DEVICE FOR IN VIVO DELIVERY OF BIOACTIVE AGENTS AND METHOD OF MANUFACTURE THEREOF
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.
1 . An implantable body, comprising:
a. a plurality of metal structural elements interconnected by a plurality of hinge regions, the plurality of hinge regions joining adjacent structural elements and having a lumen and a tubular wall circumferentially surrounding the lumen;
b. a plurality of openings passing through the tubular wall and in fluid flow communication with the lumen of at least some of the plurality of hinge regions; and
c. a bioactive agent disposed within the lumen of at least some of the plurality of hinge regions and capable of being eluted therefrom through one or more of the plurality of openings.
2 . The implantable body of claim 1 , wherein the lumen of the plurality of hinge regions is continuous along substantially the entire longitudinal axis of the plurality of hinge regions.
3 . The implantable body of claim 1 , wherein the lumen of at least some of the plurality of hinge regions further comprises plural discontinuous lumens separated by one or more separation members.
4 . The implantable body of claim 1 , wherein the plurality of metal structural elements are interconnected to the plurality of hinge regions by at least one weld.
5 . The implantable body of claim 1 , wherein a first discontinuous lumen contains a first bioactive agent and a second discontinuous lumen contains a second bioactive agent.
6 . The implantable body of claim 6 , 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 implantable body of claim 6 , 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 implantable body of claim 1 , wherein the plurality of metal structural elements 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 implantable body of claim 1 , wherein the plurality of openings are distributed unequally on the plurality of hinge regions.
10 . The implantable body of claim 1 , wherein the plurality of metal structural elements are generally sinusoidal metal tubular windings.
11 . The implantable body 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 implantable body of claim 1 , wherein the bioactive agent further comprises a carrier.
13 . The implantable body of claim 1 , wherein the bioactive agent comprises more than one compound.
14 . The implantable body of claim 1 , wherein the plurality of openings are occluded by degradable plugs.
15 . The implantable body of claim 14 , wherein the degradable plugs degrade at different rates.
16 . The implantable body of claim 1 , wherein the plurality of metal structural elements comprise a plurality of sinusoidal windings forming wall surfaces of the implantable body, some of the sinusoidal windings being welded to the plurality of hinge regions.
17 . The implantable body of claim 16 , wherein the sinusoidal windings and the plurality of hinge regions form a cylindrical conformation.