ENDOLUMINAL DEVICE FOR IN VIVO DELIVERY OF BIOACTIVE AGENTS

• US 20100274347A1
• Filed: 07/15/2010
• Published: 10/28/2010
• Est. Priority Date: 11/17/2000
• Status: Active Grant

• Current Assignee: Vactronix Scientific, LLC
• Original Assignee: Advanced Bio Prosthetic Surfaces, Ltd.
• Inventors: Boyle, Christopher T.
• Granted Patent: US 8,128,690 B2
• Time in Patent Office: Days
• US Class Current: 623/1.150
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61M 31/00 Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008

Abstract

The present invention consists of an implantable structural element for in vivo delivery of bioactive active agents to a situs in a body. The implantable structural element may be configured as an implantable prosthesis, such as an endoluminal stent, cardiac valve, osteal implant or the like, which serves a dual function of being prosthetic and a carrier for a bioactive agent. Alternatively, the implantable structural element may simply be an implantable article that serves the single function of acting as a time-release carrier for the bioactive agent.

Claims

1. An endoluminal stent, comprising:

a. at least one tubular element having an external surface, an internal surface, a wall thickness intermediate the external and internal surfaces that is substantially uniform about the transverse cross section of the tubular element, and an internal cavity concentric with the tubular element along a longitudinal axis of the tubular element;

b. a plurality of pores passing through the wall thickness distributed about the entire circumference of the tubular element that permit generally omnidirectional fluid flow therethrough from the internal cavity; and

c. a bioactive agent disposed within the internal cavity that elutes from the internal cavity through at least some of the plurality of pores;

d. wherein the at least one tubular element is configured to form structural members of the endoluminal stent.

2. The endoluminal stent of claim 1, wherein the at least one tubular element further comprises plural tubular elements operably associated with one another in such a manner as to permit diametric expansion of the endoluminal stent.

3. The endoluminal stent of claim 2, wherein the plural tubular elements are in a configuration selected from the group consisting of a grid configuration, a mesh configuration, and a braided configuration.

4. The endoluminal stent of claim 1, wherein the internal cavity further comprises plural cavities that are discontinuous along the longitudinal axis of the at least one tubular element.

5. The endoluminal stent of claim 4, wherein the discontinuous cavities are separated by one or more separation members.

6. The endoluminal stent of claim 5, wherein at least one of the discontinuous cavities contains a bioactive agent.

7. The endoluminal stent of claim 6, wherein a first discontinuous cavity contains a first bioactive agent and a second discontinuous cavity contains a second bioactive agent.

8. The endoluminal stent of claim 7, wherein the first discontinuous cavity and the second discontinuous cavity deliver the respective bioactive agents at different times or rates.

9. The endoluminal stent of claim 1, wherein the at least one tubular element is fabricate of a biocompatible material selected from the group consisting of titanium, vanadium, aluminum, nickel, tantalum, zirconium, chromium, silver, gold, silicon, magnesium, niobium, scandium, platinum, cobalt, palladium, manganese, molybdenum and alloys thereof, such as zirconium-titanium tantalum alloys, nitinol, and stainless steel.

10. The endoluminal stent of claim 1, wherein the pores are distributed unequally on the at least one tubular element.

11. The endoluminal stent of claim 10, wherein the pores are distributed predominantly toward at least one of a proximal and distal end of the endoluminal stent.

12. The endoluminal stent of claim 1, wherein the bioactive agent comprises a compound selected from the group consisting of antibiotic drugs, antiviral drugs, neoplastic agents, steroids, fibronectin, anti-clotting drugs, anti-platelet function drugs, drugs which prevent smooth muscle cell growth on inner surface wall of vessel, heparin, heparin fragments, aspirin, coumadin, tissue plasminogen activator (TPA), urokinase, hirudin, streptokinase, antiproliferatives (methotrexate, cisplatin, fluorouracil, Adriatnycin), antioxidants (ascorbic acid, beta carotene, vitamin E), antimetabolites, thromboxane inhibitors, non-steroidal and steroidal anti-inflammatory drugs, immunosuppresents, such as rapomycin, beta and calcium channel blockers, genetic materials including DNA and RNA fragments, complete expression genes, antibodies, lymphokines, growth factors (vascular endothelial growth factor (VEGF) and fibroblast growth factor (FGF)), prostaglandins, leukotrienes, laminin, elastin, collagen, nitric oxide (NO), and integrins.

16. The endoluminal stent of claim 1, wherein one or more of the pores are occluded by degradable plugs.

17. The endoluminal stent of claim 16, wherein the degradable plugs degrade at different rates.

13. The endoluminal stent of claim 13, wherein the bioactive agent further comprises a carrier.

15. The endoluminal stent of claim 13, wherein the bioactive agent comprises more than one compound.

14. The endoluminal stent of claim 14, wherein the bioactive agent further comprises an ingredient selected from the group consisting of antioxidants, stabilizing agents, and permeation enhancers.