The invention that was shared with the world: Experts came together quickly in early 2020 to create a 3D-printed nasopharyngeal swab. Today, more than 100 million swabs have been produced across the globe using this USF-patented design, and the U.S. Patent and Trademark Office is honoring the USF Health team Feb. 16, 2023.

The University of South Florida (USF) has been awarded the Patents for Humanity award by the U.S. Patent and Trademark Office (USPTO) for its patent of the 3D-printed nasopharyngeal (NP) swab, created in the early part of the pandemic as a solution to the disrupted commercial production of standard flocked NP swabs critical in diagnostic testing for COVID-19.

USF is among an exclusive group of winners receiving this year’s Patents for Humanity awards, being named alongside the National Institute of Allergy and Infectious Diseases of the NIH, Regeneron Pharmaceuticals, Gilead Sciences Inc., and Caron Products. All will be honored by the USPTO at an awards ceremony on February 16, 2023.

USF is earning this recognition for its innovative solution to the commercial NP swab shortage. Due to the urgent need worldwide, the 3D-printed NP swab team decided to forgo monetization of their invention and provided the design files and clinical data at no cost to hospitals, clinics and licensed medical device companies around the world as long as the swabs were produced for their own use.

Over the span of one week in March 2020, teams from USF Health, Northwell Health, Tampa General Hospital, and Formlabs worked together to develop a 3D printed swab prototype using Formlabs’ 3D printers and biocompatible (not harmful), autoclavable materials (able to withstand elevated temperature and pressure of an autoclave). The prototypes were then benchmarked against standard flocked swabs for viral sample retention in the laboratory and tested for patient safety and comfort by USF Health Morsani College of Medicine Department of Internal Medicine researchers. After passing these tests, the teams initiated a multisite clinical trial at dozens of hospital sites across the United States, including Tampa General Hospital, Northwell Health in New Hyde Park, New York, and Thomas Jefferson University Hospital in Philadelphia, comparing performance of the 3D-printed nasopharyngeal swabs with flocked swabs.

From that point on, the USF/Northwell design was shared with hospitals, health systems, the military, and clinics around the globe. To date, the USF-patented design for the 3D-printed nasopharyngeal swab has been shared with institutions in more than 60 countries that have produced more than 100 million swabs.

“I am so proud of how our USF Health team stepped forward to combine their expertise and innovation with the teams from Tampa General Hospital, Formlabs and Northwell Health to help save lives around the world,” said Charles J. Lockwood, MD, MHCM, executive vice president for USF Health and dean of the USF Health Morsani College of Medicine, and executive vice president and chief academic officer at Tampa General Hospital. “This recognition by the U.S. Patent and Trademark Office validates both the tremendous power of academic medicine, especially during a crisis, and the values and commitment these teams have for contributing to the greater good.”

“Our goal from the start was to help as many people as possible, as fast and safely as possible,” said Summer Decker, PhD, professor in the USF Health Morsani College of Medicine, and director for 3D Clinical Applications in USF Health’s Department of Radiology, who led the 3D printed NP swab team. “In order to do that, we assembled a team of experts in our fields and worked together toward a real-world solution. We then made our files public so that any hospital, clinic or health system could print them for their own facilities and get them to the frontline of COVID-19 testing in patients. Only when you know what you are truly facing, in this case COVID-19, can you actually fight it. This swab was a critical, missing component of the global medical community’s ability to do just that. We are very humbled by this recognition by the U.S. Patent and Trademark Office for our efforts and very grateful for this incredible opportunity to help not just USF Health and Tampa General Hospital, but also other hospitals and medical centers throughout the world.”

“COVID-19 demanded innovation and collaboration, not only from those on the front lines but across industries,” said Todd Goldstein, PhD, director of 3D Design and Innovation at Northwell Health. “It’s an honor to receive this recognition from the U.S. Patent and Trademark Office and we hope that our 3D printed nasal swab design helped alleviate burden during the height of the pandemic and showed what cooperation, even in times of crisis, can achieve.”

“We were proud to unite with USF Health, Formlabs and Northwell Health to work quickly and collaboratively to save lives during the height of COVID-19 when swabs were in short supply and in such high demand,” said John Couris, president and CEO of Tampa General Hospital. “This recognition is a true testament to not only the power of academic medicine, but the hard work, sacrifice, innovative spirit and perseverance of our clinical teams and their ability to act quickly and think strategically. We are thankful for the partnerships we developed with other health leaders to find innovative and cost-effective solutions to protect the health of our region and beyond.”

“With quick thinking and action from USF Health, the global shortage of traditional nasopharyngeal swabs was minimized with an entirely 3D printable design that could be easily printed in health care facilities around the world,” said Gaurav Manchanda, director of Medical Market Development at Formlabs. “We were honored to help in this effort and pleased to see the reliability, scalability, and accessibility of our 3D printing solutions put into action. By combining the centralized quality, regulatory, and medical manufacturing expertise at Formlabs with a decentralized production network of global medical customers, local health institutions were able to print and use millions of swabs needed during the shortage. Formlabs is proud to be recognized alongside USF Health, Northwell Health, and Tampa General Hospital in the USPTO Patents for Humanity COVID-19 category.”

The team that created the USF-patented 3D printed nasal swab, from left, Jonathan Ford, Kami Kim, John Sinnott, Summer Decker, Todd Goldstein, and Michael Teng. Not pictured is Todd Hazelton.

