Prosthetic cardiac valve formed from pericardium material and methods of making same

• US 10,058,421 B2
• Filed: 04/18/2016
• Issued: 08/28/2018
• Est. Priority Date: 03/28/2006
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Eberhardt, Carol, Shay, Janice
• Primary Examiner(s): Mathew, Seema
• Application Number:
  US15/131,753
• Publication Number:
  US 20160228245A1
• Time in Patent Office: 862 Days
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• 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 2230/0054 V-shaped
• CPC Class Codes: A61F 2310/00011 Metals or alloys
• CPC Class Codes: H01M 10/0525 Rocking-chair batteries, i.e. batteries with lithium insertion or intercalation in both electrodes; Lithium-ion batteries
• CPC Class Codes: H01M 10/0565 Polymeric materials, e.g. gel-type or solid-type
• CPC Class Codes: H01M 10/0566 Liquid materials
• CPC Class Codes: H01M 4/131 Electrodes based on mixed oxides or hydroxides, or on mixtures of oxides or hydroxides, e.g. LiCoOx
• CPC Class Codes: H01M 4/485 of mixed oxides or hydroxides for inserting or intercalating light metals, e.g. LiTi2O4 or LiTi2OxFy H01M4/505, H01M4/525 take precedence
• CPC Class Codes: H01M 4/5825 Oxygenated metallic salts or polyanionic structures, e.g. borates, phosphates, silicates, olivines
• CPC Class Codes: Y02E 60/10 Energy storage using batteries
• CPC Class Codes: Y02P 70/50 Manufacturing or production processes characterised by the final manufactured product

Abstract

A prosthetic stented heart valve which includes a compressible and expandable stent structure having first and second opposite ends, an expanded outer periphery, and a compressed outer periphery that is at least slightly smaller than the expanded outer periphery when subjected to an external radial force. The valve further includes a valve segment comprising a dual-layer sheet formed into a generally tubular shape having at least one longitudinally extending seam, and a plurality of leaflets formed by attachment of an outer layer of the dual-layer sheet to an inner layer of the dual-layer sheet in a leaflet defining pattern. The valve segment is at least partially positioned within the stent structure. The valve may further include at least one opening in the outer layer of the dual-layer sheet that is spaced from both the first and second ends of the stent structure.

Claims

1. A prosthetic heart valve comprising:

a radially compressible and expandable tubular metal frame structure having a longitudinal axis and extending from an inflow edge along the longitudinal axis to an outflow edge along the longitudinal axis; and

a tubular member comprising a multi-layer portion defining an inflow edge of the tubular member, a single-layer portion defining an outflow edge of the tubular member, and a pocket portion;

wherein the pocket portion comprises a first material layer of the multi-layer portion and a second material layer of the multi-layer portion;

wherein at least a portion of the second material layer is secured to at least a portion of the first material layer;

wherein the pocket portion comprises first and second side edge portions;

wherein the pocket portion comprises an open edge longitudinally spaced from the inflow edge of the tubular member and extending from the first side edge portion of the pocket portion to the second side edge portion of the pocket portion;

wherein the second material layer extends longitudinally from the inflow edge of the tubular member to the open edge of the pocket portion;

wherein the first material layer extends longitudinally from the inflow edge of the tubular member beyond the open edge of the pocket portion;

wherein at least a portion of the first material layer is longitudinally positioned within and attached to the metal frame structure;

wherein the pocket portion comprises an arcuate portion longitudinally spaced from the inflow edge of the tubular member and having a continuous arc extending from the first side edge portion of the pocket portion to the second side edge portion of the pocket portion;

wherein the pocket portion is configured to stop a flow of blood.

2. The prosthetic heart valve of claim 1, wherein the tubular member covers the inflow edge of the metal frame structure.

3. The prosthetic heart valve of claim 1, wherein the tubular member overlaps the inflow edge of the metal frame structure.

4. The prosthetic heart valve of claim 1, wherein the first and second material layers comprise different materials.

5. The prosthetic heart valve of claim 1, wherein the first and second material layers comprise the same material.

6. The prosthetic heart valve of claim 1, wherein the prosthetic heart valve has a one way fluid passage extending from the inflow edge of the metal frame structure to the outflow edge of the metal frame structure.

7. The prosthetic heart valve of claim 1, wherein a compressed outer periphery of the metal frame structure is sized for percutaneous insertion and implantation in an anatomical structure of a patient.

8. The prosthetic heart valve of claim 1, wherein the pocket portion defines a leaflet.

9. The prosthetic heart valve of claim 1, wherein the pocket portion comprises a plurality of pockets.

10. The prosthetic heart valve of claim 9, wherein the plurality of pockets are arranged together in a generally tubular shape.

11. The prosthetic heart valve of claim 9, wherein the plurality of pockets define a plurality of leaflets.

12. The prosthetic heart valve of claim 9, wherein each of the plurality of pockets comprises first and second side edge portions.

13. The prosthetic heart valve of claim 12, wherein each of the plurality of pockets comprises an arcuate portion longitudinally spaced from the inflow edge of the tubular member and having a continuous arc extending from the respective first side edge portion to the respective second side edge portion.

14. The prosthetic heart valve of claim 12, wherein each of the plurality of pockets comprises an open edge longitudinally spaced from the inflow edge of the tubular member and extending from the respective first side edge portion to the respective second side edge portion.

15. A prosthetic heart valve comprising:

a radially compressible and expandable tubular metal frame structure having a longitudinal axis and extending from an inflow edge along the longitudinal axis to an outflow edge along the longitudinal axis; and

a tubular member comprising a multi-layer portion defining an inflow edge of the tubular member and a single-layer portion defining an outflow edge of the tubular member, the multi-layer portion defining a plurality of pockets between a first material layer of the multi-layer portion and a second material layer of the multi-layer portion;

wherein at least a portion of the second material layer is secured to at least a portion of the first material layer;

wherein each pocket comprises first and second side edge portions;

wherein each pocket comprises an open edge longitudinally spaced from the inflow edge of the tubular member and extending from the respective first side edge portion to the respective second side edge portion;

wherein the second material layer extends longitudinally from the inflow edge of the tubular member to the open edge of each pocket;

wherein the first material layer extends longitudinally from the inflow edge of the tubular member beyond the open edge of each pocket;

wherein at least a portion of the first material layer is longitudinally positioned within and attached to the metal frame structure;

wherein each pocket comprises an arcuate portion longitudinally spaced from the inflow edge of the tubular member and having a continuous arc extending from the respective first side edge portion to the respective second side edge portion;

wherein each pocket is configured to stop a flow of blood.

16. The prosthetic heart valve of claim 15, wherein the tubular member covers the inflow edge of the metal frame structure.

17. The prosthetic heart valve of claim 15, wherein the tubular member overlaps the inflow edge of the metal frame structure.

18. The prosthetic heart valve of claim 15, wherein the first and second material layers comprise different materials.

19. The prosthetic heart valve of claim 15, wherein the first and second material layers comprise the same material.

20. The prosthetic heart valve of claim 15, wherein the prosthetic heart valve has a one way fluid passage extending from the inflow edge of the metal frame structure to the outflow edge of the metal frame structure.