SAVE THE DATE: On Thursday, June 6, 2019 at 2pm, EDT, BTG Lab’s Dr. Giles Dillingham will offer insight how to surface sensitive inspections and preparations deliver increased bond reliability.

Get a review of surface sensitive inspections, a definition of cleanliness for critical applications, a look at variables in medical device surface preparations, and how awareness of these variables permits implementation of simple process control steps that significantly increase bond reliability.

Meet your presenter: Dr. Giles Dillingham has worked in the areas of surfaces, interfaces, and adhesive bonding for 30 years, and has more than 120 publications and patents in these areas. After receiving his Ph.D. in materials science from the University of Cincinnati in 1987, Dillingham worked in the Advanced Composites Laboratory of the Dow Chemical Co. Returning to Cincinnati he worked on plasma processing of materials and adhesive bonding of advanced composites while incorporating and growing BTG Labs since 2001.

Click here to register today.

A University of Maryland unmanned aircraft delivered a donor kidney to surgeons at the University of Maryland Medical Center for successful transplantation into a 44-year-old woman from Baltimore, who spent eight years on dialysis before undergoing the transplant procedure. This success shows the potential of unmanned aircraft systems (UAS) delivering organs faster, safer, and with more availability than traditional transport methods.

The patient who was discharged from UMMC on Tuesday said "This whole thing is amazing."

The momentous flight was a collaboration between transplant physicians and researchers at the University of Maryland School of Medicine (UMSOM) in Baltimore; aviation and engineering experts at the University of Maryland (UMD); the University of Maryland Medical Center; and collaborators at the Living Legacy Foundation of Maryland (The LLF).

Among the many technological firsts of this effort include: a specially designed, high-tech apparatus for maintaining and monitoring a viable human organ; a custom-built UAS with eight rotors and multiple powertrains to ensure consistently reliable performance, even in the case of a possible component failure; the use of a wireless mesh network to control the UAS, monitor aircraft status, and provide communications for the ground crew at multiple locations; and aircraft operating systems that combined best practices from both UAS and organ transport standards.

“We had to create a new system that was still within the regulatory structure of the FAA, but also capable of carrying the additional weight of the organ, cameras, and organ tracking, communications, and safety systems over an urban, densely populated area – for a longer distance and with more endurance,” said Matthew Scassero, MPA, director of UMD’s UAS Test Site, part of A. James Clark School of Engineering. “There’s a tremendous amount of pressure knowing there’s a person waiting for that organ, but it’s also a special privilege to be a part of this critical mission.” 

Designing a UAS organ delivery system
To create a UAS designed to carry an organ and provide real-time monitoring of its condition, Scalea partnered with several medical technology companies to design and develop the Human Organ Monitoring and Quality Assurance Apparatus for Long-Distance Travel (HOMAL; patent pending). It measures and maintains temperature, barometric pressure, altitude, vibration, and location (via GPS) during transportation and transmits the information to the smartphones of transplant personnel.

The unmanned aircraft and operating systems were designed by UMD UAS Test Site engineers to meet the rigid medical, technical, and regulatory demands of carrying a donor organ for human transplantation.

“We built in a lot of redundancies, because we want to do everything possible to protect the payload,” said Anthony Pucciarella, director of operations at the UMD UAS Test Site. These safeguards included backup propellers and motors, dual batteries, a backup power distribution board, and a parachute recovery system (in case the entire aircraft fails). 

Maryland faculty and researchers believe this prototype organ transport blazes a trail for the use of UAS to expand access to donated organs, improving outcomes for more people in need of organ transplants.

“As a result of the outstanding collaboration among surgeons, engineers, the Federal Aviation Administration (FAA), organ procurement specialists, pilots, nurses, and, ultimately, the patient, we were able to make a pioneering breakthrough in transplantation,” said Joseph Scalea, MD, assistant professor of surgery at UMSOM, project lead, and one of the surgeons who performed the transplant at UMMC.

Prior to this landmark organ delivery flight, the Maryland partners worked together to develop and test the UAS by first successfully transporting saline, blood tubes, and other materials, and then by transporting a healthy, but nonviable, human kidney. These test flights were preceded in 2016 by the state of Maryland’s first civil unmanned aerial delivery of simulated medical cargo, a collaborative effort between UMD’s UAS Test Site and the University of Maryland Shore Regional Health in Easton, Maryland, to illustrate how the use of UAS could radically change medical care and impact the lives of real people.

“This history-making flight not only represents a breakthrough from a technological point of view, but provides an exemplary demonstration of how engineering expertise and ingenuity ultimately serve human needs – in this case, the need to improve the reliability and efficiency of organ delivery to hospitals conducting transplant surgery,” said Darryll J. Pines, Ph.D., dean of the A. James Clark School of Engineering and Nariman Farvardin Professor of Aerospace Engineering. “As astonishing as this breakthrough is from a purely engineering point of view, there’s a larger purpose at stake. It’s ultimately not about the technology; it’s about enhancing human life.”

