ways (in
and exhale) it can be equipped with ventilators for fresh air and easy
breathing. It can be used with traditional filters as well as our own developed
UVC light module that kills germs with ultraviolet light.

Shapeways was helpful in every way from early on in the project. I especially liked the very fast production options, the choice of materials and the amazing quality of the product.

Bernhard Neuwirth, CTO of LUMINO

Which parts of LUMINO’s products are 3D printed? Why did you choose to 3D print them?

Almost all parts
are 3D printed. The main reasons for us have been fast prototyping, fast
production, choice of materials and colours, which is important for branding
and personalization. The big difference with competitors is that we have
already working prototypes.

*LuminoGO in multiple colors. Image source: LUMINO*

What is the benefit of using Shapeways over more traditional manufacturing methods?

Shapeways was
helpful in every way from early on in the project. I especially liked the very
fast production options, the choice of materials and the amazing quality of the
product. Traditional production methods would be injection moulding. We will
certainly do that in the future. Meanwhile we produce already, while optimising
the product. We use 3D-print as a production method.

What 3D printing materials do you use and why?

We mainly use Nylon in SLS (Versatile Plastic) as material. It is cost-effective, high resolution, heat and moisture resistant, and nearly unbreakable. Furthermore there is no allergic reaction with the human wearer (good biocompatibility).

How did you find Shapeways?

I’ve known
Shapeways for many years as one of the top addresses for 3D printing, so we did
not need to search actually.

How has Shapeways’ speed of manufacturing helped with your production process?

We had about 4
iterations of prototyping, most of the time we used the fastest production and
shipping option and have saved overall probably a month in development time.

What is the most important aspect of working with Shapeways for you?

We wanted a
partner that can deliver even in difficult times. We were amazed that all the
delivery was on time and that we could easily reach sales to get support.

What are some of LUMINO’s ambitions for the future?

The aim of the [Indiegogo] campaign is to get to the market, meet the minimum order quantity for many of the electronics parts of the product and get certification for the product in the main markets.

Prototype with Shapeways

Because 3D printing offers such a quick production turnaround, the LUMINO team was able to prototype and create their face mask in a very short amount of time. This allows them to very quickly circulate a new mask that maintains visibility, comfort and safety for anyone working in close contact with others.

Do you have your own innovative ideas? Upload your design and start printing with Shapeways now.

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How is 3D Printing Innovating Medical Research in 2020?

3D printing technologies are pushing the boundaries of what was once considered only possible in science fiction novels. The advances being made by engineers from around the world are contributing to a plethora of innovations that are having a major impact on conventional medical practice. Medical researchers have been able to develop solutions in the form of patient-specific prostheses and pre-operative models, tailored, corrective insoles and orthotics, new medical devices and instruments, and 3D bioprinting and tissue engineering. In this article, we will provide a brief review of some of the latest 3D printing technologies and methods that are inspiring medical research.

Pre-operative
planning, prostheses, and implants

The rapid prototyping capability of 3D printing is offering the medical community a fast and cost-effective way of delivering life-altering medical interventions and solutions to patients. For individuals that require a prosthesis or implants such as a bionic hand or leg bone, 3D printing is providing a functional and affordable way to generate patient-tailored parts. The technology offers complete design freedom and rapid turn-around times.

Using high-resolution images, 3D printing is able to generate accurate models of human anatomy. Image data can be exported as a common medical file format, DICOM (digital imaging and communication in medicine), which can then be converted into a stereolithography format (STL) file. From this file, a 3D virtual model can be created. For orthopedic surgery, implants can be made from these models to replace fractured bones. Further, virtual or physical models can be used by surgeons in pre-operative planning and for teaching patients, alleviating their stress and anxiety by explaining what a procedure would entail.

Biological tissue
generation

In early June of this year, scientists from the University of Colorado (UC) Denver and the University of Science and Technology in China were the first to use new material to 3D print structures that could mimic cartilage. Cartilage replacement has been a notoriously difficult hurdle to cross for scientists and healthcare professionals until now. UC Denver’s mechanical engineer, professor Chris Yakacki, led the team of researchers in using a 3D printing process called digital light processing (DLP) to create a liquid crystal resin-like substance. When exposed to UV-light the researchers observed that the substance cured and formed new bonds in several thin photopolymer layers. The final cured form constituted a strong, yet soft, and compliant elastomer. when printed as a latticed, honeycomb structure, that’s when Yakacki and his team saw that it began to resemble cartilage. Their research findings were published in the journal Advanced Materials.

In addition to utilizing this breakthrough material for cartilage replacement, Yakacki also believes there is potential for liquid crystal elastomer (LCE) to be used in the creation of a spinal cage prototype. The design of complex structures like LCE’s and the use of bioinks to help produce artificial live tissue will provide the medical research community with unique scaffolds with which to generate different components of the human body.

