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Last Updated: March 28, 2024

Claims for Patent: 9,144,583


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Summary for Patent: 9,144,583
Title:Cell separation apparatus and methods of use
Abstract: The present invention provides automated devices for use in supporting various cell therapies and tissue engineering methods. The present invention provides an automated cell separation apparatus capable of separating cells from a tissue sample for use in cell therapies and/or tissue engineering. The cell separation apparatus can be used in combination with complementary devices such as cell collection device and/or a sodding apparatus to support various therapies. The automated apparatus includes media and tissue dissociating chemical reservoirs, filters, a cell separator and a perfusion flow loop through a graft chamber which supports a graft substrate or other endovascular device. The present invention further provides methods for using the tissue grafts and cell samples prepared by the devices described herein in a multitude of therapies including revascularization, regeneration and reconstruction of tissues and organs, as well as treatment and prevention of diseases.
Inventor(s): Ariff; Gregory D. (Herndon, VA), Cannon; Thomas (Honolulu, HI), Case; Jennifer L. (Alexandria, VA), Haller; Christian L. (Alexandria, VA), Kosnik; Paul (Honolulu, HI), Luddy; Charles P. (Alexandria, VA), Mauch; Craig A. (Clifton Park, NY), Vossman; Erik (Honolulu, HI), Williams; Stuart K. (Tucson, AZ)
Assignee: Tissue Genesis, Inc. (Honolulu, HI)
Application Number:11/789,188
Patent Claims:1. A cell separation apparatus comprising: a media reservoir; a cell processing device in fluid communication with the media reservoir, via at least one inlet and at least one outlet, the cell processing device having an interior chamber rotatable about a vertical axis that passes through the interior chamber, the interior chamber comprising: a plurality of lobes forming part of the water-tight interior surface of the interior chamber, each extending perpendicularly to the vertical axis; and a spray nozzle within the interior chamber for spraying a pressurized jet of fluid in a direction perpendicular to the vertical axis, the spray nozzle in communication with a rotating coupling and aligned with a support structure to fix its location within the interior chamber, wherein the interior chamber may be rotated around the vertical axis to align each of the lobes with the spray nozzle; wherein the cell processing device is configured to force cells in the interior chamber to move radially outward toward each lobe, such that the lobe collects and maintains cells while the interior chamber is rotating about the vertical axis; at least one pump in fluid communication with the media reservoir and the cell processing device; and at least one valve coupled to the cell processing device, wherein the at least one valve selectively controls fluid flow to and from the device.

2. The apparatus of claim 1, wherein the cell processing device is a centrifuge.

3. The apparatus of claim 1, wherein the cell processing device is disposable.

4. The apparatus of claim 1, wherein the apparatus is modular.

5. The apparatus of claim 1, wherein the apparatus is automated.

6. The apparatus of claim 1, further comprising a heater.

7. The apparatus of claim 1, further comprising a waste reservoir.

8. The apparatus of claim 1, further comprising a tissue dissociating chemical reservoir.

9. The apparatus of claim 8, further comprising a filter between the cell processing device inlet and the tissue dissociating chemical reservoir.

10. The apparatus of claim 9 further comprising at least one valve configured to permit a first fraction of cells from the filter to enter the cell processing device and a second fraction to enter the waste reservoir.

11. The apparatus of claim 1 further comprising a filter between an outlet of the cell processing device and a sterile cell collection device.

12. The apparatus of claim 11, wherein the sterile cell collection device is a syringe.

13. The apparatus of claim 1, wherein the cell processing device further comprises an outer bowl in fluid communication with the interior chamber.

14. The apparatus of claim 13, wherein the interior chamber further comprises an area configured for digestion and an area configured for separation.

15. The apparatus of claim 13, wherein the interior chamber further comprises at least one aperture in communication with the outer bowl.

16. The apparatus of claim 14, wherein the area configured for separation is further configured to optimize the collection of a endothelial cells and minimize collection of non-endothelial cell materials.

17. The apparatus of claim 1, further comprising a lock configured to removably lock the cell processing device to the cell separation apparatus so that the cell processing device is supported by the cell separation apparatus during rotation of the cell processing device.

18. The apparatus of claim 13, wherein the cell processing device further comprises an extraction tube in fluid communication with the interior chamber.

