Zhejiang University Seeks Technology Transfer of a High-Strength, Long-Acting Silver-Loaded Orthopedic Implant with Enhanced Anti-Infection Capability
Recently, the Institute of Industrial Technology Transfer of Zhejiang University released a public notice on patent transfer, proposing to transfer aHigh-Efficiency Vacuum Silver-Loaded Bone Implant Devices with High Binding Strength and Long-Lasting Antibacterial FunctionAssignment of relevant invention patents, with the agreed transfer amount being300,000 yuan, the patent was completed by Professor Ye Zhaoming, Director of the Department of Orthopedics at the Second Affiliated Hospital of Zhejiang University School of Medicine.
It is reported that Professor Ye currently serves as the Director of the Institute of Orthopedics at Zhejiang University, as well as the Director of the Key Laboratory of Research and Precision Diagnosis and Treatment of Musculoskeletal Diseases in Zhejiang Province. He has long focused on research into bone tumors, repair of bone defects, and the clinical application of implantable devices, excelling particularly in addressing practical issues such as postoperative infections and low osseointegration efficiency of implantable devices by aligning with clinical needs.
This patent primarily addresses two core issues:1. The clinical pain point of high postoperative infection rates associated with orthopedic and dental implants, especially in scenarios such as pelvic tumor prosthetic reconstruction and hip and knee joint replacement, effectively addressing the shortcomings of traditional instruments in terms of anti-infection capability;Second, it overcomes the technical bottlenecks of traditional antimicrobial coatings, such as low bonding strength with the substrate, poor scratch resistance, and short-lasting antimicrobial efficacy., thereby resolving process challenges such as the impact of titanium/titanium alloy surface oxidation on coating adhesion and the hindrance of antibacterial metal loading by the surface tension at the openings of TNTs.
Implantable bone medical devices are a class of devices that are implanted throughSurgical Implantation into the Human Skeletal System, medical devices used to replace damaged bone tissue, stabilize fracture sites, or reconstruct bone structures. Common types include fracture fixation plates, artificial joints, tumor endoprostheses for bone tumor reconstruction, and dental implants. Their core function isRestore the supportive and motor functions of bone, accelerating patient recovery following skeletal injury or disease.. Such products are widely used in clinical scenarios including orthopedic trauma, joint diseases, bone tumors, and dental restoration.
Postoperative Infection of Implanted DevicesIt has always been a significant challenge for clinicians and patients. Studies have shown that the overall incidence of postoperative infection in orthopedic fracture surgery ranges from 0.4% to 16%, with an infection rate of approximately 1.5% after open fracture surgery, and between 1.2% and 2.2% after knee and hip joint replacement surgeries. The associated mortality rate is as high as 2.7% to 18%. Particularly serious is the fact that the postoperative infection rate for pelvic and tibial tumor prosthesis reconstruction surgeries actuallyUp to 15%–43%。
With the continuous advancement of industries such as transportation and construction, coupled with an accelerating aging trend, the demand for various surgical procedures will increase year by year, which will also indirectly lead to a yearly rise in the number of infection cases. In view of this, the prevention and control of infections has become urgently imperative.
In recent years,Antibacterial Coating TechnologyWith its significant advantages, such as convenience and high efficiency, it has gradually gained widespread recognition from researchers and clinicians. However, despite continuous advancements in antimicrobial coating technologies and the ongoing development and promotion of various antimicrobial-coated products, substantial challenges remain in areas including the bond strength between the coating and the substrate, scratch resistance, and the duration of antimicrobial efficacy, underscoring an urgent need for further technological upgrades.
Therefore, Professor Ye Zhaoming's team proposedTechnology Based on Metal Antimicrobial AgentsThe implantable device is composed of metal-based antimicrobial components such as titanium/titanium alloys and silver/copper, and is manufactured using a combination of processes including anodization, vacuum plating, free-abrasive machining, multi-stage cleaning, and air-jet rinsing. It offers advantages such as high bonding strength and long-lasting antimicrobial efficacy.
