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

• US 20070233228A1
• Filed: 03/28/2007
• Published: 10/04/2007
• Est. Priority Date: 03/28/2006
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Eberhardt, Carol Elsa, Shay, Janice Lynn
• Granted Patent: US 8,075,615 B2
• Time in Patent Office: Days
• US Class Current: 623/1.130
• 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 stented heart valve comprising:

a compressible and expandable stent structure comprising 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; and

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;

wherein at least a portion of the valve segment is positioned within at least a portion of the stent structure, and wherein the stent structure is attached to the outer layer of the valve segment at one or more of the first and second ends of the stent structure.

2. The prosthetic valve of claim 1, wherein the dual-layer sheet comprises a single sheet of material folded to provide a fold line along a first edge of the sheet, wherein the material on one side of the fold line comprises the outer layer of the dual-layer sheet and the material on the opposite side of the fold line comprises the inner layer of the dual-layer sheet.

3. The prosthetic valve of claim 2, wherein the inner layer of the dual-layer sheet has less surface area than the outer layer of the dual-layer sheet.

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

5. The prosthetic valve of claim 1, wherein the compressed outer periphery of the stent structure is configured for surgical sutureless insertion and implantation in an anatomical structure of a patient.

6. The prosthetic valve of claim 1, wherein the compressed outer periphery of the stent structure is configured for apical insertion and implantation in an anatomical structure of a patient.

7. The prosthetic valve of claim 1, wherein the dual-layer sheet further comprises multiple layers of material that are attached to each other along multiple longitudinally extending seams.

8. The prosthetic valve of claim 7, wherein each of the multiple layers of material comprises a leaflet 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.

9. The prosthetic valve of claim 1, further comprising 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.

10. The prosthetic valve of claim 9, wherein the at least one opening in the outer layer of the dual-layer sheet comprises:

a first opening that is configured for fluid communication with a right coronary artery when the prosthetic valve is positioned in the ascending aorta of a heart; and

a second opening spaced circumferentially from the first opening for fluid communication with a left coronary artery when the prosthetic valve is positioned in the ascending aorta of the heart.

11. The prosthetic valve of claim 9, wherein a first circumferential portion of the outer layer of the dual-layer sheet extends between the first end of the stent structure and the at least one opening, and wherein a second circumferential portion of the outer layer of the dual-layer sheet extends between the second end of the stent structure and the at least one opening.

12. The prosthetic valve of claim 1, wherein the leaflet defining pattern comprises at least a first leaflet-defining seam spaced from a second leaflet-defining seam.

13. The prosthetic valve of claim 12, wherein the first leaflet-defining seam is generally parallel to the second leaflet-defining seam to provide a leaflet having generally parallel sides.

14. The prosthetic valve of claim 12, wherein the first leaflet-defining seam is angled relative to the second leaflet-defining seam to provide a generally funnel-shaped leaflet.

15. The prosthetic valve of claim 12, further comprising at least a third leaflet-defining seam spaced from the second leaflet-defining seam, wherein the third leaflet-defining seam generally coincides with the longitudinally extending seam.

16. A prosthetic heart valve comprising:

a valve segment comprising a dual-layer sheet formed into a generally tubular shape having at least one longitudinally extending seam, 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, a first opening in the outer layer of the dual-layer sheet that is configured for fluid communication with a right coronary artery when the prosthetic valve is positioned in the ascending aorta of a heart, and a second opening in the outer layer of the dual-layer sheet that is spaced circumferentially from the first opening for fluid communication with a left coronary artery when the prosthetic valve is positioned in the ascending aorta of the heart.

17. The prosthetic heart valve of claim 16, further comprising a compressible and expandable stent structure comprising 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, wherein at least a portion of the valve segment is positioned within at least a portion of the stent structure, and wherein the stent structure is attached to the outer layer of the valve segment at one or more of the first and second ends of the stent structure.

18. A method of manufacturing a prosthetic heart valve for percutaneous delivery and implantation at an implantation location of a patient, the method comprising the steps of:

providing a dual-layer sheet of material;

attaching an inner layer of the dual-layer sheet to an outer layer of the dual-layer sheet in a leaflet defining pattern;

forming the dual-layer sheet into a tubular valve segment, with the inner layer of the dual-layer sheet facing toward the center of the segment;

positioning the tubular valve segment at least partially within a compressible and expandable stent structure comprising 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; and

attaching the tubular valve segment to the stent structure at one or more of the first and second ends of the stent structure.

19. The method of claim 18, wherein the implantation location is the ascending aorta of a heart.

20. The method of claim 19, wherein the tubular valve segment further comprises:

a first opening in the outer layer of the dual-layer sheet that is configured for fluid communication with a right coronary artery when the prosthetic valve is positioned in the ascending aorta of the heart; and

a second opening in the outer layer of the dual-layer sheet spaced circumferentially from the first opening for fluid communication with a left coronary artery when the prosthetic valve is positioned in the ascending aorta of the heart.