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Last Updated: March 29, 2024

Claims for Patent: 7,514,075


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Summary for Patent: 7,514,075
Title:Systems and methods for separating and concentrating adipose derived stem cells from tissue
Abstract: Systems and methods are described that are used to separate cells from a wide variety of tissues. In particular, automated systems and methods are described that separate regenerative cells, e.g., stem and/or progenitor cells, from adipose tissue. The systems and methods described herein provide rapid and reliable methods of separating and concentrating regenerative cells suitable for re-infusion into a subject.
Inventor(s): Hedrick; Marc H. (Encinitas, CA), Fraser; John K. (San Diego, CA), Schulzki; Michael J. (Rancho Santa Fe, CA), Byrnes; Bobby (Carlsbad, CA), Carlson; Grace (San Francisco, CA), Shanahan; Robert K. (Carlsbad, CA)
Assignee: Cytori Therapeutics, Inc. (San Diego, CA)
Application Number:10/877,822
Patent Claims:1. An automated adipose-derived stem cell processing unit for isolating a concentrated population of cells comprising adipose-derived stem cells from adipose tissue obtained from a subject, wherein said adipose-derived stem cell processing unit is configured to maintain a closed system, comprising: a tissue collection chamber that is configured to receive a first portion of unprocessed adipose tissue from said subject while maintaining a closed system, wherein said tissue collection chamber comprises an aspiration port structured to be coupled to a suction device; a first filter that is disposed within said tissue collection chamber, wherein said first filter is configured to retain a first component of said unprocessed adipose tissue and pass a second component of said unprocessed adipose tissue, such that said first filter substantially separates said first component from said second component, and wherein said first component comprises a cell population that comprises adipose-derived stem cells and said second component comprises lipid, blood, mature adipocytes and saline; a processing chamber that is joined to said tissue collection chamber by a conduit such that a closed system is maintained, wherein said processing chamber comprises a second filter, a centrifuge, or a spinning membrane filter; a programmable processing device capable of communication with said tissue collection chamber and said processing chamber, wherein said processing device operates at least one pump configured to use pressure to control ingress and egress of tissues through said automated adipose-derived stem cell processing unit; and an outlet wherein said outlet is configured to allow the aseptic removal of a concentrated population of cells comprising adipose-derived stem cells obtained from said processing chamber.

2. The automated system of claim 1, wherein said first filter is housed within a filter cage within said tissue collection chamber.

3. The automated adipose-derived stem cell processing unit of claim 1, further comprising a washing solution container joined to said tissue collection chamber by a conduit such that a closed pathway is maintained.

4. The automated system of claim 3, wherein said washing solution container comprises saline.

5. The automated adipose-derived stem cell processing unit of claim 1, wherein said adipose-derived stem cell processing unit further comprises a disaggregation agent container, and wherein said disaggregation agent container comprises a disaggregating agent that is selected from the group consisting of collagenase, trypsin, lipase, hyalurondiase, deoxyribonuclease, Liberase H1, a tissue or cell re-aggregation inhibitor, and pepsin, or any combination thereof.

6. The automated adipose-derived stem cell processing unit of claim 1, wherein said processing chamber comprises a centrifugation chamber that comprises said centrifuge.

7. The automated adipose-derived stem cell processing unit of claim 6, wherein said centrifugation chamber comprises an output chamber that is configured to collect said concentrated population of cells comprising adipose-derived stem cells after centrifugation.

8. The automated adipose-derived stem cell processing unit of claim 7, wherein said output chamber is tilted at a first angle during centrifugation and a second angle during collection of said concentrated population of cells comprising adipose-derived stem cells.

9. The automated adipose-derived stem cell processing unit of claim 8, wherein said output chamber is configured to be manually re-positioned to arrive at the angle for collection of said concentrated population of cells comprising adipose-derived stem cells.

10. The automated adipose-derived stem cell processing unit of claim 1, further comprising a syringe to remove said concentrated population of cells comprising adipose-derived stem cells while maintaining said closed system.

11. The automated adipose-derived stem cell processing unit of claim 1, wherein said processing chamber further comprises a rotating seal configured to facilitate collection of said concentrated population of cells comprising adipose-derived stem cells while maintaining a closed system.

12. The automated adipose-derived stem cell processing unit of claim 11, wherein said rotating seal comprises a rotating shaft, two or more bearings, three or more lip seals, an outer housing, a circular channel and a circular spring.

13. The automated adipose-derived stem cell processing unit of claim 11, wherein said rotating seal is comprised of a rotating shaft, a single rubber seal, an air gasket, one or more spring loaded seals, and two ceramic disks.

