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CeramTec Medical Engineering BIOLOX® FAMILY THE FUTURE IN YOUR HAND 2 TECHNICALLY AND CLINICALLY PROVEN CeramTec: More than 100 years in ceramics, 40 years in medical technology In most cases, they are as invisible as they are indispensable – CeramTec ceramic products are used worldwide for key appli cations in medical devices, automotive industry, electronics, cutting tools, mechanical engineering and the chemical industry. We have always focused on the consistent development of new materials, high quality standards, specific system solutions and constant dialog with our customers. i Infobox WORLD MARKET LEADER IN CERAMIC HIP COMPONENTS Today, ninety percent of implant manufacturers purchase their ceramic components for hip replacement from CeramTec. The extremely wear resistant femoral ball heads and cup inserts have been implanted over eight million times throughout the world. No other material from any manufacturer is used as frequently for bearing couples as the components of the BIOLOX® family. Today, they are being implanted every 45 seconds. In Europe, they are used in approximately 50 percent of patients. 3 Dental ceramics Their superior biocompatibility, hydrothermal stability, strength and, not least, their natural aesthetics make ceramic materials the natural choice for use in dental medicine. CeramTec has over 20 years of experience in this field and offers a broad range of materials and manufacturing processes for dental products. Hip implants The excellent wear resistance and outstanding biocompatibility make ceramic inserts an ideal solution not only for active patients, but also for patients with metal hypersensitivity. The ceramic-on-ceramic bearing couple is by far the least susceptible to wear of all bearing couples used in total joint replacement surgery. Knee implants Components made of BIOLOX® delta are also used in knee arthroplasty. Their outstanding biological and mechanical properties make them the ideal implant, particularly for patients with metal hypersensitivity. 4 MATERIALS FOR PARTICULARLY CHALLENGING APPLICATIONS The wide range of ceramic components in medical devices For many decades, components for medical devices have been produced in various business divisions of CeramTec, including piezo-ceramic elements and specially developed high performance materials. Their particular properties ensure improved function, greater durability and superior reliability. Dental scalers LED lighting Endoscopes A piezo-ceramic transducer induces CeramCool components provide High purity alumina is bioinert and resonant oscillation in the tool. A high efficient cooling for high energy possesses excellent mechanical oscillation frequency and micrometer LED lighting technology. They properties. These are important amplitudes ensure that tartar is removed permit ideal lighting conditions in advantages for components being thoroughly without damage to the clinical settings. used in endoscopic instruments. Surgical knives Various components Ultrasonic nebulizers The device operates on the same Ceramic seal discs, valves, bearings and For respiratory diseases, piezoelectric principle as the dental scaler. With bearing rings are used in a broad range of ultrasound nebulizers permit the the oscillating scalpel blade the medical device applications. Ceramaseal® precise dosing of medications and surgeon can make precise incisions vacuum sealed ceramic-on-metal compo- the accurate setting of droplet sizes. with minimal force and preserve nents are used in the fields of analytics the surrounding tissue. and sensor technology. ® tooth. 5 i Infobox HIGH PERFORMANCE CERAMICS This term covers a variety of highly specialized ceramic materials. They are inorganic, non-metallic and excel with their unique mechanical, electrical, thermal, biological and chemical properties. By combining defined base materials and precisely adjusting specific microstructures, it is possible to steer mechanical and physical parame ters in various directions. Ceramic materials are bioinert; there have been no reported allergic reactions. They are extremely strong and provide unique surface properties. Lithotripters Piezo-ceramics make it possible to break up kidney and gall stones using ultrasonic shockwaves. The focusing and precise targeting of the piezo transducers ensure that surrounding tissue remains unharmed. Technology specialists Specialists in piezo technology: Phone: +49 9123 77 563 e-mail: [email protected] Specialists in electronic components: Phone: +49 9231 69 371 e-mail: [email protected] Specialists in system components: Phone: +49 9123 77 370 e-mail: [email protected] Specialists in mechanical components: Phone: +49 7153 611 444 e-mail: [email protected] 6 Dental Biologically safe materials allow for metal-free care meeting the highest aesthetic standards. We are working on the development of a comprehensive technology platform for ceramic dental implants. Spine Unlike plastics and metal, ceramic implants can be visualized in both radiographs and MRI clearly and without artifacts. Their hardness and defined surface properties are added benefits. Shoulder and small joints As with hip arthroplasty, the use of ceramic components in bearing couples can significantly reduce wear, minimizing the risk of aseptic loosening. The physical properties of ceramics can also improve tribological behavior in shoulders and small joints. Trauma Preventing metal hypersensitivity and reducing the risk of infection: in these respects, ceramic or ceramic coated implants can offer new solutions and help reduce complications. The thermal behavior of ceramics in the body also increases patient comfort. 