3D printed implant surgery Archives - Perfect 3D Printing Filament

Exactech Transitions from EBM to Laser 3D Printing Implants for Shoulders

Orthopedic implant device maker Exactech wants to scale up the production of its Equinoxe Stemless Shoulder implant by switching from electron beam metal additive manufacturing to direct metal 3D printing with high precision lasers. In an official statement released on July 21, 2020, the Florida-based company announced plans to transition all US stemless shoulder procedures to its laser-printed devices throughout the rest of the year.

As the latest addition to the company’s extremities product line, the Stemless Shoulder, launched in 2018, is a bone conserving prosthesis designed for anatomic total shoulder arthroplasty. Comprised of a stemless cage, humeral head, and cage glenoid, the device offers intraoperative flexibility which is ideal for conserving the bone, said the company. Furthermore, to enhance the probability of biological fixation, it incorporated a laser 3D printed porous bone cage structure that allows bone-through growth, and without the need for a stem, there is more ease of implantation, reduced operating time, and blood loss. Exactech indicated that the innovative combination of 3D porous material and bone cage technology is what differentiates it from competing products on the market.

The new Equinoxe Stemless Shoulder uses laser-printed AM (Image courtesy of Exactech)

Currently, there is a growing trend towards minimally invasive orthopedic surgeries, like stemless shoulder implant procedures mainly led by experts in Germany and France. However, US surgeons also took notice of the benefits of using stemless implants to perform arthroplasties with less bone removal and fewer complications than more conventional anatomic shoulder prosthesis.

Driven by an upsurge in the aging population, longer life expectancy, and rising prevalence of arthritis, the global shoulder arthroplasty market is expected to reach $2.4 billion by 2023, and that includes increased demand for stemless shoulder implants, as forecasted by Koncept Analytics last year. In the US alone, over 53,000 people have shoulder replacement surgery each year, according to the Agency for Healthcare Research and Quality, and with only a handful of stemless shoulder implants cleared by the US Food and Drug Administration (FDA) since 2015 (including the Equinoxe Stemless Shoulder), there is a wide-open market opportunity for medical device manufacturers to exploit. Expecting to become a leading force in the stemless implant market, Exactech is switching technologies to deliver quick solutions for patients and surgeons.

“We have been incredibly pleased with our original EBM [electron beam melting] Stemless Shoulder implant and the early positive clinical feedback we received from our surgeon customers. The new laser-printed device is built on this solid foundation while also giving us the ability to ramp up production to serve even more patients, which drives us and fulfills our mission,” said Exactech Vice President of Extremities, Chris Roche.

Orthopedic surgeons Curtis Noel, of the Crystal Clinic in Akron, Ohio, and Stephanie Muh, of the Henry Ford Health System in Detroit, Michigan, were the first shoulder specialists to perform the surgeries with the Equinoxe Stemless Shoulder implant earlier this month. As a member of the design team, Noel expressed how proud he was to be one of the first to implant the laser-printed Stemless Shoulder, mainly due to the bone conserving design, along with its compatibility to the Equinoxe Shoulder Platform System.

Laser 3D printed porous structure designed to promote bone-through growth (Image courtesy of Exactech)

Muh described that “one of my favorite features of the Stemless implant is its bone cage structure that is designed to provide initial press-fit fixation while also allowing for bone-through growth. That intentional design element, along with the porous structure being designed to mimic the trabecular nature of cancellous bone, differentiates it from competitors.”

In order to design the Stemless Shoulder implant, Exactech engineering researchers collaborated with orthopedic surgeons that combined their knowledge, expertise, and background to come up with a final design structure that could be additively manufactured with optimized pore size, porosity, and count. The design team included Noel; shoulder and elbow surgery expert’s Felix Henry Savoie, from Tulane University, and Joseph Zuckerman from New York University (NYU)’s Langone Orthopaedic Hospital; Pierre-Henri Flurin, from the Clinique du Sport in Bordeaux-Mérignac, in France; Ryan Simovitch, the Director of the Shoulder Division at the Hospital for Special Surgery (HSS) in West Palm Beach, Florida, and Thomas Wright, Director of Interdisciplinary Center for Musculoskeletal Training at the University of Florida.

