Method of replacing atrioventricular heart valves using flexible tubes
First Claim
1. A method of surgically creating a replacement semilunar heart valve in a patient in need thereof, comprising the following steps:
- a. surgically opening a ventricular outflow artery, at a location adjacent to a native semilunar heart valve having cusps which do not function properly;
b. removing the cusps from the native semilunar heart valve, thereby generating an unoccupied valve annulus between the ventricular outflow artery and a ventricular chamber;
c. inserting into said artery a tubular segment having an inlet end, a thin and flexible wall portion having diametrically opposing sides, and an outlet end;
d. circumferentially securing the inlet end of the tubular tissue segment to the unoccupied valve annulus;
e. securing the tubular segment to the ventricular outflow artery at three spaced locations around the outlet end of the tubular segment, in a manner which creates three unconstrained regions between the three spaced locations at which the outflow end is secured, wherein the unconstrained regions are capable of flexing inwardly to function as semilunar cusps in the replacement semilunar heart valve; and
, f. closing the ventricular outflow artery.
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Accused Products
Abstract
A method is disclosed for using tubular material to replace a semilunar heart valve (i.e., an aortic or pulmonary valve). To create such a replacement valve, the native valve cusps are removed from inside an aorta or pulmonary artery, and the inlet end of a tubular segment is sutured to the valve annulus. The outlet (distal) end of the tube is either “tacked” at three points distally, or sutured longitudinally along three lines; either method will allow the flaps of tissue between the suture lines to function as movable cusps. This approach generates flow patterns that reduce turbulence and closely duplicate the flow patterns of native semilunar valves. An article of manufacture is also disclosed, comprising a sterile biocompatible synthetic material which has been manufactured in tubular form, by methods such as extrusion or coating a cylindrical molding device, to avoid a need for a suture line or other seam to convert a flat sheet of material into a tubular shape. The synthetic tube is packaged within a sealed watertight enclosure that maintains sterility of the tube.
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Citations
6 Claims
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1. A method of surgically creating a replacement semilunar heart valve in a patient in need thereof, comprising the following steps:
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a. surgically opening a ventricular outflow artery, at a location adjacent to a native semilunar heart valve having cusps which do not function properly;
b. removing the cusps from the native semilunar heart valve, thereby generating an unoccupied valve annulus between the ventricular outflow artery and a ventricular chamber;
c. inserting into said artery a tubular segment having an inlet end, a thin and flexible wall portion having diametrically opposing sides, and an outlet end;
d. circumferentially securing the inlet end of the tubular tissue segment to the unoccupied valve annulus;
e. securing the tubular segment to the ventricular outflow artery at three spaced locations around the outlet end of the tubular segment, in a manner which creates three unconstrained regions between the three spaced locations at which the outflow end is secured, wherein the unconstrained regions are capable of flexing inwardly to function as semilunar cusps in the replacement semilunar heart valve; and
,f. closing the ventricular outflow artery. - View Dependent Claims (2, 3, 4, 5)
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6. An article of manufacture, comprising:
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(a) a segment of tubular synthetic material that is suited for use in surgically creating a replacement semilunar heart valve in a human, which is characterized by an absence of any longitudinal seams, and which has been manufactured according to specifications that render the segment of tubular synthetic material clinically acceptable for surgical use in creating a replacement semilunar heart valve in a human; and
,(b) a sterile package which encloses the segment of tubular synthetic material in an airtight and watertight manner and which maintains sterility of the tubular synthetic material.
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Specification