TISSUE ATTACHMENT DEVICES AND METHODS FOR PROSTHETIC HEART VALVES

• US 20100023120A1
• Filed: 04/16/2009
• Published: 01/28/2010
• Est. Priority Date: 04/23/2008
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Shay, Janice L., Majkrzak, Carolyn, Millwee, Billie J., Chiu, Cynthia H., Kupumbati, Tara S., Nguyen, Thao M., Holecek, Arin N., Eberhardt, Carol E.
• Granted Patent: US 8,696,743 B2
• Time in Patent Office: Days
• US Class Current: 623/2.190
• 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 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 layer is adjacent to the second side of the end portion of the second leaflet; and

a first seam protector adjacent to the second side of the first outer tube layer.

2. The valve of claim 1, further comprising a second seam protector adjacent to the second side of the second outer tube layer.

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, wherein the first seam protector comprises a cylindrical portion and an extending linear portion, wherein the cylindrical portion is positioned along a line about which the first leaflet will flex.

5. The valve of claim 1, wherein the first seam protector comprises an inverted U-shaped structure comprising first and second ends, a first U-shaped structure extending from a first end of the inverted U-shaped structure and adjacent to the second side of the first outer tube layer, and a second U-shaped structure extending from a second end of the inverted U-shaped structure and adjacent to the second side of the second outer tube layer.

6. The valve of claim 5, wherein the inverted U-shaped structure of the first seam protector covers the end portions of the first leaflet, the second leaflet, the first outer tube layer, and the second outer tube layer.

7. The valve of claim 5, wherein the first seam protector further includes first support member within an open area of the first U-shaped structure and a second support member within an open area of the second U-shaped structure.

8. The valve of claim 7, wherein the first and second support members each comprise a roll of material.

9. The valve of claim 7, wherein the open areas of the first and second U-shaped structures each comprise a wire and a filler material at least partially surrounding the wire.

10. The valve of claim 1, wherein the first seam protector is further adjacent to the second side of the second outer tube layer, and wherein the first seam protector comprises a wire that is at least partially covered with a layer of material.

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

12. 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.

13. The valve of claim 1, further comprising a first support insert about which the end portion of the first outer tube layer is at least partially wrapped.

14. The valve of claim 13, further comprising a second support insert about which the end portion of the second outer tube layer is at least partially wrapped, and a back panel that is secured to the end portions of the first and second leaflets and to the end portions of the first and second outer tube layers.

15. The valve of claim 14, further comprising a third support insert adjacent to the first and second leaflets and the back panel.

16. The valve of claim 1, wherein the first seam protector comprises a concave structure that at least partially covers the end portions of the first leaflet, the second leaflet, the first outer tube layer, and the second outer tube layer.

17. A multi-leaflet 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 and a free end, 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; and

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

wherein the free end of the first outer tube layer is rolled to form a first coil and the free end of the second outer tube layer is rolled to form a second coil.

18. The valve of claim 17, further comprising a seam extending through the first coil, the second coil, the end portion of the first leaflet, and the end portion of the second leaflet.

19. A multi-leaflet heart valve comprising a tube layer of material and a leaflet layer of material adjacent to the tube layer of material, wherein the tube layer and leaflet layer are folded about a seam line, and wherein the tube layer and leaflet layer are sewn to each other along the seam line.

20. The valve of claim 19, further comprising at least one seam protection element adjacent to the tube layer of material and adjacent to the seam line.