— Video and photos by Allison Long, USF Health Communications

In the video above, USF Health leaders and frontline workers look back on the successes, challenges and emotions they experienced while dealing with an incredibly challenging year amid the COVID-19 pandemic. Their stories include developing testing supplies now used around the world, creating programs aimed at treating vulnerable populations and helping rapidly develop and roll out vaccines against the disease, which Dr. Charles Lockwood, MD, Dean of the USF Health Morsani College of Medicine said “rivals the moon landing.”

USF Health College of Nursing vice dean Denise Maguire, PhD, administers a vaccine shot.

The device invented by USF Health doctors, teaming with Tampa General Hospital, Northwell Health and Formlabs, has been used worldwide to address critical shortages of test kit swabs

Tens of millions of the USF Health-invented 3D printed nasal swabs have been mass produced for use by health care providers worldwide. [Allison Long, USF Health Communications]

Now, a multisite clinical trial led by the University of South Florida Health (USF Health) Morsani College of Medicine provides the first evidence that 3D-printed alternative nasal swabs work as well, and safely, as the standard synthetic flocked nasal swabs.

The results were published online Sept. 10 in Clinical Infectious Diseases. A commentary accompanying the paper cites the authors’ timely, collaborative response to supply chain disruptions affecting testing capacity early in the pandemic.

Seeking a solution to an unprecedented demand for nasal swabs at their own institution and others, USF Health researchers in the Departments of Radiology and Infectious Diseases reached out to colleagues at Northwell Health, New York’s largest health care provider, and leading 3D-printer manufacturer Formlabs. Working around the clock, this multidisciplinary team rapidly designed, tested and produced a 3D printed nasal swab prototype as a replacement for commercially-made flocked nasal swabs. Bench testing (24-hour, 3-day, and leeching) using respiratory syncytial virus as a proxy for SARS-CoV-2, as well as local clinical validation of the final prototype (fabricated with FDA-approved nontoxic, surgical grade materials), was successfully completed in mid-March 2020.

The larger-scale clinical trial began in late March at three sites: Tampa General Hospital (TGH), Northwell Health, and Philadelphia-based Thomas Jefferson University Hospital.  (Other sites joined later.)

The paper’s first author Summer Decker, PhD, directs the USF Health Radiology-TGH Division of 3D Clinical Applications, which creates and prints 3D anatomical models for surgeons and other clinicians and designs medical devices. [Allison Long, USF Health Communications]

“In the midst of a pandemic, our team of experts representing academic medicine, health care delivery systems, and the medical device industry put aside boundaries to quickly work together toward a common purpose,” Dr. Decker said. “It’s rewarding that the novel design for a 3D swab we created has been adopted around the world, equipping more providers to diagnose COVID-19 and hopefully help prevent its spread.”

The gold standard for diagnosing respiratory infections is to look for viral genetic material found in mucosal fluid collected with a long, slender swab inserted into the patient’s nose and back of the throat. The nasal swab is put into a plastic tube with chemicals that stabilize the sample until the virus-specific genetic material can be extracted and amplified by polymerase chain reaction (PCR) in a diagnostics laboratory. Conventional swabs feature a bushy tip coated with nylon flock; the USF Health doctors designed a tip with a 3D printed textured pattern able to capture a sufficient sample for COVID testing while keeping patient safety and comfort in mind.

Kami Kim, MD, infectious diseases division director at USF Health Morsani College of Medicine, led the multisite clinical trial comparing the performance of commercial nasal swabs with the 3D-printed alternative.

The clinical trial fully tested the safety and effectiveness of this 3D printed swab in 291 symptomatic adults undergoing COVID-19 screening at the TGH, Northwell Health and Thomas Jefferson University Hospital sites. The 3D printed nasal swab was compared to the standard synthetic nasal swab across three SARS-CoV-2 testing platforms FDA-authorized for emergency use — a modified version of the Center for Disease Control and Prevention’s real-time reverse transcriptase PCR diagnostic panel, and two commercial molecular diagnostic tests.

“This trial provided the first rigorous head-to-head comparison to make sure that the 3D swab performed as well as the standard,” said principal investigator Kami Kim, MD, professor and division director for infectious disease at the USF Health Morsani College of Medicine. “Across all three platforms used in our study, we demonstrated that the commercial swab and the 3D printed swab were comparable for accurate detection of COVID-19 infection.”

For both swabs, the only adverse patient reaction documented during the trial was a few instances of slight nasal bleeding. The cost of materials per 3D printed nasal swab ranges from 26-to 46-cents, while commercial swabs cost about $1 each, the authors reported.

Given the ongoing need for widespread COVID-19 testing, the study authors concluded that 3D printing technology offers a viable, cost-efficient option to address swab supply shortages, particularly when local hospitals or other clinical sites already have 3D printing labs equipped to print and process the devices.

The 3D printed nasal swabs were specifically designed for patients using FDA-approved surgical grade material. [Allison Long, USF Health Communications]

“Among all parts 3D printed during COVID-19, nasopharyngeal swabs have received the most attention, with participants ranging from humanitarians to charlatans,” Dr. Rybicki wrote in his summary. “The authors should be congratulated for staying on the right side of the curve, and for their perseverance, leadership, scientific rigor, and good will.”

The USF Health-designed 3D printed nasal swab that broke into national news in late March is now being used by several hundred hospitals and academic medical centers around the country, many state governments, including that of Ohio, Massachusetts and Virginia, and international agencies and health care facilities.

Widespread use of the nasal swab was one of many goals when it was announced March 28 that USF Health, Formlabs, a leading 3D printing company, Northwell Health, New York’s largest healthcare provider, and Tampa General Hospital had successfully designed, tested and begun producing a 3D printed nasal swab to address emergency shortages that hospitals and health care teams were facing as testing for COVID-19 increased.

