Tissue processing apparatus with fluid suction features and methods relating to collecting and processing human biological material

• US 9,950,015 B2
• Filed: 09/23/2015
• Issued: 04/24/2018
• Est. Priority Date: 07/09/2010
• Status: Active Grant

• Current Assignee: GID Bio Incorporated
• Original Assignee: The GID Group, Inc.
• Inventors: Cimino, William W., Katz, Adam J., Llull, Ramon
• Primary Examiner(s): Zalukaeva, Tatyana
• Assistant Examiner(s): WENG, KAI H
• Application Number:
  US14/863,007
• Publication Number:
  US 20160008407A1
• Time in Patent Office: 944 Days
• Field of Search: 4352891
• 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 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 containing adipose, such as 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 an internal 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. The apparatus has fluid suction features including a suction port and a conduit providing fluid communication from the suction port to a location within the filtrate volume within a tapered portion of the internal containment volume, and optionally including a second suction port and a second conduit to a different location in the filtrate volume with the second conduit being configured to permit elevation adjustment within the filtrate volume. Methods include use of the fluid suction features during collection of human biological material and/or post collection.

Claims

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

a filter;

a container having an internal containment volume, 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 above the collection volume;

an inlet port in fluid communication with the tissue retention volume and configured for introducing human biological material comprising adipose 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

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 that is within the tapered portion of the internal containment volume;

the conduit extends through the filtrate volume from adjacent the suction port to the location within the filtrate volume;

the suction port is located above the tapered portion of the internal containment volume and above the collection volume;

the location is within the collection volume;

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;

the suction port passes through the lid;

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°

;

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°

; and

the conduit extends from the suction port through the upper portion of the internal containment volume and into the tapered portion within the lower portion of the internal containment volume.

2. An apparatus according to claim 1, wherein the suction port is configured for access through the suction port from above the container.

3. An apparatus according to claim 1, wherein all access into the internal containment volume is through one or more openings passing through the lid.

4. An apparatus according to claim 1, wherein the filter and the conduit are suspended from the lid.

5. An apparatus according to claim 1, wherein the conduit is disposed entirely within the filtrate volume.

6. An apparatus according to claim 1, 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.

7. An apparatus according to claim 6, wherein the second conduit is configured to permit adjustment of the elevation of the second location within the filtrate volume.

8. An apparatus according to claim 7, wherein the second conduit is translatable through the second suction port to adjust the elevation of the second location within the filtrate volume.

9. An apparatus according to claim 7, wherein the second conduit is configured so that at any extent of adjustment of the second location, the second location is at a higher elevation within the filtrate volume than the first location.

10. An apparatus according to claim 7, wherein the second conduit is configured to permit adjustment of the position of the second location within the filtrate volume at different elevations above the tapered portion of the filtrate volume.

11. An apparatus according to claim 7, wherein the second suction port is configured for access through the second suction port in a vertical direction from above the container.

12. An apparatus according to claim 7, wherein at any said elevation of adjustment, within the internal containment volume the second conduit is disposed only in the filtrate volume.

13. An apparatus according to claim 1, wherein the internal containment volume has a volume in a range of from 100 cubic centimeters to 1500 cubic centimeters.

14. A tissue collection and processing system comprising;

the apparatus according to claim 1, wherein the conduit is a first conduit;

a vacuum system in fluid communication with the suction port of the apparatus and capable of applying suction to the filtrate volume of the apparatus through the first conduit;

a tissue feed conduit in fluid communication with the inlet port of the apparatus to conduct human biological material comprising adipose into the tissue retention volume through the inlet port;

a suction conduit, in fluid communication with the suction port and the vacuum system, to suction fluid through the first conduit from the filtrate volume of the apparatus.

15. A tissue collection and processing system according to claim 14, wherein the tissue feed conduit is in fluid communication with a lipoplasty cannula.

16. A method for collecting human biological material comprising adipose extracted from a human patient during a lipoplasty procedure, the method comprising:

introducing a feed comprising human biological material comprising adipose into an apparatus according to claim 1, the introducing comprising passing the feed through the inlet port into the tissue retention volume;

retaining a retained portion of the feed in the tissue retention volume;

passing a separated portion of the feed through the filter from the tissue retention volume to the filtrate volume; and

during at least a portion of the introducing, removing from the filtrate volume through the conduit and the suction port at least a portion of the separated portion of the feed.

17. A method according to claim 16, wherein the volume of the separated portion of the feed is larger than available processing volume within the filtrate volume.

18. A method for processing human biological material comprising adipose within the internal containment volume of an apparatus according to claim 1, the method comprising:

washing the human biological material with a wash liquid, the washing comprising adding the wash liquid to the internal containment volume of the apparatus to contact the human biological material within the tissue retention volume and passing through the filter and removing from the filtrate volume through the conduit and the suction port at least a portion of the wash liquid along with one or more components washed from the human biological material while retaining washed human biological material in the tissue retention volume.

19. A method according to claim 18, wherein the washing comprises after the adding the wash liquid to the containment volume:

mixing contents in the tissue retention volume;

discontinuing the mixing; and

suctioning the fluids from the filtrate volume through the conduit and the suction port.

20. A method according to claim 18, comprising adding an additive to the washed human biological material in the tissue retention volume.

21. A method according to claim 20, wherein the additive comprises an ingredient for delivery to a patient in a fat graft.

22. A method according to claim 21, wherein the additive comprises a member selected from the group consisting of hormones and stem cells.

23. A method according to claim 21, comprising removing from the tissue retention volume a fat graft composition comprising at least a portion of the washed human biological material and the additive;

and

delivering the fat graft composition to a patient in a fat graft procedure.

24. A method according to claim 23, comprising:

digesting material within the containment volume, the digesting material comprising adding enzyme to the containment volume to contact at least a portion of the washed human biological material within the tissue retention volume, the enzyme being of a type capable of breaking down a portion of the washed human biological material to release target material in a form capable of passing through the filter and

after the digesting, centrifuging the apparatus to prepare in the collection volume a concentrate product comprising the target material.

25. A method according to claim 24, wherein the concentrate product comprises a cell fraction comprising stromal vascular cells from adipose.

26. A method according to claim 24, comprising after the centrifuging, selectively removing the concentrate product from the filtrate volume;

and

wherein after the centrifuging and prior to the selectively removing, the concentrate product is contained in a bottom separated layer or layers disposed within the collection volume, and the selectively removing comprises removing from the filtrate volume other separated layers within the filtrate volume disposed above the bottom separated layer or layers after the centrifuging.

27. A method according to claim 26, wherein:

the suction port is a first suction port and 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;

the apparatus comprises a second conduit extending from the second suction port to a second location within the filtrate volume, with the second conduit being configured to permit adjustment of the elevation of the second location within the filtrate volume; and

the removing from the filtrate volume other separated layers within the filtrate volume disposed above the bottom separated layer or layers comprises removing material of the other separated layers through the second conduit and the second suction port.

28. A method according to claim 27, wherein:

the second conduit is translatable through the second suction port to adjust the elevation of the second location within the filtrate volume; and

the removing material of the other separated layers comprises translating the second conduit through the second suction port to lower an open end of the second conduit within the filtrate volume.