Pre-operative X-ray (left) and postoperative X-ray (right) showing the laser-printed Stemless Shoulder and Equinoxe Cage Glenoid. (Image courtesy of Stephanie Muh)

As a developer, and producer of innovative implants, instrumentation, and computer-assisted technologies for joint replacement surgery, Exactech targeted clinical evaluations of the Stemless Shoulder immediately after release and has been aggressively expanding and upgrading its product ever since. Just like other manufacturers of stemless implants, the goal here is to try to reproduce the native shoulder anatomy and minimize humeral bone removal. Recent studies. have outlined the numerous advantages – as well as a few disadvantages – of stemless shoulder implant arthroplasty, and although its use is still emerging outside of Europe, the implant is gaining ground with surgeons and patients and is expected to surpass stemmed implants by 2025.

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Pioneering 3D Printed Wrist Prosthesis for Kienbock’s Disease

With sights set on helping medicine solve complex pathologies, the Spanish-based healthcare company BRECA has become a pioneer in Europe, specializing in the design, manufacture, and marketing of customized implants. The company believes 3D printing for personalized medical devices has major benefits for patients and surgeons, such as less blood loss during the operation, a considerable reduction in surgery time and recovery, shorter time under anesthesia, and basically the possibility of generating a custom implant for better adaptation with more aesthetic results. After a series of successes with maxillofacial and neurosurgical 3D printed medical implants, BRECA began to seriously consider offering their services to surgeons in the field of orthopedics. The company’s first customized solution, a complete wrist bone prosthesis, was 3D printed using titanium in June for implantation on a patient who had no mobility of his right wrist and was in a lot of pain. BRECA worked alongside a team of surgeons at the NeuroTraumatology Hospital and Rehabilitation, which is part of the Hospital Universitario Virgen de las Nieves in Granada, who were able to successfully carry out the procedure and after months of recovery, they have presented their case to the world.

Sergio Lopez, a 28-year-old patient, had been diagnosed with osteonecrosis in his wrist bones, also known as Kienbock’s disease. The rare and debilitating condition is known to lead to chronic pain and dysfunction. This happens when one of the eight small carpal bones in the wrist, the lunate bone, becomes damaged because there is no blood supply. Kienböck’s most commonly affects people aged from 20 to 40 years of age, and it occurs in men more often than in women; untreated, the disease will see the progressive deterioration of the wrist and even loss of function. Scientists and engineers at BRECA are constantly searching for solutions to rare and painful diseases, so this new venture into orthopedics is part of what the company is all about. This relatively new procedure replaces the bone with a prosthetic replica made of a durable material that can preserve the anatomy of the wrist bones. The team of surgeons said that most studies suggested using limited commercial prostheses (which don’t offer much mobility of the wrist) and only found one similar case in China where surgeons used a 3D printed prosthesis to successfully treat the wrist.

“Currently available surgeries lead to a total loss of mobility of the patient’s wrist joint, so we decided to look for alternatives and realized that recreating the wrist bone of the patient using 3D technology was a good choice to help overcome advanced Kienbock’s disease,” said David Peris, one of the orthopedic surgeons from the Hospital de la Virgen de las Nieves who participated in the procedure.

Surgery of the wrist

The reconstruction process began with an MRI and a CT scan of the patient’s anatomy that needed to undergo surgery; then, BRECA specialists designed the prosthesis using the patient’s healthy semilunar wrist bone on his left hand as the basis. Using CAD software and 3D printed anatomical models for practice, the experts were able to decide where to make the holes in the prosthesis to anchor it to adjacent bones during the operation, using resistant threads to give it the right stability. This was followed by the development of surgical instruments along with the final prosthesis using the company’s custom 3D printing technology. Finally, surgeons Ricardo Cardona Santana, David Peris Puchol, Enrique Miguel López Herrada and Manolo Delgado Alaminos, carried out the resection and implantation surgery. And once Lopez had fully recovered, he underwent months of rehabilitation that helped him regain mobility of his hand.

According to Peris, “the benefits of using 3D printing technologies for the manufacture of prostheses and implants are very promising, as customized anatomical replacements of diseased bones offer great maneuverability and help surgeons tackle problems that have no other solutions today. But we still have to consider that there could be a few drawbacks, such as implant rejection or even prosthetic loosening due to particle disease.”

3D reconstruction of the location of the Semilunar Bone implant

During recovery, surgeons were very pleased with López’s evolution. He went from taking three anti-inflammatories a day to none at all. According to the surgeons, this implies less risk of side effects from the drugs, as well as a reduction in pharmaceutical spending, overall improve the quality of life of the patient. With regard to mobility, surgeons claim that he has already exceeded the range of mobility and use of force that was measured prior to surgery, and even though they still don’t know how far he will recover, if a traditional procedure had been performed (called wrist arthrodesis), he would have no mobility at all.

