Method and apparatus for processing adipose tissue

• US 9,206,387 B2
• Filed: 01/11/2013
• Issued: 12/08/2015
• Est. Priority Date: 07/09/2010
• Status: Active Grant

• Current Assignee: GID Bio Incorporated
• Original Assignee: The GID Group, Inc.
• Inventors: Llull, Ramon, Katz, Adam J., Cimino, William W.
• Primary Examiner(s): Deak, Leslie
• Assistant Examiner(s): WENG, KAI H
• Application Number:
  US14/370,694
• Publication Number:
  US 20140363891A1
• Time in Patent Office: 1,061 Days
• US Class Current: 1/1
• CPC Class Codes: A61K 35/12 Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells vaccines or medicinal preparations containing antigens or antibodies A61K39/00
• CPC Class Codes: A61K 35/35 Fat tissue; Adipocytes; Stromal cells; Connective tissues adipose-derived stem cells A61K35/28; collagen A61K38/39
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61M 1/60 Containers for suction drainage, adapted to be used with an external suction source containers not adapted for subjection to vacuum A61M1/69
• CPC Class Codes: A61M 1/63 with means for emptying the suction container, e.g. by interrupting suction
• CPC Class Codes: A61M 1/892 with treatment of the collected fat
• CPC Class Codes: A61M 2202/08 Lipoids
• CPC Class Codes: A61M 2205/75 with filters
• CPC Class Codes: C12M 27/02 Stirrer or mobile mixing elements
• CPC Class Codes: C12M 33/10 by centrifugation centrifuges in general B04B; Cyclones cyclones in general B04C
• CPC Class Codes: C12M 45/09 by enzymatic treatment
• CPC Class Codes: C12N 5/0653 Adipocytes; Adipose tissue
• CPC Class Codes: C12N 5/0667 Adipose-derived stem cells [ADSC]; Adipose stromal stem cells

Abstract

A portable apparatus for collection and processing of human biological material, such as containing adipose extracted during a lipoplasty procedure, is useful for multi-step processing to prepare a concentrated product (e.g., stromal vascular fraction) or a fat graft composition. The apparatus has a container with a containment volume with a tissue retention volume and a filtrate volume separated by a filter and with a tapered portion to a collection volume for collecting concentrate product. Inlet and suction ports provide access to the tissue retention volume and filtrate volume, respectively, and an extraction port provides versatile access for removal of target processed concentrate material or fat graft material, which access may be via a lumen through a rotatable mixer shaft. Access ports may be configured for access only from above the container. A method of processing adipose tissue to concentrate leuko stromal vascular cells includes multi-step processing using a portable container.

Claims

1. An apparatus for collection of human biological material and post-collection processing of collected material, the apparatus being orientable in an access orientation, as oriented in the access orientation the apparatus comprising:

a filter;

a container having an internal containment volume having a volume in a range of from 100 cubic centimeters to 1300 cubic centimeters, the internal containment volume comprising;

a tissue retention volume and a filtrate volume separated by the filter;

a collection volume within the filtrate volume, the collection volume having a bottom elevation corresponding to a bottom elevation of the filtrate volume and a top elevation that is lower than the bottom elevation of the tissue retention volume;

a tapered portion that tapers in a downward direction with at least a portion of the tapered portion being located below the bottom elevation of the tissue retention volume;

an inlet port in fluid communication with the tissue retention volume and configured for introducing human biological material directly into the tissue retention volume;

a suction port in fluid communication with the filtrate volume and providing access to the filtrate volume for suctioning from the filtrate volume components passing through the filter from the tissue retention volume to the filtrate volume; and

an extraction port in fluid communication with the internal containment volume and configured for removing processed biological material from the internal containment volume;

wherein each of the inlet port, the suction port and the extraction port is configured for access therethrough from above the container into the internal containment volume;

a mixing device disposed at least in part within the tissue retention volume for mixing contents within the tissue retention volume, wherein the mixing device comprises a rotatable shaft extending from outside of the internal containment volume to inside of the internal containment volume, wherein the shaft is rotatable about an axis that extends through the collection volume, the apparatus further comprising;

a lumen extending through the rotatable shaft and having a proximal end located outside of the internal containment volume and a distal end located within the internal containment volume, thereby providing access from outside of the internal containment volume to inside of the internal containment volume.

2. An apparatus according to claim 1, wherein the shaft extends through the extraction port and apparatus is configured for advancing a hypodermic needle through the lumen through the extraction port to access the collection volume with an advancing tip of the hypodermic needle.

3. An apparatus according to claim 2, wherein a distal end of the lumen is located above a portion of the filter, so that the advancing tip of a hypodermic needle pierces the filter when the tip of a hypodermic needle is advanced from the distal end of the lumen extraction port into the collection volume.

4. An apparatus according to claim 2, wherein the collection volume includes a nadir and the distal end of the lumen is positioned above the nadir so that the tip of a hypodermic needle inserted through the lumen may be advanced vertically downward to the vicinity of the nadir of the collection volume.

5. An apparatus according to claim 1, wherein the suction port is in fluid communication with the tapered portion of the internal containment volume through a conduit providing fluid communication from the suction port to a location within the filtrate volume and within the tapered portion of the internal containment volume.

