Designing Next-Generation Implants for Innovative Spine Surgery

Spine surgery continues to advance and implant designs are at the forefront of innovation in the space. In the spine segment, emerging materials and designs are tailored to mimic the body’s natural biomechanics. Next-generation implants are built for compatibility with minimally invasive surgical techniques and enabling technologies.

This approach to implant design represents a significant leap forward as patient demographic factors continue to increase surgical demand.

The number of people aged 60 or older will double between 2020 and 2050, from one billion to 2.1 billion, according to the World Health Organization. Further, the organization’s data shows back pain is the leading musculoskeletal condition and cause of disability worldwide.

Companies respond to these market forces by focusing on new opportunities in minimally invasive surgical techniques and motion-preserving disc replacement devices. Spinal fusion remains a viable treatment option as minimally invasive surgery and disc replacements continue to gain acceptance among surgeons and payers.

As the global population grows and ages and the demand for spine repair continues to increase, companies are increasingly developing solutions that enable surgeons to manage even complex spine cases with greater ease and accuracy.

Minimally invasive surgery has also been a significant focus in the development of advanced spine implants. These techniques allow surgeons to perform procedures with smaller incisions, leading to faster recovery and reduced postoperative complications.

Leveraging Natural Anatomy

ZygoFix’s zLOCK device is a prime example of how contemporary spine implants are being designed to work with the body’s natural structures. The company has developed a proprietary approach to spinal stabilization and fusion, according to CEO Ofer Levy.

Traditional spinal fusion procedures involve placing pedicle screws and a short rod in the treated segment to provide stability. These pedicle screws, which form a solid bridge between adjacent vertebrae, require four to six bilateral incisions and increase complication risks due to incorrect positioning.

In contrast, the zLOCK system utilizes the patient’s natural anatomy by locking motion within the vertebrae joint with a miniature implant that anchors the bones to hinder motion.

“Our idea was to use the natural bridge to minimize the invasiveness of the surgery and enhance outcomes,” Levy said. “By locking motion inside the facet joint, we simplify the procedure. It requires only one incision and reduces the need for precise screw placement.”

Levy noted that while using the facets for posterior stabilization isn’t new, ZygoFix has addressed challenges that predecessors faced.

“The intricate anatomy of this small joint is a challenge for an off-the-shelf implant, and the bendability of zLOCK solves this problem with a simple technique,” Levy said. “The keels that anchor into the bones provide great stability.”

This approach by ZygoFix lowers the risk of nerve injury and maintains the spine’s natural loading mechanism. While the long-term benefits of preserving this natural loading are still under study, Levy believes it could reduce adjacent injuries, a significant improvement over traditional pedicle screw constructs.

“We’re hoping to see that this natural loading will reduce injury risks,” Levy said. “We’re still studying this possibility, but it could be an interesting feature of the system.”

Improved Materials and Manufacturing Methods

Improvements to implant design and materials are driving many of the new spine implants that are being introduced to the market. DePuy Synthes’ TriALTIS Spine System exemplifies these advancements, according to Sarah Brownhill, Ph.D., the company’s R&D Director of Complex Spine.

The posterior thoracolumbar pedicle screw system is built on three core pillars: technology that integrates with power and navigation systems; reliability that leverages the legacy of DePuy Synthes spine implants; and innovation that provides a new development platform and a consistent surgeon experience across all indicated pathologies.

“Every patient and case are different and require unique treatment decisions,” Dr. Brownhill said. “With TriALTIS, we’re seeking to improve spine surgery by offering a comprehensive portfolio of implants that streamlines surgical workflows.”

The system boasts an ergonomic instrument design for ease of handling and an improved surgical experience. “Additionally, the screw tips are optimized for immediate bone engagement. We’ve also improved the strength across the bone screws and set screws to prevent loosening and enhance long-term stability compared to legacy systems,” Dr. Brownhill said. “The system’s implant portfolio is extensive and designed to give surgeons what they need in the operating room.”

According to Dr. Brownhill, implants designed to improve fixation within the spine represent a significant unmet clinical need. “Our implant portfolio complements different anatomies and procedures and streamlines workflows, giving surgeons the flexibility they need to improve outcomes.”

Further, TriALTIS may provide more economic value and reduce waste. One of the system’s novel features is “Open but Not Used” packs, which allow for resterilization of screws that are not compromised during a case.

DePuy Synthes’ ALTALYNE Ultra Alignment System for adolescent spinal deformities is another enhanced implant design.
Rods with a higher bending yield strength are more resistant to flattening during surgery, allowing them to maintain their customized contour and help surgeons achieve the desired spinal alignment. ALTALYNE achieves this through advanced material science, utilizing a specific cobalt chromium alloy. While this alloy has been previously used in spinal wires, the ALTALYNE system represents the first application of the metal in spinal rods.

Manufacturing techniques are also driving the development of next-generation spine implants, with additive manufacturing playing a crucial role. This technology offers precise, repeatable outcomes and allows for the production of intricate designs that were prohibitively expensive or previously impossible to make with subtractive manufacturing methods.

“Additive manufacturing has been by far the biggest advancement that enables innovative implant design,” Levy said. “3D printing enables us to create unique designs at a lower cost. The technology allows for precise, repeatable results and the inclusion of features like undercuts that enhance bone growth.

Integrating with Enabling Technology

Robotic and navigation systems provide surgeons with enhanced visualization and surgical precision. These tools have become central to advancements in the space as more tech-savvy surgeons explore their use.

Now that enabling technologies assist surgeons in performing more precise surgery, Levy believes further innovation will occur through new, minimally invasive implant designs. “Devices that capitalize on this advanced precision can now be made smaller or designed for very specific applications,” he said.

Dr. Brownhill echoed these sentiments and highlighted the TriALTIS pedicle screw platform, which works seamlessly across the entire DePuy Synthes portfolio of enabling technology solutions. The system’s navigation-enabled drills, taps and screwdrivers can be used with or without navigation to treat complex spine conditions such as degeneration, tumors, trauma and deformity.

“TriALTIS integrates easily with surgical power tools and navigation,” Dr. Brownhill said. “We’ve developed dedicated instrumentation for navigation, such as drill sleeves, that surgeons can adjust with one hand for navigation arrays. This improves the accuracy of screw placement and overall surgical outcomes.”

Emerging Trends

The next generation of spine implants represents a significant leap forward. By leveraging advanced materials, innovative designs and enabling technologies, these implants offer improved stability, support and patient outcomes. As the field continues to evolve, the focus remains on creating implants that integrate seamlessly with the natural biomechanics of the spine, ensuring long-term success and patient satisfaction.

Looking ahead, experts see exciting trends and future directions in spine implant technology. Levy said one such area is in dynamic implants, which could be adjusted postoperatively to facilitate bone growth and improve outcomes.

“Many revision procedures are performed because implants degrade over time or were misplaced during the primary surgery,” Levy said. “If surgeons could manipulate the distraction of an implant after it’s been placed, they can avoid the need for revision surgery. The technology can also be used to improve the fusion process.”

Enabling technologies are expected to continue to drive innovation, allowing for more precise and effective surgeries. Dr. Brownhill emphasized the importance of balancing digital enablement with well-designed implants.

“We’re constantly looking at the ways digital technologies can improve outcomes while keeping the decision-making in the hands of the surgeons,” she said. “The goal is to reduce complications and enhance surgeons’ capabilities rather than replace them.”

KK

Kendal Kloiber is a contributing editor.

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