19. The apparatus of claim 1, wherein the rotating coupling further comprises at least one transport tube for use in adding or removing liquid from the interior chamber.

20. The apparatus of claim 1, wherein the at least one pump is an automatic, self-priming pump.

21. The apparatus of claim 1, wherein the at least one valve is a pinch valve.

22. The apparatus of claim 1, further comprising a pinch valve manifold rack.

23. The apparatus of claim 1 further comprising a human-machine interface.

24. The apparatus of claim 1, wherein the apparatus is a handheld apparatus.

25. The apparatus of claim 1, wherein the media is a solution containing a physiological concentration of sodium chloride at physiological pH.

26. The apparatus of claim 1, wherein the media is selected from the group consisting of M199, M199E, PBS, Saline, and Di-Cation Free DPBS.

27. The apparatus of claim 26, wherein the media is M199E.

28. The apparatus of claim 26, wherein the media is buffered physiologic saline.

29. The apparatus of claim 1, wherein the tissue dissociating chemical is collagenase.

30. The apparatus of claim 1, further comprising an electronic graphical display.

31. The apparatus of claim 1, further comprising a bar code scanner.

32. The apparatus of claim 1, further comprising a cell counting device.

33. The apparatus of claim 1, further configured for use with a cell harvesting device.

34. The apparatus of claim 2, wherein the centrifuge comprises a motor mounted within the apparatus using at least one vibration isolation member.

35. The apparatus of claim 34, wherein the vibration isolation member is a pad.

36. The apparatus of claim 1, further comprising a sensor configured to monitor a position of at least one of the lobes with respect to the spray nozzle, wherein the spray nozzle is configured to force the fluid when the sensor indicates that the spray nozzle is facing at least one of the plurality of lobes.

37. A cell separation apparatus comprising: a base; a cell processing device coupled to the base, the cell processing device having a vertically oriented interior chamber rotatable about a vertical axis that passes through the interior chamber, and a plurality of horizontally extending lobes in communication with the interior chamber and extending from the interior chamber body laterally outward from the vertical axis and gradually tapering to terminate at an end point, wherein each lobe collect cells at a respective end point while the interior chamber is rotating about the vertical axis; and a spray nozzle within the interior chamber for spraying a pressurized jet of fluid in a direction perpendicular to the vertical axis, the spray nozzle in communication with a rotating coupling and aligned with a support structure to fix its location within the interior chamber, wherein the interior chamber may be rotated around the vertical axis to align each of the lobes with the spray nozzle.

38. The cell separation apparatus of claim 1, further comprising a centrifuge motor controlled by a computer and configured to indicate the position of the centrifuge bowl.

39. The cell separation apparatus of claim 38, wherein the computer is configured to cause the centrifuge motor to rotate the interior chamber body about the vertical axis so as to align the lobe of each convexity with the spray nozzle.

40. A method comprising: placing a suspension comprising a solid phase composition suspended within a liquid phase within the interior chamber of the cell separation apparatus of claim 37; rotating the interior chamber about the vertical axis, to separate the solid phase from the liquid phase, and to cause the solid phase composition to pack within at least one of the lobes; ceasing rotation of the interior chamber; aligning at least one lobe with the spray nozzle; and spraying a pressurized jet of fluid from the spray nozzle toward said lobe.

41. The method of claim 40, wherein, the solid phase composition comprises cells.

42. The method of claim 40, wherein the pressurized jet of fluid is used to break up the solid phase composition that is packed within said at least one of the lobes.

43. The method of claim 40, wherein the pressurized jet of fluid is used to dislodge the solid phase composition that is packed within said at least one of the lobes, causing it to be carried by gravity into a different location within the interior chamber.

44. The apparatus of claim 17, wherein the lock is a twist-locking mechanism.

45. The apparatus of claim 17, wherein the lock is on a rotating horizontal platform of the cell separation apparatus.

46. The apparatus of claim 45, wherein the platform supports the cell processing apparatus from below, while rotating.

47. The apparatus of claim 37, wherein cell processing device is removably coupled to the base.

48. The apparatus of claim 47, wherein the base rotates with the cell processing device.

49. The apparatus of claim 47, wherein the coupling is a twist-locking mechanism.

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