Cell seeded expandable body

• US 8,623,066 B2
• Filed: 12/21/2007
• Issued: 01/07/2014
• Est. Priority Date: 07/11/2002
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Owens, Gary K., Looi, Kareen
• Primary Examiner(s): TYSON, MELANIE RUANO
• Application Number:
  US11/963,624
• Publication Number:
  US 20080138378A1
• Time in Patent Office: 2,209 Days
• Field of Search: 623 115- 122, 623/1.36, 623/1.39, 623/1.41, 623/1.13, 623/1.14
• US Class Current: 623/1.15
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• 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 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61L 2400/12 Nanosized materials, e.g. nanofibres, nanoparticles, nanowires, nanotubes; Nanostructured surfaces
• CPC Class Codes: A61L 31/005 Ingredients of undetermined constitution or reaction products thereof
• CPC Class Codes: A61L 31/088 Other specific inorganic materials not covered by A61L31/084 or A61L31/086
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges

Abstract

Devices, systems and methods for treating medical conditions using cell therapy via body lumens. Localized delivery is achieved with the use of a stent-like expandable body seeded with cells. The expandable body is expanded to contact at least a portion of the inner walls of the body lumen and the cells, cellular products and/or other therapeutic agents are delivered to the surrounding tissue. The therapeutic benefit provided is dependent on the type of cells used and the features of the expandable body.

Claims

1. A system for treating a patient comprising:

a tube having a first end, a second end and a tube wall extending between the first and second ends;

an expandable body attached to the tube wall having a proximal end, a distal end, a longitudinal axis therebetween, and at least one microstructure having an attached end attached to the body and a free end which is projectable radially outwardly from the expandable body; and

a plurality of cells disposed on at least one surface of the expandable body;

wherein;

the surface provides controlled time dependent release of a substance over time;

at least some of the plurality of cells have been genetically engineered to express a therapeutic gene; and

the substance comprises an agent that controls the activity of the therapeutic gene contained with the cells.

2. A system as in claim 1, wherein the at least one surface is located on an outer surface of the expandable body.

3. A system as in claim 2, wherein the surface comprises a nanoporous metallic coating wherein the coating has a morphology that provides controlled time dependent release of a substance over time.

4. A system as in claim 3, wherein the substance promotes cell adherence and/or cell growth.

5. A system as in claim 4, wherein the substance comprises a member of the TGF_β

family.

6. A system as in claim 5, wherein the substance comprises TGF_β

1.

7. A system as in claim 3, wherein the substance augments growth of endothelial cells and/or smooth muscle cells.

8. A system as in claim 7, wherein the substance comprises VEGF, bFGF, PLGF, PDGF, or a combination of these.

9. A system as in claim 1, wherein the surface includes pores.

10. A system as in claim 9, wherein the pores are sized to allow positioning of the cells within the pores.

11. A system as in claim 1, further comprising a substance on the surface which improves adhesion of the plurality of cells to the surface.

12. A system as in claim 11, wherein the substance comprises polymer substrates, biocompatible proteins, growth factors, extracellular matrix components or a combination of any of these.

13. A system as in claim 1, wherein the at least one surface is located on an internal lumen within the at least one microstructure.

14. A system as in claim 13, wherein the plurality of cells comprise cells which are non-autologous to the patient, and wherein the non-autologous cells are disposed within the at least one microstructure so that the non-autologous cells are immunologically isolated from the patient'"'"'s immune system.

15. A system as in claim 1, wherein expansion of the body creates forces which deploy the at least one microstructure from an undeployed position wherein the free end is substantially aligned with an outer surface of the expandable body to a deployed position wherein the free end projects radially outwardly from the expandable body.

16. A system as in claim 1, wherein the plurality of cells comprise smooth muscle cells, autologous smooth muscle cells, non-autologous smooth muscle cells, stem cell derived smooth muscle cells, or smooth muscle progenitor cells.

17. A system as in claim 1, wherein the plurality of cells comprise endothelial cells.

18. A system as in claim 1, wherein the plurality of cells comprise epithelial cells.

19. A system as in claim 1, wherein the plurality of cells comprise stem cell derived cell populations.

20. A system as in claim 1, wherein the plurality of cells comprise embryonic stem cells and/or derivatives of embryonic stem cells.

21. A system as in claim 1, wherein the plurality of cells comprise pancreatic beta cells, myofibroblasts, cardiac myocytes, skeletal muscle satellite cells, dendritic cells, multi-potential somatic stem cells, derivatives of multi-potential somatic stem cells, neuronal cells, glial cells, hepatocytes, or endocrine cells.

22. A system as in claim 1, wherein the plurality of cells are genetically modified.

23. A system as in claim 22, wherein the plurality of cells are genetically modified to over-express endothelial nitric oxide synthase, inducible nitric oxide synthase, TGF_β

1, IL-4, IL-10, IL-13, PDGF, PLGF, VEGF, or a combination of these.

24. A system as in claim 1, wherein the expandable body is sized for positioning within a body lumen having a wall.

25. A system as in claim 24, wherein the free end is projectable radially outwardly from the expandable body a distance sufficient to penetrate the wall of the body lumen.

26. A system as in claim 24, wherein the body lumen comprises a blood vessel.

27. A system as in claim 24, wherein the body lumen is disposed within the gastro-intestinal tract, the pulmonary system, the urinary system or the reproductive system.

28. A system as in claim 1, for repair of an aneurysm in a blood vessel of a patient.

29. A system as in claim 28, wherein the blood vessel comprises a segment of an aorta having two iliac arteries therewith at an aortic bifurcation, and wherein the tube further comprises an opening between the first end and the second end to align with one of the iliac arteries.