BICUSPID VASCULAR VALVE AND METHODS FOR MAKING AND IMPLANTING SAME

• US 20080065198A1
• Filed: 11/13/2007
• Published: 03/13/2008
• Est. Priority Date: 01/23/2004
• Status: Active Grant

• Current Assignee: James Quintessenza
• Original Assignee: James Quintessenza
• Inventors: Quintessenza, James
• Granted Patent: US 7,862,610 B2
• Time in Patent Office: Days
• US Class Current: 623/1.24
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2475 Venous valves

Abstract

A vascular valve constructed from a biocompatible material that is designed to be surgically implanted in a patient'"'"'s blood vessel, such as the right ventricular outflow tract. At the first end of the valve there is an orifice defined by at least two opposing free edges, and which can occupy either a first, closed position or a second, open position. At the second end of the valve there are at least two flexible members attachable to an anterior and a posterior wall of a patient'"'"'s blood vessel. A length of the orifice between said at least two opposing free edges when the orifice is generally closed is equal to about 1.5 to 2 times the diameter of a patient'"'"'s blood vessel. Optionally, the two flexible members to a stent or tubular graft. The valved stent or tubular graft can be inserted into a patient'"'"'s blood vessel or heart.

Claims

1. A vascular valve comprising:

a generally tubular element with first and second ends;

the first end comprising an orifice that 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;

the second end comprising at least two flexible members, each of the flexible members including an edge region having no frame structure, and

wherein a length of said orifice between said at least two opposing free edges when said orifice is generally closed is equal to about 1.5 to 2 times the diameter of a patient'"'"'s right ventricular outflow tract or blood vessel.

2. The vascular valve of claim 1, wherein the valve is attachable to walls of a patient'"'"'s blood vessel by at least one of suturing, and implantation of prongs attached to the flexible members into the wall of the right ventricular outflow tract or blood vessel.

3. The vascular valve of claim 1 wherein the tubular element is formed of either one of a fluoropolymer, polytetrafluoroethylene, and a biocompatible, synthetic resin.

4. The vascular valve of claim 1, further including an outer tubular structure, the flexible members attached to the outer tubular structure such that said tubular element is disposed within the outer tubular structure.

5. The vascular valve of claim 4, wherein the outer tubular structure includes either a stent, a graft tube, or both a stent and a graft tube.

6. A method of making a vascular valve comprising the steps of:

measuring the diameter of a patient'"'"'s blood vessel into which the valve is to be implanted;

cutting from a sheet of flexible synthetic biocompatible material a generally elliptical shape having a minor axis;

incising said elliptical shape along a portion of the minor axis, such that said incision extends along the minor axis for a distance approximately equal to 1.5 to 2 times the measured diameter of the patient'"'"'s blood vessel;

folding said elliptical shape along said minor axis to form two flexible members from end portions of the elliptical shape; and

forming said folded elliptical shape into 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 or blood vessel.

7. The method of claim 6, wherein incising said elliptical shape includes forming an incision having ends that are each about a 1 mm to 3 mm distance from the edge of the elliptical shape.

8. The method of claim 7, wherein incising said elliptical shape includes forming an incision having ends that are each about 2 mm from the edge of the elliptical shape.

9. A method of treating vascular or heart disease, comprising:

measuring the diameter of a patient'"'"'s blood vessel;

cutting from a sheet of flexible synthetic biocompatible material a generally elliptical shape having a minor axis;

incising said elliptical shape along a portion of the minor axis, such that said incision extends along the minor axis for a distance approximately equal to 1.5 to 2 times the measured diameter of the patient'"'"'s blood vessel;

folding said elliptical shape along said minor axis to create at least two flexible members; and

forming said incision into an orifice of predetermined diameter and shape such that said flexible synthetic biocompatible material forms a generally tubular shape with said incision at one end thereof forming an orifice that can open and close.

10. The method of claim 9, further comprising making an incision into the blood vessel of the patient.

11. The method of claim 9, further comprising attaching each of said flexible members to the anterior and posterior wall of the patient'"'"'s blood vessel, such that said flexible members are generally parallel to each other, and such that said generally tubular structure is maintained.

12. The method of claim 11, wherein attaching each of said flexible members includes suturing the flexible members to the anterior and posterior wall of the infundibular septum of the right ventricular outflow tract.

13. The method of claim 9, further comprising:

attaching each of said flexible members to a stent or a graft tube, the stent or the graft tube sized for insertion into the patient'"'"'s blood vessel, such that said flexible members are generally parallel to each other, and such that said generally tubular structure is maintained to form a valve;

inserting the stent or the graft tube containing the valve into the patient'"'"'s blood vessel; and

attaching the stent or the graft tube to either the heart, blood vessel walls, or both the heart and blood vessel walls.

14. The method of claim 13, wherein inserting the stent or the graft tube containing the valve into the patient'"'"'s blood vessel includes inserting the stent or graft tube using a peripheral transvenous catheter technique.

15. The method of claim 9, further comprising:

attaching each of said flexible members to a stent or graft tube, the stent or the graft tube sized for insertion into the patient'"'"'s heart, such that said flexible members are generally parallel to each other, and such that said generally tubular structure is maintained to form a valve;

inserting the stent or graft tube containing the valve into the patient'"'"'s heart; and

attaching the stent or graft tube to the either the heart, a blood vessel wall, or both the heart and blood vessel wall.

16. The method of claim 15, wherein inserting the stent or the graft tube containing the valve into the patient'"'"'s blood vessel includes inserting the stent or graft tube using a limited surgical access method or an open surgical procedure.

17. A method of surgically reconstructing a right ventricular outflow tract of a patient, comprising:

making an incision into the right ventricular outflow tract;

measuring the diameter of the right ventricular outflow tract;

cutting from a flat sheet of flexible synthetic biocompatible material a generally elliptical shape 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 elliptical shape along the minor axis, such that said incision extends along the minor axis for a distance approximately equal to 1.5 to 2 times the measured diameter of the patient'"'"'s right ventricular outflow tract, and is defined by said at least two peripheral edges;

folding said elliptical shape in half on itself along said minor axis;

forming said incision into an orifice of predetermined diameter and shape such that said flexible synthetic biocompatible material 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 blood vessel; and

suturing each of said plurality of flexible members to the anterior and posterior wall of the infundibular septum of the right ventricular outflow tract, such that said flexible members are generally parallel to each other, and such that said generally tubular structure is maintained, whereby the valve is held in place in the right ventricular outflow tract and the orifice can open and close with the flow of blood through the right ventricular outflow tract.