Bioinks

One particular area gaining interest by researchers and clinicians is
the design of patient-specific bone grafts. Associate professor at the Department of Biomedical
Engineering at Texas A&M University, Dr. Akhilesh Gaharwar, believes that developing
replacement bone tissues may be an exciting prospect in the generation of
treatments to help people with dental infections, arthritis, craniofacial
defects, and bone fractures. This is where bioinks enter the scene. In a recent
publication, Dr.
Gaharwar outlines the creation of a structurally stable, biodegradable, and
highly printable bioink. Garharwar’s nanoengineered ionic covalent entanglement
(NICE) bioinks involve two reinforcement techniques known as nonreinforcement
and ionic-covalent network. The use of these two techniques results in much
more stable tissue structures.

Following bioprinting, the NICE
networks form crosslinks with encapsulated stem cells to create stronger
scaffolds. Within the period of three months, the cells start to produce
cartilage-like extracellular matrix which calcifies to form mineralized bone.
The team used next-generation RNA-sequencing technology to establish the role
of nanosilicates (a component of the bioink) in inducing the formation of bone
tissue. Dr. Gaharwar and his team successfully demonstrated the ability of NICE
bioink to create patient-specific implantable 3D frameworks for the repair of craniofacial defects.

Orthoses

Medical research centered around the custom design of orthotics still
bears the stigma of a high price tag and inaccessibility which can be an
irritable deterrent for healthcare providers trying to do the best for their
patients and a disheartening prospect for patients respectively. The revelatory
story of Matej
and his son Nik, shows how powerful a tool 3D printing can be in advancing
medical and engineering research, efficient medical practice, and optimizing
patient care.

One of the latest uses for 3D printing in the world of orthotics was the design of a cervical collar using a novel workflow for a patient with a neurological disability with no alternative means of therapy. Dr. Luke Hale and Associate Professor Dr. Deepak Kalaskar from UCL’s Institute of Musculoskeletal Sciences (IOMS) led the research which was published in Scientific Reports. The research team scanned the head and neck of the patient with a handheld scanner to generate a 3D scan mesh. This framework was then imported into Houdini software (SideFX software, version 16.5). The geometry projected onto the 3D scan conforms with it completely to create a comfortable orthosis.

Using the scan, the design of the orthosis was optimized to incorporate modifications including a porous pattern to improve ventilation. This also reduces the cost and weight of the final orthosis. Four prototypes of the cervical collar were made to accommodate patient feedback and achieve the most comfortable design. The research validated the use of using 3D printing and scanning alongside a tailored workflow for clinically beneficial outcomes while allowing for iteration, modification, and improvement of the design.

These are only some of the latest medical research advancements coming
to fruition with the revolutionary technology of 3D printing. 4D printing and
the use of novel bioinks for organ tissue generation are some more fascinating
research prospects to look forward to in 2020.

Are you a veteran of medical 3D printing looking for a bespoke manufacturing service, or, are you new to the scene and would like expert guidance? Find out how Shapeways can help with your medical 3D printing needs.

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How 3D Printing Boosts Innovation in the Medical Field

3D printing is becoming a crucial tool in the innovation of medical supplies, equipment and procedures as it caters to a rising demand in patient-specific products. The technology’s capacity for complex design, customization, time/cost efficiency and the availability of sterilizable, biocompatible materials have all led to substantial advancements in the medical industry in recent years. Here are a few examples of how 3D printing has led to positive progress.

Training & Practicing

3D Printing offers an affordable way of printing specific models that can allow for more precise training for surgeons. Models of organs, for example, can be printed in a material that resembles human tissue, like silicone, and can be a more affordable and less-stressful source of practice than using human cadavers. Thanks to CTs, MRIs and 3D scanning technology, physicians can 3D print exact replicas of organs, bones, or any other part of their patient to gain a better understanding of what they will be facing in surgery or treatment. This gives them a chance to practice and develop improved surgical planning, which can speed up surgery time, creating less chances of infection and minimizing patient trauma.

Surgical Instruments

In any surgical procedure, the utmost precision is needed to ensure success. Thanks to rapid prototyping and the ability for customization, 3D printing allows for surgeons to have access to personalized and procedure-specific instruments. These instruments can be altered to better fit a surgeon’s hands, or a patient’s anatomy, and patient specific surgical guides can increase accuracy and efficiency to greatly improve surgical outcomes. Because modifications on 3D printed tools can be achieved quickly, this equips physicians with functionally improved tools that facilitate their operative techniques and the procedure at hand. Instruments can be printed in a number of different materials depending on their needs, including titanium, stainless steel as well as sterilizable biocompatible plastics. The potential for customization is limitless, and costs do not necessarily increase with instrument complexity.