The world-wide interest in the swabs kicked in quickly after the announcement and hasn’t let up since, said Dr. Summer Decker, associate professor in the Department of Radiology in the USF Health Morsani College of Medicine and director of 3D Clinical Applications.

“We are grateful that we were able to work as a team to get this solution out so quickly in order to hopefully help many people. The response has been overwhelming,” Decker said. “It’s been very rewarding to speak to so many hospitals across the world to hear their experiences and see how we can help. This situation has stripped away many of the barriers between us so we can work together for the common goal of saving lives.”

Dr. Summer Decker

The nasal swab design came about when, after identifying in mid-March that nasal swabs for testing COVID-19 were in high demand and extremely limited in supply, a team from the USF Health’s 3D Clinical Applications Division created an initial design, working with Northwell Health and collaborating with Formlabs to develop prototypes and secure materials for a 3D printed alternative.

Over the span of one week, the teams worked together to develop a nasal swab prototype and test it in the USF Health and Northwell Health labs. In two days, USF Health and Northwell Health, using Formlabs’ 3D printers and biocompatible, autoclavable resins, developed prototypes.

Key milestones in testing the swabs were conducted by USF Health faculty researchers in the Departments of Radiology and Infectious Diseases in collaboration with Northwell Health, including validation testing (24-hour, 3-day, and leeching), and rapid clinical testing at Northwell Health and Tampa General Hospital. All testing showed that the 3D printed nasal swabs perform equally to standard swabs used for testing for COVID-19.

Once that clinical validation was complete, 3D printers at USF Health and Northwell Health began producing the swabs and providing them to their patients – USF Health has produced more than 50,000 swabs for its patients and that of some of its affiliates, including Tampa General Hospital, Moffitt Cancer Center, and the James A. Haley Veterans’ Hospital.

“To see the widespread adoption of USF Health’s nasal swab test has been particularly gratifying, and I cannot speak highly enough about Dr. Summer Decker and her team for taking the initiative to meet this pressing need. Health care providers all across the nation are now better equipped to diagnose and prevent the spread of Covid-19,” said Charles J. Lockwood, MD, MHCM, senior vice president for USF Health and dean of the USF Health Morsani College of Medicine.

Photos by Allison Long, USF Health Communications

USF Health researchers have launched several clinical trials as part of the world-wide effort to reduce the severity and even prevent COVID-19.

In connection with Tampa General Hospital, the USF Health researchers are leading the examination of a range of medications and treatment protocols that could impact the disease at a symptoms-level for patients and at the cellular level of the virus.

“The USF Health Office of Clinical Research and supporting parties are making strides that we’ve never made before,” said Rachel Karlnoski PhD, CHRC, director of Clinical Research Operations for USF Health.

“The typical start-up timeframe for new clinical trials in an academic medical center is 90 days or more. Our goal for COVID-19 trials was five days or less and we have succeeded. Communication, collaboration and prioritization from our budget and contract analysts, onsite legal counsel, USF IRB, central IRBs, investigators, study teams and regulatory manager have enabled our success.”

The united, expedited efforts paid off and now USF Health and TGH are conducting multiple front-line studies that link to larger efforts across the country, all in sync for finding treatments and cures for COVID-19.

“I am humbled by the response from our MCOM research staff, and their willingness to volunteer and put themselves at risk,” Karlnoski said. “We have over 30 volunteers from all departments comprised of nurses, coordinators, regulatory specialists, and data analysts who are ready to be deployed when a COVID trial becomes available. The silver lining behind the pandemic is the visibility it has brought to the importance of clinical research in the advancement of medicine. I am optimistic that we will find an effective treatment.”

One of the main overarching research efforts is the inclusion of data related to COVID-19 as part of a national registry tracking many aspects of the virus and those infected with it, such as pregnant women and their babies. USF Health and TGH providers are actively submitting information to this registry.

Among the clinical trials being set up or currently underway are:

• Testing sarilumab to determine effectiveness in blocking inflammation in the lungs in hospitalized severely ill patients.
• Two studies, one in adults and the other in children, are looking at the emergency use of remdesivir, an antiviral drug that may help kill the virus. These studies are for critically ill COVID-19 patients.
• Several studies looking at hydroxychloroquine, on three main fronts:
  • For severely ill patients: Given to patients coming into the emergency department who are severely ill and are going to be hospitalized.
  • For health care workers: A multi-site clinical trial involving 15,000 health care workers across the country to determine if hydroxychloroquine can prevent COVID-19.
  • For outpatient use: Given to those who test positive for COVID-19 but are not severely ill and don’t need to be hospitalized.
• Using convalescent sera/plasma from people who have recovered from COVID-19 in those who currently have the disease to test the sera’s ability treat these COVID-19.
• Testing 3D printed nasal swabs to confirm their ability to prevent so many false negatives compared with standard swabs when used for testing for COVID-19.
• Testing in outpatient settings the use of inhaled nitric oxide to help treat patients with COVID-19 who require supplemental oxygen.
• Studying Ruxolitinib in critically ill patients with COVID-19 and the impact of the medication in easing or stopping the associated cytokine storm, when the patient’s immune system becomes overwhelmed and attacks healthy cells.
• Other studies are looking into ways for treating pneumonia associated with so many cases of patients with COVID-19; assessing the safety and anti-coronavirus response of combined suppression of host nucleotide synthesis in hospitalized adults with COVID-19; testing Brequinar, an antiviral drug for treating COVID-19.

