Bicuspid pulmonary heart valve and method for making same

Claim 1

A heart valve comprising: a generally tubular element with first and second ends; the first end comprising an orifice of a predetermined size and shape, and defined by at least two opposing free edges, wherein said orifice can occupy either a first or a second position, wherein said first position is flat and generally closed, and said second position is generally circular and open; and the second end comprising at least two flexible members, each of the flexible members including an edge region having no frame structure.

Claim 7

A method of making a heart valve comprising the steps of: measuring the diameter of a patient's right ventricular outflow tract; cutting from a flat sheet of flexible synthetic resin an ellipse having a major and a minor axis, wherein the minor axis has a predetermined length and is defined by at least two peripheral edges; incising said ellipse along the minor axis, such that said incision extends along the minor axis for a distance approximately equal to 1.5 times the measured diameter of the patient's right ventricular outflow tract, and is defined by said at least two peripheral edges; folding said ellipse in half on itself along said minor axis; and forming said incision into an orifice of predetermined diameter and shape such that the flexible synthetic resin sheet forms a generally tubular shape with said incision at one end thereof forming an orifice that can open and close when inserted into the patient's right ventricular outflow tract.

Claim 8

A method of making a heart valve comprising the steps of: measuring the diameter of a patient's right ventricular outflow tract; cutting from a flat sheet of flexible synthetic resin an ellipse having a major and a minor axis, wherein the minor axis has a predetermined length and is defined by at least two peripheral edges; incising said ellipse along the minor axis, such that said incision extends along the minor axis for a distance approximately equal to 1.5 times the measured diameter of the patient's right ventricular outflow tract, and is defined by said at least two peripheral edges; folding said ellipse in half on itself along said minor axis; and forming said incision into an orifice of predetermined diameter and shape such that the flexible synthetic resin sheet forms a generally tubular shape with said incision at one end thereof forming an orifice that can open and close when inserted into the patient's right ventricular outflow tract.

Claim 10

A method of treating heart disease comprising the steps of: making an incision into a right ventricular outflow tract of a patient; measuring the diameter of the patient's right ventricular outflow tract, cutting from a flat sheet of flexible synthetic resin an ellipse having a major and a minor axis, wherein the minor axis has a predetermined length and is defined by at least two peripheral edges; incising said ellipse along the minor axis such that said incision extends along the minor axis for a distance approximately equal to 1.5 times the measured diameter of the patient's right ventricular outflow tract, and is defined by said at least two peripheral edges; folding said ellipse in half on itself along said minor axis to form at least two flexible members; forming said incision into an orifice of predetermined diameter and shape such that the flexible synthetic resin sheet forms a generally tubular shape with said incision at one end thereof forming an orifice that can open and close when inserted into the patient's right ventricular outflow tract; and attaching each of said flexible members to the anterior and posterior wall of the infundibular septum of said right ventricular outflow tract, such that said flexible members are generally parallel to each other, and such that said generally tubular structure is maintained.

Claim 11

A method of treating heart disease comprising the steps of: making an incision into a right ventricular outflow tract of a patient; measuring the diameter of the patient's right ventricular outflow tract, cutting from a flat sheet of flexible synthetic resin an ellipse having a major and a minor axis, wherein the minor axis has a predetermined length and is defined by at least two peripheral edges; incising said ellipse along the minor axis such that said incision extends along the minor axis for a distance approximately equal to 1.5 times the measured diameter of the patient's right ventricular outflow tract, and is defined by said at least two peripheral edges; folding said ellipse in half on itself along said minor axis to form at least two flexible members; forming said incision into an orifice of predetermined diameter and shape such that the flexible synthetic resin sheet forms a generally tubular shape with said incision at one end thereof forming an orifice that can open and close when inserted into the patient's right ventricular outflow tract; and attaching each of said flexible members to the anterior and posterior wall of the infundibular septum of said right ventricular outflow tract, such that said flexible members are generally parallel to each other, and such that said generally tubular structure is maintained.