6. An apparatus according to claim 5, wherein:

the suction port is a first suction port, the conduit is a first conduit and the location within the filtrate volume is a first location within the filtrate volume;

the apparatus comprises a second suction port through which components passing through the filter from the tissue retention volume to the filtrate volume may be suctioned from the filtrate volume; and

the apparatus comprises a second conduit extending from the second suction port to a second location within the filtrate volume, wherein the second conduit is translatable through the second suction port to adjust an elevation of the second location within the filtrate volume.

7. An apparatus according to claim 1, wherein all access to the internal containment volume is through access ports wherein each said access port is configured for access through the said access port from above the container.

8. An apparatus according to claim 7, wherein each said access port is configured for access through the said access port in a vertical direction from above the container.

9. An apparatus according to claim 1, wherein the container comprises:

a fluid containment shell with an internal cavity portion forming at least a part of the internal containment volume, the internal cavity portion being open to above; and

a lid attached to the shell and disposed to cover from above the internal cavity portion;

wherein, the suction port passes through the lid.

10. An apparatus according to claim 9, wherein all access into the internal containment volume is through one or more openings passing through the lid.

11. An apparatus according to claim 9, wherein the filter is suspended from the lid into the tissue retention volume.

12. An apparatus according to claim 9, wherein:

the shell comprises walls around the internal cavity portion except where the cavity portion is open to above; and

the apparatus is configured with no access into the internal containment volume through the walls of the shell.

13. An apparatus according to claim 9, wherein:

the shell comprises an upper portion having a first wall surface portion defining a corresponding upper portion of the internal containment volume, wherein substantially all of the first wall surface portion has an incline relative to horizontal of at least 75°

; and

the shell comprises a lower portion located below the upper portion and having a second wall surface portion defining a corresponding lower portion of the internal containment volume, the lower portion comprising a tapered wall surface portion defining the tapered portion of the internal containment volume, substantially all of the tapered wall surface portion having an incline relative to horizontal in a range of from 30°

to 60°

.

14. An apparatus according to claim 13, wherein the tapered portion of the internal containment volume occupies substantially the entire lower portion of the internal containment volume.

15. An apparatus according to claim 1, wherein the tapered portion of the internal containment volume has a tapered portion nadir corresponding with a bottom elevation of the internal containment volume.

16. An apparatus according to claim 1, wherein the internal containment volume has an available processing volume for receiving and processing fluids and the available processing volume is at least 100 cubic centimeters and is no larger than 1000 cubic centimeters.

17. An apparatus according to claim 16, wherein the collection volume comprises no more than 5 percent of the available processing volume.

18. An apparatus according to claim 17, wherein the tissue retention volume comprises at least 70 percent of the available processing volume.

19. An apparatus according to claim 1, wherein the collection volume is no larger than 30 cubic centimeters.

20. An apparatus according to claim 1, wherein the apparatus is containable within a first envelope volume defined by a rectangular cuboid having a length dimension of no more than 16 centimeters, a depth dimension of no more than 15 centimeters and a height dimension of no more than 18 centimeters.

21. An apparatus according to claim 20, wherein the apparatus is not containable within a second envelope volume defined by a rectangular cuboid having any one of a length dimension, depth dimension or height dimension that is smaller than 10 centimeters.

22. An apparatus according to claim 1, wherein the filter has a separation size in a range of from 70 microns to 800 microns.

23. An apparatus according to claim 1, wherein the apparatus is configured to be received by a centrifuge for centrifuging.

24. An apparatus according to claim 1, comprising human biological material disposed within the internal containment volume.

25. An apparatus according to claim 1, comprising, disposed within the in the collection volume, a stromal vascular fraction from adipose tissue.

26. An apparatus according to claim 1, wherein the shaft comprises a handle interface outside of the internal containment volume;

and

the apparatus comprises a handle interfaced to the handle interface, wherein rotating the handle causes the shaft to rotate.

27. An apparatus according to claim 1, further comprising a removable plug disposed in a proximal end of the lumen, wherein the removable plug seals the lumen.

28. An apparatus according to claim 1, wherein the lumen provides access to the collection volume for aspiration therefrom and injection thereto.

29. An apparatus according to claim 1, wherein the mixing device comprises at least one mixing member disposed in the tissue retention volume and connected with the shaft, wherein the at least one mixing member moves through the tissue retention volume when the shaft is rotated.

30. An apparatus according to claim 29, wherein at least a portion of the tissue retention volume is within the tapered portion of the internal containment volume and at least a portion of the at least one mixing member is disposed within the tapered portion of the internal containment volume.

31. An apparatus according to claim 30, wherein when the mixing device comprises a filter contact member that moves when the shaft is rotated, the filter contact member contacting the filter at least periodically when the shaft is rotated.

32. An apparatus according to claim 31, wherein when the shaft is rotated, the filter contact member continuously contacts the filter.

33. An apparatus according to claim 1, wherein the apparatus is configured for advancing a hypodermic needle through the lumen and out of the distal end of the lumen to access the collection volume with an advancing tip of the hypodermic needle, wherein the distal end of the lumen is located in the tissue retention volume above a portion of the filter so that the advancing tip of the hypodermic needle pierces the filter when the tip of the hypodermic needle exits the distal end of the lumen and is advanced from the distal end of the lumen into the collection volume, and wherein the collection volume includes a nadir and an axis of the lumen is aligned so that the tip of a hypodermic needle exiting the distal end of the lumen may be advanced to the vicinity of the nadir of the collection volume.