Systems for assessing and cutting bioprosthetic tissue

Patent metadata

Field	Value
Publication number	US-11517427-B2
Application number	US-202117390130-A
Country	US
Kind code	B2
Filing date	Jul 30, 2021
Priority date	Jun 30, 2011
Publication date	Dec 6, 2022
Grant date	Dec 6, 2022

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 die 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.

First claim

What is claimed is:

1. A system for assessing and cutting sheet bioprosthetic tissue, comprising:
a flat platen on which a sheet of bioprosthetic tissue may be supported;
a measurement and cutting head mounted above the platen having a vertically-movable die for cutting bioprosthetic tissue on the platen, the die having a sharp die cutting pattern defining an opening within an outer boundary, the measurement and cutting head comprising an automated elevation system that can raise or lower the die to various heights relative to the platen and a distance measurement gauge with a vertically movable probe adapted to pass through the opening and measure the thickness of the bioprosthetic tissue on the platen;
an indicator panel that displays the indication of tissue thickness from the probe; and
a die control for lowering the die and cut bioprosthetic tissue on the platen.

2. The system of claim 1 , wherein the die includes a plate defining a plurality of the openings within the outer boundary.

3. The system of claim 2 , wherein the distance measurement gauge has a plurality of the vertically movable probes each of which is aligned with one of the openings, and the indicator panel displays the indication of tissue thickness from all of the probes.

4. The system of claim 1 , wherein the distance measurement gauge has a plurality of the vertically movable probes which are aligned to pass simultaneously through the opening within the outer boundary, and the indicator panel displays the indication of tissue thickness from all of the probes.

5. The system of claim 4 , wherein the indicator panel has a plurality of LED indicators, one for each probe, and the indicator panel is calibrated to illuminate each LED with a particular color when the associated probe measures the tissue thickness within a predetermined desirable range.

6. The system of claim 1 , wherein the vertically movable probe is weighted and configured to be dropped from a predetermined height so as to compress the bioprosthetic tissue, and the distance measurement gauge is calibrated to leave the probe in a dropped position for a predetermined time period prior to measuring the thickness of the tissue with the probe.

7. The system of claim 6 , wherein the vertically movable probe is stainless steel with a circular foot that contacts the bioprosthetic tissue.

8. The system of claim 1 , further including an automated movement system adapted to displace the platen horizontally in two axes under the measurement and cutting head.

9. The system of claim 8 , wherein the automated movement system is adapted to displace the platen in three axes.

10. The system of claim 1 , wherein the die cutting pattern is in the shape of a heart valve leaflet, and there are at least three of the vertically movable probes.

11. A system for assessing and cutting sheet bioprosthetic tissue, comprising:
a flat platen on which a sheet of bioprosthetic tissue may be supported;
a measurement and cutting head mounted above the platen having a vertically-movable die for cutting bioprosthetic tissue on the platen, the die having a sharp die cutting pattern defining an opening within an outer boundary, the measurement and cutting head comprising a plurality of vertically movable probes each adapted to pass through the opening and measure the thickness of the bioprosthetic tissue on the platen;
an indicator panel that displays the indication of tissue thickness from the probes, wherein the indicator panel is calibrated to provide a positive indication when each probe measures the tissue thickness within a predetermined desirable range; and
a die control for lowering the die and cut bioprosthetic tissue on the platen.

12. The system of claim 11 , wherein the die includes a plate defining a plurality of the openings within the outer boundary.

13. The system of claim 12 , wherein the each of the vertically movable probes is aligned with one of the openings.

14. The system of claim 11 , wherein the opening is large enough for all of the vertically movable probes to pass simultaneously therethrough.

15. The system of claim 11 , wherein the indicator panel has a plurality of LED indicators, one for each probe, and the indicator panel is calibrated to illuminate each LED with a particular color when the associated probe measures the tissue thickness within the predetermined desirable range.

16. The system of claim 11 , wherein the vertically movable probes are weighted and configured to be dropped from a predetermined height so as to compress the bioprosthetic tissue, and the distance measurement gauge is calibrated to leave the probe in a dropped position for a predetermined time period prior to measuring the thickness of the tissue with the probe.

17. The system of claim 16 , wherein the vertically movable probe is stainless steel with a circular foot that contacts the bioprosthetic tissue.

18. The system of claim 11 , further including an automated movement system adapted to displace the platen horizontally in two axes under the measurement and cutting head.

19. The system of claim 18 , wherein the automated movement system is adapted to displace the platen in three axes.

20. The system of claim 18 , wherein the measurement and cutting head comprises an automated elevation system that can raise or lower the die to various heights relative to the platen.

21. The system of claim 11 , wherein the die cutting pattern is in the shape of a heart valve leaflet, and there are at least three of the vertically movable probes.

Assignees

• Edwards Lifesciences Corp

Inventors

• Nguyen Oanh H
• Jankovic Ivan
• Nguyen-Thien-Nhon Diana
• Velez Juan C
• Boomgarden Jon

Classifications

• A61F2/2415 Primary

  Manufacturing methods · CPC title

• A61F2240/001

  Designing or manufacturing processes · CPC title

• Y10T83/0405

  With preparatory or simultaneous ancillary treatment of work · CPC title

• A61F2/2472 Primary

  Devices for testing · CPC title

• A61F2/24

  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 title