One of the largest applications of 3D modeling and design in medicine is pre-surgical planning.
In early December 2021, Dr. Laurence Mermelstein at Long Island Spine Specialists in New York contacted Med Dimensions about a complex spine case.
A new patient presented with severe pain and limited mobility in his low back. He previously had been through two spine procedures and a hip procedure that had not solved his issues. In the second back surgery, the doctors removed old hardware and attempted a spinal fusion, but it failed over time, as the fused levels sheared and shifted the vertebral body both anteriorly and laterally, causing spinal rotation. Somehow, this patient was still substantially mobile.
Somehow, this patient was still walking into his office!
X-Rays showed the patient’s deformities in two dimensional images- but with multiple deformities collocated, it was impossible to see the full extent of the deformation.
Dr. Mermelstein approached Med Dimensions to turn his two dimensional challenge into a three dimensional solution.
“I was able to plan reduction maneuvers for this patient, as the vertebral body had been shifted and there was an element of rotation. This twisted anatomy was challenging, and the model being accurate helped me plan how to piece it together.”
Dr. Laurence Mermelstein, Long Island Spine Specialists
We were able to take this patient’s images and turn them into an accurate model for Dr. Mermelstein that replicated precisely what he would encounter in the operating room. Collaborating with our partner Vent Creativity, Med Dimensions printed a 3D model that looks, feels, and moves like real bone. The surgeon was able to minimize the unknowns he had prior to the surgery.
With this model, he was able to determine that a posterior surgical approach was ideal, and further that a lateral/anterior approach for operation would potentially be harmful to the patient. (Below are post operative x-rays)
Flash forward to today, this patient is up, moving, and doing well! Pre-operative models for planning and practice are becoming the new standard for patient care, and Med Dimensions is on the forefront of this technology.
VENT Creativity Corporation., a leading provider of Principal Density Analysis software applications for medical imaging modalities, and Med-Dimensions, LLC., a veterinary medical device company specialising in patient-specific education and surgical solutions, today announced the availability of an integration between the two development environments to streamline the imaging to custom 3D printed cutting guides for canine hip replacement surgeries at an unparalleled speed and cost.
The direct connection between VENT Creativity’s 3D CAD based density analysis AI software, Minerva, and Med Dimension’s biocompatible 3D printed cutting guide technology allows companies or hospitals to quickly optimize product designs through rapid design and simulation cycles with minimal cost to the surgeon customers.
Digital simulation software is growing in healthcare as more surgeons analyze surgical plans and cutting guides for the surgeries they plan. This trend toward patient specific and fast analysis – where digital simulation occurs as part of the surgical process – benefits surgeons and patients by providing patient specific optimal quality, reduced OR time with guides that fit the patient anatomy everytime, and reduced guess work for in surgery decision making.
For the healthcare system where time and costs are decision drivers for products used, moving from manual tools that do not always fit the patients to custom deliveredguides that fit each patient everytime is a value driver. The integration between VENT Creativity and Med Dimensions allows the easy exchange of information so design and simulation run in parallel.
Dr Rory Todhunter on the value added to the medical community from this partnership:
“The goal of elective surgery is to improve quality of life for the patient while reducing the risk of surgical error. Training, practice, and experience reduce the risk of error. However, if freehand implantation of a femoral stem in a total hip replacement procedure is not coaxially aligned, femoral fracture can result. A 3D printed reaming guide to develop coaxially aligned preparation of the femoral canal that can be produced quickly and cost effectively from a CT will reduce surgical error and complications for surgeons of differing experience. The risk of surgical error and operative time should be reduced.”
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From Cornell School of Veterinary Medicine, 08/18/2020
There are many gateways to the veterinary medical field. For Rochester Institute of Technology (RIT) graduate Sean Bellefeuille, it was 3D printing.
“As an undergraduate in biomedical engineering at RIT, I became really passionate about 3D printing,” he says.
