Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Heart valve – Annular member for supporting artificial heart valve
Reexamination Certificate
1998-04-20
2001-01-23
Willse, David H. (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Heart valve
Annular member for supporting artificial heart valve
C623S002400
Reexamination Certificate
active
06176877
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to mechanical heart valve prostheses. More specifically, the invention relates to a mechanism for attaching and implanting heart valve prostheses.
BACKGROUND OF THE INVENTION
Implantable mechanical heart valves are used for replacement of defective valves in hearts of patients. One common method employs a sewing ring or suture cuff which is attached to and extends around the outer circumference of the mechanical valve orifice. The sewing cuff is made of a biocompatible fabric suitable for allowing a needle and suture to pass therethrough. The valves are typically sutured to a tissue annulus that is left when the surgeon removes the existing valve from the patient's heart. The sutures are tied snugly, thereby securing the valve to the heart.
Sewing cuffs are labor intensive and difficult to manufacture and are difficult to secure to the valve orifice. Further, attaching the suture cuff to the tissue annulus is time consuming and cumbersome. The complexity of suturing provides a greater opportunity for mistakes and requires a patient to be on cardiopulmonary bypass for a lengthy period. It is also desirable to provide a large lumen through the valve orifice relative to the overall valve diameter. However, techniques for attaching the sewing cuff to the valve orifice typically require the area of the valve lumen be reduced to accommodate an attachment mechanism. For example, the sewing cuff is typically retained between two rims of the valve orifice. One of the rims normally defines the outside diameter of the valve orifice and thus limits the size of the valve lumen.
Another technique for attaching heart valves uses a series of pins which pierce the tissue annulus of the heart. The pins are crimped or bent, thereby locking the valve to the heart tissue and preventing the valve from separating from the heart. This technique is described in U.S. Pat. Nos. 3,574,865 and 3,546,710. Another technique for attaching a prosthetic heart valve to the heart tissue is shown in U.S. Pat. No. 4,705,516 in which an outer orifice ring is sutured to the tissue annulus and an inner orifice ring is then screwed into the outer orifice ring. However, the rings are not locked together and may become unscrewed after extended use.
SUMMARY OF THE INVENTION
The present invention includes a prosthetic heart valve for implantation in a heart. The heart valve includes an outer orifice ring for coupling to a tissue annulus of a heart. An inner orifice ring includes an occluding mechanism such as at least one leaflet (occluder) carried in a lumen of the inner orifice ring which is movable between an open position, which allows blood flow through the lumen, and a closed position which blocks blood flow through the lumen. The inner orifice ring is adapted to be coupled to the outer orifice ring after the outer orifice ring has been attached to the tissue annulus.
In one aspect of the invention, the outer orifice ring is attached to the tissue annulus by a helical screw. In another aspect, the outer orifice ring is coupled to the inner orifice ring by a snap fit. Yet another aspect includes an attachment tool for coupling the inner orifice ring to the outer orifice ring.
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Allan Bob
Anderson Kimberly A.
Buchanan Eric S.
Girard Michael J.
Holmberg William R.
Finucane, Esq. Hallie A.
St. Jude Medical Inc.
Westman Champlin & Kelly P.A.
Willse David H.
LandOfFree
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