Prosthetics

Prosthetics also benefit hugely from an ability to create patient-specific models, as getting them fitted is traditionally a prolonged and expensive process. Using 3D printing to create prosthetics that can fit someone’s particular anatomy perfectly is a cheaper and faster alternative. Prosthetics can be flexible, stronger, less bulky and easily personalized with the help of 3D printing. The significantly lower costs make them a better option for children who need access to new prosthetics as they grow. With contactless 3D scanning and printing, maxillofacial prosthetics can be produced easier than ever before. Eye, nose and ear prosthetics have been printed with silicone to perfectly fit patients who have lost or were born without facial parts to restore facial geometry and aesthetic. The customization power of 3D technology will continue to make it a key player in the innovation of future prosthetics.

Orthopaedic Implants

3D printing contributes greatly to the advancement of orthopaedic implants. The possibility of geometric freedom, customization options and quick iterations have the potential to produce implants that fit patients better than ever before, therefore increasing their longevity and comfort. 3D technology also facilitates the creation of porous bone replacement scaffolds, allowing for natural bone ingrowth and ongrowth.

Hearing Aids

Thanks to 3D scanning, hearing aid shells and earpieces can be digitally fitted to exact anatomical specifications and customized pieces can be mass-produced. This has the potential of giving many more people than ever access to hearing aids with optimal fit, all thanks to the digitization of the design process.

Testing / Covid Swabs

With the spread of COVID-19, the healthcare industry saw an immobilizing shortage of supplies due to the closure of traditional suppliers. 3D printing was able to meet many urgent needs by producing PPE supplies and ventilator parts at an astounding rate. Face shield designs were quickly optimized and printed by the thousands to help protect healthcare and plant workers dealing with exposure. Sterilized nasal swabs were also produced quickly to help increase testing ability. The speed and efficiency of 3D printing processes made it a crucial tool in providing immediate relief to emergency medical shortages.

Tissue Engineering

Tissue engineering focuses on finding new ways of developing or regenerating damaged tissue, creating models that can be used to study tissue development or for screening drugs. In order to regenerate or grow tissue, an appropriate scaffold needs to provide the right environment for growth. 3D bioprinting provides more control than conventional methods and enables the fabrication of structurally and biologically complex constructs and scaffolds to facilitate tissue engineering with the use of bio-inks. Researchers from the Rensselaer Polytechnic Institute have developed a way of 3D printing living skin by using two sets of bio-inks. Grafted onto the backs of immunodeficient mice, the blood vessels of the 3D printed skin successfully transferred blood and nutrients to the mice’s blood vessels. Though this research is not quite ready for use with humans, it is one of many examples of the immense potential of 3D printing in live tissue engineering.

Medical Grade Materials

To print medical equipment it is especially important that, depending on the application, the material be compatible with a biological system. Instruments must be sterilizable and strong, implants or other pieces to be placed inside the body must be biocompatible and corrosion-resistant. 3D printing provides many plastics and metals that are suitable. Nylon PA-12 is durable, sterilizable and corrosion-resistant and is also one of the most affordable medical grade materials to use. Stainless steel is also biocompatible and good for surgical instruments and temporary implants.

3D printing is quickly becoming an essential tool in the medical industry where personalization and precision are key. From improved surgical planning and tools, to better fitting prosthetics and implants and advancing tissue regeneration, 3D printing will only continue to boost the potential to improve and save lives.

Shapeways offers industrial, medical-grade materials in our FDA-listed facilities. For all of your medical 3D printing needs, find out how we can help.

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How 3D Printing is Contributing to COVID-19 Relief

The rapid spread of Coronavirus across the world has meant that healthcare facilities have quickly become overloaded and are experiencing a severe deficit in necessary equipment and supplies. Many members of the 3D printing community have set to work producing protective wear for medical personnel, as well as anti-contamination accessories and more. Though not everything can be fully 3D printed due to FDA regulations and the complexity of medical equipment, 3D printing offers a fast prototyping and production process so that it may step in where traditional manufacturing falls short.

1. Valves & Ventilator Parts

As Coronavirus cases in hospitals grew, valves and other ventilator parts quickly ran out. In Italy, after the supply of Venturi valves disappeared and the original manufacturer was unable to produce more fast enough, they turned to 3D printing. A local startup, Issinova, was able to produce working parts in 24 hours. The valves were first printed using a filament extrusion system at the hospital, and were later printed using a polymer laser powder bed fusion process and a custom polyamide based material.

2. Snorkeling Mask Ventilator

Issinova also successfully tested a 3D printed adapter part printed from Nylon PA11 and PA12 to turn a commercial snorkeling mask into an emergency non-invasive respirator. Though the mask is not certified as a medical device, it has still been helpful as a last resort or in areas where other equipment is scarce.