For more information about these and other clinical research taking place at USF Health, please email the Office of Clinical Research at ocr@usf.edu

TAMPA, FL, SOMERVILLE, MA, and NEW HYDE PARK, NY – March 28, 2020 – The University of South Florida (USF) Health, Formlabs, a leading 3D printing company, and Northwell Health, New York’s largest healthcare provider, today announced they have successfully produced and tested a 3D printed nasal swab to address emergency shortages that hospitals and health care teams may face as testing for COVID-19 increases.

Key milestones in testing the swabs were conducted by USF Health faculty researchers in the Departments of Radiology and Infectious Diseases in collaboration with Northwell Health, including validation testing (24-hour, 3-day, and leeching), and rapid clinical testing at Northwell Health and Tampa General Hospital. All testing showed that the 3D printed nasal swabs perform equally to standard swabs used for testing for COVID-19.

After identifying that nasal swabs for testing COVID-19 were in high demand and extremely limited in supply, a team from the USF Health’s 3D Clinical Applications Division created an initial design, working with Northwell Health and collaborating with Formlabs to develop prototypes and secure materials for a 3D printed alternative. Over the span of one week, the teams worked together to develop a nasal swab prototype and test it in the USF Health and Northwell Health labs. In two days, USF Health and Northwell Health, using Formlabs’ 3D printers and biocompatible, autoclavable resins, developed prototypes. The swabs were tested by clinicians at Northwell Health, USF Health and Tampa General Hospital for patient safety and comfort. Now that clinical validation is complete, 3D printers at USF Health and Northwell Health will produce the swabs and provide them to their patients.

“This is a prime example of the incredible impact we can have on human lives when teams of experts across academia, health care delivery, and the tech industry come together,” said Charles J. Lockwood, MD, MHCM, senior vice president for USF Health and dean of the USF Health Morsani College of Medicine. “During this current COVID-19 outbreak, there is little time for delay, and the swift, agile and adept action of everyone on this effort will greatly improve this nation’s ability to test patients.”

Summer Decker, PhD, directs the 3D Clinical Applications Division in the USF Health Morsani College of Medicine and has been at the forefront of USF Health Radiology’s department trailblazing use of 3D modeling in clinical capacities.

“When we were notified of the shortage of swabs by Dr. Lockwood, we immediately began working as a team to create a novel design in a printed material that was proven safe for patients, as is Formlabs’ surgical grade resin,” said Summer Decker, PhD, associate professor in the USF Health Morsani College of Medicine and director for 3D Clinical Applications in USF Health’s Department of Radiology. “We reached out to Northwell Health and Formlabs to work with us on this response initiative. With our collaborators in USF Health Infectious Diseases, we’ve been able to validate the printed swabs utility for this purpose and are extremely optimistic about the pending clinical testing results. With 3D printed swabs, we will be able to add thousands of swabs a day to testing kits developed here at USF Health, and treat more patients safely and effectively. We look forward to continuing to work with Northwell Health and Formlabs to further combat the COVID-19 pandemic.”

In addition to Drs. Lockwood and Decker, faculty from across USF joined in the design and creation of the 3D printed nasal swabs, including: Jonathan Ford, PhD, Todd Hazelton, MD, Gilberto Jaimes, Howard Kaplan, Kami Kim, MD, John Sinnott, MD, Michael Teng, PhD.

Jonathan Ford, PhD, a biomedical engineer in the USF Health 3D Lab, pulls newly printed nasal swabs made of specialized clinical/surgical material and ready to be used for testing for COVID-19.

“Northwell Health is proud to collaborate with Formlabs and USF to address the global health crisis of COVID-19,” said Todd Goldstein, PhD, Director of Northwell Health 3D Design and Innovation. “When we saw that the testing kits were limited in supply, our 3D printing lab immediately changed focus from creating materials for surgeries to designing and creating materials that help our front-line healthcare providers treating COVID-19 patients. In one weekend, we worked together to develop a nasal swab prototype and test it in the lab. After our positive testing results, we then immediately went to work and have already started producing 1,000-1,500 swabs per day. Not only will these swabs be provided to Northwell Health patients, we are also proud to be sharing the design with other institutions that can 3D print so that patients across the country can benefit from our work.”

Formlabs’ CEO and co-founder, Max Lobovsky, said: “Formlabs has been working around the clock to provide assistance in the wake of the COVID-19 pandemic, and we’re hopeful that our efforts will help patients get the care they need. It is important that the medical devices we supply to medical professionals on the frontlines battling this disease are safe and work effectively so as not to put workers or their patients at risk. By working hand-in-hand with Northwell Health and USF Health to design and safely produce these swabs, Formlabs is providing a viable solution to the current shortage of nasopharyngeal (NP) swabs and can now produce them at scale to help hospitals better treat patients.”

“During this unprecedented time, Tampa General Hospital is proud to unite with USF Health, Formlabs and Northwell Health to ultimately help save lives. I’ve been humbled and inspired by the perseverance, sacrifice and teamwork of our clinical teams collaborating to create the 3D printed nasal swabs to test patients in need, during emergency shortage situations. Thank you to Formlabs 3D printers for being a true partner to all of our physicians and teams working tirelessly to protect the health and safety of our community and beyond,” said John Couris, president & CEO of Tampa General Hospital.

