Do you know what I developed in my activity?
I managed activity of funded project both like partner than as leader coordinator into partner members.
I devised an original injection catheter to use for injection of dense fluids like gel added with particular substances to promote growth of particular cells. The catheter has to be used with two high pressure syringes, the first to inflate a stabilizing ballon and the second to inject gel. Between two operations must be manually protruded a bending needle that, passing through the coronary vessel, reaches deep myocardial tissues, injecting active gel. The best original idea of this system is the bending needle made of Nitinol tube cut according to a shape that allows it to be thermoformed in bended conditions. Electro-polishing process gives to the needle a smooth surface and a second internal thin plastic tube gives him tightness.
In other funded project, partners and R&D of enterprise where I work reached the target to find the technology to cut a planar sheet made of a blend of biodegradable polymers (PLLA-PLGA 75-25%) with a geometry suitable to make a bio-absorbable stent. This technology was the laser source of ultra short pulses (300 fs) used with his second harmonic of wavelength (..)
I contributed with R&D team to identify proper technology to engrave and cut Nitinol in order to obtain an innovative product that complements super elasticity properties of peripheral stents with capability to carry and elute drugs when implanted like other coronary DES.
We found the technology and supplier of the machine that combine laser source and numerical control to move tube to cut stent.
The team obtained samples cut and engraved and started to perfect processes for parts apparently similar to those previously completely developed, but showing differences depending from grooves.
Some tests was performed to confirm preliminary security of geometry when stressed under fatigue tests.
NEWCORTEC (spin off of Tecnobiomedica) was a small enterprise based in Pomezia (RM) devoted to develop VAD and obtain CE mark to commercialize it.
Development of artificial soft ducts to allow the blood to be put in circulation externally to heart. We used, as base material, a commercial expanded ptfe vascular graft suitably modified never to change biocompatible polymeric material of which the blood sac was made.
First type of duct called “apical” had the function to transfer blood from ventricular apex of heart to inlet of the polymeric blood sac contained in metallic case of VAD. This duct was proper to soft surgical fixation to heart at an end and suitable to be firmly connected to inlet port of VAD case at the other one so as not to have blood leakage at all.
The second type of duct developed was called “aortic” and had the same internal coating material of apical duct, but with progressive stiffness and its function was to transfer blood from the sac to the aorta to which was joined by means of surgical suture of its end that was trimmed by surgeon to fit patient anatomy.
Development of a blood sac made with a biocompatible and flexible polymer. The shape of sac was accurately studied for a long time by the team in order to tolerate high peak of pressure and numerous cycles requested. To make the sac, reverse dipping technology was applied, solving important problems about constancy of thickness of sac walls and smoothness of junction with ducts.
I developed production processes solving problems connected with defects caused by reverse dipping technology, bubbles, coating thinning, by polymer solvent solution, filtration, viscosity, humidity and by process quality, measures, internal inspection into blood sac and ducts, final washing and sterilization.
I took care of other technologies like stereo-lithography of metallic dusts, laser casting of plastics and liquid stereo-lithography of UV post-cured polymers.
I partecipate to pre-clinical tests in Italy, Clinica Veterinaria San Piero, Univ. Pisa, and in France, Paris, Institute Mutualiste Montsouris.
Good implantation results and ventricular assistance too in seven implanted patients in Italy, Germany and France.
TECNOBIOMEDICA was a small enterprise based in Pomezia (RM) always gave technical consulting in biomedical field.
Bioreactor for thermostatic culture of cells seeded on proper scaffold of tubular shape to mime blood vessel.
Study, design and realization in house of all mechanical particulars for a double section hydraulic circuit in order to separate chemically sterilized part from the other one not. Durable no friction pulsatile pumping system to drive, outside of thermostatic chamber, the internal sterile section in physiological conditions of flux and pressure. Designed and developed hydraulic resistance remotely actuated in order to change resistivity of circuit acting from outside of thermostatic chamber.
Managed assembling and maintenance of basins for durability test of Total Artificial Heart developed before my arrival in the team.
Micro-assembling of surface mounting elements in non conventional geometry to realize a localized accelerometer sensor on the tip of an electrode for ventricular stimulation, monitoring the heart shaking force.
Industrial and technological study about spark erosion of high performance Ti, Al, V alloy with particular electrode material allowing to inhibit contamination with oxygen and hydrogen of worked surfaces of alloy. Reached good levels in terms of quality results and process speed applied to pilot production of a cardiac medical device.
Advanced study, development and realization of an innovative silicon bag for urinary collection jointly implanted with nefrostomic catheters that feed it continuously. Artificial bladder had an external tap to empty it when desired. Good results of three human implant. Advanced study, development and realization of metallic mini bone plates for facial and cranial bones fixation.
Studied and developed a new manually operated phonatory prostheses that was processed in house making dismountable moulds, performing moulding of biocompatible silicon rubber and applying stabilizing thermal cure.
To actuate automatically the prostheses described before was studied and developed a new system to control it by means of micro-pneumatic home designed and made elements powered with compressed gas stored in a little metallic gas cylinder and a battery integrated in a central unit within electronic controls and sensors.
We had other collaborations with Politecnico in Turin, University of Cagliari, with Hospital of Le Molinette in Turin, Hospital San Gerardo in Monza (MI), Civil hospital in Vicenza.and other small enterprise in inter-land of Turin.
Study research and development of a long life battery based on thermoelectric conversion of thermal energy generated by a Plutonium cell housed in an insulating metallic dewar.
It was used technology of vacuum thermal evaporation of polycrystalline doped compound to obtain multiple series of termocouples on polymeric substrate to roll up in shape of cylindrical conversion modulus inserted into the dewar.
Hardware for electronic set up to programme implanted tunable pacemaker.
Titanium welding technology to make cases to contain hybrid electronic circuits and long life electric storage cells. (Lithium ions)
Welding technologies (argon plasma, Electron beam, electrical resistance) of custom made electrically insulated feed-through to join them to metallic lid in order to seal up the case of electro stimulating device.
Leak detection technology of pacemaker case.