Onx, Inc.

Medical Carbon Research Institute, LLC

Carbon Implants, Inc.

Medtronic, Inc.

Medtronic Carbon Implants, Inc.

Michael R Emken

Axel D Haubold

Jack C Bokros

Jonathan C Stupka

T Scott Peters

John L Ely

C Thomas Waits

James A Accuntius

David S Wilde

Billie F Hightower

Mark Seeley

Pyrolytic carbon of extremely uniform crystalline characteristics and essentially free of discontinuities is obtained in a fluidized bed coater by creating an asymmetric recirculation of the fluidized bed within the high temperature coating chamber. Through the use of any of a variety of gas injection schemes, fluidizing/coating gas mixtures are injected through the three-dimensionally curved concave bottom surface of the coater to create a pattern where the fluidized bed ascends within about one-half of the volume of the coater and then spills over to become a descending bed in the other half.

Deposition of pyrocarbon

Deposition of a pyrocarbon coating of precise thickness onto one or more substrates being levitated along with a bed of particles in a fluidized bed coating enclosure is accomplished by varying the amount of hydrocarbon supplied to the bed as a part of an upward levitating flow to compensate for changes which are detected in the size of the fluidized bed. Increases and decreases in the size of the bed are detected by monitoring either the differential pressure above and below the bed or the weight of the bed, and compensating changes are made to return the bed to its desired size by changing the flow rate of hydrocarbon. For example, when a growth in bed size is detected that is not attributable to an aberration in either particle supply or withdrawal, the amount of hydrocarbon being supplied to the bed is decreased so as to cause the size of the bed to gradually return to its desired value.

Precise regulation of pyrocarbon coating

A prosthetic heart valve is shown which incorporates a valve body design and leaflet pivot arrangements that minimize turbulence and shear stresses having a tendency to generate thrombosis. A valve body having an axially curved entrance that is smoothly joined to a generally cylindrical body of extended axial length provides excellent fluid flow characteristics when combined with leaflets that can assume orientations perfectly aligned with the downstream flow of blood. By constructing such a pyrocarbon valve body which receives a metal ring at an appropriate location, suture rings that permit the tissue annulus to directly contact the exterior surface of the cylindrical valve body are accommodated.

Prosthetic heart valve with improved blood flow

Pure unalloyed pyrocarbons having wear resistance suitable for use in pyrocarbon-coated heart valve components and having mechanical properties, such as flexural strength and toughness, superior to commercial silicon-alloyed pyrocarbons are deposited in fluidized bed coaters. Coating conditions are carefully controlled so as to maintain a precise bed size within a defined coating enclosure which will assure a substantially constant surface deposition temperature that in turn assures deposition of homogenous unalloyed pyrocarbons having these improved mechanical properties.

Pyrocarbon and process for depositing pyrocarbon coatings

A bileaflet heart valve incorporates a pivot arrangement that minimizes resistance to downstream blood flow in the open position yet has prompt response and therefore minimal regurgitation upon flow reversal. A valve body having an axially curved entrance that smoothly joins a generally cylindrical body of extended axial length provides excellent fluid flow characteristics when combined with leaflets that can assume orientations perfectly aligned with the downstream flow of blood. Identical flat leaflets can assume a parallel orientation in the fully open position during downstream blood flow or can assume other low energy positions. Flat ears, which extend laterally from opposite surfaces of the leaflets, interengage with cavities of unique design having upstream and downstream lobes separated by an intermediate throat portion defined by inward and outward fulcrums. The downstream lobes may be designed to facilitate movement to the parallel orientation or to cause the leaflets to optionally prerotate toward the closed position. As soon as reverse flow begins, upstream displacement of the leaflets causes the ears to contact straight camming surfaces located upstream of the outward fulcrums which, in combination with the fulcrums and a downwardly directed, concave surface at the upstream end of the upstream lobe, positively guide each leaflet through efficient closing which ends in substantially rotational movement. A pyrocarbon valve body receives suture rings that permit the tissue annulus to directly contact an exterior surface region of the valve body.

Prosthetic heart valve

A bileaflet heart valve is shown which incorporates a pivot arrangement that minimizes resistance to downstream blood flow in the open position yet has prompt response and therefore minimal regurgitation upon flow reversal. The valve employs a pair of identical flat leaflets that can assume a precisely parallel orientation in the fully open position at or near peak downstream blood flow or can alternatively assume other low energy positions. As the downstream flow of blood slows near the end of a pumping stroke, downstream displacement of the leaflets results in their prerotation toward the closed position orientation, all being controlled by the interengagement of flat ears, which extend laterally from opposite surfaces of the leaflets, and receiving cavities of unique design. The cavities include upstream and downstream lobes separated by an intermediate throat portion defined by inward and outward fulcrums. As soon as reverse flow begins, upstream displacement of the leaflets causes the ears to contact straight camming surfaces located upstream of the outward fulcrums which, in combination with the fulcrums and a downwardly directed, concave surface at the upstream end of the upstream lobe, positively guide each leaflet through efficient closing which ends in substantially rotational movement.

