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

• US 9,364,588 B2
• Filed: 06/06/2014
• Issued: 06/14/2016
• Est. Priority Date: 02/04/2014
• Status: Expired due to Fees

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Ding, Ni, Pacetti, Stephen, Kamberi, Marika, Kerrigan, Cameron
• Primary Examiner(s): Listvoyb, Gregory
• Application Number:
  US14/298,616
• Publication Number:
  US 20150217029A1
• Time in Patent Office: 739 Days
• Field of Search: 424/423, 623/1.2, 623/1.15, 623/1.46
• US Class Current: 1/1
• CPC Class Codes: A61K 31/436 the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
• CPC Class Codes: A61K 47/593 Polyesters, e.g. PLGA or polylactide-co-glycolide
• CPC Class Codes: A61K 47/6957 the form being a device or a kit, e.g. stents or microdevices
• 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 2420/02 Methods for coating medical devices
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61P 7/00 Drugs for disorders of the blood or the extracellular fluid
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system
• 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

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.

Claims

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.

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.

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.