Copyright
© Françoise Herrmann
On
Dec. 18, 2013, the CARMAT prosthetic heart was implanted in a first 75-year old male patient, in France, at the Georges Pompidou European hospital in Paris. This event marked the onset of clinical
Phase II trials with terminally ill volunteer patients, where the safety and
efficacy of the device is being evaluated, prior to larger scale trials and eventual
marketing. To date the first patient is
making very satisfactory progress!
This
particular artificial heart was the result of an interesting collaboration between
a French cardiologist, Pr. A. Carpentier, and the French industrial aviation
and automobile constructor MATRA , resulting on the one hand in the
creation of the French medtech company called CARMAT S.A., which went public to
raise needed funding, and on the other hand, in a heart with miniature electronic
pressure sensors and hydraulics for the regulation of blood flow, as
sophisticated as those found in the construction of a “fighter plane”….
The CARMAT heart is thus heralded as an
uncommon and extraordinary success story, at the intersection of medical, scientific,
industrial and financial innovation, involving many subsequent and additional players
from the medical establishment, and the French public sector, and in several bilateral
business partnerships.
Heart
failure progresses rapidly through three phases: 1. tiredness, palpitations and
breathlessness with continued effort; 2. symptoms at the least effort and 3. symptoms
at rest (CARMATSA). Worldwide, there are
about 100,000 patients registered in need of heart transplants and there are
approximately 4000 donors per year.
Beyond
fulfilling hopes in the desperate need for functioning hearts, the CARMAT heart
brings many solutions to the disadvantages of the prior art.
First,
the CARMAT heart is an autonomous device. Previous artificial hearts were
temporary, requiring patients to be tethered to the wiring and controls of the artificial
heart, as they waited for transplant from a donor. The CARMAT heart is designed as a permanent
prosthesis. It contains miniature blood pressure sensors in order to internally
and automatically regulate the flow of blood through the heart, which
additionally bypasses the discomforts of any lag time in manual adjustments. The
CARMAT heart also ensures autonomy with a miniature fuel cell battery that last
about 12 hours, compared to heavy battery pack equipment for a 3 to 4 hour
charge.
Secondly
the CARMAT heart is made of a special new type of micro-porous bio-plastic designed
to resolve problems of haemo-compatibility which causes blood clots to form on
the surface of prosthetic materials in contact with blood, and the resulting risks
of embolism.
Finally,
the CARMAT heart also has two ventricles driven by an embedded rotary pump and miniaturized
sensors with algorithms that respond to and regulate blood flow, thus mimicking
heart contraction, and ensuring that each ventricle empties after each cycle. The
result is a completely implantable device due to all the miniaturized components.
Consequently,
this is also a mega-patented device. There are patents filed for each of the
innovative components of this artificial heart, whether these are related to
the new bioplastic materials and their method of production, the miniaturized
sensors, actuators and ejectors, the rotary pump, the specific hydraulics, the embedded
programmed controls, or the fuel cell.
Below,
you will find the abstract from one of the patents, US2012089226 for the Implantable one- piece
heart prosthesis, including a patent drawing and above an image of the CARMAT
heart form the CARMAT S.A. website.
Abstract
US2012089226
Implantable
one-piece heart prosthesis. According to the invention, the prosthesis
comprises a main hydraulic actuator (13t) arranged between the artificial
ventricles (2 and 8) and designed to actuate, with desired flow rates, one (8)
of said artificial ventricles, and also an auxiliary hydraulic actuator (7t)
designed to correct the diastolic and systolic flow rates of the other (2) of
said ventricles.
Below appears a list of several of the patents related to various components
of the CARMAT heart, and filed in various countries in Europe, the US and the world
under the WIPO PCT:
US20090276041
Device for connection between a heart
prosthesis and the natural auricles
US20090204206 Device for rapid connection between a
totally implantable heart prosthesis and natural auricles
US20080279910
Composite hemocompatible material and
method for its production
US2012089226 Implantable one- piece heart prosthesis
US 2009/0192607 One piece heart prosthesis implantable in an anatomic position
WO2012/127145 Prosthesis for connecting an
anatomical duct
WO2008/145870 Process for
producing a haemocompatible article of complex configuration and article thus
obtained.
WO2007/135261 A rotary displacement pump with
space-saver radial
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On the other side of this
extraordinary adventure in the design of medical prosthesis, and unquestionable
success story for the purposes of alleviating human suffering, it remains to be
seen how accessible this heart will be to all patients in need of a new heart,
including those from the Third World, for whom the device is also intended and indicated.
