Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Heart valve – Having rigid or semirigid pivoting occluder
Reexamination Certificate
1998-12-04
2001-01-23
Isabella, David J. (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Heart valve
Having rigid or semirigid pivoting occluder
C623S002100
Reexamination Certificate
active
06176876
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to mechanical or prosthetic heart valves of the type which are used to replace the natural heart valve of a patient.
BACKGROUND OF THE INVENTION
Prosthetic heart valves are used as a replacement for natural heart valves of patients. A standard implantable mechanical heart valve typically includes an annular valve housing or body (often called an “annular body”) to provide a lumen or passageway therethrough for blood flow. One or more occluders mounted to the valve are movable in response to blood flow between an open position, allowing blood flow, and a closed position, which stops or blocks blood flow in one direction. In many mechanical valves, the occluders are essentially plate-like flat or curved members called “leaflets.” Typical configurations include one, two or more leaflets in the valve body.
There has been an ongoing effort to improve the efficiency of prosthetic heart valves. One critical factor in heart valve efficiency is the total area through which blood can flow when the valve is in the open position. One factor which limits the total area is how far that the leaflet(s) can open during normal operation of the valve. The more that the leaflet(s) can open to a direction that is parallel with the flow, the more efficient the valve becomes. U.S. Pat. Nos. 5,192,309 and 5,350,421 show a technique which uses a sliding pivot to increase the leaflet opening angle. However, this technique required a complex mechanism which tended to fail in actual use.
SUMMARY OF THE INVENTION
A bi-leaflet prosthetic heart valve includes an annular body having an upstream edge, a downstream edge and a passageway therebetween. First and second leaflets are pivotally mounted in the annular body and each have an upstream edge and a downstream edge. The leaflets have lengths between their upstream edge and their downstream edge. First and second leaflet pivot axes are associated respectively with the first and second leaflets and the leaflets rotate about their respective pivot axes between an open position allowing blood flow through the passageway of the valve body and a closed position blocking blood flow. The pivot axes have pivot downstream offset distances between the annular body downstream edge and the pivot axes. The leaflets have an angle in the open position of more than about 85°.
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“Cineradiographic Evaluation of ATS Open Pivot Bileaflet Valves”, by S. Aoyagi et al.,The Journal of Heart Valve Disease, 1997, pp. 258-263.
Brochure entitled: “Bileaflet Mechanical Heart Valves”, by St. Jude Medical, Inc. 1986.
Brochure entitled: “Mechanical Heart Valve Comparison, The St. Jude Medical®Mechanical Heart Valve and ATS Medical™Heart Valve”, by St. Jude Medical, Inc., 1994.
Fordenbacher Paul J.
Girard Michael J.
Petersen Stephen A.
Shipkowitz Tanya
Woo Yi-Ren
Finucane, Esq. Hallie A.
Isabella David J.
St. Jude Medical Inc.
Stewart Alvin
Westman Champlin & Kelly P.A.
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