Self-adjusting tissue holder

• US 10,660,754 B2
• Filed: 06/18/2018
• Issued: 05/26/2020
• Est. Priority Date: 07/23/2014
• Status: Active Grant

• Current Assignee: Clemson University
• Original Assignee: Clemson University
• Inventors: Sierad, Leslie, Pascal, III, Richard, deBorde, Chris, Simionescu, Dan, Simionescu, Agneta
• Primary Examiner(s): Koehler, Christopher M
• Application Number:
  US16/010,889
• Publication Number:
  US 20180296342A1
• Time in Patent Office: 708 Days
• CPC Class Codes: A61F 2/2472 Devices for testing

Abstract

Tissue holders that can be used for gripping natural or synthetic heart valves are described. The tissue holder can include a clamping mechanism and a spring and can be self-adjusting with regard to pressure applied to the tissue gripped in the holder. The tissue holder can be removably attached to systems for processing the tissues and can provide completely hands-free processing of a tissue from development or excisement to implantation and/or completion of testing.

Claims

1. A method for gripping a tissue in a tissue holder, the method comprising:

associating a first portion of the tissue with a first holding plate of the tissue holder, the first holding plate comprising a first side and a second side, the first portion of the tissue being associated with the second side of the first holding plate, the first holding plate defining a primary opening that passes from the first side of the first holding plate to a second side of the first holding plate;

aligning a second holding plate with the first holding plate, the second holding plate defining a primary opening that passes from a first side of the second holding plate to a second side of the second holding plate, the primary opening of the second holding plate and the primary opening of the first holding plate being axially aligned upon the alignment, the second side of the first holding plate and the first side of the second holding plate being adjacent to one another with the first portion of the tissue being held between the second side of the first holding plate and the first side of the second holding plate upon the alignment, a second portion of the tissue extending from the first portion that is held between the first and second holding plates and extending across the primary openings;

tightening a clamping mechanism to apply a clamping force on the tissue first portion that is held between the two holding plates, the clamping force also being applied to a spring that applies a force to either the first holding plate or the second holding plate; and

decellularizing the tissue as it is held in the tissue holder, wherein a thickness of the tissue first portion changes during the decellularization, the clamping mechanism self-adjusting upon the change in thickness and maintaining the clamping force on the tissue first portion during the decellularization.

2. The method of claim 1, wherein the second portion of the tissue comprises a heart valve.

3. The method of claim 2, the tissue further comprising a heart valve root, the method further comprising attaching the heart valve root to a containment aide that is a component of the tissue holder.

4. The method of claim 1, wherein each of the first holding plate and the second holding plate further comprise one or more flow openings.

5. The method of claim 4, wherein the one or more flow openings are adjacent to the primary openings and pass from the first side to the second side of the first and second holding plates, respectively.

6. The method of claim 5, the method further comprising aligning the flow openings of the first holding plate and the second holding plate.

7. The method of claim 4, the method further comprising blocking flow through the flow openings.

8. The method of claim 1, wherein the tissue comprises a synthetic tissue.

9. The method of claim 1, wherein the tissue comprises a natural tissue.

10. The method of claim 1, wherein the spring comprises a coil spring, a leaf spring, or a wave spring.

11. The method of claim 1, wherein cells are seeded on the decellularized tissue.

12. The method of claim 1, wherein the decellularized tissue is subjected to strength testing.

13. The method of claim 1, wherein the primary openings of the first and second holding plates are circular.

14. The method of claim 1, wherein the primary openings of the first and second holding plates are non-circular.

15. The method of claim 1, wherein the first holding plate comprises one or more three dimensional features on the second side of the first holding plate, a first side of the first portion of the tissue contacting the one or more three dimensional features of the first holding plate upon the association.

16. The method of claim 15, wherein the second holding plate comprises one or more three dimensional features on the first side of the second holding plate, a second side of the first portion of the tissue contacting the one or more three dimensional features of the second holding plate upon the association such that the tissue is gripped between the three dimensional features of the first holding plate and the three dimensional features of the second holding plate.

17. A method for gripping a tissue in a tissue holder, the method comprising:

associating a first portion of a tissue with a first holding plate of a tissue holder, the first holding plate comprising a first side and a second side, the first portion of the tissue being associated with the second side of the first holding plate, the first holding plate defining a primary opening that passes from the first side of the first holding plate to a second side of the first holding plate;

aligning a second holding plate with the first holding plate, the second holding plate defining a primary opening that passes from a first side of the second holding plate to a second side of the second holding plate, the primary opening of the second holding plate and the primary opening of the first holding plate being axially aligned upon the alignment, the second side of the first holding plate and the first side of the second holding plate being adjacent to one another with the first portion of the tissue being held between the second side of the first holding plate and the first side of the second holding plate upon the alignment, a second portion of the tissue extending from the first portion that is held between the first and second holding plates and extending across the primary openings; and

tightening a clamping mechanism to apply a clamping force on the tissue first portion that is held between the two holding plates, the clamping force also being applied to a spring that applies a force to either the first holding plate or the second holding plate, the spring comprising a coil spring, a leaf spring, or a wave spring.

18. The method of claim 17, wherein the tissue comprises a synthetic tissue or a natural tissue.

19. The method of claim 17, further comprising decellularizing the tissue as the tissue is gripped in the tissue holder.

20. The method of claim 19, further comprising seeding cells on the decellularized tissue as the tissue is gripped in the tissue holder.