Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Heart valve – Annular member for supporting artificial heart valve
Reexamination Certificate
2000-12-21
2004-04-06
Willse, David H. (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Heart valve
Annular member for supporting artificial heart valve
C623S002410
Reexamination Certificate
active
06716244
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to the field of prosthetic heart valves and more particularly to a valve having a sewing cuff assembly that may be easily and securely coupled to the valve for implantation in an annulus of a human heart. In addition, the invention relates to a method for attaching a sewing cuff to a prosthetic heart valve.
BACKGROUND OF THE RELATED ART
Prosthetic heart valves are used to replace diseased heart valves in humans. Prosthetic heart valves include mechanical heart valves, bioprosthetic valves using biological tissue, and polymer valves. The term “mechanical valve” as used herein refers to bi-leaflet heart valves comprising a valve orifice fabricated at least in part of a rigid, biologically compatible material such as pyrolytic carbon, and comprising essentially no biological components. The term “bioprosthetic valve” refers to a bi-leaflet or tri-leaflet heart valve comprising at least some biological components such as tissue or tissue components. The biological components of tissue valves are obtained from a donor animal (typically bovine or porcine), and the valve may comprise either biological materials alone or biological materials with man-made supports or stents. The term “polymeric valve” refers to a tri-leaflet or bi-leaflet heart valve comprising at least some elastomeric polymer components, including at least elastomeric polymer valve leaflets.
Conventional prosthetic heart valves, whether mechanical, bioprosthetic, or polymer valves, typically include an annular valve body comprising an orifice for blood flow through the valve. The valve body can be made of materials such as biocompatible pyrolitic carbon (mechanical valves), porcine or bovine pericardium tissue (bioprosthetic valves), or silicone or polyurethane (polymer valves). Leaflets are coupled to the annular body for movement between an open position and a closed position to allow or prevent blood flow through the orifice. Heart valves may include one, two or three leaflets. The leaflets can he made of pyrolytic carbon, treated tissue, or polymers. The valve is typically attached to a human heart with sutures via a sewing cuff, or some other mechanical attachment means (e.g., staples).
Sewing cuffs generally comprise a toroidal member that is attached to the periphery of the annular valve body to form a site for anchoring sutures to the annulus of the heart during implantation of the heart valve. Sewing cuffs are typically covered with a cloth material, such as polyester, and may also comprise a filler material such as Teflon felt or Dacron cloth. The sewing cuff may be coupled to a peripheral groove on the lower end of the valve body by circumferential cinch-like sutures, or may be mechanically captured adjacent to a stiffening ring, as in U.S. Pat. Nos. 5,397,346 and 5,397,348, hereby incorporated by reference herein.
Existing methods of coupling the sewing cuff to the valve body involve prolonged and repeated handling of the heart valve body. Because attachment of the sewing cuff to the heart valve is a relatively labor-intensive and expensive part of valve fabrication, and because heart valves are more susceptible to damage the more they are handling during assembly, packaging and storage, there is a need for a sewing ring that can be quickly and securely coupled to the valve body with minimal handling.
Another problem associated with prosthetic heart valves is the size and configuration of the suture cuff used to attach the heart valve in the body. It is desirable to maximize the flow area (i.e. the orifice) of the valve. Accordingly, the radial thickness added by the sewing ring is desirably kept to a minimum. Currently, some replacement heart valve designs have large or bulky sewing cuffs, thereby reducing the area available for blood flow. These designs may include additional material located on the outer diameter of the base of the replacement valve. The added bulk of the sewing cuff also makes the valve less flexible, thus making conformation to natural anatomy more difficult.
Therefore, there is a need for a heart valve and sewing cuff which can be assembled together with a minimum of handling, and a method for rapidly and securely affixing a sewing cuff to a heart valve. The assembled valve preferably minimizes the radial thickness of the sewing cuff assembly and maximizes the blood flow orifice area.
SUMMARY OF THE INVENTION
The present invention generally provides a sewing cuff assembly and a heart valve to which the sewing cuff assembly is coupled. The invention further provides a method for attaching a sewing cuff assembly to a heart valve and attaching the assembled heart valve and sewing cuff assembly in a human heart.
In one aspect, embodiments of the invention provide a heart valve comprising a valve body having an outer circumferential rim and a suture cuff assembly comprising at least one lock ring and a material disposed at least partially around and secured to the lock ring. The suture ring may include a filler material disposed inside at least a portion of the material disposed around the lock ring.
In another aspect, a sewing ring for a heart valve is provided comprising at least a pair of lock rings and an attachment material disposed at least partially around the pair of lock rings. A filler material may be disposed at least partially between the attachment material and the lock rings.
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Carbomedics Inc.
Jackson Suzette J.
William, Morgan and Amerson, P.C.
Willse David H.
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