It is worth noting that the “FDA believes that a nasopharyngeal specimen is the preferred choice for swab-based SARS-CoV-2 testing,” and that “collection should be conducted with a sterile swab.” With years of experience in the medical industry and hundreds of hospitals already using its technology to develop tools for surgery on-premises, Formlabs adheres to a wide range of required sterilization, regulatory, safety, biocompatibility, and manufacturing standards. The company produces sterilizable, surgical-grade plastics for use in medical and dental applications, and its FDA-registered manufacturing site has an ISO 13485 certification. By turning to proven 3D printing technology to improve production processes, shorten supply chains and localize manufacturing, healthcare providers can quickly and efficiently gain better access to the supplies they need to combat COVID-19.

Photos and video by Allison Long, USF Health Communications.

Using data specific to each patient, 3D models of bone and organs can be created to guide surgeons and educate patients.

Cardiologist Fadi Matar, MD, holds a model of a heart in his hand, studying the route he will take to insert wiring into his patient during surgery.

The model is not a generic, one-size-fits-all example of a heart using average measurements. This heart model is built using the exact measurements of that patient’s own heart.

This specific, anatomically correct heart model was created using 3D printing and a complicated algorithm that combines data from ultrasound, CT, and MRI scans for that patient. This heart – along with other organs and bone structures – is from the USF Health Department of Radiology, built by printers housed in one of USF Health’s flagship clinical facilities, the South Tampa Center for Advanced Healthcare.

Summer Decker, PhD, an imaging scientist, and Jonathan Ford, PhD, a biomedical engineer, are the two-member team creating the organ and bone models that are altering both medical care and standard approaches to surgical planning.

Dr. Summer Decker (left) and Dr. Jonathan Ford make a 3D model of a heart in USF Health’s Department of Radiology in USF Health South Tampa Center for Advanced Healthcare in downtown Tampa. Dr. Decker, the director of imaging research, and Dr. Ford, a biomedical engineer for imaging research, have been at the forefront of USF Health Radiology’s department trailblazing use of 3D modeling in clinical capacities.

“I have surgeons tell me they won’t even think about starting surgery without one of our 3D prints first,” said Dr. Decker, associate professor of radiology and director of the USF Health 3D Imaging Lab.

“We are taking multiple data sets to recreate an organ in print so surgeons can use it as a surgical guide. No surgeon is going to operate unless the model is anatomically accurate. I can hand a surgeon their case in advance of surgery and they could tell the patient ‘I’ve used your exact heart to practice’ before going into the actual surgery. This could greatly reduce errors, as well as surgery time.”

Incorporating 3D printing into clinical medicine is fairly new. USF Health’s use of a 3D printer so directly with patient care, especially surgery, and in such close partnership with its primary teaching hospital, is another story altogether, Dr. Decker said.

“There is nothing in our region like this,” she said. “The company that installed our Stratasys printer chose USF Health as a site because of our close partnership with and our proximity to Tampa General Hospital. Having a top-tier hospital and its surgery facilities right next door to our 3D Imaging Lab made all the difference. USF Health has the technology and 3D expertise, and TGH has the surgical cases. We are one in about two dozen in the world, and the first the Tampa Bay area, to do this.”

***

USF Health is this region’s only academic medical center. With three primary missions – research, education, and patient care – Dr. Decker and Dr. Ford could be considered a ‘triple threat’ for incorporating medical 3D printing into all three areas.

In clinical care, their 3D prints are used by physicians at USF Health, and across the globe.

For research, the team has studied and published on this topic for well over a decade and laid the foundational research that confirmed all of the measurement translations taken from scans and incorporated into 3D printed output.

“We had to make the final model anatomically correct or this entire effort would be useless for improving direct patient care,” Dr. Decker said. “It would be just another hobby-level 3D print we’ve all seen.”

Dr. Summer Decker.

And for education, it might not be too far from the truth to say that any clinical institution or hospital building a 3D printing operation today has tapped into the expertise found in the USF Health 3D Imaging Lab.

Dr. Decker teaches resident physicians, and Dr. Ford trains other biomedical engineers. They both present at conferences and host training sessions, graciously and eagerly sharing the details that have made the USF Health 3D Imaging Lab a success.

“Medicine and the field of radiology is changing to include 3D printing, and I want students and residents in many specialties to know about this technology because it will be a part of their careers, I promise them,” Dr. Decker said.

“This is really revolutionary for education,” Dr. Ford said. “You can teach from actual case examples and allow students to interact with a complex pathology in a real tactile sense.”

Dr. Jonathan Ford.

***

Every detail and nuance pertinent to this patient is in that model. Thicker tissue here and thinner there, variations in heart valve size, possible obstructions, etc. – all details that might not show up on the individual scans but, because data is combined, the 3D model now tells the surgeon more exactly what he will face when he is maneuvering around a real heart in his very real patient.

The anatomically correct model is how Dr. Matar knows exactly what he will do during surgery and, perhaps more importantly, what he needs to avoid – all before his patient is in the operating room, before he is under anesthesia.

“The advantages are many,” Dr. Matar said. “Surgeons can see, feel and even ‘practice’ the upcoming procedure before actual surgery. In addition to helping define a stronger surgical plan, it also reduces the time of the surgery, both of which equate to better patient outcomes. Patients can see and better understand their conditions and the treatments and surgeries being recommended, and sometimes why a procedure cannot be done.”

The technology also allows for taking on far more complicated cases, Dr. Matar said.

“We are using three-dimensional printing of cardiac structures for multiple reasons, the most important one is to understand the complex anatomies that present to us how we can tackle more advanced and more complex anatomies.”

***

3D printing is not new – it’s the clinical application of it, building anatomical models, the exact replica of the patient’s organ or skull or spine that is at the forefront of medicine.

