Peak Performance Compounding LLC now offers medical polymer compounding in a dedicated white room environment. Peak has become a leading player in the medical material community by offering fast lead times, no minimum run sizes, and flexibility with customer requirements. Peak’s experienced staff understands the unique needs of the medical device market and strictly adheres to the quality and regulatory standards of the industry.

The 1,000ft² white room is climate controlled and equipped with a 32mm co-rotating twin-screw extruder, which is dedicated to medical material processing.  This medical compounding line offers multiple feeders for dispersion of highly filled materials and is suited to process commodity resins (including PE, PP, PS, and ABS), engineering polymers (including PEBA, PA 11/12, and PC) and high-temperature materials (including PEEK, PAEK, PEKK, PSU, and PEI). 

"Our team has extensive experience in medical material processing, and we look forward to serving medical manufacturers with the highest degree of material quality and service," says Todd Marchand, president of Peak Performance Compounding LLC.  Compounding capabilities include custom-colored polymers and radiopacificed materials (using barium sulfate, bismuth subcarbonate, bismuth oxychloride & tungsten) for Class I and Class II medical device applications, including minimally invasive devices and components.

By taking advantage of a phenomenon that leads to fractures in metal, MIT researchers have designed medical devices that could be used inside the body as stents, staples, or drug depots, then safely broken down on demand when they’re no longer needed.

The researchers showed that biomedical devices made from aluminum can be disintegrated by exposing them to a liquid metal known as eutectic gallium-indium (EGaIn). In practice, this might work by painting the liquid onto staples used to hold skin together, for example, or by administering EGaIn microparticles to patients.

Triggering the disintegration of such devices this way could eliminate the need for surgical or endoscopic procedures to remove them, the researchers say.

“It’s a really dramatic phenomenon that can be applied to several settings,” says Giovanni Traverso, the Karl van Tassel Career Development Assistant Professor of Mechanical Engineering at MIT and a gastroenterologist at Brigham and Women’s Hospital. “What this enables, potentially, is the ability to have systems that don’t require an intervention such as an endoscopy or surgical procedure for removal of devices.”

Traverso is the senior author of the study, which appears in Advanced Materials. Vivian Feig, an MIT postdoc, is the lead author of the paper.

Breaking down metals
For several years, Traverso’s lab has been working on ingestible devices that could remain in the digestive tract for days or weeks, releasing drugs on a specific schedule.

Most of those devices are made from polymers, but recently the researchers have been exploring the possibility of using metals, which are stronger and more durable. However, one of the challenges of delivering metal devices is finding a way to remove them once they’re no longer needed.

To create devices that could be broken down on demand inside the body, the MIT team drew inspiration from a phenomenon known as liquid metal embrittlement. This process has been well-studied as a source of failure in metal structures, including those made from zinc and stainless steel.

“It’s known that certain combinations of liquid metals can actually get into the grain boundaries of solid metals and cause them to dramatically weaken and fail,” Feig says. “We wanted to see if we could harness that known failure mechanism in a productive way to build these biomedical devices.”

One type of liquid metal that can induce embrittlement is gallium. For this study, the researchers used eutectic gallium-indium, an alloy of gallium that scientists have explored for a variety of applications in biomedicine as well as energy and flexible electronics.

For the devices themselves, the researchers chose to use aluminum, which is known to be susceptible to embrittlement when exposed to gallium.

Gallium weakens solid metals such as aluminum in two ways. First, it can diffuse through the grain boundaries of the metal — border lines between the crystals that make up the metal — causing pieces of the metal to break off. The MIT team showed that they could harness this phenomenon by designing metals with different types of grain structures, allowing the metals to break into small pieces or to fracture at a given point.

Gallium also prevents aluminum from forming a protective oxide layer on its surface, which increases the metal’s exposure to water and enhances its degradation.

The MIT team showed that after they painted gallium-indium onto aluminum devices, the metals would disintegrate within minutes. The researchers also created nanoparticles and microparticles of gallium-indium and showed that these particles, suspended in fluid, could also break down aluminum structures.

On-demand disintegration
While the researchers began this effort as a way to create devices that could be broken down in the gastrointestinal tract, they soon realized that it could also be applied to other biomedical devices such as staples and stents.

To demonstrate GI applications, the researchers designed a star-shaped device, with arms attached to a central elastomer by a hollow aluminum tube. Drugs can be carried in the arms, and the shape of the device helps it be retained in the GI tract for an extended period of time. In a study in animals, the researchers showed that this kind of device could be broken down in the GI tract upon treatment with gallium-indium.

The researchers then created aluminum staples and showed that they could be used to hold tissue together, then dissolved with a coating of gallium-indium.

