Bioprosthetic tissue repair and reinforcement

• US 10,299,916 B2
• Filed: 12/19/2016
• Issued: 05/28/2019
• Est. Priority Date: 01/07/2016
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Tien, Tracey, Eberhardt, Carol, Garde, Kshitija, Wong, Benjamin, Wang, Wei, Howard, Elliot, McKinley, Laura, Olney, Karl, Winters, Taylor
• Primary Examiner(s): Stewart, Alvin J
• Application Number:
  US15/383,077
• Publication Number:
  US 20170196686A1
• Time in Patent Office: 890 Days
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61L 24/06 obtained by reactions only involving carbon-to-carbon unsaturated bonds A61L24/043, A61L24/046 take precedence
• CPC Class Codes: A61L 24/108 Specific proteins or polypeptides not covered by groups A61L24/102 - A61L24/106
• CPC Class Codes: A61L 2430/20 for reconstruction of the heart, e.g. heart valves
• CPC Class Codes: A61L 2430/40 Preparation and treatment of biological tissue for implantation, e.g. decellularisation, cross-linking
• CPC Class Codes: A61L 27/26 Mixtures of macromolecular compounds
• CPC Class Codes: A61L 27/3625 Vascular tissue, e.g. heart valves
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 27/507 for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062
• CPC Class Codes: C08L 35/04 Homopolymers or copolymers of nitriles C08L35/06, C08L35/08 take precedence
• CPC Class Codes: C09J 189/00 Adhesives based on proteins; Adhesives based on derivatives thereof
• CPC Class Codes: C09J 4/00 Adhesives based on organic non-macromolecular compounds having at least one polymerisable carbon-to-carbon unsaturated bond ; adhesives, based on monomers of macromolecular compounds of groups C09J183/00 - C09J183/16

Abstract

A method of reinforcing or repairing a bioprosthetic tissue for use as a prosthetic valve leaflet. The method includes evaluating a bioprosthetic tissue, identifying a defect in the bioprosthetic tissue, and selectively applying an adhesive to a surface of the bioprosthetic tissue at the defect prior to implantation in a patient.

Claims

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

evaluating a bioprosthetic tissue, the bioprosthetic tissue comprised of harvested naturally occurring tissue or synthetic material;

identifying at least one defect in the bioprosthetic tissue; and

selectively applying an adhesive to a surface of the bioprosthetic tissue at the at least one defect to locally reinforce or repair the bioprosthetic tissue prior to assembling the tissue into a prosthetic valve.

2. The method of claim 1, wherein the step of selectively applying includes preparing the adhesive by mixing a protein and glutaraldehyde as the adhesive is selectively applied.

3. The method of claim 2, wherein the protein and the glutaraldehyde are separately contained until the adhesive is selectively applied.

4. The method of claim 2, wherein the glutaraldehyde and the protein are mixed in a predetermined ratio.

5. The method of claim 2, wherein the protein is albumin.

6. The method of claim 1, wherein the adhesive is cyanoacrylate.

7. The method of claim 1, wherein the step of selectively applying the adhesive includes filling a fenestration with the adhesive such that the adhesive extends across the fenestration to contact tissue at a perimeter of the fenestration.

8. The method of claim 1, wherein the defect is a separation of tissue layers and the step of selectively applying seals the layers together.

9. The method of claim 1, further comprising after the step of selectively applying the adhesive:

assembling the tissue into a prosthetic valve, including suturing the bioprosthetic valve leaflets to a valve frame; and

selectively applying the adhesive to the leaflets at suturing sites.

10. The method of claim 1, wherein the adhesive includes collagen.

11. The method of claim 1, wherein the adhesive is synthetic.

12. A valve assembly, comprising:

a valve frame; and

prosthetic valve leaflets formed of bioprosthetic tissue assembled to the valve frame with mounting members, the bioprosthetic tissue comprised of harvested naturally occurring tissue or synthetic material, at least one of the prosthetic valve leaflets including a defect and including an adhesive applied at a select area including the defect to locally reinforce or repair the bioprosthetic tissue at the defect, wherein the defect comprises a fenestration or a separation of tissue layers, and wherein the defect is reinforced or repair prior to the prosthetic valve leaflets being assembled to the valve frame.

13. The valve assembly of claim 12, further comprising the adhesive applied to the prosthetic valve leaflet at a select area of penetration openings formed by the mounting members.

14. The valve assembly of claim 13, wherein the adhesive is less than 100 μ

m thick at the penetration openings.

15. The valve assembly of claim 12, wherein the select area has a greater tensile strength than an untreated area of the leaflet.

16. The valve assembly of claim 12, wherein the adhesive is comprised of protein and glutaraldehyde.

17. The valve assembly of claim 16, wherein the protein is albumin.

18. The valve assembly of claim 12, wherein the adhesive is cyanoacrylate.