MANUFACTURE, METHOD AND USE OF ACTIVE SUBSTANCE-RELEASING MEDICAL PRODUCTS FOR PERMANENTLY KEEPING BLOOD VESSELS OPEN

• US 20100063585A1
• Filed: 07/03/2007
• Published: 03/11/2010
• Est. Priority Date: 07/03/2006
• Status: Abandoned Application

• Current Assignee: Hemoteq AG (Freudenberg & Company KG)
• Original Assignee: Hemoteq AG (Freudenberg & Company KG)
• Inventors: Küsters, Sabine, Hoffmann, Michael, Horres, Roland, Hoffmann, Erika
• Application Number:
  US12/307,261
• Publication Number:
  US 20100063585A1
• Time in Patent Office: Days
• US Class Current: 623/1.460
• 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 2300/45 Mixtures of two or more drugs, e.g. synergistic mixtures
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61L 29/18 Materials at least partially X-ray or laser opaque
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 31/08 for leprosy
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 37/06 Immunosuppressants, e.g. drugs for graft rejection
• CPC Class Codes: A61P 9/10 for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence
• CPC Class Codes: C08L 81/06 Polysulfones; Polyethersulfones

Abstract

The invention relates to stents and catheter balloons having optimized coatings for eluting rapamycin as well as methods for manufacturing these coatings.

Claims

1. Stent coated with a polysulfone containing the active agent rapamycin and a methanol-swellable polymer, wherein the methanol-swellable polymer is contained with a weight portion of 0.1% to 50% by weight with respect to the mass of the total coating.

6. Stent according to claim 1, wherein the stent has a lowermost coating of a hemocompatible polymer.

7. Stent according to claim 6, wherein the hemocompatible coating is bound covalently to the stent surface.

8. Stent according to claim 1, wherein the methanol-swellable polymers are selected from the group comprising:

polyvinylpyrrolidone, glycerine, polyethylene glycol, polypropylene glycol, polyvinyl alcohol, polyhydroxyethyl methacrylates, polyacrylamide, polyvalerolactones, poly-ε

-decalactones, polylactonic acid, polyglycolic acid, polylactides, polyglycolides, copolymers of the polylactides and polyglycolides, poly-ε

-caprolactone, polyhydroxybutanoic acid, polyhydroxybutyrates, polyhydroxyvalerates, polyhydroxybutyrate-co-valerates, poly(1,4-dioxane-2,3-diones), poly(1,3-dioxane-2-ones), poly-para-dioxanones, polyanhydrides such as polymaleic acid anhydrides, fibrin, polycyanoacrylates, polycaprolactonedimethylacrylates, poly-b-maleic acid, polycaprolactone butylacrylates, multiblock polymers such as from oligocaprolactonedioles and oligodioxanonedioles, polyether ester multiblock polymers such as PEG and poly(butyleneterephthalate), polypivotolactones, polyglycolic acid trimethyl-carbonates, polycaprolactone-glycolides, poly-g-ethylglutamate, poly(DTH-iminocarbonate), poly(DTE-co-DT-carbonate), poly(bisphenol-A-iminocarbonate), polyorthoesters, polyglycolic acid trimethylcarbonates, polytrimethylcarbonates, polyiminocarbonates, poly(N-vinyl)-pyrrolidone, polyvinylalcohols, polyesteramides, glycolated polyesters, polyphosphoesters, polyphosphazenes, poly[p-carboxyphenoxy)propane], polyhydroxypentanoic acid, polyanhydrides, polyethyleneoxide-propyleneoxide, soft polyurethanes, polyurethanes with amino acid residues in the backbone, polyether esters such as polyethyleneoxide, polyalkeneoxalates, polyorthoesters as well as copolymers thereof, lipids, carrageenans, fibrinogen, starch, collagen, protein based polymers, polyamino acids, synthetic polyamino acids, zein, modified zein, polyhydroxyalkanoates, pectic acid, actinic acid, modified and non modified fibrin and casein, carboxymethyl sulfate, albumin, hyaluronic acid, chitosan and its derivatives, chondroitine sulfate, dextran, b-cyclodextrins, copolymers with PEG and polypropylene glycol, gum arabic, guar, gelatine, collagen, collagen-N-hydroxysuccinimide, lipids, phospholipids, modifications and copolymers and/or mixtures of the above mentioned substances.

2. Stent coated with an active agent layer of rapamycin and a bioresorbable protective layer.

3. Stent according to claim 2, wherein the stent is coated with an alternating sequence of an active agent layer of rapamycin and a bioresorbable protective layer.

4. Stent according to claim 3, wherein the stent has 3 to 20 layers.

10. Stent according to claim 2, wherein the stent has a lowermost coating of a hemocompatible polymer.

11. Stent according to claim 10, wherein the hemocompatible coating is bound covalently to the stent surface.

12. Stent according to claim 3, wherein the stent has a lowermost coating of a hemocompatible polymer.

13. Stent according to claim 12, wherein the hemocompatible coating is bound covalently to the stent surface.

14. Stent according to claim 4, wherein the stent has a lowermost coating of a hemocompatible polymer.

15. Stent according to claim 14, wherein the hemocompatible coating is bound covalently to the stent surface.

5. Stent coated with a polymer layer of PLGA which contains rapamycin.

16. Stent according to claim 5, wherein the stent has a lowermost coating of a hemocompatible polymer.

17. Stent according to claim 16, wherein the hemocompatible coating is bound covalently to the stent surface.

9. Catheter balloon coated with a combination of rapamycin and a vasodilator or rapamycin and a contrast agent or rapamycin and a vasodilator and a contrast agent.