Drug eluting encapsulated stent

• US 20020133224A1
• Filed: 03/06/2002
• Published: 09/19/2002
• Est. Priority Date: 03/13/2001
• Status: Abandoned Application

• Current Assignee: Cardiotech International, Implant Sciences Corporation
• Original Assignee: Cardiotech International, Implant Sciences Corporation
• Inventors: Bajgar, Clara, Szycher, Michael
• Application Number:
  US10/092,177
• Publication Number:
  US 20020133224A1
• Time in Patent Office: Days
• US Class Current: 623/1.39
• 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 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: C08L 75/04 Polyurethanes

Abstract

A stent substantially completely encapsulated with a microporous polymeric membrane is provided. Encapsulation of the stent may be accomplished by an electrostatic deposition process. The microporous polymeric membrane may contain variable concentrations of one or more pharmacotherapeutic agents. After deployment to a site of interest, the stent and more specifically, the membrane, provides local delivery of sustained or controlled therapeutic dose of one or more of suitable pharmacotherapeutic agent.

Claims

1. A device for intravascular placement, the device comprising:

a substantially cylindrical hollow body;

a membrane positioned about a periphery of the body, the membrane containing at least one pharmacotherapeutic agent for the treatment or prevention of restenosis; and

a plurality of micropores throughout the membrane.

2. A device as set forth in claim 1, wherein the body includes an expandable mesh support having openings defined by mesh support.

3. A device as set forth in claim 1, wherein the body is metallic.

4. A device as set forth in claim 1, wherein the membrane includes string-like structures defining the micropores within the membrane.

5. A device as set forth in claim 4, wherein the membrane includes additional micropores in the body of each string-like structure.

6. A device as set forth in claim 1, wherein the membrane is made from a polymer.

7. A device as set forth in claim 6, wherein the polymer is hydrolytically and proteolytically stable.

8. A device as set forth in claim 6, wherein the polymer is a biodurable polyurethane.

9. A device as set forth in claim 1, wherein the pharmacotherapeutic agent includes at least one of an immunosuppressant, an antibiotic, a cell cycle inhibitor, an anti-inflammatory, an anticoagulant, an antiallergen, and a gene therapy and a ceramide therapy compound.

10. A device as set forth in claim 1, wherein the pharmacotherapeutic agent is Rapamycin.

17. A method as set forth in claim 10 further including allowing the membrane to elute the pharmacotherapeutic agent in a controlled time release manner.

11. A method of manufacturing an intravascular device for local delivery of a pharmacotherapeutic agent, the method comprising:

forming a polymeric solution;

adding at least one pharmacotherapeutic agent into the polymeric solution, so as to generate a polymer-agent mixture;

applying the mixture on to a periphery of an intravascular device, so as to encapsulate the device; and

permitting a porous membrane to form from the mixture applied to the device.

12. A method as set forth in claim 11, wherein, in the step of forming, the polymeric solution comprises a hydrolytically and proteolytically stable polymer.

13. A method as set forth in claim 11, wherein the step of applying includes electrostatic field assisted depositing the mixture on to the device.

14. A method as set forth in claim 13, wherein electrostatically depositing the mixture on to the device results in the deposition of string-like structures, the overlapping of which define a primary porosity, on the resulting membrane.

15. A method as set forth in claim 11, wherein the step of adding further includes adding an alkaline metal carbonate to the polymeric solution.

16. A method as set forth in claim 15 further including exposing the membrane to a weak hydrochloric acid so as to permit a chemical reaction with the alkaline metal carbonate to generate secondary porosity in string-like structures within the membrane.