3D models of vertebrates after printing for three hours at USF Health’s 3D Imaging Lab.

A 3D print of pancreatic cancer helped a patient have a better understanding why surgery was not a viable option.

Dr. Decker and Dr. Ford have spent the better part of the last two decades learning and refining the printing, then teaching and training others how to incorporate 3D printing into pre-operative planning and patient education.

Dr. Decker and Dr. Ford are clearly making an impact.

This team has won awards, is invited to present nationally, has taught physicians across the world how to effectively implement 3D printing, and has garnered lots of attention from industry media.

“This has gone past ‘wow, this is cool but what can you do with it?’ to actually being clinically applicable and helping save lives,” Dr. Ford said.

Dr. Decker added, “That’s why people are flying to USF Health from all over the world to learn about this.”

Photos and video by Allison Long, story by Sarah Worth, USF Health Office of Communications.

//www.youtube.com/watch?v=EukhXneKoRY

USF Health isn’t usually called upon to scale the anatomy of a patient from human to animal, but the USF Radiology team has that expertise – and was ready when a Busch Gardens veterinarian reached out to schedule a CT scan for a young sloth with dental issues.

“When it comes to the specialty of radiology, Dr. Summer Decker and her team have been unbelievable,” said Dominique Keller, DVM, senior veterinarian at Busch Gardens Tampa Bay. In the past, USF Health helped the zoological park’s veterinary team with advanced diagnostic scans of penguins and wallabies, but this would be their first sloth.

Kodiak, a 1-year-old, two-toed sloth, was seen by USF’s Radiology team for a CT scan to help determine treatment for an off-set jaw.

USF Health’s Summer Decker, PhD, assistant professor and director of imaging research in the Department of Radiology, holds several patented imaging techniques embracing 3D virtual and 3D printing technologies to visualize anatomy.

“We take pictures in slices and take all of those slices and push them back together to get the exact same patient in 3D,” Decker said. “You can essentially fly through the body.”

Kodiak, a 1-year-old, two-toed sloth, looked as though he was smiling when he arrived at USF in August 2017 for the CT scan. But, in fact, his “smile” was an off-set jaw, contributing to elongated teeth that prevented his mouth from closing properly and made eating difficult. The CT scan would help determine if Kodiak’s issue was a condition caused by his foot-sucking habit or a jaw deformity.

The CT scan and a 3D model of Kodiak’s head helped create  prints that the team used  to develop a dental treatment plan. Periodically filing down some areas of the sloth’s teeth allows his mouth to fully close.

First the radiation dose and scan protocol was modified to meet modified pediatric guidelines by USF CT technologist Joe Henry, and the images were reviewed by neuroradiologist Ryan Murtagh, MD, MBA, associate professor, Department of Radiology.

“Because of Kodiak’s size, he is basically a little kid, like a baby and has to be scanned differently than an adult,” Decker said.

The sloth’s unlikely interprofessional health care team included his veterinarian, a dentist, William Geyer DDS, two imaging research scientists and a radiologist. Before the craniofacial scan, they surrounded Kodiak and worked cautiously, avoiding his “razorblade sharp teeth.” While the images were generated, the team used normal sloth skulls from Busch Gardens’ skeletal reference collection to compare.

3D prints helped the interprofessional  team visualize a treatment plan. From left, Summer Decker, PhD, assistant professor and director of imaging research in the USF Health Department of Radiology; Tampa dentist William Geyer, DDS; and Dominique Keller, DVM, senior veterinarian at Busch Gardens Tampa Bay.

Comparisons from normal sloth skulls shown with a 3D print from Kodiak’s scan.

“None of us had ever scanned a sloth before so we were unfamiliar with the anatomy. Using a reference like the normal skull allows us to determine where Kodiak’s differences are,” Decker said.

The 3D modelling analysis was operated by Jonathan Ford, PhD, biomedical engineer and assistant professor in the Division of Imaging Research at the Department of Radiology. No evidence of a jaw structural deformity was seen. But, Ford was able to virtually open and close Kodiak’s mouth to help identify the areas of jaw and teeth misalignment that led to Kodiak’s bite problem and show the changes that needed to be made to correct the issue.

“That’s why the CT is so nice” Dr. Keller said. “You can take an image, rotate it in three-dimensions and look exactly at what’s happening with him.”

In early October, the Busch Gardens team with Dr. Geyer returned to USF for a follow up. Decker’s team helped provide a treatment plan. A 3D print, made from the scan and 3D model, clearly showed where and how individual teeth would need shaving to correct the sloth’s bite.

Dr. Geyer and USF Health’s Decker review digital models of Kodiak’s craniofacial scans with Joe Henry, USF CT technologist.

A couple weeks later, dental consultant Dr. Geyer shaved down Kodiak’s teeth at the Busch Gardens Animal Care Center with the whole team looking on. The procedure was simple and also a teaching moment for the small group of children who watched behind a glass wall.

“Will he be OK?” they asked.

Kodiak did well. However, his teeth will continue to grow and he’ll need similar dental treatments periodically for the rest of his life.

“This was very different from what we normally do,” said Decker, whose 8-year-old-self was fascinated to learn about sloths and jumped at the opportunity to “draw on all the different fields and combine that knowledge to create a solution.”

USF Health’s radiology team worked with a veterinarian and a dental consultant from Busch Gardens Tampa Bay to form the unlikely team. Members drew upon their different fields to create a solution.