The team throughAnodization Technology Introduces Primary TNT (Titanium Nanotube) Array Structures on the Surface of Titanium/Titanium Alloy Materials, while simultaneously overcoming the surface tension challenge at the TNT pore openings through vacuum plating technology, thereby efficiently introducing metal-based antimicrobial coatings such as silver and copper into the interior of the TNT arrays. This coating forms a secondary interlocking composite structure with the TNT arrays, resulting in the development of a highly efficient vacuum-silver-loaded bone implant device characterized by high bonding strength and long-lasting antimicrobial efficacy. Leveraging the unique properties of TNTs, this deviceNot only does it feature high coating adhesion strength and superior wear resistance, but it also achieves long-term anti-infection performance.。
Compared with similar products on the market and traditional technologies, this technology has formed multi-dimensional differentiated advantages in process design, performance, and clinical adaptability, which can be summarized into four points:
1. Dual breakthroughs in coating bond strength and wear resistance.By leveraging the core process combination of “anodization to construct TNT arrays + vacuum plating to form a secondary interlocking mosaic structure,” this solution fundamentally addresses the technical pain point of loose adhesion between traditional coatings and substrates—coating bond strengthUp to 57.2 MPa。
Meanwhile, leveraging the high hardness of titanium/titanium alloy oxides, the TNT array constructs a physical protective barrier for the relatively soft silver/copper antibacterial coating, effectively resisting scratch damage during use. Its wear resistance is significantly superior to that of similar domestically produced devices that rely solely on single-metal coatings.
Second, dual assurance of long-lasting antimicrobial efficacy and biosafety.By leveraging the encapsulation and sustained-release properties of the TNT array for silver/copper antimicrobial metals, this approach achieves the slow and continuous release of antimicrobial components, i.e., the amount of silver ions released within 0 days canPrecise control at 18.26±2.59 μg/mlThis approach not only covers the full spectrum of infection risk windows from the immediate postoperative period to the long term, thereby providing sustained inhibition of bacterial proliferation, but also avoids the potential biotoxicity associated with the excessive short-term release of metal ions.
Moreover, unlike traditional nano-antibacterial coatings, this solution employs elemental silver/copper coatings, offering superior biocompatibility.Live cell ratio reached 95.3%, significantly higher than most antimicrobial implantable devices on the market, reducing the risk of postoperative adverse tissue reactions.
Third is the dual integration of “anti-infection + bone repair” functions.While addressing the core needs of infection prevention and control, this approach innovatively preserves the inherent osteogenic properties of the TNT array—precisely exposing the TNT structure via free abrasive machining to create a favorable microenvironment for new bone growth at the implantation site, thereby truly achieving“Simultaneous Advancement of Anti-Infection and Bone Repair”。
This design addresses the functional limitations of comparable products on the market, making it better suited for clinical scenarios that require balancing healing efficiency, such as fracture repair and tumor prosthesis reconstruction, thereby accelerating postoperative recovery.
Fourth, dual optimization of process adaptability and clinical practicality.In terms of process compatibility, this solution employs free-abrasive machining technology, enabling flexible adaptation to irregular profiles and 3D-printed devices, thereby addressing the challenge of traditional polishing techniques in accessing complex corners of medical instruments. Furthermore, unlike antibiotic-eluting implants, this technology does not rely on antibiotics, fundamentally mitigating the risk of antibiotic resistance and further enhancing the safety and sustainability of clinical applications.
In the current global orthopedic device market, anti-infection products targeting post-implantation infections have established diverse technological pathways, encompassing metal ion-based antimicrobials, antibiotic-eluting systems, and polymer composite coatings.
Zimmer Biomet’s Natural Nail System is an orthopedic trauma implant that combines the Bactiguard antimicrobial coating with a clinically validated intramedullary nailing system, primarily used for fracture fixation. Its core antimicrobial mechanism involves a gold, silver, and palladium alloy in the coating that generates microcurrents in bodily fluids, reducing bacterial adhesion and biofilm formation through the galvanic effect. As a non-antibiotic-releasing anti-infection technology, it helps lower the risk of infection in trauma surgeries such as those for open fractures.
