Methods of assembling a valved aortic conduit

• US 10,058,425 B2
• Filed: 09/10/2015
• Issued: 08/28/2018
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Murad, Michael C., Fann, Hilda Z., Van Nest, Mark, Wang, John X.
• Primary Examiner(s): Mathew, Seema
• Application Number:
  US14/850,829
• Publication Number:
  US 20160067042A1
• Time in Patent Office: 1,083 Days
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2230/0076 ellipsoidal or ovoid
• CPC Class Codes: A61F 2230/0095 Saddle-shaped
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/006 modular

Abstract

A valved conduit including a bioprosthetic aortic heart valve connected to a tubular conduit graft forming an ascending aorta. The conduit graft may attach to the heart valve in a manner that facilitates a redo operation in which the valve is replaced with another valve. A sewing ring may be pre-attached to the inflow end of the graft, and then the valve connected to a delivery holder advanced into the graft and secured to the sewing ring. Dry bioprosthetic valves coupled with conduit grafts sealed with a bioresorbable medium can be stored with the delivery holder.

Claims

1. A method of assembling a valved conduit, comprising:

forming a subassembly of a fabric conduit graft and an annular sewing ring, the conduit graft comprising a longitudinal tubular portion between an upper end and a lower end, the lower end having a collar portion, the sewing ring comprising an inner core and an outer fabric covering, the step of forming comprising positioning the sewing ring adjacent the lower end of the conduit graft so that the collar portion contacts an inner wall of the annular sewing ring and securing the collar portion thereto;

leak testing the subassembly of the conduit graft and sewing ring;

providing a prosthetic heart valve having an inner support frame covered with fabric and defining a flow orifice and a plurality of leaflets extending inward from the support frame to ensure one-way blood flow through the heart valve, the fabric covering the support frame extending downward in a tubular segment;

attaching a holder to the heart valve; and

positioning the heart valve within the lower end of the leak tested subassembly of the conduit graft and sewing ring and folding the tubular segment of the fabric covering radially outward underneath the subassembly and secured the tubular segment thereto with sutures, the holder having a length sufficient to extend from the heart valve out of the upper end of the conduit graft.

2. The method of claim 1, wherein the collar portion has an undulating shape around its circumference with peaks and valleys, and the sewing ring also has an undulating shape around its circumference with peaks and valleys, wherein the peaks and valleys of the collar portion align with the peaks and valleys of the sewing ring.

3. The method of claim 1, including securing the conduit graft to the sewing ring using sutures.

4. The method of claim 1, including securing the conduit graft to the sewing ring by welding.

5. The method of claim 1, wherein the heart valve leaflets are made of bioprosthetic tissue.

6. The method of claim 5, wherein the conduit graft comprises a tubular matrix impregnated with gelatin.

7. The method of claim 5, wherein the heart valve leaflets are formed of bovine pericardium that has been cross-linked using glutaraldehyde or other aldehyde containing agents, treated with a capping agent, and is dehydrated with a glycerol solution.

8. The method of claim 1, wherein the step of leak testing the subassembly includes pulsatile testing with saline.

9. A method of assembling a valved conduit, comprising:

forming a subassembly of a fabric conduit graft and an annular sewing ring, the conduit graft comprising a longitudinal tubular portion between an upper end and a lower end, the lower end having a collar portion, the sewing ring comprising an inner core and an outer fabric covering, the step of forming comprising positioning the sewing ring adjacent the lower end of the conduit graft so that the collar portion contacts an inner wall of the annular sewing ring and securing the collar portion thereto;

leak testing the subassembly of the conduit graft and sewing ring;

providing a prosthetic heart valve having an annular support frame covered with fabric but without a sewing ring attached thereto and flow-occluding leaflets mounted within the support frame;

positioning the prosthetic heart valve within the lower end of the leak tested subassembly of the conduit graft and sewing ring, with the annular support frame adjacent to and in contact with the inner wall of the annular sewing ring; and

securing the prosthetic heart valve within the lower end with sutures between the fabric covering the annular support frame and the annular sewing ring.

10. The method of claim 9, wherein the collar portion has an undulating shape around its circumference with peaks and valleys, and the sewing ring also has an undulating shape around its circumference with peaks and valleys, wherein the peaks and valleys of the collar portion align with the peaks and valleys of the sewing ring.

11. The method of claim 9, including securing the conduit graft to the sewing ring using sutures.

12. The method of claim 9, including securing the conduit graft to the sewing ring by welding.

13. The method of claim 12, wherein the conduit graft comprises a tubular matrix impregnated with gelatin.

14. The method of claim 9, wherein the prosthetic heart valve leaflets are formed of bovine pericardium that has been cross-linked using glutaraldehyde or other aldehyde containing agents, treated with a capping agent, and is dehydrated with a glycerol solution.

15. The method of claim 9, wherein the step of positioning the prosthetic heart valve comprises:

attaching a holder to the prosthetic heart valve, the holder having a length sufficient to extend from the prosthetic heart valve out of the upper end of the conduit graft; and

advancing the holder with the prosthetic heart valve attached through the upper end of the conduit graft.

16. The method of claim 9, wherein the fabric covering the support frame extends downward in a tubular segment, and the step of securing the prosthetic heart valve includes folding the tubular segment of the fabric covering radially outward underneath the subassembly and secured the tubular segment thereto with sutures.

17. The method of claim 9, wherein the step of leak testing the subassembly includes pulsatile testing with saline.

18. A method of assembling a valved conduit, comprising:

forming a subassembly of a fabric conduit graft and an annular sewing ring, the conduit graft comprising a longitudinal tubular portion between an upper end and a lower end, the lower end having a collar portion, the sewing ring comprising an inner core and an outer fabric covering, the step of forming comprising positioning the sewing ring adjacent the lower end of the conduit graft so that the collar portion contacts an inner wall of the annular sewing ring and securing the collar portion thereto;

leak testing the subassembly of the conduit graft and sewing ring;

providing a prosthetic heart valve having an annular support frame covered with fabric but without a sewing ring attached thereto and flow-occluding leaflets mounted within the support frame;

positioning the prosthetic heart valve within the lower end of the leak tested subassembly of the conduit graft and sewing ring, with the annular support frame adjacent to and in contact with the inner wall of the annular sewing ring; and

securing the prosthetic heart valve within the lower end with sutures between the fabric covering the annular support frame and the annular sewing ring, wherein the prosthetic heart valve has a fabric covering a support frame that extends downward in a tubular segment, and the step of securing the prosthetic heart valve includes folding the tubular segment of the fabric covering radially outward underneath the subassembly and secured the tubular segment thereto with sutures.