Systems, dies, and methods for processing pericardial tissue

• US 9,358,107 B2
• Filed: 06/29/2012
• Issued: 06/07/2016
• Est. Priority Date: 06/30/2011
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Nguyen, Oanh H., Jankovic, Ivan, Nguyen-Thien-Nhon, Diane, Velez, Juan C., Boomgarden, Jon
• Primary Examiner(s): Michalski, Sean
• Assistant Examiner(s): Riley, Jonathan
• Application Number:
  US13/538,684
• Publication Number:
  US 20130012767A1
• Time in Patent Office: 1,439 Days
• Field of Search: 606/167
• US Class Current: 1/1
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2472 Devices for testing
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: Y10T 83/0405 With preparatory or simultaneous ancillary treatment of work

Claims

1. A method of assessing and cutting sheet bioprosthetic tissue, comprising:

positioning a die-cut assembly over the bioprosthetic tissue, the die-cut assembly including a die having a plate, a die pattern, and an opening, the die pattern attached to the plate, the opening formed in the plate to provide access to the bioprosthetic tissue;

measuring a thickness of the tissue through the opening;

selecting a section of the bioprosthetic tissue, based on the thickness measurement of the tissue; and

cutting the bioprosthetic tissue with the die.

2. The method of claim 1, wherein the die includes a plurality of openings, and the step of measuring comprises measuring the thickness of the tissue through each of the openings.

3. The method of claim 2, wherein the step of measuring the thickness of the tissue through each of the plurality of openings comprises simultaneously performing the measurements.

4. The method of claim 2, wherein the step of measuring the thickness of the tissue through each of the three openings comprises sequentially performing measurements through the plurality of openings.

5. The method of claim 1, wherein:

the die-cut assembly further comprises a shield including a window, and the step of positioning comprises positioning the shield between the die and the bioprosthetic tissue, wherein the die is disposed in the window.

6. The method of claim 5, wherein the shield provides a clearance between the die pattern and the bioprosthetic tissue.

7. A method for assessing and cutting heart valve leaflets from sheet bioprosthetic tissue, comprising:

positioning a die-cut assembly over a sheet of bioprosthetic tissue, the die-cut assembly including a leaflet cutting die and an opening formed therethrough to provide access to the bioprosthetic tissue, the leaflet cutting die being elevated above the tissue;

horizontally displacing the sheet of bioprosthetic tissue until a target area is underneath the die-cut assembly;

measuring a thickness of the tissue through the opening through the leaflet cutting die;

determining if the thickness of the tissue in the target area is suitable for the leaflet; and

lowering the die-cut assembly to cut the bioprosthetic tissue with the leaflet cutting die.

8. The method of claim 7, wherein the die-cut assembly is elevated by a shield, supporting the leaflet cutting die over the tissue and including a window sized larger than the opening to avoid interfering with measuring the thickness of the tissue through the opening.

9. The method of claim 7, wherein the die-cut assembly is mounted on an automated elevation system that can raise or lower the assembly to various heights, and the step of lowering is done by the automated elevation system.

10. The method of claim 9, wherein the sheet of bioprosthetic tissue is placed on a platen displaceable by an automated horizontal movement system.

11. The method of claim 7, wherein the opening through the die-cut assembly permits passage of a vertically movable probe of a distance measurement gauge, and the step of measuring is done with the gauge.

12. The method of claim 11, wherein the distance measurement gauge has a plurality of vertically movable probes each of which is aligned to pass through an opening in the die-cut assembly.

13. The method of claim 12, wherein each of the vertically movable probes is connected to provide an indication of the thickness of the tissue, and the assembly further includes an indicator panel that displays the indication of tissue thickness from each of the probes, the step of determining including monitoring the indicator panels.