“The difficulty of the operation is also given by the nature of the bone to be implanted: the semilunar bone is a crescent-shaped wrist bone, with six faces and four of them are articulated. Thanks to 3D modeling and printing technology, we can generate complex implants like this and prepare for the surgery using anatomical models reconstructed from CT scans, that also help the patient understand what will happen during surgery,” indicated Peris.

Over the last few years, BRECA has been involved with surgeons in many hospitals throughout the country, developing implants that would have otherwise been impossible to create. Earlier this year, another knee reconstruction operation at the same hospital, had BRECA participating with a prosthesis development for a 22-year-old patient who suffered massive dissecting osteochondritis and needed treatment of the damaged joint. BRECA experts claim they understand that surgeons have to deal with very complex cases, which is why they hope their know-how and technology can help them with the manufacture of specific implants and prostheses as well as planning for surgeries, manufacturing instruments to prepare biological grafts and even helping predict osteotomies.

Working alongside surgeons BRECA’s first customized solutions for the field of orthopedics seems to be turning out better than expected. Now, the company expects to keep working on their personalized, patient-specific treatments to improve patient healthcare as well as reduce time and costs during surgical procedures.

Sergio Lopez with his surgeons: Ricardo Cardona Santana, David Peris Puchol, Enrique Miguel López Herrada and Manolo Delgado Alaminos

[Image credit: BRECA, Hospital Universitario Virgen de las Nieves and EFE]

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UK Heart Patient Undergoes Rare Surgery for 3D Printed Titanium Sternum

A Fleetwood, Lancashire woman in the UK is enjoying better health today, able to perform daily tasks at home, not flinching when she coughs or sneezes—but best of all, she is now able to hug her one-year-old granddaughter. All this progress is due to a 3D printed implant fitted and inserted by surgeon, Dr. Ehab Bishay, at University Hospitals Birmingham NHS Foundation Trust.

The 52-year-old patient, Linda Edwards, had been suffering for years with angina, but even after surgery, she suffered further complications as her breastbone became extremely fragile.

After her chest plate collapsed twice post-surgery, it was obvious another solution was needed—but without anything to attach another metal plate to, her previous doctors were running out of options; however, Linda had watched a documentary featuring Dr. Bishay’s work, and she made contact with him after finding him on social media.

Although she was told she would need to ‘apply’ to have the surgery both for funding and to be cleared for the operation, she steadfastly did so and waited two years to have her 3D printed sternum implanted by Dr. Bishay—making her case the third in Britain (and fifth internationally) to undergo such a procedure.

Scan shows Ms Edwards’ ‘collapsed’ sternum before she underwent the operation

“I woke up from the operation feeling terrible and, at one point, I thought I had died, but I am feeling better every day,” she said, also mentioning that the doctors told her to take it easy and even joked with her about not falling over because she had so much money’s worth of metal in her body to protect now.

“I still feel numb because I am on a lot of drugs, but the main thing is my ribcage doesn’t keep shifting about,” explained Linda. “It feels incredible I have had an operation as advanced as this. I feel like I’ve got my life back.”

“It’s priceless. I can hold my granddaughter and that’s the best feeling in the world.”

Dr. Bishay and his team were able to open Linda’s chest again while being careful to avoid any trauma to the previous bypass area or her heart.

“It’s fantastic to see Mrs. Edwards is doing extraordinarily well given the complexity of the procedure she has undergone,” said Dr. Bishay. “My team and I removed Mrs. Edward’s original breastbone and inserted the custom-built prosthesis.”

“The plastic surgery team, led by Mr. Haitham Khalil, harvested several muscle flaps to cover all the extensive components of the prosthesis, a fundamental step in this operation,” continued Dr. Bishay. “Fortunately, complications such as those experienced by Mrs. Edward’s following previous heart surgery are rare but are notoriously difficult to manage.”

While 3D printing is an amazing technology spawning countless, fascinating inventions, we would still be going a bit far to say such processes have changed the world; they have, however, changed the lives of many patients already, worldwide—with some receiving chest implants and titanium 3D printed sternums, and even composite sternums and rib cages. What do you think of this news? Let us know your thoughts! Join the discussion of this and other 3D printing topics at 3DPrintBoard.com.

Linda Edwards, and her granddaughter, Sienna

[Source / Images: Daily Mail]

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