Bioprosthetic tissue for use as a prosthetic valve leaflet and method of preparing

• US 9,968,447 B2
• Filed: 01/22/2016
• Issued: 05/15/2018
• Est. Priority Date: 01/22/2016
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: McKinley, Laura, Wong, Benjamin, Wang, Wei, Howard, Elliot, Tien, Tracey, Olney, Karl, Dudney, Joshua
• Primary Examiner(s): Stewart, Alvin
• Application Number:
  US15/004,086
• Publication Number:
  US 20170209262A1
• Time in Patent Office: 844 Days
• Field of Search: 623 128, 623 132, 623 2374, 623 124, 623 126, 623 214, 623 2364, 623 2368, 623 218
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2240/004 Using a positive or negative model, e.g. moulds
• CPC Class Codes: A61F 2250/0015 differing in density or specific weight
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0036 differing in thickness
• CPC Class Codes: A61L 2430/20 for reconstruction of the heart, e.g. heart valves
• CPC Class Codes: A61L 27/36 containing ingredients of undetermined constitution or reaction products thereof , e.g. transplant tissue, natural bone, extracellular matrix isolated natural compounds, e.g. collagen A61L27/24
• CPC Class Codes: A61L 27/3691 characterised by physical conditions of the treatment, e.g. applying a compressive force to the composition, pressure cycles, ultrasonic/sonication or microwave treatment, lyophilisation

Abstract

Methods of preparing a sheet of bioprosthetic tissue for use as a prosthetic valve leaflet are disclosed. A method includes positioning a sheet of bioprosthetic tissue across an engagement face of a first patterned substrate. The engagement face defines a pattern having at least one raised region and areas of relief adjacent the at least one raised region. The tissue is compressed against the engagement face to deform the tissue to a deformed state corresponding with the pattern.

Claims

1. A method of preparing a sheet of bioprosthetic tissue for use as a prosthetic valve leaflet, comprising:

positioning a sheet of bioprosthetic tissue across an engagement face of a first patterned substrate, the engagement face defining a pattern having at least one raised region and areas of relief adjacent the at least one raised region, wherein the areas of relief define openings extending from the engagement face to a face opposite the engagement face; and

compressing the tissue against the engagement face to deform the tissue to a deformed state corresponding with the pattern.

2. The method of claim 1, wherein the step of positioning includes bringing a first major surface of the sheet of bioprosthetic tissue into contact with the engagement face, and further wherein the step of compressing the tissue includes imparting a pattern into the first major surface corresponding with the pattern of the engagement face.

3. The method of claim 1, wherein the deformed state of the tissue includes regions of reduced thickness corresponding to the at least one raised region.

4. The method of claim 3, wherein the deformed state includes the sheet of tissue being more readily folded along the regions of reduced thickness as compared to other regions of the sheet of tissue.

5. The method of claim 1, further comprising:

positioning a second patterned substrate against the tissue opposite the first patterned substrate.

6. The method of claim 5, wherein the step of compressing further includes:

compressing the tissue between the first and second patterned substrates to deform opposing surfaces of the tissue.

7. The method of claim 1, wherein the step of compressing the tissue against the first patterned substrate includes applying a suction force to the tissue to pull the tissue toward the first patterned substrate.

8. The method of claim 1, wherein after the step of compressing, the method further comprising:

pulling a fixative fluid through the tissue to fixate the deformed surface of the tissue.

9. The method of claim 1, wherein after the step of compressing, the method further comprising:

treating the tissue with a fixative to fixate the tissue in the deformed state.

10. The method of claim 1, further comprising:

heating the tissue to locally thin the tissue at select regions.

11. A method of preparing a sheet of bioprosthetic tissue, comprising:

extending a sheet of tissue across a patterned surface of a first substrate;

removably securing the sheet of tissue to the patterned surface;

applying a force to press the tissue against the patterned surface to compress the tissue and reduce tissue thickness in select areas corresponding to the patterned surface; and

treating the tissue with a fixative,

wherein the application of force is facilitated by a vacuum source.

12. The method of claim 11, further comprising:

positioning a second substrate against the sheet of tissue opposite the first substrate;

compressing the tissue between the first and second substrates to deform opposing surfaces of the tissue.

13. The method of claim 11, further comprising:

cutting the tissue to form a leaflet of a prosthetic valve after treating the tissue.

14. The method of claim 11, wherein treating the tissue with the fixative includes passing the fixative through the tissue.

15. The method of claim 11, further comprising:

applying a heating element to the tissue to locally thin the tissue at select regions.