Stents having bioabsorable layers

• US 10,350,333 B2
• Filed: 06/27/2017
• Issued: 07/16/2019
• Est. Priority Date: 04/17/2008
• Status: Active Grant

• Current Assignee: Micell Medtech Incorporated
• Original Assignee: Micell Technologies Inc.
• Inventors: McClain, James B., Taylor, Douglas
• Primary Examiner(s): Sharma, Yashita
• Application Number:
  US15/634,269
• Publication Number:
  US 20170290959A1
• Time in Patent Office: 749 Days
• Field of Search: 623 11- 146, 424423
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2250/0035 differing in release or diffusion time
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 2300/216 with other specific functional groups, e.g. aldehydes, ketones, phenols, quaternary phosphonium groups
• CPC Class Codes: A61L 2300/604 Biodegradation
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 2300/608 having two or more layers
• CPC Class Codes: A61L 2300/63 Crystals
• CPC Class Codes: A61L 2420/08 Coatings comprising two or more layers
• 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

Abstract

Provided herein is a device comprising: a. stent; b. a plurality of layers on said stent framework to form said device; wherein at least one of said layers comprises a bioabsorbable polymer and at least one of said layers comprises one or more active agents; wherein at least part of the active agent is in crystalline form.

Claims

1. A device comprising:

a. a substrate consisting essentially of layers of polymer and layers of pharmaceutical agent;

b. a plurality of layers deposited directly on said substrate, wherein a first layer comprises a first bioabsorbable polymer, a second layer comprises a layer of a first pharmaceutical agent, a third layer comprises a second bioabsorbable polymer, a fourth layer comprises a layer of said first pharmaceutical agent, and a fifth layer comprises a third bioabsorbable polymer,

wherein said device has a first pharmaceutical agent content of about 1 μ

g/mm to about 15 μ

g/mm, and

wherein at least a portion of the first pharmaceutical agent is in crystalline form.

2. The device of claim 1, wherein said first, second, and third bioabsorbable polymers comprise the same bioabsorbable polymer.

3. The device of claim 1, wherein said first, second, and third bioabsorbable polymers comprise different bioabsorbable polymers.

4. The device of claim 1, wherein 5% to 25% of the first pharmaceutical agent is eluted one day after the device is contacted with elution media.

5. The device of claim 1, wherein 15% to 45% of the first pharmaceutical agent is eluted 7 days after the device is contacted with elution media.

6. The device of claim 1, wherein 25% to 60% of the first pharmaceutical agent is eluted 14 days after the device is contacted with elution media.

7. The device of claim 1, wherein 35% to 70% of the first pharmaceutical agent is eluted 21 days after the device is contacted with elution media.

8. The device of claim 1, wherein said substrate comprises a stent.

9. The device of claim 1, wherein said first pharmaceutical agent comprises an antiproliferative agent.

10. The device of claim 7, wherein said antiproliferative agent is a limus drug or paclitaxel.