14. The automated adipose-derived stem cell processing unit of claim 1, further comprising a waste chamber.

15. The automated adipose-derived stem cell processing unit of claim 14, wherein said waste chamber further comprises a third filter.

16. The automated adipose-derived stem cell processing unit of claim 1, wherein said conduit further comprises at least one sensor.

17. The automated adipose-derived stem cell processing unit of claim 1, wherein said collection chamber and said processing chamber further comprise at least one valve, pump, sensor or combinations thereof.

18. The automated adipose-derived stem cell processing unit of claim 1, wherein said collection chamber, said processing chamber and said conduits are disposable.

19. They automated adipose-derived stem cell processing unit of claim 1, wherein said centrifuge and said processing device are re-usable.

20. The automated adipose-derived stem cell processing unit of claim 1, wherein said centrifuge further comprises a centrifuge motor, a centrifuge motor controller and a centrifuge brake controller.

21. The automated adipose-derived stem cell processing unit of claim 1, further comprising a pump, configured to control the flow of washing agents or disaggregation agents though said adipose-derived stem cell processing unit.

22. The automated adipose-derived stem cell processing unit of claim 1, wherein said at least one pump is a peristaltic pump.

23. The automated adipose-derived stem cell processing unit of claim 1, wherein said at least one pump is re-usable.

24. The automated adipose-derived stem cell processing unit of claim 1, wherein said processing device further comprises a user interface for an user to input parameters into said automated system.

25. The automated adipose-derived stem cell processing unit of claim 1, wherein said processing device further comprises a display screen configured to display instructions that guide a user to input parameters, confirm pre-programmed steps, warn of errors or any combination thereof.

26. The automated adipose-derived stem cell processing unit of claim 1, further comprising a sample chamber configured to receive a second portion of unprocessed adipose tissue from said patient.

27. The automated adipose-derived stem cell processing unit of claim 1, wherein said adipose-derived stem cell processing unit is configured to receive at least one additive while maintaining a closed system.

28. The automated adipose-derived stem cell processing unit of claim 27, wherein said additive is selected from the group consisting of disaggregation agents, growth factors, re-suspension fluids, cell culture reagents, cell expansion reagents, cell preservation reagents and cell modification reagents, or any combination thereof.

29. The automated adipose-derived stem cell processing unit of claim 1, wherein said adipose-derived stem cell processing unit is operably connected to a second unit, wherein said second unit is configured for culturing the concentrated population of cells comprising adipose-derived stem cells.

30. The automated adipose-derived stem cell processing unit of claim 1, wherein said adipose-derived stem cell processing unit comprises at least one filter assembly that is configured to concentrate said population of cells comprising adipose-derived stem cells obtained from said tissue collection chamber.

31. The automated adipose-derived stem cell processing unit of claim 30, wherein said filter assembly comprises a percolative filtration device, a sedimentation device, and/or a percolative filtration device.

32. The automated adipose-derived stem cell processing unit of claim 30, wherein said filter assembly comprises a hollow fiber filtration device.

33. The automated adipose-derived stem cell processing unit of claim 30, wherein said filter assembly comprises an elutriation device.

34. The automated adipose-derived stem cell processing unit of claim 1, wherein said concentrated population of cells comprising adipose-derived stem cells obtained from said processing chamber further comprises adipose-derived progenitor cells.

35. The automated adipose-derived stem cell processing unit of claim 1, wherein the tissue collection chamber is configured to be agitated or rotated.

36. The automated adipose-derived stem cell processing unit of claim 35, wherein said tissue collection chamber is configured to be rotated at an arc of about 40 degrees to about 90 degrees.

37. The automated adipose-derived stem cell processing unit of claim 27, wherein said tissue collection chamber, said processing chamber, or said tissue collection chamber and said processing chamber further comprise at least one port configured to receive said additive while maintaining a closed pathway.

38. The automated adipose-derived stem cell processing unit of claim 27, wherein said at least one additive comprises a first additive and a second additive.

39. The automated adipose-derived stem cell processing unit of claim 38, wherein said unit is configured to receive said first additive prior to said second additive.

40. The automated adipose-derived stem cell processing unit of claim 38, wherein said tissue collection chamber comprises a port configured to receive said first additive, and wherein said processing chamber comprises a port configured to receive said second additive.

41. The automated adipose-derived stem cell processing unit of claim 38, wherein said first additive and said second additive are the same.

42. The automated adipose-derived stem cell processing unit of claim 38, wherein said first additive and said second additive are not the same.

43. The automated adipose-derived stem cell processing unit of claim 5, wherein said disaggregation container comprises a tissue or cell re-aggregation inhibitor.

44. The automated adipose-derived stem cell processing unit of claim 27, wherein said additive comprises a tissue or cell re-aggregation inhibitor.

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