3. Face Shields

Selvin, registered nurse, wearing a face shield 3d printed by Shapeways

Many companies like Shapeways have been contributing to the production of face shields to help supply hospitals with PPE. Shapeways’ face shields are modified versions of the Prusa design and are printed using SLS technology with medical grade materials so that they may be disinfected for repeat use. Learn more about Shapeways’ Sponsor A Face Shield program.

4. Test Swabs

The ability to test people for Coronavirus is a crucial tool in slowing down the spread and identifying asymptomatic people. Nasal swabs are typically produced using injection molding and flocking, with a piece of polyester material attached to a plastic rod. Because traditional swabs have an intentional weak point that allows them to break to fit into the vial for transport to a lab, one challenge in printing them is making sure the material used is strong enough to collect a substantial enough sample from a patient’s nose without breaking while also being able to fit into the vial. Many parties are working on developing successful designs for swabs and are able to prototype quickly, even producing as many as 50 prototypes in 36 hours. Swabs can be printed in a material that is autoclavable, which would make them reusable. Shapeways is currently working on our own swabs as well.

5. Face Masks

The concern with 3D printed face masks is that though they might provide a physical barrier, they may not provide the same fluid resistance, air filtration and infection control of an N95 mask which utilize melt-blown fabric with ultrafine fibers. There have been several designs working towards that level of protection and others that can still be helpful used in non-medical environments. LuxMea’s bespoke Nuo face masks make for a more comfortable experience wearing a mask and use interchangeable filters. Each mask can be customized for individual fit, assuring a maximum of coverage for each person. They launched a kickstarter to fund their work in April and have already doubled their goal.

6. Door Opening Accessories

Many designs for 3D printed accessories for avoiding contamination from touch have popped up, including a wrist attachment for hand sanitizer and tools for opening doors and touching buttons. 3D LifePrints created The Distancer, a joint ID card holder and door opener for healthcare professionals as a way to reduce contamination while moving through buildings. The Corona Hook from Shapeways marketplace designer N3D can be carried as a personal accessory and allows for the opening of lever style door handles. Other designs feature screw-on hands free door openers as well as personal door openers that can be used to press buttons, can all be found on the Shapeways COVID-19 supplies hub.

7. 3D Printed Quarantine Booths

In Xianning, Chinese company Winsun 3D printed quarantine booths to relieve pressure from hospitals. Each house is 10×10 meters and 2.8 meters high and the walls of 15 houses were 3D printed in 24 hours using recyclable materials such as sand and construction rubble. Each house has a bathroom, air conditioning, meets insulation requirements and can accommodate up to 2 people.

The best materials for the production of any item to help with COVID-19 relief are those that can withstand intense cleaning processes and will not deteriorate when disinfected, such as Nylon PA12. In addition, SLS and powder bed polymer fusion technologies present less porous and smoother surfaces than extrusion printers for example, making them less likely to collect bacteria in crevices and therefore more ideal. Normally all of these items would be subject to lengthy processes of clinical trials, but because of the emergency nature of the Coronavirus spread many people are stepping up quickly to help compensate for the deficit in supplies. A lot of these innovative contributions are still in early stages, testing is ongoing and the role that 3D printing can play in COVID-19 relief will continue to develop.

Want to
Help?

Many people have made successful designs downloadable on the internet so that anyone with access to a printer could contribute. You can sponsor a face mask through Shapeways or download the 3d model file to print your own. There are also door openers available in the Shapeways marketplace. If you feel like you can contribute with your design skills, upload your design now to start printing through Shapeways.

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3D Printing Medical Products – Making The Impossible Possible

When it comes to application-specific 3D printing, the medical industry presents unique challenges and benefits. Few other areas of manufacturing touch human lives in quite the same way, as the production of medical products directly impacts the quality of life.

3D printing is increasingly coming into use as a valid — and, importantly, validated — solution for the production of medical products. What can be made today, and how are those whose lives could benefit from these products able to gain access to them?

Immediate-Need Medical Supplies

One of the most critical 3D printing applications of the moment is the production of urgently needed medical supplies including personal protective equipment (PPE). Supply shortages are impacting medical personnel on the front lines of the fight against the spread of novel coronavirus as COVID-19 cases pick up around the world. 3D printing is proving its value in immediate-need PPE such as face shields, able to provide a stop-gap solution as traditional supply chains pick up. Shapeways is among the manufacturing agencies qualifying as an “essential business” during this pandemic, and is working constantly to produce necessary equipment. Read more about Shapeways’ response to and resources for COVID-19 here.

