Drug-coated medical devices

Patent metadata

Field	Value
Publication number	US-11951269-B2
Application number	US-201916696846-A
Country	US
Kind code	B2
Filing date	Nov 26, 2019
Priority date	Nov 29, 2018
Publication date	Apr 9, 2024
Grant date	Apr 9, 2024

Abstract

A method for coating a medical device includes applying a second layer that includes a second drug on a first layer of on the medical device. The first layer includes a first drug, which may be in crystalline form. By selecting an appropriate solvent use in applying the second layer and appropriate process conditions, the second layer may be applied such that the first drug retains one or more therapeutic properties. For example, the second layer may be applied such that the first drug maintains its crystalline form. The first and second layers may be free of polymer.

First claim

What is claimed is:

1. A method for coating a medical device comprising a first layer comprising a first drug, wherein the first layer is free from polymers and the first drug is an antiproliferative agent, the method comprising:
applying a solution comprising a second drug and a solvent to form a second layer on the first layer of the medical device, wherein the second drug is an anti-inflammatory agent and the second layer is free from polymers, wherein the first drug in the first layer is in crystalline form and wherein the solution comprising the second drug is applied to the first layer of the medical device such that the first drug maintains its crystalline form.

2. The method of claim 1 , wherein the first drug is a taxol or limus-derivative.

3. The method of claim 1 , wherein the first drug is rapamycin, taxol, paclitaxel, doxetaxel, sirolimus, rapamycin, everolimus, or zotarolimus.

4. The method of claim 1 , wherein the first drug is paclitaxel.

5. The method of claim 4 , wherein the solvent comprises one or more of tetrahydrofuran, methanol, acetonitrile, dimethyl sulfoxide, dioxane, ethanol, and water.

6. The method of claim 5 , wherein the solvent comprises less than 15% water by volume.

7. The method of claim 5 , wherein the solvent comprises methanol or acetone.

8. The method of claim 1 , wherein the second drug is a glucocorticoid.

9. The method of claim 1 , wherein the second drug is dexamethasone.

10. The method of claim 1 , wherein applying the solution comprises spraying the solution.

11. The method of claim 10 , wherein spraying the solution comprises ultrasonically spraying the solution.

12. The method of claim 1 , wherein the medical device comprises a balloon or a stent.

13. The method of claim 12 , wherein the medical device comprises a balloon.

14. A medical device comprising
a body,
a first layer on the body, wherein the first layer comprises a first drug, wherein the first layer is free from polymers and the first drug is an antiproliferative agent; and
a second layer on the first layer, wherein the second layer comprises a second drug, wherein the second drug is an anti-inflammatory agent and the second layer is free from polymers,
wherein the first drug in the first layer is in crystalline form.

15. The medical device of claim 14 , wherein the first drug is paclitaxel and the second drug is dexamethasone.

16. The medical device of claim 14 , wherein the medical device comprises a balloon or a stent.

17. The medical device of claim 14 wherein the medical device comprises a balloon.

Assignees

• Medtronic Vascular Inc

Inventors

• D'Onofrio Simone
• Morero Massimo
• Steele Bradley
• Bellucci Federica
• Morris Cassandra

Classifications

• A61M25/104 Primary

  used for angioplasty · CPC title

• A61K9/1676

  having a drug-free core with discrete complete coating layer containing drug (adsorbates of liquid drug formulations on inert powders without simultaneous granulation step A61K9/141; with further drug-free outer coating A61K9/5078; drug conjugated to non-active particles A61K47/6921) · CPC title

• A61K31/337

  having four-membered rings, e.g. taxol · CPC title

• A61K31/573

  substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone · CPC title

• A61M2025/0057

  Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings · CPC title