Sunday, January 12, 2014

Oh, patents! A heart made in France

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. 

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