Seeding implantable medical devices with cells

• US 20060199265A1
• Filed: 03/02/2005
• Published: 09/07/2006
• Est. Priority Date: 03/02/2005
• Status: Abandoned Application

• Current Assignee: Kips Bay Medical, Inc.
• Original Assignee: Kips Bay Medical, Inc.
• Inventors: Wolf, Michael F., Trescony, Paul V., Yunker, Laurie A.
• Application Number:
  US11/071,597
• Publication Number:
  US 20060199265A1
• Time in Patent Office: Days
• US Class Current: 435/395
• CPC Class Codes: A61F 2/062 Apparatus for the production of blood vessels made from natural tissue or with layers of living cells prostheses made from natural tissue or living cells A61L27/507
• CPC Class Codes: A61L 27/16 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/3808 Endothelial cells
• CPC Class Codes: A61L 27/507 for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062
• CPC Class Codes: C08L 27/18 Homopolymers or copolymers or tetrafluoroethene
• CPC Class Codes: Y10S 623/915 Method or apparatus for preparing biological material
• CPC Class Codes: Y10S 623/916 Blood vessel

Abstract

The invention is directed to apparatus and methods for seeding an implantable medical device, such as a vascular prosthesis, with cells, such as endothelial cells. The invention supports techniques for seeding a luminal surface of the device with axial centrifugation. Cells are introduced in suspension into the lumen of the device, and the device is subjected to centrifugation around a longitudinal axis defined by the lumen. Axial centrifugation causes the cells to concentrate toward the luminal surface. Shortly after axial centrifugation, the seeded device can be presented for implantation in a patient.

Claims

1. A method for seeding cells comprising:

introducing cells into a lumen of an implantable medical device adapted to be implanted in a living body, wherein the lumen comprises a luminal surface comprising expanded polytetrafluoroethylene and wherein the lumen defines a longitudinal axis; and

applying centrifugation to the implantable medical device to rotate the implantable medical device around the axis.

2. The method of claim 1, further comprising placing the implantable medical device in a protective sleeve prior to introducing the cells.

3. The method of claim 1, further comprising delivering the implantable medical device for implantation in the living body after centrifugation.

4. The method of claim 3, further comprising incubating the implantable medical device after centrifugation and before delivering the implantable medical device for implantation in the living body.

5. The method of claim 4, wherein the incubating occurs for about five minutes to about two hours.

6. The method of claim 1, further comprising:

wetting the luminal surface with a wetting agent;

placing a growth medium on the luminal surface, the growth medium supplanting the wetting agent; and

introducing the cells after the growth medium is placed on the luminal surface.

7. The method of claim 1, wherein applying centrifugation to the implantable medical device comprises applying centrifugation for about 250 g to about 500 g to the luminal surface for about one to about ten minutes.

8. The method of claim 1, wherein applying centrifugation to the implantable medical device comprises applying between about 1 g and about 10,000 g.

9. The method of claim 1, wherein the cells are endothelial cells.

10. The method of claim 1, further comprising:

placing the implantable medical device in a tube prior to introducing the cells, the tube comprising at least one open end;

introducing the cells into the lumen through the open end of the tube; and

sealing the open end of the tube with a plug.

11. The method of claim 10, further comprising loading the sealed tube into a centrifuge.

12. The method of claim 1, wherein the implantable medical device comprises a vascular prosthesis.

13. The method of claim 1, wherein the implantable medical device comprises a mechanical heart valve, a bioprosthetic heart valve, a coronary stent, a stent graft or an AAA graft.

14. The method of claim 1, wherein the surface comprising expanded polytetrafluoroethylene comprises nodes formed of polytetrafluoroethylene, and wherein the surface includes recesses defined by nodes lifted from the surface.

15. A method for seeding cells comprising:

introducing cells into a lumen of an implantable medical device adapted to be implanted in a living body, wherein the lumen includes a luminal surface having recesses defined by nodes lifted from the surface, and wherein the lumen defines a longitudinal axis; and

applying centrifugation to the implantable medical device to rotate the implantable medical device around the axis.

16. The method of claim 15, wherein the luminal surface comprises expanded polytetrafluoroethylene.

17. The method of claim 16, wherein the surface comprising expanded polytetrafluoroethylene comprises nodes formed of polytetrafluoroethylene, and wherein the surface includes recesses defined by nodes lifted from the surface.

18. The method of claim 15, further comprising placing the implantable medical device in a protective sleeve prior to introducing the cells.

19. The method of claim 15, wherein applying centrifugation to the implantable medical device comprises applying centrifugation for about 250 g to about 500 g to the luminal surface for about one to about ten minutes.

20. The method of claim 15, wherein applying centrifugation to the implantable medical device comprises applying centrifugation for about 1 g to about 10,000 g.

21. The method of claim 15, further comprising:

incubating the implantable medical device after centrifugation; and

delivering the implantable medical device for implantation in the living body.

22. The method of claim 15, wherein the implantable medical device comprises a vascular prosthesis.

23. The method of claim 15, wherein the implantable medical device comprises a mechanical heart valve, a bioprosthetic heart valve, a coronary stent, a stent graft or an AAA graft.

24. An apparatus to apply centrifugation to an implantable medical device comprising:

an adapter configured to mate with a rotor of a centrifuge proximate to an axis of rotation of the rotor, the adapter comprising a chamber that extends in the direction of the axis;

a tube configured to receive the implantable medical device, and further configured to be received in the chamber, the tube including an open end; and

a plug configured to seal the open end of the tube.

25. The apparatus of claim 24, further comprising a cap configured to mate removably with the adapter to seal the tube in the chamber.

26. The apparatus of claim 25, wherein the cap is configured to bear against the plug when the tube is in the chamber, the plug sealing the tube and the cap sealing the chamber.

27. The apparatus of claim 24, further comprising a fixation mechanism configured to secure the adapter to the rotor.

28. The apparatus of claim 24, wherein the tube is configured to receive a vascular prosthesis.

29. The apparatus of claim 24, wherein the tube is configured to receive a mechanical heart valve, a bioprosthetic heart valve, a coronary stent, a stent graft or an AAA graft.

30. The apparatus of claim 24, wherein the chamber defines a height that extends in the direction of the axis, and wherein the height is less than about 22 cm.

31. An apparatus to apply centrifugation to an implantable medical device comprising:

an adapter means configured to mate with a rotor of a centrifuge proximate to an axis of rotation of the rotor, the adapter comprising a chamber; and

a container means configured to receive the implantable medical device, and further configured to be received in the chamber.

32. The apparatus of claim 31, further comprising a sealing means configured to seal the implantable medical device inside the container means.