the same day. Inflatable bone tamp (IBT)
technology comprises forming a balloon
from extruded plastic tubing and mounting
this onto the end of a stiffer plastic shaft.
A Y-adapter on the proximal end allows a
removable stylet for column strength and
a port for connecting an inflation syringe.
The peanut-shaped balloon is inflated into a
sausage shape, providing a flattened surface
for maximizing surface area to lift endplates.
The balloon represents an elegant solution
because it is able to be inserted through a
narrow diameter cannula and then inflated
to a larger diameter to open up space around
it. Inflatable balloon catheters are used in
other anatomical locations, such as to open
up blocked arteries, but bone represents a
particularly challenging environment. The
ability to engineer a balloon capable of being
inflated within bone is a unique mechanical
engineering challenge.
Such challenges include the trabecular
bone within a vertebra being of heterogeneous density, resulting in pockets of harder
bone adjacent to sections of softer bone.
This may be due to uneven fracture healing
during the time before the patient undergoes
BKP. Harder pockets are more difficult to
reduce than softer bone, and can present
sharp points that induce stress points in a
flexible material. However, a flexible material has the advantage of distributing stress
more evenly along the vertebral endplate,
thereby reducing the chance for violating the
endplate as compared to a rigid material that
may have a high stress concentration.
Inflatable bone tamps (IBTs) are placed
through the cannulas and inflated to reduce
the fracture. Once the desired reduction
is achieved, the IBTs are deflated and
removed, leaving behind a void.
The resulting void is filled with bone cement, which acts as an internal cast to stabilize
the fracture.
BKP is a minimally invasive procedure
for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesion. Keep
in mind that results of this procedure
may vary, and all treatment and outcome
results are specific to the individual patient. Results may vary. A prescription is
required. The complication rate for balloon kyphoplasty has been demonstrated
to be low. There are risks associated
with the procedure, including serious
complications, and though rare, some of
which may be fatal. These include, but
are not limited to heart attack, cardiac
arrest (heart stops beating), stroke, and
embolism (blood, fat or cement that
migrates to the lungs, heart, or brain).
Other complications include infection
and leakage of bone cement into the
muscle and tissue. Cement leakage into
the blood vessels may result in damage
to the blood vessels, lungs, heart, and/
or brain. Cement leakage into the area
surrounding the spinal cord may result
in nerve injury that can, in rare instances, cause paralysis. Please consult your
physician for a complete list of indications, contraindications, benefits, and
risks. Only you and your physician can
determine whether this procedure is
right for you. For more information, visit
www.spine-facts.com.
Reduce and fix the fracture
Since balloons tend to inflate into the path
of least resistance, they thus may form
“balloon animals” inside a fractured vertebra,
assuming an irregular shape rather than the
desired inflation pattern. Careful material
selection and processing helps to produce
less compliant balloons with greater control,
or a tendency to inflate to a pre-determined
shape, similar to how mylar balloons inflate
into shapes like stars or hearts. Detailed
engineering allows the IBT to be rated to a
maximum inflation pressure as high as 700
psi without rupturing, providing high power
in generating a large force potential for lifting the vertebral endplates and reducing the
fracture. Achieving this balloon shape and
pressure during inflation helps to maintain
the fracture reduction during introduction
of polymethylmethacrylate (PMMA) bone
cement into the newly-formed cavity.
Our balloon material is known to rupture
when in contact with PMMA. Thus, a
cement resistance technique has been developed to increase the amount of possible
contact time and thus prolong the fracture
reduction. By offering physicians access to
the latest balloon technology, we are now
able to offer the ability to control inflation
pattern and the power to lift vertebral endplates, along with the ability to deliver bone
cement while maintaining reduction.
Based on the largest clinical study comparing BKP and non- surgical management
(Boonen et al., JBMR 2011), patients experienced reduced pain, improved function,
deformity correction, and most importantly,
improved quality of life. 3 MDT
1. National Osteoporosis Foundation Website.
www.nof.org
2. Brunton S, Carmichael B, Gold D et al. Vertebral compression fractures in primary care:
recommendations from a consensus panel. J
Fam Pract. 2005 Sep;54( 9):781-8.
3. Boonen S, Van Meirhaeghe J, Bastian L, et
al. Balloon kyphoplasty for the treatment of
acute vertebral compression fractures: 2-year
results from a randomized trial. J Bone
Miner Res. 2011; 26( 7):1627-1637.
*`Balloon Kyphoplasty incorporates technology
developed by Gary K. Michelson, M.D.