Systems for assessing and cutting pericardial tissue

• US 10,335,271 B2
• Filed: 06/03/2016
• Issued: 07/02/2019
• 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, Diana, Velez, Juan C., Boomgarden, Jon
• Primary Examiner(s): Riley, Jonathan G
• Application Number:
  US15/173,435
• Publication Number:
  US 20160278917A1
• Time in Patent Office: 1,124 Days
• 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

Abstract

Systems, dies, and methods are provided for processing pericardial tissue. The method includes positioning a die-cut assembly over the pericardial tissue, the die-cut assembly including a die having a plate, a the pattern, and an opening, the die pattern attached to the plate, the opening formed in the plate to provide access to the pericardial tissue, and measuring a thickness of the tissue through the opening. The die-cut assembly may be mounted for automated vertical movement, and a platen on which the tissue is placed is capable of automated horizontal movement. Different target areas on the tissue can be assessed by measuring the thickness through the die, and when an area is deemed suitable the die pattern cuts a shape therefrom. The system is useful for cutting uniform thickness heart valve leaflets, and can be automated to speed up the process.

Claims

1. An assembly for assessing and cutting a leaflet of a prosthetic valve from a sheet of bioprosthetic tissue, the assembly comprising:

a flat surface on which a sheet of bioprosthetic tissue may be supported;

a die for cutting the leaflet having a plate and a sharp die cutting pattern resembling the leaflet and defining a boundary, an exposed portion of the sharp die cutting pattern depending downward from the plate;

an opening formed in the die within the boundary of the die cutting pattern; and

a distance measurement gauge having a vertically movable probe that passes through the opening for measuring the thickness of the tissue, wherein the opening through the die permits passage of the vertically movable probe of the distance measurement gauge at different locations within the boundary of the die cutting pattern.

2. The assembly of claim 1, further including a mechanism for elevating the die over the sheet of bioprosthetic tissue on the flat surface comprising a shield including a window sized larger than the die cutting pattern, wherein the shield supports the plate over the tissue and the downwardly depending die cutting pattern is suspended within the window over the tissue.

3. The assembly of claim 1, further including a mechanism for elevating the die over the sheet of bioprosthetic tissue on the flat surface comprises an automated elevation system that can raise or lower the die to various heights.

4. The assembly of claim 3, wherein the die is mounted over a platen having the flat surface on which the tissue is placed, and the platen is displaced by an automated horizontal movement system.

5. The assembly of claim 1, wherein the distance measurement gauge and the die are relatively movable to enable relocation of the vertically movable probe to different locations within the opening.

6. The assembly of claim 1, wherein the distance measurement gauge has a plurality of vertically movable probes each of which is aligned to pass through different locations through the die cutting pattern.

7. The assembly of claim 1, wherein the distance measurement gauge has a plurality of the vertically movable probes each of which is aligned to pass through the opening.

8. The assembly of claim 1, wherein the distance measurement gauge has a plurality of the vertically movable probes, and the assembly further includes an indicator panel that displays the indication of tissue thickness from each of the probes.

9. An assembly for assessing and cutting a leaflet of a prosthetic valve from a sheet of bioprosthetic tissue, the assembly comprising:

a flat surface on which a sheet of bioprosthetic tissue may be supported,

a die for cutting the leaflet having a sharp die cutting leaflet pattern and defining a boundary;

an opening formed in the die within the boundary of the die cutting pattern;

a distance measurement gauge having a probe configured to measure the thickness of the tissue through the opening; and

a mechanism for elevating the die over the sheet of bioprosthetic tissue on the flat surface comprising a shield including a window sized larger than the die cutting pattern, wherein the shield supports the die over the tissue and the downwardly depending die cutting pattern is suspended within the window over the tissue.

10. The assembly of claim 9, wherein the probe is a vertically movable probe configured to measure the tissue from contact therewith, and the opening through the die permits passage of the vertically movable probe of the distance measurement gauge at different locations within the boundary of the die cutting pattern.

11. The assembly of claim 10, wherein the distance measurement gauge and the die are relatively movable to enable relocation of the vertically movable probe to different locations within the opening.

12. The assembly of claim 9, wherein the shield comprises a base formed with two bifurcated prongs and a handle.

13. The assembly of claim 12, wherein the die cutting pattern is embedded within a plate wider than the two bifurcated prongs and has an exposed portion with a sharpened cutting edge that extends from the plate.

14. The assembly of claim 12, wherein the shield is made of stainless steel.