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New ceramic technology contributes to advances in medical implants
by John Mastrogiacomo
Ceramic material, with its biocompatibility and
resistance to wear, is ideally suited for a wide variety of medical
implant applications, from artificial joints to implantable electronic
sensors, stimulators and drug delivery devices. For well over a decade,
alumina, zirconia and other ceramics have successfully proven their
ability to withstand the harsh environment of the human body.
Now, driven by the industry’s need for longer-lasting
and ever smaller – yet more complex — components, materials scientists
are extending the benefits of ceramics for new medical implant
applications with innovative techniques, including injection molding,
engineered coatings and ceramic-metal assemblies. This article discusses
how these developments in ceramic material and processing are
contributing to the evolution of medical implant applications.
Ceramics for artificial joints
Advances in the use of ceramics for artificial joints
have received a great deal of attention, especially since golf legend
Jack Nicklaus received a ceramic-on-ceramic total hip replacement in
1999 in an experimental procedure at New England Baptist Hospital.
Ceramic-on-ceramic hip joints received FDA approval in 2003.
Ceramic materials have been used for artificial joints since the 1970s
when the first generation of alumina products demonstrated superior
resistance to wear, compared to the traditional metal and polyethylene
materials. Advances in material quality and processing techniques and a
better understanding of ceramic design led to the introduction of second
generation alumina components in the 1980s that offered even better wear
performance.
Traditional metal–polyethylene hip system wear generates
polyethylene particulate debris, inducing osteolysis, weakening of
surrounding bone and results in loosening of the implant, a primary
cause of costly revision operations. Ceramic materials generate
significantly less polyethylene debris when used in conjunction with
polyethylene acetabular components in bearing couples. Indeed,
state-of-the-art ceramic-on-ceramic technology, where an alumina femoral
head is mated with an alumina acetabular cup, totally eliminates
polyethylene debris and reduces wear significantly. A study from Morgan
Technical Ceramics (MTC), comprised of Morgan Advanced Ceramics (MAC)
and Morgan Electro Ceramics (MEC) of MAC’s HIP Vitox® ceramic-on-ceramic
hip joints demonstrated a wear rate of just 0.032mm3/million cycles. In
addition to resolving the problems caused by polyethylene debris, the
use of ceramic-on -ceramic hip systems alleviates any concerns over
metal ion release into the body if a metal on metal hip system were
used.
This superior wear performance extends the life of
artificial joints, giving ceramic-on-ceramic joints a predicted life of
well over 20 years. Serving the needs of the increasing numbers of
younger patients for whom such surgery is now a viable operation, these
ceramic-on-ceramic joints allow them to continue leading active
lifestyles.
Ceramics for implantable electronic devices
New developments in ceramic technology are playing an
equally important role in the evolution of implantable electronic
devices. In the forty-five years since the first cardiac pacemaker was
successfully implanted in the U.S., researchers and doctors have created
a wide array of implantable electronic devices, including pacemakers,
defibrillators, cochlear implants, hearing devices, drug delivery and
neurostimulators.

For example, medical device companies are testing
neurostimulators that pulse various nerves to treat particular medical
conditions: the hypoglossal nerve [in the neck] to treat sleep apnea;
the sacral nerve to treat bowel disorders; the stomach to treat obesity,
the thalamus to treat epilepsy, the vagus-nerve to treat chronic
depression, and other regions of the deep brain to treat migraines and
obsessive-compulsive disorder.
These devices increasingly rely on ceramic components,
such as the feed-thrus that provide the functional interface between the
device and body tissue. A feed-thru is a ceramic to metal seal assembly
that contains metal pins or small tubes that pass through a ceramic
component. These pins allow electricity to pass in or out of the
implanted device in order to sense what is going on in the body and/or
to administer an electrical charge when needed. A feed-thru can also be
used to administer drugs to the patient. The ceramic substrate of the
feed-thru acts as an electrical insulator, isolating the pins from each
other. MTC can also make ceramic housing assemblies to enclose the
electronics for the device, which can attach to a feed-thru.
Feed-thrus for implanted devices must be hermetic, with
a leak tight seal around each pin. This ensures’ that bodily fluids do
not work their way into the device and destroy the internal electronics
and that chemicals do not inadvertently escape from drug delivery
devices. A braze material, typically 99.99% gold, is used to join each
metal pin to the ceramic insulator. Developers of new and improved
implantable medical devices continually demand smaller and more complex
components. For example, MTC has created a one-inch diameter ceramic
feed-thru for drug delivery applications that houses 104 separate pins.
Voltage passes through each pin activating different combinations of
switches allowing a greater number, or more complex combinations, of
drugs administered at any given time.
The application of powder injection molding (PIM) has
furthered the pursuit of component miniaturization. This method enables
the production of intricate features and unusual geometries, most
notably for hearing-assist devices, bone screws and implantable heart
pumps. Testing of ceramic injection molded objects has shown that
net-shape as-molded parts exhibit significantly less variation in
flexural strength than green machined parts of the same formulation. MAC
also offers Metal Injection Molding (MIM) technology, which provides a
low-cost alternative to machining, investment casting, and
stamping. A MIM machine can typically mold
parts in about 10 seconds compared to minutes or even hours through
conventional techniques. MIM applications are ideally suited for
high-volume production of intricate components, ranging from
laparoscopic instruments to biopsy jaws and dental brackets.
An additional area of ceramic technical development
important to medical implant applications is ceramic-based coatings,
such as diamond-like carbon (DLC), that provide a biocompatible,
sterilization-compatible, non-leaching, and wear resistant surface for
key pivot points and wear surfaces. Such coatings are used to reduce
friction, increase surface hardness and prevent ion transfer from metal
implant components.
Driven by the rapidly expanding and evolving market for
medical implants, material scientists and ceramic component
manufacturers will continue to develop new materials and new processes
for the smaller, more sophisticated, and longer-lasting implant
applications of the future.
HPN
About the author:
John Mastrogiacomo is the business development manager at the Alberox
Products Division of Morgan Advanced Ceramics
Email: john.mastrogiacomo@morganplc.com |