The USF Radiology team thrives in USF Health’s academic clinical environment. Besides being just a call away from Dr. Keller, the clinical researchers have their hands in many other areas such as gynecology, neurosurgery, cardiothoracic surgery, plastic surgery, pathology and forensics, to name a few. Their expertise is routinely tapped by physicians and surgeons to help create “roadmaps” for treating patients, and they teach medical students and residents innovative, advanced imaging techniques.

“We need that collaboration. To me that’s the beauty of working near an academic medical institution, and USF is perfect for us,” Dr. Keller said.

A story about how the USF Health radiology doctors worked with the Busch Gardens Tampa Bay veterinary group to find a solution to Kodiak’s dental problem aired April 21 on the show Wildlife Docs.

-Video by Ryan Noone and Torie Doll, and photos by Ryan Noone, University Communications and Marketing
-Anne DeLotto Baier contributed to this story

Susan Coy, right, a Florida Aquarium veterinary technician, and intern Lauren Smith release the green sea turtle Freud at Fred Howard Park in Tarpon Springs. The Aquarium partnered with USF Health Radiology to help rehabilitate the turtle.

The green sea turtle flapped his tagged front flippers as a veterinary technician and intern from The Florida Aquarium held him just above the water.

Shielded from the rain by umbrellas, USF Health Radiology faculty and staff members cheered from the shoreline when Freud was released and slipped into the Gulf of Mexico with a splash. They were joined by other aquarium staff, some school children and others who came to Fred Howard Park in Tarpon Springs Monday.

Rapidly swimming several yards out, Freud popped his head up just once before diving into his future.

“Our whole team is going to miss Freud,” said Summer Decker, PhD, assistant professor and director of imaging research for the Department of Radiology, USF Health Morsani College of Medicine. “Everyone, from the techs to the radiologists to our engineer, has been so excited about this project, so it is a bit sad to see him go.”

“It has been such an amazing opportunity to harness the advanced imaging technologies that we use routinely to treat our human patients to help Freud. We were honored to with be our Florida Aquarium friends to see him released into the wild.”

Florida Aquarium’s Coy, right, with Summer Decker, PhD, director of research imaging for the Department of Radiology, USF Health Morsani College of Medicine.

Susan Coy, the Aquarium’s veterinary technician and sea turtle expert, said watching Freud, fully recovered from a potentially life-threatening respiratory injury, leave was “bittersweet” but rewarding.

“Having the opportunity to rescue, rehabilitate and release animals like Freud is a huge part of The Florida Aquarium’s mission and is a critical piece to protecting these amazing creature for generations to come,” Coy said.  “We greatly appreciate the partnership at USF Health for all the help in successfully rehabilitating Freud.”

Freud’s return to the ocean was made possible by the collaboration between The Florida Aquarium and USF Health.   The sea turtle was transferred from Gulf World Marine Park in Panama City Beach to The Florida Aquarium for advanced care in January 2013, a few months after he was found lethargic, bloated and covered with algae on a beach in Florida’s Panhandle.

Suffering from a suspected tear in his lung, he was taken to the USF Health Center for Advanced Medical Learning and Simulation (CAMLS) by the aquarium veterinary staff later that year.  A CT scan and bronchoscopy was performed on the sea turtle at CAMLS to try to pinpoint any injuries causing air to fill his body and make it difficult for him to dive and swim.

The radiology team including Todd Hazelton, MD, chair of the USF Health Department of Radiology analyzed the scans, consulting with Dr. Doug Mader, DVM, of the Marathon Sea Turtle Hospital, who was able to explain the significant differences between human and turtle lung tissue and help the USF team interpret the findings.  Jonathan Ford, PhD, a biomedical engineer at USF Health Radiology, then used the scans to create and print three-dimensional models of Freud’s lungs.

The Florida Aquarium staff called upon the USF Health Radiology team, who used with their imaging and 3-D modeling expertise to help diagnose Freud and confirm his recovery from a respiratory injury.

The team determined that Freud had a bronchopleural fistula, or a series of little holes in his lung.   “The imaging and 3-D modeling enabled us to find exactly where the trauma was on Freud’s lung that caused the problem,” Dr. Decker said.

Freud was the first sea turtle that USF Health Radiology had scanned, although the researchers have applied their imaging and 3-D modeling expertise to mummies,  fossils, sharks and other marine animals.

The initial treatment plan indicated surgery to repair the fistula.  But, The Florida Aquarium team providing Freud with nutrition, vitamins and other supportive care while he awaited surgery noticed signs in recent months that Freud was recovering. Whereas the sea turtle previously often floated on the surface, he was now able to dive to the bottom of the tank and glide effortlessly across the water – a huge accomplishment.

A side by side 3-D model comparison, derived from CT scans, of sea turtle Freud’s originally damaged lung (left) and the healed lung (right).

The Florida Aquarium team suspected that Freud’s injury was healing, but they needed confirmation of any physiological changes. So, once again they reached out to their partners at USF Health Radiology.

In August, the rescued sea turtle took a trip to the radiology’s imaging facility at the USF Health South Tampa Center for Advanced Healthcare for a second round of advanced diagnostic imaging.  Remarkably, the CT scan confirmed that Freud’s injury had completely healed with just some residual scar tissue, making it possible to release him back into the wild.

“We were not expecting the injury to be totally healed, so we were all blown away and happy for Freud when we saw the images,” Dr. Decker said.

Before leaving the soggy beach on Monday afternoon, Decker and Coy stood side by side smiling and waved into one of many cameras recording Freud’s send-off.

“Bye, Freud,” they said in unison as the rain continued to fall.

“Have a good adventure,” Decker said.

“We don’t want to see you again,” Coy added.