Patient-Specific Orthoses & Prostheses

Products that assist in individual mobility are much more effective when they are made for that individual. 3D printing offers the ability for manufacturers to create orthoses and prostheses that are fully personalized to fit not only the needs, but the exact anatomy of each individual. Braces, orthotics, and prosthetic limbs can all be 3D printed in durable materials to perform in real-world day-to-day life. When created through a trustworthy supplier, such devices will have been optimized with functional integration and tested in simulations and mechanical methods. Shapeways, for example, offers a market-ready solution for these uses made using EOS 3D printing technology with Nylon PA11 material. This PA11 material offers key benefits such as high elongation at break, elasticity, and high impact resistance.

Medical Devices

Medical devices including eyewear, implants, hearing aids, and surgical instruments can be 3D printed for prototyping, modifying, and completely customizing products. Rapid prototyping is speeding the time-to-market process for new products, as the latest 3D printing technologies allow for different needs during different parts of the design process. When speed is of the essence during iterative design, 3D printing can quickly produce new prototypes to get a hands-on feel for new designs and measurements. Later in the design process, realistic full-color 3D printing can produce parts that look just like the final product will. These medical devices can also be modified to suit individual or rising needs, or fully customize parts for an individual. Hearing aids, for example, are nearly all 3D printed these days, as these small devices can be made to exactly fit the wearer’s unique ear anatomy.

Surgical Tools & Guides

3D printed surgical tools and guides can be made using sterilizable materials for use directly in the operating theatre. Surgical guides can be fully personalized to fit the exact anatomy of a patient, showing surgeons exactly where to focus during an operation, saving precious time and increasing accuracy during procedures. 3D printed tools also offer the capability for custom equipment to be used, with advanced materials such as ceramics coming increasingly into play. Advances in materials science have enabled the 3D printing of tools that can be fully sterilized and safe for human contact.

Educational, Training, & Surgical Planning Models

3D printed models aren’t just for show, as medical professionals can produce patient-specific anatomies for hands-on understanding. The human mind thinks best in three dimensions, and holding an exact replica of anatomy can help a patient understand exactly what will happen during a medical procedure. Surgeons and other medical professionals can use such models to practice ahead of complex procedures, reducing time needed in the operating room and so saving the patient procedure time — encouraging faster recovery — as well as reducing the expense of running an OR. New doctors can also train in new procedures using 3D printed models that look and feel just like the real thing. Full-color, multi-material 3D printing such as with the Stratasys J750 3D printer can produce results that are astonishingly close to real life.

Medical Models

3D printing can also scale up structures for hands-on understanding. 3D printed small molecules; proteins, macromolecules, and viruses; and bacteria, cells, tissues, and other organisms can be created from digital files for scaled-up, hands-on learning and training that could not be achieved on a screen. Students of many ages, from grade school to medical student and beyond, can gain better understanding of the world around us — and the pieces that comprise it.

Bioprinting

Perhaps the pinnacle of medical 3D printing is bioprinting. In this application, living cells and tissues are 3D printed to create new structures capable of life. Often created with cellular scaffolds, tissues of organs such as the skin, liver, and kidney have been successfully 3D printed for research, drug and cosmetic testing, and even early transplant efforts. The ultimate — and still years-ahead — goal for bioprinting is to provide lab-made organs for people waiting on the organ transplant list, helping to save lives.

Offering end-to-end 3D printing manufacturing and fulfillment services to 130 countries, Shapeways offers a base to start the medical 3D printing journey. Find out more about Shapeways’ medical 3D printing offerings here.

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Copper3D Antimicrobial Filament Device Attempts To Reduce HIV Transmission From Breastfeeding

3D printing startup Copper3D, based in Chile and the US, uses nano-copper additives, and adds antimicrobial properties to polymers like PLA and TPU to create antibacterial 3D printed objects. Last year, Copper3D partnered with NASA to study microbial risks in outer space, but now the startup is working on an important project that’s a little closer to home.

According to UNICEF, the number of children and adolescents living with HIV in 2017 reached 3 million, with 430,000 newly infected people and 130,000 deaths from AIDS-related causes. UNAIDS reports that in 2018, 26,000 new HIV infections among children up to the age of 14 resulted from withdrawal of treatment during pregnancy, and breastfeeding. But even with this knowledge, the World Health Organization reports that 37.9 million people around the world were living with HIV at the end of 2018, 8.1 million of which didn’t even know they had the disease to begin with.

Companies and scientists around the globe are working to use technology to help control dangerous bacteria and viruses with high replication rates, like HIV. Copper3D has created a 3D printed device, with its copper nanotechnology, that can effectively inactivate the HIV virus under the right conditions on certain objects- a project that the startup’s Director of Innovation Daniel Martínez tells us is “the result of more than one year of research in antimicrobial polymers and the role on inactivating high replication rate viruses like HIV.”

