Carbon Implants, Inc.

Alan S Schwartz

Jonathan C Stupka

T Scott Peters

C Thomas Waits

A method of making a prosthetic heart valve having an occluder which is supported to pivot between open and closed positions in an annular valve body made of pyrocarbon or a pyrocarbon-coated substrate. The valve body contains diametrically opposed pivot supports formed on the interior surface thereof and is distended by subjecting it to diametrically opposed compressive forces of a nature which place extensive exterior regions of the valve body in compression while increasing the distance between the pivot supports. After the occluder is installed in the distended annular valve body, removal of the opposed compressive forces permits the valve body to return to an unstressed, generally circular configuration with the occluder operatively secured between the pivot supports. These forces are applied using flexible, inextensible cables or resilient pressure pads.

Assembly of heart valve by installing occluder in annular value body

Pyrolytic carbon products are manufactured so as to have improved structural properties. Pyrolytic carbon is deposited on a substrate in a fluidized bed of small particles at a temperature of about 1200.degree. to about 1400.degree. C., and after cooling to ambient temperature, the pyrolytic carbon is machined to desired physical dimensions for a heart valve component or the like. By heating such pyrolytic carbon structures in an inert gas atmosphere to a temperature in the range of about 1000.degree.-1500.degree. C. for at least about one hour following machining, it is found that stresses created in the pyrolytic carbon as a result of the machining are relieved without adverse effect to mechanical properties of the pyrocarbon, resulting in components having greater structural integrity.

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Austin, TX, United States of America

Alan S Schwartz