Drug delivery scaffold or stent with a novolimus and lactide based coating such that novolimus has a minimum amount of bonding to the coating

Patent metadata

Field	Value
Publication number	US-9364588-B2
Application number	US-201414298616-A
Country	US
Kind code	B2
Filing date	Jun 6, 2014
Priority date	Feb 4, 2014
Publication date	Jun 14, 2016
Grant date	Jun 14, 2016

Abstract

Disclosed herein are drug delivery medical devices. A polymer coating for a medical device is provided which comprises a minimum amount of a drug bonded to the polymer in the coating.

First claim

What is claimed is:

1. A bioabsorbable scaffold comprising a scaffold body and a coating on the scaffold body, the coating comprising a poly(D,L-lactide) polymer and novolimus conjugated to the polymer, wherein the amount of novolimus conjugated to the polymer is less than or equal to 0.35% (weight novolimus to weight polymer), as measured by liquid chromatography-mass spectrometry (LC-MS).

2. The bioabsorbable scaffold of claim 1 , wherein the amount of novolimus conjugated to the polymer is less than or equal to 0.30% (weight novolimus to weight polymer), as measured by liquid chromatography-mass spectrometry (LC-MS).

3. The bioabsorbable scaffold of claim 1 , wherein the amount of novolimus conjugated to the polymer is less than or equal to 0.1% (weight novolimus to weight polymer), as measured by Gel Permeation Chromatography with Refractive Index and Ultraviolet detection (GPC-RI/UV).

4. The bioabsorbable scaffold of claim 1 , wherein the coating comprises novolimus which is not conjugated to the polymer.

5. The bioabsorbable scaffold of claim 1 , wherein the novolimus is conjugated to the polymer via an ester linkage.

6. A method of treating restenosis, vulnerable plaque, or a vascular condition in a mammal comprising delivering the scaffold of claim 1 to the mammal.

7. The method of claim 6 , wherein the scaffold absorbs away anywhere from 5 months to 2 years after delivery.

8. A bioabsorbable scaffold comprising a scaffold body and a coating on the scaffold body, the coating comprising a polymer, wherein the polymer comprises a lactide or lactic acid based polymer and novolimus conjugated to the lactide or lactic acid based polymer, wherein the amount of novolimus conjugated to the polymer is less than or equal to 0.35% (weight novolimus to weight polymer), as measured by liquid chromatography-mass spectrometry (LC-MS).

9. The bioabsorbable scaffold of claim 8 , wherein the amount of novolimus conjugated to the polymer is less than or equal to 0.30% (weight novolimus to weight polymer), as measured by liquid chromatography-mass spectrometry (LC-MS).

10. The bioabsorbable scaffold of claim 8 , wherein the amount of novolimus conjugated to the polymer is less than or equal to 0.1% (weight novolimus to weight polymer), as measured by Gel Permeation Chromatography with Refractive Index and Ultraviolet detection (GPC-RI/UV).

11. The bioabsorbable scaffold of claim 8 , wherein the novolimus is conjugated to the polymer via an ester linkage.

12. The bioabsorbable scaffold of claim 1 , wherein the coating further comprises novolimus in a dose per mm scaffold body of less than or equal to about 8 mcg.

Assignees

• Abbott Cardiovascular Systems

Inventors

• Ding Ni
• Pacetti Stephen
• Kamberi Marika
• Kerrigan Cameron

Classifications

• A61P7/00

  Drugs for disorders of the blood or the extracellular fluid · CPC title

• A61P9/00

  Drugs for disorders of the cardiovascular system · CPC title

• A61P9/10

  for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis · CPC title

• A61L2300/416

  Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus · CPC title

• A61L31/10 Primary

  Macromolecular materials · CPC title