Each month the newsletter features a partial record from ASM’s acclaimed database, Materials for Medical Devices, which includes a Cardiovascular Module and an Orthopaedic Module. This month’s record is in both modules.
Fe-17Cr-14Ni-2.5Mo
Materials for Medical Devices>Materials
General Information
Designation
Fe-17Cr-14Ni-2.5Mo (low-carbon). NOTE: This steel is also commonly known as 316L. Because of the more reliable corrosion resistance, many manufacturers use the modification Fe-18Cr-14Ni-2.5Mo (low-carbon vacuum-remelted), known as 316LVM, of this historic composition with implant devices used for extended implant times (Gibbons 2007). The terms 316L and 316LVM have been used interchangeably in recent years in the literature and within the steel industry. However, they are not equivalent in properties and should not be assumed to be equal in the implant environment (Helmus 2007, Taylor 2007).
Bioactivity
Bioactive Response: Biotolerant
Mechanisms Responsible for Bioactivity
Stainless steels are generally regarded as ‘biotolerant’ (Niinomi 2002), a material that does not show direct contact with bone; instead being surrounded by a connective tissue layer (Osborn and Newesley 1980, de Groot et al. 1998).
Degradation in Body Fluid
Systemic Toxicity of Degradation Products
Experiments conducted to detect trace metal concentrations of ions released as a result of the corrosion of 316L stainless steel into rabbit tissues and organs reported a high iron and chromium concentration (relative to controls) in the muscles around the implant site and high chromium concentrations in the liver, kidney, spleen, and lungs (Ferguson et al. 1962). Metallic ions, including iron, chromium, nickel, and molybdenum, have both localized and systemic effects as well as localized effects on bone cells and so on (see cytotoxicity). They have been shown to alter the expression of human lymphocyte surface antigens, which results in immune response inhibition (Tracana et al. 1994).
Blood Compatibility
Hemolysis
In experiments by Armitage et al. (2003), 316L stainless steel discs were observed to be nonhemolytic. However, in later experiments, Armitage et al. (2003) observed 0.2 to 0.3% hemolysis of platelets in response to a 316L stainless steel surface.
Devices
(1 of) 25 Linked Records
- Bare Metal Stent (General)-Prosthetic-Cardiovascular Devices
The stent is fabricated from 316L stainless steel tubing and is comprised of a series of cylindrically oriented corrugated rings aligned along a common longitudinal axis (USFDA-SSED for Intravascular Coronary Stent).
Manufacturer Specific Devices Containing This Material
(1 of) 128 Linked Records
- Orthofix External Fixation Screw (Pin) with Hydroxyapatite Coating (K974186)
The device is manufactured from Fe-17Cr-14Ni-2.5Mo (316L)
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Biomedical R&D targeted in federal stimulus package
The American Association for the Advancement of Science estimates that the final version of the 2009 economic stimulus appropriations bill that President Obama signed into law on Feb. 17, 2009 contains $21.5 billion in federal R&D funding. Biomedical research is one of the high priorities in the final economic recovery bill as evidenced by appropriations to the National Institutes of Health of $10.4 billion and the National Science Foundation of $3.0 billion. Pending final approval of the federal FY2009 budget, the NIH budget is expected to reach nearly $40 billion.
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Diamond coatings reduce blood clotting in heart pumps
Using a process originally developed for industrial equipment, Advanced Diamond Technologies, Inc. and Jarvik Heart, Inc. are collaborating to develop improved blood contacting surfaces using ADT’s form of diamond, known as UNCD. Because the coating is both thin and exceptionally smooth, it is expected to inhibit the formation of blood clots inside the device, and to reduce the need for blood thinning medications. Freed from anticoagulation medication, the heart assist devices could be used for tens of thousands more patients suffering from heart failure. The image shows a heart pump elbow with the UNCD coating.
Other potential applications for the UNCD coating include artificial heart valves, cardiac stents, and metal and ceramic components of intravascular prostheses. JHI is investigating using the diamond coatings on heart pumps for infants and children. Because the pumps are so small, about the size of a AAA battery, flow channels are tiny and the risk of blood clotting is even higher than with adult pumps.
