Delivery of therapeutic capable agents

• US 7,083,642 B2
• Filed: 07/25/2002
• Issued: 08/01/2006
• Est. Priority Date: 12/22/2000
• Status: Expired due to Fees

• Current Assignee: Avantec Vascular Corporation
• Original Assignee: Avantec Vascular Corporation
• Inventors: Yan, John, Sirhan, Motasim
• Primary Examiner(s): Barrett, Thomas
• Assistant Examiner(s): Izquierdo, David A.
• Application Number:
  US10/206,853
• Publication Number:
  US 20030139801A1
• Time in Patent Office: 1,468 Days
• Field of Search: 623 139- 148, 623/23.29, 623/23.3
• 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 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0071 breakable or frangible
• 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 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

The present invention provides improved stents and other prostheses for delivering substances to vascular and other luminal and intracorporeal environments. In particular, the present invention provides for therapeutic capable agent eluting stents with minimized undesirable loss of the therapeutic capable agent during expansion of the stent.

Claims

1. A device for intracorporeal use, the device comprising:

a structure; and

at least one source of at least one therapeutic capable agent associated with the structure, the at least one therapeutic capable agent having a textured surface wherein the surface has peaks and valleys with a distance between the peaks ranging from about 5 μ

m to about 50 μ

m.

2. A device as in claim 1, wherein the distance between the peaks is a mean distance.

3. A device as in claim 1, wherein the surface has a peak height ranging from about 0.01 μ

m to about 10 μ

m.

4. A device as in claim 1, wherein the surface has a peak height ranging from about 0.05 μ

m to about 1.5 μ

m.

5. A device as in claim 1, wherein the surface has a peak height ranging from about 0.1 μ

m to about 1 μ

m.

6. A device as in claim 3, 4, or 5, wherein the peak height is an average peak height.

7. A device as in claim 1, wherein the therapeutic capable agent forms a layer having a thickness ranging from about 0.1 μ

m to about 20 μ

m.

8. A device as in claim 1, wherein the therapeutic capable agent forms a layer having a thickness ranging from about 0.5 μ

m to about 7.5 μ

m.

9. A device as in claim 1, wherein the therapeutic capable agent forms a layer having a thickness ranging from about 1.0 μ

m to about 5 μ

m.

10. A device as in claim 7, 8, or 9, wherein the layer thickness is an average thickness.

11. A device as in claim 1, wherein the textured therapeutic capable agent surface forms the outer most layer of the device.

12. A device as in claim 1, wherein the therapeutic capable agent is selected from the group consisting of immunosuppressants, anti-inflammatories, anti-proliferatives, anti-migratory agents, anti-fibrotic agents, proapoptotics, vasodilators, calcium channel blockers, anti-neoplastics, anti-cancer agents, antibodies, anti-thrombotic agents, anti-platelet agents, IIb/IIIa agents, antiviral agents, mTOR (mammalian target of rapamycin) inhibitors, non-immunosuppressant agents, and combinations thereof.

13. A device as in claim 1, wherein the therapeutic capable agent is selected from the group consisting of mycophenolic acid, mycophenolic acid derivatives (e.g., 2-methoxymethyl derivative and 2-methyl derivative), VX-148, VX-944, mycophenolate mofetil, mizoribine, methylprednisolone, dexamethasone, Certican (e.g., everolimus, RAD), rapamycin, ABT-773 (Abbot Labs), ABT-797 (Abbot Labs), TRIPTOLIDE, Methotrexate, phenylalkylamines (e.g., verapamil), benzothiazepines (e.g., diltiazem), 1,4-dihydropyridines (e.g., benidipine, nifedipine, nicarrdipine, isradipine, felodipine, amlodipine, nilvadipine, nisoldipine, manidipine, nitrendipine, barnidipine (Hypoca)), Ascomycin, Wortmannin, LY294002, Camptothecin, flavopiridol, isoquinoline, HA-1077 (1-(5-isoquinolinesulfonyl)-homopiperazine hydrochloride), TAS-301 (3-bis(4-methoxyphenyl)methylene-2-indolinone), Topotecan, hydroxyurea, Tacrolimus (FK 506), cyclophosphamide, cyclosporine, daclizumab, azathioprine, prednisone, diferuloymethane, diferuloylmethane, diferulylmethane, Gemcitabine, cilostazol (Pletal), tranilast, enalapril, quercetin, suramin, estradiol, cycloheximide, tiazofurin, zafurin, AP23573, rapamycin derivatives, non-immunosuppressive analogues of rapamycin (e.g., rapalog, AP2 1967, derivatives of rapalog), CCI-779 (an analogue of rapamycin available from Wyeth), sodium mycophernolic acid, benidipine hydrochloride, sirolimus, rapamine, metabolites, derivatives and combinations thereof.

14. A device as in claim 1, wherein the therapeutic capable agent is selected from the group consisting of mycophenolic acid, mycophenolate mofetil, rapamycin, Certican (everolimus, RAD), TRIPTOLIDE, benidipine, Tacrolimus (FK 506), cilostazol (Pletal), metabolites, derivatives and combinations thereof.