The product has been clinically validated and commercially launched, accompanied by a range of specifications including tibial nails and femoral nails. It is supported by comprehensive surgical guidelines and clinical data, and has been widely used in the treatment of orthopedic trauma in Europe and other regions.
Clemson University’s independent nonprofit organization has proposed a multifunctional antimicrobial coating solution for orthopedic external fixation devices. This technology is based onPoly(glycidyl methacrylate) (PGMA)Based on a copolymerization process that integrates hydrophilic and hydrophobic monomer structures, the coating can simultaneously load multiple active ingredients, including antibiotics, anti-inflammatory drugs, and growth factors. It exhibits high mechanical stability, withstands shear forces during device implantation, prevents coating delamination, and achieves sustained, stable drug release.
The team has currently completed in vitro preclinical studies, validating the coating’s mechanical stability, drug-loading efficiency, and sustained antibacterial activity; however, it has not yet entered the clinical trial phase.
As a leading enterprise in China’s orthopedic device industry, Weigao Orthopedics has also introduced corresponding solutions to address intraoperative infections. Its flagship silver-antibacterial bone plate and bone screw product series uses titanium alloy as the base material and incorporates silver-ion antibacterial components through surface modification technology; these products are primarily used for internal fixation of limb fractures. The core of their design isLeverage the broad-spectrum antimicrobial properties of silver ions to inhibit bacterial proliferation, while relying on a titanium alloy substrate to ensure the mechanical support performance of the device.
The product series has been approved by the National Medical Products Administration (NMPA) and is now in commercial production, widely used in orthopedic trauma surgeries across hospitals at all levels.
DaBo Medical has developed antimicrobial-coated artificial joint prostheses to address the challenge of postoperative infections in joint replacement surgery. The product features a composite coating containing rifampin and vancomycin applied to the surface of cobalt-chromium-molybdenum alloy prostheses, enabling localized anti-infective effects through controlled antibiotic release. Additionally, the articulating surfaces of the prosthesis are designed for wear resistance to extend service life, making it suitable for hip and knee joint replacement procedures.
The product has completed clinical trials and received marketing approval. As an antibiotic sustained-release anti-infection device, it has been incorporated into the joint replacement clinical protocols of numerous Grade A tertiary hospitals.
Postoperative infections associated with implanted devices have garnered significant attention from both academic and industrial communities worldwide, leading to the proposal of solutions across various levels and technical dimensions.
Addressing the persistent core challenge of postoperative infections associated with implanted devices, which has long plagued both clinical practice and the industry, academic and industrial sectors worldwide have continued to exert significant efforts in technological exploration. These range from mature commercialized solutions by imported companies leveraging metal ion-based antimicrobial mechanisms, to localized breakthroughs by domestic manufacturers focusing on antibiotic elution or single-layer silver-coated technologies, and further to this patent’s“Structural Innovation + Process Integration”The constructed multidimensional solution leverages the unique strengths of various technological approaches to provide infection prevention and control options for diverse clinical scenarios.
In fact, there is no“Absolute Optimal Solution”, only“Scenario-Adapted Solutions”. In the future, driven by the growing demand for orthopedic surgeries due to an aging population, as well as the clinical pursuit of “precision medicine” and “minimally invasive repair,” implant device technology will further evolve toward"Multifunctional Synergy," "Low Toxicity and Long-Acting"Directional upgrade. Whether it is the technological translation of this patent by Zhejiang University or the iterative optimization of similar products, ultimately they will return to“Clinical Needs at the Core”the essence. That is, through differentiated competition driven by technological innovation, to jointly propel the implantable device industry from merely “addressing availability” to “pursuing excellence.” This will not only provide richer technical support for reducing postoperative infection rates and improving patients’ quality of life, but also inject sustained momentum into the development of global orthopedic healthcare.