7 CERAMTEC MEDICAL ENGINEERING Innovations for better medical care Our customers from the medical devices industry are constantly asking us about new capabilities and uses of bioceramics: the most urgent requests are for wear debris reduction, improving imaging, preventing microbial contamination and providing options for pa tients with hypersensitivity to metals. Bioinert ceramic components offer proven and potential approaches to solving these problems. They are the focal point of our research and development. The goal of CeramTec Medical Engineering is to create ceramic products for new medical treatment options. i Infobox BIOCERAMICS SURVEY CeramTec surveyed practicing surgeons in various specialties to identify which new applications for bioceramics were of particularly great interest to them. Based on the proportion of those who checked the “very interested” box, the list of applications in order of priority is as follows: • Trauma implants (72%) • Dental implants and instruments (70%) • Implants for small joints (64%) • Spinal implants (49%) • Surgical instruments (31%) 8 BIOLOX®forte BIOLOX® delta 3Y zirconia Millions of joint replacement compo- This advancement on BIOLOX forte pos- Zirconia (ZrO2) has the highest crack nents made of BIOLOX®forte help people sesses the same outstanding biocompat- resistance of the ceramic materials. across the world achieve a better quality ibility as its predecessor. The base mate- The manufacture of these components of life. The classical high performance rial is still alumina. However, its strength requires the use of stabilizers, such as material made from alumina (Al2O3) and fracture toughness are more than yttrium oxide, which make it possible has been used in hip arthroplasty since doubled as a result of the addition of to achieve strengths of over 1600 MPa. 1995 and serves as a benchmark for the oxides and ceramic platelets. This has As is the case with BIOLOX® delta, cracks the evaluation of ceramic materials in made it possible to offer components are prevented from spreading by what medical devices worldwide. The proven in additional sizes and it addresses new is known as conversion reinforcement. strengths of the material include its applications such as knee arthroplasty. Zirconia can be used to make sharp excellent biocompatibility, outstand- BIOLOX delta is an alumina matrix edges, which together with its visual ing mechanical properties and its high composite. characteristics make the material also ® ® degree of chemical and hydrothermal ideal for dental medicine. stability. 2 µm Microstructure of BIOLOX®delta 2 µm Microstructure of yttrium stabilized zirconia 10 µm 100 µm Microstructure of silicon nitride 5 µm Microstructure of ATZ 2 µm Microstructure of BIOLOX®forte Indenter impression in Ce zirconia Ce zirconia Silicon nitride ATZ Cerium oxide (Ce2O3) can also be used The high level of dynamic fracture Alumina toughened zirconia (ATZ) con- as a stabilizer for zirconia. With an op- toughness and extraordinary edge sists of the same ceramic constituents timal crystalline structure, this material strength make this non-oxide ceramic as ZTA, but with zirconia as the basic achieves an even higher level of fracture a special material. For example, even material. Of all of the ceramic materials, toughness. It also permits limited plastic iron materials can be cut with compo- it possesses the highest flexural strength deformation, similar to metal. Conversely, nents made from silicon nitride (Si3N4). (approximately 1700 MPa) and is there- the strength and hardness are lower Its specific qualities make it an inter- fore used, for example, in tools subjected than is the case with 3Y zirconia. With esting material for numerous types of to high levels of stress. ATZ drilling and its additional increased elasticity, this medical device applications. milling heads are already used in dentistry material can also serve as an alternative when preparing for dental prostheses. for trauma implants – either as base ma- That way metal contact with the area terial or coating, for example in patients of the implant can be avoided completely, with a hypersensitivity to metal. when ceramic dental prostheses are being used. 9 THE BIOLOX FAMILY ® Custom materials with a wide range of performance characteristics In terms of hardness, only diamond is superior to ceramics. Ceramics are bioinert, permit ideal surface qualities, exhibit good wettability and are extremely wear resistant. Depending on the base materials