Mechanical heart valve prostheses having either a single occluder or a pair of occluders are designed to permit such occluders to assume an open position parallel to the longitudinal axis of the valve passageway. The pivot arrangements are such that an occluder pivots about a constant center or pivot axis substantially offset from the locations where engagement occurs between the occluder and the valve body, whereby prompt smooth pivoting movement toward the closed position is initiated from an open position parallel to the valve centerline. For example, elongated arcuate shoes protruding from lateral edges of the occluders follow arcuate paths of matching complementary curvature defined by grooves in diametrically opposed flat sidewall sections of the valve body.

Heart valve prostheses

Heart valves are shown which utilize pivot arrangements that create prompt response to flow reversal and minimize resistance to blood flow in the open position. Illustrated are valves having a pair of identical leaflets that can assume an orientation in the fully open position near maximum blood flow rate that is precisely parallel to the centerline of the passageway. The ability of the leaflets to assume a precisely parallel or low energy position in the bloodstream reduces pressure drop across the valve and results in improved flow characteristics. A camming action adjacent the upstream edges of the leaflets in combination with interengagement at downstream locations on the valve body, spaced from the locations where the camming action with said upstream edges occurs, positively guide the leaflets to assure effective closing movement regardless of momentary deviations in the dynamics of the reverse flow of blood through the valve. More particularly, slight closing movement pivoting, following assumption of such a parallel orientation, is effected by designing the interengagement so that the leaflets shift slightly downstream from the precisely parallel orientation when the blood flow slows prior to reversing and simultaneously rotate slightly toward their closed position orientation.

A coating-fluidizing gas supply system for a flat-bottom fluidized bed coater that maintains a high degree of uniform fluidization of levitated particles for a long enough time period to coat medical-device components. The coating-fluidizing gas supply system prevents premature pyrolysis of the coating component of the gas from plugging gas-distributor holes of a flat plate at the bottom of a flat-bottom fluidized bed coater, by directing multiple gas streams uniformly against the entire undersurface of the flat gas-distributor plate, creating an overall cooling-effect on the gas-distributor plate which prevents clogging.

Coating-fluidizing gas supply system and method for flat bottom coater

Precise control of pyrocarbon being coated upon an object in a fluidized particle bed is achieved by monitoring the weight change of the fluidized particle bed over a period of time. Measurement of such weight change is truly representative of bed size in such a coater, which is a most important factor in achieving the desired characteristics of the pyrocarbon being deposited. By monitoring the bed size by repeatedly determining such changes in the weight, compensating adjustments are made by either adding additional particles to the bed or by changing the rate at which particles are withdrawn so that precise coating characteristics are achieved, and coatings can be deposited within very close thickness tolerances.

Precise regulation of fluidized bed weight in pyrolytically coating

Bi-leaflet heart valves have valve body contours and pivot arrangements that create quick valve response to flow reversal. Valve members or leaflets, which can have flat or curved inflow and outflow surfaces, are slidably and pivotally mounted in a heart valve body of contoured profile so they can be aligned precisely parallel to blood flow in the open position. The leaflets engage either projections extending radially inward from flat wall sections in the valve body sidewall or grooves in these flat wall sections. The shape and relationship of these interengaging surfaces, together with a centrally directed surge of backflowing blood which results from the strategic location of a pair of downstream recesses in the annular valve body, cooperate to provide prompt closing rotation of the leaflets from a parallel open orientation.

A 'closed-loop' moisture control system for use in vibratory mass finishing systems. A substantially constant amount of a grinding and/or polishing slurry is maintained in a finishing reservoir of the vibratory mass finishing system by controlling the amount of such fluid flowing from a supply reservoir into the finishing reservoir, and/or the amount of such fluid flowing from the finishing reservoir into a collection reservoir. In operation, a total weight of the supply reservoir and its contents, and of the collection reservoir and its contents is monitored and, in the event there is an increase in the total weight, a control means increases the amount of polishing fluid flowing from the supply reservoir into the finishing reservoir, and/or decreases the amount of polishing fluid flowing from the finishing reservoir into the collection reservoir. Conversely, in the event there is a decrease in the total weight, the control means decreases the amount of polishing fluid flowing from the supply reservoir into the finishing reservoir, and/or increases the amount of polishing fluid flowing from the finishing reservoir into the collection reservoir.

Moisture control in vibratory mass finishing systems

Bi-leaflet and single occluder heart valves have improved pivot arrangements that create quick valve response to flow reversal and minimize impact. Valve members or occluders, which have curved inflow and outflow surfaces, are slidably and pivotally mounted in a heart valve body and can be aligned precisely parallel to blood flow in the open position. Lugs on the valve members engage surfaces on projections extending radially inward from flat wall sections in the valve body sidewall, and the shape and relationship of these interengaging surfaces provide prompt initial rotation, low wear and reduced impact upon closing. Laterally directed ears engage the valve body arcuate sidewall and assist in defining the path of closing movement.

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Austin, TX, United States of America

Michael R Emken