Dr. Claudia Soto, Copper3D’s Medical Director, said, “Understanding the global problem behind the HIV statistics and analyzing the role that our antimicrobial materials could have in containing the transmission of HIV virus led us think that we could develop some kind of device that acts like an interface between mother and child to prevent the spread of this virus through breastfeeding, which is one of the main routes of infection.

“The initial idea is based on some of the few available studies that establish that copper based additives and filters can inactivate HIV virus in a solution of breastmilk, acting specifically against the protease (essential for viral replication) where copper ions non-specifically degrade the virus phospholipidic plasmatic membrane and denaturalize its nucleic acids; nevertheless, several issues such as toxicity levels, milk nutritional degradation, time for virus inactivation, or the optimal size/form of these filters remain unsolved.”

3D concept of the Viral Inactivator (patent pending)

Copper3D, led by co-founders Martínez, Dr. Soto, and CEO Andrés Acuña, began work on a project with, as the startup stated in a release sent to 3DPrint.com, “two lines of research.” Last year, they submitted a patent application for the project, called Viral Inactivation System for a Breastmilk Shield to Prevent Mother-to-Child Transmission of HIV. First, the viral inactivation effectiveness of its PLACTIVE material was tested with samples of HIV-infected breast milk, and then the team designed an object that optimizes the “viral inactivation of HIV” in the milk, acting as a mother-to-child interface during breastfeeding.

“Our purpose as a company has always been related to make a global impact through innovation in materials and nanotechnology. This line of research of active/antimicrobial medical devices and applications that opens with these studies, fills us with pride as a company. We believe that we are marking a before and after in the industry and we take this honor with a great sense of responsibility,” stated Acuña. “We will continue on the path of applied innovation, always thinking of playing an important role in the most urgent global healthcare challenges, where our antimicrobial materials, intelligent 3D designs, rigorous processes of technical validations and laboratory certifications, can generate a new category of antimicrobial/active devices that can avoid infections at a global scale and save millions of lives.”

Virology Laboratory at Hospital Clínico Universidad de Chile

The startup commissioned a proof-of-concept laboratory study at the Hospital Clínico Universidad de Chile’s Virology Laboratory to validate PLACTIVE’s potential HIV viral inactivation capacity. The study used a split-sample protocol to test and treat 20 sub-samples of HIV-1 (subtype B, cultivated from infectious clone NL4-3, with CXCR4 co- receptor).

The sub-samples were randomized into different groups: A, B, and Control. Samples for A and B were placed in either a green or blue 3D printed box, with and without the nano-copper additive; for a proper blind study, the researchers did not know which was which. The samples were exposed to the medical device for 15, 60, 120, and 900 seconds, and then cultured with HIV-1 Jukat reporter cells LTR-luciferase Cells (1G5); Copper3D performed culture measures on the samples 24, 48, 72, and 96 hours post-treatment.

“The preliminary results showed a reduction of viral replication up to of 58.6% by simply exposition of the samples to the 3D printed boxes containing copper nanoparticles. Fifteen (15) seconds of exposition were enough to achieve such a reduction. These data allow us to infer that by increasing the contact surface by a factor of 10X, we could obtain much higher inactivation rates, very close to 100% (log3) and according to our calculations, most probably in less than 5 seconds,” explained Martínez. “These results are coherent with the hypothesized reduction times proposed by Borkow, et. al. To the best of our knowledge, this is the first essay aiming to study the inactivation of HIV virus by using this new kind of polymers with antimicrobial copper nanotechnology in 3D printed objects.”

3D model of the Viral Inactivator (patent pending)

These results are pretty promising, which bolstered the team as they moved on to the second part of the study – designing a device, with a surface of contact expanded 10X, for HIV-contaminated milk, that’s embedded in nano-copper for use during breastfeeding.

“Like any innovation project, this is a constantly evolving process. We have learned a lot along the way, and we will continue designing, iterating, testing, validating and learning about antimicrobial materials and devices in the future. The preliminary results obtained in the first phase of our investigation with viral inactivation on active/antimicrobial nanocomposites materials gives us a great drive to continue in that line of research,” said Martínez. “We hope in the coming months to conclude the second phase of this study. For these purposes we develop a new antimicrobial flexible TPU based material (MDflex), with the same nanocopper additive as PLACTIVE, to test with new iterations of the design of this viral inactivation device with expanded surfaces of contact that we believe will be much more effective. These new insights will allow the development of a whole new range of active medical devices and applications, with incredible capabilities to interact with the environment, eliminating dangerous bacteria and viruses and protecting patients and users around the globe. This second and final phase of the study will be concluded in Q2 of 2020.”