“Right now, removing the staples can actually induce more tissue damage,” Feig says. “We showed that with our gallium formulation we can just paint it on the staples and get them to disintegrate on-demand instead.”

The researchers also showed that an aluminum stent they designed could be implanted in esophageal tissue, then broken down by gallium-indium.

Currently, esophageal stents are either left in the body permanently or endoscopically removed when no longer needed. Such stents are often made from metals such as nitinol, an alloy of nickel and titanium. The researchers are now working to see if they could create dissolvable devices from nitinol and other metals.

“An exciting thing to explore from a materials science perspective is: Can we take other metals that are more commonly used in the clinic and modify them so that they can become actively triggerable as well?” Feig says.

In this study, the researchers conducted initial toxicity studies in rodents and found that gallium-indium was non-toxic even at high doses. However, more study would be needed to ensure it would be safe to administer to patients, the researchers say.

The research was funded by the Bill and Melinda Gates Foundation, MIT’s Department of Mechanical Engineering, the Brigham and Women’s Hospital Division of Gastroenterology, the Schmidt Science Fellows Program, and the Rhodes Trust.

Other authors of the paper include Eva Remlova, Benjamin Muller, Johannes Kuosmanen, Nikhil Lal, Anna Ginzburg, Kewang Nan, Ashka Patel, Ahmad Mujtaba Jebran, Meghana Bantwal, Niora Fabian, Keiko Ishida, Joshua Jenkins, Jan-Georg Rosenboom, Sanghyun Park, Weema Madani, and Alison Hayward.

In celebration of National Manufacturing Month, https://www.preplus.com/ held its inaugural Youth Apprentice Signing Ceremony, in conjunction with its annual MFG Day Open House, on Thursday, October 20, 2022, at its 40,000ft² state-of-the-art manufacturing facility in Elkhorn, Wisconsin. The event featured a showcase circuit of educational institutions and industry partners, guided tours by their team of manufacturing professionals, a signing ceremony commemorating their newly inducted Youth Apprentices, and esteemed speakers and public figures.

“Our primary goal for events like this is to inspire, educate, and enlighten our community, educational, and industry partners on the advanced manufacturing industry. Additionally, it is an opportunity to showcase the various educational programs and continuous training initiatives we have implemented over the years,” Ray Jargstorf, marketing coordinator, expressed. “Our organization continues to lead the way in changing the narrative of modern-day machining while educating and shaping the next generation of manufacturing professionals.”

Precision Plus’s MFG Day 2022 Showcase Circuit featured educational and industry partner exhibits that educated guests on the significance of manufacturing, real-world applications, and the variety of careers the industry has to offer. Exhibitors included the Elkhorn Area School District, Gateway Technical College, the Milwaukee School of Engineering, the Precision Machined Products Association, Doig Corporation, Morris Midwest Group, Tsugami America, and Parker Hannifin.

During the guided tours led by a team of manufacturing professionals, guests had the opportunity to see first-hand the production process for various precision machined components and solutions that Precision Plus produces for its clients in the medical, dental, military, firearms, industrial and pneumatic industries. This included stops at their quality assurance lab, Swiss cam machines, Swiss CNC lathes, and other precision machining and support equipment.

The evening continued with the organization’s inaugural Youth Apprentice Signing Ceremony, which included remarks from Wisconsin Department of Workforce Development Secretary Amy Pechacek and U.S. House of Representative Bryan Steil. Pechacek and Steil discussed the significant impact that Youth Apprenticeship and Intern programs, like the one at Precision Plus, have on the continued development of Wisconsin’s workforce and overall economic success.

The newly inducted YAs were met onstage by their families in a ceremonial jersey and hatting presentation that symbolized Precision Plus’s commitment to their successful journey in the precision machining and advanced manufacturing industries.

“One of the most fulfilling aspects of my role in Human Resources is to showcase the amazing careers available in manufacturing with the next generation of manufacturing professionals,” says Amanda Griffoul, human resources manager, who spearheads the Youth Apprenticeship Program. “The smiles on the faces of the students as they signed their letters of commitment to our Youth Apprenticeship Program at Precision Plus on Thursday is the driving force behind what makes events like this so special!”

For the last few decades, battery research has largely focused on rechargeable lithium-ion batteries, which are used in everything from electric cars to portable electronics and have improved dramatically in terms of affordability and capacity. But non-rechargeable batteries have seen little improvement during that time, despite their crucial role in many important uses such as implantable medical devices like pacemakers.

Now, researchers at MIT have come up with a way to improve the energy density of these non-rechargeable, or primary, batteries. They say it could enable up to a 50% increase in useful lifetime, or a corresponding decrease in size and weight for a given amount of power or energy capacity, while also improving safety, with little or no increase in cost.