He joined a club that specialized in the technology, working with organizations that helped get custom, 3D-printed prosthetics to children with amputations. “That’s where I learned the basics of design and printing,” he says. He continued an in-depth exploration of the technology, studying the market needs and gaps, and discovered that veterinary medicine held huge potential for 3D printing.
Currently, only a handful of companies produce anatomical models and prosthetics for animals, and their products are highly expensive, Bellefeuille explains.
The spark that ignited his business came from a Rochester-area emergency veterinary hospital, which reached out to RIT’s biomedical engineering department in hopes of expertise. They had a difficult orthopedic case — a patient with a rare femoral deformity that needed surgical intervention. To prepare for the procedure, the surgeon wanted a 3D printed model of the bone to examine.
“The department funneled it down to me and couple other students who worked with 3D printing,” says Bellefeuille. “Without knowing how, we said ‘sure we’ll do it’.”
Using a CT scan provided by the veterinarians, Bellefeuille and his colleagues printed a 3D model of the femur. The RIT students were invited to watch the surgery, during which the surgeon paused and asked to look at the femur for reference before making a certain cut. “That was a big moment,” says Bellefeuille. “It was proof that our 3D printed anatomical models delivered a real benefit to a veterinarian in a clinical setting. We figured, if this person uses it, there are definitely others that will use it too.”
This was the beginning of “M3Dimensions” (pronounced “med-dimensions”) Bellefeuille’s start-up biomedical printing company. They are currently working on a business and strategy plan with a goal of formally launching in January 2021.
“Our goal is to increase accessibility for 3D printing technology, 3D models and other types of related tech such as custom cutting guides and templates to help with surgical cuts,” says Bellefeuille. “We’ve identified a demand for devices which would actually attach to the bone to assist the orthopedic surgeon in making more accurate cuts.”
This synergy of biomedical engineering and veterinary medicine also inspired Bellefeuille to pursue the veterinary profession. “I always enjoyed the medical and biological aspects of my undergraduate program,” he says. “And then saw how open the veterinary medical field was — that there was an opportunity to bring in my engineering knowledge.” Bellefeuille ended up shadowing and working at the same emergency veterinary hospital and surgeon whom he had printed the femur for, and from thereon, was inspired to pursue veterinary medicine.
With that career in his sights, Cornell was quickly Bellefeuille’s first choice. “Cornell has always had a great reputation,” he says. “And, being based in Rochester, a lot of the veterinarians I worked with for my business had gone to Cornell and spoke of it highly.” Plus, as a New York state resident, Bellefeuille knew that tuition would be markedly more affordable.
Cornell also strongly appealed to Bellefeuille thanks to personal connections he made prior to applying. “I reached out to [Maurice R. and Corinne P. Greenberg Professor of Surgery] Dr. Rory Todhunter letting him know of my interest, and he invited me to come spend a day with his surgery team,” he says. “I got to spend a day shadowing them, watched some surgeries — it was really great to start a relationship with a well-established surgeon at Cornell.”
Bellefeuille also got to know Jorge Colón ’92, D.V.M. ’95, senior lecturer with the Center for Veterinary Business and Entrepreneurship, who immediately connected him with the Center for Veterinary Business and Entrepreneurship’s resources and introduced him to CVM veterinary entrepreneurs like Drs. Jonathan Cheetham and Rodrigo Bicalho. “It was great to get those connections before starting school,” he says.
Like everyone, Bellefeuille has been affected by the COVID-19 pandemic. Veterinary business slowed down considerably as elective surgeries were canceled or postponed. Rather than go idle, Bellefeuille and his team decided to volunteer their expertise and work with a local Rochester group to 3D print face shields for local hospitals and veterinary practices — donating as many as 25,000 shields in total. “We didn’t have much to do, so we just wanted to figure out a way to help,” Bellefeuille says.
As Cornell slowly begins its reopening process and welcoming students back to campus for the fall 2020 semester, Bellefeuille is excited to embark on this next step of his career. “I’m so excited to learn anatomy and to get that real hands-on knowledge,” he says. He plans to pursue veterinary medicine as his primary profession, potentially in a specialty service, and have his 3D printing business support the work he would do as a veterinarian. “I definitely want to incorporate 3D printing in whatever I’m doing,” he says.
