Prosthetic heart valves and methods of attaching same

• US 9,011,524 B2
• Filed: 04/23/2010
• Issued: 04/21/2015
• Est. Priority Date: 04/24/2009
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Eberhardt, Carol E.
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): PRESTON, REBECCA STRASZHEIM
• Application Number:
  US12/766,554
• Publication Number:
  US 20100274354A1
• Time in Patent Office: 1,824 Days
• Field of Search: None
• US Class Current: 623/2.14
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0037 differing in height or in length
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0048 differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability
• CPC Class Codes: A61L 27/3625 Vascular tissue, e.g. heart valves

Abstract

A stented valve including a compressible and expandable stent frame having a generally tubular body portion having an interior area and a longitudinal axis, a bioprosthetic valve positioned at least partially within the interior area of the tubular body portion of the stent frame and having an inner wall from which a plurality of leaflets extend; and a tubular covering material including a first portion extending from a first end of the stent frame to a second end of the stent frame, and a second portion extending beyond the second end of the stent frame.

Claims

1. A stented valve suitable for implantation within a patient, the stented valve extending between, and terminating at, opposing first and second terminal ends, the stented valve comprising:

a compressible and expandable stent frame comprising a generally tubular body portion having an interior area and a longitudinal axis;

a prosthetic heart valve positioned within the interior area of the tubular body portion of the stent frame and provided as a homogeneous, biological valve structure comprising an inner wall from which a plurality of leaflets extend, the prosthetic heart valve selected from the group consisting of a porcine valve, a bovine valve, and an equine valve; and

a tubular covering material comprising a first portion on an outside of the stent frame and extending from a first end of the stent frame to a second end of the stent frame, the tubular covering material securely stitched to the first end and the second end, the first end of the stent frame coinciding with the first terminal end, and a second portion of the tubular covering material extending beyond the second end of the stent frame to the second terminal end, wherein an end of the first portion of the tubular covering material is attached to the second end of the stent frame, and wherein an entirety of the second portion comprises a single layer of unsupported tubular covering material configured for anastomotic attachment, the second portion defining a continuous, uninterrupted, closed perimeter shape in a plane perpendicular to the longitudinal axis beyond the second end of the stent frame and the prosthetic heart valve.

2. The stented valve of claim 1, wherein the tubular covering material comprises pericardial material.

3. The stented valve of claim 1, wherein the stent frame comprises a shape memory material.

4. The stented valve of claim 1, wherein stitches at the first end of the stent frame form a proximal attachment pattern along which the first portion of the tubular covering material is attached to the first end of the stent frame.

5. The stented valve of claim 4, wherein the proximal attachment pattern comprises a zigzag pattern.

6. The stented valve of claim 5, wherein the proximal attachment pattern generally follows wire segments that define the first end of the stent frame.

7. The stented valve of claim 1, wherein stitches at the second end of the stent frame form a distal attachment pattern along which the first portion of the tubular covering material is attached to the second end of the stent frame and from which the second portion of the tubular covering material extends.

8. The stented valve of claim 7, wherein the distal attachment pattern comprises a zigzag pattern.

9. The stented valve of claim 8, wherein the distal attachment pattern generally follows wire segments that define the second end of the stent frame.

10. The stented valve of claim 1, wherein the plurality of leaflets comprises three leaflets.

11. The stented valve of claim 1, wherein the plurality of leaflets are formed from pericardial tissue.

12. The stented valve of claim 1, wherein the plurality of leaflets are formed from porcine, bovine or equine tissue.

13. The stented valve of claim 1, wherein the leaflets are formed from porcine, bovine or equine pericardial tissue.

14. The stented valve of claim 1, wherein the plurality of leaflets are provided as a biological valve structure derived from a pig, cow or horse.

15. The stented valve of claim 1, wherein an outer diameter defined by the stent frame is greater than an outer diameter defined by the second portion of the tubular covering material in a normal state of the stented valve.