Medical Device Including Drug-Loaded Fibers

• US 20090143855A1
• Filed: 11/29/2007
• Published: 06/04/2009
• Est. Priority Date: 11/29/2007
• Status: Abandoned Application

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Weber, Jan, Kokate, Jaydeep Y., Iftekar, Arif
• Application Number:
  US11/946,946
• Publication Number:
  US 20090143855A1
• Time in Patent Office: Days
• US Class Current: 623/1.420
• 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 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 2300/00 Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
• CPC Class Codes: A61L 2400/12 Nanosized materials, e.g. nanofibres, nanoparticles, nanowires, nanotubes; Nanostructured surfaces
• CPC Class Codes: A61L 31/088 Other specific inorganic materials not covered by A61L31/084 or A61L31/086
• CPC Class Codes: A61L 31/14 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified 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

Abstract

An endovascular or intraluminal stent comprising an expandable framework including a plurality of interconnected undulating or otherwise connected segments, and a plurality of fibers disposed on the expandable framework. At least a portion of the plurality of fibers is loaded with a therapeutic agent.

Claims

1. A stent comprising:

an expandable framework having a first end, a second end, an outer surface, and an inner surface defining a lumen, the expandable framework including a plurality of interconnected segments; and

a plurality of fibers disposed on the expandable framework;

wherein at least a portion of the plurality of fibers include an annular porous sidewall having an outer diameter and an inner diameter, the inner diameter of the annular porous sidewall defining a central lumen;

wherein at least a portion of the central lumen of at least some of the plurality of fibers is loaded with a therapeutic agent.

2. The stent of claim 1, wherein the plurality of fibers are disposed on the outer surface of the expandable framework.

3. The stent of claim 1, wherein the plurality of fibers are interwoven with the expandable framework.

4. The stent of claim 1, wherein the plurality of fibers are wrapped around the outer surface of the expandable framework.

5. The stent of claim 1, wherein the plurality of the fibers have an average pore size of about 1 nanometer to about 1000 nanometers.

6. The stent of claim 1, wherein the plurality of fibers have an average pore size of less than about 2 nanometers.

7. The stent of claim 1, wherein the plurality of fibers have an average pore size of about 2 nanometers to about 50 nanometers.

8. The stent of claim 1, wherein the plurality of fibers have an average pore size greater than about 50 nanometers.

9. The stent of claim 1, wherein the porosity of the plurality of fibers allows diffusion of the therapeutic agent through the sidewall of the plurality of fibers.

10. An intraluminal stent for placement within a vessel lumen, the intraluminal stent comprising:

an expandable framework having a first end, a second end, an outer surface, and an inner surface defining a lumen, the expandable framework including a plurality of interconnected segments; and

a plurality of nanoporous ceramic fibers disposed on the expandable framework, wherein at least a portion of the plurality of nanoporous ceramic fibers is loaded with a therapeutic agent.

11. The intraluminal stent of claim 10, wherein the plurality of nanoporous ceramic fibers forms a nonwoven mesh.

12. The intraluminal stent of claim 10, wherein the plurality of nanoporous ceramic fibers comprise a metal oxide.

13. The intraluminal stent of claim 10, wherein the plurality of nanoporous ceramic fibers are interwoven with the expandable framework.

14. The intraluminal stent of claim 10, wherein the plurality of nanoporous ceramic fibers are wrapped around an outer surface of the expandable framework.

15. The intraluminal stent of claim 10, wherein each of the nanoporous ceramic fibers has a central lumen, wherein the therapeutic agent is loaded within the central lumen of the nanoporous ceramic fibers.

16. The intraluminal stent of claim 10, wherein each of the nanoporous ceramic fibers comprises a plurality of interstitial spaces, wherein the therapeutic agent is loaded within the interstitial spaces of the nanoporous ceramic fibers.

17. A method of forming a drug releasing medical device, the method comprising:

forming a plurality of fibers, each fiber having a porous annular sidewall having an outer surface and an inner surface, the inner surface of the fiber defining a central lumen extending through the fiber;

loading the central lumen of at least a portion of the fibers with a therapeutic agent; and

placing the plurality of fibers on a medical device.

18. The method of claim 17, wherein the plurality of fibers are formed through an electrospinning process.

19. The method of claim 17, wherein the medical device includes an expandable framework, wherein the plurality of fibers are interwoven with the expandable framework.

20. The method of claim 17, wherein the medical device includes an expandable framework having an outer surface, wherein the plurality of fibers are wrapped around the outer surface of the expandable framework.

21. The method of claim 17, wherein the plurality of fibers comprise ceramic fibers.

22. A method of treating a stenosis of a lumen of a patient, the method comprising:

providing a stent comprising an expandable framework having a first end, a second end, an outer surface, and an inner surface defining a lumen, the expandable framework including a plurality of interconnected segments, wherein a plurality of nanoporous ceramic fibers are disposed on the expandable framework, wherein each of the plurality of nanoporous ceramic fibers is loaded with a therapeutic agent;

placing the stent including the plurality of nanoporous ceramic fibers loaded with the therapeutic agent across a stenosis of a lumen;

expanding the stent to engage with a tissue wall of the stenosis; and

diffusing the therapeutic agent from the plurality of nanoporous ceramic fibers over a duration of time.

23. The method of claim 22, wherein the plurality of nanoporous ceramic fibers are interposed between the expandable framework and the tissue wall of the stenosis.

24. The method of claim 22, wherein the therapeutic agent is loaded in a central lumen of the nanoporous ceramic fibers.

25. The method of claim 22, wherein the therapeutic agent diffuses through a porous sidewall of the nanoporous ceramic fibers.