DISCLOSURE: Dr. Scalea is founder of a private data analytics company, Transplant Logistics and Informatics. Funding for this research was provided by the Maryland Technology Development Corporation (TEDCO) with additional resources from the UAS Test Site, UMSOM, UMMC, the University of Maryland, Baltimore, Office of Technology Transfer, and the City of Baltimore.

Assembling a microrobot used to require a pair of needle-nosed tweezers, a microscope, steady hands, and at least eight hours. But now University of Toronto (U of T) engineering researchers have developed a method that requires only a 3D printer and 20 minutes.

In the lab of Professor Eric Diller, researchers create magnetized microrobots – the size of the head of a pin – that can travel through fluid-filled vessels and organs within the human body. Diller and his team control the motion of these microrobots wirelessly using magnetic fields.

Each microrobot is built by precisely arranging microscopic sections of magnetic needles atop a flat, flexible material. Once deployed, the researchers apply magnetic fields to induce microrobots to travel with worm-like motion through fluid channels or close its tiny mechanical jaws to take a tissue sample.

"These robots are quite difficult and labor-intensive to fabricate because the process requires precision," says graduate student, Tianqi Xu. "Also because of the need for manual assembly, it's more difficult to make these robots smaller, which is a major goal of our research."

That is why Xu and his lab mates developed an automated approach that significantly cuts down on design and development time, expanding the types of microrobots they can manufacture.

Smaller and more complex microrobots are needed for future medical applications, such as targeted drug delivery, assisted fertilization, or biopsies.

"If we were taking samples in the urinary tract or within fluid cavities of the brain – we envision that an optimized technique would be instrumental in scaling down surgical robotic tools," Diller says.

To demonstrate the capabilities of their new technique, the researchers devised more than 20 different robotic shapes, which were then programmed into a 3D printer. The printer then builds and solidifies the design, orienting the magnetically patterned particles as part of the process.

"Previously, we would prepare one shape and manually design it, spend weeks planning it, before we could fabricate it. And that's just one shape," Diller says. "Then when we build it, we would inevitably discover specific quirks – for example, we might have to tweak it to be a little bigger or thinner to make it work."

"Now we can program the shapes and click print," Xu adds. "We can iterate, design and refine it easily. We have the power to really explore new designs now."

The researchers' optimized approach opens the doors for developing even smaller and more complex microrobots than the current millimeter-size.

"We think it's promising that we could one day go 10x smaller," Diller says.

Diller's lab plans to use the automated process to explore more sophisticated and complicated shapes of microrobots.

"As a robotics research community, there's a need to explore this space of tiny medical robots," Diller adds. "Being able to optimize designs is a really critical aspect of what the field needs."

“Additive is booming,” says Alaedeen Abu-Mulaweh, director of engineering at Nexxt Spine a medical device company focused on designing, manufacturing and distributing innovative spinal implant solutions.

In a release from the company, which designs and manufactures 100% of its implants from its facility in Noblesville, Indiana, only began its additive manufacturing (AM) journey two years ago – and in that time has come a long way. So, the company is taking delivery of its fourth and fifth Concept Laser Mlab 100R machines.

Established in 2009 and initially producing specialty spinal screws, rods, and plates using conventional subtractive manufacturing techniques, Nexxt Spine’s first investment in metal additive manufacturing (MAM) was the acquisition of its a Concept Laser Mlab 100R in 2017.

“We used the first Mlab primarily for R&D purposes, but we soon realized 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 maximize healing. 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,” Abu-Mulaweh says.

The investment in Concept Laser Mlab machines has allowed the Nexxt Spine team to take ownership of the entire design, production, and distribution process in-house, eliminating the need for contract manufacturers and accelerating the speed of development and commercialization. 

Focus on core science
The team at Nexxt Spine are pioneers in the design and development of spinal fusion implants that incorporate interconnected micro-lattice architectures with the goal of promoting osteoconduction, osteointegration, and bony fusion.

Launched in 2017 was its Nexxt Matrixx System – a collection of porous titanium spinal fusion implants that interweave highly differentiated surface texturing technology with novel 3D-printed cellular scaffolding. Deviating from the status quo, where other medical manufacturers have used AM to develop devices that directly mimic bone’s trabecular geometry, Nexxt Spine blends cellular porosity, inspired by natural bone biology, with core engineering fundamentals to develop structurally sound devices, optimized for fusion.

“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. 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,” says Abu-Mulaweh.

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

Additive opens new frontiers
With design, manufacturing, and distributions functions in-house, combined with the shift to serial AM production, Nexxt Spine is well-placed to service and scale to meet the growth in demand for spinal fusion device.