The new findings, which involve substituting the conventionally inactive battery electrolyte with a material that is active for energy delivery, are reported in the journal Proceedings of the National Academy of Sciences, in a paper by MIT Kavanaugh Postdoctoral Fellow Haining Gao, graduate student Alejandro Sevilla, associate professor of mechanical engineering Betar Gallant, and four others at MIT and Caltech.

Replacing the battery in a pacemaker or other medical implant requires a surgical procedure, so any increase in the longevity of their batteries could have a significant impact on the patient’s quality of life, Gallant says. Primary batteries are used for such essential applications because they can provide about three times as much energy for a given size and weight as rechargeable batteries.

That difference in capacity, Gao says, makes primary batteries “critical for applications where charging is not possible or is impractical.” The new materials work at human body temperature, so would be suitable for medical implants. In addition to implantable devices, with further development to make the batteries operate efficiently at cooler temperatures, applications could also include sensors in tracking devices for shipments, for example to ensure that temperature and humidity requirements for food or drug shipments are properly maintained throughout the shipping process. Or, they might be used in remotely operated aerial or underwater vehicles that need to remain ready for deployment over long periods.

Pacemaker batteries typically last from five to 10 years, and even less if they require high-voltage functions such as defibrillation. Yet for such batteries, Gao says, the technology is considered mature, and “there haven’t been any major innovations in fundamental cell chemistries in the past 40 years.”

The key to the team’s innovation is a new kind of electrolyte – the material that lies between the two electrical poles of the battery, the cathode and the anode, and allows charge carriers to pass through from one side to the other. Using a new liquid fluorinated compound, the team found that they could combine some of the functions of the cathode and the electrolyte in one compound, called a catholyte. This allows for saving much of the weight of typical primary batteries, Gao says.

While there are other materials besides this new compound that could theoretically function in a similar catholyte role in a high-capacity battery, Gallant explains, those materials have lower inherent voltages that do not match those of the remainder of the material in a conventional pacemaker battery, a type known as CFx. Because the overall output from the battery can’t be more than that of the lesser of the two electrode materials, the extra capacity would go to waste because of the voltage mismatch. But with the new material, “one of the key merits of our fluorinated liquids is that their voltage aligns very well with that of CFx,” Gallant says.

In a conventional CFx battery, the liquid electrolyte is essential because it allows charged particles to pass through from one electrode to the other. But “those electrolytes are actually chemically inactive, so they’re basically dead weight,” Gao says. This means about 50% of the battery’s key components, mainly the electrolyte, is inactive material. But in the new design with the fluorinated catholyte material, the amount of dead weight can be reduced to about 20%, she says.

The new cells also provide safety improvements over other kinds of proposed chemistries that would use toxic and corrosive catholyte materials, which their formula does not, Gallant says. And preliminary tests have demonstrated a stable shelf life over more than a year, an important characteristic for primary batteries, she says.

So far, the team has not yet experimentally achieved the full 50% improvement in energy density predicted by their analysis. They have demonstrated a 20% improvement, which in itself would be an important gain for some applications, Gallant says. The design of the cell itself has not yet been fully optimized, but the researchers can project the cell performance based on the performance of the active material itself. “We can see the projected cell-level performance when it’s scaled up can reach around 50% higher than the CFx cell,” she says. Achieving that level experimentally is the team’s next goal.

Sevilla, a doctoral student in the mechanical engineering department, will be focusing on that work in the coming year. “I was brought into this project to try to understand some of the limitations of why we haven’t been able to attain the full energy density possible,” he says. “My role has been trying to fill in the gaps in terms of understanding the underlying reaction.”

One big advantage of the new material, Gao says, is that it can easily be integrated into existing battery manufacturing processes, as a simple substitution of one material for another. Preliminary discussions with manufacturers confirm this potentially easy substitution, Gao says. The basic starting material, used for other purposes, has already been scaled up for production, she says, and its price is comparable to that of the materials currently used in CFx batteries. The cost of batteries using the new material is likely to be comparable to the existing batteries as well, she says. The team has already applied for a patent on the catholyte, and they expect that the medical applications are likely to be the first to be commercialized, perhaps with a full-scale prototype ready for testing in real devices within about a year.

Further down the road, other applications could likely take advantage of the new materials as well, such as smart water or gas meters that can be read out remotely, or devices like EZPass transponders, increasing their usable lifetime, the researchers say. Power for drone aircraft or undersea vehicles would require higher power and so may take longer to be developed. Other uses could include batteries for equipment used at remote sites, such as drilling rigs for oil and gas, including devices sent down into the wells to monitor conditions.

The team also included Gustavo Hobold, Aaron Melemed, and Rui Guo at MIT and Simon Jones at Caltech. The work was supported by MIT Lincoln Laboratory and the Army Research Office.