Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Heart valve – Having rigid or semirigid pivoting occluder
Patent
1996-11-26
1997-12-02
Jones, Mary Beth
Prosthesis (i.e., artificial body members), parts thereof, or ai
Heart valve
Having rigid or semirigid pivoting occluder
137527, A61F 224
Patent
active
056930909
DESCRIPTION:
BRIEF SUMMARY
The present invention relates to a heart valve prosthesis, and in particular to a bileaflet heart valve prosthesis.
Bileaflet heart valve prostheses are known from, for example, European patent specification EP-A-289404 which discloses a bileaflet prosthetic heart valve having a pair of valve sealing leaflets pivotally mounted in an annular support body, the leaflets being pivotal to permit or restrict blood flow through the valve. To assemble the valve, the annular support body, which is unitary, is resiliently deformed to an extent to enable the pivot formations on the leaflets to be received in corresponding formations on the body, the annular body is then allowed to return to its original shape thereby returning the pivot formations of the leaflets in the formations on the annular body. Deflection of the resilient annular support body during assembly inherently subjects the annular support body to stresses; furthermore the requirements that the support ring be deformable to permit mounting of the leaflets during assembly runs contrary to the requirement that the ring must be rigid enough to ensure that muscular forces acting on the ring when in position in the heart must not cause sufficient deflection of the ring to enable the leaflets tb become detached therefrom.
An improved prosthetic heart valve has now been devised which alleviates the above-mentioned disadvantages with known prostheses.
According to a first aspect, the present invention provides a heart valve prosthesis comprising a substantially annular valve body having pivot formations arranged to engage with complementary pivot formations provided on each of a respective pair of leaflets such that the leaflets are pivotally mounted to the valve body to be pivotable between respective open positions, in which blood is permitted to pass through the valve, and respective closed positions in which blood flow through the valve is substantially inhibited, wherein the valve body is constructed of at least two part-annular elements and each respective leaflet is provided with at least two spaced pivot formations, each arranged to engage with a respective complementary pivot formation provided on a different part-annular element.
The annular valve body is preferably substantially circular or ring like in projection. Alternatively, the annular valve body may be substantially square, or oblong in projection, and the term substantially annular should be interpreted to cover such constructions.
It is preferred that the annular body is of two part construction comprising a pair of semi-annular part-annular elements connected to one another at diametrically opposed positions.
In this embodiment it is preferred that each semi-annular element of the valve body carries pivot formations arranged to complementarily engage with respective pivot formations provided on each of the leaflets. Desirably, in the closed position, the leaflets define a diametrical sealing line which is arranged to extend transversely (preferably substantially perpendicularly) to a line joining the diametrically opposed connection positions of the semi-annular valve body elements.
It is preferred that the annular valve body is substantially rigid when constructed, advantageously comprised of bio-compatible metallic construction preferably comprising titanium or a titanium alloy.
It is preferred that mechanical fixing means such as for example connecting pins are used to secure the part-annular elements of the valve body. In addition, or alternatively, the respective part-annular elements may be chemically bonded by adhesives, or more preferably by means of fusion bonding or welding at the respective connection positions.
It is particularly preferred that each of the annular valve body and the leaflets are provided with a coating layer of a material having good biocompatibility properties, preferably being a haemocompatible material.
Such a material may for example be pyrolytic carbon or, more preferably, the form of carbon commonly known as "diamond like" carbon. An alternative biocompat
REFERENCES:
patent: 3938197 (1976-02-01), Milo
patent: 5061278 (1991-10-01), Bicer
Angelini Gianni Davide
Pistolesi Claudio
Unsworth William David
Cardio Carbon Company Ltd.
Jones Mary Beth
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