Copy to clipboard 
The demand for small joint reconstructive implants is on the rise globally. This growth is driven by several factors, including an aging population, an increase in orthopedic conditions like arthritis and a preference for minimally invasive surgical procedures. From the fingers and toes to the wrist and ankle, these small yet crucial joints are essential for daily function and quality of life. However, the very nature of these high-motion, small-load joints presents significant challenges for implant longevity and performance.
Patients undergoing procedures like joint arthroplasty or total joint replacement often face complications with traditional implant materials. Metals and silicone, while widely used, have known limitations in these demanding environments. These issues can lead to implant failure, requiring painful and costly revision surgeries. As the market expands, the need for a superior biomaterial that can withstand the unique stresses of small articulating joints has never been more critical.
Common Failures of Traditional Implant Materials
When it comes to small joint reconstruction, the materials used are just as important as the surgical technique. The constant, repetitive motion in joints like the knuckles or wrist places immense strain on an implant. Traditional materials often fall short, leading to a range of problems for patients.
Material Wear and Debris
One of the most significant issues with metal and some polymer implants is wear over time. As the implant components articulate against each other, microscopic particles can break off. This wear debris can trigger an inflammatory response in the surrounding tissue, leading to pain, swelling and a condition known as osteolysis, where the bone around the implant begins to degrade. This can cause the implant to loosen and ultimately fail.
Implant Fracture and Instability
The dynamic forces within small joints can lead to material fatigue and stress cracking, particularly in more rigid materials. An implant fracture is a catastrophic failure that necessitates immediate surgical intervention. For patients, especially those with arthritis, this instability negates the very purpose of the replacement: failing to restore motion and alleviate pain. Silicone implants, while flexible, can also be prone to tearing and fracture under repetitive stress.
Stiffness and Loss of Motion
The goal of a joint implant is to restore natural, pain-free movement. However, metal implants can be overly rigid, failing to mimic the natural biomechanics of the joint. This stiffness can limit the patient’s range of motion and create unnatural stress shielding and higher stress on the adjacent bone and soft tissues. This mechanical mismatch can compromise the long-term success of the reconstruction.
Medureon™ Bionate™: The Engineered Solution
Overcoming complex medical challenges requires a biomaterial that’s engineered specifically for the job. Medureon™ Bionate™, a specialized polycarbonate urethane (PCU) from the Biomedical division of dsm-firmenich, sets a new standard in implant technology. We designed this solution to move beyond generic polymers and deliver exceptional performance exactly where patients need it most.
The portfolio offers multiple elastic grades across a wide range of softness levels. You can process the material through thermal methods or directly from solution, which gives you the flexibility to support diverse device designs and manufacturing routes. With a clinical history spanning over 30 years in demanding orthopedic applications, Bionate™ delivers proven results that industry professionals trust.
Unmatched Abrasion Resistance
Bionate™ has been engineered for superior durability. Its molecular structure provides exceptional abrasion resistance, dramatically reducing the generation of wear debris compared to other materials¹. In the high-shear environment of a small articulating joint, this property is paramount. By minimizing particle shedding, Bionate™ may help reduce the risk of inflammation and osteolysis², promoting long-term implant stability and biocompatibility.
Superior Toughness and Flexibility
Unlike rigid metals, Bionate™ possesses a unique combination of toughness and flexibility. This allows it to absorb and distribute the dynamic loads experienced in the ankle or wrist with excellent resistance to stress cracking or fracture. Its mechanical properties more closely mimic those of natural cartilage and bone³, enabling more natural joint kinematics and a comfortable range of motion for the patient.
This biomechanical compatibility may reduce stress shielding and promote better integration with the surrounding anatomy.
Excellent Oxidative Stability
One of the long-term concerns with any implanted polymer is degradation. Over time, the body’s oxidative environment can break down polymer chains, reducing molecular weight, therefore compromising the material’s integrity. Medureon™ Bionate™ is designed for excellent biostability. Its chemistry is inherently resistant to oxidative degradation, helping the implant maintain its mechanical properties for the long haul4. This stability provides peace of mind that the implant will perform as intended.
Proven Biocompatibility
Decades of use in load-bearing orthopedic applications have established Bionate™ for its stability and biocompatability5. The material demonstrates a long history of favorable interaction with the body, making it a safe and reliable choice for permanent implantation6. This proven track record is essential for gaining both regulatory approval and clinical confidence in new device designs.
dsm-firmenich: A Partner in Medical Innovation
Choosing a material supplier is about more than just the product; it’s about partnership. With dsm-firmenich, medical device manufacturers gain a collaborator with deep expertise in biomedical materials. The company is committed to the medical field, providing not only advanced polymers but also the support needed to bring innovative devices to market.
This partnership offers several distinct advantages:
- Regulatory Support. dsm-firmenich maintains established FDA Master Files for its materials, which can streamline the regulatory submission process for new devices.
- Quality Assurance. All materials are manufactured in an ISO 13485-certified facility, adhering to the strictest quality management standards for medical devices.
- Unrivaled Expertise. With a 30-year clinical history, the team at dsm-firmenich understands the challenges from both a customer and a patient perspective, offering insights that go beyond material science.
Setting a New Standard in Small Joint Care
The rising demand for small joint reconstruction highlights a clear need for innovation. The limitations of traditional materials have left both patients and surgeons seeking a more reliable, durable and biocompatible solution.
Medureon™ Bionate™ by dsm-firmenich directly addresses these challenges. Its unique combination of abrasion resistance, toughness, and biostability makes it the ideal material for high-motion, small-load applications. By minimizing wear debris, resisting stress fractures and enabling natural movement, Bionate™ offers the potential for lifelong implant performance. For medical device engineers and orthopedic companies, partnering with dsm-firmenich provides access to a material backed by decades of expertise and a commitment to quality, paving the way for the next generation of successful small joint implants.
References:
- Smith, S. L., Ash, H. E., & Unsworth, A. (2000). A tribological study of UHMWPE acetabular cups and polyurethane compliant layer acetabular cups. Journal of Biomedical Materials Research, 53(6), 710–716.
- Wippermann B, Kurtz S, Hallab N, Treharne R. Explanation and analysis of the first retrieved human acetabular cup made of polycarbonate urethane: a case report. J Long Term Eff Med Implants. 2008;18(1):75-83.32
- Scholes, S. C., et al. “”Compliant layer acetabular cups: friction testing of a range of materials and designs for a new generation of prosthesis that mimics the natural joint.”” Proceedings of the Institution of Mechanical Engineers, Part H: Journal of Engineering in Medicine 220.5 (2006): 583-596.
- Dempsey DK, Carranza C, Chawla CP, Gray P, Eoh JH, Cereceres S, Cosgriff-Hernandez EM. Comparative analysis of in vitro oxidative degradation of poly(carbonate urethanes) for biostability screening. J Biomed Mater Res A. 2014 Oct;102(10):3649-65. doi: 10.1002/jbm.a.35037. Epub 2013 Nov 21. PMID: 24265203.
- Data on file at dsm-firmenich
- Bionate™ Biocompatibility: In Vivo Study in Rabbits ACS Omega 2022 7 (34), 29647-29654
DOI: 10.1021/acsomega.2c01690
