Prosthetic valves and methods of manufacturing
First Claim
1. A ball prosthetic valve comprising a T-shaped annular housing having an inner surface which defines a central passageway for the flow of a biological fluid therethrough;
- and a sphere occluder entrapped in said T-shaped annular housing acting as a valve to open and close the passageway for the flow of the biological fluid unidirectionally from the main body to the two arms perpendicular to main body of the housing.
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Abstract
The present invention relates to noval design of mechanical valve prostheses and manufacturing methods. A series of prosthetic valves with novel design and a unique manufacturing approach are disclosed. These devices possess unique designs and are made of nanostructurely engineered biomaterial. In addition, a novel manufacturing approach will be used to produce these devices because the convention technique is incapable of fabricating the devices due to the small size, design requirements and material properties restrain. Furthermore, it provides the convenience and thus low cost in manufacturing. The devices are particularly but not exclusively useful in human circulation system to restore the normal functions.
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Citations
49 Claims
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1. A ball prosthetic valve comprising
a T-shaped annular housing having an inner surface which defines a central passageway for the flow of a biological fluid therethrough; - and
a sphere occluder entrapped in said T-shaped annular housing acting as a valve to open and close the passageway for the flow of the biological fluid unidirectionally from the main body to the two arms perpendicular to main body of the housing. - View Dependent Claims (2, 3, 4, 5)
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6. A method of fabricating a ball prosthetic valve, comprising the steps of:
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coating a graphite sphere with pyrolytic carbon to form a sphere occluder polishing the surfaces of the sphere occluder embedding the occluder into graphite or carbon to form a T-shaped mandrel coating the surface of the T-shaped mandrel with pyrolytic carbon removing the graphite or carbon core polishing all the surfaces of and the T-shaped annular housing and the sphere occluder through abrasive flow
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7. A monoleaflet prosthetic valve comprising:
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an annular housing having an inner surface which defines a central passageway for biological fluid flow therethrough;
a single disc occluder mounted in the annular housing acting as a valve to allow and to stop the flow of biological fluid;
a pair of ears extending along opposite ends of an eccentric line across the occluder and interfiting with a groove of the annular housing, which guide the swings of the occluder between the open and close position; and
a frang-like outlet formed on an exterior surface of the annular housing which facilitates the attachment of the valve to the tissue. - View Dependent Claims (8, 9, 11, 26)
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10. A method of fabricating a monoleaflet prosthetic valve, comprising the steps of:
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coating a graphite disc substrate with pyrolytic carbon to form a disc occluder machining and polishing the surfaces of the disc occluder embedding the occluder into graphite or carbon to form a mandrel coating the surface of the mandrel with pyrolytic carbon removing the graphite or carbon core polishing all the surfaces of and the annular housing and the occluder through abrasive flow
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12. A monoleaflet prosthetic valve comprising:
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an annular housing having an inner surface which defines a central passageway for biological fluid flow therethrough;
a single disc occluder mounted in the annular housing acting as a valve to allow and to stop the flow of biological fluid;
a pair of ears extending along opposite ends of an eccentric line across the occluder and interfiting with two hinges in the annular housing, which guide the occluder swings between open and closed positions;
a peripheral groove formed on an exterior surface of the annular housing which facilitates the attachment of the valve to the tissue; and
a frang-like outlet formed on an exterior surface of the annular housing which facilitates the attachment of the valve to the tissue. - View Dependent Claims (13, 14, 15, 16, 38, 39, 40, 41)
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17. A bileaflet valve prosthesis comprising
an annular valve body having a central passageway extending therethrough; - and
a pair of valve leaflets and hinges supporting the pair of leaflets for substantially pivotal movement on a pair of eccentric axes between a closed position blocking the blood flow therethrough and an open position allowing blood flow therethrough, wherein the leaflets each including guides projecting in opposite directions along the pivotal axis, said guides having a rounded bottom end, said support hinges including pairs of generally triangular depression holes at generally diametrically opposite locations, each of said depressions having a curved top edge and generally straight outer and inner edges which meet at a vertex, said leaflet guides being received in said depressions with said bottom ends at the vertex thereof, said vertex being formed with a radius of curvature matched to the radius of curvature of said bottom ends and providing pivot points for each bottom end, whereby said leaflets each move between an open position wherein said guides are located generally adjacent said outer edges and a closed position wherein said guides are located generally adjacent said inner edges. - View Dependent Claims (18, 19, 20, 21, 22, 23, 24, 25, 27, 28)
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29. A tri-leaflet prosthetic valve comprising
an annular valve body having an inner surface and being disposed around a central axis and three substantially identical leaflets mounted in said annular valve body and configured to translate between a closed position impeding blood flow through the valve and an open position allowing blood flow therethrough, said annular body having three pairs symmetrically placed hinges spaced around an inner surface of said annular body for pivotaily supporting said leaflets, each hinge having a plane of symmetry containing said central axis; - and each of said leaflets having opposed ears for engaging said hinges and a flat edge adjacent each of said ears for engaging said surface segment.
- View Dependent Claims (30, 31, 32, 33, 34, 35, 36, 37)
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42. A method of making a valve substrate comprising the steps of:
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providing a mixture of graphite or carbon powder from 10 to 80 wt %, commercial chopped carbon fibers or carbon nanofibers from 10 to 80 wt % and organic thermosetting binders between 5- to 10 wt %;
doping the mixture with 5-10 wt % high density refractory radio opaque metals such as tungsten, W and Tantalum, Ta;
molding the valve substrates green body;
carbonizing the green body in inert gas at temperature higher than 1800°
C.
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43. A method of coating a substrate with a nanostructurally engineered pyrolytic carbon comprising the steps of:
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Providing a reactor system with heating element, reactor chamber, insulation, chemical introducing and exhaust treatment systems, and particle feeding and withdrawing systems, wherein the reactor chamber contains single or multiple gas introducing ports;
Loading a pre-machined substrate in the reactor chamber filled with a media;
Introducing chemicals comprising hydrocarbons and mixtures of propane and methane, and catalysts of organic metallic compounds comprising transition metals, aloy and oxide particles;
Incorporating vapor grown carbon fibers into the high density pyrolytic carbon matrix to have randomly spaced junctions between individual fibers during in situ growth of said vapor grown carbon fibers; and
Removing the substrate from the reactor chamber. - View Dependent Claims (44, 45, 47, 48, 49)
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Specification