METHODS FOR INHIBITING STENOSIS, OBSTRUCTION, OR CALCIFICATION OF A STENTED HEART VALVE OR BIOPROSTHESIS

• US 20180280573A1
• Filed: 06/04/2018
• Published: 10/04/2018
• Est. Priority Date: 10/22/2012
• Status: Active Grant

• Current Assignee: ConcieValve, LLC
• Original Assignee: ConcieValve, LLC
• Inventors: Rajamannan, Nalini M.
• Granted Patent: US 10,729,811 B2
• Time in Patent Office: Days
• 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61K 31/337 having four-membered rings, e.g. taxol
• CPC Class Codes: A61K 31/40 having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61L 2300/204 with nitrogen-containing functional groups, e.g. aminoxides, nitriles, guanidines
• CPC Class Codes: A61L 2300/21 Acids
• CPC Class Codes: A61L 2300/258 Genetic materials, DNA, RNA, genes, vectors, e.g. plasmids
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 2400/02 Treatment of implants to prevent calcification or mineralisation in vivo
• CPC Class Codes: A61L 2430/20 for reconstruction of the heart, e.g. heart valves
• CPC Class Codes: A61L 27/3625 Vascular tissue, e.g. heart valves
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 31/14 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

Methods for inhibiting stenosis, obstruction and/or calcification of a heart valve following implantation in a vessel having a wall are disclosed. In one aspect the method includes providing a bioprosthetic heart valve mounted on an elastical stent; treating the bioprosthetic heart valve with a tissue fixative; coating the stent and the bioprosthetic valve with a coating composition including one or more therapeutic agents; implanting the bioprosthetic valve into the vessel in a diseased natural valve site; eluting the coating composition from the bioprosthetic valve; and inhibiting stenosis, obstruction and/or calcification of the bioprosthetic heart valve by preventing the attachment of stem cells to the bioprosthetic heart valve, the stem cells circulating external and proximate to the bioprosthetic heart valve by activating nitric oxide production (i) in the circulating stem cells, (ii) in an endothelial cell lining covering the bioprosthetic heart valve tissue, (iii) or both.

Claims

1-16. -16. (canceled)

17. A method for inhibiting stenosis, obstruction and/or calcification of a mechanical heart valve following implantation in a vessel having a wall, said method comprising:

providing a mechanical heart valve having a sewing ring covered by a Gortex material;

coating said mechanical heart valve, said Gortex material, or both with a coating composition comprising one or more therapeutic agents;

implanting said mechanical heart valve into said vessel in the site of a diseased natural valve site;

eluting said coating composition from said mechanical heart valve, said Gortex material or both;

inhibiting stenosis, obstruction and/or calcification of the mechanical heart valve by preventing the attachment of stem cells to the mechanical heart valve or Gortex material, said stem cells circulating external and proximate to the mechanical heart valve by activating nitric oxide production (i) in the circulating stem cells, (ii) in an endothelial cell lining covering the mechanical heart valve and/or Gortex material, (iii) or both.

18. A method for inhibiting stenosis, obstruction and/or calcification of a heart valve following implantation in a vessel having a wall, said method comprising:

providing an unstented surgical heart valve having a sewing ring comprising, said surgical heart valve including tissue having one or more cusps, said surgical heart valve for replacement of a natural diseased valve;

treating said surgical heart valve with a tissue fixative;

coating said surgical heart valve, one or more cusps and/or sewing ring with a coating composition comprising one or more therapeutic agents;

implanting said surgical heart valve into said vessel in a diseased natural valve site;

eluting said coating composition from said sewing ring, one or more cusps, or both;

inhibiting stenosis, obstruction and/or calcification of the surgical heart valve by preventing the attachment of stem cells to the surgical heart valve, said stem cells circulating external and proximate to the surgical heart valve by activating nitric oxide production (i) in the circulating stem cells, (ii) in an endothelial cell lining covering the surgical heart valve, (iii) or both.

19. An apparatus for inhibiting stenosis, obstruction and/or calcification of a heart valve following implantation in a vessel having a wall comprising:

a bioprosthetic heart valve having one or more cusps, said bioprosthetic heart valve mounted on an elastical stent for replacement of a natural diseased valve;

a first coating composition coated on said stent, said one or more cusps or both, said coating composition comprising one or more therapeutic agents,

wherein said coating composition when eluted inhibits stenosis, obstruction and/or calcification of the bioprosthetic heart valve when implanted by preventing the attachment of cKit positive stem cells, SCA1 cells, COP cells, and/or mesenchymal stem cells to the bioprosthetic heart valve by activating nitric oxide production (i) in the circulating stem cells, (ii) in an endothelial cell lining covering the bioprosthetic heart valve tissue, (iii) or both.