Methods for using a stent having nanoporous layers

• US 8,449,602 B2
• Filed: 02/10/2006
• Issued: 05/28/2013
• Est. Priority Date: 11/13/2002
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc), University of Virginia Patent Foundation (University of Virginia)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Lye, Whye-Kei, Owens, Gary K., Wamhoff, Brian R., Hudson, Matthew S., Spradlin, Joshua, Looi, Kareen
• Primary Examiner(s): PELLEGRINO, BRIAN E
• Application Number:
  US11/352,426
• Publication Number:
  US 20060193888A1
• Time in Patent Office: 2,664 Days
• Field of Search: 623/1.39, 623/1.4, 623/1.42, 623/16.11, 623/23.72, 623/23.74, 623/902, 623/903, 623/908, 623/17.11, 623/17.16, 604/8, 604/62
• US Class Current: 623/1.42
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 2400/12 Nanosized materials, e.g. nanofibres, nanoparticles, nanowires, nanotubes; Nanostructured surfaces
• CPC Class Codes: A61L 31/022 Metals or alloys
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61L 31/18 Materials at least partially X-ray or laser opaque
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence

Abstract

Implantable medical devices having at least one porous layer, and methods for making such devices, and loading such devices with therapeutic agents are described. A mixture or alloy is placed on the surface of a medical device, then one component of the mixture or alloy is generally removed without generally removing the other components of the mixture or alloy to create the pores of the porous layer. The porous layer may be adapted for bonding non-metallic coating, including drug eluting polymeric coatings. A porous layer may have a random pore structure or an oriented or directional grain porous structure. The medical device may be a vascular stent having at least one porous layer adapted to resist stenosis or cellular proliferation.

Claims

1. A method for treating a mammal, comprising:

implanting a stent into a lumen in the body of the mammal, the stent comprising a porous metal surface with an outer surface, an interstitial space, a tortuosity factor of greater than about 1.1, an average thickness of less than 10 microns and a peak-valley surface roughness of less than about 2 microns, and a therapeutic agent occupying at least a portion of the interstitial space;

wherein the first therapeutic agent is selected from one of cyclosporine, FK-506, rapamycin, paclitaxel, taxotere, and further including a second therapeutic agent occupying at least a portion of the interstitial space, wherein the second therapeutic agent is ritonavir.

2. The method for treating a mammal as in claim 1, wherein the lumen is a blood vessel.

3. The method for treating a mammal as in claim 1, wherein the lumen is a portion of the gastrointestinal tract.

4. The method for treating a mammal as in claim 1, wherein the lumen is a portion of the genitourinary tract.

5. The method for treating a mammal as in claim 1, further comprising eluting the therapeutic agent.

6. The method for treating a mammal as in claim 5, wherein the implantable device further comprises a polymeric topcoat on an outer surface of the porous surface.

7. The method for treating a mammal as in claim 6, wherein the implantable device further comprises a polymeric elution-rate controlling topcoat on the outer surface of the porous surface.

8. The method for treating a mammal as in claim 5, wherein the implantable device further comprises an eluting rate modifying topcoat on an outer surface of the porous surface.

9. The method for treating a mammal as in claim 8, wherein the eluting rate modifying topcoat comprises a material selected from the group consisting of:

polyurethanes, silicones, polyesters, polyolefins, polyisobutylene, ethylene-alphaolefin copolymers, acrylic polymers and copolymers, vinyl halide polymers and copolymers such as polyvinyl chloride, polyvinyl ethers such as polyvinyl methyl ether, polyvinylidene halides such a polyvinylidene fluoride and polyvinylidene chloride, polyacrylonitrile, polyvinyl ketones, polyvinyl aromatics such as polystyrene, polyvinyl esters such as polyvinyl acetate;

copolymers of vinyl monomers, copolymers of vinyl monomers and olefins such as ethylene-methyl methacrylate copolymers, acrylonitrile-styrene copolymers, ABS resins, ethylene-vinyl acetate copolymers, polyamides such as Nylon 66 and polycaprolactone, alkyd resins, polycarbonates, polyoxymethylenes, polyimides, polyethers, epoxy resins, polyurethanes, rayon-triacetate, cellulose, cellulose acetate, cellulose butyrate, cellulose acetate butyrate, cellophane, cellulose nitrate, cellulose propionate, cellulose ethers, carboxymethyl cellulose, collagens, chitins, polylactic acid, polyglycolic acid, and polylactic acid-polyethylene oxide copolyers, lactone-based copolyesters, polyanhydrides, polyaminoacids, polysaccharides, polyphosphazenes, poly (ether-ester) copolymers, and blends of such polymers, poly (ethylene) vinylacetate, poly (hydroxyl) ehtylemethylmethacrylate, polyvinal pyrrolidone;

polytetrafluoroethylene, cellulose esters, elastomeric polymers such as silicones (e.g. polysiloxanes and substituted polysiloxanes), polyurethanes, thermoplastic elastomers, ethylene vinyl acetate copolymers, polyolefin elastomers, and EPDM rubbers, EVAL, poly(hydroxyvalerate), poly(L-lactic acid), polycaprolactone, poly(lactide-co-glycolide), poly(hydroxybutrate), poly (hydroxybutrate-co-valerate), polydioxanone, polyorthoesters, polyanhydride, poly(glycolic acid), poly(D,L-lactic acid), poly(glycolic acid-co-trimethylene carbonate), polyphosphoesters, polyphosphoester urethanes, poly(amino acids), cyanoacrylates, poly(trimethylene carbonate), poly(iminocarbonate), co-poly(ether-esters)(e.g. PEO/PLA), polyalkylene oxalates, polyphosphazenes, biomolecules (such as fibrin fibrinogen, cellulose, starch, collagen and hyaluronic acid), polyurethanes, silicones, polyesters, polyolefins, polyisobutylene and ethylene-alphaoletinc copolyers, acrylic polymers and copolymers, vinyl halide polymers and copolymers (such as polyvinyl chloride), polyvinylidene halides (such as polyvinylidene fluoride and polyvinylidene chloride), polyvinyl ethers (such as polyvinyl methyl-ether), polyacrylonitrile, polyvinyl ketones, polyvinyl aromatics (such as polystyrene), polyvinyl esters (such as polyvinyl acetate), copolymers of vinyl monomers with each oether and olefins (such as ethylene-methyl methacrylate copolymers, acrylonitrile-styrene copolymers, ABS resins, and ethylene-vinyl acetate copolymers), polyamides (such as NYLON 66 and polycaprolactam), alkyd resins, polybarcbonates, polyoxymethylenes, polyimides, polyethers, epoxy resins, polyurethanes, rayon, rayon-triacetate, cellulose, cellulose acetate, cellulose butyrate cellulose acetate butyrate, cellulose nitrate, cellulose propionate, cellulose ethers, carboxymethyl cellulose, CELLOPHANE, PEG, PEG-acrylate or methacrylate, silk-elastin protein block co-polymer, and mixtures thereof.

10. The method for treating a mammal as in claim 9, wherein the eluting rate modifying topcoat comprises poly(lactide-co-glycolide).

11. The method for treating a mammal as in claim 8, wherein the eluting rate modifying topcoat has a thickness in the range of about 1 micron to about 100 microns.

12. The method for treating a mammal as in claim 11, wherein the eluting rate modifying topcoat has a thickness in the range of about 2 microns to about 15 microns.