Abstract This invention comprises a method of using tubular material (200) to replace a
heart valve (118)(120)(162) during cardiac surgery. To create a replacement
atrioventricular (mitral or tricuspid) valve (120)(160), the tube inlet is sutured to a
valve annulus (121)(162) from which the native leaflets have been removed, and
the tube outlet is sutured to papillary muscles (126)(128)(170) in the ventricle
(112)(152). To create a semilunar (aortic or pulmonary) valve (118), the tube inlet
is sutured to an annulus from which the native cusps have been removed, and the
tube is either "tacked" at three points distally inside the artery, or sutured
longitudinally along three lines; this allows the flaps of tissue between the three
fixation points at the valve outlet to function as movable cusps. These approaches
generate flow patterns that closely duplicate the flow patterns of native valves. A
preferred tubular material (200) comprises submucosal tissue from the small
intestine; this can be taken from the same patient who is undergoing the cardiac
operation, to reduce antigenicity. Animal or cadaver intestinal tissue can also be
used if properly treated, or a biocompatible synthetic tubular material can be used.
This invention also discloses a properly treated intestinal tissue segment or
synthetic tubular segment (500) suitable for implantation as a replacement heart
valve, enclosed in a sealed sterile package (510).
An article of manufacture comprising a container and an enclosed tubular segment
suitable for surgical implantation as a replacement valve in a mammalian heart, the
tubular segment comprising: a thin and flexible wall portion; an inlet end, an outlet end and an interior surface; three attachment points adjacent the outlet end, each of the attachment points
configured so that the interior surface of the wall portion is engaged with itself in a facing
relationship at the attachment point; and three cusps between the attachment points, each of the cusps adapted to flex inwardly
into and out of engagement with others of the cusps in response to differential pressures
on either side of the cusp in order to close and open the valve, said valve adapted to be
open when at rest and to close as the heart cycle changes from systole to diastole.
Claim 2
Dependent Claim
32 words
A prosthetic heart valve as in Claim 1, wherein a suture holds the interior surface
of the wall portion engaged with itself in a facing relationship at each of the attachment
points.
Claim 3
Dependent Claim
16 words
A prosthetic heart valve as in Claim 2 additionally comprising reinforcing pieces
adjacent the attachment points.
Claim 4
Dependent Claim
22 words
A prosthetic heart valve as in Claim 1, wherein the cusps are biased partially
closed even when the valve is generally open.
Claim 5
Dependent Claim
20 words
A prosthetic heart valve as in Claim 1, wherein the wall portion comprises a flat
material fashioned into a tube.
Claim 6
Dependent Claim
14 words
A prosthetic heart valve as in Claim 5, wherein the wall portion comprises
pericardium.
Claim 7
Dependent Claim
17 words
A prosthetic heart valve as in Claim 1, wherein the cusps are scalloped at the
outlet end.
Claim 8
Dependent Claim
16 words
A prosthetic heart valve as in Claim 1, wherein the attachment points are about
120° apart.
Claim 9
Dependent Claim
18 words
An article of manufacture comprising the prosthetic heart valve of Claim 1
disposed within a sealed sterile package.
References Cited (Backward Citations)
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