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MPMD 2009 – Where the medical device industry goes to get results
ASM International’s MPMD is the only medical devices conference that brings together materials scientists and engineers, metallurgists, product designers, researchers, and clinicians.
Conference Sessions
- Bioactive / Biomimetic Surfaces and Drug Delivery Systems
- Nanotechnology
- Surface Engineering of Medical Devices
- Advanced Materials and Emerging Technologies
- Fabrication Processes for Medical Devices
- Corrosion, Degradation and Durability
- Effect of Materials on Surgical Techniques
- Materials R&D
- Materials Modeling
- Active Implant Materials
- Regulatory Affairs Related to Materials
MPMD Conference and Exposition provide the technical knowledge and networking opportunities to impact your career and the entire medical device industry. Don’t miss your opportunity to shape what happens next!
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High-precision glucose detector made of gold-palladium nanocubes tethered by SWCNTs
 Purdue University researchers have created a high-precision biosensor for detecting blood glucose and potentially many other biological molecules by using single-wall carbon nanotubes (SWCNT) anchored to gold-coated palladium "nanocubes." The device resembles a tiny cube-shaped tetherball.
The tetherball design lends itself to sensing applications because the sensing portion of the system extends out far from the rest of the device so that it can come into contact with target molecules more easily. The system does not have to wait for target molecules to diffuse to the surface, and it can move into other regions within the range of the tether for enhanced sensing. The technology may have applications detecting other types of biological molecules or in future biosensors for scientific research. (Image by Jeff Goecker, Discovery Park, Purdue University.)
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USC group studies feasibility of carbon nanotube synthetic brain
Professors Alice Parker and Chongwu Zhou at the University of Southern California are taking the first steps to build neurons from carbon nanotubes that emulate human brain function. Unlike computer software that simulates brain function, a synthetic brain will include hardware that emulates brain cells, their amazingly complex connectivity, and their "plasticity," which allows the artificial neurons to learn through experience and adapt to changes in their environment the way real neurons do. Using mathematical models, the researchers have shown that portions of a neuron can be modeled electronically using carbon nanotube circuit models.
Engineering challenges that could benefit from technological solutions that involve artificial neural structures include autonomous vehicle navigation, identity determination, robotic manufacturing, and medical diagnostics. This technology could revolutionize neural prosthetics, and yield some pretty amazing biomimetic devices.
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Materials and Processes for Medical Devices Customized Training
Times are tough! ASM can help you gain the tools you need to accelerate medical device innovation of cardiovascular, neurological, pulmonary, and orthopedic devices, and dental implants and appliances. We have the expertise to customize courses on materials engineering for medical devices including:
| MATERIALS SCIENCE |
DEVICE DESIGN |
| Stainless steels |
Design validation |
Cobalt-chromium |
Failure analysis |
| Titanium |
Meeting functional requirements |
| Polymers |
Material testing methods for combination devices |
Nitinol |
Drug delivery technology |
| Ceramics |
Biomedical microdevices. |
Our instructors work with your examples, or can provide case studies relevant to your products. If your staff needs to learn more about materials and applications for medical design – customized to your company’s needs – we can help. Please contact John Cerne, Corporate Sales Manager, at 440-338-5417 for details.
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Rejection-free, bioreabsorbable scaffold for jaw implant
Custom-Fit, an EU research program involving 30 partners from 12 European countries, is developing a bioresorbable material for mandibular and other joints. Once implanted, the prosthetic is replaced with re-grown, natural bone in 6-12 months. The consortium is using computerized tomography, CAD, and rapid manufacturing technologies to design and fabricate implants customized to the individual shape of the human body.
Although approval for implantation in patients is several years away, the technology offers several advantages: no rejection of foreign material, new bone will be able to grow over time (for children), further treatment like dental implants remains possible, and the implant will be completely replaced by new natural bone.
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Cardo Medical’s Press-Fit Total Hip system
 Cardo Medical has released its Press-Fit Total Hip system. The Press-Fit Total Hip system incorporates a dual taper design which has a long, proven clinical history with great implant success rates. As a complement to the Press-Fit Total Hip system, Cardo Medical is also preparing to release its Bipolar Hip system within the next month.
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