Bioprosthetic tissue for use in a prosthetic valve

• US 10,660,748 B2
• Filed: 04/27/2018
• Issued: 05/26/2020
• 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, Dudney, Joshua, Tien, Tracey, Olney, Karl
• Primary Examiner(s): Stewart, Alvin J
• Application Number:
  US15/964,403
• Publication Number:
  US 20180243089A1
• Time in Patent Office: 760 Days
• 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

Conditioned bioprosthetic tissues for forming prosthetic valves including a sheet of bioprosthetic tissue having a first major surface and a second major surface. The first major surface has a pattern including at least one depressed region and areas of relief adjacent to the at least one depressed region. The at least one depressed region has a first tissue density that is greater than a second tissue density of the areas of relief.

Claims

1. A conditioned bioprosthetic tissue, comprising:

a sheet of bioprosthetic tissue having a first major surface and a second major surface, wherein the first major surface has a pattern including at least one depressed region and areas of relief adjacent to the at least one depressed region, wherein the at least one depressed region has a first tissue density that is greater than a second tissue density of the areas of relief;

wherein the second major surface has at pattern including at least one depressed region and areas of relief adjacent to the at least one depressed region.

2. The conditioned bioprosthetic tissue of claim 1, wherein the tissue extending between the first major surface and the second major surface has areas of increased tissue density corresponding to the at least one depressed region.

3. The conditioned bioprosthetic tissue of claim 2, wherein the tissue is more readily folded along regions of increased tissue density as compared to other regions of the sheet of bioprosthetic tissue.

4. The conditioned bioprosthetic tissue of claim 1, wherein the pattern of the first major surface including at least one depressed region and areas of relief adjacent to the at least one depressed region is set with a fixative.

5. The conditioned bioprosthetic tissue of claim 1, wherein the at least one depressed region has a first tissue thickness that is less than a second tissue thickness of the areas of relief.

6. A prosthetic valve, comprising:

an expandable frame; and

a valve member including one or more patterned leaflets, the patterned leaflets comprising a first bioprosthetic tissue having a first major surface and a second major surface, wherein the first major surface has a pattern including at least one depressed region and areas of relief adjacent to the at least one depressed region, wherein the at least one depressed region has a first tissue density that is greater than a second tissue density of the areas of relief;

wherein the patterned tissue is more readily folded along depressed regions of tissue compared to other regions of the tissue.

7. The prosthetic valve of claim 6, further comprising a skirt.

8. The prosthetic valve of claim 7, wherein the skirt is patterned.

9. A prosthetic valve, comprising:

an expandable frame; and

a valve member including one or more patterned leaflets, the patterned leaflets comprising a first bioprosthetic tissue having a first major surface and a second major surface, wherein the first major surface has a pattern including at least one depressed region and areas of relief adjacent to the at least one depressed region, wherein the at least one depressed region has a first tissue density that is greater than a second tissue density of the areas of relief;

wherein the patterned tissue comprises a radial pattern projecting from a central point.

10. A prosthetic valve, comprising:

an expandable frame; and

a valve member including one or more patterned leaflets, the patterned leaflets comprising a first bioprosthetic tissue having a first major surface and a second major surface, wherein the first major surface has a pattern including at least one depressed region and areas of relief adjacent to the at least one depressed region, wherein the at least one depressed region has a first tissue density that is greater than a second tissue density of the areas of relief;

wherein the patterned tissue comprises a wavelike pattern.

11. A prosthetic valve, comprising:

an expandable frame;

a patterned skirt; and

a valve member including one or more patterned leaflets, the patterned leaflets comprising a first bioprosthetic tissue having a first major surface and a second major surface, wherein the first major surface has a pattern including at least one depressed region and areas of relief adjacent to the at least one depressed region, wherein the at least one depressed region has a first tissue density that is greater than a second tissue density of the areas of relief;

wherein the patterned skirt comprises a second bioprosthetic tissue having a first major surface and a second major surface, wherein the first major surface has a pattern including at least one depressed region and areas of relief adjacent to the at least one depressed region, wherein the at least one depressed region has a first tissue density that is greater than a second tissue density of the areas of relief.

12. The prosthetic valve of claim 11, wherein the first major surface of the patterned skirt is configured for exposure to blood flow and the second major surface of the patterned skirt is attached against the frame.

13. The prosthetic valve of claim 11, wherein the second bioprosthetic tissue is more readily folded along depressed regions of tissue compared to other regions of tissue.