From Kevin Oklobzija of the Rochester Business journal, 3/24/2020
In normal times, M3Dimensions would be bettering the surgical process for veterinarians and providing veterinary students with 3D models to enhance learning.
But during this global coronavirus pandemic, the Rochester-based medical device company is instead creating lightweight, protective face shields for health care workers.
M3Dimensions, a startup launched by a group of former and current Rochester Institute of Technology students, has been in contact with medical professionals on Long Island to design and produce a practical face shield.
“We’re trying to work with their protocols so there’s an airtight seal,” said Sean Bellefeuille, co-founder and CEO of the firm. “We have to make sure everything fits their needs.”
The goal is to supply health care workers with a tangible extra layer of protection, using the firm’s 3D printing process to create the top band that holds the shield. The shield uses a closed-cell foam cushion and polyethylene terephthalate plastic, which does not absorb moisture or harbor bacteria.
“With everything going on, a lot of people are trying to help,” Bellefeuille said. “But you don’t want something that isn’t safe and gives someone a false sense of security. This would be an extra barrier to block the virus.”
Based on printer inventory, Bellefeuille figures M3Dimensions can produce 40 to 60 shields a day. Other firms with Fused Deposition Modeling 3D printers can also produce the shields, he said. The M3Dimensions website provides more information.
M3Dimensions was founded in the summer of 2019, though the seven-person group has been working together on implementation of the business idea since 2018.
The company works to provide veterinarians a precise 3D model of a knee ailment or bone abnormality before surgery. The anatomical model is made from polylactic acid plastic and is created from an MRI or CT scan. The technology can also be used in the medical field.
By examining the model ahead of time, doctors can determine what exactly must be done in surgery to correct the existing medical issue. That reduces time in the operating room and time under anesthesia for the pet, said Michael Campbell, director of business development for M3Dimensions.
The firm has also provided veterinary schools with a batch of anatomical models so students can see, touch and feel what they would find in surgery.
This week in the Times we’re going to share a story from Med Dimensions co-founder, Sean Belefeuille:
A local surgeon we have been working with reached out and asked for a femur and tibia/fibula 3D model for one of his patients, a medium sized and mixed breed dog. Dr. Hofmann suspected deformities in both the tibia and the femur. The main issue was several bone deformities that could affect patient movement and cause pain, eventually resulting in osteochondral arthritis and a plethora of other orthopedic complications if it were to go untreated. The surgical challenge in this case with having multiple deformities is that it would require the surgeon to do multiple procedures during the same surgery. This increases the surgery time, the risk to the patient and the cost to the family. After reviewing the models we provided him with, the surgeon determined one of the deformations was not as severe as he had thought while reviewing the imaging scan (CT). He decided the second procedure could be cut out, decreasing the surgery time and the cost of hospital stay.
The actual process of repairing the issue was very similar to the first, a sort of deformation that he cut out a wedge to better align the bone. The procedure of a corrective osteotomy was a tremendous success in pre-op management, during surgery, and post-op follow up.
Med Dimensions has the capability to suit any and all surgeons needs through only the highest quality products and services!
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One of first reported uses of the technology for a cerebrovascular malformation
From the Cleveland Clinic, 06/05/2019
In April 2019, clinicians in Cleveland Clinic’s Cerebrovascular Center performed one of the first reported brain aneurysm repairs guided by preoperative and intraoperative use of a 3D-printed replica of the aneurysm.
The patient was an otherwise healthy man in his 50s with a large (12-mm) aneurysm of the anterior communicating artery. He underwent a complication-free open craniotomy with clipping and was on track to a full functional recovery several weeks after the surgery.
The 3D-printed model (shown with a clip in photo below) was produced at actual size based on angiograms of the aneurysm processed by radiologists and other members of a multidisciplinary team in Cleveland Clinic’s Lerner Research Institute. To date, the team has generated over 100 3D-printed anatomic models to help guide complex surgeries ranging from liver transplants to congenital heart defect repairs.