Copper3D’s concept for its Viral Inactivator is to study how the antimicrobial capacity of its nano-copper materials impacts HIV inactivation, and how different shapes and designs for the 3D printed device can increase the surface of contact with breast milk, while using the nano-copper to enhance effectiveness. The device was made with various layers and “rugosities” in order to imitate what has been observed in the human gastrointestinal tract.

Collaborators at the University of Nebraska at Omaha’s Department of Biomechanics will perform mechanical characterization testing of Copper3D’s prototype.

“Copper3D has once again disrupted the field of medical devices by creating this revolutionary device that can have a tremendous impact in reducing mother-to-child transmission of HIV,” said Jorge Zuniga PhD, Associate Professor of Biomechanics with the university. “Our laboratory is fortuned to partner with Copper3D, in such an impactful project.”

Concept of applications with the Viral Inactivator

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Costa Rica: Researchers Design 3D Printed Medical Device for Suturing Extremities

Our skin protects us from invading microorganisms and foreign substances, eliminates harmful toxins, helps to regulate our core body temperature, and is in charge of receiving both tactile and thermal stimulation. But, it’s fragile and easily damaged, which can lead to open wounds that get infected. Michelle Orozco-Brenes, José A. Jiménez-Chavarría, and Dagoberto Arias-Aguilar, researchers out of Costa Rica, published a paper, titled “Design of a medical device for superficial suturing upper and lower extremities,” about their work creating a medical suturing device.

“This work presents the design for a class 2 medical device that meets the basic requirements of the current and known suturing methods in Costa Rica,” the abstract states. “The design process was achieved in three main stages, (i)Research on similar technologies; e.g. The operation principles of a sewing machine, materials used; (ii) The study of types of skin traumas; (iii) General approach toward the suturing device, including device functionality, integration with the human body and manufacturing process. The device model was designed and fabricated using 3D printing technology, this allowed the team to analyze ergonomics, the assembly of the parts and the equipment’s motion. The printed prototype made it possible for potential users to provide feedback on the design and suggestions for improvement.”

Figure 1. SolidWorks design of the medical device to be printed.

Suturing means to connect blood vessels with a specific material, such as thread, when tissue is torn in a way that halts natural healing. You can find many suturing devices on the market around the world, but Costa Rican hospitals don’t typically use them, as they are complex and costly. So the team set out to design a class 2 FDA electronic medical device that could both reduce tissue damage and uniformly, and quickly, suture a wound so an “aesthetically acceptable” scar is left behind.

“The idea for a medical device to suture arose for three main reasons,” the researchers wrote. “First, physicians were noticing poorly sutured wounds that would result in large scars. These in some cases required further procedures like plastic surgery. Also, time consumption, making the search for a device that would make the method faster a necessity. Finally, sutures stitched by hand are sometimes left too loose or too tight, causing bleeding from the wound.”

Table 2. Schematic representation of the function of the suturing medical device.

Device specifications were functionality, cost, durability, modularity, and reliability. They used SOLIDWORKS software to create the design for their model, which required three specific functions:

Stabilize the skin
Rotate the needle on its axis to join tissue sections
Initiate and finish with the least possible amount of user interference

“The final design was oriented to have the area and volume of the shell as similar as possible for the needle to rotate 360° without any problem,” the researchers explained.

In order to test out several functionality features, they 3D printed a prototype first, using Polyjet technology to fabricate the piston and and an FDM printer for most of the other parts. Due to its high strength and toughness, corrosion and fatigue resistance, and low friction coefficient, they used the AISI 316L alloy for the prototype.

The suturing device has seven main components. The shell encases the device, while two guides allow the movement of the guide pin, which is used to tie a double knot. Rollers provide the rotational movement that allows for the suturing, while a piston gives the rollers their movement. The final parts are a ½ circle needle with tapered tip, and nylon thread, which has good elasticity for skin retention and closure.

Figure 2. Final design for the suturing medical device.

To use the device, the needle is first threaded in its initial position at the top of the shell, and then set in the rollers. The piston lowers the shell, and the needle is rotated 270° to pinch the tissue for suturing. The knot is initiated when the rollers, guided by the holder, turn 45° to the right, and the pin is set in place over the guide. The needle makes a 360° turn on its axis, and the guides turn over the shell and let go of the guide pin, “letting it fall due to gravity over the guides” beneath it to finish the first knot. The first few steps are repeated, and after the final full turn, the user tenses the thread through the top hole, until it’s kept that way through the guide pin. The lower guides will release, and the guide pin is removed, completing the double knot.

“After the prototype was assembled and design functions checked, the final step required a survey,” the team wrote. “The study contained questions about the medical device presented via prototype and they were asked to elaborate on their answers regarding their opinion as health professionals.”