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Tampa, Fla. (Aug. 27, 2014) — The Florida Aquarium’s rescued sea turtle Freud took another trip to USF Health for a second round of high-tech diagnostic help — this time using USF Health Radiology’s state-of-the-art advanced imaging systems.

Freud, an endangered green sea turtle was found lethargic, bloated and covered in algae on Navarre Beach in November 2012. He was then transferred to The Florida Aquarium in January.  Suffering from a suspected a tear in his lung, Freud was taken to the USF Health’s Center for Advanced Medical Learning and Simulation (CAMLS) facility in December 2013. The Aquarium vet staff, along with faculty members from USF Health Radiology, and Dr. Luis Llerena, medical director of CAMLS Surgical and Interventional Training Center, performed a CT scan and bronchoscopy on Freud to see if there were any injuries potentially causing air to fill his body and impeding the sea turtle’s ability to swim.

Freud, the rescued green sea turtle, arrives at the USF Health South Tampa Center for Advanced Healthcare for CT imaging to verify whether his injury had healed.

When no obvious signs of damage appeared on the bronchoscopy, the CT scans were taken back to USF Health Radiology for further analysis. A team from the USF Health Morsani College of Medicine’s Department of Radiology including Dr. Summer Decker, director of imaging research and assistant professor;  Dr. Todd Hazelton, professor and chairman; and Dr. Jonathan Ford, biomedical engineer, analyzed the scans and created three-dimensional models of Freud’s lungs to visualize the extent of the damage. Working with sea turtle expert Dr. Doug Mader of the Marathon Sea Turtle Hospital, it was determined that Freud had a bronchopleural fistula, an abnormal connection between the small air tubes of lung and the space around the lung. The Florida Aquarium and USF Health Radiology collaborated to create a treatment plan for Freud’s recovery.

Since the diagnosis was confirmed in January, The Florida Aquarium team has been working with Freud on his recovery and in the recent months saw huge improvements in his swimming abilities. Whereas he was previously seen floating on the surface, Freud was now able to swim to the bottom of the tank and glide across the water effortlessly.

Susan Coy, a veterinary technician with The Florida Aquarium, positions Freud as Dr. Summer Decker of USF Health Radiology looks on.

The Florida Aquarium veterinarian, Kathy Heym explains: “We had been monitoring some slight progress in Freud’s rehabilitation and felt confident that he was slowly getting better.  It wasn’t until a couple months ago when we first noticed that he was able to rest comfortably at the bottom of the tank that I knew we needed to get him back to USF Health for a follow-up CT scan.”

Up until this point Freud was barely able to dive underwater so seeing him resting at the bottom was a huge accomplishment in itself, but because the tear in his lung was so small, the staff at The Florida Aquarium was unable to make a definite diagnosis stating he was completely healed. The Aquarium once again reached out to their partners at USF Health Radiology for help.

Setting the target for the CT scan.

The team set up another CT scan but this time at the USF Health South Tampa Center for Advanced Healthcare  imaging facility on the Tampa General Hospital campus. They wanted to determine if Freud’s fistula had completely healed, making it possible to release him back into the wild.

“The advanced imaging technology here at USF Health combined with the amazing teamwork between USF Health and The Florida Aquarium played a vital role in making sure Freud would have the best possible chance to recover. We couldn’t be more pleased with the outcome and opportunity to work alongside our friends and collaborators at the Aquarium. This has truly been a team effort,” said Dr. Decker, the USF Health Radiology team leader on the project.

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The CT scans confirmed that Freud’s injury has completely healed with minor residual scarring, so he can now safely be released back into the wild.  The Florida Aquarium team is working with Florida Fish and Wildlife on determining when and where Freud’s release will take place, but this is a huge accomplishment for The Florida Aquarium and USF Health partnership.

“We simply couldn’t have done it without the help of our friends at USF Health” said Heym. “Freud’s success is due in a large part to their willingness to utilize their equipment and expertise to help us make a proper diagnosis and develop a plan of action to successfully treat this turtle. We are extremely thankful for their support.”

Dr. Jonathan Ford, biomedical engineer, and Dr. Decker examine a 3D model of Freud’s lungs.

L to R: Dr. Todd Hazelton, professor and chairman of the USF Health Department of Radiology; Dr. Summer Decker, director of imaging research and assistant professor of radiology; Kathy Heym, The Florida Aquarium veterinarian; and Susan Coy, veterinary technician.

Now that Freud’s injury has completely healed with minor residual scarring, The Florida Aquarium is working with Florida Fish and Wildlife to determine when and where the endangered sea turtle’s release will take place.

Photos by Eric Younghans, USF Health Communications

About The Florida Aquarium:
The Florida Aquarium is a 501(c)(3) nonprofit institution whose mission is to entertain, educate and inspire stewardship about our natural environment. The Florida Aquarium is home to more than 20,000 aquatic plants and animals representing species from Florida and around the world.

About USF Health:
USF Health’s mission is to envision and implement the future of health. It is the partnership of the USF Health Morsani College of Medicine, the College of Nursing, the College of Public Health, the College of Pharmacy, the School of Biomedical Sciences and the School of Physical Therapy and Rehabilitation Sciences; and the USF Physician’s Group. The University of South Florida is a Top 50 research university in total research expenditures among both public and private institutions nationwide, according to the National Science Foundation. For more information, visit www.health.usf.edu

Media contacts:
Katherine Claytor, The Florida Aquarium: 813-486-1645, kclaytor@flaquarium.org
Anne DeLotto Baier, USF Health Communications: 813- 974-3303, abaier@health.usf.edu