CRDM prototypes aortal sleeve for Marfan syndrome sufferers
1 March 2011
CRDM, a specialist in component prototyping, has partnered
with Exstent to offer a groundbreaking solution for supporting the
weak aorta of Marfan syndrome sufferers.
Marfan syndrome is an inherited disorder of the body’s structural
tissues that affects 12,000 people in the UK. It causes a deficiency
in fibrillin — a structural protein fibre — and can affect many
areas of the body. The most detrimental consequence involves the
aorta — the main arterial conduit from the heart, which runs the
risk of dilating and ultimately rupturing.
A sufferer of Marfan syndrome himself and unhappy with the
existing surgical options available, process engineer and Exstent
founder Tal Golesworthy set out to find an alternative solution to
major heart surgery — a daunting prospect for many sufferers of the
disorder.
The question posed was, if the aorta is only weak in tensile
strength within its wall; why not simply externally support it with
a bespoke sleeve in a suitable material? The answer to this was the
creation of the EARS (external aortic root support).
After combining magnetic resonance imaging (MRI), computer-aided
design (CAD) and rapid prototyping (RP), Golesworthy put together a
proposal to manufacture a bespoke external support for the ascending
aorta.
Enlisting the help of reputable figures in the medical field and
with the support of private investors, Tal started working on the
EARS project. Existing medical MRI was used to get suitable images
and Imperial College, London, was contracted to assist with the
required CAD work. The next stage was to transform the imaging into
rapid prototyping.
CRDM was chosen for converting the CAD stl files into solid
polymeric formers for manufacture of the EARS implants.
An aortal sleeve
As each implant needs to be unique to the individual patient,
they must all be distinctively identifiable. CRDM has been actively
involved in solving this problem. To ensure that each former is
given to the correct patient, CRDM carries out an alphanumeric
recessed text process situated on a non-morphologically sensitive
part of the former. This gives surgeons the ability to distinguish
one former from another.
After the manufacture of the former had been completed, it was
taken to a cleanroom environment where it was solvent washed and
dried before the textile EARS implant was formed onto it.
To date, 23 patients including Golesworthy have received the
implants, all of which have been manufactured by CRDM. The
manufacturing procedure will remain unchanged until the breakthrough
surgery reaches 50 patients. After this milestone, the process will
be reviewed, addressing everything from imaging protocol through to
CAD routine, rapid prototyping and manufacturing methods.