Stents and other devices having extracellular matrix coating

• US 10,232,092 B2
• Filed: 04/20/2011
• Issued: 03/19/2019
• Est. Priority Date: 04/22/2010
• Status: Active Grant

• Current Assignee: Micell Medtech Incorporated
• Original Assignee: Micell Technologies Inc.
• Inventors: McClain, James B., Benvenuto, Arthur J.
• Primary Examiner(s): Schall, Matthew
• Application Number:
  US13/090,525
• Publication Number:
  US 20110264190A1
• Time in Patent Office: 2,890 Days
• Field of Search: 623 142
• CPC Class Codes: A61L 2300/30 Compounds of undetermined constitution extracted from natural sources, e.g. Aloe Vera
• CPC Class Codes: A61L 2300/62 Encapsulated active agents, e.g. emulsified droplets
• CPC Class Codes: A61L 2420/02 Methods for coating medical devices
• CPC Class Codes: A61L 2420/08 Coatings comprising two or more layers
• 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: C09D 167/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C09D167/06 takes precedence

Abstract

Provided herein are devices comprising a stent; and a coating on said stent comprising a polymer and an active agent, wherein the active agent comprises at least one of: extracellular matrix and an extracellular matrix component. Provided herein are methods of preparing a device comprising a stent and a coating on said stent; said method comprising: providing a stent; and forming a plurality of layers on said stent; wherein the coating comprises a polymer and at least one of said layers comprises one or more active agents; wherein at least a portion of the active agent comprises at least one of extracellular matrix and an extracellular matrix component.

Claims

1. A device comprising

a substrate;

and

a coating on said substrate comprising a first polymer and an active agent, wherein the active agent comprises a macrolide immunosuppressive drug in crystalline form and an extracellular matrix, wherein the extracellular matrix comprises an interlocking mesh of fibrous proteins and glycosaminoglycans (GAGs).

2. The device of claim 1, wherein the extracellular matrix comprises an extracellular matrix component comprising at least one of:

heparin sulfate, choindroitin sulfate, keratan sulfate, hayaluronic acid, collagen, elastin, fibronectin, laminin, merosin, tenascin, vitronectin, and fibrillin.

3. The device of claim 1, wherein the substrate is at least one of a stent, an angioplasty balloon and a cutting balloon.

4. The device of claim 1, wherein the first polymer is at least one of:

a bioabsorbable polymer and a durable polymer.

5. The device of claim 1, wherein substantially all of the active agent remains within said coating and on said substrate until the implantable device is deployed at an intervention site inside the body of a subject, wherein upon deployment of said device in the body of said subject a portion of the active agent is delivered at said intervention site along with at least a portion of said polymer, and wherein the device is adapted to be delivered to a body lumen.

6. The device of claim 1, wherein active agent particles are sequestered or encapsulated within a microstructure.

7. The device of claim 1, wherein the coating is formed on said substrate through a process comprising depositing said polymer active agent by an e-RESS, an e-SEDS, or an e-DPC process.

8. The device of claim 1, wherein the coating comprises a plurality of layers a first layer comprises the first polymer, a second layer comprises the active agent, a third layer comprises a second polymer, a fourth layer comprises the active agent, and a fifth layer comprises a third polymer.

9. The device of claim 8, wherein at least two of said first polymer, said second polymer and said third polymer are the same polymer.

10. A stent delivery system comprising:

an elongate member having an inflation lumen and a guidewire lumen therein;

a balloon having an interior that is in fluid communication with the inflation lumen; and

a coated stent mounted on the balloon, wherein the coated stent comprises a stent and a plurality of layers that form a coating on said stent;

wherein at least one of said layers comprises a polymer and at least one of said layers comprises an active agent, wherein the active agent comprises a macrolide immunosuppressive drug in crystalline form and an extracellular matrix, wherein the extracellular matrix comprises an interlocking mesh of fibrous proteins and glycosaminoglycans (GAGs).

11. A bioabsorbable device comprising

a bioabsorbable substrate comprising a first active agent;

and

a coating on said substrate wherein the coating comprises a first polymer,

wherein the first active agent comprises a macrolide immunosuppressive drug in crystalline form and an extracellular matrix, wherein the extracellular matrix comprises an interlocking mesh of fibrous proteins and glycosaminoglycans (GAGs).

13. The device of one of claims 11 and 12, wherein the bioabsorbable substrate comprises at least one of a bioabsorbable metal framework and a second polymer, wherein the second polymer is bioabsorbable.

14. The device of one of claims 11 and 12, wherein the first polymer degrades by at least one of bulk erosion and surface erosion.

15. The device of one of claims 11 and 12, wherein the device is delivered to a target tissue and returns endothelial function to the target tissue at 28 days from device delivery.

12. A bioabsorbable device comprising

a bioabsorbable substrate;

and

a coating on said substrate wherein the coating comprises a first polymer, a first active agent and a second active agent, wherein the first active agent comprises extracellular matrix, the extracellular matrix comprises an interlocking mesh of fibrous proteins and glycosaminoglycans (GAGs), and the second active agent comprises a macrolide immunosuppressive drug in crystalline form.