Replacement heart valve leaflet stitching method and device

• US 8,778,020 B2
• Filed: 11/08/2012
• Issued: 07/15/2014
• Est. Priority Date: 11/08/2011
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Gregg, Peter W., Hildebrand, Daniel K.
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): SCHALL, MATTHEW WAYNE
• Application Number:
  US13/671,796
• Publication Number:
  US 20130116778A1
• Time in Patent Office: 614 Days
• Field of Search: 623/2.1, 623 212- 219
• US Class Current: 623/2.13
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

Abstract

A replacement heart valve and stitching method for reducing the unexpanded profile of the replacement heart valve are herein provided. The method includes whip stitching a plurality of leaflets together with a first whip stitch pattern a second whip stitch pattern which overlaps the first whip stitch pattern and is wound in an opposite direction. The method further involves securing the valve leaflets to one another via a running stitch.

Claims

1. A method of forming a replacement heart valve, the method comprising:

providing a plurality of valve leaflets, each leaflet having a side edge;

positioning two of the valve leaflets in facing orientation such that side edges of the leaflets are aligned;

providing a first thread of suture material;

threading the first thread of suture material through the two valve leaflets in a first pattern of whip stitches;

threading the first thread of suture material through the two valve leaflets in a second pattern of whip stitches, wherein the first pattern of whip stitches is threaded in a first direction and the second pattern of whip stitches is threaded in a second direction opposite the first direction;

providing a second thread of suture material;

threading the second thread of suture material through the two valve leaflets in a first running stitch, the first running stitch being parallel to the side edges; and

threading the second thread of suture material through the two valve leaflets in a second running stitch, the second running stitch being parallel to the side edges.

2. The method of claim 1, wherein the plurality of valve leaflets further comprises a third valve leaflet, and the method of forming a replacement heart valve further comprises positioning the third valve leaflet in facing orientation with the two valve leaflets such that side edges of the three valve leaflets are aligned with one another to form a tri-leaflet valve.

3. The method of claim 2, wherein each leaflet comprises a first side edge and a second side edge, the first side edge of a first leaflet being attached to a second side edge of the third leaflet, the second side edge of the first leaflet being attached to the first side edge of the second leaflet, and the second side edge of the second leaflet being attached to the first side edge of the third leaflet.

4. The method of claim 2, wherein the replacement heart valve is attached to an expandable anchor.

5. The method of claim 1, wherein the step of positioning two of the valve leaflets comprises aligning the leaflets with a fixture.

6. The method of claim 5, wherein the fixture defines a plurality of slots along an edge thereof.

7. The method of claim 6 further comprising inserting temporary sutures through the slots and leaflets.

8. The method of claim 7 further comprising removing the fixture and the temporary sutures.

9. The method of claim 5, wherein the fixture defines a hole, and the method comprises the step of marking an initial insertion location for the first thread of suture material with the hole.

10. The method of claim 1, wherein the first thread of suture material has a leading end and a trailing end, and the method comprises tying the leading end and the trialing end of the first thread in a knot.

11. The method of claim 10, wherein the second thread has a leading end and a trailing end, and the method comprises tying the leading and the trialing end of the second thread in a knot.

12. The method of claim 1, wherein the leaflets are formed from synthetic material.

13. The method of claim 1, wherein the leaflets are formed from animal tissue.