An unprecedented window into anatomy
“I was able to hold the aneurysm model in my hand, which greatly enhanced my understanding of the patient’s anatomy and enabled us to develop a truly patient-specific surgical plan,” says Mark Bain, MD, MS, Head of Cerebrovascular and Endovascular Neurosurgery and lead surgeon on the case.
“The 3D-printed model allowed me to visualize the surgical approach before I made a single incision,” he continues, “enabling me to select the clip size in advance and know the exact location of the important daughter branches coming out of the aneurysm.”
The model also gave Dr. Bain a preoperative heads-up about an artery that was stuck to the aneurysm, which allowed him to determine that it was clear of the neck of the aneurysm where the clip would be applied. “It was really helpful to know that going in and not be blindsided by that artery at the time of surgery,” he shares. “I was genuinely surprised by how helpful the model was.”
That utility continued into the intraoperative phase, where the model was at the surgical team’s side for reference throughout the procedure, Dr. Bain notes, “allowing us to check and recheck the anatomy.”
A bevy of benefits
Dr. Bain identifies at least five distinct benefits that 3D-printed anatomical replicas promise for appropriate future cases.
1) Better operative planning, with potential for fewer complications. Dr. Bain’s comments above illustrate the clear benefits for preoperative planning and intraoperative visualization. Whether these lead to improved outcomes is something his group is eager to study in the months and years ahead. “We’re starting a couple of studies of this question,” he says.
2) Potential for reduced operative time. He estimates that the advance planning made possible by the model in this first case shortened the operative time by about half “because I knew exactly where to go and where to put the clip, and I already had the clip selected.”
3) Better patient education. Before his operation, the case patient and his family members were able to hold the model in their hands while Dr. Bain explained the procedure. “It was very valuable in helping them fully understand why we were choosing the procedure we did,” he says, adding that this promises to enhance patient satisfaction.
4) Value for resident and fellow training. “Residents present for this case said the anatomy of the aneurysm was so much clearer to them during the procedure by dint of having the model as an intraoperative reference,” notes Dr. Bain, shown in the photo below holding the model in hand as he discusses the procedure with trainees. “And one of our departing fellows raved about how much clearer she could see the anatomy thanks to the 3D model and how valuable this will be for training new physicians.”
5) Likely utility in procedure selection. Although the 3D replica didn’t influence procedure choice in this case, Dr. Bain says 3D-printed models likely will for some future patients. “I can foresee instances where the replica will reveal, for example, that a particular branch would not be appropriate for planned stenting or that a particular spot would be unlikely to hold a coil well,” he explains. “This may help improve our selection of cases or choice of procedure.” He adds that this includes decisions on when to use an endovascular versus open surgical approach. To that end, his team plans to generate hollow 3D-printed aneurysm replicas to help explore catheter navigation inside vessels for cases where endovascular procedures are planned.
How broadly to apply the technology?
While the case above was ideal for introducing 3D printing technology because of the large size of the aneurysm (12 mm), Dr. Bain says the technology can be used to replicate aneurysms of sizes down to 5 mm or even smaller. “Some of the branches in this first model were under 1 mm and we could still see them well,” he notes. “This technology has the resolution to pick up details at very small scale.”
So if aneurysm size is not much of a limiting factor, how will his team decide when to use this technology moving forward? “That’s one of the things we’ll be looking to explore in the studies we’re getting underway surrounding this,” he says. He explains that his team is pursuing grant funding to continue generation of 3D-printed replicas so they can accumulate enough data to begin to assess effects on outcomes and overall costs.
The cost of 3D printing is one limiting factor, as is time. Because it typically takes a couple of weeks to generate a replica, the technology is limited to nonurgent elective cases.
In an ideal world, Dr. Bain says, “I’d love to take every vascular malformation for which we get good imaging — arteriovenous malformations, fistulas, aneurysms — and send those images off for 3D printing. But we’ll have to see where the data fall to determine how broadly this should be applied.”