Stentless heart valve and holder

• US 5,197,979 A
• Filed: 09/07/1990
• Issued: 03/30/1993
• Est. Priority Date: 09/07/1990
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Baxter International Inc.
• Inventors: Cosgrove, Delos M., Nguyen-Thien-Nhon, Diana, Quintero, Lillian J.
• Primary Examiner(s): Green, Randall L.
• Assistant Examiner(s): BRITTINGHAM, DEBRA
• Application Number:
  US07/579,464
• Time in Patent Office: 935 Days
• Field of Search: 623/2, 623/900
• US Class Current: 623/1.26
• 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 combination valve holder and prosthetic aortic segment comprising:

(a) a stentless aortic valve prosthesis comprising a low-pressure tanned animal aortic segment having intact the aortic valve, the aortic valve having left and right coronary arteries, a right coronary septal shelf, an inflow rim, an outflow rim and a pseudoannulus line, the aortic valve retaining its natural shape and flexibilty;

and coronary openings formed by cutting away the left and right coronary arteries while leaving intact a band of aortic wall at least about 2 millimeters wide surrounding the coronary openings; and

a suturable covering provided with edges and affixed along the entire right coronary septal shelf externally, the inflow rim both internally and externally, and covering at the outflow rim an area running internally directly above the pseudoannulus line and along the coronary openings, leaving uncovered a portion of aortic wall from 2 to 3.5 millimeters in width between the edges of the covering and each valve commissure;

(b) a disposable holder body having an elongate detachable handle; and

(c) a plurality of means for detachably attaching the holder body to the covering on the aortic segment.

2. The combination of claim 1 wherein the means for attaching comprise holes drilled through the holder body.

3. The combination of claim 2 wherein the means for attaching is selected from the group consisting of sutures, wires and elastic materials.

4. The combination of claim 2 wherein the means for attaching further comprise suture threads passing through the holes and through an orifice of the valve for suspension of the holder body within the orifice.

5. The combination of claim 1 wherein the holder body comprises a biocompatible plastic.

6. The combination of claim 5 wherein the plastic comprises polysulfone.

7. The combination of claim 1 wherein the handle comprises a metal rod.

8. The combination of claim 7 wherein the handle is threaded and screws into a threaded cylindrical depression in the holder body.

9. The combination of claim 1 wherein the holder body comprises a first right cylindrical section conjoined to and coaxially aligned with a second right cylindrical section of greater diameter, both first and second right cylindrical sections having a wall, and wherein a coaxially aligned right cylindrical depression runs throughout the first cylindrical section and penetrates into the second cylindrical section, the walls of the cylindrical section having threads thereon and further wherein the handle is a rod having threads along one end so that the handle can be detachably affixed to the holder body by screwing the threaded end of the rod into the cylindrical depression.

10. The combination of claim 9 wherein the handle comprises metal.

11. The combination of claim 9 wherein the handle comprises a biocompatible plastic.

12. The combination of claim 9 wherein the first right cylindrical section has a diameter from about 5 to 10 millimeters and has a length of from about 4 to 16 millimeters and wherein the second right cylindrical section has a diameter from about 8 to 13 millimeters and a length of from about 2 to 8 millimeters and wherein sides of the cylindrical depression have a length from about 4 to 22 millimeters.

13. The combination of claim 12 wherein one to six spaced bore holes extend through the second cylindrical section and wherein suture threads are passed through the aortic segment and the bore holes and secured so as to suspend the holder body within an outflow orifice of the aortic segment.

14. The combination of claim 1 wherein the band of aortic wall can be trimmed without damaging the valve.

15. The combination of claim 1 wherein the aortic wall remains intact for a distance of from 2 to 4 millimeters from the pseudoannular line to the edge of the coronary openings.

16. The combination of claim 1 wherein the arotic wall remains intact for a distance of from 2.5 to 3 millimeters from the pseudoannular line to the edge of the coronary openings.

17. The combination of claim 1 wherein a distance is defined from the edge of the coronary openings to the commissures, and wherein said distance is from about 2 to 5 millimeters.

18. The combination of claim 1 wherein a distance is defined from the edge of the coronary openings to the commissures, and wherein said distance is from about 2.5 to 3 millimeters.

19. The combination of claim 1 having a thin rim or cartilage adjacent to the right coronary shelf.

20. The combination of claim 1 wherein the aortic valve comprises cusps provided on valve leaflets, and wherein the inflow rim is trimmed on the same plane as the cusps of the valve leaflets.