Table 3. Survey on trained medical physicians.

The 3D printed prototype device was presented to Dr. Stephanie Gómez Najéra, Dr. Pamela Villareal Valverde, and Dr. Tatiana Piedra Chacón. The numbers listed in the survey results are the average between these three Costa Rican physicians, and the scale, based on the Likert scale, goes from 1-5, with 1 being strongly disagree and 5 being strongly agree.

“The comments reference that the usefulness depends on the context of where it would be applied, for example a jail or emergency room,” the researchers wrote of the doctors’ opinions on their device.

“One main drawback is that the device may not be suitable for all types of wounds. Other concerns raised by the physicians were related to the price and size of the device.”

Based on observations from the survey, the researchers modified the final prototype to “improve its ergonomic factor” by adding a holder at the top of the shell for more stability and easier manipulation.

Next steps include standardizing parts of the prototype so that some pieces can be purchased in the market, and optimizing the mechanisms, like the servomotor, sensors, and motors, that generate the device’s movements.

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Nexxt Spine Increases Investment in GE Additive’s Concept Laser Metal 3D Printing

Founded in 2009, Indiana-based medical device company Nexxt Spine first invested in metal 3D printing two years ago, with the purchase of its first Concept Laser Mlab 100R system. The company works in the expanding spinal cage sector and is working to increase procedural efficiency and patient outcomes for those suffering from debilitating spinal conditions. While Nexxt Spine originally used more traditional manufacturing methods to fabricate specialty spinal plates, rods, and screws, the business is scaling rapidly and increasing its metal additive investment with the installation of its fourth and fifth Mlab 100R systems from GE Additive this month.

Alaedeen Abu-Mulaweh, the director of engineering at Nexxt Spine, stated, “Additive is booming.”

Nexxt Spine aims to drive medical device innovation, and designs, manufactures, and distributes all of its spinal implants from its Noblesville facility. With its latest 3D printer purchase, the company is looking to, as GE Additive put it, “tap further into the growing global spinal implant market.”

“We are seeing ongoing adoption of additive manufacturing in the orthopaedic industry and an exciting shift from research and development to serial production,” said Stephan Zeidler, senior global and key accounts director for the medical sector at GE Additive. “Early innovators like Nexxt Spine are scaling up and there is a significant increase in production volumes.”

By continuing to invest in Concept Laser’s LaserCUSING metal 3D printing technology, which has been used in medical and military applications, to name just a few, Nexxt Spine is able to eliminate the need for contract manufacturers. Because it now owns the whole design, production and distribution process on-site, the company can increase how quickly it develops and commercializes its spinal implants.

Alaedeen Abu-Mulaweh

“We used the first Mlab primarily for R&D purposes, but we soon realised that further investment in additive technology could add value not only to our overall growth strategy, but also at a clinical application level with the ability to develop implants with very intricate micro-geometries that could maximise healing,” Alaedeen explained. “Over the past two years, we have made a seamless jump from R&D to serial production and in doing so have significantly accelerated the time from concept to commercialization.

“Like I said, additive is absolutely booming. It is driving our business and innovation strategy forward and our design team is actively developing and testing new applications, parameters and surgical devices to target new markets. We are excited for what the future holds for us.”

Nexxt Spine knows what it’s talking about when it comes to designing, developing, and fabricating spinal fusion implants – its products use interconnected micro-lattice architectures to promote osteoconduction, osteointegration, and boney fusion. A flagship product introduced in 2017 is the company’s Nexxt Matrixx System, which includes multiple porous titanium spinal fusion implants that combine novel 3D printed cellular scaffolding with highly differentiated surface texturing technology.

The company blends cellular porosity that’s inspired by the natural biology of bones with the underlying fundamentals of engineering in order to create fusion-optimized, structurally sound medical devices. This is a big difference from other medical manufacturers that use 3D printing to create devices which merely mimic the trabecular geometry of bone.

“Titanium – porous or otherwise – is physically incapable of biological remodeling, so using additive to directly mimic the structural randomness of bone doesn’t make a whole lot of sense,” Alaedeen explained. “Rather than simply looking like bone, Nexxt Matrixx® was designed with functionality in mind to fulfil our vision of actively facilitating the body’s natural power of cellular healing.”

Now that Nexxt Spine has shifted to serial additive manufacturing production and moved all of its design, manufacturing and distribution functions on-site in Indiana, it will be able to service customers and scale up as much as it needs to continue meeting the increased demand for better spinal fusion implants.

Zeidler concluded, “Nexxt Spine is another great example that shows the power of our Mlab machine, which is proven to be an easily accessible machine for research & development, with the capability to be a reliable, scalable and modular production machine at the same time.”

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[Images provided by GE Additive]