and the processing technology, ceramic materials can be made with additional unique properties. The BIOLOX® family offers the materials to meet your future challenges. The strengths of ceramic in comparison to conventional implant materials From a surgeon‘s point of view CERAMIC METAL POLYMERS Trend Biocompatibility Infections Allergies From a material expert‘s point of view Hardness Wear resistance Weight Deformation resistance Corrosion resistance Fracture toughness beneficial neutral less beneficial We are working on Infection resistance: New materials Optimized mechanical properties: and surfaces which physically counteract Ceramic materials and components microbial contamination, such as the which move significantly beyond the filling of microcavities with hydrogel. existing limits for the material and Direct-to-bone: Ceramic surfaces permit a tissue-friendly treatment. which offer a defined level of rough New ways forward: In continuous ness to permit and promote direct dialog with physicians, implant manu bone ingrowth. facturers and material scientists, we Coating: Ceramic-on-metal, metal-on- are considering solutions which were ceramic, different combinations of previously inconceivable and improbable. ceramics – according to requirement. We make innovation possible. 10 FOUR DECADES OF CERAMIC MEDICAL DEVICES Certified production, quality assurance and clinical evaluation Testing laboratory Production Medical Product Know-how Clinical studies Packaging Quality management Approval In the field of medical devices, people’s lives and health can depend on the consistent quality of the products. The reliability of our processes is an essential part of our quality system and it is confirmed by regular audits performed by our customers and health authorities around the world. Our four decades of experience in the development, evaluation and approval of ceramic medical products is a unique expertise available to CeramTec’s customers. 11 Production The development and manufacture of ceramics with high performance capabilities imposes the highest standards throughout the whole process. This starts from preparing the carefully selected raw materials to make a physically and chemically perfect ceramic powder. From the various molding processes (dry pressing, injection molding, extruding and tape casting) and the green machining of blanks, to thermal processes and surface treatment (grinding, lapping and polishing), CeramTec brings together the full spectrum of ceramic knowhow. State of the art production facilities are used at all steps of the production process. They meet the high requirements for medical device production. Validated processes are the basis for the delivery of outstanding quality. Quality assurance Quality management plays a critical role in the production of medical devices. All production, final inspection and packaging processes meet the latest quality assurance standards and are DIN and ISO certified. Implants are subjected to a one hundred per cent – in other words piece by piece – final inspection. During this inspection, all important quality and product characteristics are documented in full. The quality of materials and products is constantly being assessed in the testing and analytical laboratory. Each year, the safety of CeramTec products is assessed and confirmed by the fact that approximately twenty audits are conducted yearly by CeramTec customers and heath authorities from around the world. Approval CeramTec has four decades of experience in the evaluation and approval of medical products. Our experts are well versed with all the steps and regulatory details required to obtain approval for our products. This can include anything from laboratory testing to clinical studies. BIOLOX® components are approved for clinical use in practically all countries around the world. CeramTec possesses comprehensive knowhow in obtaining approval for implants and medical devices in almost all markets worldwide. Of course, our expertise in this field is also available to our customers in the medical devices industry. We can assist you with all issues related to product certification, clinical testing and market authorization. Medical Engineering Division Luitpoldstraße 15 91207 Lauf, Germany Phone:+49 9123 77-530 Fax: +49 9123 77-443 [email protected] www.ceramtec.com The information contained in this document was gathered and compiled by medical experts and qualified CeramTec employees to the best of their knowledge. The greatest care was taken to ensure the accuracy and ease of understanding of the information used and presented. CeramTec does not assume any liability, however for the up-to-dateness, accuracy, completeness or quality of the information and excludes any liability for tangible or intangible losses that may be caused by the use of this information. In the event that this document could be construed as an offer at any time, such offer shall not be binding in any event and shall require subsequent confirmation in writing. ME120002 · EN · 1000 · 1205 · Loopkomm Infomarketing · Printed in Germany CeramTec GmbH