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-9724452-B2
Application number	US-201615161084-A
Country	US
Kind code	B2
Filing date	May 20, 2016
Priority date	Feb 4, 2014
Publication date	Aug 8, 2017
Grant date	Aug 8, 2017

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 method of treating restenosis, vulnerable plaque, or a vascular condition in a mammal comprising delivering to the mammal 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 in an amount, 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); wherein conjugation of the novolimus to the polymer includes conjugation via an ester linkage.

2. The method of claim 1 , wherein the bioabsorbable scaffold absorbs away anywhere from 5 months to 2 years after delivery.

3. A method of manufacturing a bioabsorbable scaffold comprising forming 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 in an amount, wherein the manufacturing processes or standards are set, adjusted, selected and/or determined such that 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); wherein conjugation of the novolimus to the polymer includes conjugation via an ester linkage.

4. The method of claim 3 , 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).

5. The method of claim 3 , 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).

6. The method of claim 3 , wherein the coating comprises novolimus which is not conjugated to the polymer.

7. The method of claim 3 , wherein the manufacturing processes or standards that are set, adjusted, selected and/or determined include one or a combination of solvent selection, drug and polymer dissolution parameters, spraying parameters, dipping parameters, inkjet printing parameters, annealing parameters, drying parameters, heating parameters, crimping parameters, sterilizing parameters, packaging, temperature, and/or humidity.

8. A method of treating restenosis, vulnerable plaque, or a vascular condition in a mammal comprising delivering the bioabsorbable scaffold of claim 3 to the mammal.

9. The method of claim 8 , wherein the bioabsorbable scaffold absorbs away anywhere from 5 months to 2 years after delivery.

10. A method of manufacturing a bioabsorbable scaffold comprising forming a scaffold body and a coating on the scaffold body, the coating comprising a lactide or lactic acid based polymer and novolimus conjugated to the polymer in an amount, wherein the manufacturing processes or standards are set, adjusted, selected and/or determined such that 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); wherein conjugation of the novolimus to the polymer includes conjugation via an ester linkage.

11. The method of claim 10 , 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).

12. The method of any of claim 10 , 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).

13. The method of claim 10 , wherein the coating comprises novolimus which is not conjugated to the polymer.

14. The method of claim 10 , wherein the manufacturing processes or standards that are set, adjusted, selected and/or determined include one or a combination of solvent selection, drug and polymer dissolution parameters, spraying parameters, dipping parameters, inkjet printing parameters, annealing parameters, drying parameters, heating parameters, crimping parameters, sterilizing parameters, packaging, temperature, and/or humidity.

15. A method of treating restenosis, vulnerable plaque, or a vascular condition in a mammal comprising delivering the bioabsorbable scaffold of claim 10 to the mammal.

16. The method of claim 15 , wherein the bioabsorbable scaffold absorbs away anywhere from 5 months to 2 years after delivery.

17. The method of claim 1 wherein the amount of novolimus conjugated to the polymer is greater than 0.01 wt % and less than or equal to 0.35% (weight novolimus to weight polymer), as measured by liquid chromatography-mass spectrometry (LC-MS).

18. The method of claim 3 wherein the amount of novolimus conjugated to the polymer is greater than 0.01 wt % and less than or equal to 0.35% (weight novolimus to weight polymer), as measured by liquid chromatography-mass spectrometry (LC-MS).

19. The method of claim 10 wherein the amount of novolimus conjugated to the polymer is greater than 0.01 wt % and less than or equal to 0.35% (weight novolimus to weight polymer), as measured by liquid chromatography-mass spectrometry (LC-MS).

Assignees

• Abbott Cardiovascular Systems Inc

Inventors

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

Classifications

• 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

• 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

• A61L31/16 Primary

  Biologically active materials, e.g. therapeutic substances {(A61L31/047 takes precedence)} · CPC title

• A61L31/148

  Materials at least partially resorbable by the body · CPC title