Endoluminal device for in vivo delivery of bioactive agents

• US 8,128,690 B2
• Filed: 07/15/2010
• Issued: 03/06/2012
• Est. Priority Date: 11/17/2000
• Status: Expired due to Fees

• Current Assignee: Vactronix Scientific, LLC
• Original Assignee: Advanced Bio Prosthetic Surfaces, Ltd.
• Inventors: Boyle, Christopher T.
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): Miller, Cheryl
• Application Number:
  US12/837,443
• Publication Number:
  US 20100274347A1
• Time in Patent Office: 600 Days
• Field of Search: 623/1.27, 623/1.42, 623/1.43, 623/1.44, 623/1.45, 623/23.64, 623/23.7
• US Class Current: 623/1.42
• 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. A bioactive agent-eluting endoluminal stent, comprising:

a. a plurality of metal tubular structural support members each having a lumen and a tubular wall circumferentially surrounding the lumen, the plurality of metal tubular structural support members being formed into the bioactive agent-eluting endoluminal stent, a plurality of welds joining two adjacent tubular structural support members of the plurality of metal tubular structural support members, and a plurality of non-welded regions separating the plurality of welds;

b. a plurality of openings passing through the tubular wall and in fluid flow communication with the lumen of at least some of the metal tubular structural support members; and

c. a bioactive agent disposed within the lumen of at least some of the plurality of metal tubular structural support members and capable of being eluted therefrom through one or more of the plurality of openings.

2. The bioactive agent-eluting endoluminal stent of claim 1, wherein the lumen of the plurality of metal tubular structural support members is continuous along substantially the entire longitudinal axis of the plurality of metal tubular structural support members.

3. The bioactive agent-eluting endoluminal stent of claim 1, wherein the lumen of at least some of the plurality of metal tubular structural support members further comprises plural discontinuous lumens separated by one or more separation members.

4. The bioactive agent-eluting endoluminal stent of claim 3, wherein the one or more separation members comprise welds.

5. The bioactive agent-eluting endoluminal stent of claim 3, wherein a first discontinuous lumen contains a first bioactive agent and a second discontinuous lumen contains a second bioactive agent.

6. The bioactive agent-eluting endoluminal stent of claim 5, wherein the first discontinuous lumen and the second discontinuous lumen elutes the first bioactive agent and second bioactive active, respectively, at different elution rates.

7. The bioactive agent-eluting endoluminal stent of claim 5, wherein the first discontinuous lumen and the second discontinuous lumen elutes the first bioactive agent and second bioactive active, respectively, at different times.

8. The bioactive agent-eluting endoluminal stent of claim 1, wherein the plurality of metal tubular structural support members are fabricated of a biocompatible material selected from the group of biocompatible materials 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.

9. The bioactive agent-eluting endoluminal stent of claim 1, wherein the plurality of openings are distributed unequally on the plurality of metal tubular structural support members.

10. The bioactive agent-eluting endoluminal stent of claim 1, wherein the plurality of metal tubular structural support members are generally sinusoidal metal tubular windings.

11. The bioactive agent-eluting endoluminal stent of claim 1, wherein the bioactive agent comprises a compound selected from the group of compounds 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, urokinase, hirudin, streptokinase, antiproliferatives, antioxidants, 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 and fibroblast growth factor) prostaglandins, leukotrienes, laminin, elastin, collagen, nitric oxide and integrins.

12. The bioactive agent-eluting endoluminal stent of claim 1, wherein the bioactive agent further comprises a carrier.

13. The bioactive agent-eluting endoluminal stent of claim 1, wherein the bioactive agent comprises more than one compound.

14. The bioactive agent-eluting endoluminal stent of claim 1, wherein the plurality of openings are occluded by degradable plugs.

15. The bioactive agent-eluting endoluminal stent of claim 14, wherein the degradable plugs degrade at different rates.

16. The bioactive agent-eluting endoluminal stent of claim 1, wherein the plurality of metal tubular structural support members comprise a plurality of sinusoidal windings forming wall surfaces of the stent, some of the sinusoidal windings being welded to adjacent sinusoidal windings.