Stentless heart valve and holder

• US 5,336,258 A
• Filed: 12/14/1992
• Issued: 08/09/1994
• Est. Priority Date: 09/07/1990
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Baxter International Inc.
• Inventors: Quintero, Lillian J., Cosgrove, Delos M., Nguyen-Thien-Nhon, Diana
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): BRITTINGHAM, DEBRA
• Application Number:
  US07/990,211
• Time in Patent Office: 603 Days
• Field of Search: 623/2, 623/900
• US Class Current: 623/2.1
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: Y10S 623/90 Stent for heart valve

Abstract

A stentless aortic heart valve having a disposable holder with a removable handle can be manually reversed by the physician during suturing to provide a relatively unobstructed view into the patient'"'"'s aorta. A covering applied to strategic regions on the exterior and interior of the device provides a firm ground for suturing the prosthetic heart valve into position, and for attaching the detachable holder.

Claims

1. A stentless aortic valve prosthesis comprising an animal aortic segment having an external surface and an internal surface, the aortic segment further comprising an aortic root, an outflow rim adjacent the aortic root, an inflow rim, a left coronary artery, a right coronary artery, a right coronary septal shelf, a plurality of valve leaflets, each valve leaflet having cusps and edges with the adjacent edges of the valve leaflets meeting to form commissures, and a pseudoannulus line located adjacent the commissures along the internal surface of the aortic segment, the improvement comprising:

coronary openings formed by cutting away the left and right coronary arteries while leaving intact a band of aortic wall adjacent the outflow rim.

2. The prosthesis of claim 1, further comprising a suturable covering affixed along the entire right coronary septal shelf on the external surface of the aortic segment, and the inflow rim on both the internal and external surfaces of the aortic segment.

3. The prosthesis of claim 2, wherein the suturable covering further comprises edges, and further covers, at the outflow rim, an area running along the internal surface of the aortic segment between the pseudoannulus line and the coronary openings, leaving uncovered a portion of aortic wall between the edges of the suturable covering and each commissure.

4. The prosthesis of claim 2 wherein the prosthesis is manually reversible and wherein the suturable covering is a biocompatible cloth stitched flat to the aortic segment with nondissolvable biocompatible thread.

5. The prosthesis of claim 4 wherein the thread is Teflon®

.

6. The prosthesis of claim 4 wherein the cloth is cut on the diagonal.

7. The prosthesis of claim 4 wherein the cloth is laser cut.

8. The prosthesis of claim 4 wherein the cloth covering the pseudoannulus line and the coronary openings comprises two pieces from 2 to 4 millimeters in width diagonally cut to match the shape of the left and right coronary arteries wherein from 1 to 4 millimeters of space is left uncovered between each send of the cloth and the nearest commissure.

9. The prosthesis of claim 8 wherein the cloth has an edge and the coronary openings further comprise edges, and wherein the stitches comprises a line of in-and-out stitches about 0.5 millimeter in length placed between the pseudoannulus line and the coronary openings, and a line of whipstitches running along the edge of the cloth adjacent to the edges of the coronary openings.

10. The prosthesis of claim 4 wherein each valve leaflet comprises a mid-cusp point, and wherein the cloth covering the inflow rim extends from about 2 to 3 millimeters on each side of the rim and wherein markings are located on the cloth surface along the inflow rim about each of the mid-cusp points.

11. The prosthesis of claim 10 wherein the cloth is white Dacron and the markings are stitches in a contrasting color of thread.

12. The prosthesis of claim 1 wherein the coronary openings comprise edges and wherein the band of aortic wall remains intact for a distance of from 2 to 4 millimeters from the outflow rim to the edge of the coronary openings.

13. The prosthesis of claim 12 wherein the intact band of aortic wall has a width of 2 to 5 millimeters.

14. The prosthesis of claim 1 further comprising a distance from the edge of the coronary openings to the commissures, and wherein the distance is from about 2 to 5 millimeters.

15. The prosthesis of claim 1 further comprising a thin rim of cartilage adjacent to the right coronary shelf.

16. The prosthesis of claim 1 wherein the inflow rim is trimmed on the same plate as the cusps of the valve leaflets.

17. The prosthesis of claim 16 wherein the plurality of valve leaflets comprise hinges, and wherein the inflow rim has a segment of intact aortic wall between 3 and 4 millimeters in width as measured from the hinges of the valve leaflets.

18. A stentless aortic valve prosthesis comprising an animal aortic segment having an external surface and an internal surface, the aortic segment further comprising an aortic root, an outflow rim adjacent the aortic root, an inflow rim, a left coronary artery, a right coronary artery, a right coronary septal shelf, a plurality of valve leaflets, each valve leaflet having cusps and edges with the adjacent edges of the valve leaflets meeting to form commissures, and a pseudoannulus line located adjacent the commissures along the internal surface of the aortic segment, the aortic segment further comprising:

coronary openings formed by cutting away the left and right coronary arteries while leaving intact a band of aortic wall adjacent the outflow rim; and

a suturable covering affixed along the entire right coronary septal shelf on the external surface of the aortic segment, and the inflow rim on both the internal and external surfaces of the aortic segment;

the suturable covering comprising edges and covering, at the outflow rim, an area running along the internal surface of the aortic segment between the pseudoannulus line and the coronary openings, leaving uncovered a portion of aortic wall between the edges of the suturable covering and each commissure.

19. The prosthesis of claim 18 wherein the coronary openings comprise edges and wherein the band of aortic wall remains intact for a distance of from 2 to 4 millimeters from the outflow rim to the edge of the coronary openings.

20. The prosthesis of claim 18 further comprising a distance from the edge of the coronary openings to the commissures, and wherein the distance is from about 2 to 5 millimeters.