Tissue attachment devices and methods for prosthetic heart valves

• US 8,696,743 B2
• Filed: 04/16/2009
• Issued: 04/15/2014
• Est. Priority Date: 04/23/2008
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Holecek, Arin N., Majkrzak, Carolyn, Eberhardt, Carol E., Millwee, Billie J., Nguyen, Thao M., Shay, Janice L., Chiu, Cynthia H., Kupumbati, Tara S.
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): Mathew, Seema
• Application Number:
  US12/424,768
• Publication Number:
  US 20100023120A1
• Time in Patent Office: 1,825 Days
• Field of Search: 623 217- 219, 623/1.24, 623/1.26, 623/2.1
• US Class Current: 623/2.12
• 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 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

Abstract

A multi-leaflet valve, which includes at least two leaflets, an outer tube, and a seam protector for each seam. Each seam protector is positioned to be in contact with a portion of the outer tube, with tube portions and leaflet ends being positioned between adjacent seam protection pieces. The seam protectors provide a lower stress surface about which the leaflets can bend or flex during their opening and closing. The seam protectors may include an enlarged end portion with an extending straight surface, an inverted U-shaped structure, or a sinusoidal-shaped structure, for example. The valve can further be provided with a seam cover or protector that is stitched onto the seam allowance of the layers of one or more of the seams. The seams can be provided with one or more inserts to fill spaces between adjacent tissue layers and create tension in certain material sheets.

Claims

1. A multi-leaflet heart valve defining a lumen, the heart valve comprising;

a first leaflet having first and second sides;

a second leaflet having first and second sides, wherein the first side of an end portion of the first leaflet is adjacent to the first side of an end portion of the second leaflet;

a first outer tube layer having first and second sides, wherein the first side of an end portion of the first outer tube layer is adjacent to the second side of the end portion of the first leaflet;

a second outer tube layer having first and second sides, wherein the first side of an end portion of the second outer tube is adjacent to the second side of the end portion of the second leaflet; and

a first seam protector adjacent to and lying along at least a portion of the surface of the second side of the first outer tube layer;

wherein the first seam protector comprises a first curved surface facing the lumen of the heart valve, the first curved surface being positioned along a line about which the first leaflet will flex;

wherein the first seam protector comprises an enlarged cylindrical portion and an extending linear portion, wherein the cylindrical portion defines the first curved surface.

2. The valve of claim 1, further comprising a second seam protector;

wherein the second seam protector is adjacent to the first seam protector;

wherein the second seam protector is adjacent to and lying along at least a portion of the surface of the second side of the second outer tube layer; and

wherein the second seam protector comprises a second curved surface facing the lumen of the heart valve, the second curved surface being positioned along a line about which the second leaflet will flex.

3. The valve of claim 2, wherein each of the first and second seam protectors comprises a first end, a second end, and multiple sewing holes, wherein the sewing holes are sized and spaced between the first and second ends of the seam protector at a predetermined distance from first and second flexure lines about which the first and second leaflets will open and close, respectively.

4. The valve of claim 1, further comprising a third leaflet, wherein the valve comprises three seams.

5. The valve of claim 1, wherein at least one of the first and second leaflets and the first and second outer tube layers comprise a sheet of pericardial material.

6. The valve of claim 1, wherein the first seam protector is at least slightly more rigid than each of the first and second leaflets and the first and second outer tube layers.

7. The valve of claim 6, wherein the first seam protector comprises at least one of silicone, reinforced silicone, and plastic.

8. The valve of claim 7, wherein each of the first and second leaflets and the first and second outer tube layers is formed from one of a sheet of pericardium material, a polymer film, and a bio-engineered film.

9. The valve of claim 1, further comprising:

a third leaflet having first and second sides, wherein the first side of an end portion of the second leaflet is adjacent to the first side of an end portion of the third leaflet;

a third outer tube layer having first and second sides, wherein the first side of an end portion of the third outer tube layer is adjacent to the second side of the end portion of the third leaflet; and

a third seam protector adjacent to and lying along at least a portion of the surface of the second side of the second outer tube layer.

10. A prosthetic heart valve defining a lumen, the heart valve comprising:

a first tissue layer having first and second sides;

a second tissue layer having first and second sides, wherein the first side of the first tissue layer is adjacent to the first side of the second tissue layer to form a seam of the heart valve; and

a first seam protector adjacent to and lying along at least a portion of the surface of the second side of the second tissue layer, the first seam protector comprising a first enlarged cylindrical portion and a first extending linear portion, wherein the first cylindrical portion defines a first curved surface facing the lumen of the heart valve and positioned along a line about which the second tissue layer flexes.

11. The heart valve of claim 10, further comprising a second seam protector, the first and second tissue layers being positioned between the first and second seam protectors.

12. The heart valve of claim 11, wherein the second seam protector comprises a second enlarged cylindrical portion and a second extending linear portion, wherein the second cylindrical portion defines a second curved surface facing the lumen of the heart valve.

13. The heart valve of claim 10, wherein the first seam protector comprises a first end, a second end, and multiple sewing holes, wherein the sewing holes are sized and spaced between the first and second ends of the first seam protector at a predetermined distance from a flexure line about which the second tissue layer will flex.

14. The heart valve of claim 10, wherein the first seam protector is at least slightly more rigid than each of the first and second tissue layers.

15. The heart valve of claim 14, wherein the first seam protector comprises at least one of silicone, reinforced silicone, and plastic.

16. The heart valve of claim 10, wherein each of the first and second tissue layers comprises pericardium.