21. The combination of claim 20 wherein the valve leaflets have hinges and wherein the inflow rim has a segment of intact aortic wall between 2 and 4 millimeters in width as measured from the hinges of the valve leaflets.

22. The combination of claim 21 wherein the inflow rim has a segment of intact aortic wall between 2.5 and 3 millimeters in width as measured from the hinges of the leaflets.

23. The combination of claim 1 wherein the prosthesis is manually reversible.

24. The combination of claim 1 wherein the covering is a biocompatible cloth stitched flat to the aortic segment along each edge with nondissolvable biocompatible thread.

25. The combination of claim 24 wherein the thread is Teflon®

.

26. The combination of claim 24 wherein the cloth is cut along a diagonal.

27. The combination of claim 26 wherein the cloth is laser cut.

28. The combination of claim 26 wherein the cloth covering the pseudoannulus line and the coronary openings comprises two pieces of cloth from 1 to 3 millimeters in width diagonally cut to match the shape of the coronary arteries wherein from 2 to 3.5 millimeters of space is left uncovered between each end of the cloth and each adjacent commissure.

29. The combination of claim 28 wherein the stitches comprise a line of in-and-out stitches about 0.5 millimeter in length placed immediately above the pseudoannulus line and a line of whipstitches running along an edge of the cloth adjacent to the edges of the coronary openings.

30. The combination of claim 26 wherein the cloth covering the inflow rim extends from about 2 to 3 millimeters on each side of the inflow rim and wherein markings are located on a surface of the cloth along the inflow rim.

31. The combination of claim 30 wherein the cloth is white Dacron and the marking are stitches in a contrasting color of thread.

32. A combination valve holder and prosthetic aortic segment comprising:

(a) a stentless aortic valve prosthesis comprising a low pressure tanned porcine aortic segment having intact the aortic valve, the aortic valve having left and right coronary arteries, a right coronary septal shelf, an inflow rim, an outflow rim and a pseudoannulus line, the aortic valve retaining its natural shape and flexibility;

and coronary openings formed by cutting away the left and right coronary arteries while leaving intact a band of aortic wall at least about 2 millimeters wide surrounding the coronary openings; and

cloth provided with edges and covering the entire right coronary septal shelf externally, the inflow rim both internally and externally, and covering at the outflow rim an area running internally directly above the pseudoannnulus line and along the coronary openings, leaving uncovered a portion of aortic wall from 2 to 3.5 millimeters in width between the edges of the cloth and each valve commissure;

wherein the cloth is stitched flat to the aortic segment along each edge with nondissolvable biocompatible thread and wherein a circular band of aortic wall remains intact for a distance of from 2 to 4 millimeters from the pseudoannulus line to an edge of the coronary openings;

and further wherein the band of aortic wall can be trimmed to remove portions contiguous to the coronary artery openings without impairing the aortic valve;

(b) a disposable holder body having an elongate detachable handle; and

(c) a plurality of means for detachably attaching the holder body to the covering on the aortic segment.

33. A combination valve holder and prosthetic aortic segment comprising:

(a) a stentless aortic valve prosthesis comprising a reversible porcine aortic segment having intact the aortic valve, the aortic valve having left and right coronary arteries, a right coronary septal shelf, an inflow rim, an outflow rim and a pseudoannulus line, the aortic valve retaining its natural shape and flexibility;

and coronary openings formed by cutting away the left and right coronary arteries while leaving intact a band of aortic wall at least about 2 millimeters wide surrounding the coronary openings; and

cloth provided with edges and covering the entire right coronary septal shelf externally, the inflow rim both internally and externally, and covering at the outflow rim an area running internally directly above the pseudoannulus line and along the coronary openings, leaving uncovered a portion of aortic wall from 2 to 3.5 millimeters in width between the edges of the cloth and each valve commissure;

wherein the cloth is stitched flat to the aortic segment along each edge with nondissolvable biocompatible thread and wherein the aortic wall remains intact for a distance of from 2 to 4 millimeters from the pseudoannular line to an edge of the coronary openings, and wherein the distance from the edge of the coronary openings to the commissures is from about 2 to 5 millimeters;

(b) a disposable holder body having an elongate detachable handle; and

(c) a plurality of means for detachable attaching the holder body to the covering on the aortic segment.